500mg vials (with diluent)

Approved for use in line with NECN Extravasation Policy – only through specialist Cancer Centre

Commissioner: NHS England – Anthracycline Extravasation - Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

15mg tablets
3mg, 15mg, 30mg & 300mg injections

For Methotrexate-Induced Mucositis and Myelosuppression

1g in 10ml injection; 400mg tablets

For Urothelial Toxicity 

25mg & 100mg injections

Commissioner: NHS England 

Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm. 

Approved for use in accordance with the following NICE TA: 

TA216: Bendamustine for the first-line treatment of chronic lymphocytic leukaemia

The following indications are funded through Cancer Drugs Fund

Treatment of low grade lymphomas, mantle cell NHL or relapsed multiple myeloma.

MHRA Drug Safety Update (July 2017):  Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation

2mg tablets; 25mg capsules u
60mg in 10ml inj

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved: NICE TA121

2mg tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

50mg tablets
1g injection

For treatment of inflammatory conditions unresponsive to other agents, only in accordance with a locally agreed drug protocol.

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

140mg capsules

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

1g and 2g powder for concentrate for solution for injection vials

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

10mg u & 40mg capsules

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

2mg tablets; 50mg injection

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

1g and 5g powder for solution for injection

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA640: Treosulfan with fludarabine for malignant disease before allogeneic stem cell transplant

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

15,000 units injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

MHRA Drug Safety Update (July 2020): Liposomal and lipid-complex formulations: name change to reduce medication errors

50mg injection
20mg & 50mg pegylated liposomal injection

Commissioner: NHS England

Approved for use in accordance with the following NICE TA OR if indication funded from the Cancer Drugs Fund.

NICE TA389: as a monotherapy treatment option or in combination with platinum for recurrent ovarian cancer

MHRA Drug Safety Update (July 2020): Liposomal and lipid-complex formulations: name change to reduce medication errors

50mg injection

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

5mg & 10mg capsules

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

10mg, 20mg & 40mg injections

0.04% preservative free eye drops (unlicensed)

Intravenous Injection
Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Bladder Installation
Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Opthalmic Use (injection or drops)
Only prescribed by a consultant ophthalmologist for use in theatre.

20mg in 10ml injection

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

29mg powder for concentrate for solution for infusion

Commissioner: NHS England

Approved for use in accordance with the following NICE TA

NICE TA306: as a monotherapy treatment option for adults with multiply relapsed or refractory aggressive non-Hodgkin's B‑cell lymphoma under the conditions specified within the TA.

100mg vial

Commissioner: NHS England

Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA:

NICE TA218: as a treatment option for adults who are not eligible for haematopoietic stem cell transplantation under conditions specified within the TA.

Not approved for use in accordance with the following NICE TA:

NICE TA399: as a treatment option for acute myeloid leukaemia with more than 30% bone marrow blasts in patients aged 65 years or older who are not eligible for haematopoietic stem cell transplant.

150mg, 300mg & 500mg tablets

Commissioner: NHS England

Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs:

NICE TA61: as a first-line treatment option in combination with folinic acid for metastatic colorectal cancer.

NICE TA100: as a monotherapy adjuvant treatment option for stage III (Dukes' C) colon cancer following surgery

NICE TA191: as a first-line treatment option in combination with platinum-based regimen for inoperable advanced gastric cancer

Not approved for use in accordance with the following NICE TAs

NICE TA263: as a first-line treatment option in combination with bevacizumab for metastatic breast cancer

MHRA Drug Safety Update January 2014: Capecitabine: risk of severe skin reactions - discontinue treatment

MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

10mg in 10ml solution for preparing infusions,
2mg in 1ml subcutaneous injection

10mg tablets

NHS England – Multiple Sclerosis - as per NICE TA616

NHS England - not routinely commissioned - Pulmonary Langerhans Histiocytosis

Litak formulation
Commissioner: NHS England - Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

MHRA Drug Safety Alert (Dec 2017):  Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected 

Commissioner: NHS England - Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm OR if indication funded from the Cancer Drugs Fund.

100mg in 5ml & 1g in 10ml injections
50mg vial- Intrathecal injection , cytarabine encapsulated in liposomes

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Intravenous injections only
Intravenous administration would normally only be part of Level 2 or higher haematology protocols and should be undertaken at a specialist haematology centre.
50mg vial intrathecal injection , cytarabine encapsulated in liposomes
Prescribing MUST be in accordance with intrathecal prescribing policies.

MHRA Drug Safety Update (July 2020): Liposomal and lipid-complex formulations: name change to reduce medication errors

10mg tablets

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA

NICE TA29: as a second-line treatment option for B-cell chronic lymphocytic leukaemia (CLL) under conditions specified within the TA.

2.5g in 50ml & 2.5g in 100ml injections

10mg in 0.4ml subconjunctival injection u

Intravenous injection or infusion
Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

For ophthalmic use
Only when prescribed by a consultant ophthalmologist for use in opthalmology theatre.

MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

200mg & 1g & 2g injection

Commissioner: NHS England - Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs

NICE TA116: as a treatment option for metastatic breast cancer only when docetaxel monotherapy or docetaxel plus capecitabine are also considered appropriate.

NICE TA389: as a treatment option in combination with carboplatin for first recurrence of platinum‑sensitive ovarian cancer:

The following indication is funded via Cancer Drugs Fund

NG85: treatment of untreated metastatic pancreatic cancer only if other combination chemotherapies are unsuitable and they would otherwise have gemcitabine monotherapy.

50mg tablets

Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

AMBER when used for inflammatory bowel disease (see chapter 1) 

2.5mg tablets
10mg in 5ml oral solution u
Injections (various strengths) – including prefilled syringesu
5mg in 2ml intrathecal injection

For medical management of ectopic pregnancy / pregnancy of unknown origin only where prescribed by a consultant obstetrician.

Otherwise only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

When prescribed as intrathecal chemotherapy only in accordance with intrathecal prescribing policies.

AMBER when used in chronic inflammatory conditions, e.g. Crohn’s disease, rheumatoid arthritis. Prescriptions will be for ONCE WEEKLY administration ONLY.

(Note Subcutaneous injection in chronic inflammatory conditions is RED drug in Tees)

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

100mg & 500mg injection

Commissioner: NHS England 

Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs:

NICE TA135:  as a treatment option for malignant pleural mesothelioma only in people who have a World Health Organization (WHO) performance status of 0 or 1, who are considered to have advanced disease and for whom surgical resection is considered inappropriate.

NICE TA181: as a first-line treatment option in combination with cisplatin  for locally advanced or metastatic non-small-cell lung cancer (NSCLC) only if the histology of the tumour has been confirmed as adenocarcinoma or large-cell carcinoma.

NICE TA190: as a maintenance treatment option for locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology if disease has not progressed immediately following platinum-based chemotherapy in combination with gemcitabine, paclitaxel or docetaxel.

NICE TA402: as a maintenance treatment option for locally advanced or metastatic non‑squamous non‑small‑cell lung cancer in adults under conditions specified within the TA.

Not recommended for use in accordance with the following NICE TA:

NICE TA124: as a treatment option for locally advanced or metastatic small-cell lung cancer.

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Teysuno^®

^{MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity}

Uftoral®

MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

15mg/6.14mg & 20mg/8.19mg film-coated tablets

Commissioner – NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA:

NICE TA405: as a treatment option for metastatic colorectal cancer under conditions specified within the TA

50mg & 100mg capsules
100mg in 5ml & 500mg in 25ml injections

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

10mg injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Administration MUST be by the intravenous route only. Infusions MUST be diluted to 50ml.

2mg in 2ml injection
2mg in 20ml prefilled syringe
2mg in 50ml infusion bags

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Administration MUST be by the intravenous route only. Infusions MUST be diluted to 50ml.

5mg injection

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Administration MUST be by the intravenous route only. Infusions MUST be diluted to 50ml

NHSE Commissioned

Not Approved: NICE TA272

20mg, 30mg and 80mg capsules
10mg in 1ml & 50mg in 5ml injections

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Administration MUST be by the intravenous or oral route only. Infusions MUST be diluted to 50ml.

ORAL doses are not equivalent to intravenous.

50mg, 100mg and 150mg film coated tablets

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA563: Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
• NICE TA579: Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

5mg in 1ml powder for suspension for infusion

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA:

NICE TA476: as a treatment option for untreated metastatic adenocarcinoma of the pancreas in adults, under the conditions specified within the TA

Not approved in accordance with the following NICE TA:

TA362: as a treatment option for adults with untreated non‑small‑cell lung cancer when potentially curative surgery or radiation therapy or both are unsuitable.

20mg, 30mg, 40mg, 50mg film coated tablets

Commissioner: NHS England

Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA

NICE TA310: as a treatment option in adults with locally advanced or metastatic non-small-cell lung cancer only if:

• the tumour tests positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and
• the person has not previously had an EGFR-TK inhibitor and
• the manufacturer provides afatinib with the discount agreed in the patient access scheme.

40mg/ml solution for injection

25mg/ml concentrate for solution for infusion ▼

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Not approved in accordance with the following NICE TA:

NICE TA307: as a treatement option in combination with irinotecan and fluorouracil for metastatic colorectal cancer that is resistant to or has progressed after an oxaliplatin-containing regimen.

MHRA Drug Safety Update (April 2016): Aflibercept (Zaltrap▼): minimising the risk of osteonecrosis of the jaw

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

150mg capsules

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA536: Alectinib for untreated ALK-positive advanced non-small-cell lung cancer

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

1mg/ml conc for soln for infusion.

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA526: recommended, within its marketing authorisation, as an option for inducing remission and consolidation in acute promyelocytic leukaemia (characterised by the presence of the t[15;17] translocation or the PML/RAR-alpha gene) in adults with untreated, low-to-intermediate risk disease (defined as a white blood cell count of 10x103 per microlitre or less), when given with all-trans-retinoic acid (ATRA) relapsed or refractory disease, after a retinoid and chemotherapy.

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

YESCARTA 0.4 – 2 x 108 cells dispersion for infusion.

YESCARTA (axicabtagene ciloleucel) is a CD19-directed genetically modified autologous T cell immunotherapy. To prepare YESCARTA, patient's own T cells are harvested and genetically modified ex vivo by retroviral transduction to express a chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (scFv) linked to CD28 and CD3-zeta co-stimulatory domains. The anti-CD19 CAR-positive viable T cells are expanded and infused back into the patient, where they can recognize and eliminate CD19-expressing target cells.

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :
• NICE TA559: Axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

1mg, 3mg, 5mg and 7mg film coated tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA:

NICE TA333: as a treatment option for adults with advanced renal cell carcinoma after failure of treatment with a first‑line tyrosine kinase inhibitor or a cytokine, only if the company provides axitinib with the discount agreed in the patient access scheme.

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

For ophthalmological uses in accordance with NTAG recommendations (see chapter 11)

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Various indications funded via Cancer Drugs Fund

Not approved for use in accordance with the following NICE TAs:

NICE TA285: as a treatment option for first recurrence of platinum-sensitive advanced ovarian cancer (including fallopian tube and primary peritoneal cancer) who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents.

NICE TA284: as a first-line treatment option for advanced ovarian cancer in combination with paclitaxel and carboplatin.

NICE TA353: as a treatment option for relapsed, platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal cancer because no evidence submission was received from Roche Products for the technology.

NICE TA436: as a treatment option for epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer because no evidence submission was received from Roche for the technology.

NICE TA560: Bevacizumab with carboplatin, gemcitabine and paclitaxel for treating the first recurrence of platinum-sensitive advanced ovarian cancer (terminated appraisal)

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

Commissioner: NHS England 

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

3.5mg injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA228: in combination with an alkylating agent and a corticosteroid as a treatment option for the first-line treatment of multiple myeloma under the circumstances specified within the TA
• NICE TA129: as a treatment option for progressive multiple myeloma in people who are at first relapse having received one prior therapy and who have undergone, or are unsuitable for, bone marrow transplantation, under the circumstances specified within the TA.
• NICE TA311: as an induction treatment option in combination with dexamethasone, or with dexamethasone and thalidomide, in adults with previously untreated multiple myeloma, who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
• NICE TA370: as a treatment option for previously untreated mantle cell lymphoma in adults for whom haematopoietic stem cell transplantation is unsuitable

100mg and 500mg film-coated tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

NICE TA401: as a treatment option for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults, when:

• they have previously had 1 or more tyrosine kinase inhibitor and
• imatinib, nilotinib and dasatinib are not appropriate and
• the company provides bosutinib with the discount agreed in the patient access scheme (as revised in 2016).

Not approved in accordance with the following NICE TAs:

• NICE TA576: Bosutinib for untreated chronic myeloid leukaemia (terminated appraisal)

MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund:

• NICE TA446: as a treatment option for CD30-positive Hodgkin lymphoma in adults under the conditions specified within the TA.
• NICE TA478: as a treatment option for relapsed or refractory systemic anaplastic large cell lymphoma in adults under the conditions specified within the TA.
• NICE TA524: recommended as an option for treating CD30‑positive Hodgkin lymphoma in adults with relapsed or refractory disease, only if they have already had autologous stem cell transplant or they have already had at least 2 previous therapies when autologous stem cell transplant or multi-agent chemotherapy are not suitable.
• NICE TA577: Brentuximab vedotin for treating CD30-positive cutaneous T-cell lymphoma
• NICE TA641: Brentuximab vedotin in combination for untreated systemic anaplastic large cell lymphoma

Not approved in accordance with the following NICE TAs:

• NICE TA594: Brentuximab vedotin for untreated advanced Hodgkin lymphoma (terminated appraisal)

30mg, 90mg and 180mg film coated tablets 

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

40mg/1ml concentrate for IV infusion

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA

NICE TA391: as a treatment option in combination with prednisone or prednisolone for metastatic hormone‑relapsed prostate cancer in people whose disease has progressed during or after docetaxel chemotherapy under the circumstances specified within the TA.

MHRA Drug Safety Update (Nov 2013): Cabazitaxel - risk of medication error resulting in overdose.  .

20mg, 40mg and 60mg tablets

20mg and 80mg capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA

• NICE TA463: as a treatment option for treating advanced renal cell carcinoma in adults after vascular endothelial growth factor (VEGF)-targeted therapy, only if the company provides cabozantinib with the discount agreed in the patient access scheme.
• NICE TA516: as an option for treating progressive medullary thyroid cancer in adults with unresectable, locally advanced or metastatic disease, only if the company provides cabozantinib with the discount agreed in the patient access scheme.
• NICE TA542: Cabozantinib for untreated advanced renal cell carcinoma

Not approved in accordance with the following NICE TAs:

• NICE TA582: Cabozantinib for previously treated advanced hepatocellular carcinoma (terminated appraisal)

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

50mg in 5ml & 450mg in 45ml injections

Commissioner: NHS England      

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

10 mg powder for solution for infusion
30 mg powder for solution for infusion
60 mg powder for solution for infusion

Commissioner: NHS England

Approved for use in accordance with the following NICE TA:

• NICE TA457: as a treatment option in combination with dexamethasone for multiple myeloma in adults under the circumstances specified within the TA
• NICE TA657: Carfilzomib for previously treated multiple myeloma

MHRA Drug Safety Update (Aug 2019): Carfilzomib (Kyprolis▼): reminder of risk of potentially fatal cardiac events

MHRA Drug Safety Update (Dec 2019): Carfilzomib (Kyprolis▼): risk of reactivation of hepatitis B virus

350mg concentrate for solution for infusion

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA592: Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

150mg capsule

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs

NICE TA395:  as a treatment option for advanced anaplastic lymphoma kinase positive non‑small‑cell lung cancer in adults who have previously had crizotinib.only if the company provides it with a discount agrees in patient access scheme

NICE TA500: as a treatment option for untreated anaplastic lymphoma kinase (ALK)‑positive advanced non-small-cell lung cancer in adults, only if the company provides it with the discount agreed in the patient access scheme.

100mg in 20ml & 500mg in 100ml vials for IV infusion

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs

• NICE TA145: as a treatment option in combination for radiotherapy for locally advanced squamous cell cancer of head and neck in patients who have a Karnofsky performance status of 90% or greater and when all forms of platinum based chemoradiotherapy are contraindicated. Patients are referred to tertiary centre for treatment
• NICE TA439: as a treatment option for previously untreated EGFR-expressing, RAS wild-type metastatic colorectal cancer in combination with FOLFOX or FOLFIRI regimes only if companies provide them with discount under the commercial access scheme.
• NICE TA473:  as a treatment option in combination with platinum-based chemotherapy for recurrent or metastatic squamous cell cancer of head and neck under conditions specified within the TA.

Not approved for use in accordance with the following NICE TA

NICE TA242: as a treatment option for monotherapy or combination therapy for metastatic colorectal cancer that has progressed after first-line chemotherapy.

MHRA Alerts

• May 2012: Risk of keratitis and ulcerative keratitis.
• February 2014: Importance of determining RAS mutation status in metastatic colorectal cancer

50mg in 50mL injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Not approved for use in accordance with the following NICE TA

NICE TA414: as a treatment option for unresectable or metastatic melanoma in adults with a BRAF V600 mutation.

200mg and 250mg capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs

• NICE TA406: as a treatment option for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer in adults only if the company provides it with the discount agreed in the patient access scheme.
• NICE TA422: as a treatment option for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer in adults only if the company provides it with the discount agreed in the patient access scheme.
• NICE TA529: Crizotinib is recommended for use within the Cancer Drugs Fund as an option for treating ROS1‑positive advanced non-small-cell lung cancer (NSCLC) in adults, only if the conditions in the managed access agreement are followed.

MHRA Drug Safety Update November 2015: Risk of cardiac failure

50mg and 75mg capsules

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma

Not approved in accordance with the following NICE TAs:

• NICE TA564: Dabrafenib with trametinib for treating advanced metastatic BRAF V600E mutation-positive non-small-cell lung cancer (terminated appraisal)

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

500mg injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

15mg, 30mg, and 45mg film coated tablets

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA595: Dacomitinib for untreated EGFR mutation-positive non-small-cell lung cancer

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

20mg/ml solution for infusion

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA

• NICE TA510: Daratumumab monotherapy for treating relapsed and refractory multiple myeloma
• NICE TA573: Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma

Not approved in accordance with the following NICE TAs:

• NICE TA634: Daratumumab with lenalidomide and dexamethasone for untreated multiple myeloma (terminated appraisal)

MHRA Drug Safety Update (Aug 2019): Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus

20mg,50mg, 80mg, 100mg and 140mg film-coated tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs or in indication funded from Cancer Drugs Fund:              

• NICE TA425: as a treatment option for chronic or accelerated phase Philadelphia-chromosome-positive CML in adults, if they cannot have imatinib, or their disease is imatinib-resistant and the manufacturer provides dasatinib with the discount agreed in the patient access scheme.
• NICE TA426: as a treatment option for chronic phase Philadelphia-chromosome-positive CML, only if the manufacturer provides it with the discount agreed in the patient access scheme.

MHRA Alerts

May 2016: BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation

Daunorubicin/cytarabine 44mg/100mg powder for conc for soln for inf in vial

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :
• NICE TA552: Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

20mg & 80mg injections

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs

• NICE TA101: as a treatment option for hormone-refractory metastatic prostate cancer only if the Karnofsky performance-status score is at least 60%
• NICE TA109: as a treatment option in combination with doxorubicin and cyclophosphamide for adjuvant treatment of women with early node-positive breast cance

50mg/ml conc for solution for infusion

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA578: Durvalumab for treating locally advanced unresectable non-small-cell lung cancer after platinum-based chemoradiation

Not approved in accordance with the following NICE TAs:

• NICE TA662: Durvalumab in combination for untreated extensive-stage small-cell lung cancer (terminated appraisal)

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

50mg and 75mg capsules

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma 

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

0.44mg/ml solution for injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA or if indication funded through Cancer Drugs Fund

NICE TA423: as a treatment option for locally advanced or metastatic breast cancer under the conditions specified within the TA

Not approved for use in accordance with the following NICE TA

NICE TA515: as a treatment option for locally advanced or metastatic breast cancer in adults who have had only 1 chemotherapy regimen

25mg, 100mg & 150mg tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs

• NICE TA258: as a treatment option for first-line treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) under the conditions specified within the TA.
• NICE TA374: as a treatment option for locally advanced or metastatic non‑small‑cell lung cancer that has progressed after non‑targeted chemotherapy in patients with tumours of unknown epidermal growth factor receptor tyrosine kinase (EGFR‑TK) mutation status, only if all of the criteria specified within the TA are met

Not approved for use in accordance with the following NICE TA

NICE TA227: as a maintenance treatment option in people with locally advanced or metastatic non-small-cell lung cancer who have stable disease after platinum-based first-line chemotherapy

Roche Healthcare Professional Letter (January 2016): Tarceva® (erlotinib): First line maintenance indication now restricted to treatment of patients whose tumors harbor an EGFR-activating mutation

2.5mg, 5mg and 10mg tablets

2mg, 3mg and 5mg dispersible tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs 

• NICE TA421: as a treatment option in combination with exemestane for advanced human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor-positive breast cancer in postmenopausal women without symptomatic visceral disease that has recurred or progressed after a non-steroidal aromatase inhibitor. Condition of discount in accordance with local access schemes as specified within the TA applies.
• NICE TA432: as a treatment option for advanced renal cell carcinoma that has progressed during or after treatment with vascular endothelial growth factor targeted therapy, only if the company provides it with the discount agreed in the patient access scheme.
• NICE TA449: as a treatment option for the indications specified within the TA only when the company provides it with discount agreed in the patient access scheme.
• NICE TA498: as a treatment option along with lenvatinib for advanced renal cell carcinoma in adults who have had 1 previous vascular endothelial growth factor (VEGF)-targeted therapy, only if their Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1 and the company provides lenvatinib with the discount agreed in the patient access scheme.

Everolimus for the following indications is not routinely commissioned by NHS England

• Preventing organ rejection in liver transplantation
• Preventing organ rejection in heart transplantation

250mg tablets

Commissioner: NHS England once if used in accordance with NICE TA192

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA192: as a first-line treatment option for locally advanced or metastatic non-small-cell lung cancer (NSCLC) if the conditions specified within the TA are met.

Not approved for use in accordance with the following NICE TA

NICE TA374: as a treatment option for locally advanced or metastatic non‑small‑cell lung cancer that has progressed after non‑targeted chemotherapy in people with tumours that are EGFR‑TK mutation‑positive.

5mg powder for conc for soln for infusion

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :
• NICE TA545: Gemtuzumab ozogamicin for untreated acute myeloid leukaemia

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

100mg and 1000mg tablets

500mg capsules

500mg in 5ml suspension u

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

AMBER when used to treat non-malignant conditions in accordance with a clearly documented shared care protocol. https://medicines.necsu.nhs.uk/download/county-durham-and-darlington-hydroxycarbamide-hydroxyurea-shared-care-guideline/

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm 

Approved for use in accordance with the following NICE TAs or if indication funded from the Cancer Drugs Fund 

• NICE TA429: as atreatment option for chronic lymphocytic leukaemia in adults with 17p deletion or TP53 mutation under the conditions specified within the TA
• NICE TA491: as a treatment option for Waldenstrom’s macroglobulinaemia in adults under the conditions specified within the TA. This indication is funded through Cancer Drugs Fund.
• NICE TA502: as an option for treating relapsed or refractory mantle cell lymphoma in adults under the conditions specified within the TA.

Not approved for use in accordance with the following NICE TAs 

• NICE TA437: as a treatment option with bendamustine and rituximab for relapsed or refractory chronic lymphocytic leukaemia after systemic therapy. NICE unable to make a recommendation as no eveidence submission was received from Jannssen-Cilag.
• NICE TA452: as a treatment option for untreated chronic lymphocytic leukaemia without a 17p deletion or TP53 mutation because no evidence submission was received from Janssen–Cilag. The company has confirmed that it does not intend to make a submission.
• NICE TA608: Ibrutinib with rituximab for treating Waldenstrom’s macroglobulinaemia (terminated appraisal)

MHRA Drug Safety Update (August 2017): Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections

100mg & 150mg film coated tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA359: as a treatment option with rituximab for the following indications only if the company provides the drug with discount agreed in the simple discount agreement

• Untreated chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation
• chronic lymphocytic leukaemia in adults when the disease has been treated but has relapsed within 24 months.

Not approved for use in accordance with the following NICE TAs

• NICE TA328: as a treatment option for follicular lymphoma that is refractory to 2 prior lines of treatment because no evidence submission was received from Gilead Sciences.
• NICE TA469: as a treatment option with ofatumumab for chronic lymphocytic leukaemia because no evidence submission was received from Gilead Sciences.
• NICE TA604: delalisib for treating refractory follicular lymphoma

MHRA Alerts

MHRA Drug Safety Update (May 2016): Idelalisib (Zydelig▼): interim measures following signal of serious infection and deaths related to infection found in clinical trials.

MHRA Drug Safety Update (September 2016): Idelalisib (Zydelig▼): updated indications and advice on minimising the risk of infection  

100mg ▼ and 400mg tablets (only Gilvec brand is ▼)

100mg and 400mg capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs

• NICE TA70: as a treatment option for the following groups of patients:

          Philadelphia-chromosome-positive chronic myeloid leukaemia (CML) who initially present in the accelerated phase or           with blast crisis.

          Philadelphia-chromosome-positive chronic myeloid leukaemia (CML) who initially present in the chronic phase and               then progress to accelerated phase or blast crisis if they have not received imatinib before.

• NICE TA86: as a treatment option for KIT (CD117)-positive unresectable and/or KIT (CD117)-positive metastatic gastro-intestinal stromal tumours (GISTs) under the conditions specified within the TA.
• NICE TA326: as a treatment option for adjuvant treatment for up to 3 years for adults who are at high risk of relapse after surgery for KIT (CD117)‑positive gastrointestinal stromal tumours, as defined by the Miettinen 2006 criteria[1] (based on tumour size, location and mitotic rate).
• NICE TA426: as a treatment option for untreated, chronic-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults.

Not recommended for use in accordance with the following NICE TAs

• NICE TA209: as a treatment option (600mg or 800mg per day dose) for unresectable and/or metastatic gastrointestinal stromal tumours whose disease has progressed after treatment with 400 mg per day imatinib.
• NICE TA425: as a high dose (600mg in chronic phase and 800mg in accelerated and blast-crisis phases) treatment option for Philadelphia-chromosome-positive chronic myeloid leukaemia in adults whose disease is imatinib-resistant.

MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation

1mg powder for conc for solution for infusion

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :
• NICE TA541:Inotuzumab ozogamicin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

50mg vial for preparing IV infusion

Commissioner NHS England

Approved in accordance with the following NICE TAs

NICE TA268: as a treatment option for advanced (unresectable or metastatic) melanoma in people who have received prior therapy, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme. Patient are referred to tertiary centre for treatment.

NICE TA319: as a treatment option for previously untreated advanced (unresectable or metastatic) melanoma, only if the manufacturer provides ipilimumab with the discount agreed in the patient access scheme. Patients are referred to tertiary centre for treatment.

NICE TA400: as a treatment option with nivolumab for advanced (unresectable or metastatic) melanoma in adults, only when the company provides ipilimumab with the discount agreed in the patient access scheme. Patients are referred to tertiary centre for treatment.

MHRA Drug Safety Update (July 2017): Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): reports of organ transplant rejection

MHRA Drug Safety Update (Jan 2019): Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation

Related NICE guidance: NG14: Melanoma: assessment and management

40mg in 2ml & 100mg in 5ml injections

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

50mg (5 mg/ml) concentrate for solution for infusion

Not approved as per NICE TA440

MHRA Drug Safety Update (March 2019): Onivyde (irinotecan, liposomal formulations): reports of serious and fatal thromboembolic events

MHRA Drug Safety Update (July 2020): Liposomal and lipid-complex formulations: name change to reduce medication errors

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

2.3mg, 3mg and 4mg capsules 

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs:

• NICE TA505 - Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma.

250mg tablet

Commissioner: NHS England - Only when used in line with a current chemotherapy protocol from the North of England Cancer Network in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

4mg and 10mg capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs:

• NICE TA498:  as a treatment option along with everolimus for advanced renal cell carcinoma in adults who have had 1 previous vascular endothelial growth factor (VEGF)-targeted therapy, under the conditions specified within the TA.
• NICE TA535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine.
• NICE TA551: Lenvatinib for untreated advanced hepatocellular carcinoma

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA539: Lutetium (177Lu) oxodotreotide for treating unresectable or metastatic neuroendocrine tumours  

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

25mg capsules

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund:

• NICE TA523: recommended, within its marketing authorisation, as an option in adults for treating newly diagnosed acute FLT3-mutation-positive myeloid leukaemia with standard daunorubicin and cytarabine as induction therapy, with high-dose cytarabine as consolidation therapy, and alone after complete response as maintenance therapy. 

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Not approved for use in accordance with the following NICE TA

NICE TA411: as a treatment option along with gemcitabine for locally advanced or metastatic epidermal growth factor receptor (EGFR)-expressing squamous non-small-cell lung cancer that has not been treated with chemotherapy in adults.

40mg film coated tablets

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA612: Neratinib for extended adjuvant treatment of hormone receptor-positive, HER2-positive early stage breast cancer after adjuvant trastuzumab

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

150mg & 200mg capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs

• NICE TA425: as a treatment option along with dasatinib for chronic- or accelerated-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults, under the conditions specified within the TA
• NICE TA426: as a treatment option along with dasatinib for untreated chronic-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults only if the companies provide them with the discounts agreed in the relevant patient access schemes.

MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation

100mg and 150mg soft capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs

NICE TA347: as a treatment option in combination with docetaxel for locally advanced, metastatic or locally recurrent non‑small‑cell lung cancer of adenocarcinoma histology that has progressed after first‑line chemotherapy, only if the company provides nintedanib with the discount agreed in the patient access scheme.

Also approved for use in idiopathic pulmonary fibrosis in accordance with the following TA.

Commissioned by NHS England

NICE TA379: as a treatment option for idiopathic pulmonary fibrosis under the conditions specified within the TA.

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

1mg powder for conc for soln for inf in vial

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA541: notuzumab ozogamicin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia   

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

50mg capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs:

• NICE TA381: as a treatment option for adults with relapsed, platinum sensitive ovarian, fallopian tube or peritoneal cancer who have BRCA1 or BRCA2 mutations and whose disease has responded to platinum based chemotherapy under the conditions specified within the TA.
• NICE TA598: as an option for the maintenance treatment of BRCA mutation‑positive, advanced (FIGO stages 3 and 4), high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer that has responded to first-line platinum-based chemotherapy in adults. It is recommended only if the conditions in the managed access agreement for olaparib are followed.
• NICE TA620: Olaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer

40mg and 80mg tablets

Commissioner: Cancer Drugs Fund

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA:

• NICE TA416: as a treatment option for locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small-cell lung cancer in adults whose disease has progressed under the conditions specified within the TA.
• NICE TA653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer

Not approved in accordance with the following NICE TAs:

• NICE TA621: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer

50mg & 100mg injections

Commissioner: NHS England  

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs.

NICE TA100: as an adjuvant treatment option in combination with 5-flurouracil and folinic acid for stage III (Dukes' C) colon cancer following surgery for the condition.

30mg in 5ml, 100mg in 16.7ml and 150mg in 25ml concentrate for preparing IV infusion

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs.

• NICE TA55: as an alternative treatment option to first-line chemotherapy for ovarian cancer in combination with a platinum-based compound (cisplatin or carboplatin) (usually following surgery)
• NICE TA389: as a monotherapy treatment option or in combination with platinum for recurrent ovarian cancer

75mg, 100mg and 125mg capsules 

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs:

• NICE TA495: as a treatment option in combination with aromatase inhibitor for hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy in adults only if the company provides it with the discount agreed in the patient access scheme.
• NICE TA619: Palbociclib with fulvestrant for treating hormone receptor-positive, HER2-negative, advanced breast cancer

20mg/ml injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA439: as a treatment option for previously untreated RAS wild-type metastatic colorectal cancer in adults in combination with FOLFOX or FOLFIRI only when the companies provide them with the discount agreed in the patient access scheme

MHRA Alerts

• MHRA Drug Safety Update (May 2010): Panitumumab (Vectibix): serious hypersensitivity reactions
• MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
• MHRA Drug Safety Update (September 2012): Panitumumab (Vectibix): risk of necrotising fasciitis
• MHRA Drug Safety Update (September 2013): Panitumumab: treatment of metastatic colorectal cancer

10mg, 15mg and 20mg hard capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA380: as a treatment option in combination with bortezomib and dexamethasone for relapsed or refractory multiple myeloma in patients who have received at least 2 prior regimens including bortezomib and an immunomodulatory agent when the manufacturer provides panobinostat with the discount agreed in the patient access scheme.

200mg & 400mg tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA215: as a first-line treatment option for advanced renal cell carcinoma under the conditions specified within the TA.

3750 units/5ml solution for injection vials

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA408: as part of antineoplastic combination therapy for treating acute lymphoblastic leukaemia only in patients with untreated newly diagnosed disease.

50mg vial for preparing IV infusion

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs OR if indication funded from Cancer Drugs Fund

• NICE TA357: as a treatment option for advanced (unresectable or metastatic) melanoma in adults under conditions specified within the TA
• NICE TA366: as a treatment option for advanced (unresectable or metastatic) melanoma that has not been previously treated with ipilimumab, in adults, only when the company provides pembrolizumab in line with the commercial access agreement with NHS England.
• NICE TA428: as a treatment option for locally advanced or metastatic PD‑L1‑positive non‑small‑cell lung cancer in adults who have had at least one chemotherapy (and targeted treatment if they have an epidermal growth factor receptor [EGFR]- or anaplastic lymphoma kinase [ALK]‑positive tumour), under conditions specified within the TA
• NICE TA447: as a treatment option for untreated PD-L1-positive metastatic non-small-cell lung cancer in adults, under conditions specified within the TA.
• NICE TA519: Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy
• NICE TA522: Pembrolizumab for untreated PD-L1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable
• NICE TA531: Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer
• NICE TA540: Pembrolizumab for treating relapsed or refractory classical Hodgkin lymphoma
• NICE TA553: Pembrolizumab for adjuvant treatment of resected melanoma with high risk of recurrence
• NICE TA557: Pembrolizumab with pemetrexed and platinum chemotherapy for untreated, metastatic, non-squamous non-small-cell lung cancer
• NICE TA600: Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer
• NICE TA661: Pembrolizumab for untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma

Not approved in accordance with the following NICE TAs:

• NICE TA570: Pembrolizumab for treating recurrent or metastatic squamous cell carcinoma of the head and neck after platinum-based chemotherapy (terminated appraisal)
• NICE TA650: Pembrolizumab with axitinib for untreated advanced renal cell carcinoma

MHRA Drug Safety Update (July 2017): Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): reports of organ transplant rejection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs

• NICE TA424: as a treatment option in combination with trastuzumab and chemotherapy for neoadjuvant treatment of adults with human epidermal growth factor receptor 2 (HER2)‑positive breast cancer; that is, in patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer at high risk of recurrence only if the company provides pertuzumab with the discount agreed in the patient access scheme.
• NICE TA509: as a treatment option in combination with trastuzumab and docetaxel for HER2‑positive metastatic or locally recurrent unresectable breast cancer, in adults who have not had previous anti‑HER2 therapy or chemotherapy for their metastatic disease, only if the company provides pertuzumab within the agreed commercial access arrangement
• NICE TA569: Pertuzumab, with intravenous trastuzumab and chemotherapy, is recommended for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults, only if they have lymph node-positive disease and the company provides it according to the commercial arrangement.

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA427: as a treatment option with low-dose dexamethasone for multiple myeloma in adults at third or subsequent relapse; that is, after 3 previous treatments including both lenalidomide and bortezomib, only when the company provides pomalidomide with the discount agreed in the patient access scheme.

Not approved in accordance with the following NICE TAs:

• NICE TA602: Pomalidomide with bortezomib and dexamethasone for treating relapsed or refractory multiple myeloma (terminated appraisal)

MHRA Drug Safety Update (June 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA451: as a treatment options for chronic-, accelerated or blast-phase chronic myeloid leukaemia and Philadelphia-chromosome-positive acute lymphoblastic leukaemia under conditions specified within the TA for each type of leukaemia.

MHRA Alerts

• MHRA Drug Safety Update (December 2014): Ponatinib (Iclusig▼): risk of vascular occlusive events
• MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
• MHRA Drug Safety Update (April 2017): Ponatinib (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction
• MHRA Drug Safety Update (October 2018): Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome
• MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

50mg capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

110 kBq/ml solution for injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA or if indication funded from Cancer Drugs Fund

NICE TA412: as a treatment option for hormone-relapsed prostate cancer, symptomatic bone metastases and no known visceral metastases in adults, under conditions specified within the TA.

MHRA Drug Safety Update (December 2017): Radium-223 dichloride (Xofigo▼): do not use in combination with abiraterone and prednisone/prednisolone, following clinical trial signal of increased risk of death and fractures  

10mg/ml concentrate for solution for infusion

Commissioner: NHS England (Not routinely commissioned)

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Not approved for use in accordance with the following NICE TAs. Individual funding requests needed for commissioning:

NICE TA378: as a treatment option in combination with paclitaxel for advanced gastric cancer or gastro–oesophageal junction adenocarcinoma previously treated with chemotherapy.

NICE TA403: as a treatment option in combination with docetaxel for locally advanced or metastatic non-small-cell lung cancer in adults whose disease has progressed after platinum-based chemotherapy

NICE TA609: Ramucirumab for treating unresectable hepatocellular carcinoma after sorafenib (terminated appraisal)

NICE TA635: Ramucirumab with erlotinib for untreated EGFR-positive metastatic non-small-cell lung cancer (terminated appraisal)

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

40mg tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA:

• NICE TA488: as a treatment option for unresectable or metastatic gastrointestinal stromal tumours in adults whose disease has progressed on, or who are intolerant to, prior treatment with imatinib and sunitinib, under the conditions specified within the TA.
• NICE TA555: Regorafenib for previously treated advanced hepatocellular carcinoma

Not approved for use in accordance with the following NICE TAs

• NICE TA334: as a treatment option for metastatic colorectal cancer  after treatment for metastatic disease as no evidence was received from Bayer. 
• NICE TA514: as a treatment option for advanced unresectable hepatocellular carcinoma in adults who have had sorafenib.

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

200mg tablet

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs:

NICE TA496: as a treatment option with an aromatase inhibitor for hormone receptor-positive, human epidermal growth factor receptor 2‑negative, locally advanced or metastatic breast cancer as initial endocrine-based therapy in adults. only if the company provides it with the discount agreed in the patient access scheme.

NICE TA593: ribociclib with fulvestrant is recommended for use within the Cancer Drugs Fund as an option for treating hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in people who have had previous endocrine therapy only if exemestane plus everolimus is the most appropriate alternative to a cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor and the conditions in the managed access agreement for ribociclib with fulvestrant are followed.

200mg, 250mg and 300mg film coated tablets 

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA611: Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

5mg, 15mg and 20mg tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA386: as a treatment option for disease-related splenomegaly or symptoms in adults with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis, under conditions specified within the TA.

200mg tablet

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs: 

• NICE TA474: as a treatment option for dvanced hepatocellular carcinoma only for people with Child-Pugh grade A liver impairment, only if the company provides sorafenib within the agreed commercial access arrangement.
• NICE TA535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine. 

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

1g injection (only available on a named patient basis)^u

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

12.5 mg, 25mg, 37.5mg and 50mg hard capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs

NICE TA169: as a first-line treatment option for advanced and/or metastatic renal cell carcinoma who are suitable for immunotherapy and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 under the conditions specified within the TA.

NICE TA179: as a treatment option for people with unresectable and/or metastatic malignant gastrointestinal stromal tumours under conditions specified within the TA.

NICE TA449: as a treatment option for well- or moderately differentiated unresectable or metastatic neuroendocrine tumours (NETs) of pancreatic origin in adults with progressive disease.

MHRA Drug Safety Update (January 2011): Bevacizumab and sunitinib: risk of osteonecrosis of the jaw.

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Kymriah® 1.2 x 106 – 6 x 108 cells dispersion for infusion

Kymriah is an immunocellular therapy containing tisagenlecleucel, autologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA554: Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years
• NICE TA567: Tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

1.34mg capsule

Commissioner: NHS England

 
Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TA:

• NICE TA512 - Tivozanib for treating advanced renal cell carcinoma

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

0.25mg & 1mg capsules
1mg & 4mg vials

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs

NICE TA183: as a treatment option in combination with cisplatin for recurrent or stage IVB cervical cancer only if they have not previously received cisplatin. Patients are referred to tertiary centre for treatment.

NICE TA184: as a oral treatment option for relapsed small-cell lung cancer under conditions specified within the TA

Not to be used in accordance with the following NICE TA

NICE TA389: as a treatment option for recurrent platinum‑resistant or platinum‑refractory ovarian cancer.

250microgram injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA185: as a treatment option for advanced soft tissue sarcoma under conditions specified within the TA. Patients are referred to tertiary centre for treatment.

500microgram and 2mg film coated tablets

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

NICE TA396: as a treatment option in combination with dabrafenib for unresectable or metastatic melanoma in adults with a BRAF V600 mutation only when the company provides trametinib and dabrafenib with the discounts agreed in the patient access schemes.

MHRA Drug Safety Update (May 2016): Trametinib (Mekinist▼): risk of gastrointestinal perforation and colitis.

150mg vial for preparing IV infusion
600mg s/c injection

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TAs

NICE TA34: as a treatment option for the following cancers under the conditions specified within the TA

• In combination with paclitaxel for tumours expressing human epidermal growth factor receptor 2 (HER2) scored at levels of 3+
• as monotherapy for tumours expressing HER2 scored at levels of 3+ who have received at least two chemotherapy regimens for metastatic breast cancer.

NICE TA107: as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) under conditions specified within the TA.

NICE TA208: as a treatment option for human epidermal growth factor receptor 2 (HER2)-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction under conditions specified within the TA.

100 mg powder for concentrate for solution for infusion.
160 mg powder for concentrate for solution for infusion.

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Approved for use in accordance with the following NICE TA

• NICE TA458: as a treatment option for human epidermal growth factor receptor 2 (HER2)‑positive, unresectable, locally advanced or metastatic breast cancer in adults under conditions specified within the TA.
• NICE TA632: Trastuzumab emtansine for adjuvant treatment of HER2-positive early breast cancer

Care should be taken to ensure Kadcyla® is not confused with Herceptin®
Kadcyla should not be given at the same time as chemotherapy

10mg capsules

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

Not approved in accordance with the following NICE TAs:

• NICE TA550: Vandetanib for treating medullary thyroid cancer

MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection

NHSE Commissioned

Approved: NICE TA269

Not Approved: NICE TA414 (in combination with cobimetinib)

10mg, 50mg and 100mg tablets

Commissioner: NHS England (Cancer Drugs Fund)

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm. Indication funded via Cancer Drugs Fund

NICE TA487: as a treatment option for chronic lymphocytic leukaemia, that is, in adults under conditions specified within the TA.

NICE TA561: as an option for treating chronic lymphocytic leukaemia in adults who have had at least 1 previous therapy

NHSE Commissioned for Cancer indications

Not Approved: NICE TA489

25mg and 100mg film coated tablets

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund: 

• NICE TA628: Lorlatinib is recommended, within its marketing authorisation, as an option for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor OR crizotinib and at least 1 other ALK tyrosine kinase inhibitor.

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

20 mg/mL oral solution

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund:

• NICE TA630: Larotrectinib is recommended for use within the Cancer Drugs Fund as an option for treating neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumours in adults and children if the disease is locally advanced or metastatic or surgery could cause severe health problems and they have no satisfactory treatment options.

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

40 mg film-coated tablets

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund:

• NICE TA642: Gilteritinib for treating relapsed or refractory acute myeloid leukaemia

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

100mg and 200mg hard capsules

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA643: Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer
• NICE TA644: Entrectinib for treating NTRK fusion-positive solid tumours

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

20 mg/mL concentrate for solution for infusion

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA645: Avelumab with axitinib for untreated advanced renal cell carcinoma

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

25mg and 100mg film coated tablets

Not approved in accordance with the following NICE TAs:

• NICE TA646: Glasdegib with chemotherapy for untreated acute myeloid leukaemia (terminated appraisal)

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

30mg and 140mg powder for concentrate for solution for infusion

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA649: Polatuzumab vedotin with rituximab and bendamustine for treating relapsed or refractory diffuse large B-cell lymphoma

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

20mg/mL concentrate for solution for infusion.

Approved for use in accordance with the following NICE TAs OR if indication funded from the Cancer Drugs Fund :

• NICE TA658: Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

NHS England – Not routinely commissioned

NHS England – Not routinely commissioned

Tablets - 25mg, 50mg

50mg in 5ml u suspension
Shared Care (Amber) for non-cancer indications

Capsules - 250mg, 500mg

1g in 5ml (200mg/ml) oral suspension

Shared Care (Amber) for non-cancer indications

MHRA Drug Safety Update (Jan 2015): Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasis

MHRA Drug Safety Update (Dec 2015): Mycophenolate mofetil, mycophenolic acid: new pregnancy-prevention advice for women and men

MHRA Drug Safety Update (Feb 2018):  Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patients

180mg & 360mg e/c tablets

2nd line therapy in patients who do not tolerate mycophenolate mofetil.

Capsules - 10mg, 25mg, 50mg & 100mg

100mg in 1ml sugar-free oral solution (oily)

Shared Care (Amber) for non-cancer indications

1mg & 2mg tablets
1mg per ml oral solution

Approved for renal transplantation in children and adolescents in line
with NICE

30mg in 1ml concentrate for IV infusion
- for use in lymphocytic leukaemia & prevention of graft vs. host disease on bone marrow transplant patients
- approved for use in high-risk kidney and pancreas transplantation 
12mg in 1.2ml concentrate for IV infusion

-for adult patients with relapsing remitting multiple sclerosis

Approved for use in accordance with the following NICE TAs:

• NICE TA312: Alemtuzumab for treating relapsing‑remitting multiple sclerosis

Commissioner: NHS England

MHRA Drug Safety Update (May 2019): Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements

MHRA Drug Safety Update (Feb 2020): Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions

Approved for use in accordance with the following NICE TAs:

NICE TA517 as an option for treating metastatic Merkel cell carcinoma in adults, only if they have had 1 or more lines of chemotherapy for metastatic disease.

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

1000mg in 40ml concentrate for IV infusion

Commissioner: NHS England

Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Approved for use in accordance with the following NICE TAs

NICE TA343: as a treatment option in combination with chlorambucil,  for untreated chronic lymphocytic leukaemia under conditions specified within the TA.

NICE TA513: as a treatment option for untreated advanced follicular lymphoma under conditions specified within the TA

NICE TA629: Obinutuzumab with bendamustine followed by obinutuzumab maintenance is recommended, within its marketing authorisation, as an option for treating follicular lymphoma that did not respond or progressed up to 6 months after treatment with rituximab or a rituximab-containing regimen

The indication for treating follicular lymphoma ib patients refractory to rituximab is funded by the Cancer Drugs Fund in accordance with the following NICE TA

NICE TA472: as a treatment option in combination with bendamustine followed by obinutuzumab maintaince therapy under conditions specified within the TA.

100mg in 10ml & 500mg in 50ml concentrate for IV infusion

1400 mg solution for subcutaneous injection

Treatment of rheumatological conditions in line with NICE guidance otherwise Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm.

Commissioner: NHS England

Approved for use in accordance with the following NICE TAs

NICE TA137: as a treatment option in combination with chemotherapy for the induction of remission in relapsed stage III or IV follicular non-Hodgkin's lymphoma. Additionally, rituximab is licensed as a monotherapy treatment option for follicular non-Hodgkin’s lymphoma. Please see the TA for full details.

NICE TA174: as a treatment option in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukaemia in patients for whom fludarabine in combination with cyclophosphamide is considered appropriate.

NICE TA193: as a treatment option in combination with fludarabine and cyclophosphamide for people with relapsed or refractory chronic lymphocytic leukaemia under conditions specified within the TA.

NICE TA226: as a treatment option for follicular non‑Hodgkin's lymphoma that has responded to first-line induction therapy with rituximab in combination with chemotherapy.

NICE TA243: as a treatment option for symptomatic stage III and IV follicular lymphoma in previously untreated patients according to various combinations specified within the TA.

MHRA Drug Safety Update Decmeber 2013: Rituximab: screen for hepatitis B virus before treatment.

1mg tablets

Initiated with specialist advice.

For use in prostate and breast cancer

100mg & 200mg tablets
500mg in 2.5ml injections

Specialist initiation Only

Tablets - 160mg

5mg tablets