National Cancer Drugs Fund List (Updated 13 February 2014)

Transcription

1 National Cancer Drugs Fund List (Updated 13 February 2014) DRUG Abiraterone Aflibercept Axitinib Bendamustine NCDF APPROVED CRITERIA The treatment of metastatic castration resistant prostate cancer where all the 2. Castrate-resistant metastatic prostate cancer 3. Chemotherapy naïve for metastatic disease 4. PS 0 or 1 5. Asymptomatic or mildly symptomatic patients 6. Chemotherapy not yet indicated The second line treatment of metastatic colorectal cancer where all the 2. Metastatic colorectal cancer 3. PS Progression following first line treatment with oxaliplatin-based combination chemotherapy with or without bevacizumab 5. Given in combination with irinotecan-based combination chemotherapy until unacceptable toxicity or disease progression Note: Aflibercept is ONLY approved for use in combination with irinotecan-based combination chemotherapy and is not approved as a single agent maintenance therapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) The treatment of advanced renal cell carcinoma where all the 2. Histologically or cytologically confirmed renal cell carcinoma 3. Patient progressed after only 1st line cytokine or after only one line of treatment with a Tyrosine Kinase Inhibitor The treatment of Chronic Lymphocytic Leukaemia where all the 2. Chronic lymphocytic leukaemia (not licensed in this indication) 3. a) 2nd line indication OR b) 3rd line indication OR c) 4th line indication

2 Bendamustine Bendamustine Bendamustine Bendamustine Bendamustine 4. To be used within the treating Trust s governance framework, as Bendamustine is not licensed for this indication The first line treatment of low grade lymphoma where all the 2. Low grade non-hodgkin s lymphoma 3. Option for 1st-line chemotherapy 4. Can be used in combination with Rituximab, which is commissioned by NHS England in this indication 5. To be used within the treating Trust s governance framework, as Bendamustine is not licensed in this indication The treatment of relapsed low grade lymphoma where all the 2. Low grade non-hodgkin s lymphoma 3. Relapsed disease 4. Unable to receive CHOP-R 5. Unable to receive FCR 6. Unable to receive high dose-therapy 7. Can be used in combination with Rituximab, which is commissioned by NHS England in this indication 8. To be used within the treating Trust s governance framework, as Bendamustine is not licensed in this indication The treatment of rituximab refractory low grade lymphoma where all the 2. Low grade non-hodgkin s lymphoma 3. Refractory to Rituximab monotherapy or Rituximab-containing combination The first line treatment of mantle cell non-hodgkin's lymphoma where all the 2. Mantle cell non-hodgkin s lymphoma 3. 1st-line treatment in patients unsuitable for standard treatment 4. Can be used in combination with Rituximab, which is commissioned by NHS England in this indication 5. To be used within the treating Trust s governance framework, as Bendamustine is not licensed in this indication The treatment of relapsed mantle cell non-hodgkin's lymphoma where all the 2. Mantle cell non-hodgkin s lymphoma 3. Option for 2nd or subsequent line chemotherapy

3 4. No previous treatment with Bendamustine 5. Can be used in combination with Rituximab, which is commissioned by NHS England in this indication 6. To be used within the treating Trust s governance framework, as Bendamustine is not licensed in this indication Bendamustine The treatment of relapsed multiple myeloma where all the following criteria are met: 2. Multiple myeloma 3. Relapsed disease where other treatments contraindicated or inappropriate 4. To be used within the treating Trust s governance framework, as Bendamustine is not licensed in this indication The treatment of advanced breast cancer where all the following criteria are met: 2. Advanced Breast Cancer 3. Triple negative disease (ER, PR, and HER2 negative) 4. a) 1st line indication OR b) 2nd line indication 5. To be given in combination with paclitaxel The first line treatment of advanced colorectal cancer with a single agent fluoropyramidine where all the 2. Advanced colorectal cancer 3. PS Given in combination with a single agent fluoropyrimidine as 1st line treatment 5. Patient assessed as unfit to receive combination oxaliplatin- or irinotecan-based combination chemotherapy 6. No previous treatment with Note: is not approved for use as a single agent maintenance therapy on its own. Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) The first line treatment of advanced colorectal cancer with combination chemotherapy where all the 2. Advanced Colorectal Cancer 3. 1st line indication 4. a) Given in combination with oxaliplatin-based combination chemotherapy OR b) Given in combination with irinotecan-based combination chemotherapy 5. No previous treatment with bevacizumab

4 Note: If excessive toxicity with oxaliplatin or irinotecan, bevacizumab can be continued with a fluoropyrimidine alone until disease progression only. Note: is ONLY approved for use in combination with chemotherapy and is not approved for use as a single agent maintenance therapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) The second or third line treatment of advanced colorectal cancer where all the 2. Advanced Colorectal Cancer 3. a) 2nd line indication, OR, b) 3rd line indication 4. No previous treatment with 5. Given in combination with oxaliplatin-based combination chemotherapy Note: If excessive toxicity with oxaliplatin, bevacizumab can be continued with a fluoropyrimidine alone until disease progression only. Note: is ONLY approved for use in combination with oxaliplatin-based combination chemotherapy and is not approved for use as a single agent maintenance therapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) The first line treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer where all the 2. Chemotherapy naïve advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (not licensed at this dosage) 3. 1st line indication 4. Either FIGO stage III debulked but residual disease more than 1cm, or FIGO stage IV 5. Given with Carboplatin and Paclitaxel combination chemotherapy 6. to start with: 1st or 2nd cycle of chemotherapy following debulking surgery or an attempt at debulking surgery (either performed prechemotherapy or after 3 cycles of neo-adjuvant chemotherapy), OR 1st or 2nd cycles of chemotherapy for those patients with stage IV disease OR inoperable disease 7. dose to be 7.5mg/kg every 3 weeks 8. Maximum of 18 cycles of 9. As this dosage of is not licensed in ovarian cancer it must be used within the treating Trust s governance framework Note: This policy is NOT for patients with stage I-III disease who have had optimal debulking

5 Bortezomib The second line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer where all the following criteria are met: 2. 2nd line indication 3. Platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer (6 or more months after completion of first line chemotherapy) 4. Given with Carboplatin and Gemcitabine combination chemotherapy 5. PS 0 or 1 6. No previous treatment with bevacizumab or other anti-vegf treatment 7. dose to be 15mg/kg every 3 weeks Note: should be discontinued due to toxicity or disease progression, which ever occurs first. The treatment of relapsed/refractory mantle cell lymphoma where all the 2. Pathologically confirmed mantle cell lymphoma 3. Relapsed disease after one or more prior chemotherapies (including Rituximab), or autologous stem cell transplantation 4. To be used within the treating Trust s governance framework, as Bortezomib is not licensed in this indication Bortezomib Bortezomib Bortezomib The treatment of bortezomib naive relapsed multiple myeloma where all the 2. Relapsed myeloma 3. No previous Bortezomib as 2nd line (NICE approved) treatment The treatment of relapsed multiple myeloma where all the following criteria are met: 2. Relapsed myeloma 3. Previous PR or CR of 6 months or more duration with Bortezomib 4. No contraindications to further Bortezomib treatment The treatment of relapsed Waldenstrom's Macroglobulinaemia where all the 2. Waldentrom s Macroglobulinaemia (not licensed for this indication) 3. Previous treatment with alkylating agents 4. Previous treatment with purine analogues

6 Bosutinib 5. To be used within the treating Trust s governance framework, as Bortezomib is not licensed for this indication The treatment of refractory chronic phase Chronic Myeloid Leukaemia where all the 2. Chronic phase Chronic Myeloid Leukaemia 3. Refractory to nilotinib or dasatinib (if Dasatinib accessed via a clinical trial or via its current approved CDF indication) Bosutinib The treatment of refractory accelerated phase Chronic Myeloid Leukaemia where all the 2. Accelerated phase Chronic Myeloid Leukaemia 3. Refractory to nilotinib or dasatinib (if Dasatinib accessed via a clinical trial or via its current approved CDF indication) Bosutinib The treatment of refractory blast crisis Chronic Myeloid Leukaemia where all the 2. Blast crisis Chronic Myeloid Leukaemia 3. Refractory to nilotinib or dasatinib (if Dasatinib accessed via a clinical trial or via its current approved CDF indication) Bosutinib The treatment of chronic phase Chronic Myeloid Leukaemia where there is intolerance of treatment(s) and where all the following criteria are met: 2. Chronic phase Chronic Myeloid Leukaemia 3. Significant intolerance to dasatinib (Grade 3 or 4 adverse events) (if Dasatinib accessed via its current approved CDF indication) 4. Significant intolerance to nilotinib (Grade 3 or 4 events) Bosutinib The treatment of accelerated phase Chronic Myeloid Leukaemia where there is intolerance of treatments and where all the following criteria are met: 2. Accelerated phase Chronic Myeloid Leukaemia

7 3. Significant intolerance to dasatinib (Grade 3 or 4 adverse events) (if Dasatinib accessed via its current approved CDF indication) 4. Significant intolerance to nilotinib (Grade 3 or 4 events) Bosutinib The treatment of blast crisis Chronic Myeloid Leukaemia where there is intolerance of treatments and where all the following criteria are met: 2. Blast crisis Chronic Myeloid Leukaemia 3. Significant intolerance to dasatinib (Grade 3 or 4 adverse events) (if Dasatinib accessed via its current approved CDF indication) 4. Significant intolerance to nilotinib (Grade 3 or 4 events) Brentuximab Brentuximab Cabazitaxel Cetuximab Cetuximab The treatment of refractory systemic anaplastic lymphoma where all the 2. Relapsed or refractory systemic anaplastic large cell lymphoma 3. As a bridge to transplant where no other salvage treatment is available The treatment of relapsed or refractory CD30+ Hodgkin lymphoma where all the 2. Relapsed or refractory CD30+ Hodgkin lymphoma 3. a) Following autologous stem cell transplant (ASCT), OR, b) Following at least two prior therapies when ASCT or multiagent chemotherapy is not a treatment option The treatment of castrate-resistant Metastatic Prostate Cancer where all the 2. Castrate-resistant Metastatic Prostate Cancer 3. Previous treatment with docetaxel based regimens The first line treatment of advanced head and neck cancer where all the 2. Advanced Head and Neck Cancer 3. Use with standard 1st line palliative combination chemotherapy 4. Performance status 0 or 1 5. No previous treatment with Cetuximab The first line treatment of metastatic colorectal cancer where all the

8 Cetuximab 2. Metastatic colorectal cancer 3. 1st line indication 4. Patients with wild-type RAS 5. Given in combination with Irinotecan-based combination chemotherapy 6. Cetuximab given as a 2-weekly regimen at a dose of 500mg/m 2 7. a. Not eligible for NICE TA176 approved indications OR b. Eligible for treatment under TA176 and no progression after receiving the approved 16 weeks treatment with cetuximab but unsuitable for surgery and meeting criteria No previous treatment with Cetuximab or Panitumumab (unless meeting condition 7b) NOTE: Cetuximab is not approved for use as 1st line treatment with any oxaliplatin-based combination other than FOLFOX4 or FOLFOX6 or OxMdG or with upfront single agent fluoropyrimidine chemotherapy Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with irinotecan, cetuximab can be continued with a fluoropyrimidine alone until disease progression only. The first line treatment of metastatic colorectal cancer where all the 2. Metastatic colorectal cancer 3. 1st line indication 4. Patients with wild-type RAS 5. Given in combination with the FOLFOX4 or FOLFOX6 or OxMdG chemotherapy regimens 6. Cetuximab given as a 2-weekly regimen at a dose of 500mg/m 2 7. a. Not eligible for NICE TA176 approved indications OR b. Eligible for treatment under TA176 and no progression after receiving the approved 16 weeks treatment with cetuximab but unsuitable for surgery and meeting criteria No previous treatment with Cetuximab or Panitumumab (unless meeting condition 7b) NOTE: Cetuximab is not approved for use as 1st line treatment with other oxaliplatin-based regimens or upfront single agent fluoropyrimidine chemotherapy. Specifically in this setting cetuximab is not to be used with capecitabine and oxaliplatin combinations. Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with oxaliplatin, cetuximab can be continued with a fluoropyrimidine alone until disease progression only.

9 Cetuximab Cetuximab The second or third line treatment of metastatic colorectal cancer with combination chemotherapy where all the following criteria are met: 2. Metastatic colorectal cancer 3. a) 2nd line indication OR b) 3rd line indication 4. Patients with wild-type RAS 5. Given in combination with irinotecan-based chemotherapy 6. Performance status of 0 or 1 7. No previous treatment with Cetuximab or Panitumumab NOTE: NOTE: Cetuximab is not approved for use as 2nd or 3rd line treatment with any oxaliplatin-based combinations or with upfront single agent fluoropyrimidine Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with irinotecan, cetuximab can be continued with a fluoropyrimidine alone until disease progression only. The second or third line treatment of metastatic colorectal cancer with combination chemotherapy where all the following criteria are met: 2. Metastatic colorectal cancer 3. a) 2nd line indication OR b) 3rd line indication 4. Patients with wild-type RAS 5. Given in combination with irinotecan-based chemotherapy 6. Performance status of 0 or 1 Cetuximab 7. Response to previous Cetuximab in the context of NICE TA176 and discontinuation at 16 weeks for consideration of surgery (and therefore not treated to disease progression) NOTE: NOTE: Cetuximab is not approved for use as 2nd or 3rd line treatment with any oxaliplatin-based combinations or with upfront single agent fluoropyrimidine Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with irinotecan, cetuximab can be continued with a fluoropyrimidine alone until disease progression only. The third or fourth line treatment of metastatic colorectal cancer as a single agent where all the 2. Metastatic colorectal cancer

10 Cetuximab Clofarabine Clofarabine Crizotinib 3. a) 3rd line indication b) 4th line indication 4. Patients with wild-type RAS 5. Performance status of 0 or 1 6. No previous treatment with Cetuximab or Panitumumab Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) The third or fourth line treatment of metastatic colorectal cancer as a single agent where all the 2. Metastatic colorectal cancer 3. a) 3rd line indication b) 4th line indication 4. Patients with wild-type RAS 5. Performance status of 0 or 1 6. Response to previous Cetuximab in the context of NICE TA176 and discontinuation at 16 weeks for consideration of surgery (and therefore not treated to disease progression) Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) The treatment of relapsed/refractory acute lymphoblastic leukaemia where all the 2. Acute lymphoblastic leukaemia 3. Relapsed/ refractory disease with intent to use treatment to bridge to bone marrow transplant The treatment of relapsed/refractory acute myeloblastic leukaemia where all the 2. Acute myeloblastic leukaemia (not licensed for this indication) 3. Relapsed/ refractory disease with intent to use treatment to bridge to bone marrow transplant 4. To be used within the treating Trust s governance framework, as Clofarabine is not licensed for this indication The treatment of ALK +ve advanced or metastatic non-small cell lung cancer where all the 2. ALK +ve advanced or metastatic non-small cell lung cancer 3. 2nd or subsequent line treatment post 1st line combination chemotherapy

11 Dabrafenib Dasatinib Dasatinib Dasatinib Dasatinib The treatment of unresectable or metastatic melanoma with a BRAF V600 mutation and intolerance to vemurafenib where all the 2. Advanced melanoma 3. BRAF V600E mutation 4. PS 0 or 1 5. Severe intolerance necessitating discontinuation of vemurafenib within 2 months of initiating vemurafenib 6. An absence of disease progression whilst on full dose vemurafenib 7. No other previous systemic therapy for the treatment of melanoma other than vemurafenib The treatment of Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia and lymphoid blast crisis chronic myeloid leukaemia where all the 2. a) Philadelphia Chromosome positive (Ph+) Acute Lymphoblastic Leukaemia OR b) Lymphoid blast crisis chronic myeloid leukaemia 3. Refractory or significant intolerance or resistance to prior therapy including imatinib (Grade 3 or 4 adverse events) 4. a) 2nd line indication OR b) 3rd line indication The treatment of chronic phase chronic myeloid leukaemia where all the 2. Chronic phase chronic myeloid leukaemia 3. Refractory or significant intolerance to imatinib (Grade 3 or 4 adverse events) 4. Significant intolerance to nilotinib (Grade 3 or 4 adverse events) The treatment of accelerated phase chronic myeloid leukaemia where all the 2. Accelerated phase chronic myeloid leukaemia 3. Refractory or significant intolerance to imatinib (Grade 3 or 4 adverse events) 4. Significant intolerance to nilotinib (Grade 3 or 4 adverse events) The treatment of blast crisis chronic myeloid leukaemia where all the 1. Blast crisis chronic myeloid leukaemia

12 Enzalutamide 2. Refractory or significant intolerance to imatinib (Grade 3 or 4 adverse events) 3. Significant intolerance to nilotinib (Grade 3 or 4 adverse events) The treatment of castrate-resistant Metastatic Prostate Cancer where all the 2. Castrate-resistant metastatic prostate cancer 3. Progressive disease following docetaxel chemotherapy 4. PS No previous treatment with abiraterone before or after docetaxel Eribulin Everolimus Everolimus Everolimus The treatment of advanced breast cancer where all the following criteria are met: 2. Advanced breast cancer 3. At least 2 prior chemotherapy regimens for advanced disease The treatment of advanced breast cancer where all the following criteria are met: 2. ER +ve, HER2 ve metastatic breast cancer 3. No symptomatic visceral disease 4. In combination with exemestane 5. Previous treatment with a non-steroidal aromatase inhibitor 6. No previous treatment with exemestane for metastatic breast cancer 7. No more than one line of chemotherapy for the treatment of advanced breast cancer The treatment of pancreatic neuroendocrine carcinomas where all the 2. Pancreatic neuroendocrine carcinomas 3. a) 1st line indication, OR, b) 2nd line indication The treatment of metastatic renal cell carcinoma where all the 2. Biopsy proven renal cell carcinoma 3. Use in patients: Who have previously been treated with a VEGF targeted agent OR With intolerance or contraindications to a VEGF inhibitor

13 Imatinib Lapatinib Lenalidomide Lenalidomide Nelarabine Ofatumumab The adjuvant treatment of gastrointestinal stromal tumour where all the 2. Completely resected gastrointestinal stromal tumour 3. High risk of relapse (based on risk criteria or mutation analysis) NOTE: Treatment should continue for a maximum of 3 years only. The treatment of advanced breast cancer where all the following criteria are met: 2. Progressing advanced or metastatic breast cancer 3. HER-2 over-expression 4. Previous treatment with anthracyclines or anthracyclines contra-indicated 5. Previous treatment with taxanes 6. Previous treatment with trastuzumab in the metastatic setting 7. Use in combination with capecitabine The second line treatment of multiple myeloma where all the 2. Multiple myeloma 3. 2nd line indication 4. a. Contra-indication to the use of Bortezomib OR b. Previously received Bortezomib in the first line setting The treatment of myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality where all the following criteria are met: 2. Low or intermediate risk MDS 3. Associated with an isolated deletion 5q cytogenetic abnormality 4. Transfusion dependent anaemia (< 8 consecutive weeks without RBC transfusions within 16 weeks prior to commencing treatment) 5. Other therapeutic options insufficient OR inadequate The treatment of refractory T-cell acute lymphoblastic leukaemia or refractory T-cell lymphoblastic non-hodgkin's lymphoma where all the 2. a) Refractory T-cell acute lymphoblastic leukaemia, OR b) Refractory T-cell lymphoblastic non-hodgkin s lymphoma 3. Treatment intent is to proceed to bone marrow transplantation The treatment of chronic lymphocytic leukaemia where all the

14 Panitumumab Pazopanib Pegylated Liposomal Doxorubicin 2. a) 2nd line indication, OR b) 3rd line indication 3. Patient refractory to treatment with Fludarabine combination and/or Alemtuzumab OR treatment with Fludarabine combination and/or Alemtuzumab contra-indicated The first line treatment of metastatic colorectal cancer where all the 2. Metastatic colorectal cancer 3. 1st line indication 4. Patients with wild-type RAS 5. Given in combination with the FOLFOX4 or FOLFOX6 or OxMdG chemotherapy regimens 6. No previous treatment with Panitumumab or Cetuximab NOTE: Panitumumab is not approved for use as 1st line treatment with other oxaliplatin-based regimens, irinotecan-based combinations, or upfront single agent fluoropyrimidine chemotherapy and is not approved for use in any line of therapy after 1st line treatment. Specifically in this setting panitumumab is not to be used with capecitabine and oxaliplatin combinations Note: No treatment breaks of more than 4 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or in the case of intercurrent co-morbidities) Note: If excessive toxicity with oxaliplatin, panitumumab can be continued with a fluoropyrimidine alone until disease progression only. The treatment of advanced non-adipocytic soft tissue sarcoma where all the 2. Histologically confirmed advanced non-adipocytic soft tissue sarcoma 3. Two previous lines of chemotherapy for advanced soft tissue sarcoma or contraindication or intolerance to chemotherapy 4. Progression within 6 months of treatment for metastatic disease The treatment of named sarcomas where all the following criteria are met: 2. a) Angiosarcoma, 1st line indication, OR b) Angiosarcoma, 2nd line indication, OR c) Sarcoma in patients with cardiac impairment requiring an anthracycline, 1st line indication, OR d) Sarcoma in patients with cardiac impairment requiring an anthracycline, 2nd indication, OR OR e) Sarcoma of the heart and great vessels, 1st line indication, f) Fibromatosis, 2nd line indication

15 Pemetrexed Pemetrexed Peptide Receptor Radionucleotide Therapy (Lutetium177 Octreotate or Yttrium90 Octreotide/ Octreotate) Pertuzumab 3. To be used within the treating Trust s governance framework, as Pegylated Liposomal Doxorubicin is not licensed in these indications The maintenance treatment of advanced non-squamous non-small cell lung cancer where all the 2. Non-squamous non-small cell lung cancer 3. As maintenance therapy following 1st line chemotherapy with Cisplatin and Pemetrexed not progressing after 4 cycles of such chemotherapy 4. PS 0 or 1 at time to commence maintenance pemetrexed Note: the evidence for the use of maintenance pemetrexed following induction chemotherapy with the combination of pemetrexed and carboplatin has not been established and is therefore not approved The second line treatment of advanced non-squamous non-small cell lung cancer where all the 2. Advanced or metastatic non-squamous non-small cell lung cancer 3. Used as 2nd line treatment 4. No previous Pemetrexed treatment The treatment of advanced neuroendocrine tumours where all the 2. Histologically confirmed well differentiated neuroendocrine tumour 3. Octreotide scintigraphy or Gallium-68 Octreotate PET scan at least as high as that in normal liver tissue 4. Either: Pancreatic NET, progressed or symptoms not controlled, despite or not suitable for other systemic therapy OR, Other NET, progressed or symptoms not controlled following prior somatostatin analogue therapy The first line treatment of locally advanced or metastatic breast cancer where all the 2. Locally advanced or metastatic breast cancer 3. HER2 3+ or FISH positive 4. PS 0 or 1 5. Any adjuvant HER2 therapy should have been completed more than 12 months prior to metastatic diagnosis 6. No prior treatment with chemotherapy or HER2 therapy for metastatic disease 7. To be given as first line treatment in combination with docetaxel and trastuzumab NOTE: not to be used beyond first disease progression

16 Pomalidomide The treatment of relapsed and refractory multiple myeloma where the 2. Multiple myeloma 3. PS Previously received treatment with adequate trials of at least all of the following options of therapy: bortezomib, lenalidomide and alkylating agents 5. Failed treatment with bortezomib or lenalidomide as defined by progression on or before 60 days of treatment or progressive disease 6 or less months after achieving a partial response or intolerance to bortezomib 6. Refractory disease to previous treatment 7. No resistance to high dose dexamethasone used in the last line of therapy 8. No peripheral neuropathy of grade 2 or more Ponatinib Ponatinib Radium-223 Dichloride The treatment of Chronic Myeloid Leukaemia with T315I Mutation where all the 2. Chronic Myeloid Leukaemia 3. a) Chronic Phase OR b) Accelerated Phase OR c) Blast Phase 4. Documented T315I mutation The treatment of Ph+ Acute Lymphoblastic Leukaemia with T315I Mutation where all the 2. Philadelphia chromosome positive ALL 3. Documented T315I mutation The treatment of castration-resistant prostate cancer patients with bone metastases where the 2. Histologically confirmed, progressive castration-resistant prostate cancer with two or more bone metastases detected on skeletal scintigraphy 3. PS Absence of visceral metastases on recent scanning and no previous history of visceral spread

17 5. Received prior docetaxel, were not healthy enough or declined to receive it 6. Received prior docetaxel, or docetaxel contraindicated or docetaxel refused by patient 7. Symptomatic disease with regular use of analgesic medication or treatment with external-beam radiation therapy required for cancer related bone pain within the previous 12 weeks 8. No previous hemibody external radiotherapy, systematic radiotherapy with radioisotopes within the previous 24 weeks 9. No malignant lymphadenopathy that is more than 3cm in diameter 10. No imminent or established spinal cord compression 11. If receiving treatment with abiraterone or enzalutamide, a sufficient trial of treatment with the abiraterone or enzalutamide has been given to relieve bone symptoms before consideration of radium-223 Regorafenib Ruxolitinib Sorafenib Treatment of adult patients with advanced gastro-intestinal stromal tumours (GIST) after failure of at least previous imatinib and sunitinib where the 2. Histologically confirmed, metastatic or unresectable GIST 3. PS Disease progression on or intolerance to previous imatinib 5. Disease progression on previous sunitinib The treatment of symptomatic splenomegaly in primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis where all the following criteria are met: 2. a) Intermediate / high risk primary myelofibrosis, OR b) Post polycythaemia myelofibrosis, OR c) Post essential thrombocytosis myelofibrosis 3. a) 1st line indication, OR b) 2nd line indication 4. Symptomatic splenomegaly and/or constitutional symptoms 5. Unsuitable for a stem cell transplant The first line treatment of advanced hepatocellular carcinoma where all the 2. Hepatocellular carcinoma 3. a) Child-Pugh grade A liver impairment OR b) Child-Pugh grade B liver impairment with low disease burden 4. No previous systemic therapy

18 Sorafenib Sunitinib Temsirolimus Trastuzumab Emtansine (Kadcyla) Vandetinib 5. No role for surgery or after failure of surgery or after failure of locoregional therapy The treatment of papillary or follicular thyroid cancer where all the 2. Papillary or follicular thyroid cancer (not licensed for this indication) 3. Inoperable or metastatic disease 4. Refractory to radioiodine 5. To be used within the treating Trust s governance framework, as Sorafenib is not licensed in this indication The treatment of pancreatic neuroendocrine carcinomas where all the 2. Biopsy proven well differentiated pancreatic neuroendocrine tumour 3. a) 1st line indication, OR, b) 2nd line indication, OR, c) 3rd line indication 4. No previous VEGF targeted therapy The treatment of advanced renal cell carcinoma where all the 2. Renal cell carcinoma 3. 1st line indication 4. Poor risk patients (at least 3 of 6 prognostic risk factors) The treatment of HER2-positive locally advanced/ unresectable or metastatic (Stage IV) breast cancer 2. Progression of her-2 positive locally advanced or metastatic breast cancer 3. Progression during or after the most recent treatment for advanced stage disease or within 6 months of completing treatment for early stage disease 4. Previous treatment with a taxane 5. Previous treatment with trastuzumab 6. PS 0 or 1 7. Left ventricular ejection fraction of 50% or more To minimise the risk of errors due to the similarity of the product name Trastuzumab Emtansine (Kadcyla) with that of Trastuzumab (Herceptin) the recommendations in the Risk Minimisation Plan educational material from the manufacturer should be followed when prescribing, dispensing and administering the product The treatment of medullary thyroid cancer where all the following criteria are met:

19 Vismodegib 2. Locally advanced and unresectable or metastatic medullary thyroid cancer 3. Symptomatic disease 4. No previous biological therapy The treatment of locally advanced or metastatic Basal Cell Carcinoma where all the 2. Application approved by relevant specialist skin cancer MDT 3. Locally advanced or metastatic basal cell carcinoma 4. Curative resection not possible as assessed by a specialist in dermatological surgery, head and neck surgeon or plastic surgeon 5. Previous radiotherapy unless contraindicated or inappropriate 6. PS Fit for Vismodegib therapy

20 National Cancer Drugs Fund Not Approved (Updated 03 February 2014) Afatinib DRUG Albumin Bound Paclitaxel Albumin Bound Paclitaxel Bendamustine Bendamustine Bortezomib Bortezomib Brentuximab INDICATION APPLIED FOR AND NOT APPROVED 3rd line treatment for metastatic NSCLC in good performance status patients with EGFR positive disease. Advanced adenocarcinoma of pancreas in combination with gemcitabine Metastatic breast cancer in patients with ECOG PS <2 and visceral dominant disease who have progressed following at least one line of chemotherapy in the metastatic setting In combination with Rituximab for the treatment of relapsed/ refractory DLBCL. Relapsed/ refractory classical Hodgkin Lymphoma Treatment of progressive (recurrent) glioblastoma after initial treatment with radiotherapy and temozolomide. Continued use of bevacizumab with standard second line fluoropyrimidine-based chemotherapy after first progression on bevacizumab and fluoropyrmidine-based chemotherapy in metastatic colorectal cancer. The second line treatment of advanced colorectal cancer in combination with irinotecan-based combination chemotherapy. Treatment breaks in the treatment of metastatic colorectal cancer 1st line treatment recurrent or metastatic cervical cancer in combination with carboplatin and paclitaxel In combination with vinorelbine for the 3rd line treatment of metastatic breast cancer In combination with chemotherapy for platinum resistant, relapsed ovarian cancer 1st line treatment option in metastatic colorectal cancer with triplet combination chemotherapy Induction therapy prior to high dose melphalan and ASCT in newly diagnosed multiple myeloma In combination with dexamethasone (VD), or with dexamethasone and thalidomide (VTD), is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Treatment of relapsed CD30 positive T-cell lymphomas

21 Lapatinib Lapatinib Panitumumab Pemetrexed Pixantrone Pixantrone Ponatinib Ponatinib Regorafenib Sorafenib Trabectedin Vinflunine Treatment of adult patients with breast cancer, whose tumours overexpress HER2 (ErbB2) in combination with an aromastase inhibitor (AI) for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy. Treatment of adult patients with breast cancer, whose tumours overexpress HER2, in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy. Third-line monotherapy of patients with metastatic rectal adenocarcinoma Maintenance treatment following carboplatin and pemetrexed induction chemotherapy in non squamous non small-cell lung cancer Monotherapy for treatment of multiply relapsed or refractory aggressive B-cell non-hodgkin lymphoma 3rd line monotherapy for treatment of multiply relapsed or refractory aggressive B-cell Non-Hodgkin Lymphoma as a bridge to transplant Philadelphia-chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib, who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate Chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib, who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate Treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. 3rd line treatment of relapsed/refractory FLT3 +ve acute myeloid leukaemia (AML) as a bridging to transplant or post transplant salvage therapy as a bridge to DLI therapy Relapsed platinum sensitive ovarian cancer for patients who will benefit from a non platinum therapy as next option. For locally advanced or metastatic transitional cell carcinoma of the urothelial tract after a prior platinum containing regimen

22 National Cancer Drugs Fund List Decisions awaiting further information (Updated 12 February 2014) DRUG Everolimus (Votubia) Imatinib (High Dose) Pentostatin NCDF APPLICATION COHORT 3rd line therapy for low grade gliomas of childhood and young adults Treatment of patients aged 3 years and older with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery. Gastro-intestinal Stromal Tumours with exon 9 mutation in KIT Treatment of T-PLL in patients refractory to alemtuzumab