Commissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December

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Commissioning policies agreed by PCTs in Yorkshire and the Humber at Board meeting of YH SCG on December 17 2010. 32/10 Imatinib for gastrointestinal stromal tumours (unresectable/metastatic) (update on NICE TA 86) 33/10 Ofatumumab for chronic lymphocytic leukaemia 34/10 Trastuzumab for gastric cancer (HR2-positive metastatic) To be routinely funded in accordance with NICE TA 209 (and previously issued TA 86) To be not routinely funded in accordance with NICE TA 202 To be routinely funded in accordance with NICE TA 208 NICE TA 209 NICE TA 202 NICE TA 208 35/10 Alemtuzumab Not routinely funded for the first-line treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate, including patients with 17p deleted B-CLL. 36/10 Azacitidine Not routinely funded for the treatment of patients with: intermediate -2 and high-risk myelodysplastic syndromes (MDS); chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder; acute myeloid leukaemia (AML) with 20-30 % blasts and multilineage dysplasia. 37/10 Bevacizumab Not routinely funded for the treatment of patients with glioblastoma No robust of costeffectiveness No robust of costeffectiveness No robust of costeffectiveness

38/10 Bevacizumab (with taxane) Not routinely funded for the 1st line treatment of patients with triple negative breast cancer with rapidly progressive disease SCG previously agreed to not routinely fund bevacizumab for 1 st -line treatment of metastatic breast cancer. For this subgroup of patients, with triple negative disease, there is limited information about overall survival. Therefore, the PCT is not able to assure itself that this is a cost-effective use of resource. 39/10 Bortezomib (with melphalan and prednisolone) Not routinely funded for the treatment of patients with previously untreated multiple myeloma, including in patients with renal failure, who are not eligible for high-dose chemotherapy with bone marrow transplant 09/09 Cetuximab Not routinely funded for the treatment (as monotherapy) of patients with EGFR-expressing, KRAS wild-type metastatic colorectal cancer who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. 40/10 Clofarabine As a single agent for patients with acute lymphoblastic leukaemia in relapse or refractory to 1st salvage treatment with disease 1st presentation age of <21 41/10 Dasatinib Not routinely funded for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy including imatinib 42/10 Erlotinib Not routinely funded for the 3rd line treatment of NSCLC, including those patients who entered a 2nd line trial and did not receive erlotinib No robust of costeffectiveness Previously agreed SCG Published estimates of costeffectiveness are based on limited clinical data. The PCT is not able to assure itself that this is a cost-effective No robust of costeffectiveness No robust of costeffectiveness

04/10 Everolimus Not routinely funded for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy 43/10 Imatinib Not routinely funded for the treatment of patients with: newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), in younger, fitter patients, integrated with chemotherapy OR relapsed or refractory Ph+ ALL as monotherapy in patients not previously exposed to a tyrosine kinase inhibitor 44/10 Lapatinib (with Capecitabine) Not routinely funded for the treatment of advanced or metastatic breast cancer. 45/10 Pemetrexed Not routinely funded Monotherapy for the secondline treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients who did not receive 1 st line pemetrexed e.g. 1st line clinical trial 46/10 Rituximab Not routinely funded as 1st line maintenance therapy in patients with follicular lymphoma who have responded to induction treatment 12/10 Sorafenib Not routinely funded for 1st line treatment of hepatocellular carcinoma 47/10 Sunitinib Not routinely funded for the treatment of advanced pancreatic neuroendocrine tumours (NET) 06/09 Temsirolimus Not routinely funded for the 1st line treatment of patients with advanced renal cell carcinoma. Previously agreed SCG No robust of costeffectiveness Previously agreed with SCG on basis of recommendation from the tri-network Cancer Drugs Group. No robust of costeffectiveness No robust of costeffectiveness No robust of costeffectiveness Previously agreed SCG based on NICE TA189 No robust of costeffectiveness Previously agreed SCG based on NICE TA178

48/10 Topotecan (with cisplatin) Not routinely funded for the 2nd line treatment of cervical cancer in patients having received cisplatin > 12 months previously NICE TA 183 recommends that topotecan, in combination with cisplatin, is recommended as a possible treatment for women with recurrent or stage IVB cervical cancer only if they have not received cisplatin before. There is no robust of cost-effectiveness available to support use this sub-group of women who have received cisplatin more than 12 months previously so the

General 32/10 (brand name, manufacturer) For the treatment of Commissioning Imatinib (Glivec, Novartis) Unresectable and/or metastatic gastrointestinal stromal tumours To be routinely funded, to a maximum of 400mg daily, for the first-line management of people with KIT (CD117)- positive unresectable and/or KIT (CD117)-positive metastatic gastro-intestinal stromal tumours (GISTs) in accordance with NICE TA 86 and NICE TA 209, subject to assessment of response every 12 weeks and discontinuation if of lack of response. Following a review of clinical and cost effectiveness, NICE states that imatinib, to a maximum dose of 400mg daily, is recommended for the for the first-line management of people with KIT (CD117)-positive unresectable and/or KIT (CD117)-positive metastatic gastro-intestinal stromal tumours (GISTs). Response should be assessed at 12 weeks and continued only if there is objective of response. should be reviewed every 12 weeks and discontinued if there is no objective of response. reviewed by Contact for this Paul McManus

General 33/10 (brand name, manufacturer) For the treatment of Commissioning Effective from Ofatumumab (Arzerra, GlaxoSmithKline) Chronic lymphocytic leukaemia To be not routinely funded, for the treatment of patients with chronic lymphocytic leukaemia that is refractory to fludarabine and alemtuzumab, in accordance with NICE TA 202. 27 October 2010 (date of publication by NICE) Following assessment of clinical and cost effectiveness, NICE states that ofatumumab is not recommended for the treatment of chronic lymphocytic leukaemia that is refractory to fludarabine and alemtuzumab. reviewed by Contact for this Paul McManus

General 34/10 (brand name, manufacturer) For the treatment of Commissioning Effective from Trastuzumab (Herceptin, Roche) Gastric cancer (HER2-positive, metastatic) To be routinely funded for the treatment of certain people with human epidermal growth factor receptor 2 (HER2)-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction, in accordance with NICE TA208. 24 February 2011 (3-months from publication of NICE technology appraisal) Following assessment of clinical and cost effectiveness, NICE states that trastuzumab, in combination with cisplatin and capecitabine or 5-fluorouracil, is recommended as an option for the treatment of people with human epidermal growth factor receptor 2 (HER2)- positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who: have not received prior treatment for their metastatic disease and have tumours expressing high levels of HER2 as defined by a positive immunohistochemistry score of 3 (IHC3 positive). reviewed by Contact for this Paul McManus

General 35/10 Alemtuzumab For the treatment of B-cell chronic lymphocytic leukaemia Commissioning To be not routinely funded for the first-line treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL) for whom fludarabine combination chemotherapy is not appropriate, including patients with 17p deleted B-CLL. No robust of cost-effectiveness available so the Contact for this Paul McManus

General 36/10 Azacitidine For the treatment of Commissioning - intermediate -2 and high-risk myelodysplastic syndromes (MDS); - chronic myelomonocytic leukaemia (CMML) with 10-29 % marrow blasts without myeloproliferative disorder; - acute myeloid leukaemia (AML) with 20-30 % blasts and multi-lineage dysplasia. To be not routinely funded for the treatment of patients with the above indications. No robust of cost-effectiveness itself that this is a cost-effective reviewed by Contact for this Paul McManus

General 37/10 For the treatment of Commissioning Bevacizumab Glioblastoma To be not routinely funded for the treatment of patients with glioblastoma No robust of cost-effectiveness itself that this is a cost-effective Contact for this Paul McManus

General 38/10 Bevacizumab For the treatment of Metastatic breast cancer Commissioning To be not routinely funded for the 1st line treatment of patients with triple negative breast cancer with rapidly progressive disease SCG previously agreed to not routinely fund bevacizumab for 1 st -line treatment of metastatic breast cancer. For this subgroup of patients, with triple negative disease, there is limited information about overall survival. Therefore, the itself that this is a cost-effective Contact for this Paul McManus

General 39/10 For the treatment of Commissioning Bortezomib Multiple myeloma (1 st -line) To be not routinely funded for the treatment of patients with previously untreated multiple myeloma, including in patients with renal failure, who are not eligible for highdose chemotherapy with bone marrow transplant No robust of cost-effectiveness itself that this is a cost-effective Contact for this Paul McManus

General 40/10 For the treatment of Commissioning Clofarabine Acute lymphoblastic leukaemia To be not routinely funded as a single agent for the treatment of patients with acute lymphoblastic leukaemia in relapse or refractory to 1st salvage treatment with disease first presenting at age 21 years or lower. Published estimates of cost-effectiveness are based on limited clinical data. The itself that this is a cost-effective Contact for this Paul McManus

General 41/10 For the treatment of Commissioning Dasatinib Acute lymphoblastic leukaemia; chronic myeloid leukaemia To be not routinely funded for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy including imatinib No robust of cost-effectiveness itself that this is a cost-effective use of resource Contact for this Paul McManus

General 42/10 Erlotinib For the treatment of Non-small cell lung cancer (3 rd line) Commissioning To be not routinely funded for the third line treatment of patients with NSCLC, including those patients who entered a 2nd line trial and did not receive erlotinib No robust of cost-effectiveness itself that this is a cost-effective Contact for this Paul McManus

General 43/10 Imatinib For the treatment of Acute lymphoblastic leukaemia Commissioning To be not routinely funded for the treatment of patients with: newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), in younger, fitter patients, integrated with chemotherapy; OR relapsed or refractory Ph+ ALL as monotherapy in patients not previously exposed to a tyrosine kinase inhibitor No robust of cost-effectiveness itself that this is a cost-effective use of resource Contact for this Paul McManus

General 44/10 Lapatinib For the treatment of Breast cancer Commissioning To be not routinely funded for the treatment of patients with advanced or metastatic breast cancer Recommendation from the Tri-Network Cancer Drugs Group. No robust of cost-effectiveness available so the Contact for this Paul McManus

General 45/10 Pemetrexed For the treatment of Non-small cell lung cancer (2 nd line) Commissioning To be not routinely funded as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients who did not receive 1 st line pemetrexed (e.g. 1st line clinical trial) No robust of cost-effectiveness itself that this is a cost-effective use of resource Contact for this Paul McManus

General 46/10 Rituximab For the treatment of Follicular lymphoma (1 st line maintenance) Commissioning To be not routinely funded as 1st line maintenance therapy in patients with follicular lymphoma who have responded to induction treatment No robust of cost-effectiveness available so the use of resource Contact for this Paul McManus

General 47/10 Sunitinib For the treatment of Advanced pancreatic neuroendocrine tumours (NET) Commissioning To be not routinely funded for the treatment of patients with advanced pancreatic neuroendocrine tumours (NET) No robust of cost-effectiveness itself that this is a cost-effective Contact for this Paul McManus

General 48/10 Topotecan For the treatment of Cervical cancer (in patients having received cisplatin > 12 months previously) Commissioning To be not routinely funded for the 2nd line treatment of cervical cancer in patients having received cisplatin > 12 months previously NICE TA 183 recommends that topotecan, in combination with cisplatin is recommended as a possible treatment for women with recurrent or stage IVB cervical cancer only if they have not received cisplatin before. There is no robust of cost-effectiveness available to support use this sub-group of women who have received cisplatin more than 12 months previously so the use of resource Contact for this Paul McManus