NICE TECHNOLOGY APPRAISAL MEDICINES REPORT 2017

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1 NICE TECHNOLOGY PPRISL MEDICINES REPORT St George s Healthcare NHS Trust key for medicine-related NICE Technology ppraisals. has been approved by the Drugs and Therapeutics Committee as recommended within the NICE technology appraisal. has been terminated or not recommended C. is not relevant to the Trust as the treatment pathway is not commissioned Red: St George s Healthcare formulary diverges from the NICE recommendations Green: pproved on National Cancer Drug Fund (CDF) list for specific indications (provided patient fulfils specific criteria) Last Updated: pril

2 NICE TECHNOLOGY PPRISL MEDICINES REPORT Ref T Title Date 427 Pomalidomide for multiple myeloma with lenalidomide and bortezomib Pomalidomide, in combination with low dose dexamethasone, is recommended as an option for treating 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. Pembrolizumab is recommended as an option for treating locally advanced or metastatic PD L1 positive non small cell lung cancer in adults who have had at 428 Pembrolizumab for treating PD-L1- positive non-small-cell lung cancer after chemotherapy least one chemotherapy (and targeted treatment if they have an epidermal growth factor receptor [EGFR]- or anaplastic lymphoma kinase [LK] positive tumour), only if: pembrolizumab is stopped at 2 years of uninterrupted treatment and no documented disease progression, and the company provides pembrolizumab with the discount agreed in the patient access scheme revised in the context of this appraisal. 429 Ibrutinib for chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation Ibrutinib alone is recommended within its marketing authorisation as an option for treating chronic lymphocytic leukaemia in adults: who have had at least 1 prior therapy or who have a 17p deletion or TP53 mutation, and in whom chemoimmunotherapy is unsuitable and only when the company provides ibrutinib with the discount agreed in the patient access scheme Last Updated: pril

3 NICE TECHNOLOGY PPRISL MEDICINES REPORT Ref T Title Date Sofosbuvir velpatasvir is recommended as an option for treating chronic hepatitis C in adults, only if the company provides the drug with the discount agreed in the simple discount agreement, regardless of treatment history, and in the following cases: Genotype 1, 4, 5, and 6 with or without compensated cirrhosis 430 Sofosbuvir velpatasvir for treating chronic hepatitis C Genotype 2 with compensated cirrhosis. Genotype 3 without cirrhosis dditionally it is recommended: With ribavirin for Genotype 1 6 with decompensated cirrhosis. With or without ribavirin for Genotype 3 with compensated cirrhosis. For genotype 2 without cirrhosis. For previously untreated Genotype 2 without cirrhosis who cannot tolerate interferon or it is not suitable for them Last Updated: pril

4 NICE TECHNOLOGY PPRISL MEDICINES REPORT Ref T Title Date Mepolizumab, as an add-on to optimised standard therapy, is recommended as an option for treating severe refractory eosinophilic asthma in adults, only if: the blood eosinophil count is 300 cells/microlitre or more in the previous 12 months and the person has agreed to and followed the optimised standard treatment plan and o has had 4 or more asthma exacerbations needing systemic corticosteroids in the previous 12 months or 431 Mepolizumab for treating severe refractory eosinophilic asthma o has had continuous oral corticosteroids of at least the equivalent of prednisolone 5 mg per day over the previous 6 months and the company provides the drug with the discount agreed in the patient access scheme. t 12 months of treatment: stop mepolizumab if the asthma has not responded adequately or continue treatment if the asthma has responded adequately and assess response each year. n adequate response is defined as: at least 50% fewer asthma exacerbations needing systemic corticosteroids in those people with 4 or more exacerbations in the previous 12 months or a clinically significant reduction in continuous oral corticosteroid use while maintaining or improving asthma control Last Updated: pril

5 NICE TECHNOLOGY PPRISL MEDICINES REPORT Ref T Title Date 432 Everolimus for advanced renal cell carcinoma after previous treatment February Everolimus is recommended within its marketing authorisation as an option for treating 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. 1.1 premilast, alone or in combination with disease-modifying antirheumatic drugs (DMRDs), is recommended as an option for treating active psoriatic arthritis in adults only if: they have peripheral arthritis with 3 or more tender joints and 3 or more swollen joints and their disease has not responded to adequate trials of at least 2 standard DMRDs, given either alone or in combination and the company provides apremilast with the discount agreed in the patient access scheme. 1.2 Stop apremilast at 16 weeks if the psoriatic arthritis has not shown an adequate response using the Psoriatic rthritis response Criteria (PsRC), defined as an improvement in at least 2 of 433 premilast for treating active psoriatic arthritis February the 4 PsRC criteria (including joint tenderness or swelling score) with no worsening in any criteria. If the disease has a Psoriasis rea and Severity Index (PSI) 75 response, a dermatologist should decide whether to continue treatment with apremilast after 16 weeks based on skin response. 1.3 When using the PsRC healthcare professionals should take into account any physical, sensory or learning disabilities, or communication difficulties that could affect a person's responses to components of the PsRC and make any adjustments they consider appropriate. 1.4 This guidance is not intended to affect the position of patients whose treatment with apremilast was started within the NHS before this guidance was published. Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop Last Updated: pril

6 NICE TECHNOLOGY PPRISL MEDICINES REPORT Ref T Title Date Elotuzumab for multiple myeloma Tenofovir alafenamide for treating chronic hepatitis evacizumab for treating EGFR mutation-positive non-small-cell lung cancer (terminated appraisal) NICE was unable to make a recommendation about the use in the NHS of elotuzumab for multiple myeloma because no evidence submission was received from ristol Myers Squibb, but will review this decision if the company decides to make a submission. NICE was unable to make a recommendation about the use in the NHS of tenofovir alafenamide for treating chronic hepatitis because no evidence submission was received from Gilead, but will review this decision if the company decides to make a submission. NICE was unable to make a recommendation about the use in the NHS of bevacizumab for treating epidermal growth factor receptor mutation-positive non-small-cell lung cancer because no evidence submission was received from Roche, but will review this decision if the company decides to make a submission. Non- Non- Non- 437 Ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy NICE was unable to make a recommendation about the use in the NHS of ibrutinib with bendamustine and rituximab for treating relapsed or refractory chronic lymphocytic leukaemia after systemic therapy because no evidence submission was received from Janssen-Cilag, but will review this decision if the company decides to make a submission. Non- 438 lectinib for anaplastic lymphoma kinase-positive advanced non-smallcell lung cancer NICE is unable to make a recommendation about the use in the NHS of alectinib for anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer with crizotinib because no evidence submission was received from Roche. We will review this decision if the company decides to make a submission. Non Last Updated: pril

Summary of Main Points from the Meeting held on Monday 13 th March 2017

Summary of Main Points from the Meeting held on Monday 13 th March 2017 2. Minutes and Summary Notes from last meeting The Minutes and Summary notes from the February 2017 Medicines Group meeting were