SMC Advice - Formulary Decisions October - November 2014

Scottish Medicines Consortium Recommendations

Date / Product/Manufacturer / SMC Advice / Decision of ADTC / Rationale
October 2014
772/12 / saxagliptin, 2.5mg and 5mg, film-coated tablets (Onglyza®)
Bristol-Myers Squibb/AstraZeneca
In adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control . as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Comparator Medicines:
Exenatide, lixisenatide, pioglitazone, canagliflozin*, dapagliflozin*
* Canagliflozin and dapagliflozin were recently accepted by SMC in combination with insulin, so were not considered comparators in the company’s submission.
None of the DPP-4 inhibitors have been accepted for use within NHS Scotland in combination with insulin. / saxagliptin (Onglyza®) is accepted for use within NHS Scotland.
Indication under review: In adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
A phase IIIb, randomised, double-blind, placebo-controlled, parallel-group study in adult patients with type 2 diabetes mellitus and inadequate glycaemic control on a stable dose of insulin showed that addition of saxagliptin 5mg daily was superior to placebo for the primary endpoint of change from baseline in HbA1c at 24 weeks.
The manufacturer’s submission related only to the use of saxagliptin in combination with insulin (with or without metformin). SMC cannot recommend the use of saxagliptin as monotherapy. / Included on the Fife Formulary for this new indication. / SMC saxagliptin
October 2014
1003/14 / aflibercept, 40mg/mL solution for injection (Eylea®)
Bayer
For adults for the treatment of visual impairment due to diabetic macular oedema (DMO).
Comparator Medicines:
Intravitreal ranibizumab / aflibercept (Eylea®) is accepted for restricted use within NHS Scotland.
Indication under review: For adults for the treatment of visual impairment due to diabetic macular oedema (DMO).
SMC restriction: treatment of visual impairment due to DMO in adults with best corrected visual acuity (BCVA) 75 Early Treatment Diabetic Retinopathy Study (ETDRS) letters or less at baseline.
Intravitreal aflibercept significantly improved BCVA at 52 weeks compared with laser photocoagulation in two phase III, double-masked studies.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of aflibercept. This advice is contingent upon the continuing availability of the patient access scheme, or a list price that is equivalent or lower, in NHS Scotland. / Included on the Fife Formulary for this indication.
Alternative to ranibizumab (Lucentis®)
Hospital use only. / SMC aflibercept
October 2014
1002/14 / daclatasvir 30mg and 60mg film-coated tablets (Daklinza®)
Bristol-Myers Squibb
In combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Comparator Medicines:
Peginterferon-free comparator regimens are sofosbuvir plus ribavirin or simeprevir plus sofosbuvir ± ribavirin. Other antiviral + PR for genotype 1 CHC include telaprevir + PR and boceprevir + PR. For patients with genotype 4 CHC, treatment is with sofosbuvir + PR, simeprevir + PR or PR alone / daclatasvir (Daklinza®) is accepted for restricted use within NHS Scotland.
Indication under review: In combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.
SMC restriction: use is restricted to patients with significant fibrosis (Metavir scores F3-F4) or compensated cirrhosis.
In a phase II study 89% to 99% of patients with genotype 1 and 3 HCV treated with daclatasvir in various peginterferon-free regimens achieved a sustained virological response at 12 weeks (SVR12). In a phase III study of patients with genotype 4 HCV, the superiority of daclatasvir with peginterferon-alfa plus ribavirin (PR) versus placebo + PR was demonstrated for the primary endpoint of SVR12. / Included on the Fife Formulary.
Restricted to patients with significant fibrosis (Metavir scores F3-F4) or compensated cirrhosis.
Hospital use only. / SMC daclatasvir_Daklinza
October 2014
913/13 / mifepristone 200mg tablet and misoprostol 0.2mg vaginal tablets combipack (Medabon®)
Sun Pharma
Product Update / mifepristone tablet and misoprostol vaginal tablets combipack (Medabon®) is accepted for use within NHS Scotland.
Indication under review: for medical termination of developing intra-uterine pregnancy of up to 63 days of amenorrhoea.
For patients in whom mifepristone and misoprostol is an appropriate choice of therapy, Medabon® provides the two components in a single pack at a lower cost than the individual components. / Included on the Fife Formulary.
For restricted use for early medical discharge termination of pregnancy patients.
Hospital use only. / SMC mifepristone_Medabon
Preferred formulary options are mifepristone and misoprostol as separate ingredients.
October 2014
991/14 / brinzolamide 10mg/mL and brimonidine tartrate 2mg/mL eye drops, suspension (Simbrinza®)
Alcon Eye Care UK Ltd
Product Update
(No: 956/14) / brinzolamide / brimonidine tartrate eye drops, suspension (Simbrinza®) is accepted for use within NHS Scotland.
Indication under review: decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction.
There is no significant additional cost associated with the combination product compared with the individual components and it allows patients to administer fewer drops. / Not included on the Fife Formulary because clinicians do not support Formulary inclusion. / SMC brinzolamide-brimonidine_Simbrinza
Not preferred.
Individual components are both listed on the Fife Formulary.
http://www.fifeadtc.scot.nhs.uk/formulary/11-eye.aspx
October 2014
595/10 / everolimus 2.5mg, 5mg and 10mg tablets (Afinitor®)
Ferring Novartis Pharmaceuticals UK Limited
Resubmission
Treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy
Comparator Medicines:
Other medicines licensed for second-line use in RCC include axitinib (after sunitinib or cytokines), sorafenib, sunitinib (after interferon or interleukin), pazopanib (first-line but also second-line after cytokines). However only axitinib has been accepted for second-line use by SMC. / everolimus (Afinitor®) is accepted for use within NHS Scotland.
Indication under review: the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with vascular endothelial growth factor (VEGF)-targeted therapy.
Everolimus, in conjunction with best supportive care (BSC), increased median progression-free survival (PFS) by three months compared with placebo plus BSC in heavily pre-treated patients with metastatic renal cell carcinoma.
The economic case for everolimus was based on patients whose disease has progressed on or after one previous VEGF-targeted therapy. / Not included pending protocol. / SMC everolimus_Afintor
Await formulary submission by SCAN and Lothian Formulary Committee decision.
October 2014 997/14 / ipilimumab 5mg/mL concentrate for solution for infusion (Yervoy®)
Bristol-Myers Squibb Pharmaceuticals Ltd
Treatment of advanced (unresectable or metastatic) melanoma in adults.
The license extension relates to treatment of previously untreated adult patients with advanced (unresectable or metastatic) melanoma (i.e. first-line use).
Comparator Medicines:
Vemurafenib, dacarbazine / ADVICE: following a full submission considered under the end of life/orphan medicine process.
ipilimumab (Yervoy®) is accepted for use within NHS Scotland.
Indication under review: Treatment of advanced (unresectable or metastatic) melanoma in adults (first-line use).
In a phase III, randomised study median overall survival was extended by 2.1 months in patients treated with ipilimumab plus dacarbazine (an unlicensed dose regimen) compared with dacarbazine alone. Efficacy data for the licensed dose of ipilimumab are limited to two retrospective single-arm observational studies where median overall survival was 11.5 to 14.3 months.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of Ipilimumab. This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting / Not included pending protocol. / SMC ipilimumab_Yervoy
Await formulary submission by SCAN and Lothian Formulary Committee decision.
October 2014
1013/14 / denosumab (Prolia®) 60 mg solution for injection in a pre-filled syringe Amgen Ltd
Non SMC Submission / ADVICE: in the absence of a submission from the holder of the marketing authorisation
denosumab (Prolia®) is not recommended for use within NHS Scotland.
Indication under review: osteoporosis in men at increased risk of fractures
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland.
NICE (National Institute for Health and Clinical Excellence) is currently undertaking a multiple technology appraisal (MTA) that includes the use of denosumab in this indication. However, due to the significant time interval between product availability and the expected date of NICE guidance, not recommended advice has been issued. / Not recommended.
Requires submission and approval of an IPTR. / SMC denosumab_Prolia
Non-submission
October 2014
897/13 / pertuzumab 30mg/mL concentrate for solution for infusion (Perjeta®)
Roche Products Ltd
For use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease
Comparator Medicines:
The current first-line chemotherapy regimen for metastatic or locally recurrent unresectable breast cancer in patients who have not received a taxane over the preceding year is a taxane (docetaxel or paclitaxel) plus trastuzumab. Pertuzumab is likely to be added to trastuzumab and docetaxel, to create a new regimen of pertuzumab, docetaxel and trastuzumab / ADVICE: following a re-submission considered under the end of life/orphan medicine process.
pertuzumab (Perjeta®) is not recommended for use within NHS Scotland.
Indication under review: for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Addition of pertuzumab to current first-line treatment, trastuzumab plus docetaxel, significantly increased progression-free and overall survival for women with HER2-positive metastatic breast cancer.
The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment’s cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting. / Not recommended.
Requires submission and approval of an IPTR. / SMC pertuzumab_Perjeta
Lack of evidence of health benefits compared to cost.
October 2014
1015/14 / telavancin hydrochloride (Vibativ®) 250 mg and 750 mg powder for concentrate for solution for infusion
Clinigen Healthcare Ltd
Non SMC Submission / ADVICE: in the absence of a submission from the holder of the marketing authorisation
telavancin hydrochloride (Vibativ®) is not recommended for use within NHS Scotland.
Indication under review: treatment of adults with nosocomial pneumonia (NP) including ventilator associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA).
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. / Not recommended.
Requires submission and approval of an IPTR. / SMC telavancin_hydrochloride_Vibativ
Non-submission
October 2014
1014/14 / voriconazole (Vfend®) 50 mg and 200 mg film-coated tablets / 200 mg powder for solution for infusion / 200 mg powder and solvent for solution for infusion / 40 mg/ml powder for oral suspension
Pfizer Ltd
Non SMC Submission / ADVICE: in the absence of a submission from the holder of the marketing authorisation
voriconazole (Vfend®) is not recommended for use within NHS Scotland.
Indication under review: Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
The holder of the marketing authorisation has not made a submission to SMC regarding this product in this indication. As a result we cannot recommend its use within NHSScotland. / Not recommended for this indication.
Requires submission and approval of an IPTR. / SMC voriconazole_Vfend
Non-submission
November 2014
1008/14 / obinutuzumab 1,000mg concentrate for solution for infusion (Gazyvaro®)
Roche Products Limited
In combination with chlorambucil, obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia and with comorbidities making them unsuitable for full-dose fludarabine based therapy
Comparator Medicines:
Chorambucil monotherapy; rituximab+chlorambucil; bendamustine monotherapy; rituximab+bendamustine. / obinutuzumab (Gazyvaro®) is accepted for use within NHS Scotland.
Indication under review: In combination with chlorambucil, obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy.
The combination of obinutuzumab plus chlorambucil produced a statistically and clinically significant increase in progression free survival compared with an alkylating agent alone or an alkylating agent/antibody combination, in older patients with previously untreated CLL who had substantial comorbidities. / Included on the Fife Formulary.
To be used in combination with chlorambucil in patients who are unsuitable for treatment with full dose fludarabine.
Hospital use only. / SMC obinutuzumab (Gazyvaro)
November 2014
972/14 / pomalidomide 1mg, 2mg, 3mg and 4mg hard capsules (Imnovid®)
Celgene Ltd
Resubmission
In combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy
Comparator Medicines:
There is no standard of care for patients with relapsed or refractory multiple myeloma after at least two other treatments. Possible options include retreatment with bortezomib or lenalidomide, clinical trials, older agents, bendamustine (not accepted by SMC) or palliation. / pomalidomide (Imnovid®) is accepted for use within NHS Scotland.
Indication under review: in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Pomalidomide plus dexamethasone significantly increased progression-free survival compared with high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.