Area Drug and Therapeutics Committee Prescribing Supplement No 33 November 2009

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 33 In this issue Drugs currently being considered by SMC advice due on 7 th December 2009 Latest changes to the formulary New drugs considered by SMC in August, September and October Drugs currently being considered by the SMC with advice due on 7 th December 2009 SMC REVIEW INDICATION Tafluprost (Saflutan ) No 581/09 Liraglutide (Victoza ) No 585/09 Imatinib (Glivec ) No 584/09 Bemiparin sodium (Zibor ) No 204/05 Valganciclovir (Valcyte ) No 586/09 Valganciclovir (Valcyte ) No 587/09 Pramipexole (Mirapexin ) No 580/09 Glaucoma Type 2 diabetes Gastrointestinal stromal tumour Prevention of thromboembolic disease in patients undergoing orthopaedic surgery. Induction and maintenance treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. Prevention of cytomegalovirus disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor. Prolonged release formulation for the treatment of idiopathic Parkinson s disease Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1

2 LATEST CHANGES TO THE FORMULARY OF MOST RELEVANCE TO PRIMARY CARE ADDITIONS Terlipressin acetate 0.12mg/ml solution for injection (Glypressin Solution) - Treatment of bleeding oesophageal varices. Enoxaparin prefilled syringes and multidose vial (Clexane ) - Treatment of acute STsegment elevation myocardial infarction (STEMI) Calcipotriol and betamethasone dipropionate, 50 micrograms/g micrograms/g gel - The topical treatment of scalp psoriasis. (Xamiol ) Vildagliptin 50mg tablets (Galvus ) - For the treatment of type 2 diabetes mellitus as dual oral therapy in combination with a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea or for whom metformin is inappropriate due to contraindications or intolerance. RESTRICTED NON-FORMULARY USE Rotigotine, transdermal patch (Neupro ) - Symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome in adults. formulary for general use but non-formulary use allowed as per the SMC - It should only be used in patients with a baseline score of 15 points or more on the International Restless Legs Scale (IRLS). Metformin prolonged release tablets (Glucophage SR ) - Treatment of type 2 diabetes mellitus in adults. It is restricted to use in patients who are intolerant of immediate release metformin and in whom the prolonged release tablet allows the use of a dose of metformin not previously tolerated or in patients for whom a once-daily preparation offers a clinically significant benefit. Esomeprazole, 40mg vial of powder for solution for intravenous injection or infusion (Nexium I.V. ) - Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. If IV treatment needs to be followed by use of an oral PPI then it is essential that a formulary drug is chosen i.e. omeprazole or lansoprazole. NOT RECOMMENDED FOR USE IN NHSL Agomelatine, 25mg film-coated tablets (Valdoxan ) - Treatment of major depressive episodes in adults. Olmesartan medoxomil/amlodipine as besilate tablet (Sevikar ) - Treatment of essential hypertension Etoricoxib (Arcoxia ) - Ankylosing spondylitis Ranolazine prolonged release tablets (Ranexa) - Add on therapy for the symptomatic treatment of patients with angina pectoris. Estradiol/dienogest (Qlaira ) - Oral contraception Quetiapine tablets (Seroquel ) - Treatment of major depressive episodes associated with bipolar disorder Nepafenac (Nevanac ) - For prevention and treatment of postoperative pain and inflammation associated with cataract surgery. The following new drugs have been reviewed by the Scottish Medicines Consortium in August, September and October : - Colour coding of decisions about new medicines: - Green = accepted for general use in Lanarkshire and added to the Joint Formulary Orange = accepted for restricted use in Lanarkshire and added to the Joint Formulary only for the restricted use advised by the Scottish Medicines Consortium (SMC) Light orange = treatment or pending specialist advice on formulary status. Non acceptable if the drug is s and Red = not accepted for use in Lanarkshire and not added to the Joint Formulary. A request to prescribe a drug in this category must be clinically justified by the prescriber. Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 2

3 No 566/09 No 562/09 Drug/product Indication SMC Lanarkshire and ADTC comments Darunavir, 400mg tablets (Prezista ) Prasugrel 5 and 10mg tablets (Efient ) Darunavir, co-administered with low dose ritonavir, is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection in antiretroviral therapy (ART) naïve adults. Co-administered with aspirin, for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) (i.e. unstable angina, non-st segment elevation myocardial infarction [UA/NSTEMI] or ST segment elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI). Darunavir (Prezista ) co-administered with low dose ritonavir and in combination with other antiretroviral medicinal products is accepted within NHS Scotland for the treatment of human immunodeficiency virus (HIV-1) infection in antiretroviral therapy (ART) naïve adults. After 48 weeks the combination of darunavir and ritonavir was noninferior to a standard boosted protease inhibitor regimen in ART naïve adults. The combined regimen was associated with lower incidences of diarrhoea and lipid adverse effects. Prasugrel (Efient ) co-administered with aspirin is accepted for restricted use within NHS Scotland for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing primary or delayed percutaneous coronary intervention. Use is restricted to patients who are eligible to receive the 10mg dose of prasugrel. When compared to an alternative antiplatelet agent, prasugrel demonstrated a significant reduction in the incidence of ischaemic events, mainly non-fatal myocardial infarction, in patients with acute coronary syndrome undergoing percutaneous coronary intervention. Prasugrel was, however, also associated with an increased risk of clinically significant bleeding events. specialist nature of the acceptable if the drug is used according to SMC s and specialist nature of the acceptable if the drug is used according to SMC s and Alternative treatments are available at a lower drug acquisition cost. 3

4 No 563/09 No 565/09 Drug/product Indication SMC Lanarkshire and Mecasermin, 10mg/mL solution for injection (Increlex ) Ranolazine 375mg, 500mg and 750mg prolonged release tablets (Ranexa) For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (primary IGFD). Add on therapy for the symptomatic treatment of patients with angina pectoris. Mecasermin (Increlex ) is accepted for use within NHS Scotland for the longterm treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (primary IGFD). Mecasermin significantly improved mean height velocity, mean height velocity standard deviation (SD) score and mean cumulative change in height SD score for at least 6 years. Serious adverse effects including hypoglycaemia and tonsillar hypertrophy are common and long-term safety data are lacking. Ranolazine (Ranexa ) is not recommended for use within NHS Scotland as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists). s and. When added to standard doses of antianginal drugs, ranolazine increased exercise duration at trough drug levels after 12 weeks compared with placebo. However, the effect size was small. No 431/07 Fosamprenavir 50mg/ml oral suspension and 700 mg film-coated tablet (Telzir ) Abbreviated Submission In combination with low dose ritonavir for the treatment of HIV-1 infected adolescents and children of six years and above in combination with other antiretroviral medicinal products The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit. Fosamprenavir (Telzir ) in combination with low dose ritonavir is accepted for use within NHS Scotland for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adolescents and children of six years and above in combination with other antiretroviral medicinal products. Fosamprenavir is listed in the British National Formulary for Children for the treatment of HIV infection. The Scottish Medicines Consortium has previously accepted this product for use in this indication in adults. s and 4

5 No 569/09 No 570/09 Drug/product Indication SMC Lanarkshire and Lamivudine/zidovudine fixed-dose combination (Combivir ) Abbreviated Submission Etanercept (Enbrel ) Abbreviated Submission Treatment of HIV-1 in paediatric patients. Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years. Lamivudine/zidovudine fixed dose combination (Combivir ) in antiretroviral combination therapy is accepted for use within NHS Scotland for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) in paediatric patients weighing 14kg to 30kg. This combination is listed in the British National Formulary for Children for the treatment of HIV infection. It was previously licensed for use in adults and adolescents weighing at least 30kg. The availability of both the combination product and its active ingredients pre-date the establishment of the Scottish Medicines Consortium. Etanercept (Enbrel ) is accepted for restricted use within NHS Scotland for the treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. It should be used only when the following criteria are met: - The disease is severe as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10; - The psoriasis has failed to respond to standard systemic therapies including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation); or the person is intolerant to, or has a contraindication to, these treatments; - Etanercept treatment should be discontinued in patients whose psoriasis has not responded adequately at 12 weeks. s and s and Etanercept has previously been accepted for use in this indication in adults in NHS Scotland as NHS QIS advised that NICE Multiple Technology Appraisal No 103 is valid for Scotland. Etanercept is also listed in the British National Formulary for Children as one of a number of drugs affecting the immune response available for treatment of severe refractory psoriasis. 5

6 No 568/09 No 576/09 No 502/08 No 582/09 Drug/product Indication SMC Lanarkshire and Brinzolamide/timolol eye drops, suspension (Azarga ) Abbreviated Submission Etoricoxib (Arcoxia ) Non Submission 11.7mg etonogestrel / 2.7mg ethinylestradiol vaginal ring (NuvaRing ) Resubmission Hydroxycarbamide (Siklos ) Non Submission Reduction of intraocular pressure. Ankylosing spondylitis Contraception Prevention of recurrent painful vaso-occlusive crises. Brinzolamide/timolol eye drops, suspension (Azarga ) are accepted for use within NHS Scotland for the decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. The combination product allows patients to administer fewer drops at a modestly increased cost over separate administration of the constituents. Etoricoxib (Arcoxia ) is not recommended for use within NHSScotland for the treatment of ankylosing spondylitis. 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. Etonogestrel / ethinylestradiol vaginal ring (NuvaRing ) is accepted for use within NHS Scotland for contraception. Results from two randomised phase III clinical studies indicate that the contraceptive efficacy of NuvaRing is similar to that of two combined oral contraceptives. NuvaRing produces good cycle control and user acceptability. Cost-effectiveness has been demonstrated in women who chose to discontinue oral contraceptives. Other non-oral contraceptives are available at lower cost. Hydroxycarbamide (Siklos ) is not recommended for use within NHS Scotland for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in paediatric and adult patients suffering from symptomatic Sickle Cell Syndrome. 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. formulary use is acceptable if the drug is used according to SMC s and formulary use is acceptable if the drug is used according to SMC s and. 6

7 Recommendation No 571/09 No 148/04 Drug/product Indication SMC Lanarkshire and ADTC comments Vildagliptin 50mg tablets (Galvus ) Metformin prolonged release tablets 500mg, 750mg, 1000mg (Glucophage SR ) 2 nd Resubmission For the treatment of type 2 diabetes mellitus as dual oral therapy in combination with a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea or for whom metformin is inappropriate due to contraindications or intolerance. Treatment of type 2 diabetes mellitus in adults. Vildagliptin (Galvus ) is accepted for use within NHS Scotland for the treatment of type 2 diabetes mellitus as dual oral therapy in combination with a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea or for whom metformin is inappropriate due to contraindications or intolerance. When added to a sulphonylurea, vildagliptin had a modest beneficial effect on glycated haemoglobin (HbA1C). Vildagliptin is also licensed for use in combination with metformin or thiazolidinedione drugs for the treatment of type 2 diabetes. SMC has already issued advice on use in combination with metformin. As this submission from the manufacturer related only to the use of vildagliptin in combination with a sulphonylurea, SMC cannot recommend the use of vildagliptin in combination with thiazolidinedione drugs. Metformin hydrochloride prolonged release tablets (Glucophage SR ) are accepted for restricted use for the treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. This new formulation appears to have similar short-term efficacy to immediate-release metformin. Evidence of improved gastrointestinal tolerability is not convincing and the prolonged-release formulation is more expensive than the immediate-release formulation. It is restricted to use in patients who are intolerant of immediate release metformin and in whom the prolonged release tablet allows the use of a dose of metformin not previously tolerated or in patients for whom a once-daily preparation offers a clinically significant benefit. formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and 7

8 Recommendation No 573/09 No 574/09 No 583/09 No 549/09 Drug/product Indication SMC Lanarkshire and Methotrexate 50mg/ml (Metoject ) pre-filled syringes 7.5mg, 10mg, 15mg, 20mg, 25mg Abbreviated Submission Olmesartan medoxomil/amlodipine as besilate tablet 20mg/5mg, 40mg/5mg, 40mg/10mg (Sevikar ) Abbreviated Submission Estradiol/dienogest (Qlaira ) Non Submission Quetiapine 25mg, 100mg, 200mg, 300mg tablets (Seroquel ) Severe recalcitrant disabling psoriasis. Treatment of essential hypertension Oral contraception Treatment of major depressive episodes associated with bipolar disorder Methotrexate injection 50mg/ml (Metoject ) is accepted for use in NHS Scotland for the treatment of severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients. For patients in whom parenteral methotrexate is appropriate, this is the first licensed parenteral formulation for this indication. Olmesartan medoxomil/amlodipine as besilate (Sevikar ) is accepted for use in NHS Scotland for treatment of essential hypertension in patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy. In patients for whom concomitant use of these medicines is appropriate it allows administration of a single tablet at a lower or modestly increased cost compared to the individual components (depending on dose). Angiotensin receptor blockers are an alternative to ACE inhibitors where these are not tolerated. This fixed dose combination is one of many options for the treatment of hypertension, many of which are less expensive. Estradiol/dienogest (Qlaira ) is not recommended for use within NHSScotland for oral contraception. 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. Quetiapine (Seroquel ) is not recommended for use within NHS Scotland for the treatment of major depressive episodes associated with bipolar disorder. In monotherapy studies quetiapine was superior to placebo and compared favourably with two active comparators. Efficacy relative to current practice for the management of depression in the framework of bipolar disorder in NHS Scotland involving combination therapy with a mood stabiliser or an atypical antipsychotic plus an antidepressant, was not demonstrated formulary use is acceptable if the drug is used according to SMC s and however this drug is not added to the formulary as there are adequate existing formulary options for the treatment of hypertension 8

9 Recommendation No 553/09 No 578/09 No 579/09 Drug/product Indication SMC Lanarkshire and Romiplostim, 250 microgram vial of powder for solution for subcutaneous injection (Nplate ) Esomeprazole, 40mg vial of powder for solution for intravenous injection or infusion (Nexium I.V. ) Fentanyl 50 micrograms / dose, 100 micrograms/dose, 200 micrograms / dose nasal spray (Instanyl ) Treatment of adult chronic immune (idiopathic) thrombocytopenic purpura splenectomised patients. Prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers Management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain Romiplostim (Nplate ) is accepted for restricted use within NHS Scotland for adult chronic immune (idiopathic) thrombocytopenic purpura (ITP) splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Romiplostim is also accepted for restricted use as second line treatment for adult nonsplenectomised patients where surgery is contra-indicated. Romiplostim is restricted to use in patients with severe symptomatic ITP or patients with a high risk of bleeding. Romiplostim was significantly better than placebo in maintaining platelets at (or above) a minimum target level in previously treated patients with ITP. Esomeprazole (Nexium I.V. ) is accepted for use within NHS Scotland for prevention of rebleeding following therapeutic endoscopy for acute bleeding gastric or duodenal ulcers. In patients with high-risk peptic ulcer bleeding, high-dose intravenous esomeprazole significantly reduced recurrent bleeding at 72 hours compared to placebo. Fentanyl nasal spray (Instanyl ) is accepted for restricted use within NHS Scotland for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. In an open-label comparative study intranasal fentanyl was superior to another fentanyl formulation used in the treament of breakthrough pain in terms of time to onset of pain relief, although more episodes using the intranasal formulation required a second dose. Use of fentanyl nasal spray should be restricted to patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations. It should be noted that the doses of fentanyl nasal spray are significantly lower than doses of fentanyl given by other routes of administration for this indication. s and s and s and 9

10 Recommendation No 564/09 Drug/product Indication SMC Lanarkshire and Agomelatine, 25mg film-coated tablets (Valdoxan ) Treatment of major depressive episodes in adults. Agomelatine (Valdoxan ) is not recommended for use within NHS Scotland for the treatment of major depressive episodes in adults. When used in a flexible dosing schedule, agomelatine significantly reduced the symptoms of depression and increased the number of patients who responded to treatment compared with placebo. There are limited comparative data against existing antidepressants and the results of such comparisons are variable. No 302/06 No 588/09 Bortezomib, 3.5mg vial of powder for solution for intravenous injection (Velcade ) Second Resubmission Nepafenac (Nevanac ) Non Submission As mono-therapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation. For prevention and treatment of postoperative pain and inflammation associated with cataract surgery. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Bortezomib (Velcade ) is accepted for use within NHS Scotland as mono-therapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation. Bortezomib, compared to high dose dexamethasone, prolonged time to disease progression and improved survival in patients who had progressive multiple myeloma despite previous treatment with one to three lines of therapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bortezomib. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland. Nepafenac (Nevanac ) is not recommended for use within NHSScotland for prevention and treatment of postoperative pain and inflammation associated with cataract surgery. 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. s and 10

11 Recommendation No 577/09 Drug/product Indication SMC Lanarkshire and Filgrastim, 30 million units (300 microgram)/0.5ml and 48 million units (480 microgram)/0.8ml, prefilled syringe containing solution for injection or infusion (Ratiograstim ) As per SMC s Filgrastim (Ratiograstim ) is accepted for use within NHS Scotland for: Reduction in the duration of neutropenia and the incidence of febrile neutropenia (FN) in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. Mobilisation of peripheral blood progenitor cells (PBPC). s and As long term administration, to increase neutrophil counts and to reduce the incidence and duration of infection-related events in children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/L, and a history of severe or recurrent infections. For the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate. Filgrastim (Ratiograstim ) is a biosimilar product and has demonstrated equivalency in terms of efficacy and safety to a reference granulocyte colony stimulating factor (filgrastim (Neupogen ). The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name. 11

12 Recommendation No 275/06 Drug/product Indication SMC Lanarkshire and Sunitinib, 12.5mg, 25mg, 50mg hard capsules (Sutent ) Resubmission Treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance. Sunitinib (Sutent ) is accepted for use within NHS Scotland for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance. Sunitinib compared with placebo delayed tumour progression by approximately five months. Treatment with sunitinib should not be continued if there is evidence of unacceptable toxicity or progression of disease. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of sunitinib. This SMC advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland. s and 12