Area Drug and Therapeutics Committee Prescribing Supplement No 16 May 2007

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 16 In this issue Drugs currently being considered by the SMC advice due on 11 June 07. Correction to the last edition (No 15) of the prescribing supplement New drugs reviewed by the SMC during March and April 2007 Drugs currently being considered by the SMC with advice due on 11 June 2007 SMC REVIEW INDICATION 377/07 Darifenacin hydrobromide (Emselex ) Urinary frequency/urgency 378/07 Darunivir (Prezista ) Treatment of HIV-1 infection 379/07 Posaconazole (Noxafil ) Prophylaxis of invasive fungal infection 381/07 Ranibizumab (Lucentis ) Macular degeneration 375/07 Formoterol inhaler (Easyhaler ) Treatment of asthma 362/07 Budesonide/formoterol turbohaler Treatment of asthma (Symbicort SMART ) 372/07 Testosterone 2% gel (Tostran ) Testosterone deficiency 368/07 Esomeprazole tablets (Nexium ) GORD in year age group Correction to the previous edition number 15, April The following statement which was added to the joint formulary has now been removed Section Pioglitazone can also be used in combination with insulin for type 2 patients who have insufficient glycaemic control on insulin and for whom metformin is inappropriate because of contraindications or intolerance. Although this is a new licensed indication for pioglitazone local expert opinion would suggest that this combination with insulin would only be used occasionally as both Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1

2 drugs together can cause significant weight gain. Therefore it has been agreed that the statement should not appear in the formulary. The following new drugs have been reviewed by the Scottish Medicines Consortium in March and April 2007 : - 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 = Not added to the formulary due to the specialist nature of the treatment or pending specialist advice on formulary status. Non formulary use is acceptable if the drug is used according to SMC s and local protocols. 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 318/06 No 359/07 No 361/07 and Infliximab (Remicade ) 100mg powder for infusion Azelaic acid 15% gel (Finacea ) Dexrazoxane for infusion (Savene ) Treatment of moderate to severe plaque psoriasis in adults who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapy including ciclosporin, methotrexate or psoralen ultraviolet A (PUVA). Topical treatment of papulopustular rosacea. Treatment of anthracycline extravasation Infliximab (Remicade ) is accepted for restricted use in NHS Scotland for the treatment of severe plaque psoriasis in adults who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapy including ciclosporin, methotrexate or psoralen ultraviolet A (PUVA). Infliximab, compared to placebo, improves both signs and symptoms of psoriasis and quality of life in adults with plaque psoriasis. The economic case was demonstrated when used for patients with severe psoriasis who achieve a PASI 75 response or a 50% reduction in PASI and a 5 point reduction in DLQI from baseline at 10 weeks. It is one of several biologic interventions for the treatment of plaque psoriasis, some of which have lower drug acquisition costs. Azelaic acid 15% gel (Finacea ) is accepted for use in NHS Scotland for the topical treatment of papulopustular rosacea. It shows equivalent efficacy at a lower cost compared to another topical preparation used for rosacea. Dexrazoxane, 20mg/ml for infusion (Savene ) is not recommended for use in NHS Scotland for the treatment of anthracycline extravasation. There are data indicating that administration of dexrazoxane is associated with a relatively low rate of surgery and adverse sequelae following extravasation of anthracyclines. However these data are from non-comparative, open-label phase II studies, and there are no data comparing dexrazoxane to Scottish Practice. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. 3 Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and approved local protocols. Accepted for general use in Lanarkshire and added to the Joint Formulary Not accepted for use in Lanarkshire and not added to the Joint Formulary

4 No 360/07 No 234/06 No 357/07 and Sitaxentan 100mg tablets (Thelin ) Buprenorphine transdermal patches (BuTrans ) Resubmission Desmopressin 240 microgram oral lyophilisate (DesmoMelt ) Abbreviated submission Treatment of pulmonary arterial hypertension Treatment of severe opioid responsive pain conditions which are not adequately responding to nonopioid analgesics. Primary nocturnal enuresis Sitaxentan sodium (Thelin ) is accepted for restricted use in NHS Scotland for the treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease. Data suggest that sitaxentan 100mg daily has a benefit/risk ratio comparable to the other licensed endothelin receptor antagonist. Noninferiority has not been formally demonstrated as sitaxentan is an orphan drug with limited clinical evidence. It is restricted to initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit. Buprenorphine transdermal patches (BuTrans ) are not recommended for use in NHS Scotland for the treatment of severe opioid responsive pain conditions which are not adequately responding to non-opioid analgesics. Clinical effectiveness has not been demonstrated in the patient population under consideration in the resubmission. Desmopressin 240 microgram oral lyophilisate (DesmoMelt ) is accepted for use in NHS Scotland for the treatment of primary nocturnal enuresis. In patients for whom desmopressin oral lyophilisate is an appropriate choice of therapy, it offers a higher dose formulation at an equivalent cost to existing formulations. for restricted use. Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s.. Not accepted for use in Lanarkshire and not added to the Joint Formulary Accepted for general use in Lanarkshire and added to the Joint Formulary 4

5 No 358/07 No 374/07 No 363/07 and Desmopressin 60, 120 and 240 microgram oral lyophilisate (DDAVP Melt ) Abbreviated submission Infliximab for infusion (Remicade ) Non submission Infliximab for infusion (Remicade ) Diabetes insipidus and posthypophysectomy polyuria/polydipsia Moderately to severely active ulcerative colitis Maintenance treatment of severe active Crohn s disease Desmopressin oral lyophilisate (DDAVP Melt ) is accepted for use in NHS Scotland for the treatment of vasopressin-sensitive cranial diabetes insipidus and in the treatment of post-hypophysectomy polyuria/polydipsia. In patients for whom desmopressin is an appropriate choice of therapy, it offers a sublingual formulation at an equivalent cost to a clinically equivalent dose in a solid oral dose formulation. Infliximab (Remicade ) is not recommended for use in NHS Scotland for the treatment of moderately to severely active ulcerative colitis in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies. 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 in NHS Scotland. Infliximab (Remicade ) is not recommended for use in NHS Scotland for maintenance treatment of severe, active Crohn s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. Infliximab for the treatment of acute severe, active Crohn s disease was approved by NICE in Infliximab maintenance treatment, compared to placebo, is associated with higher rates of clinical remission and a longer time to loss of response in patients with active Crohn s disease. The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC. Accepted for general use in Lanarkshire and added to the Joint Formulary 5

6 No 364/07 No 365/07 and Infliximab for infusion (Remicade ) Dibotermin alfa 12mg kit for implant (InductOs ) Maintenance treatment of fistulising, active Crohn s disease. Treatment of acute tibia fractures, as an adjunct to standard care. Infliximab (Remicade ) is not recommended for use in NHS Scotland for maintenance treatment of fistulising, active Crohn s disease, in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy). Infliximab was not approved by NICE in 2002 for patients with fistulating Crohn s disease who do not have the other criteria for severe active Crohn s disease. Infliximab maintenance treatment, compared to placebo, was associated with a longer time to loss of fistula response in patients with fistulising Crohn s disease. The manufacturer s justification of the treatment cost in relation to its health benefits was not sufficient to gain acceptance by SMC. Dibotermin alfa (InductOs ) is accepted for restricted use in NHS Scotland for the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary nail fixation in patients in whom there is substantial risk of non-union. It is restricted to patients treated with unreamed intramedullary nails. Cost effectiveness has only been shown in Gustilo-Anderson Grade IIIB fractures. for restricted use. Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s. 6

7 No 366/07 No 367/07 and ADTC comments Topotecan powder for concentrate for infusion (Hycamtin ) Standardised allergen extract of grass pollen (Grazax ) Treatment of patients with relapsed small cell lung cancer. Treatment of grass pollen induced rhinitis and conjunctivitis in adult patients. Topotecan (Hycamtin ) is not recommended for use in NHS Scotland for the treatment of patients with relapsed small cell lung cancer for whom re-treatment with the first line regimen is not considered appropriate In a trial comparing oral topotecan plus active symptom control (ASC) to ASC alone the difference in median survival was 12 weeks, in favour of the oral topotecan plus ASC group. Topotecan is not available as an oral formulation in the UK, however in one trial the response rate and median survival duration were similar for oral and IV topotecan groups. The treatment s cost in relation to its health benefits was not sufficient to gain acceptance by SMC. Standardised allergen extract of grass pollen 75,000 per oral lyophilisate (Grazax ) is not recommended for use in NHS Scotland for the treatment of grass pollen induced rhinitis and conjunctivitis in adult patients with clinically relevant symptoms and diagnosed with a positive skin prick test and/or specific IgE test to grass pollen. The place in the treatment of seasonal allergic rhinitis, the patient population and the long-term benefits of Grazax still have to be fully established as evidence from only the first year of a three-year treatment programme has been published. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC... 7

8 No 369/07 No 370/07 No 371/07 and Docetaxel concentrate for solution for infusion (Taxotere ) Dasatinib tablets (Sprycel ) Dasatinib tablets (Sprycel ) Induction treatment of patients with unresectable locally advanced squamous cell carcinoma of the head and neck. Treatment of adults with chronic, accelerated or blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib mesylate. Treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia with resistance or intolerance to prior therapy. Docetaxel (Taxotere ) is accepted for restricted use in NHS Scotland for the induction treatment of patients with unresectable locally advanced squamous cell carcinoma of the head and neck in combination with cisplatin and 5-fluorouracil. It is restricted to patients in whom induction chemotherapy is appropriate. The docetaxel containing induction regimen was associated with improved progression-free and overall survival, compared with cisplatin and 5-fluorouracil alone, in patients with good performance status. Dasatinib 20mg, 50mg, 70mg tablets (Sprycel ) is accepted for restricted use in NHS Scotland for the treatment of adults with chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib mesylate. It should be restricted to use in patients who are in the chronic phase of the disease. The manufacturer s justification of the treatment s cost in relation to its health benefits for the accelerated or blast phases was not sufficient to gain acceptance by SMC. Dasatinib 20mg, 50mg, 70mg tablets (Sprycel ) is not recommended for use in NHS Scotland for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia with resistance or intolerance to prior therapy. It has been associated with haematological and cytogenetic responses in patients resistant or intolerant to existing treatment. However, the economic case was not sufficiently robust and the manufacturer s justification of the treatment s cost in relation to its health benefits was not sufficient to gain acceptance by SMC. endorsed the SMC for restricted use. Not added to the formulary due to the specialist nature of the treatment. Use to be determined by the regional cancer prescribing advisory group. endorsed the SMC for restricted use. Not added to the formulary due to the specialist nature of the treatment. Use to be determined by the regional cancer prescribing advisory group. endorsed the SMC. 8

9 No 286/06 and Lanthanum carbonate chewable tablets (Fosrenol ) Phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis. Lanthanum carbonate (Fosrenol ) is accepted for restricted use in NHS Scotland as a phosphate-binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis. Lanthanum carbonate is as effective as calcium carbonate in reducing phosphate to target levels. It is restricted to use as a second-line agent in patients where a nonaluminium, non-calcium phosphate binder is required. Accepted for restricted use in Lanarkshire and added to the Joint Formulary only for the restricted use advised by the Scottish Medicines Consortium (SMC) 9