Area Drug and Therapeutics Committee Prescribing Supplement No 47 July 2011

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 47 In this issue Drugs reviewed by in May / June 2011 ADTC UPDATES ON DRUGS REVIEWED BY THE SMC The following new drugs have been reviewed by the Scottish Medicines Consortium in May / June 2011: - Colour coding of ADTC decisions about new medicines: - Green = accepted for general use in and added to the Joint Formulary Orange = accepted for restricted use in 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 s Red = not accepted for use in 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 NHSL Headquarters or prescribing@lanarkshire.scot.nhs.uk 1

2 No 704/11 Drug/product SMC Filgrastim, 30 million units (300 micrograms)/0.5 ml, 48 million units (480 micrograms)/0.5 ml, solution for injection or infusion in prefilled syringe (Zarzio ) filgrastim (Zarzio ) is accepted for use within NHS Scotland. Indications under review: Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and 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. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy. Mobilisation of peripheral blood progenitor cells (PBPC). s In children and 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, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events. Treatment of persistent neutropenia (ANC 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate. Filgrastim (Zarzio ) is a biosimilar product 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. Other granulocyte colony stimulating factor products are available at lower cost. 2

3 No 463/08 No 705/11 Drug/product SMC Ferric carboxymaltose 50mg iron/ml solution for injection/infusio n (Ferinject ) Triptorelin (Decapeptyl SR ) 22.5mg powder and solvent for suspension for injection Abbreviated submission ADVICE: following a second resubmission ferric carboxymaltose (Ferinject ) is accepted for restricted use within NHS Scotland. Indication under review: the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. The diagnosis must be based on laboratory tests. SMC restriction: use is restricted to administration by intravenous infusion within the licensed indication but excluding use in patients receiving haemodialysis. The manufacturer s economic case did not consider the cost-effectiveness of iv bolus administration or use in haemodialysis patients. Ferric carboxymaltose was superior to oral ferrous sulphate in raising haemoglobin levels in non-dialysisdependent patients with chronic kidney disease and iron deficiency anaemia. ADVICE: following an abbreviated submission triptorelin pamoate 22.5mg (Decapeptyl SR ) is accepted for use within NHS Scotland. Indication under review: Treatment of patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration. Treatment of metastatic prostate cancer. This new preparation of triptorelin allows 6-monthly administration (as triptorelin pamoate in a 22.5mg dose). Triptorelin 11.25mg (as acetate) is administered every 3 months and has previously been accepted by SMC. Bioequivalence of the pamoate and acetate salts has been demonstrated and the new preparation is cost neutral. Note: The indication for triptorelin 11.25mg formulation was reworded in 2007 to achieve consistency Europe-wide and now reads as per the indication for triptorelin 22.5mg s s 3

4 No 654/10 Drug/product SMC Tapentadol, 50, 100, 150, 200 and 250mg prolonged-release tablets (Palexia SR) ADVICE: following a second resubmission tapentadol prolonged-release (Palexia SR) is accepted for restricted use within NHS Scotland. Indication under review: the management of severe chronic pain in adults, which can be adequately managed only with opioid analgesics. SMC restriction: patients in whom morphine sulphate modified release has failed to provide adequate pain control or is not tolerated. Results of a meta-analysis of three, 12-week studies suggest that tapentadol prolonged release has improved gastrointestinal tolerability and similar efficacy compared to another long-acting opioid included as an active control. s The manufacturer s submission related only to the use of tapentadol prolonged release in severe chronic pain. SMC has not yet received a submission for tapentadol immediate release tablets for the relief of moderate to severe acute pain in adults, which can be adequately managed only with opioid analgesics. Tapentadol immediate release tablets are not recommended for use in NHS Scotland. 4

5 No 708/11 No 653/10 Drug/product SMC Omalizumab (Xolair ) 75mg, 150mg solution for injection as prefilled syringe Abbreviated submission Prucalopride 1mg and 2mg tablet (Resolor) ADVICE: following an abbreviated resubmission omalizumab 75mg, 150mg (Xolair ) solution for injection is accepted for restricted use within NHS Scotland. Indication under review: omalizumab is indicated in adults, adolescents (12 years of age and older) and children (6 to <12 years of age) with convincing IgE (immunoglobulin E) mediated asthma. SMC restriction: Use is restricted to patients who are prescribed chronic systemic steroids and in whom all other treatments have failed. The response to omalizumab treatment should be assessed in all patients at 16 weeks and treatment should be discontinued in patients who have not shown a marked improvement in overall asthma control. SMC has previously accepted omalizumab (Xolair ) 150mg powder and solvent for injection for restricted use in adults, adolescents and children. This submission is for a new solution for injection formulation that will replace the existing formulation. The 150mg solution for injection formulation is bioequivalent to the 150mg powder and solvent for injection formulation and costs the same. The new 75mg strength is half the cost of the 150mg injection and should eliminate wastage that occurred previously with certain doses. ADVICE: following a resubmission prucalopride (Resolor) is not recommended for use within NHS Scotland. Indication under review: for symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC. s The licence holder has indicated their intention to resubmit. 5

6 No 713/11 No 711/11 Drug/product SMC Paliperidone palmitate 50mg, 75mg, 100mg and 150mg prolonged release suspension for injection (Xeplion) Ranibizumab, 10mg/mL solution for injection (Lucentis ) paliperidone palmitate prolonged release suspension for injection (Xeplion) is not recommended for use within NHS Scotland. Indication under review: maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, it may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed. Overall the manufacturer did not present a sufficiently robust clinical and economic case to gain acceptance by SMC. ranibizumab (Lucentis ) is not recommended for use within NHS Scotland. Indication under review: Treatment of visual impairment due to diabetic macular oedema in adults. Ranibizumab significantly improved visual acuity over 12 months compared with standard laser photocoagulation treatment. The manufacturer s justification of the treatment s health benefits in relation to its cost was not sufficient and in addition, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit. 6

7 No 712/11 No 452/08 Drug/product SMC Retigabine, 50mg, 100mg, 200mg, 300mg and 400mg film-coated tablets (Trobalt ) Trabectedin, 0.25 and 1mg powder for concentrate for solution for infusion (Yondelis ) Second retigabine (Trobalt ) is accepted for restricted use within NHS Scotland. Indication under review: Adjunctive treatment of partial onset seizures with or without secondary generalisation in adults aged 18 years and above with epilepsy. SMC restriction: patients with refractory epilepsy. Treatment should be initiated only by physicians who have appropriate experience in the treatment of epilepsy. In two placebo-controlled studies in patients with refractory epilepsy retigabine was superior to placebo in terms of the proportion of patients experiencing 50% reduction in partial seizure frequency per 28 days. An indirect comparison indicates that retigabine has similar efficacy to two other antiepileptic drugs used as adjunctive therapy. ADVICE: following a second resubmission trabectedin (Yondelis ) is not recommended for use within NHS Scotland. Indication under review: treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are unsuited to receive these agents. Efficacy data are based mainly on liposarcoma and leiomyosarcoma patients. In a phase II randomised study in patients with advanced leiomyosarcoma and liposarcoma in which two trabectedin dose schedules were compared, the licensed 3-weekly schedule was superior to the alternative schedule for the primary endpoint, time to progression. The manufacturer s justification of the treatment s cost in relation to its health benefits was not sufficient and in addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC. s 7