Area Drug and Therapeutics Committee Prescribing Supplement No 20 December 2007

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 20 In this issue Drugs currently being considered by SMC advice due on 14 January Lanarkshire Joint Formulary 2 nd edition November 2007 New drug decisions of most relevance to primary care New drugs reviewed by SMC in October and November 2007 Drugs currently being considered by the SMC with advice due on 14 January 2008 SMC REVIEW INDICATION 367/07 Standardised allergen extract (Grazax ) Grass pollen allergy 432/07 Latanoprost&timolol eyedrops (Xalacom ) Reduction of intraocular pressure 373/07 Beclometasone/formoterol inhaler (Fostair ) Management of asthma 348/07 Calcium carbonate/vit D3 tablets (Natecal ) Correction of vitamin D and calcium deficiency Lanarkshire Joint Formulary 2 nd Edition November 2007 The second edition of the Lanarkshire joint formulary is now available and a paper copy will be circulated to all prescribers, including non-medical prescribers, in primary and acute care, over the next few weeks. The printed copy includes all updated information and additions and deletions up to the end of October General practitioners have been provided with an updated copy of the electronic formulary for use with practice prescribing software programmes. The most up to date version of the formulary is found on the Lanarkshire intranet and it can also be accessed from a link on the NHS Lanarkshire public website homepage. The web based formulary is updated each month in between publication of the printed version and for the very latest information the web based formulary should always be checked. The web addresses are Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1

2 follow the link to drugs and prescribing follow the link to NHS Lanarkshire Joint Formulary If you have any questions about the formulary please contact Fiona Graham, formulary pharmacist on or New Drugs decisions of most relevance to Primary Care in this issue- Conjugated estrogen 0.3mg tablets (Premarin ) hormone replacement therapy in postmenopausal deficiency new low dose added to the formulary. Formoterol metered dose inhaler (Atimos Modulite ) long acting beta 2 agonist added to the formulary for relief of symptoms due to chronic obstructive pulmonary disease. Tiotropium respimat inhaler (Spiriva Respimat ) treatment to relieve symptoms of chronic obstructive pulmonary disease added to the formulary as an alternative device for those unable to use Spiriva handihaler. Rivastigmine transdermal patch (Exelon ) treatment of moderately severe Alzheimer s dementia added to the formulary for use only when a transdermal formulation is indicated. Erdosteine 300mg capsules (Erdotin ) - Not recommended for use as an expectorant for acute exacerbations of chronic bronchitis and not added to the formulary. Ciclesonide high dose inhaler (Alvesco ) Not added to the formulary as other less expensive inhaled corticosteroids are already included in the formulary. Esomeprazole tablets (Nexium ) treatment of Zollinger-Ellison syndrome not added to the formulary as existing options of omeprazole or lansoprazole are adequate. Risedronate sodium tablets (Actonel ) treatment of osteoporosis in men not added to the formulary for this indication. Alendronate is indicated. The following new drugs have been reviewed by the Scottish Medicines Consortium in October and November 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 415/07 No 416/07 No 417/07 Drug/product Indication SMC Lanarkshire and Erdosteine 300mg capsules (Erdotin ) Rufinamide tablets (Inovelon ) Adalimumab 40mg injection (Humira ) As an expectorant for the symptomatic treatment of acute exacerbations of chronic bronchitis in adults. Adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients four years and older. Treatment of severe, active Crohn s disease in adult 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. Erdosteine (Erdotin ) is not recommended for use in NHS Scotland as an expectorant for the symptomatic treatment of acute exacerbations of chronic bronchitis in adults. Evidence for the clinical efficacy of erdosteine is limited and was obtained from studies that do not reflect current practice for the management of chronic obstructive pulmonary disease (COPD) in NHS Scotland. The manufacturer did not present a sufficiently robust clinical or economic case for erdosteine to gain acceptance by SMC. Rufinamide (Inovelon ) is not recommended for use in NHS Scotland as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients four years and older. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Adalimumab (Humira ) is not recommended for use in NHS Scotland for the 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 immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. In both induction and maintenance studies in patients with severe active Crohn s disease, more patients treated with adalimumab achieved and maintained clinical remission than with placebo. However, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC. Erdosteine is not added to the formulary. Rufinamide is not added to the formulary. 3

4 No 418/07 No 412/07 No 413/07 No 419/07 08/10/07 No 349/07 Drug/product Indication SMC Lanarkshire and Epoetin delta for injection (Dynepo ) Ciclesonide 80 mcg, 160 mcg inhaler (Alvesco ) Conjugated estrogen 0.3mg tablet (Premarin ) Dexrazoxane (Cardioxane ) Formoterol 12 micrograms metered dose inhaler (Atimos Modulite ) Treatment of anaemia in patients with chronic renal failure. Epoetin delta may be used by patients on dialysis and those not on dialysis. High dose treatment to control persistent asthma in adolescents and adults (12 years and older) Hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women. Prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin. Relief of bronchoobstructive symptoms in patients with chronic obstructive pulmonary disease (COPD) Epoetin delta (Dynepo ) is accepted for use in NHS Scotland for the treatment of anaemia in patients with chronic renal failure. It may be used in patients on dialysis and in patients not on dialysis. Clinical studies have demonstrated epoetin delta s efficacy and safety profile in correcting and maintaining haemoglobin levels for up to a year in predialysis, haemodialysis and peritoneal dialysis patients, when administered via both the subcutaneous and intravenous routes. Ciclesonide inhaler (Alvesco ) is accepted for use in NHS Scotland at high doses (up to 640 mcg daily for up to 12 weeks) to control persistent asthma in adolescents and adults (12 years and older). The higher dose should be used in patients for whom ciclesonide is an appropriate choice of maintenance inhaled corticosteroid therapy. Alternative inhaled steroids are available at lower costs. Conjugated estrogens 0.3mg tablet (Premarin ) is accepted for use in NHS Scotland as hormone replacement therapy for estrogen deficiency symptoms in postmenopausal women. It should be used for patients in whom conjugated estrogens is an appropriate choice of hormone replacement therapy and in whom the lower dose preparation provides adequate control of symptoms. Dexrazoxane (Cardioxane ) is not recommended for use in NHS Scotland for the prevention of chronic cumulative cardiotoxicity caused by doxorubicin or epirubicin use in advanced and/or metastatic cancer patients after previous anthracycline containing treatment. 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 Formoterol 12 micrograms metered dose inhaler (Atimos Modulite ) is accepted for use in NHS Scotland for the relief of broncho-obstructive symptoms in patients with chronic obstructive pulmonary disease (COPD). It should be used in patients for whom formoterol is an appropriate choice of long-acting beta-agonist and for whom a metered dose inhaler is an appropriate delivery device. The committee noted the SMC however epoetin beta is not added to the formulary. Darbepoetin alfa remains the preferred formulary drug choice. noted the SMC however ciclesonide is not added to the formulary as other inhaled corticosteroids are already included in the formulary and have a lower cost. endorsed the SMC Added to the joint formulary. endorsed the SMC endorsed the SMC Added to the joint formulary. 4

5 Recommendation No 420/07 No 421/07 No 422/07 Drug/product Indication SMC Lanarkshire and Fondaparinux sodium for injection, pre-filled syringe (Arixtra ) Topotecan 1mg, 4mg powder for concentrate for solution for infusion (Hycamtin ) Esomeprazole 20mg and 40mg tablets (Nexium ) Treatment of unstable angina or non-st segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (<120 minutes) invasive management (PCI) is not indicated. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination. Treatment of Zollinger-Ellison syndrome Fondaparinux (Arixtra ) is accepted for use in NHS Scotland for the treatment of unstable angina or non-st segment elevation myocardial infarction in patients for whom urgent (< 120 minutes) invasive management (Percutaneous Coronary Intervention) is not indicated. Fondaparinux was shown to be non-inferior to a low molecular weight heparin in preventing death, myocardial infarction or refractory ischaemia in the nine days following onset of symptoms. Fondaparinux also had a significantly lower major bleeding event rate than a low molecular weight heparin. Topotecan (Hycamtin ) is accepted for restricted use in NHS Scotland in combination with cisplatin for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. It is restricted to patients who are cisplatin-naïve. In an open-label study, overall and progression-free survival were significantly longer for cisplatin plus topotecan compared with cisplatin alone. Haematological adverse events were more common in the cisplatin plus topotecan group. The economic submission demonstrated that topotecan plus cisplatin was cost effective compared to cisplatin alone in cisplatin-naïve patients. However, the manufacturer s justification of the treatment s cost in relation to its health benefit was not sufficient to gain acceptance by SMC for use in patients with previous exposure to cisplatin. Esomeprazole (Nexium ) is accepted for use in NHS Scotland for the treatment of Zollinger-Ellison syndrome. Other proton pump inhibitors are available for this indication at a lower cost per treatment period. Added to the joint formulary. 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 local protocols. noted the SMC however esomeprazole is not added to the formulary. Formulary options already include omeprazole and lansoprazole 5

6 No 423/07 No 411/07 Drug/product Indication SMC Lanarkshire and Sevelamer hydrochloride 800mg tablets (Renagel ) Tiotropium 2.5 mcg respimat inhaler (Spiriva- Respimat ) Control of hyperphosphataemia in adult patients receiving peritoneal dialysis. Maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease. Sevelamer (Renagel ) is not recommended for use in NHS Scotland for control of hyperphosphataemia in adult patients receiving peritoneal dialysis. It was non-inferior to a calcium-based phosphate binder in reducing serum phosphate and was associated with a lower rate of hypercalcaemia. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Tiotropium respimat inhaler (Spiriva Respimat ) is accepted for restricted use in NHS Scotland as maintenance bronchodilator treatment to relieve symptoms of patients with chronic obstructive pulmonary disease. It may be used for patients in whom tiotropium is an appropriate choice of maintenance bronchodilator treatment but it is restricted to patients who have poor manual dexterity and therefore have difficulty using the Handihaler device. Accepted for restricted use in Lanarkshire and added to the Joint Formulary only for the restricted use advised by the Scottish Medicines Consortium (SMC). No 424/07 No 425/07 No 436/07 Risedronate sodium (Actonel ) Bevacizumab (Avastin ) Eculizumab (Soliris ) Treatment of osteoporosis in men at high risk of fractures. In addition to platinum-based chemotherapy for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Treatment of patients with paroxysmal nocturnal haemoglobinuria. Risedronate sodium (Actonel ) is not recommended for use in NHS Scotland for the treatment of osteoporosis in men at high risk of fractures. Bevacizumab (Avastin ) in addition to platinum-based chemotherapy, is not recommended for first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. use within NHS Scotland. Eculizumab (Soliris ) is not recommended for use in NHS Scotland for the treatment of patients with paroxysmal nocturnal haemoglobinuria. use within NHS Scotland. 6

7 No 431/07 No 414/07 No 426/07 Drug/product Indication SMC Lanarkshire and Fosamprenavir (Telzir ) Rivastigmine 4.6mg/24 hour and 9.5mg/24hour transdermal patch (Exelon ) In combination with low dose ritonavir for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adolescents and children of 6 years and above in combination with other antiretroviral medicinal products. Symptomatic treatment of moderately severe Alzheimer s dementia only. relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukaemia (PH+ALL) as monotherapy. Fosamprenavir (Telzir ) in combination with low dose ritonavir is not recommended for use in NHS Scotland for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adolescents and children of 6 years and above in combination with other antiretroviral medicinal products. Rivastigmine transdermal patch (Exelon ) is accepted for restricted use in NHS Scotland for symptomatic treatment of moderately severe Alzheimer s dementia only. It should be used in accordance with guidance from NHS Quality Improvement Scotland on the application of the National Institute for Health and Clinical Excellence (NICE) technology appraisal number 111. Within this context it is suitable for patients in whom rivastigmine is an appropriate choice of acetylcholinesterase inhibitor and in whom a transdermal patch is an appropriate choice of formulation. treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukaemia (PH+ALL) as monotherapy. Accepted for restricted use in Lanarkshire and added to the Joint Formulary only for the restricted use advised by the Scottish Medicines Consortium (SMC) No 427/07 newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (PH+ALL) in combination with chemotherapy. treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (PH+ALL) in combination with chemotherapy. 7

8 No 428/07 No 429/07 No 430/07 Drug/product Indication SMC Lanarkshire and myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet derived growth factor receptor gene re-arrangements. advanced hypereosinophilic syndrome and/or chronic eosinophilic leukaemia with FIP1L1-PDGFRά rearrangement. unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet derived growth factor receptor gene rearrangements. treatment of adult patients with advanced hypereosinophilic syndrome and/or chronic eosinophilic leukaemia with FIP1L1-PDGFRά rearrangement. treatment of adult patients with unresectable dermatofibrosarcoma protuberans (DFSP) and adult patients with recurrent and/or metastatic DFSP who are not eligible for surgery. 8