Area Drug and Therapeutics Committee Prescribing Supplement No 22 June 2008

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 22 In this issue Drugs currently being considered by SMC advice due on 09 ADTC decisions carried over from the previous bulletin in February 2008 New product launch melatonin prolonged release tablets (Circadin ) New drugs reviewed by SMC in February, March and April Drugs currently being considered by the SMC with advice due on 09 June 2008 SMC REVIEW INDICATION 465/08 Anidulafungin (Ecalta ) Invasive candidiasis. 466/08 Dabigatrin (Pradaxa ) Primary prevention of venous thromboembolic events following total knee or hip replacement. 467/08 Epoetin zeta (Retacrit ) Treatment of anaemia associated with chronic renal failure. 468/08 Adalimumab (Humira ) Treatment of chronic plaque psoriasis in adult patients. 469/08 Bevacizumab (Avastin ) Metastatic carcinoma of the Colon or rectum. 471/08 Glucosamine (Alateris ) Osteoarthritis of the knee. 464/08 Botulinum neurotoxin Type A (Xeomin ) Blepharospasm and cervical dystonia. 473/08 Perindopril arginine (Coversyl Arginine ) Hypertension, heart failure. 474/08 Perindopril arginine and indapamide Hypertension. (Coversyl Arginine Plus ) 483/08 Lidocaine plaster (Rapydan ) Surface anaesthesia of the skin in connection with needle puncture or in cases of superficial surgical procedures. 484/08 Loteprednol eye drops (Lotemax ) Post operative inflammation following ocular surgery. 485/08 Bosentan (Tracleer ) To reduce the number of new Digital ulcers in patients with systemic sclerosis. Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1

2 SMC REVIEW INDICATION 486/08 Panitumumab (Vectibix ) EGFR expressing metastatic colorectal carcinoma. 487/08 Teriparatide (Forsteo ) Corticosteroid induced osteoporosis. 440/08 Nilotinib (Tasigna ) Chronic phase Philadelphia chromosome positive chronic myelogenous leukaemia. ADTC decisions on new drugs carried over from the last bulletin February SMC REVIEW 373/07 on 14/01/08 - Beclometasone/formoterol metered dose inhaler (Fostair ). Indication Treatment of asthma where use of a combination product is appropriate. ADTC decision following comments from the respiratory specialist sub-group of the ADTC it was agreed that this product would not be added to the joint formulary at this time. The existing formulary options of fluticasone/salmeterol (Seretide ) or budesonide/formoterol (Symbicort ) were considered to provide sufficient options at similar cost to Fostair **New Product Launch in the UK** Please note that Lundbeck Ltd has just launched melatonin prolonged release tablets (Circadin ). Circadin is indicated only for the short term treatment of primary insomnia characterised by poor quality of sleep in patients aged 55 and over. Maximum course of treatment is 3 weeks. As with all new drugs doctors are advised to refrain from prescribing until the drug has been assessed by the SMC and advice on formulary status has been issued by the. The following new drugs have been reviewed by the Scottish Medicines Consortium in February, March and April 2008 : - 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 = 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 10/03/2008 No 446/08 Drug/product Indication SMC Lanarkshire and ADTC comments Diclofenac 75mg/2ml solution for intravenous injection (Dyloject ) By the intravenous route, treatment or prevention of post-operative pain in supervised healthcare settings. Diclofenac (Dyloject ) is accepted for restricted use in NHS Scotland for the treatment or prevention of post-operative pain by intravenous injection, in supervised healthcare settings. When given as an intravenous bolus, it showed non-inferiority to a comparator non-steroidal anti-inflammatory drug infusion at providing pain relief over an initial 4 hour period and caused less thrombophlebitis. 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 447/08 No 448/08 Zolendronic acid 5mg solution for infusion (Aclasta ) Infliximab 100mg powder for solution for infusion (Remicade ) Treatment of osteoporosis in post-menopausal women at increased risk of fractures. Treatment of severe, active Crohn s disease, in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy. The manufacturer s submission related only to intravenous use of diclofenac (Dyloject ) in the post-operative setting. SMC cannot recommend its use by the intramuscular route. Zolendronic acid 5mg solution for infusion (Aclasta ) is accepted for restricted use in NHS Scotland for treatment of osteoporosis in postmenopausal women at increased risk of fractures. Intravenous zolendronic acid is restricted to use in patients who are unsuitable for or unable to tolerate oral treatment options for osteoporosis. Treatment initiation should be under specialist supervision. This preparation is licensed for administration once a year and has been shown to reduce the incidence of vertebral and hip fractures over 3 years compared with placebo. Infliximab (Remicade ) is accepted for use in NHS Scotland for the treatment of severe, active Crohn s disease, in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. In an open label study 88% of patients had a clinical response following the induction regimen and this was maintained at one year in significantly more patients receiving infliximab every 8 weeks compared with every 12 weeks. specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and local protocols specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and local protocols 3

4 No 449/08 No 450/08 No 444/08 Drug/product Indication SMC Lanarkshire and ADTC comments Daptomycin, 350mg and 500mg vials of powder for solution for infusion (Cubicin ) Salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler ) Follitropin alfa 150 IU/lutropin alfa 75 IU for solution for injection (Pergoveris ) Abbreviated submission For the treatment of Staphylococcus aureus bacteraemia when associated with right sided infective endocarditis or with complicated skin and softtissue infections in adults. Symptomatic treatment of patients with chronic obstructive airways disease (COPD) with a forced expiratory volume (FEV1) < 60% predicted normal (prebronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. Stimulation of follicular development in women with severe LH and FSH deficiency. Daptomycin (Cubicin ) is accepted for restricted use in NHS Scotland for the treatment of Staphylococcus aureus bacteraemia when associated with right-sided infective endocarditis (RIE) or with complicated skin and soft-tissue infections in adults. Daptomycin should be restricted to use in patients with known or suspected methicillin resistant S. aureus (MRSA) infection and on the advice of local microbiologists or specialists in infectious disease. Daptomycin has been shown to be as effective as standard therapy in patients with S. aureus bacteraemia with or without endocarditis, though data on the subgroup of patients with RIE due to MRSA are very limited. Daptomycin has a higher acquisition cost than some alternative treatments; it does not, however, require therapeutic drug monitoring. Salmeterol/fluticasone 50/500 microgram inhaler (Seretide Accuhaler ) is not recommended for use in NHS Scotland for the symptomatic treatment of patients with chronic obstructive airways disease (COPD) with a forced expiratory volume in 1 second (FEV 1 ) 50% to < 60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy. While there was an improvement in lung function tests and a reduction in both moderate and severe exacerbations with salmeterol/fluticasone in comparison with placebo, there was no difference in mortality rate over 3 years. In addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC. Follitropin alfa 150 IU/Lutropin alfa 75 IU solution for injection (Pergoveris ) is accepted for use in NHS Scotland for stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/l. It may be used in cases where the use of both of these agents, at the doses provided by this formulation, is appropriate. specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and local protocols. non - for this indication. Seretide Accuhaler is however already included in the formulary for the treatment of asthma and COPD when FEV 1 < 50% predicted normal. specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and local protocols. 4

5 No 445/08 No 459/08 11/02/08 No 351/07 11/02/08 No 295/06 Drug/product Indication SMC Lanarkshire and ADTC comments Mesalazine 1200mg gastroresistant, prolonged release tablet (Mezavant XL ) Product Update Bevacizumab (Avastin ) Non-submission Valsartan 320mg tablet (Diovan ) Product Update Losartan 100mg/hydrochlorothiazide 12.5mg tablet (Cozaar-Comp 100/12.5 ) Product Update Induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis, and for maintenance of remission. First line treatment of advanced and/or metastatic renal cell cancer Treatment of hypertension Treatment of hypertension Mesalazine 1200mg gastro-resistant prolonged release tablet (Mezavant XL ) is accepted for use in NHS Scotland for the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis, and for maintenance of remission. It may be used in cases where mesalazine is an appropriate choice of treatment and offers the possible advantage of once-daily administration. Bevacizumab (Avastin ) is not recommended for use in NHS Scotland in combination with interferon alfa-2a for the first line treatment of patients with advanced and/or metastatic renal cell cancer. 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. Valsartan 320mg tablet (Diovan ) is accepted for use in NHS Scotland for the treatment of hypertension. In patients for whom the use of valsartan is appropriate it allows administration of a 320mg dose as a single tablet at less cost than 2 x 160mg capsules. Angiotensin receptor blockers are an alternative to ACE inhibitors where these are not tolerated. Losartan 100mg/ hydrochlorothiazide 12.5mg tablet (Cozaar-Comp 100/12.5 ) is accepted for use in NHS Scotland for the treatment of hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy. In patients for whom this combination of antihypertensive agents is appropriate, it allows more flexible dosing than previously available combination products. This fixed dose combination is one of many options for the treatment of hypertension, including other less expensive angiotensin receptor blocker/diuretic combinations.. Added to the formulary as an option for once daily dosing. noted the SMC however this product is not added to the formulary as existing formulary options are adequate. noted the SMC however this product is not added to the formulary as existing formulary options are adequate. 5

6 No 453/08 No 454/08 No 455/08 No 458/08 Drug/product Indication SMC Lanarkshire and ADTC comments Paliperidone prolonged release tablets (Invega ) Nelarabine 5mg/ml solution for infusion (Atriance ) Methoxy polyethylene glycolepoetin beta for injection (Mircera ) Maraviroc tablets (Celsentri ) Treatment of schizophrenia T- cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma Anaemia associated with chronic kidney disease (CKD). In combination with other antiretroviral medicinal products. Paliperidone (Invega ) is not recommended for use in NHS Scotland for the treatment of schizophrenia. Paliperidone has been shown to be superior to placebo in reducing symptoms of schizophrenia. However, there are limited statistical comparative data versus other atypical antipsychotics. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Nelarabine (Atriance ) is accepted for restricted use in NHS Scotland for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T- cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to, or has relapsed following, treatment with at least two chemotherapy regimens. It is restricted to patients in whom nelarabine is being used as a treatment to bridge to allogenic stem cell transplant and restricted to use by specialists in haematooncology. It is not cost-effective when used for palliation. Methoxy polyethylene glycol-epoetin beta (Mircera ) is accepted for use in NHS Scotland for treatment of anaemia associated with chronic kidney disease. Clinical studies have demonstrated the efficacy of methoxy polyethylene glycolepoetin beta in correcting and maintaining haemoglobin levels for up to a year in dialysis patients, when administered by either the subcutaneous or intravenous route. Non-inferiority to other erythropoiesis stimulating agents, with respect to achieving and maintaining haemoglobin levels, was demonstrated. Maraviroc (Celsentri ) as 150mg and 300mg tablets is not recommended for use in NHS Scotland in combination with other antiretroviral medicinal products, for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. When added to optimised background therapy, maraviroc was associated with a significant reduction in viral load compared with addition of placebo in heavily pre-treated patients. However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit. 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. 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. 6

7 No 435/07 No 442/08 Drug/product Indication SMC Lanarkshire and ADTC comments Vildagliptin tablets (Galvus ) Efavirenz 600mg, emtricitabine 200mg, tenofovir disoproxil 245mg as fumarate (Atripla ) Abbreviated submission Treatment of type 2 diabetes mellitus as dual oral therapy. Treatment of human immunodeficiency virus-1 infection in adults. Vildagliptin (Galvus ) is accepted for restricted use in NHS Scotland for the treatment of type 2 diabetes mellitus as dual oral therapy in combination with metformin, in patients with insufficient glycaemic control despite maximal tolerated doses of monotherapy with metformin. It is restricted to use in patients only when the addition of sulphonylureas is not appropriate and represents an alternative to other agents such as thiazolidinediones. Efficacy, as assessed by measurement of glycated haemoglobin (HbA1 C ) is similar to thiazolidinedione drugs added at this stage in therapy. It appears to have minimal effect on body weight. Vildagliptin is also licensed for use in combination with sulphonylureas or thiazolidinedione drugs for the treatment of type 2 diabetes. The manufacturer s submission related only to the use of vildagliptin in combination with metformin. SMC cannot recommend the use of vildagliptin in combination with these agents. Efavirenz 600mg, emtricitabine 200mg, tenofovir disproxil 245mg as fumarate (Atripla ) is accepted for use in NHS Scotland for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with virologic suppression to HIV-1 RNA levels of <50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in this fixed dose combination prior to initiation of their first antiretroviral treatment regimen. It may be used to simplify the regimen of patients for whom this combination is indicated (see above) and in whom all three agents are appropriate components at the doses provided by this fixed dose combination. noted the SMC however not added to the formulary because there is an existing formulary choice in this drug class sitagliptin already included in the formulary. specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and local protocols. 7

8 No 456/08 No 457/08 No 472/08 Drug/product Indication SMC Lanarkshire and ADTC comments Insulin glargine 100units/ml solution for injection in a pre-filled pen (Lantus SoloStar ) Abbreviated Submission Insulin glulisine 100 units/ml solution for injection in a pre-filled pen (Apidra SoloStar ). Abbreviated Submission Retapamulin (Altargo ) Non - Submission Treatment of diabetes mellitus in adults and children of 6 years or above. Treatment of diabetes mellitus in adults. Short term treatment of impetigo and infected small lacerations, abrasions or sutured wounds. Insulin glargine 100 units/ml solution for injection in a pre-filled pen (Lantus SoloStar ) is accepted for restricted use in the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required. It may be used in patients in whom treatment with this insulin analogue is appropriate and in whom the use of a pre-filled pen offers advantages over a pen and cartridge device. The use of insulin glargine should be targeted on patients with type 1 diabetes who are at risk of or experience unacceptable frequency and/or severity of nocturnal hypoglycaemia on attempting to achieve better hypoglycaemic control during treatment with established insulins. It is also acceptable as a once daily insulin therapy for patients who require carer administration of their insulin. In patients with type 2 diabetes it should be restricted to those who suffer from recurrent episodes of hypoglycaemia or require assistance with their insulin injections. Insulin glulisine 100 units/ml solution for injection in a pre-filled pen (Apidra SoloStar ) is accepted for restricted use in NHS Scotland for the treatment of adult patients with diabetes mellitus in whom treatment with this insulin analogue is appropriate and in whom the use of a pre-filled pen offers advantages over a pen and cartridge device. Insulin glulisine has similar efficacy to other short-acting insulins in reducing glycated haemoglobin and a similar pharmacokinetic profile to at least one other insulin analogue. It is restricted to use in patients where regular human insulin is inappropriate. Retapamulin (Altargo ) is not recommended for use in NHS Scotland for the short term treatment of the following superficial skin infections: Impetigo and infected small lacerations, abrasions or sutured wounds. 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. Accepted for restricted use in Lanarkshire and added to the Joint Formulary only for the restricted use advised by the Scottish Medicines Consortium (SMC) Accepted for restricted use in Lanarkshire and added to the Joint Formulary only for the restricted use advised by the Scottish Medicines Consortium (SMC) 8

9 12/05/08 No 441/08 12/05/08 No 461/08 12/05/08 No 385/07 Drug/product Indication SMC Lanarkshire and ADTC comments Lenalidomide capsules (Revlimid ) Raltegravir 400mg film-coated tablet (Isentress ) Imiquimod 5% cream (Aldara ) Resubmission In combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least one prior therapy. In combination with other antiretroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV-1) infection. Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp. Lenalidomide (Revlimid ) is not recommended for use in NHS Scotland in combination with dexamethasone for the treatment of multiple myeloma in patients who have received at least one prior therapy. Lenalidomide plus dexamethasone significantly increased the time to disease progression compared with dexamethasone alone in multiple myeloma patients who had been treated with at least one prior therapy. The manufacturer did not present a sufficiently robust case and in addition the manufacturer s justification of the treatment s cost in relation to its health benefits was not sufficient to gain acceptance by SMC. Raltegravir (Isentress ) is accepted for restricted use in NHS Scotland in combination with other antiretroviral medicinal agents for the treatment of Human Immunodeficiency Virus (HIV-1) infection in treatment experienced adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. It is restricted to patients with triple class resistant HIV-1 infection. Addition of raltegravir to optimised background therapy in treatment experienced patients with documented resistance to at least one drug in each of the three HIV antiviral classes, significantly increased the number of patients achieving clinically significant reductions in viral load. Imiquimod (Aldara ) is accepted for restricted use in NHS Scotland for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate. It should be restricted to use in patients after specialist advice. Imiquimod was more effective than vehicle in clearing actinic keratosis lesions. specialist nature of the treatment. Non formulary use is acceptable if the drug is used according to SMC s and local protocols. 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

10 12/05/08 No 475/08 12/05/08 No 462/08 Drug/product Indication SMC Lanarkshire and ADTC comments Escitalopram tablets and oral drops (Cipralex ) Non-Submission Aliskiren (Rasilez ) Non-Submission Social anxiety disorder Essential hypertension Escitalopram (Cipralex ) is not recommended for use in NHS Scotland for the treatment of social anxiety disorder. 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 NHS Scotland. Aliskiren (Rasilez ) is not recommended for use in NHS Scotland for the treatment of essential hypertension. 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 NHS Scotland. 10