NHS Ayrshire & Arran Formulary Bulletin

Transcription

1 Area Drug & Therapeutics Committee NHS Ayrshire & Arran Formulary Bulletin October 2009 Edition In this issue: Metformin hydrochloride prolonged release tablets (Glucophage SR ) 11.7mg etonogestrel / 2.7mg ethinylestradiol vaginal ring (NuvaRing ) Terlipressin acetate solution for injection (Glypressin Solution) Olmesartan medoxomil/amlodipine as besilate tablet (Sevikar ) SMC Not recommended for use medicines o Quetiapine tablet (Seroquel ) o Hydroxycarbamide (Siklos ) o Estradiol/dienogest (Qlaira ) Discontinued preparations ADTC issues includes approved clinical guidelines and protocols Medicines under review by MRG Medicines under review by AMT Medicines under review by the FMG Medicines launched, not yet reviewed and not for prescribing The following medicines were considered at October 2009 meeting of the Formulary Management Group (FMG) and recommendations were made regarding their use within primary and secondary care. Endorsement of these decisions will be obtained at Area Drug & Therapeutics Committee (ADTC) meeting in November 2009 Metformin hydrochloride 500mg, 750mg, 1000mg prolonged release tablets (Glucophage SR ) 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. Scottish Medicines Consortium 148/04 (resubmission): accepted for restricted use within NHS Scotland 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 oncedaily preparation offers a clinically significant benefit. restricted ADTC Decision include in formulary for use as per ADTC 11: Guidelines on the control of HbA1c in adult type 2 diabetes Implication for all NHS A & A Prescribers for prescribing within NHS Ayrshire & Arran as per clinical guideline ADTC 11 (Guidelines on the control of HbA1c in adult type 2 diabetes) 11.7mg etonogestrel / 2.7mg ethinylestradiol vaginal ring (NuvaRing ) Contraception Scottish Medicines Consortium 502/08 (resubmission): accepted for restricted use within NHS Scotland 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. ADTC Decision include in formulary for initiation by Associate Specialists and Consultants working within Sexual Health. restricted Implication for all NHS A & A Prescribers for prescribing within NHS Ayrshire & Arran by Associate Specialists and Consultants working within Sexual Health NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit October 2009 Page 1 of 6

2 Terlipressin acetate 0.12mg/ml solution for injection (Glypressin Solution) Treatment of bleeding oesophageal varices in patients for whom terlipressin is an appropriate choice of therapy Scottish Medicines Consortium 555/09 : accepted for use within NHS Scotland It replaces a formulation that requires reconstitution and is associated with only a modest cost increase. ADTC Decision exclude from formulary as powder formulation currently available. X Exclude Implication for all NHS A & A Prescribers Glypressin Solution not for prescribing within NHS Ayrshire & Arran, but powder formulation remains available. Olmesartan medoxomil/amlodipine as besilate tablet 20mg/50mg, 40mg/5mg, 40mg/10mg (Sevikar ) Treatment of essential hypertension in patients whose blood pressure is not adequately controlled on olmesartan medoxomil or amlodipine monotherapy Scottish Medicines Consortium SMC 574/09: accepted for use within NHS Scotland 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. ADTC Decision exclude from formulary as suitable formulary alternatives available X Implication for all NHS A & A Prescribers not for prescribing within NHS Ayrshire & Arran Exclude Scottish Medicines Consortium advice: not recommended for use within NHS Scotland All of the following products have not been recommended for use and are therefore excluded from the NHS Ayrshire & Arran formulary 549/09 Quetiapine 25mg, 100mg, 200mg, 300mg tablet (Seroquel ) 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 The licence holder has indicated their intention to resubmit. 582/09 Hydroxycarbamide (Siklos ) 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. 583/09 Estradiol/dienogest (Qlaira ) 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. X ADTC Decision exclude from the formulary Exclude Implication for all A & A Prescribers - not for prescribing within NHS Ayrshire & Arran NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit October 2009 Page 2 of 6

3 All of the following products have not been reviewed by Scottish Medicines Consortium since launch and are therefore excluded from the NHS Ayrshire & Arran formulary, for the indications stated The Formulary Management Group will only consider addition to formulary following a formulary appeal Atorvastatin (Lipitor ) tablets - diabetics with at least one additional risk factor without CHD Dexibuprofen (Seractil ) tablets osteoarthritic pain, primary dysmenorrhoea & other mild to moderate pain Botulinum Toxin Type A (Vistabel ) moderate to severe glabellar lines Cinnarizine/ Dimenhydrinate (Arlevert ) tablets vertigo Oxybutynin (Lyrinel XL ) - detrusor hyperrflexia (child > 6 yrs) Perindopril (Coversyl ) tablets stable coronary artery disease who have a history of MI or revascularisation Escitalopram (Cipralex ) oral solution all indications Lanreotide (Somatuline Autogel ) injection - neuroendocrine tumours Sodium valproate mr granules (Epilim Chronosphere ) new presentation Tetracycline (Topicycline ) cutaneous solution acne X Exclude ADTC Decision exclude from the formulary Implication for all A & A Prescribers - not for prescribing within NHS Ayrshire & Arran Discontinued Preparations Formulary items Formulary Items Discontinued Hydrocortisone /clioquinol (Vioform Hydrocortisone ) cream and ointment Discontinued. Non-formulary items for information Actinac lotion (Chloramphenicol, hydrocortisone, butoxyethyl nicotinate, allantoin, precipitated sulphur) Aztreonam (Azactam ) 500mg vials Benylin Children s Coughs and Colds Carmustine (BiCNU ) 100mg injection Galactose (Echovist ) Sodium phosphate monobasic monohydrate, disodium phosphate anhydrous (Diafalk ) 1500mg tablets Area Drug & Therapeutics Committee (ADTC) issues The following clinical guidelines have been approved by the Medicines, Guidelines and Protocols Group/ ADTC and are available on the ADTC intranet section within AthenA (under Clinical Guidelines and Prescribing Information) Clinical guidelines approved ADTC 07: Medication Notes for Heart Failure Nurse Service (updated guideline) ADTC 79: Guidelines on the care and maintenance of epidural infusions in adults (updated version) ADTC 80: Protocol for the Administration of Levobupivacaine 2.5mg/ml or Diamorphine or Levobupivacaine 1mg/ml (0.1%) and Fentanyl (2micrograms/ml) as Epidural Boluses by the Pain Management Nurse Practitioners (updated version) ADTC 87: Guidelines for continuous local anaesthetic infusions in adults (updated version) NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit October 2009 Page 3 of 6

4 Medicines under review by Area Drug & Therapeutics Committee (ADTC) NHS Ayrshire and Arran Area Drug and Therapeutics Committee The medicines listed below are still being considered by the ADTC. A final decision will be communicated in the near future but in the meantime they are excluded from the NHS Ayrshire & Arran formulary Rivaroxaban tablets (Xarelto ) - prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery (SMC 519/08) Urokinase (Syner-KINASE ) lysis of blood clots Medicines under review by the Medicines Resource Group NHS Ayrshire & Arran: Medicines Resource Group (MRG) The medicines listed below have been considered by the ADTC and are currently being considered by the MRG. Recurring funding has not yet been identified for the medicine and a final decision on their formulary status has not been made by the MRG. However the medicines listed below may be requested on a case by case basis, according to SMC access criteria. Requests should be sent to the Director of Pharmacy for consideration. Where it is intended to use the medicines out with SMC access criteria an exceptional case application must be completed and sent to the Medical Director for consideration. Most relevant to Primary Care: Pregabalin capsules (Lyrica ) - treatment of peripheral neuropathic pain in adults (SMC 157/05) Most relevant to Secondary Care: Adalimumab injection (Humira ) - treatment of active polyarticular juvenile idiopathic arthritis in adolescents aged years (SMC 533/09) Alitretinoin capsules (Toctino ) - severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids (SMC 538/09) Mecasermin injection (Increlex ) - Long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency (SMC 563/09) Peginterferon alfa-2a pre-filled injections (Pegasys ) - in combination with ribavirin for the treatment of chronic hepatitis C in adult patients who have failed previous treatment with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin (SMC 561/09) Rituximab infusion (MabThera ) first line treatment of patients with chronic lymphocytic leukaemia in combination with fludarabine and cyclophosphamide (SMC 540/09) Romiplostim subcutaneous injection (Nplate ) adult chronic immune (idiopathic) thrombocytopenic purpura splenectomised patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Second line treatment for adult non splenectomised patients where surgery is contraindicated (SMC 553/09) Topotecan capsules (Hycamtin ) monotherapy for relapsed small cell lung cancer (SMC 545/09) Antimicrobial Management Team NHS Ayrshire and Arran Antimicrobial Management Team (AMT) The medicines listed below are still being considered by the AMT. A final decision will be communicated in the near future but in the meantime they are excluded from the NHS Ayrshire & Arran formulary Caspofungin (Cancidas ) injection empirical therapy in febrile, neutropenic paediatric patients (SMC551/09), treatment of invasive candidiasis in paediatric patients (SMC 552/09) Daptomycin (Cubicin ) inj Staphylococcus aureus bacteraemia associated with right-sided infective endocarditis or with skin and soft tissue infections (SMC 449/08) Doripenem infusion (Doribax ) - treatment of complicated intra-abdominal infections (529/09), treatment of nosocomial pneumonia (including ventilator associated pneumonia) in adults (539/09) Temocillin (Negaban ) inj. treatment of septicaemia, urinary tract infection and lower respiratory tract infection NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit October 2009 Page 4 of 6

5 Medicines under review by the Formulary Management Group NHS Ayrshire and Arran Formulary Management Group (FMG) The medicines listed below have been considered by the ADTC and their formulary status is currently being reviewed by the FMG. A final decision will be communicated in the near future but in the meantime they are excluded from the NHS Ayrshire & Arran formulary. Atazanavir (Reyataz ) capsules - treatment naïve HIV-1 infected adults (SMC 520/08) Atomoxetine (Strattera ) capsules ADHD (children 6 years & adolescents (SMC 153/05) Brinzolamide/timolol eye drop (Azarga ) open-angle glaucoma or ocular hypertension (SMC 568/09) Darunavir (Prezista ) tablets - HIV infection in antiretroviral therapy naïve adults.(smc 566/09) Enoxaparin (Clexane ) prefilled syringes/ multidose vials treatment of STEMI (SMC 380/07) Etanercept (Enbrel ) - chronic severe plaque psoriasis in children and adolescents (SMC 570/09) Galantamine (Reminyl XL ) mild to moderately severe dementia in Alzheimer s disease (SMC 139/04) Histrelin acetate implant (Vantas ) palliative treatment of advanced prostatic cancer (SMC557/09) Lamivudine/zidovudine (Combivir ) - HIV-1 in paediatric patients (SMC 569/09) Methotrexate 50mg/ml pre-filled syringes (Metoject ) - severe recalcitrant disabling psoriasis and severe psoriatic arthritis in adult patients (SMC 573/09) Methylphenidate (Equasym XL & Medikinet XL brands) ADHD (SMC 99/04 and 388/07) Prasugrel (Efient ) tablets - prevention of atherothrombotic events in patients with ACS or STEMI undergoing or delayed PCI (SMC 562/09) Etravirine (Intelence ) tablets HIV (SMC 530/09) Rivastigmine (Exelon ) transdermal patch - Moderately severe Alzheimer s dementia (SMC 414/07) Fluticasone (Avamys ) nasal spray allergic rhinitis (SMC 544/09) Fosamprenavir suspension and tablet (Telzir ) (SMC 431/07) Rotigotine (Neupro ) transdermal patch moderate to severe idiopathic restless legs syndrome (SMC548/09) Vildagliptin (Galvus ) tablets type 2 diabetes in combination with a sulphonylurea (SMC 571/09) SMC approved medicines available on a Case by case or Exceptional case basis in NHS Ayrshire & Arran Full updated lists of all the medicines which are available within NHS Ayrshire & Arran on a case by case basis according to SMC criteria or on an exceptional case basis can be located on the Joint Formulary website, located on the NHS Ayrshire & Arran intranet. These can be accessed via Bulletin downloads and Area Drug & Therapeutics Committee minutes, then click on managed entry of new drugs. For further information please refer to the SMC website Scottish Medicines Consortium Medicines Not Recommended for Use A full updated list of medicines which are not recommended for use within NHS Scotland for specific indications can be located on the Joint Formulary website, located on the NHS Ayrshire & Arran intranet. These can be accessed via Bulletin downloads and Area Drug & Therapeutics Committee minutes, then click on managed entry of new drugs. For access to these medicines an exceptional case application must be completed and sent to the Medical Director for consideration. For further information please refer to the SMC website NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit October 2009 Page 5 of 6

6 Medicines launched, not yet reviewed and not for prescribing The following are medicines that have been launched or have had an extension to their licensed indications but have not as yet been considered by the ADTC. Since they have yet to be considered by the SMC, they are therefore NOT recommended for prescribing within NHS Ayrshire & Arran until a decision is communicated from the ADTC. They are however available on an exceptional case application basis. Requests should be sent to the Medical Director for consideration. Agomelatine (Valdoxan ) tablets - depression Losartan (Cozaar ) tablets - chronic heart failure (in patients 60 years) Alemtuzumab (MabCampath ) inf first line CLL Miglustat (Zavesca ) caps - treatment of neurological Azacitidine (Vidaza ) injection - pts not eligible for haematopoietic stem cell transplantation with; Intermediate-2 and high risk myelodysplastic syndromes, CML or AML Betamethasone (Betesil ) medicated plaster - eczema, lichenification, lichen planus, granuloma annulare, palmoplantar pustulosis and mycosis fungoides. Bortezomib (Velcade ) untreated multiple myeloma with melphalan & prednisolone Buprenorphine (BuTrans ) patch non-malignant moderate chronic pain C1-Esterase inhibitor (Berinert ) - Hereditary angioedema type I and II (acute episode) Calcium acetate (PhosLo ) capsules prevention and management of hyperphosphataemia in dialysis patients Calcium carbonate/colecalciferol/ calcium lactate gluconate (Sandocal + D 1200 ) efff tabs- Prevention and treatment of calcium and vitamin D deficiency & as an adjunct in osteoporosis Carmellose/ Glycerine (Optive ) eye drops dry eyes Darunavir (Prezista ) tabs HIV in children and adolescents Doripenem (Doribax) inj complicated UTIs Doxycycline (Efracea ) capsules - treatment of rosacea Droperidol (Xomolix ) injection post op nausea & vomiting Ertapenem (Invanz ) inj community acquired pneumonia & acute gynaecological infections Esomeprazole injection - prevention rebleeding following endoscopy (72 hour infusion) Etanercept (Enbrel MYCLIC ) prefilled pen - all etanercept indications in adults Fentanyl (Instanyl ) nasal spray - breakthrough pain in chronic cancer pain. Gefitinib (Iressa ) tablets locally advanced or metastatic non-small cell lung cancer with activating mutations of EGFR-TK Glatiramer (Copaxone ) injection - treatment of first clinical episode and in those at high risk of developing multiple sclerosis Grass Pollen Extract (Grazax ) tablets use in children Insulin Glargine (Lantus OptiClik ) new insulin device Liraglutide (Victoza ) injection type 2 diabetes manifestations of Niemann-Pick type C disease Movicol Paediatric Plain - chronic constipation and prevention of recurrence (child 2-11 yrs) Nepafenac (Nevanac ) eye drop cataract surgery Nicotinic Acid/ Laropiprant (Tredaptive ) tabs - dyslipidaemia Olanzapine (Zypadhera ) prolonged release injection maintainance tretament for schizophrenia Omalizumab (Xolair ) asthma (children 6 and 12 years of age) Plerixafor (Mozobil ) injection - haematopoietic stem cell mobilisation in autologous transplantation (lymphoma and multiple myeloma) Recombinant Antithrombin (ATryn ) prophylaxis of venous thromboembolism Risperidone (Risperdal ) oral formulations aggression in moderate to severe Alzheimer s (short term use), short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children (from 5 years) and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria Rupatadine (Rupafin ) allergic rhinitis, chronic idiopathic urticaria Sitagliptin tablets (Januvia ) - type 2 diabetes mellitus (1 st line treatment) Somatropin (Humatrope ) inj growth disturbance in short children. Growth failure associated with SHOX deficiency TachoSil medicated sponge - promotion of tissue sealing and suture support in vascular surgery Tafluprost (Saflutan ) eye drops - open angle glaucoma or ocular hypertension. Temsirolimus (Torisel ) infusion advanced renal cell ca. Tolvaptan (Samsca ) tablets - hyponatraemia secondary to SIADH secretion Trospium (Regurin XL ) mr capsules - overactive bladder syndrome Urofollitropin (Fostimon ) injection infertility Ustekinumab (Stelara ) injection moderate to severe plaque psoriasis Valganciclovir (Valcyte ) oral solution Valsartan (Diovan ) - symptomatic heart failure NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit October 2009 Page 6 of 6