Area Drug & Therapeutics Committee NHS Ayrshire & Arran Formulary Bulletin January 2009 Edition In this issue: Salbutamol inhaler (Salbulin MDPI Novolizer) Ertapenem infusion (Invanz ) Thalidomide capsules (Thalidomide Pharmion ) Buprenorphine transdermal patch 7-day formulation (BuTrans ) Salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler ) Aliskiren tablets (Rasilez ) Stiripentol capsules and suspension in sachet (Diacomit ) Zoledronic acid infusion (Aclasta ) SMC Not recommended for use medicines 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 the January 2009 meeting of the Formulary Management Group (FMG) and recommendations were made regarding their use within primary and secondary care. Endorsement of these decisions has been obtained at the Area Drug & Therapeutics Committee (ADTC) meeting in January 2009. Salbutamol (as sulphate) 100 micrograms per dose as powder for inhalation (Salbulin MDPI Novolizer) Indication In patients with reversible airways obstruction such as asthma for relief and prevention of asthma symptoms Comment Scottish Medicines Consortium 504/08: accepted for use within NHS Scotland It may be used in patients in whom treatment with this short-acting beta agonist is appropriate and for whom delivery by a breath-activated dry powder inhaler device offers advantages over other delivery systems. It should be used to relieve asthma symptoms when they occur and to prevent symptoms in circumstances known by the patient to precipitate symptoms, for example prior to exercise or allergen exposure. It should be used for patients in whom a short-acting beta-agonist is appropriate and for whom a dry powder inhaler is an appropriate delivery device. It has a similar cost to other dry powder inhaled formulations of salbutamol X Exclude ADTC Decision exclude from formulary as suitable alternatives available Implication for all A & A Prescribers not for prescribing within NHS Ayrshire & Arran Ertapenem, 1g vial of powder for solution for intravenous infusion (Invanz ) Indication Treatment of diabetic foot infections of the skin and soft tissue when caused by bacteria known or very likely to be susceptible to ertapenem and where broad spectrum parenteral therapy is appropriate Comment Scottish Medicines Consortium 335/06: accepted for restricted use within NHS Scotland It is restricted to use by specialists managing diabetic foot infection or on the advice of a microbiologist. Ertapenem showed non-inferiority to a penicillin/beta-lactamase inhibitor combination in the pivotal trial. Although ertapenem has a greater acquisition cost than some treatment options, its once-daily dosing regimen may allow changes in service delivery that have individual patient or organisational benefits. Efficacy of ertapenem in the treatment of diabetic foot infection with concurrent osteomyelitis has not been established. X Exclude ADTC Decision exclude from formulary as suitable alternatives available Implication for all A & A Prescribers not for prescribing within NHS Ayrshire & Arran NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit January 2009 Page 1 of 6
The following medicine was considered by the Medicines Resource Group (MRG) and a recommendation made regarding their use within secondary care. Thalidomide 50mg hard capsules (Thalidomide Pharmion ) Indication In combination with melphalan and prednisone, as first line treatment of patients with untreated multiple myeloma, aged 65 years or over or ineligible for high dose chemotherapy. Thalidomide is prescribed and dispensed according to the Thalidomide Pharmion Pregnancy Prevention Programme Comment Scottish Medicines Consortium 525/08: accepted for restricted use within NHS Scotland In the pivotal trial in patients aged 65 to 75 years, at 51.5 months median follow-up, the addition of thalidomide to melphalan and prednisone gave an overall survival advantage of 18.4 months. Case by case application ADTC Decision Available on a case by case application basis only as per SMC access criteria through the Director of Pharmacy. Implication for all A & A Prescribers for prescribing within NHS Ayrshire and Arran on a case by case application basis only as per SMC access criteria through the Director of Pharmacy. The following medicines were considered by the Area DTC and recommendations were made regarding their use 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 234/06 (resubmission) 450/08 (resubmission) 462/08 (resubmission) Buprenorphine transdermal patch 5, 10 & 20 microgram/hour 7-day formulation (BuTrans ) For the treatment of severe opioid responsive pain conditions, which are not adequately responding to non-opioid analgesics In the patient population considered in this submission, severe osteoarthritis pain in elderly patients whose pain is not adequately controlled by non-opioid analgesics, or for whom other analgesics are not suitable, buprenorphine transdermal 7-day patch was superior to placebo and similar in efficacy to World Health Organisation (WHO) Step 2 analgesic comparator agents. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Salmeterol/fluticasone 50/500 micrograms inhaler (Seretide 500 Accuhaler ) 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 were improvements in lung function tests and reductions in moderate exacerbations with the salmeterol/fluticasone combination compared to placebo and to salmeterol alone, there were no significant differences in mortality rates over 3 years. In addition, the manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC. Aliskiren 150mg and 300mg film coated tablets (Rasilez ) For the treatment of essential hypertension. Aliskiren has shown comparable efficacy to other antihypertensive agents in terms of blood pressure reduction, though its effects on mortality and long-term morbidity are currently unknown. The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC for the position sought. 524/08 Stiripentol, 250mg hard capsules and 250mg powder for oral suspension in sachet and 500mg hard capsules and 500mg powder for oral suspension in sachet (Diacomit ) For use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalised tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet s syndrome) whose seizures are not adequately controlled with clobazam and valproate. The number of responders with >50% reduction in the number of clonic (or tonic-clonic) seizures was significantly greater in SMEI patients receiving adjunctive stiripentol than in patients receiving placebo. The product did not gain acceptance by SMC as the manufacturer did not present a formal economic evaluation. 535/08 Zoledronic acid 5mg/100ml solution for infusion (Aclasta ) For the treatment of osteoporosis in men at increased risk of fracture, including those with a recent low-trauma hip fracture. 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. X Exclude ADTC Decision exclude from the formulary Implication for all A & A Prescribers - not for prescribing within NHS Ayrshire & Arran NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit January 2009 Page 2 of 6
Discontinued Preparations Formulary items Podophyllotoxin (Warticon ) solution Previously marketed in 2 different formats: Warticon for male patients and Warticon FEM for females, with both formulations being identical. Warticon FEM has been discontinued and Warticon will now be used for both indications. Non-formulary items for information Eskamel cream Rimonabant (Acomplia ) marketing authorisation suspended. Separate communication has been sent to all prescribers by the manufacturer 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 50: Guidelines for the management of drug therapy in the pre-operative period (updated guideline) ADTC 79: Guidelines on the care and maintenance of epidural infusions in adult patients aged 16 years and over (updated guideline) ADTC 80: Protocol for the administration of Bupivacaine 0.25% or Diamorphine or 0.1% Bupivacaine and Fentanyl (2micrograms/ml) as Epidural Boluses by the Pain Management Nurse Practitioners ADTC 81: Guidelines on the use of Patient Controlled Analgesia (PCA) in adult patients aged 16 years and over (updated guideline) MHP 01: Guidelines on McKinley T34 Syringe Pump for use in Palliative Care Clinical protocols for expensive medicines Cinacalcet (Mimpara ) in Secondary and Tertiary Hyperparathyroidism Formulary Reviews BNF section 4.8 Antiepileptics A review regarding switching between generic and branded products of anti-epileptics, namely sodium valproate, phenytoin and carbamazepine was undertaken. The current formulary advises that Patients should be maintained on the same brands of phenytoin, carbamazepine and sodium valproate. Different brands of these drugs are not interchangeable. As a result the prescribing notes in formulary on this subject were reviewed. FMG agreed to change the formulary notes on use to reflect those in the BNF 56 edition i.e. Carbamazepine Different preparations may vary in bioavailability; to avoid reduced effect or excessive side-effects, it may be prudent to avoid changing the formulation Phenytoin - there may be a pharmacokinetic basis for maintaining the same brand of phenytoin in some patients Sodium valproate no notes BNF section 11.8.1 Tear deficiency, ocular lubricants, and astringents Remove sodium chloride 0.9% Minims no longer used Add unit dose vials for Ophthalmology initiation, as no preparations currently listed in formulary. Preparations chosen: o Carmellose sodium 0.5% and 1% unit dose vials (Celluvisc ) 1 st choice unit dose vial o Polyvinyl alcohol 1.4%. unit dose vials (Liquifilm ) 2 nd choice unit dose vial NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit January 2009 Page 3 of 6
Prescribing of tacrolimus Recent prescribing information was sent to all prescribers by Astellas Pharma Ltd, reminding prescribers that the two preparations available containing tacrolimus, Prograf and Advagraf, are not interchangeable. Their licensed indications are not identical and are available in different formulations: Prograf - immediate release formulation that must be taken twice daily Advagraf - prolonged release formulation that must be taken once daily Prescribers are reminded when prescribing tacrolimus this should be done by brand name to avoid any confusion. Copies of this information can be obtained by contacting Medicines Information (telephone: 01292 614506) 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 Alteplase (Actilyse ) acute ischaemic stroke (SMC Urokinase (Syner-KINASE ) lysis of blood clots 87/04) Rivaroxaban tablets (Xarelto ) - prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery (SMC 519/08) 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: None Most relevant to Secondary Care: None 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 use in children Daptomycin (Cubicin ) inj Staphylococcus aureus bacteraemia associated with right-sided infective endocarditis or with skin and soft tissue infections (SMC 449/08) Temocillin (Negaban ) inj. treatment of septicaemia, urinary tract infection and lower respiratory tract infection NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit January 2009 Page 4 of 6
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. Aripiprazole intramuscular injection (Abilify ) - rapid control of agitation and disturbed behaviours in patients with schizophrenia when oral therapy is not appropriate (SMC 522/08) Atazanavir 300mg capsules (Reyataz ) - treatment naïve HIV-1 infected adults (SMC 520/08) Atomoxetine (Strattera ) capsules ADHD (children 6 years & adolescents (SMC 153/05) Fosaprepitant, 115mg powder for solution for infusion (Ivemend ) - prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy (SMC 506/08) Galantamine (Reminyl XL ) mild to moderately severe dementia in Alzheimer s disease (SMC 139/04) Methylphenidate (Equasym XL & Medikinet XL brands) ADHD (SMC 99/04 and 388/07) Rivastigmine 4.6mg/24h and 9.5mg/24h transdermal patch (Exelon ) - Moderately severe Alzheimer s dementia (SMC 414/07) Sitagliptin tablet (Januvia ) - type 2 diabetes with a sulphonylurea or metformin (SMC 505/08) Vildagliptin 50mg tablets (Galvus ) Type 2 diabetes mellitus (SMC 435/07) Vildagliptin 50mg/Metformin hydrochloride 850mg film coated tablets and Vildagliptin 50mg/metformin hydrochloride 1000mg film coated tablets (Eucreas ) Type 2 diabetes (SMC 477/08) SMC approved medicines available on a Case by case or Exceptional case basis in NHS Ayrshire and Arran Full updated lists of all the medicines which are available within NHS Ayrshire and 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 www.scottishmedicines.org 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 www.scottishmedicines.org NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit January 2009 Page 5 of 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 and 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. Adalimumab (Humira ) inj in combination with methotrexate for polyarticular juvenile idiopathic arthritis Alemtuzumab (MabCampath ) inf first line CLL Alitretinoin (Toctino ) caps - treatment of adults with severe chronic hand eczema Atorvastatin (Lipitor ) tabs - diabetics with at least one additional risk factor without CHD Bortezomib (Velcade ) untreated multiple myeloma in combination with melphalan & prednisolone Botulinum Toxin Type A (Vistabel ) moderate to severe glabellar lines, when these have a psychological impact Calcipotriol & Betamethasone dipropionate (Xamiol ) gel scalp psoriasis Caffeine 5mg/ml injection - apnoea of prematurity Carmellose 0.5% /Glycerine (Optive ) eye drops dry eyes Cetuximab (Erbitux ) infusion - metastatic colorectal cancer of the KRAS wild-type, squamous cell ca of head & neck in combination with platinum-based chemotherapy Cinnarizine/ Dimenhydrinate (Arlevert ) tabs vertigo Combivir (Lamivudine, zidovudine) tabs HIV (paeds) Dexibuprofen (Seractil ) tablets osteoarthritic pain, primary dysmenorrhoea and other mild to moderate pain Doripenem (Doribax) inj nosocomial pneumonia, complicated intra-abdominal infections, complicated UTIs Ertapenem (Invanz ) inj Community acquired pneumonia & acute gynaecological infections Escitalopram (Cipralex ) oral solution all indications Etoricoxib (Arcoxia ) tablets - ankylosing spondylitis Etravirine (Intelence ) tabs HIV Insulin Glargine (Lantus OptiClik ) new insulin device Lanreotide (Somatuline Autogel ) - neuroendocrine tumours Lapatinib (Tyverb ) tabs advanced or metastatic breast ca Leuprorelin (Prostap ) Metastatic prostate cancer; locally advanced prostate cancer, as an alternative to surgical castration; adjuvant treatment to radiotherapy in patients with high risk localised advanced prostate cancer; adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression Lacosamide (Vimpat ) tabs partial onset seizures ( 16 years of age) Mecasermin (Increlex ) solution for injection - treatment of growth failure in children and adolescents Movicol Paediatric Plain - chronic constipation and prevention of recurrence (child 2-11 yrs) Olanzapine (Zypadhera ) prolonged release injection maintainance tretament for schizophrenia Oxybutynin (Lyrinel XL ) - detrusor hyperrflexia (child > 6 yrs) Pemetrexed (Alimta ) - first line treatment of patients with locally advanced or metastatic non-small cell lung cancer Perindopril (Coversyl ) tabs stable coronary artery disease who have a history of MI or revascularization Progesterone (Utrogestan ) caps HRT Recombinant Antithrombin (ATryn ) prophylaxis of venous thromboembolism Risperidone (Risperdal ) oral formulations aggression in moderate to severe Alzheimer s (short term use) Sodium valproate mr granules (Epilim Chronosphere ) new presentation Somatropin (Humatrope ) inj growth disturbance in short children, born small for gestational age who fail to show catch up growth by four years or later. Growth failure associated with SHOX deficiency, as confirmed by DNA analysis Sugammadex Sodium (Bridion ) injection - reversal of neuromuscular blockade induced by rocuronium or vecuronium Temsirolimus (Torisel ) inf advanced renal cell ca. Tetracycline (Topicycline ) cutaneous solution acne Topotecan (Hycamtin ) caps monotherapy for relapsed SCLC Urofollitropin (Fostimon ) inj infertility NHS Ayrshire & Arran Formulary Bulletin, Medicines Utilisation Unit January 2009 Page 6 of 6