Area Drug and Therapeutics Committee Prescribing Supplement No 3 November 2003

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1 Area Drug and Therapeutics Committee Prescribing Supplement No 3 In this issue Drugs currently being considered by the SMC advice due on 8 December SMC Notice of meeting: Patient power Making a Difference, New Medicines in Scotland. Promotion of medicines by the pharmaceutical industry. Scottish Medicines Consortium (SMC) - Decisions on new drugs issued in November The following drugs will be reviewed and assessed by the Scottish Medicines Consortium with final advice published on their website on December The next meeting of the Lanarkshire ADTC is on December and following this meeting the Lanarkshire recommendations on these drugs will be published in ADTC supplement number 4. SMC Ref. Drug Indication 71/03 Teriparatide (Forsteo ) Established (severe) osteoporosis in postmenopausal women 81/03 Adalimumab (Humira ) Treatment of rheumatoid arthritis (RA) 82/03 Fluticasone/salmeterol Severe chronic obstructive pulmonary (Seretide Accuhaler ) disease 83/03 Testosterone gel (Testogel ) Replacement therapy for adult male hypogonadism Scottish Medicines Consortium notice of meeting on 23 January 2004 The Scottish Medicines Consortium has arranged a Patient & Public involvement event to be held at the Royal College of Physicians and Surgeons, 176 St Vincent Street, Glasgow on the 23 January This is a unique educational opportunity aimed at a wide stakeholder audience. The event should be of interest to lay members of NHS Boards or committees, NHS patient and public interest staff and also NHS personnel. Prescribing Department alistair.thorburn@lanpct.scot.nhs.uk

2 Cost for the day NHS staff 25 Patient Interest Groups 25 The topic for the day is Patient Power Making a Difference, New Medicines in Scotland An electronic version of the programme and registration form is available from the SMC website Closing date for applications is 13 January SMC phone contact Promotion of Medicines by the Pharmaceutical Industry Important reminder for all prescribers. Advertising and promotion of medicines is strictly regulated under the Medicines (Advertising) Regulations (1994) and it is important that all health professionals including nurse and supplementary prescribers make their choice of medicinal product for their patients on the basis of clinical suitability and value for money alone. As part of medicines promotion companies may provide inexpensive gifts and benefits, for example pens, diaries or mouse mats. Personal gifts are prohibited and it is an offence to solicit or accept a prohibited gift or inducement. Companies may also offer hospitality at a professional or scientific meeting or at meetings to promote medicines, but such hospitality should be reasonable in level and subordinate to the main purpose of the meeting. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for enforcing legislation on advertising and promotion of medicines. Any complaints about promotional activities related to prescription medicines should be referred to the MHRA or to the industry self-regulatory body, the Prescription Medicines Code of Practice Authority. (PMCPA) MHRA: PMCPA: 12 Whitehall, London SW1A 2DY The above information has been reproduced from the MHRA website. Additional references on the promotion of medicines to NHS personnel 1. Abbasi K, Smith R. No more free lunches. BMJ(2003); 326: Wager E. How to dance with porcupines: rules and guidelines on doctors relations with drug companies. BMJ (2003); 326: The following recommendations have been published by the SMC and reviewed by the Lanarkshire ADTC during - ADTC Formulary Pharmacist 2 Fax Prescribing Department alistair.thorburn@lanpct.scot.nhs.uk

3 Date of SMC recommendation No 35/03 No 50/03 No 51/03 No 58/03 Drug/product Indication SMC recommendation Lanarkshire recommendation and ADTC comments Pimecrolimus cream (Elidel ) Methyl aminolevulinate 160mg/g cream (Metvix ) Methyl aminolevulinate 160mg/g cream (Metvix ) Interferon beta 1a (Avonex liquid) In a prefilled syringe Abbreviated submission Short-term treatment of signs and symptoms and intermittent long-term treatment for prevention of progression to flares of mild to moderate atopic dermatitis (eczema) in patients aged 2 years and over Treatment of thin or nonhyperkeratotic and non-pigmented actinic keratoses on the face and scalp when other therapies are considered less appropriate Treatment of superficial and/or nodular basal cell carcinoma unsuitable for other available therapies due to possible treatment related morbidity and poor cosmetic outcome: such as lesions on the mid-face or ears, lesions on severely sun-damaged skin, large lesions or recurrent lesions Treatment of selected ambulatory patients with relapsing-remitting multiple sclerosis under the provision of a risksharing scheme between the Scottish Executive and the manufacturer Not recommended for use within NHS Scotland. There is no evidence of an advantage in terms of efficacy or safety when compared with alternative treatments, which include mild to moderately potent topical corticosteroids. The economic case for using this expensive preparation is unproven. Accepted for use within NHS Scotland. Evidence for efficacy for this indication is not strong. Health economic evidence is incomplete, though it suggests similar costs to the alternative treatment (cryotherapy). However, Metvix appears to have a place for treatment of those patients when other therapies are considered less appropriate and should be delivered by a dermatologist experienced in this therapy. Appears to be effective for the treatment of basal cell carcinoma in those patients in whom standard treatment with surgery or cryotherapy is contraindicated. Its use should be restricted to specialist dermatologists and to superficial lesions where penetration is most effective This is a liquid formulation, which replaces a powder formulation of the same strength. It is supplied at the same price. This product is used for the treatment of selected ambulatory patients under the provision of a risk-sharing scheme between the Scottish Executive and the manufacturer. In Lanarkshire therefore pimecrolimus cream (Elidel ) should not be used for this indication. noting that a dermatologist experienced in using this therapy should only initiate treatment. General Practitioners should not initiate treatment. noting that use should be restricted to specialist dermatologists. General Practitioners should not initiate treatment. noting the current special arrangements for the prescribing of drugs for the treatment of relapsingremitting multiple sclerosis.

4 Date of SMC recommendation No 65/03 Drug/product Indication SMC recommendation Lanarkshire recommendation and ADTC comments Ketotifen hydrogen fumarate (Zaditen eye drops) Treatment of seasonal allergic conjunctivitis. Not recommended for use in NHS Scotland. The licence holder failed to make a submission to the SMC. Therefore not recommended for use in Lanarkshire. No 68/03 No 78/03 No 79/03 No 80/03 Sertraline (Lustral ) Olmesartan Medoxomil (Olmetec ) Mometasone furoate (Asmanex Twisthaler ) Clostridium botulinium type A neurotoxin complex (Botox ) Treatment of post-traumatic stress disorder in women. Not normally recommended for males. Treatment of essential hypertension Regular treatment to control persistent asthma in adults and adolescents 12 years of age and older. Focal spasticity, including the treatment of wrist and hand disability due to upper limb spasticity associated with stroke in adults. Not recommended for use in NHS Scotland for this indication. Sertraline has demonstrated some benefit in treating posttraumatic stress disorder (PTSD) in two of four 12-week double blind treatment studies and in extension studies for up to 64 weeks. The product licence restricts its use to women only; a narrower indication than for the other drug currently licensed for treating PTSD, and against which no comparative trials has been conducted. The manufacturer submitted no evidence to demonstrate the cost-effectiveness of their drug Accepted for restricted use in NHS Scotland. At least as effective as other angiotensin II antagonists for the treatment of hypertension. It may be considered for use, along with other angiotensin II antagonists, as an alternative in patients unable to tolerate an ACE inhibitor. Mometasone is the fourth inhaled steroid licensed for the treatment of asthma. It is available as a dry powder inhaler. Efficacy and adverse event profile is similar to other available inhaled steroids. It is suitable for use as a second line agent following treatment failure on first line inhaled steroids. Not recommended for use within NHS Scotland. Produces a localised reduction in muscle tone in patients with post-stroke hand and wrist spasticity and may improve disability. However, the place in therapy was not clearly defined nor was the economic case proven. Therefore sertraline should not be used in Lanarkshire, for the treatment of PTSD. The ADTC agreed that olmesartan should not be used in Lanarkshire at present and should be referred to the ADTC cardiovascular sub-group to consider inclusion in the joint formulary The ADTC agreed that Asmanex Twisthaler ( ) should not be used in Lanarkshire at present and should be referred to the ADTC respiratory subgroup for further advice. Therefore not to be used in Lanarkshire ADTC Formulary Pharmacist 2 Fax

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