Area Drug and Therapeutics Committee Prescribing Supplement No 30 April 2009

Size: px

Start display at page:

Download "Area Drug and Therapeutics Committee Prescribing Supplement No 30 April 2009"

Aubrey Quinn
6 years ago
Views:

Area Drug and Therapeutics Committee Prescribing Supplement No 30 In this issue Drugs currently being considered by SMC advice due on 11 May 2009 Drug Safety Update (MHRA) New updated wound

1 Area Drug and Therapeutics Committee Prescribing Supplement No 30 In this issue Drugs currently being considered by SMC advice due on 11 May 2009 Drug Safety Update (MHRA) New updated wound management formulary for NHS Lanarkshire Recent additions to the Lanarkshire Joint Formulary New drugs reviewed by the SMC in February and March 2009 Drugs currently being considered by the SMC with advice due on 11 May 2009 SMC REVIEW Caffeine base 5mg/ml injection (No 550/09) Pregabalin capsules (Lyrica ) (No 157/05) Caspofungin for infusion (Cancidas ) (No 551/09) Caspofungin for infusion (Cancidas ) (No 552/09) Paclitaxel (Abraxane ) (No 556/09) INDICATION Apnoea of prematurity Peripheral neuropathic pain Fungal infections in febrile neutropenic patients (12 months to 17 years) Invasive candidiasis in paediatric patients (12 months to 17 years) Metastatic breast cancer Drug Safety Update (MHRA) (Highlights) Antiepileptics: Adverse effects on bone Methylthioninium chloride (methylene blue): Update on CNS toxicity with serotonergic drugs. Yellow Card Scheme update: Human papillomavirus immunisation programme safety update Off-label or unlicensed use of medicines: prescribers responsibilities Over-the-counter cough and cold medicines for children Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1

2 New updated wound management formulary for NHS Lanarkshire due May 2009 A new updated edition of the Lanarkshire wound management formulary will soon be available. The formulary will be launched at a series of roadshow events hosted by specialist nurses from the tissue viability service. The wound management formulary will complement the Lanarkshire Joint Formulary and there will be similar procedures for monitoring the use of wound management products and for dealing with requests for the addition of new products or for the use of nonformulary products. Initially posters depicting different types of wounds and their management will be produced and sent to all clinical areas including care homes. Diary card reminders of the poster content will be sent to all nurses involved in wound management. A web based version of the formulary is currently under construction and this will be available on FirstPort in the near future. Recent changes to the Lanarkshire Joint Formulary Testosterone undecanoate 1000mg/4mL oily injection (Nebido ) added to the formulary testosterone replacement therapy for male hypogonadism section Budesonide CFC free metered dose inhaler (Pulmicort ) added to the formulary management of asthma section 3.02 Brinzolamide 10mg/mL eye drops (Azopt ) added to the formulary - treatment of ocular hypertension and open angle glaucoma section Fluticasone furoate nasal spray (Avamys ) added to the formulary treatment of allergic rhinitis section Flecainide acetate capsules 200mg (Tambocor XL ) added to the formulary treatment of arrhythmias section 2.03 Fluticasone propionate nasal spray (Flixonase ) removed from the formulary section The following new drugs have been reviewed by the Scottish Medicines Consortium in February and March 2009 : - 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 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 539/09 No 538/09 Drug/product Indication SMC Lanarkshire and ADTC comments Doripenem, 500mg powder for solution for infusion (Doribax ) Alitretinoin 10mg, 30mg capsules (Toctino ) Treatment of nosocomial pneumonia (including ventilator-associated pneumonia) in adults. Treatment of severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Doripenem (Doribax ) is accepted for restricted use within NHS Scotland for the treatment of nosocomial pneumonia (including ventilatorassociated pneumonia) in adults. Doripenem demonstrated similar clinical cure rates to other drugs used for the treatment of nosocomial pneumonia (including ventilator-associated pneumonia). It is an alternative option to existing carbapenems and should only be used on the advice of local microbiologists or specialists in infectious diseases. Doripenem is also licensed for the treatment of complicated urinary tract infections in adults. As the manufacturer has not made a submission for this indication, SMC cannot recommend the use of doripenem in the treatment of complicated urinary tract infections in adults. Alitretinoin (Toctino ) is accepted for use within NHS Scotland in adults who have severe chronic hand eczema that is unresponsive to treatment with potent topical corticosteroids. Evidence is limited to a randomised placebo-controlled study where alitretinoin was superior to placebo in terms of the primary endpoint, Physician Global Assessment of response. 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 This is an ALERT antibiotic and advice must be sought from a microbiologist or ID specialist prior to prescribing. 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 It is recommended that alitretinoin is dispensed by a hospital-based pharmacy. This is a hospital only drug for prescribing and dispensing 3

4 No 308/06 No 541/09 No 407/07 Drug/product Indication SMC Lanarkshire and ADTC comments Testosterone undecanoate, 1000mg/4ml oily solution for injection (Nebido ) Oxycodone/naloxone 10mg/5mg and 20mg/10mg prolonged release tablets (Targinact ) Betaine anhydrous oral powder (Cystadene ) Re-submission Testosterone replacement therapy for male hypogonadism. Treatment of severe pain, which can be adequately managed only with opioid analgesics. Adjunctive treatment of homocystinuria Testosterone undecanoate (Nebido ) is accepted for use within NHS Scotland as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests. Compared with alternative intramuscular preparations it offers the advantage of reduced frequency of dosing with less inter-dose fluctuation of testosterone levels. Oxycodone/naloxone prolonged release tablets (Targinact ) are not recommended for use within NHS Scotland for the treatment of severe pain which can be adequately managed only with opioid analgesics. The addition of naloxone to oxycodone did not impair analgesia and improved bowel function when patients were not receiving regular laxative therapy. However the clinical benefit in patients receiving regular laxative therapy is uncertain and the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Betaine anhydrous (Cystadane ) is not recommended for use within NHS Scotland as adjunctive treatment of homocystinuria involving deficiencies or defects in cystathionine beta-synthase (CBS), 5,10-methylene-tetrahydrofolate reductase (MTHFR) or cobalamin cofactor metabolism (cbl). Clinical efficacy data for betaine anhydrous are limited. The manufacturer did not present a sufficiently robust economic evaluation to gain acceptance by SMC. SMC recommends that patients already receiving betaine anhydrous continue to receive treatment if it is currently proving to be clinically effective. 4

5 Recommendation No 537/09 No 547/09 No 314/06 Drug/product Indication SMC Lanarkshire and ADTC comments Cladribine 2mg/ml solution for injection (Litak ) Cetuximab 5mg/ml solution for infusion (Erbitux ) Tobramycin 300mg/4ml nebuliser solution (Bramitob ) Treatment of hairy cell leukaemia Squamous cell cancer of the head and neck. Treatment of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis Cladribine (Litak ) is accepted for use in NHS Scotland for the treatment of hairy cell leukaemia. In patients for whom cladribine is an appropriate agent for this indication, the 2mg/ml solution allows administration by subcutaneous bolus injection over five consecutive days rather than by continuous intravenous infusion of the existing 1mg/ml solution for seven consecutive days. This may confer advantages in terms of convenience to patients and service delivery at a lower cost per course. Cetuximab (Erbitux ) is not recommended for use within NHSScotland for the treatment of patients with squamous cell cancer of the head and neck in combination with platinum-based chemotherapy for recurrent and/or metastatic disease. 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. Tobramycin 300mg/4ml nebuliser solution (Bramitob ) is accepted for use in NHS Scotland for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients with cystic fibrosis aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents. This preparation offers an alternative to an existing nebuliser solution at a lower cost per dose. This assessment is based on data submitted by the applicant company up to and including 16 January 2009 and costs from evadis on 21 January 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 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 5

6 Recommendation No 544/09 Drug/product Indication SMC Lanarkshire and ADTC comments Fluticasone furoate 27.5 micrograms/actuation nasal spray (Avamys ) Allergic rhinitis Fluticasone furoate (Avamys ) is accepted for use within NHS Scotland for the treatment of the symptoms of allergic rhinitis in adults, adolescents (12 years and over) and children (6 to 11 years). Evidence to support its efficacy comes from a number of comparator- and placebocontrolled studies conducted in adults and children with seasonal and perennial allergic rhinitis. Prescribers should be aware that the recommended doses of fluticasone furoate are not equivalent, on a microgram per microgram basis, to other fluticasone nasal sprays currently available. Flixonase nasal spray now removed from the No 545/09 No 536/09 Topotecan 0.25mg, 1mg capsules (Hycamtin ) Budesonide CFC-free inhaler 100 micrograms and 200 micrograms per actuation (Pulmicort ) Treatment of relapsed small cell lung cancer. Treatment of asthma. Other intranasal steroids are available at a lower cost. Topotecan capsules (Hycamtin ) are accepted for restricted use within NHS Scotland as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate. The efficacy of topotecan capsules relative to standard IV chemotherapy is unknown. Topotecan capsules are restricted to use in patients for whom standard intravenous chemotherapy is inappropriate and who would otherwise receive best supportive care. In one study, oral topotecan plus best supportive care (BSC) was superior to BSC alone for the primary endpoint of median survival. Budesonide CFC-free inhaler (Pulmicort ) is accepted for use in NHS Scotland for the treatment of asthma. Budesonide CFC-free inhaler (Pulmicort ) (hydrofluoroalkanes [HFA] pressurised metered dose inhaler [pmdi]) replaces the equivalent CFC-containing pmdi formulations at a similar cost per microgram. 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. 6

7 Recommendation No 543/09 Drug/product Indication SMC Lanarkshire and ADTC comments Cetuximab, 100mg/20mL and 500mg/100mL solution for intravenous infusion (Erbitux ) Treatment of patients with epidermal growth factor receptorexpressing, Kirsten rat sarcoma wild-type metastatic colorectal cancer in combination with chemotherapy. Cetuximab (Erbitux ) is not recommended for use within NHS Scotland for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy. Outcomes for patients with KRAS wild-type disease were derived from retrospective, post hoc analyses of one phase ll and one phase lll study. Both these analyses showed an increase in overall response rate and a small, but statistically significant, increase in median progression free survival time when cetuximab was added to standard first-line chemotherapy. No 542/09 No 546/09 Micronised progesterone, 100mg, 200mg capsules (Utrogestan ) Brinzolamide 10mg/ml eye drops (Azopt ) Adjunctive use with oestrogen HRT therapy. Treatment of glaucoma in combination with prostaglandin analogues The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Micronised progesterone (Utrogestan ) is not recommended for use within NHS Scotland for adjunctive use with oestrogen in post-menopausal women with an intact uterus (HRT). Micronised progesterone was as effective as another progestogen in protecting the endometrium from the hyperplastic changes associated with oestrogen therapy. However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. Brinzolamide (Azopt ) eye drops are accepted for use within NHS Scotland to decrease elevated intraocular pressure in ocular hypertension and open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom betablockers are contraindicated, or as adjunctive therapy to beta-blockers or prostaglandin analogues. This abbreviated submission relates to a licence extension to cover use of brinzolamide with prostaglandin analogues. For patients in whom brinzolamide is an appropriate choice of therapy, this licence extension is not associated with a price increase and is not expected to increase drug usage. 7

Area Drug and Therapeutics Committee Prescribing Supplement No 31 - June 2009

Area Drug and Therapeutics Committee Prescribing Supplement No 31 - In this issue Drugs currently being considered by SMC advice due on 13 th July 2009 Drug Safety Update STOP PRESS Clopidogrel and PPIs