Area Drug and Therapeutics Committee Prescribing Supplement No 6 December 2004

Transcription

1 Area Drug and Therapeutics Committee Prescribing Supplement No 6 In this issue Drugs currently being considered by the SMC Advice due on 13. Joint Formulary Update. Drugs currently being considered by the SMC Advice due early in Drugs reviewed by the SMC in October with a published recommendation and a Lanarkshire ADTC formulary recommendation. Drugs currently being considered by the SMC with advice due on 13 - Reminder New drugs currently being considered by the SMC should not be prescribed prior to a final recommendation being issued by the SMC and advice being provided by Lanarkshire ADTC. Miglustat (Zavesca ) Treatment of mild to moderate type 1 Gaucher disease. Ertapenem (Ivanz ) Intra-abdominal infections in adults. Rituximab (MabThera ) Stage 111-1V follicular lymphoma. Eplerenone (Inspra ) Used post myocardial infarction in addition to standard therapy, to reduce the risk of cardiovascular mortality and morbidity in those with clinical evidence of heart failure. Paracetamol infusion (Perfalgan ) Treatment of moderate pain, fever, when the IV route is clinically justified or when other routes of administration are not possible. Laronidase (Aldurazyme ) Resubmission Mucopolysaccharidosis I Rosiglitazone maleate/metformin hydrochloride (Avandamet ) Creon micro (Creon ) New formulation for infants Voriconazole (VFEND ) Product update oral formulation. Etomidate -Lipuro Product update new formulation. Etanercept (Enbrel ) Protocol for psoriatic arthropathy. Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1

2 Lanarkshire Joint Formulary Progress Report The Lanarkshire Joint Formulary is nearing completion! It is planned that the formulary will be available in three formats: A slim A5 spiral-bound paper copy The e-formulary version for GPASS users A web page version accessible through the NHS Lanarkshire web-site and via the Lanarkshire Acute Hospitals intranet (MedEd) Lanarkshire consultants, GPs and pharmacists have been contributing to the content of the formulary over the last 15 months and it is planned that 1500 copies of the paper version will be available in February The e-formulary version for GPASS users is available at the moment and can be obtained by asking your LHCC pharmacist. The e-formulary will allow rapid and easy access to recommended drug choices, when prescribing using the GPASS system, during patient consultations. All GPs are encouraged to take up this offer and gain experience of using an electronic formulary. If you are unsure of how to use the electronic formulary training is available from your LHCC pharmacist. At present the e-formulary has been provided with the agreement of NHS Lothian and the final Lanarkshire version is due in spring The final stage will be the web based formulary due to be up and running by summer Watch this space, for further updates and the launch date for the paper version of the formulary. Drugs currently being considered by the SMC with advice due early in 2005: - Pregabalin (Lyrica ) Treatment of peripheral neuropathic pain. Atomoxetine (Strattera ) Treatment of attention deficit hyperactivity disorder The following new drugs have been reviewed by the Scottish Medicines Consortium in October 2004 : - Colour coding of Lanarkshire ADTC 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) Red = not accepted for use in Lanarkshire and not added to the Joint Formulary Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 2

3 Recommendation No 119/04 No 122/04 No 123/04 recommendation and ADTC comments Duloxetine (Yentreve ) Ibandronic acid (Bondronat ) Ibandronic acid (Bondronat ) Treatment of moderate to severe stress urinary incontinence (SUI) Treatment of tumour-induced hypercalcaemia with or without metastases Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. Duloxetine is accepted for restricted use in NHS Scotland for the treatment of moderate to severe stress urinary incontinence (SUI). It should be used only as part of an overall management strategy for SUI in addition to pelvic floor muscle training. Patients should be reviewed after 12 weeks of therapy to assess progress and determine whether it is appropriate to continue treatment. Because of the short duration of treatment in the studies supplied, it is recommended that the manufacturers collect further data on the longterm effects of this pharmacological approach to the management of SUI. Ibandronic acid is accepted for use in NHS Scotland for the treatment of tumour-induced hypercalcaemia with or without metastases. It has been shown to be a cost-effective option in reducing serum calcium in patients with hypercalcaemia of malignancy. Ibandronic acid is accepted for use in NHS Scotland for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases). It reduces the rate of skeletal events consisting of a composite of vertebral fractures, pathological non-vertebral fractures and the need for radiotherapy or surgery to deal with bone complications. It can be given both by the oral or intravenous route. ADTC referred this recommendation to be considered by the Urology Sub-Group in light of the potential large number of patients for whom it would be more appropriate. The committee noted the recommendation and the fact that it had been referred to the WoSCAN prescribing The committee noted the recommendation and the fact that it had been referred to the WoSCAN prescribing 3

4 recommendation No 124/04 No 125/04 No 126/04 recommendation and ADTC comments Esomeprazole I/V formulation (Nexium IV ) Oxycodone (OxyNorm ) Bortezomib (Velcade ) Gastrooesophageal reflux disease (GORD) in patients with oesophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate. Treatment of moderate to severe pain in patients with cancer. Treatment of patients with multiple myeloma who have received at least two prior therapies and have demonstrated disease progression on the last therapy. Intravenous esomeprazole (Nexium IV ) is accepted for use within NHS Scotland for the treatment of gastrooesophageal reflux disease in patients with oesophagitis and/or severe symptoms of reflux as an alternative to oral therapy when oral intake is not appropriate. Intravenous esomeprazole seems to be as effective as oral esomeprazole in terms of gastric acid suppression and healing of erosive oesophagitis. However comparisons with other IV proton pump inhibitors are restricted to pre-clinical studies. Esomeprazole has similar acquisition costs to other IV proton pump inhibitors. Oxycodone (Oxynorm ) injection is accepted for restricted use within NHS Scotland only for the treatment of moderate to severe pain in patients with cancer. Use of this drug should be restricted to patients who have difficulty in tolerating morphine or diamorphine therapy. Limited data indicate that it provides analgesia similar to parenteral morphine at similar doses. However, there are no comparative data with diamorphine, the opioid recommended by the Scottish Intercollegiate Guidelines Network (SIGN) for patients with cancer who require parenteral opioids. Oxycodone is more expensive than diamorphine and the economic case for this product replacing the other products has not been clearly demonstrated. Bortezomib (Velcade ) is accepted for use in NHS Scotland for the treatment of patients with multiple myeloma who have received at least two prior therapies, have demonstrated disease progression on the last therapy and who are refractory to alternative licensed treatments for this stage of the disease. Bortezomib produced a disease response in approximately one third of these patients in an open-label uncontrolled study. The manufacturers are encouraged to mount an observational study in collaboration with haemato-oncologists to gain more information on the benefits and risks of this therapy. ADTC noted that this product would be for hospital use only. It was agreed that transfer to oral therapy would be to a formulary PPI i.e omeprazole or lansoprazole. The use of esomeprazole IV was not endorsed in Lanarkshire, at present, pending a submission to ADTC, from the thoracic surgeons. The recommendation. Oxycodone injection is added to the Joint Formulary for use in accordance with the SMC restrictions The ADTC agreed to wait for the recommendation of the WoSCAN prescribing 4

5 Recommendation No 127/04 128/04 No 129/04 No 130/04 recommendation and ADTC comments Sumatriptan succinate 50mg and 100mg tablets (Imigran Radis ) Testosterone 30mg mucoadhesive buccal (prolonged release) tablets (Striant ) Solifenacin (Vesicare ) Conjugated oestrogen, medroxyprogesterone (Premique Low Dose) Acute relief of migraine, with or without aura provided there is a clear diagnosis of migraine. Abbreviated submission Testosterone replacement therapy in men with primary or secondary hypogonadism Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. Hormone replacement therapy for oestrogen deficiency symptoms in postmenopausal women with an intact uterus Imigran Radis film-coated tablets are accepted for use within NHS Scotland for acute relief of migraine attacks, with or without aura, provided there is a clear diagnosis of migraine. They offer a fast disintegrating oral formulation of sumatriptan succinate. No increased cost is associated with this product compared to prescribing conventional Imigran tablets. Testosterone as mucoadhesive buccal tablet 30mg (Striant SR ) is accepted for restricted use within NHS Scotland as testosterone replacement therapy in men with primary or secondary hypogonadism. It offers an alternative to other routes, including transdermal application by patches or gel, for patients who would particularly benefit from this mode of administration where intramuscular treatment is not suitable. Solifenacin is not recommended for use within NHS Scotland for the symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. Solifenacin is effective in reducing symptoms associated with overactive bladder including frequency, urgency and incontinence. It is associated with adverse events typical of antimuscarinic agents used in this condition. Comparison with other treatments is limited to one placebo-controlled trial involving tolterodine as an active control, and this trial was not designed to detect differences between active treatments. The economic case for using the product was not demonstrated. Conjugated oestrogen 0.3mg, medroxyprogesterone 1.5mg (Premique Low Dose ) is accepted for use within NHS Scotland as hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with an intact uterus. It is effective in controlling vasomotor symptoms and is associated with lower rates of breast pain and endometrial bleeding compared to other products with higher oestrogen content. It is more expensive than several other HRT therapies, but less expensive than the current market leader. recommendation and this formulation is added to the Joint Formulary. recommendation for restricted use. Further advice to be obtained from endocrinologists. recommendation and this drug should not be used in NHS Lanarkshire. recommendation and Premique Low Dose is accepted for use in Lanarkshire if a preparation with a lower oestrogen content is preferred. 5

6 Recommendation No 131/04 132/04 recommendation and ADTC comments Losartan (Cozaar ) Aprepitant (Emend ) To delay the progression of renal disease and to reduce proteinuria in type 2 diabetic patients with nephropathy Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based chemotherapy. Aprepitant is given as part of combination therapy. Losartan is accepted for restricted use within NHS Scotland to delay the progression of renal disease and to reduce proteinuria in type 2 diabetic patients with nephropathy. Losartan, for the management of renal disease in patients with hypertension and type 2 diabetes mellitus, is effective, but has not been shown to be any more effective than ACE inhibitors, which are generally less expensive products and from which there is a strong evidence base in diabetic renal disease and other forms of cardiovascular disease. Therefore, losartan should be considered, along with other angiotensin II antagonists licensed for diabetic renal disease, as an alternative in patients unable to tolerate an ACE inhibitor. Aprepitant is accepted for restricted use within NHS Scotland for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based chemotherapy. The antiemetic regimen incorporating aprepitant was superior to one regimen (where dexamethasone alone was used in the delayed phase of treatment), for the prevention of cisplatin-induced nausea and vomiting in the acute and delayed phases. It should be initiated only by appropriate hospital based specialists. recommendation for this extended licence indication for losartan. Losartan is already included in the Joint Formulary for patients where an ACE inhibitor is poorly tolerated. The ADTC agreed to wait for the recommendation of the WoSCAN prescribing 6