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

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1 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 Latest additions to the Lanarkshire Formulary Drugs reviewed by the SMC in April and May 2009 Drugs currently being considered by the SMC with advice due on 13 th July 2009 SMC REVIEW Infliximab for infusion (Remicade ) (No 374/07) INDICATION Active ulcerative colitis Pegylated liposomal doxorubicin (Caelyx ) (No 503/08) Progressive multiple myeloma Terlipressin acetate solution (Glypressin ) (No 555/09) Bleeding oesophageal varices Enoxaparin pre-filled syringes (Clexane ) (No 380/07) acute STEMI Drug Safety Update (MHRA) STOP PRESS Clopidogrel and PPIs The European Medicines agency (EMEA) issued advice on 29 th May following a review of the available evidence for an interaction between clopidogrel and PPIs. Their conclusion is that the data support a clinically significant interaction that makes clopidogrel less effective when given with a PPI. The agency has recommended that the concomitant use of a PPI and clopidogrelcontaining medicines should be avoided unless absolutely necessary. The EMEA has also recommended that the product information for all clopidogrel-containing medicines should be altered to reflect this new advice. Implications: - When choosing an appropriate drug for gastroprotection, prescribers should be aware of the possibility of a drug interaction between clopidogrel and any of the PPIs. Prescribing Department alastair.thorburn@lanarkshire.scot.nhs.uk 1

2 Histamine H 2 - receptor antagonists (e.g. ranitidine) do not inhibit CYP isoenzymes, but are not licensed for prophylaxis of NSAID-induced gastric/duodenal ulceration. In Lanarkshire, following MI/ACS patients taking aspirin plus clopidogrel will now be prescribed ranitidine for routine gastroprotection rather than a PPI. This is on the basis that there is no interaction between ranitidine and clopidogrel. PPIs must only be prescribed in line with their licensed indications and it is worth checking that patients who are taking clopidogrel are not purchasing over the counter packs of omeprazole. Where possible, aspirin plus PPI should be considered as an alternative to clopidogrel monotherapy. If it is absolutely necessary for a patient taking clopidogrel to continue with a PPI the usual formulary PPI should be continued (omeprazole or lansoprazole). A change to pantoprazole is not advocated at this time. Different PPIs have different capacity to affect the metabolism of clopidogrel and as the outcome studies have not fully reflected the different effect of PPIs on the activation of clopidogrel, there may be more than one explanation for the effect of this class of medicines on clopidogrel. Latest additions to the NHS Lanarkshire Joint Formulary- Formoterol/beclometasone CFC free metered dose inhaler (Fostair ) (added to section 3.02c) Sodium hyaluronate cream/lotion (Atopiclair ) preparations for the treatment of hand eczema (added to section 13.03) Tadalafil 2.5mg and 5mg tablets (Cialis ) once daily dosage within the usual NHS restrictions for prescribing drugs to treat erectile dysfunction. (added to section ) Oxybutynin m/r tablets (Lyrinel XL ) (Added to section ) Calcium and vitamin D tablets (Natecal ) (Added to sections and 6.06) Methoxy polyethylene glycol-epoetin beta (Mircera ) (Added to section ) The following new drugs have been reviewed by the Scottish Medicines Consortium in April and May 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 s and local protocols. 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 550/09 No 157/05 Drug/product Indication SMC Lanarkshire and ADTC comments Caffeine base 5mg/ml solution for injection Full Submission Pregabalin capsules (Lyrica ) Second Resubmission apnoea of prematurity peripheral neuropathic pain Caffeine base 5mg/ml solution for injection is accepted for restricted use within NHS Scotland for the treatment of apnoea of prematurity. Short-term studies have demonstrated the efficacy of caffeine on apnoeic episodes and one longer-term study has shown reduction in disabilities relevant to these infants. It should be restricted to use on the advice of specialists in neonatal paediatrics. Prescribers should note that, although the SPC describes this product in terms of caffeine base (5mg/ml), the neonatal formulary and the British National Formulary for Children currently recommend prescribing the dose as caffeine citrate (equivalent to 10mg/ml). Pregabalin (Lyrica ) is accepted for restricted use within NHS Scotland for the treatment of peripheral neuropathic pain in adults. The clinical evidence of efficacy in patients with peripheral neuropathic pain who are refractory to treatment was based on open-label, uncontrolled, non-randomised studies, with small patient numbers and different methodologies. Pregabalin is restricted to use in patients who have not achieved adequate pain relief from, or have not tolerated, conventional first and second line treatments for peripheral neuropathic pain. Treatment should be stopped if the patient has not shown sufficient benefit within 8 weeks of reaching the maximally tolerated therapeutic dose. Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used s and local protocols. Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used s and local protocols. 3

4 No 551/09 Drug/product Indication SMC Lanarkshire and ADTC comments Caspofungin powder for concentrate for solution for infusion (Cancidas ) Abbreviated Submission Empirical therapy for presumed fungal infection, in neutropenic paediatric patients (12 months to 17 years) Caspofungin acetate (Cancidas ) is accepted for use within NHS Scotland as empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropenic paediatric patients (12 months to 17 years). The Scottish Medicines Consortium has previously accepted this product for restricted use for this indication in adults. Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used s and local protocols. No 552/09 No 556/09 Caspofungin powder for concentrate for solution for infusion (Cancidas ) Abbreviated Submission Paclitaxel (Abraxane ) Non Submission Invasive candidiasis in paediatric patients (12 months to 17 years) Metastatic breast cancer A comparative study in adults found that caspofungin was as effective as a lipid formulation of amphotericin in terms of overall response. In addition it was better tolerated with fewer drug-related adverse events including less nephrotoxicity and infusion-related events. Caspofungin acetate (Cancidas ) is accepted for restricted use within NHS Scotland for the treatment of invasive candidiasis in paediatric patients (12 months to 17 years). The Scottish Medicines Consortium has previously accepted this product for restricted use for this indication in adults. Caspofungin provides an additional agent for the treatment of invasive candidiasis. Its use should be restricted to patients with fluconazoleresistant Candida infection who do not respond to, or cannot tolerate amphotericin B therapy or who are at an increased risk of serious side effects with amphotericin (eg. transplant patients, especially those receiving bone marrow transplants). Paclitaxel (Abraxane ) is not recommended for use within NHSScotland for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard anthracycline containing therapy is not indicated. Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used s and local protocols. endorsed the SMC 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. 4

5 Recommendation No 540/09 Drug/product Indication SMC Lanarkshire and ADTC comments Rituximab 100mg and 500mg concentrate for solution for infusion (MabThera ) Full Submission First line treatment of patients with chronic lymphocytic leukaemia in combination with fludarabine and cyclophosphamide. Rituximab (MabThera ) is accepted for restricted use within NHS Scotland for first-line treatment of patients with chronic lymphocytic leukaemia (CLL) in combination with fludarabine and cyclophosphamide. Rituximab in combination with fludarabine and cyclophosphamide resulted in significantly longer progression free survival than fludarabine and cyclophosphamide alone. The patient population in the pivotal clinical study had an Eastern Cooperative Oncology Group Performance Status of 0 or 1 and was a younger population than that generally seen in practice. Evidence in patients over 70 years of age is limited. Not added to the formulary due to the specialist nature of the treatment. Non formulary use is acceptable if the drug is used s and local protocols. No 498/08 Aripiprazole oral formulations (Abilify ) Resubmission moderate to severe manic episodes in bipolar 1 disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Rituximab is restricted to use by specialists in haematology and haematooncology. Aripiprazole oral formulations (Abilify ) are not recommended within NHS Scotland for the treatment of moderate to severe manic episodes in bipolar I disorder and for the prevention of a new manic episode in patients who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Aripiprazole demonstrated superior efficacy to placebo in reducing manic symptoms at week three and a treatment effect comparable to other agents used in the treatment of bipolar I disorder was maintained at week 12. Aripiprazole also demonstrated superior efficacy to placebo in prevention of relapse. Aripiprazole has not been directly compared to other atypical antipsychotics in this indication, although there is only one other atypical antipsychotic licensed for prevention of new manic episodes. The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC. 5

6 Recommendation No 531/09 No 554/09 Drug/product Indication SMC Lanarkshire and ADTC comments Pemetrexed, 100mg, 500mg powder for concentrate for solution for infusion (Alimta ) Resubmission Tadalafil 2.5mg and 5mg film-coated tablets (Cialis ) Abbreviated Submission In combination with cisplatin, for the first-line treatment of patients with locally advanced or metastatic nonsmall cell lung cancer other than predominantly squamous cell histology. patients with erectile dysfunction, once daily administration. Pemetrexed (Alimta ), in combination with cisplatin, is not recommended for use within NHS Scotland for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. In a planned subgroup analysis of a study comparing pemetrexed plus cisplatin with another platinum-based combination regimen, treatment with pemetrexed plus cisplatin resulted in a small improvement in median survival in patients with a non-squamous histology. The manufacturer did not present a sufficiently robust economics case to gain acceptance by SMC. Tadalafil 2.5mg and 5mg tablets (Cialis ) are accepted for use in NHS Scotland for regular once-daily administration in patients with erectile dysfunction responding to an ondemand regimen of tadalafil who anticipate frequent use (at least twice weekly). Compared with this level of on-demand use, the low dose regular regimen is expected to be cost-neutral overall.. Added to the joint formulary. No 558/09 Sapropterin (Kuvan ) 100mg soluble tablets Non Submission hyperphenylalanina emia Tadalafil represents an alternative to other phosphodiesterase type 5 inhibitors, primarily for patients for whom the longer duration of action represents a significant advantage. This drug is subject to the same NHS prescribing restrictions as other drug treatments for erectile dysfunction in terms of National Health Service (General Medical Services) (Scotland) Regulations. Sapropterin (Kuvan ) is not recommended for use within NHSScotland for the treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU) and for the treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with tetrahydrobiopterin (BH4) deficiency. 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. 6