Formulary Group Decisions September 2010


Press Statement: Europe-wide suspension of marketing authorisation for Avandia® (rosiglitazone)

The European Medicines Agency's (EMA) Committee on Medicinal Products for Human Use (CHMP) has today (23rd September 2010) recommended the suspension of the marketing authorisation for Avandia® because the benefits no longer outweigh the risks.

CHM has reviewed the available data and has concluded that there is an increased cardiovascular risk for rosiglitazone. It has not been possible to identify additional measures that would reduce the cardiovascular risk or to identify a patient population in whom the benefits continue to outweigh the risks. CHM has therefore concluded that the benefits of rosiglitazone no longer outweigh its risks.
Advice for healthcare professionals and patients
  • Prescribers should put in place a system to ensure that all patients are reviewed and changed to another suitable treatment in line with NICE recommendations.
  • While this change could happen at the next routine appointment, prescribers may wish to see patients sooner rather than later in order to reduce patient anxiety.
  • Patients who are concerned should not stop their treatment but should contact the healthcare professional supervising their diabetic treatment.
Further information is available on the Link opens in new windowMHRA and Link opens in new windowEMEA websites, and the local Diabetic MCN will issue advice within the next few days.
 

 

Approved for use in NHS Grampian

 
Betaine anhydrous powder (Cystadane®)
Drugs used in metabolic disorders BNF 9.8.1
Betaine anhydrous powder (Cystadane®) was approved for inclusion in the Grampian Joint Formulary for restricted use 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). Use is restricted to patients who are not responsive to vitamin B6 treatment. Available for restricted use under specialist supervision, treatment to be initiated in hospital prior to handover.  Betaine anhydrous treatment should be supervised by a physician experienced in the treatment of patients with homocystinuria.  Due to the orphan nature of this disease, specialists should liaise with GP(s) and provide an individual care plan (if required) before prescribing is requested in primary care.
 
Safety warning 21st January 2011 - Possible risk of liver injury with dronedarone (Multaq®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product - Link opens in new windowsee MHRA advice
Dronedarone tablets (Multaq®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Drugs for arrhythmias BNF 2.3.2
Dronedarone tablets (Multaq®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product was approved for inclusion in the Grampian Joint Formulary for restricted use for the prevention of recurrence of AF in patients in whom beta-blockers, class 1c drugs or amiodarone are contra-indicated, ineffective or not tolerated.  If ineffective it should be stopped and not used for rate control in permanent AF. Treatment should be initiated on specialist advice only.  Available for restricted use under specialist supervision, treatment should be initiated in the community on the recommendation of a consultant/specialist.
 
Following publication of the SMC advice the May Formulary Group decision has been updated:
Febuxostat tablets (Adenuric®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product 
Gout and cytotoxic-induced hyperuricaemia BNF 10.1.4
Febuxostat tablets (Adenuric®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product  was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence, of tophus and/or gouty arthritis), and only when treatment with allopurinol is inadequate, not tolerated or contraindicated.  Available for restricted use under specialist supervision, treatment may be initiated in the community on the recommendation of a consultant/specialist.
 
Imatinib 100mg and 400mg tablets (Glivec®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Imatinib 100mg and 400mg tablets (Glivec®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product  was approved for inclusion in the Grampian Joint Formulary for restricted use as adjuvant treatment for gastrointestinal stromal tumours (GIST).  Patients who have a low or very low risk of recurrence should not receive adjuvant treatment.
Imatinib is restricted to use in adult patients at high risk (according to the Armed Forces Institute of Pathology (AFIP) risk criteria) of recurrence following complete resection of Kit (CD117)-positive gastrointestinal stromal tumours.  Available for restricted use under specialist supervision, recommended for hospital use only.  Imatinib should be initiated by a physician experienced in the treatment of patients with haematological malignancies and malignant sarcomas, as appropriate.  Treatment period limited to one year.
 
Vinorelbine 20mg and 30mg capsules (Navelbine®)
Vinca alkaloids and etoposide BNF 8.1.4
Vinorelbine 20mg and 30mg capsules (Navelbine®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of advanced breast cancer stage III and IV relapsing after, or refractory to, an anthracycline-containing regimen.  It is restricted to use by specialist oncologists as an alternative to the intravenous formulation of vinorelbine where vinorelbine is considered to be appropriate. Available for restricted use under specialist supervision, licensed for hospital use only.
 

 

Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian

 
Epoetin theta (Eporatio®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Drugs used in hypoplastic, haemolytic, and renal anaemias BNF 9.1.3
Epoetin theta (Eporatio®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product for the treatment of symptomatic anaemia associated with chronic renal failure in adult patients. Epoetin theta demonstrated non-inferiority to another erythropoietin analogue in maintaining stable haemoglobin levels in renal failure associated anaemia both in patients not yet receiving dialysis (subcutaneous route) and in those receiving haemodialysis (intravenous route).
The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name. Other erythropoietin stimulating agents are available at lower cost.
Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
 
Ketoprofen/omeprazole (Axorid®)
Non-steroidal anti-inflammatory drugs BNF 10.1.1
Ketoprofen/omeprazole (Axorid®) for the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential.
Studies in healthy volunteers demonstrated the bioequivalence of this combination product to the reference products, modified-release ketoprofen and omeprazole. Other nonsteroidal anti-inflammatory drugs can be co-prescribed with proton pump inhibitors at lower cost.
Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
 

 

Not approved for use in NHS Grampian

 
Dutasteride plus tamsulosin capsules (Combodart®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Drugs for urinary retention BNF 7.4.1
Dutasteride plus tamsulosin capsules (Combodart®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product was not approved for inclusion in the Grampian Joint Formulary.  One of the components, dutasteride, is non-formulary.  Cost-effective alternatives available.  Not approved for use in NHS Grampian - will not be included in Grampian Joint Formulary for this indication.
 
Lanthanum carbonate tablets (Fosrenol®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Phosphate-binding agents BNF 9.5.2.2
Lanthanum carbonate tablets (Fosrenol®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland [ Link opens in new windowSMC 640/10].
Indication under review: as a phosphate binding agent for use in the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphate levels ≥1.78mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.
When compared with placebo, in patients with chronic kidney disease not yet on dialysis, more patients treated with lanthanum carbonate achieved a serum phosphate concentration ≤1.49mmol/L.
The manufacturer did not present a sufficiently robust clinical or economic analysis to gain acceptance by SMC. Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
Pemetrexed injection (Alimta®)
Antimetabolites BNF 8.1.3
Pemetrexed injection (Alimta®) is not recommended for use within NHS Scotland [ Link opens in new windowSMC 642/10].
Indication under review: monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy.  First-line treatment should be a platinum doublet with gemcitabine, paclitaxel or docetaxel.
In a sub-group analysis of patients with non-squamous NSCLC, progression free survival and overall survival (secondary endpoint) were significantly longer for pemetrexed plus best supportive care (BSC) compared to placebo plus BSC.
However, the manufacturer did not present a sufficiently robust economic case and their justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
Roflumilast tablets (Daxas®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Respiratory system BNF 3
Roflumilast tablets (Daxas®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland [ Link opens in new windowSMC 635/10].
Indication under review: maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (forced expiratory volume in 1 second [FEV1] post-bronchodilator <50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.
Roflumilast has been associated with improved lung function and reduced the rate of moderate and severe COPD exacerbations compared to placebo in studies of patients representing the licensed population.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
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