Formulary Group Decisions February 2010
Approved for use in NHS Grampian
Atazanavir capsules (Reyataz®)
HIV infection, Protease inhibitors BNF 5.3.1
Atazanavir capsules (Reyataz®) was approved for inclusion in the GJF for restricted use for the treatment of HIV-1 infected adults:
HIV infection, Protease inhibitors BNF 5.3.1
Atazanavir capsules (Reyataz®) was approved for inclusion in the GJF for restricted use for the treatment of HIV-1 infected adults:
- in antiretroviral treatment experienced adults, in combination with other antiretroviral medicinal products in those patients who do not require concomitant statin use as per [
SMC 120/04]. - in antiretroviral treatment naïve HIV-1 infected adults in combination with other antiretroviral medicinal products as per [
SMC 520/08].
- unboosted regimen [unlicensed] in adults in whom side effects or compliance is a problem.
Fostair®
Corticosteroids BNF 3.2
Beclometasone 100mcg, formoterol 6mcg metered dose aerosol inhalation (Fostair®) was approved for inclusion in the GJF for the treatment of asthma where use of a combination inhaled corticosteroid and long-acting beta-2-agonist is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist; or patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2-agonists.
It should be used in patients for whom beclometasone and formoterol are appropriate choices of corticosteroid and long-acting beta-2-agonist, respectively, and for whom a metered dose inhaler is an appropriate delivery device. It has costs similar to other combination products containing a corticosteroid and long-acting beta-2-agonist to which it was clinically non-inferior. The 100mcg dose of beclometasone in Fostair® is not bioequivalent to a 100mcg dose of beclometasone in several other inhaler formulations. The Fostair®summary of product characteristics contains information on transferring from these inhalers to Fostair® . Available for general use and treatment may be initiated in either hospital or community.
Corticosteroids BNF 3.2
Beclometasone 100mcg, formoterol 6mcg metered dose aerosol inhalation (Fostair®)
was approved for inclusion in the GJF for the treatment of asthma where use of a combination inhaled corticosteroid and long-acting beta-2-agonist is appropriate: patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting beta-2-agonist; or patients already adequately controlled on both inhaled corticosteroids and long-acting beta-2-agonists.
It should be used in patients for whom beclometasone and formoterol are appropriate choices of corticosteroid and long-acting beta-2-agonist, respectively, and for whom a metered dose inhaler is an appropriate delivery device. It has costs similar to other combination products containing a corticosteroid and long-acting beta-2-agonist to which it was clinically non-inferior. The 100mcg dose of beclometasone in Fostair® is not bioequivalent to a 100mcg dose of beclometasone in several other inhaler formulations. The Fostair®
summary of product characteristics contains information on transferring from these inhalers to Fostair® . Available for general use and treatment may be initiated in either hospital or community.Liraglutide solution for injection (Victoza®)
Other antidiabetic drugs BNF 6.1.2.3
Liraglutide solution for injection (Victoza®) was approved for inclusion in the GJF for restricted use for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control:
Other antidiabetic drugs BNF 6.1.2.3
Liraglutide solution for injection (Victoza®)
was approved for inclusion in the GJF for restricted use for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control:- in combination with metformin or a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or a sulphonylurea.
- in combination with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy.
Restriction: Liraglutide is restricted to use as a third-line antidiabetic agent, the economic case for second-line use, added to metformin in place of a sulphonylurea, has not been demonstrated.
Liraglutide 1.8mg daily is not recommended for the treatment of people with type 2 diabetes mellitus. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist. Specialist would include GPs with a specialist interest in diabetes, and have undertaken supplementary training to care for this patient group.
Pemetrexed injection (Alimta®)
Antimetabolites BNF 8.1.3
Pemetrexed injection (Alimta®) was approved for inclusion in the GJF, as per
Antimetabolites BNF 8.1.3
Pemetrexed injection (Alimta®) was approved for inclusion in the GJF, as per
[
SMC 531/09] in combination with cisplatin for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
It is restricted to patients in whom histology has been confirmed as adenocarcinoma or large cell carcinoma. Available for restricted use under specialist supervision and recommended for hospital use only. It should only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
SMC 531/09] in combination with cisplatin for the first line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
It is restricted to patients in whom histology has been confirmed as adenocarcinoma or large cell carcinoma. Available for restricted use under specialist supervision and recommended for hospital use only. It should only be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Bemiparin injection (Zibor®)
Parenteral anticoagulants BNF 2.8.1
Bemiparin injection (Zibor®) is accepted for use within NHS Scotland for the prevention of thromboembolic disease in patients undergoing orthopaedic surgery.
Bemiparin was associated with a lower incidence of thromboembolic complications than unfractionated heparin and was non-inferior to another low molecular weight heparin.
Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Parenteral anticoagulants BNF 2.8.1
Bemiparin injection (Zibor®)
is accepted for use within NHS Scotland for the prevention of thromboembolic disease in patients undergoing orthopaedic surgery.
Bemiparin was associated with a lower incidence of thromboembolic complications than unfractionated heparin and was non-inferior to another low molecular weight heparin.
Approved by SMC, not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Not approved for use in NHS Grampian
Extended release epidural morphine (Depodur®)
Opioid analgesics BNF 4.7.2
Extended release epidural morphine (Depodur®) is not recommended for use within NHS Scotland for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery.
Extended-release epidural morphine has shown some advantages in terms of efficacy versus a single dose of epidural opioid. However, as there are limited comparative data versus epidural analgesia techniques currently used in NHS Scotland it was difficult to assess clinical efficacy in relation to current Scottish practice.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC [SMC 528/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Opioid analgesics BNF 4.7.2
Extended release epidural morphine (Depodur®) is not recommended for use within NHS Scotland for the relief of post-operative pain following major orthopaedic, abdominal or pelvic surgery.
Extended-release epidural morphine has shown some advantages in terms of efficacy versus a single dose of epidural opioid. However, as there are limited comparative data versus epidural analgesia techniques currently used in NHS Scotland it was difficult to assess clinical efficacy in relation to current Scottish practice.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC [
SMC 528/09].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Ketoprofen/omeprazole (Axorid®)
Drugs used in rheumatic diseases and gout BNF 10.1
Ketoprofen/omeprazole (Axorid®) is not recommended for use within NHS Scotland 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.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
The licence holder has indicated their intention to resubmit [SMC 606/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Drugs used in rheumatic diseases and gout BNF 10.1
Ketoprofen/omeprazole (Axorid®) is not recommended for use within NHS Scotland 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.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
The licence holder has indicated their intention to resubmit [
SMC 606/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
ADVICE: in the absence of a submission from the holder of the marketing authorisation.
Rupatadine tablets (Rupafin®)
Antihistamines BNF 3.4.1
Rupatadine (Rupafin®) is not recommended for use within NHS Scotland for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and adolescents (over 12 years of age).
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 NHS Scotland [SMC 612/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Rupatadine tablets (Rupafin®)
Antihistamines BNF 3.4.1
Rupatadine (Rupafin®)
is not recommended for use within NHS Scotland for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and adolescents (over 12 years of age).
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 NHS Scotland [
SMC 612/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
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