Formulary Group Decisions April 2010


Reclassification of Advice

 
Ferrous fumarate 210 mg
Oral iron BNF 9.1.1.1
Ferrous fumarate 210mg tablets will replace ferrous sulphate as the first-choice oral iron preparation.
Available for general use, treatment may be initiated in hospital or community.
 
Rabeprazole sodium tablets
Proton pump inhibitors BNF 1.3.5
Due to the cost-differential between rabeprazole and the other formulary choice proton pump inhibitors (omeprazole and lansoprazole), rabeprazole has been removed from the Grampian Joint Formulary.  Rabeprazole has been reclassified - evidence now favours alternative products - recommended that this drug be removed from the GJF.
 
Topical NSAIDs
Drugs for the relief of soft-tissue inflammation BNF 10.3
Topical NSAIDs, piroxicam was noted as the cheapest preparation so should be considered as the first-choice agent.
 
Xyloproct ointment®
Compound haemorrhoidal preparations with corticosteroids BNF 1.7.2
Xyloproct® ointment will replace Proctosedyl® as the first-choice compound haemorrhoidal with corticosteroid preparation.
Available for general use, treatment may be initiated in hospital or community.
 

 

Approved for use in NHS Grampian

 
Bortezomib injection (Velcade®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Other antineoplastic drugs BNF 8.1.5
Bortezomib injection (Velcade®) 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 monotherapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.  Available for restricted use under specialist supervision, recommended for hospital use only.  Treatment must be initiated and administered under the supervisor of a physician qualified and experienced in the use of chemotherapeutic agents.
 
Caphosol® mouthwash is classified as a medical device rather than a licensed medicine.
Caphosol® supersaturated calcium phosphate rinse was approved for restricted use for the prevention of mucositis in patients undergoing chemotherapy.  Use is restricted to prescribing by haematologists or oncologists for the prevention of mucositis in patients undergoing chemotherapy for AML, patients who have previously developed mucositis or prior to haematopoietic stem cell transplant.  Recommended for hospital use only.
 
Cetuximab intravenous infusion (Erbitux®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Other antineoplastic drugs BNF 8.1.5
Cetuximab intravenous infusion (Erbitux®) 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 patients with epidermal growth factor receptor (EGFR)-expressing, Kirsten rat sarcoma (KRAS) wild-type metastatic colorectal cancer in combination with chemotherapy.
Post hoc analyses from one phase III and one phase II study in patients with KRAS wild-type status who had not previously received chemotherapy for metastatic disease, 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 combination chemotherapy.
Cetuximab is restricted to use in patients who have not previously received chemotherapy for their metastatic disease, with liver metastases only that are considered non-resectable but in whom potentially curative liver metastasis resection would be undertaken if the lesions became resectable after treatment with chemotherapy and cetuximab.  Available for restricted use under specialist supervision, recommended for hospital use only.  This advice takes account of the benefits of a PAS that improves the cost-effectiveness of cetuximab.  The SMC advice is contingent upon the continuing availability of the PAS scheme in NHS Scotland.
 
Metformin hydrochloride sugar-free oral powder (Glucophage®)
Biguanides BNF 6.1.2.2
Metformin powder for oral solution (Glucophage®) was approved for inclusion in the GJF as per [ Link opens in new windowSMC 610/10].  This recommendation is in line with the Formulary Group advice [ Link opens in new windowNovember 2009]. 
Available for restricted use for the treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control:
  • In adults, metformin may be used as monotherapy or in combination with other oral antidiabetic agents or insulin;
  • In children, from 10 years of age and adolescents, metformin may be used as monotherapy or in combination with insulin.
Available for restricted use under specialist supervision and treatment may be initiated in either hospital or community.  Use is restricted to patients who are unable to swallow the solid dosage formulation.
 
Methoxypsoralen 0.005% gel
Preparations for psoriasis BNF 13.5.2
Methoxypsoralen 0.005% gel [unlicensed product] was approved for restricted use under specialist supervision for photochemotherapy of psoriasis.  Unlicensed product recommended for hospital use only.  Use is restricted to prescribing by dermatologists experienced in PUVA treatment in patients who do not respond to narrow-band UVB therapy and in whom localised topical therapy is considered appropriate.
 
Otocomb Otic® ointment
Otitis externa BNF 12.1.1
Otocomb Otic® ointment [unlicensed product] was approved for restricted use for the topical treatment of otitis externa.  Unlicensed product recommended for hospital use only.  Use is restricted to use by Ear, Nose and Throat specialists for the treatment of otitis oxterna.  To be administered by impregnating ribbon gauze prior to insertion into the auditory canal.
 
Tacrolimus 0.03% ointment (Protopic®)
Drugs affecting the immune response BNF 13.5.3
Tacrolimus 0.03% ointment (Protopic®) was approved for inclusion in the Grampian Joint Formulary for restricted use for maintenance treatment of moderate to severe atopic dermatitis in children (aged 2 to15 years) for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring 4 or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected).  Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist.  Use is restricted to initiation by dermatologists in secondary care who have experience in treating atopic dermatitis using immunomodulatory therapy.
 
Ulipristal acetate tablet (EllaOne®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Emergency contraception BNF 7.3.5
Ulipristal acetate tablet (EllaOne®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product was approved for inclusion in the Grampian Joint Formulary for emergency contraception within 72 to 120 hours (3 to 5 days) of unprotected sexual intercourse or contraceptive failure.  Available for general use, treatment may be initiated in either hospital or community.
 

 

Not approved for use in NHS Grampian

 
ADVICE: in the absence of a submission from the holder of the marketing authorisation.
Abatacept Intravenous infusion (Orencia®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Drugs that suppress the rheumatic disease process, cytokine modulators BNF 10.1.3
Abatacept Intravenous infusion (Orencia®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland for the treatment of juvenile idiopathic arthritis [ Link opens in new windowSMC 618/10].
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.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
CosmoFer® injection
Parenteral iron BNF 9.1.1.2
CosmoFer® injection, iron (as iron dextran) 50 mg/mL, was not approved for inclusion in the Grampian Joint Formulary for the treatment of adults with iron deficiency. 
Not recommended for use in NHS Grampian - will not be included in the Grampian Joint Formulary for this indication.
 
Gefitinib tablets (Iressa®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Other antineoplastic drugs BNF 8.1.5
Gefitinib tablets (Iressa®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Licensed indication under review: the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK).
In a comparative study in previously untreated patients, gefitinib was superior to a platinum-based doublet chemotherapy regimen in terms of progression-free survival; subgroup analysis supported this finding in patients with activating mutations of EGFR-TK [ Link opens in new windowSMC 615/10].
However, the manufacturer's justification of the treatment's cost in relation to its health benefits was not sufficient to gain acceptance by SMC and in addition, the manufacturer did not present a sufficiently robust economic case 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.
 
Saxagliptin tablets (Onglyza®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Other antidiabetic drugs BNF 6.1.2.3
Saxagliptin tablets (Onglyza®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product was not approved for inclusion in the Grampian Joint Formulary for the treatment of adult patients with type 2 diabetes mellitus. 
Not recommended for use in NHS Grampian - will not be included in the Grampian Joint Formulary for this indication.
 
ADVICE: in the absence of a submission from the holder of the marketing authorisation.
Telmisartan tablets (Micardis)
Angiotensin-II receptor antagonists BNF 2.5.5.2
Telmisartan tablets (Micardis) is not recommended for use within NHS Scotland for use in cardiovascular prevention (to reduce cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage [ Link opens in new windowSMC 631/10].
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.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
 
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