Formulary Group Decisions September 2011
Approved for use in NHS Grampian
Ajmaline 5mg/mL vial [unlicensed product]
Cardiovascular BNF 2
Ajmaline 5mg/mL vial [unlicensed product] was approved for restricted use in adults and adolescents for the purpose of unmasking the diagnostic ECG pattern of Brugada syndrome.
Restriction: Specialist use only. Consent to be completed by the consultant, and limited to administration in the Coronary Care Unit under the supervision of a Cardiology SPR grade or above. Unlicensed product available for specialist use only and recommended for hospital use only.
Antimetabolites BNF 8.1.3
Azacitidine injection (Vidaza®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (SCT) with intermediate-2 and high-risk myelodysplastic syndrome (MDS), chronic myelomonocytic leukaemia (CMML) or acute myeloid leukaemia (AML). Available for restricted use under specialist supervision and hospital use only. Vidaza treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic agents. Patients should be premedicated with anti-emetics for nausea and vomiting. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of azacitidine. This advice is contingent upon the continuing availability of the PAS in NHS Scotland.
Vitamin D, cholecalciferol BNF 9.6.4
Calcium carbonate and cholecalciferol (Kalcipos-D®) was approved for inclusion in the Grampian Joint Formulary.
Indications under review:
- Prevention and treatment of calcium and vitamin D deficiency in the elderly.
- Vitamin D and calcium supplement in addition to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.
This is a new combination product with a different ratio of calcium to cholecalciferol than alternative combination preparations. It is a similar price to an alternative product containing 800IU of cholecalciferol per tablet but is more expensive than some other calcium and cholecalciferol combinations. Available for general use and treatment may be initiated in either hospital or community.
Thiazides and related diuretics BNF 2.2.1
Indapamide 2.5mg tablets was approved for inclusion in the Grampian Joint Formulary for the management of hypertension. As per NICE Clinical Guideline 127, it may be used combined with other antihypertensive agents or as sole therapy. Available for general use and treatment may be initiated in either hospital or community.
Parenteral iron BNF 188.8.131.52
Iron isomaltoside 1000 injection (Monofer®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of iron deficiency anaemia in the following conditions:
- when oral iron preparations are ineffective or cannot be used;
- where there is a clinical need to deliver iron rapidly.
Restriction: use is restricted to administration by high dose infusion within the licensed indication but excluding use in patients receiving haemodialysis. The manufacturer's economic case did not consider the cost-effectiveness of iv bolus administration or use in haemodialysis patients.
Efficacy data are limited to two small open-label non comparative studies in patients with chronic kidney disease and chronic heart failure. Haemoglobin levels significantly increased from baseline in one study only.
Available for restricted use under specialist supervision and licensed for hospital use only.
Other immunomodulating drugs BNF 8.2.4
Mifamurtide intravenous infusion (Mepact®) was approved for inclusion in the Grampian Joint Formulary for restricted use in combination with post-operative multi-agent chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection, in children, adolescents and young adults. Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis.
Mifamurtide has been shown to increase overall survival compared with multi-agent chemotherapy alone in patients aged up to 30 years with newly-diagnosed resectable osteosarcoma.
Available for restricted use under specialist supervision and recommended for hospital use only.
Other antineoplastic drugs, protein kinase inhibitors BNF 8.1.5
Nilotinib 150mg hard capsules (Tasigna®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.
Drugs affecting gonadotrophins, gonadorelin analogues BNF 6.7.2
Triptorelin pamoate 22.5mg (Decapeptyl SR®) was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of :
- patients with locally advanced, non-metastatic prostate cancer, as an alternative to surgical castration.
- metastatic prostate cancer.
Not approved for use in NHS Grampian
Indication under review: In combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs including methotrexate or a tumour necrosis factor (TNF)-alpha inhibitor.
There is no head to head study comparing abatacept with other biologic or conventional disease-modifying anti-rheumatic drugs. In combination with methotrexate, abatacept reduced the progression of joint damage and improved physical function more than placebo in patients with moderate to severe rheumatoid arthritis who responded inadequately to previous therapy with methotrexate alone.
The submitting company's justification of the treatment's cost in relation to its health benefits was not sufficient and in addition, the company did not present a sufficiently robust economic analysis to gain acceptance by SMC [SMC 719/11].