Formulary Group Decisions April 2011
NICE (Multiple) Technology Appraisal Guidance
The Group noted NHS QIS's advice that the recommendations are as valid for Scotland as for England and Wales.
The review and re-appraisal of donepezil, galantamine, rivastigmine and memantine for the treatment of Alzheimer's disease has resulted in a change in the guidance. Specifically:
- donepezil, galantamine and rivastigmine are now recommended as options for managing mild as well as moderate Alzheimer's disease, and
- memantine is now recommended as an option for managing moderate Alzheimer's disease for people who cannot take AChE inhibitors, and as an option for managing severe Alzheimer's disease.
Approved for use in NHS Grampian
Drugs for dementia BNF 4.11
Memantine tablets was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of patients with moderate to severe Alzheimer's disease. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist. Only specialists in the care of patients with dementia (that is, psychiatrists including those specialising in learning disability, neurologists, and physicians specialising in the care of older people) should initiate treatment.
Local anaesthesia BNF 15.2
4% Articaine with 1:100,000 epinephrine injection solution (Septanest® 1:100,000) was approved for inclusion in the Grampian Joint Formulary for restricted use by the dental service. To be used in addition to lidocaine especially in cases of acute pulpitis when insufficient analgesia has been obtained with lidocaine alone. For use in dental anaesthesia only, available for restricted use under specialist supervision and treatment may be initiated in either hospital or community.
Denosumab injection (Prolia®)
Bisphosphonates and other drugs affecting bone metabolism BNF 6.6.2
Denosumab injection (Prolia®)
was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. Use is restricted to women with a bone mineral density (BMD) T-score <-2.5 and ≥-4.0 for whom oral bisphosphates are unsuitable due to contraindication, intolerance or inability to comply with the special administration instructions. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a specialist.
Lamotrigine tablets
Antimanic drugs BNF 4.2.3
Lamotrigine tablets was approved for inclusion in the Grampian Joint Formulary for restricted off-label use for the prophylaxis of bipolar disorder when other treatment options have failed. Available for restricted use under specialist supervision and treatment may be initiated in the community on the recommendation of a consultant/specialist.
Pazopanib tablets (Votrient®)
Other antineoplastic drugs, protein kinase inhibitors 8.1.5
Pazopanib tablets (Votrient®)
was approved for inclusion in the Grampian Joint Formulary for restricted use for the first-line treatment of advanced renal cell carcinoma (RCC). Available for restricted use under specialist supervision and recommended for hospital use only. Treatment should only be initiated by a physician experienced in the administration of anti-cancer agents.
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of pazopanib, and is contingent upon the continuing availability of the PAS in NHS Scotland.
Prilocaine hydrochloride 2% hyperbaric solution for injection (Prilotekal®)
Local anaesthesia BNF 15.2
Prilocaine hydrochloride 2% hyperbaric solution for injection (Prilotekal®) was approved for inclusion in the Grampian Joint Formulary for restricted use in spinal anaesthesia in ambulatory surgery settings (such as day surgery units). Available for restricted use under specialist supervision and licensed for hospital use only.
Approved by SMC, not requested by local clinicians - not approved for use in NHS Grampian
Drugs used in neutropenia BNF 9.1.6
Filgrastim injection (Nivestim®)
is accepted for use within NHS Scotland.
Indications under review: The reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes);
Reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia;
The mobilisation of peripheral blood progenitor cells (PBPC);
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤ 0.5 x 109/L and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events;
The treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Filgrastim (Nivestim®)
is a biosimilar product and has demonstrated equivalence in terms of efficacy and safety to a reference granulocyte colony stimulating factor, filgrastim (Neupogen®).
The British National Formulary advises that it is good practice to prescribe biological medicinal products by brand name.
Not requested by local clinicians - Not recommended for use in NHS Grampian for this indication.
Not approved for use in NHS Grampian
Tadalafil tablets (Adcirca®)
Vasodilator antihypertensive drugs BNF 2.5.1
Tadalafil tablets (Adcirca®) is not recommended for use within NHS Scotland [SMC 710/11].
Indication under review: for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Antipsychotic drugs, atypical antipsychotic drugs BNF 4.2.1
Quetiapine tablets (Seroquel®/Seroquel® XL) is not recommended for use within NHS Scotland [SMC 549/09].
Indication under review: Treatment of major depressive episodes in bipolar disorder.
In monotherapy studies quetiapine was superior to placebo and compared favourably with two active comparators. Efficacy relative to current practice for the management of depression in the framework of bipolar disorder in NHS Scotland involving combination therapy with a mood stabiliser or an atypical antipsychotic plus an antidepressant was not demonstrated.
The manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.
Quetiapine (Seroquel®/Seroquel® XL) is also licensed for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment. The manufacturer's submission related only to use in the treatment of major depressive episodes in bipolar disorder. Therefore, SMC cannot recommend its use for preventing recurrence in bipolar disorder in patients whose manic, mixed or depressive episode has responded to quetiapine treatment.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.
Vitamin E BNF 9.6.5
Tocofersolan oral solution (Vedrop®) is not recommended for use within NHS Scotland [SMC 696/11].
Indication under review: vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.
In an open-label, single-arm study, 96% of patients had an improved or stable neurological score after 2.5 years of treatment with tocofersolan.
The manufacturer did not supply any economic analysis therefore the cost-effectiveness could not be assessed.
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication.