Formulary Group Decisions December 2011


Approved for use in NHS Grampian

Darunavir (Prezista®) 400mg tablet
HIV infection, protease inhibitors BNF 5.3.1

Darunavir (Prezista®) 400mg tablet was approved for inclusion in the Grampian Joint Formulary for restricted use for the treatment of HIV-1 infection.
Indication under review: darunavir 800mg once daily co-administered with low dose ritonavir (100mg once daily) for the treatment of HIV-1 infection in antiretroviral therapy experienced adults with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count ≥100 cells/mm3. Available for restricted use under specialist supervision and recommended for hospital use only.


Not approved for use in NHS Grampian

Clofarabine concentrate for intravenous infusion
Antimetabolites BNF 8.1.3

Clofarabine concentrate for intravenous infusion (Evoltra®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use in within NHS Grampian.
Indication under review: Clofarabine for the off-label use in adult patients with acute myeloid leukaemia (AML), either as single-agent or combination therapy. On the basis of the evidence considered by the Group the case for clinical-effectiveness (evidence too preliminary) and cost-effectiveness was not made (no evidence relating to cost effectiveness was submitted). Not approved for use within NHS Grampian. 

In the absense of a submission from the holder of the marking authorisation:
Denosumab 120 mg injection (Xgeva®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Bisphosphonates and other drugs affecting bone metabolism BNF 6.6.2
Denosumab 120mg injection (Xgeva®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Indication: Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.
NICE (National Institute for Health and Clinical Excellence) is currently undertaking a multiple technology appraisal (MTA) that includes the use of denosumab in this indication. However due to the significant time interval between product availability and the expected date of NICE guidance, not recommended advice has been issued. 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 752/11].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication

Dexamethasone intravitreal implant (Ozurdex®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
Corticosteroids BNF 11.4.1
Dexamethasone intravitreal implant (Ozurdex®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use within NHS Scotland.
Indication under review: treatment of adult patients with macular oedema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
In two phase III studies dexamethasone 700 microgram intravitreal implant was superior to sham administration at day 90 for the proportion of patients with a best corrected visual acuity improvement of 15 letters. Longer-term effectiveness of treatment is uncertain.
The submitting company did not provide a sufficiently robust clinical and economic analysis to gain acceptance by SMC. The licence holder has indicated their intention to resubmit [SMC 652/10].
Not recommended by SMC for use within NHS Scotland - will not be included in Grampian Joint Formulary for this indication - updated December 2012

Prucalopride tablets (Resolor®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product
5HT4-receptor agonists BNF 1.6.7
Prucalopride tablets (Resolor®) Black Triangle symbol indicating that the CHM and MHRA are intensively monitoring this product is not recommended for use in within NHS Grampian.
Indications under review:

  • women and men (off-label) for whom treatment with at least two laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and invasive treatment (heading to major surgery) for constipation is being considered: restricted to patients with proven slow-transit constipation.
  • women for whom treatment with at least two laxatives from different classes, at the highest tolerated recommended doses for at least 6 months, has failed to provide adequate relief and invasive treatment for constipation is being considered.

On the basis of the evidence considered by the Group the case for clinical-effectiveness and cost-effectiveness was not made. Not approved for use within NHS Grampian for these indications. 

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