The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Denosumab (Prolia®) has been accepted for restricted use in postmenopausal women at increased risk of fractures provided the bone mineral density (BMD) T-score is < -2.5 and ≥ -4.0 for whom oral bisphosphonates are unsuitable. The same drug has been rejected for use in men treated with hormonal manipulation for prostate cancer who are at increased risk of fractures. The manufacturer did not make a submission for this indication.
Tacrolimus granules (Modigraf®) has been accepted for restricted use in prophylaxis of transplant rejection and treatment of allograft rejection in patients for whom tacrolimus is an appropriate choice and where small dose adjustment may be needed or where seriously ill patients are unable to swallow tacrolimus capsules.
Ranolazine (Ranexa®) has been rejected for use as add-on therapy for the symptomatic treatment of patients with stable angina pectoris. The economic analysis was not sufficiently robust to gain acceptance.
Etonogestrel 68mg implant (Nexplanon®) has been accepted for use as a long-acting choice of contraception. This is the x-ray opaque version of Implanon®.
Diclofenac 4% spray gel (Mobigel Spray®) has been rejected for the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma. The manufacturer failed to make a submission.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.