Latest approvals from the SMC

Positive opinions on Lyxumia (lixisenatide), Sayana Press (medroxyprogesterone acetate) and Esbriet (pirfenidone) feature in the latest guidance from the Scottish Medicines Consortium (SMC).

The SMC approved lixisenatide (Lyxumia) for type II diabetes when a GLP-1 agonist is appropriate.
The SMC approved lixisenatide (Lyxumia) for type II diabetes when a GLP-1 agonist is appropriate.

Since June, the following drugs have been approved by the SMC for unrestricted use within NHS Scotland:

Approved 

  • Subcutaneous medroxyprogesterone acetate (Sayana Press), for long-term female contraception.
  • Rifaximin (Targaxan), for reducing recurrent episodes of overt hepatic encephalopathy.
  • Elvitegravir/cobicistat/emtricitabine/tenofovir combination tablet (Stribild), for HIV infection, if provided at the price set in the patient access scheme.
  • Argatroban (Exembol), for anticoagulation in patients with heparin-induced thrombocytopenia who require parenteral antithrombotic therapy.

Suitable for restricted use

The following drugs may be prescribed with restrictions:

  • Lixisenatide (Lyxumia), for type II diabetes when a GLP-1 agonist is required.
  • Aripiprazole (Abilify), for use by specialists in the treatment of moderate to severe manic episodes in bipolar I disorder in adolescents aged 13 years and older.
  • Pirfenidone (Esbriet), for mild to moderate idiopathic pulmonary fibrosis provided the predicted forced vital capacity (FVC) is ≤80%.
  • Adalimumab (Humira), for paediatric Crohn’s disease and polyarticular juvenile idiopathic polyarthritis when used under a paediatric specialist.
  • Latanoprost (Monopost), for reducing intraocular pressure in open angle glaucoma and ocular hypertension in patients sensitive to benzalkonium chloride.
  • Rituximab (MabThera), for severe active granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis that has relapsed following treatment with cyclophosphamide or when cyclophosphamide is unsuitable.
  • Abatacept (Orencia), for subcutaneous administration in rheumatoid arthritis provided the disease activity score is >5.1 and the manufacturer provides the drug with the discount agreed in the patient access scheme.

The Scottish body also approved etravirine (Intelence), raltegravir (Isentress) and tenofovir (Viread) for HIV in children when prescribed by a specialist, although raltegravir should only be used when NNRTIs and protease inhibitors are unsuitable. Tenofovir tablets are also approved for the treatment of hepatitis B in adults and adolescents and the oral granule formulation is approved for all licensed indications in adults unable to swallow tablets.

Not recommended

The SMC rejected aflibercept (Zaltrap), ocriplasmin (Jetrea) and chloroprocaine (Ampres) within their licensed indications as the manufacturers did not provide sufficiently robust economic analyses, and everolimus (Afinitor) when used within its licence for the treatment of breast cancer for the same reason.

Further information: The Scottish Medicines Consortium

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