The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Abatacept (Orencia®) has been accepted for restricted use 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 TNF-alpha inhibitor. Use is only recommended in individuals with a disease activity score (DAS28) greater than 5.1 confirmed on at least two occasions, 1 month apart.
Elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild) has been accepted for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV-1 without known mutations associated with resistance to the three antiretroviral agents in this product. It is noted that this advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness.
Pirfenidone (Esbriet®) has been accepted for restricted use in the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). Use is only recommended in patients with a predicted forced vital capacity (FVC) less than or equal to 80%.
Ursodeoxycholic acid (Ursofalk®) has been accepted for use in the dissolution of cholesterol gallstones in the gall bladder. The product licence limits use to when the gallstones do not show as shadows on X-ray images and do not exceed 15mm in diameter and the gall bladder must be functioning despite the gallstone(s).
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.