The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Adalimumab (Humira®) has been rejected for use in the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy. The manufacturer failed to make a submission.
Azilsartan (Edarbi®) has been rejected for the treatment of essential hypertension in adults. The manufacturer failed to make a submission.
Azithromycin dihydrate (Azyter®) has been rejected for the local antibacterial treatment of conjunctivitis caused by susceptible strains. The manufacturer failed to make a submission.
Eplerenone (Inspra®) has been accepted for use in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%).
Golimumab (Simponi®) has been accepted for restricted use for the treatment of active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. It can be used alone or in combination with methotrexate when at least two standard DMARDs have failed to provide a response and at the dose of 50mg only.
Tadalafil (Adcirca®) has been accepted for restricted use in the treatment of adults with pulmonary arterial hypertension (PAH) classified as World Health Organisation functional class (WHO-FC) II and III, to improve exercise capacity. The restriction limits treatment initiations to specialists working in the Scottish Pulmonary Vascular Unit or similar specialists.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.