- Prescribing Advice for GPs - https://www.prescriber.org.uk -

SMC Update - November 2015

The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.

Atazanavir and cobicistat (Evotaz®) has been accepted for use in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.

Edoxaban (Lixiana®) has been accepted for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Edoxaban (Lixiana®) has been accepted for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

Everolimus (Certican®) has been rejected for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a cardiac transplant or for prophylaxis of organ rejection in patients receiving a hepatic transplant. The manufacturer failed to make a submission. It is noted that NICE are currently producing guidance.

Raltegravir chewable tablets (Isentress®) have been accepted for restricted use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in children from the age of 4 weeks to <2 years. The restriction limits use to patients who are intolerant or resistant to alternatives or where alternatives are limited by interactions. They must also be prescribed under the supervision of specialists in paediatric HIV.

Raltegravir granules for oral suspension (Isentress®) have been accepted for restricted use in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in in adults, adolescents, children, toddlers and infants from the age of 4 weeks. The restriction limits use to patients who are intolerant or resistant to alternatives or where alternatives are limited by interactions. They must also be prescribed under the supervision of specialists in paediatric HIV.

Tiotropium / Olodaterol (Spiolto Respimat®) has been accepted for use as maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Triamcinolone hexacetonide has been accepted for use in juvenile idiopathic arthritis (JIA). This is a new licence extension for JIA where previously an unlicensed preparation has been used.

Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.