The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Apremilast (Otezla®) has been accepted for use in the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).
Apremilast (Otezla®) has been accepted for restricted use alone or in combination with disease modifying anti-rheumatic drugs (DMARDs), for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. The restriction limits use to patients who have had an inadequate response with at least two prior DMARD therapies or who are intolerant to such therapies.
Levonorgesterel (Levosert®) has been accepted for use as a contraceptive or in heavy menstrual bleeding. It is noted that this product contains the same total amount of levonorgestrel with the same release profile as an existing levonorgestrel-containing IUS at a lower unit cost.
Linagliptin and metformin (Jentadueto®) has been accepted for restricted use in the treatment of adult patients with type 2 diabetes mellitus in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control when insulin and metformin alone do not provide adequate glycaemic control. The restriction limits use to patients where a combination of linagliptin and metformin is an appropriate choice of therapy and the fixed doses are considered appropriate.
Magnesium aspartate dehydrate (Magnaspartate®) has been accepted for the treatment and prevention of magnesium deficiency, as diagnosed by a doctor.
Ombitasvir / paritaprevir / ritonavir (Viekirax®) and dasabuvir (Exviera®) have been accepted for use with or without ribavirin for the treatment of genotype 1 chronic hepatitis C (CHC) in adults and in combination with ribavirin for the treatment of genotype 4 CHC in adults.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
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