The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Budesonide (Cortiment®) is accepted for restricted use in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where aminosalicylate (5-ASA) treatment is not sufficient. The restriction limits use to patients with active left-sided disease and/or proctosigmoiditis who are not suitable for oral prednisolone, as an alternative to budesonide rectal formulations or off-label oral budesonide.
Budesonide / formoterol dry powder and pressurised aerosol inhalers (Symbicort Turbohaler® and pMDI) have been rejected for the treatment of patients with chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 50% to 70% predicted normal (post bronchodilator) and an exacerbation history despite regular bronchodilator therapy. The manufacturer failed to make a submission. This intervention has previously been accepted for those with an FEV1% predicted of less than 50% and an exacerbation history despite regular bronchodilator therapy. As such this treatment can be used in severe and very severe COPD but is not recommended for moderate COPD.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.