The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Abiraterone (Zytiga®) has been accepted for use in combination with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
Budesonide (Cortiment®) has been rejected for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient. Similar clinical effectiveness compared to standard treatment with rectally applied budesonide has not been demonstrated.
Ciclosporin (Ikervis®) has been accepted for the treatment of severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes.
Everolimus (Afinitor®) has been rejected for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. The submitting company did not present a sufficiently robust economic analysis
Insulin degludec / Liraglutide (Xultophy®) has been accepted for restricted use in the treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with a GLP-1 receptor agonist or with basal insulin do not provide adequate glycaemic control. The restriction limits use to who those who are uncontrolled on basal insulin analogues (HbA1c > 59mmol/mol [7.5%]) and for whom a GLP-1 receptor agonist is appropriate as an add-on intensification therapy to basal insulin to obtain glucose control.
Midodrine (Bramox®) has been accepted for use in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate.
Travoprost (Travatan®) has been accepted for use to decrease of elevated intraocular pressure in paediatric patients aged 2 months to > 18 years with ocular hypertension or paediatric glaucoma.
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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