- As part of its new approvals, the SMC has agreed to provide coverage for Takeda's Entyvio ---a biologic used to treat moderate-to-severe active forms of ulcerative colitis.
- SMC also approved coverage of two blood cancer drugs, including Arzerra from Novartis and Zydelig from Gilead.
- Additional cost approvals included Ozurdex (Allergan); Budenofalk (Dr. Falk Pharma); Victoza (Novo Nordisk) and Trajenta (Boehringer Ingelheim).
The broad categories that the SMC---and most other regulatory bodies responsible for approving cost outlays---use to determine whether a drug should be covered are cost-effectiveness and rather the drug represents an advance in the standard of care. In the case of Entyvio, the SMC decided that the drug is both cost-effective and an advance in the standard of care because of its unique mode of action, which selectively suppresses immune activity in the gut.
Interestingly, three of the seven drugs approved for coverage were diabetes-related, including Ozurdex for diabetic macular edema, Victoza for type II diabetes and Trajenta, which is used in combination with insulin to treat type II diabetes. Despite the spate of approvals, the SMC did reject some drugs, including Swedish Orphan's Xiapex for Peyronie's disease in men and Novo's Trediba for diabetes.