Establishing Therapeutic Equivalence of Complex Pharmaceuticals: The Case of Dabigatran.

Dabigatran is widely used for stroke prevention in atrial fibrillation. Dabigatran is no longer patent-protected in Canada and 2 generic formulations were recently approved by Health Canada. Branded dabigatran uses a complex formulation to maintain the acidic microenvironment required for maximal absorption.

Aligning health care policy with evidence-based medicine: the case for funding direct oral anticoagulants in atrial fibrillation.

Misalignment between evidence-informed clinical care guideline recommendations and reimbursement policy has created care gaps that lead to suboptimal outcomes for patients denied access to guideline-based therapies. The purpose of this article is to make the case for addressing this growing access barrier to optimal care. Stroke prevention in atrial fibrillation (AF) is discussed as an example.