Depression | Access and Reimbursement | EU5 | 2016

Nearly 23 million people across the EU5 suffer from major depressive disorder. Generic availability of a growing number of therapies has improved patient access to antidepressants and loosened restrictions on off-label adjunctive use of atypical antipsychotics. New branded therapies will face increasing market access challenges as they compete for positioning in this crowded market. Clear demonstration of improved efficacy over standard-of-care comparators is necessary, though in some markets, safety or quality of life improvements are acceptable when accompanied by noninferior efficacy, and successfully targeting subpopulations or unmet treatment needs are additional keys to therapies securing favorable formulary placement and reimbursement terms.

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