Clinical Data (CLDA)

[pcrutch]

Basically guaranteed Medicare covarega. CMS (Centers for Medicare and Medicaid Services) puts very tight controls on Part D sponsors. However, antidepressants are uniquely covered without much trouble, hence Viibryd will be covered automatically by things like Medicare / Medicaid.

Section 30.2.5 in Chapter 5 of the CMS Part D manual addresses what they call "beneficiary protections". One of these protections is a mandate that formularies don't materially restrict access to drugs in the "Six Classes of Clinical Concern" aka "Protected Classes".

Antidepressants is one of the classes. The net result of the reg is that Part D sponsors must include virtually all drugs within the six classes on their formularies with minimal barriers (ie strict Prior Authorization). Thus, Viibyrd will be on all Part D formularies by this rule. CMS also has generous low income subsidies for many beneficiaries so even if plans put Viibyrd on a high cost tier many beneficiaries would still be able to access the drug at a low out of pocket expense.

http://www.cms.gov/PrescriptionDrugCovContra/Downloads/Chapter6.pdf