What is the timeline for formulary decisions?

The decision that a controller makes to cover or exclude a drug, and even to impose access restrictions, is always a strategic one. Contrary to popular belief, controllers do not necessarily review a drug as soon as it is approved by the FDA. Their timelines vary depending on several factors.

After the FDA accepts a manufacturer’s application for approval, the company may begin outreach to payers and PBMs to discuss the new therapy. Each pharmacy and therapeutics (P&T) committee will meet several times to evaluate the drug’s clinical use and efficacy, the applicability of regulatory mandates, and whether the drug provides sufficient benefits or clinical differentiation to justify its cost.

Once the drug is FDA approved, each controller’s P&T committee will meet—typically within the first 90 days—to determine whether to place the drug on formulary, with or without access restrictions.

Learn more by reading the full ebook The Essentials of Market Access: How to Build a Strong Commercialization Strategy for Your Pharmacy Benefit Therapy.