Defining Specialty Pharmacy

The Academy of Managed Care Pharmacy (AMCP) recently published its latest Format for Formulary Submissions, version 3.1. (free download) Starting on page 34, the Format tries to answer two seemingly straightforward questions: What is a specialty drug? What is a specialty pharmacy?

The AMCP’s answers, which are intended for manufacturers, certainly won’t satisfy every constituent and may be rapidly outdated due to marketplace developments. Nonetheless, I find them useful for clarifying the discussion. Read on and see if you agree.

P.S. Today is the last day for discounted pricing on the 2012–13 Economic Report on Retail, Mail, and Specialty Pharmacies.

WHAT IS A SPECIALTY DRUG?

Here is the definition of “specialty pharmaceutical” from the AMCP Format:

Within the current version of the Format, a product can be classified as a specialty pharmaceutical if:

• It requires a difficult or unusual process of delivery to the patient (preparation, handling, storage, inventory, distribution, Risk Evaluation and Mitigation Strategy (REMS) programs, data collection, or administration) or,
• Patient management prior to or following administration (monitoring, disease or therapeutic support systems).

The AMCP Format is intended as a guide for “…manufacturers of pharmaceuticals, biologics and vaccines who are responding to an unsolicited request from a healthcare system to support reimbursement and/or formulary placement consideration of a new product, new indication, or new formulation of an existing product.”

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