AMCP Revises Formulary Document to Reflect New Recommendations for Specialty Pharmaceuticals

Updates to this invaluable industry guide include new portions pertaining to specialty pharmaceuticals, comparative effectiveness research, and companion diagnostics tests, as well as a new definition for the term “specialty pharmacy.”

Despite the fact that various (and often differing) definitions of “specialty pharmacy” exist, an official definition of the term has been issued by the Academy of Managed Care Pharmacy (AMCP) in the version 3.1 release of the AMCP Format for Formulary Submissions.

According to the addendum, a product can be defined 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)

Many of the sources to which the organization referred in their systematic review of definitions identified specialty pharmaceuticals in terms of price—but AMCP was careful to say that although price is usually evaluated in formulary decisions, it would not be included in their current definition. “High cost is not enough to define a product as a specialty pharmaceutical, as this definition alone would potentially capture an expensive branded drug with no other special needs for delivery or patient management,” noted the addendum.

Along with a new definition of specialty pharmacy, the new version of this industry resource has been revised to reflect new guidance in the areas of comparative effectiveness research, specialty pharmaceuticals, and companion diagnostics tests.

The Format, which had not been updated since 2009, is used by managed care organizations to evaluate new and existing pharmaceuticals for formulary placement, coverage, and reimbursement decisions. Generally, health organizations use the guide to request information from manufacturers when evaluating pharmaceuticals for potential formulary inclusion.

Within the revised guidance sections, it is now recommended that manufacturers submitting a specialty drug for potential formulary inclusion provide Healthcare Common Procedure Coding System codes applicable to these products, as well as Current Procedural Codes that are relevant to reimbursement under the medical benefit.

To enhance the evidence dossier for their medication, manufacturers are also encouraged to submit and an expanded product description with information on distribution and prescribing restrictions, as well as the inclusion of any factors that may affect channel considerations or access assistance.

Other recommendations among those noted in the addendum include (but are not limited to) providing greater detail about the conditions that are to be treated with the medication, submitting a description of post-marketing obligations, and offering justification for care management decisions, including estimated costs of care management, delivery, administration, and setting of care.

Of particular note is the section of the guide that refers to the classification of biosimilars and biologics. Contrary to some media reports that liken biosimilars to generics—categorizing biosimilars as generic versions of high-priced specialty medications—the guidance points out that “biosimilars are not generic biologics.” “Due to the nature of biologicals, the current FDA evaluation process for authorizing a generic version of the innovator product is impractical,” the guide concludes. The guide also provides a definition for both biologic products and biosimilars, and explains how a biologic product—which is broadly defined by the FDA as a therapy used to treat diseases and health conditions—may be demonstrated to be “biosimilar.”

Pete Penna, PharmD, chair of the AMCP Format Executive Committee, noted in a press release that the updated portions of the Format will help health care providers “more confidently answer the question, ‘Which drugs offer the greatest value and opportunity to improve patient heath at reasonable costs?’”

To see a complete list of the proposed recommendations, click here: The AMCP Format for Formulary Submissions Version 3.1.