Newly updated formulary tool aims to help payers get early information on unapproved drugs

Drugs and money sign
A format for formulary submissions has been updated to enable drug companies to share information with payers on unapproved products. (Getty/ADragan)

A formulary submission tool has been updated to enable payers to get access to drugs' product information before they are approved in order to make decisions faster.

The Food and Drug Administration (FDA) gave greater flexibility to drugmakers in 2018 to share information on unapproved products with insurers and formulary managers. The Academy of Managed Care Pharmacy (AMCP) updated its format for formulary submissions to include new ways for drug companies to share information on unapproved products.

The AMCP format is traditionally used by drug companies to create a dossier for payers to help them decide whether to cover a product on their formulary. The dossier contains information on the safety and effectiveness of the drug.

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The format was updated in late December to include ways for drug companies to voluntarily share information with payers on products that are about 12 to 18 months away from FDA approval.

RELATED: AHIP, BCBSA come to defense of prior authorization as docs urge overhaul in MA

AMCP wanted to address a growing trend among drug manufacturers.

“We have seen biopharmaceutical companies that have begun to share information about a product’s pre-approval,” said Cindy Reilly, chief operating officer for the academy. “What the dossier does for the first time is it provides a standardized format in terms of how that information is created.”

The FDA released final guidance back in June 2018 that details how drug companies can share information on unapproved products.

Payers want to know information that includes efficacy, safety and cost-effectiveness of approved products. By getting this information earlier, they can help outline their budget for pharmaceutical spending, Reilly said.

“One of the key things that healthcare decision-makers want to know is what is the expected indication, which helps figure out the expected population and helps them budget,” she said.

The new format comes as insurers have struggled with how to deal with rising pharmaceutical costs.

RELATED: Insurers aim to get physicians to incorporate electronic processes for prior authorization 

Insurers have increasingly adopted formulary management tools such as prior authorization that require approval from the insurer before a doctor can prescribe pricey treatments.

However, the shift toward prior authorization has increased costs on physicians. A recent study from the Council for Affordable Quality Healthcare (CAQH) found that the costs to manually generate a request to insurers for prior authorization for a prescription went up 60% in 2019.

Reilly said that as more insurers move toward prior authorization, there are efforts to move requests to insurers electronically. This way a physician wouldn’t have to use manual processes like a fax machine.

But the CAQH study found that overall industry use of electronic prior authorization only rose slightly to 13% in 2019, up from 12% in 2018.

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