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FDA Week

AMCP Shopping Plan To Let Formularies Get Pre-Approval Drug Info

January 05, 2017

Academy of Managed Care Pharmacy (AMCP) is drafting legislative language to share with the incoming administration that would allow for dissemination of biopharmaceutical clinical and economic information with formularies and other population health decision makers about 12 to 18 months before FDA approval. But patient advocates say such pre-approval information coming from pharmaceutical companies runs a high risk of being biased.

"We look forward to sharing [the legislative language] with the new administration in coming weeks. Based on Hill briefings … there is bipartisan support for moving forward," Susan A. Cantrell, AMCP CEO, told Inside Health Policy. She added that AMCP believes it is important for such information to be available to population health decision makers in the planning and budgeting of health benefit design. AMCP defines population health decision makers as those "beyond health plan formulary committees, including organizations, or individuals in their role in an organization, who make health care decisions for patient populations and organizations that evaluate HCEI or develop value frameworks and compendia, including individuals in such organizations."

"Current communications have to come from an unsolicited request. Population health decision makers have to initiate a request for information … but they have to go on scavenger hunt," Cantrell said, referring to current hurdles in decision makers getting such information.

She compared the current process to searching for pieces of a puzzle that pharmacies and decision makers then have to put together. According to Cantrell, this is a time-consuming and confusing process that oftentimes doesn't allow health decision makers to get all the information they need.

"Health care decision makers have to identify each puzzle piece then start putting together," she said. "You have to know what questions to ask and who to ask questions of. Unless you are very psychic and already have all the information put together for you, you're always going to have pieces missing. The goal with this is to eliminate the scavenger hunt so manufacturers can provide health care decision makers with the puzzle pieces they need to put the puzzle together."

AMCP had stressed a need for access to pre-approval information about biopharmaceuticals during a stakeholder forum in September 2016, according to proceedings from the forum printed in the January issue of Journal of Managed Care & Specialty Pharmacy. If biopharmaceutical manufacturers were able to inform formularies and others about emerging therapies prior to FDA approval it would give the decision makers information they need to move forward with accurate forecasting and rate setting, according to the proceedings.

But Diana Zuckerman, president of the National Center For Health Research, told IHP she is not sure why decision makers need unvetted information from the companies when they can get FDA-scrubbed information at advisory committees prior to a product's approval.

"We understand the desire to have information further in advance and not have to wait until a product is approved. But many of these products do have data that are made public at FDA advisory committee meetings," Zuckerman said. "That information is very good information because it includes all the information that the company has provided to FDA, and it includes FDA's scrutiny of that information. It's generally available at least two months before a product is approved … and it's been vetted very carefully. So, why do they want to get information from the company that hasn't been vetted?"

According to Cantrell, the information the group is talking about wouldn't necessarily need to include pricing data. She said there's other information that can help formularies and others in their planning.

"We recognize that pricing information may not be available. Other information that can help may be used … that includes route of administration. Does it need to be given in conjunction with other therapies? Is it a one-time treatment or long-term? Is it a lifetime continuous therapy versus a one-time cure? We're really looking at how all that information helps build that better picture," Cantrell told IHP. "[A]ll that is restricted from being shared. Health care decision makers have to ask it. You can't ask blanket questions … you have to be very specific."

However, Zuckerman said such information might be biased.

"They want to get information on products that aren't approved and may not be approved. So, that's a waste of time," she said. "Second, they're going to get industry information through rose-colored glasses … it's never going to be objective. [In the proceedings, they say] information should be truthful, non-misleading and include a broad range of information. What does that mean? I mean, yes, it should be truthful and non-misleading, but in the eyes of which beholder?"

Cantrell told IHP that if there's concern about bias, decision makers would be able to communicate further with manufacturers.

"To minimize the potential for bias, information provided under PIE [pre-approval information exchange] would have to meet the truthful and non-misleading standard and the methods used to derive the information would have to be transparent, disclosed, reproducible, accurate, and valid," she said. "In addition, the bidirectional communication process is very important as population health decision makers will have the ability to ask additional questions of manufacturers if there are concerns with bias in the information presented."

AMCP's forum also addressed protection of public health to ensure it isn't disseminated to a wider audience beyond those for whom it is intended -- manufacturers and health decision makers.

"A safeguard would be put in place to make sure it's only shared between those two," Saha said, citing FDA Modernization Act section 114. "There are safeguards in place already to limit communication to specific entities. Recommendations here state that similar safeguards should be put in place."

The proceedings article adds that stakeholders at the forum agreed the protections already in place may be enough. "The stakeholders agreed that certain public health protections are already in place through other legislation, so there may not be a need to create further protections beyond those already enacted," the article said.

But Zuckerman said there's a concern that manufacturers will use the information to market products. "We know there's a lot of concern about this being just a way to weaken restrictions on promoting off-label uses. There's clear concern about basically marketing products that aren't even approved," she said. "This smells like marketing products that haven't even been approved and in some cases may not have even been submitted yet for approval."

Cantrell emphasized that the group's call for pre-approval information exchange is not the same as off-label communication. "What we're talking about here is a safe harbor for dissemination of info to specific audience ... individuals involved in population health decision making," she said. "This is a different concept from broad off-label information dissemination to health care professionals and patients. We're talking about a very different audience. -- Beth Wang