Featured Health Business Daily Story, Nov. 20, 2017

Payers, Drugmakers Struggle With Sharing Economic Information

Reprinted from DRUG BENEFIT NEWS, biweekly news and proven cost management strategies for health plans, PBMs, pharma companies and employers. Subscribe today!

By Diana Manos, Senior Reporter
October 27, 2017Volume 18Issue 20

It has been 20 years since the passage of the Food and Drug Administration Modernization Act of 1997, which included Section 114 (FDAMA 114) governing the proactive dissemination of health care economic information (HCEI) by manufacturers to payers. With the 21st Century Cures Act signed into law last year, lawmakers intended to modernize that process. But the sharing of HCEI still is problematic for both drugmakers and payers, according to industry insiders who spoke at the Academy of Managed Care Pharmacy’s (AMCP) annual conference, held in Dallas Oct. 17-19.

At the Oct. 18 session, titled “Payer & Manufacturer Communications: What’s Changed & How Does it Impact Managed Care Pharmacy?” speaker Soumi Saha, Pharm.D., director of pharmacy and regulatory affairs at AMCP, said the first thing everyone asks about HCEI is “what has changed?” To begin with, the landscape has been changing rapidly, Saha said. Changes include the shift from paying for volume to paying for value; the increased availability of comparative effectiveness research and real-world evidence; the rise of big data, allowing more observational studies; and the introduction of sophisticated economic models, she said.

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Payers Push for HCEI Earlier in Process

Also, AMCP has heard regularly from its members that they need HCEI prior to FDA approval in order to properly plan, budget and forecast, she said. If payers aren’t aware of a drug that is going to come onto the market by the time they file premium rates, it could mean that patients might not be able to access that drug upon FDA approval.

In addition, with the new focus on value-based payment models, if payers and manufacturers aren’t able to discuss the drugs prior to approval, it slows the development of such pacts. And some drugs are approved by the FDA before all data are available, making payers hesitant to cover these drugs. Discussion ahead of time between manufacturers and payers could help prevent this from happening, Saha said.

AMCP conducted a survey of payers and manufacturers last year to understand the attitudes and perceptions of the two groups regarding FDAMA 114. The association wanted to use the information learned from the survey to help shape future regulatory guidance on the proactive dissemination of HCEI, Saha said.

The AMCP survey revealed some good news and some bad news. The good news is that 73% of payer respondents said they are receiving some type of HCEI from manufacturers. The bad news is, 64% of them said there is still a gap between the type of HCEI they need for formulary decision making and what is available in the literature and/or supplied by the manufacturer. Some 53% of payer respondents indicated that decision making would be “very much” or “extremely improved” if this gap were to be filled, according to Saha.

On the other side, AMCP discovered that manufacturers want to provide useful HCEI, but it is difficult. A majority of manufacturer respondents (91%) said they are having a hard time gaining approval from their company for HCEI materials to be shared with payers.

Because of these findings, AMCP and other stakeholders are calling for more federal clarification on FDAMA 114, and they are proposing the creation of a pre-approval safe harbor, which they have unofficially dubbed the Pre-Approval Information Exchange (PIE) (“because everybody loves pie,” Saha said). “There absolutely needs to be a safe harbor for manufacturers to pro-actively share clinical and economic information about emerging therapies with health care decision-makers at least 12 to 18 months prior to FDA approval,” Saha said. The safe harbor is needed to make clear that proactive dissemination of this information doesn’t violate any laws and regulations.

In addition, “payers need to communicate back to manufacturers” what they’re looking for and the level of evidence they need to make a coverage decision, she added. What FDA needs to determine approval of a drug based on its safety and efficacy does not match what payers need to cover a drug. Discussions between manufacturers and payers prior to FDA approval could perhaps remedy this situation, she said.

Definition of HCEI Has Changed

Speaker Mark Gaydos, vice president of global regulatory affairs at Sanofi, a Bridgewater, N.J.-based life sciences innovation company, said since 1997, manufacturer-payer communication has not been a major focus for FDA, but in the last five years it has become more of a “front and center” issue for the agency and lawmakers.

Under the FDAMA, HCEI was defined as “any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to another drug to another health care intervention or to no intervention,” Gaydos said.

Now, under the Cures Act, the definition of HCEI is “any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.”

Read more about the AMCP Nexus 2017 conference at www.amcpmeetings.org.


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