Data Sharing: Navigating New FDA HCEI Rules

One year ago, the FDA released the health care economic information (HCEI) draft guidance on approved communication between pharmaceutical manufacturers and health care decision-makers, including payers, formulary committees, or similar entities. First Report Managed Care spoke with stakeholders for their insights and experiences on why access to HCEI is critical to better care for patients, how the guidance has impacted payers, why it is important to continue incorporating HCEI into decision making while waiting for FDA to finalize the  guidelines, and where industry stands on HCEI a year later.

The Value of Access

HCEI, which is part of the 21st Century Cures Act, is an important consideration during the formulary decision-making process, according to Jay Jackson, PharmD, MPH, senior vice president of consulting services, Xcenda, who served on a panel during a session on the latest in pharmaceutical and payer communications on drug information at AMCP Nexus 2017. “As new pharmaceutical products are approved and enter the market, HCEI can provide a more comprehensive picture of the benefits of a particular therapy, thus assisting payers in making more informed coverage decisions. Formulary committees are constantly forecasting the impact of new therapies, and without HCEI, they may develop inaccurate forecasts for a particular therapy,” he said. Furthermore, without HCEI, formulary committees may not update coverage decisions, leaving patients to potentially pay more for therapy.

“When payers can evaluate the data earlier in the process, it allows us to make better decisions and earlier decisions which should allow better patient access to drugs that could be life changing or lifesaving,” said S Russell Spjut, PharmD, formulary management pharmacist, MagellanRx Management.

Kat Wolf Khachatourian, PharmD, MBA, vice president of pharmacy services, delegation oversight, QualChoice Health Plan Services, agreed that HCEI is important for improving patient care, “due to the delay in publications, official releases, and formalized processes that often limit payers’ ability to cover services due to awaiting FDA approval of indications or publications from peer-reviewed journals on clinical best practices. By conducting open dialogues with those closest to the information, in a truthful and nonmisleading fashion, this could expedite the progress made in effectively treating and curing disease.”

Also, the creation of a safe harbor preapproval information exchange may result in improved patient care for less cost. “Creating a safe harbor is important to enable stakeholders to have access to truthful and nonmisleading information that will decrease the inefficiencies in the system and result in better patient care at a more affordable level,” she said.

Impact on Payers

Dr Spjut and colleagues he spoke with agreed that HCEI is positive step in the decision-making process. “We all appreciate having data available earlier which allows us to plan better, initiate better strategies, and prepare for potential budget impacts,” he said. “The payers I am familiar with have all taken advantage of the guidance to gain access to clinical trial and impact data earlier in the decision-making process. Having a clear understanding of the timing for potential FDA approval and the intended indication really makes a difference in the decision-making process.”

“The new guidance has positively impacted our interaction with some pharmaceutical companies,” said Jeffrey Dunn, PharmD, MBA, chief clinical officer/senior vice president, VRx Pharmacy Services, in an interview, noting that some pharmaceutical companies are taking a conservative approach to sharing information.

Dr Khachatourian, who also sat on the panel with Dr Jackson, pointed out that guidance has provided a recommendation, but because it is nonbinding, “we haven’t seen a great amount of uptake throughout the industry to change data sharing from the status quo pre-FDA guidance. There has been an increased dialogue of need, but actionable exchange of data has not substantially changed.”

The guidelines provide more clarity, but also specify a list of contextual information (eg, type of analysis, modeling technique, outcome measures, cost estimates) and disclosures (eg, generalizability, limitations, and sensitivity analyses) that must be included in communications, according to Dr Jackson’s presentation. We asked him if payers and/or manufacturers are happy about these requirements.

“While we don’t currently have direct feedback on their satisfaction with the requirements, the contextual information and disclosures do add much more supporting detail to the communication vehicle to help tell a product’s value story. It is important to include this information in an effort to be truthful and nonmisleading,” he explained. “Moving forward, it will be important for companies to determine how best to package the information with enough detail to support the HCEI without overwhelming the decision maker. It will also be important for those developing HCEI for dissemination to understand approved company guidance to avoid delays in approval of HCEI for dissemination.”

Dr Spjut believes the HCEI guidance has helped to increase communication between pharma and payers. “My team has met with a number of payers over the last year to discuss information that falls under the HCEI guidance that we would not have had access to prior to the release of the guidance.”

Dr Khachatourian acknowledged challenges associated with communication between pharma and payers, noting that in health care, organizations are risk averse. “Payers don’t want to cover products without evidence to support their use, and manufacturers don’t want to share information that could be perceived as off-label promotion of their products. This creates an impasse with patients stuck in the middle,” she said. “This leads to budgeting and forecasting for uses that we know about according to label, and rely on retro-review of experience to interpret the full extent of actual real-world practice and utilization. This adds additional inefficiency and unnecessary cost to the overall health care system.”

Moving Forward

Drs Spjut and Khachatourian shared why stakeholders need to keep moving forward with incorporation HCEI into the decision-making process while awaiting the FDA to finalize the guidelines.

“The progress made in information sharing made possible with the draft guidance has already made an impact to formulary planning and design. It is important that this trend continues in order to allow earlier access to medications that patients truly need,” said Dr Spjut.

“[We need] to continue to move forward with this important HCEI work because drug development, coverage decisions, patient access to therapies, clinical trial design protocols for future therapies, and budgeting and forecasting for sustainability and affordability do not wait for FDA to finalize guidelines. These processes will continue, and likely in a less efficient manner, if we await finalized guidance that may take years,” added Dr. Khachatourian.

HCEI a Year Later

Stakeholders told First Report Managed Care that since the FDA released the draft guidance pharma companies and payers are doing a better job of sharing HCEI.

“We are certainly moving in the right direction.  Companies that may have been reluctant to proactively share HCEI in the past are developing and implementing a process to proactively communicate HCEI,” said Dr Jackson, noting that if the Pharmaceutical Information Exchange (PIE) Act of 2017 is passed, industry will like see more proactive communication.

He also said the use of field teams responsible for delivering HCEI proactively vary by company and “could potentially spur a new type of field personnel that is able to blend the science and business to appropriately communicate HCEI proactively.”

“We still have a ways to go before we see full adoption, but it is an improvement over the previous environment,” added Dr Dunn.

Dr Spjut noted that while the guidance still leaves some questions, and each pharma company has interpreted the guidance differently, “we have had a lot more HCEI information shared with us over the last year. It has really allowed a type of understanding and collaboration between payers and pharma that we did not see before.”