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Closing the Gaps in Pre-Approval Information Exchange to Accelerate Product Success and Patient Access

By Xcenda

This article originally ran in Pharmaceutical Executive and is republished here with permission.
Gaps remain in the pre-approval information process leave payers without all of the information they need to make the proper decisions.

As more innovative pharmaceutical products enter the pipeline, payers (defined by FDA as healthcare decision-makers in the 2018 guidance) seek more detailed information about products earlier in the approval process to inform their budget planning and formulary decisions. Given the heightened demand for pre-approval information exchange (PIE), it is increasingly important for biopharma companies to proactively develop and share information, such as anticipated indication, clinical trial results, target patient demographics and epidemiology, and product pricing insights, up to 12 months prior to the projected approval date. While pre-approval communication has increased over the last five years, there remains a gap in the information payers receive versus what they need to make informed decisions for their beneficiaries, according to a survey AmerisourceBergen’s Consulting team conducted among payers participating in its proprietary Managed Care Network.

Current Landscape

Payers use PIE to facilitate actuarial planning for future product approvals and associated early product reviews, coverage, and reimbursement decisions. In turn, biopharma companies can raise awareness and share credible information about new products and new indications prior to Food and Drug Administration (FDA) approval—without an unsolicited request from payers.

Four years ago, the FDA issued guidance that addressed common questions related to sharing information with payers about products not yet approved or cleared for use. While it represented an important step forward, the current guidance is not a permanent safe harbor. As such, some biopharma companies have been reluctant to share pre-approval information. The FDA has not indicated that there have been challenges or concerns with the way the guidance is being implemented. However, today, several years after the FDA guidance was introduced, there are still misconceptions and questions about implementing PIE.

Lingering questions and uncertainties have contributed, in part, to the pre-approval information gaps that exist today. Most national payers (65%) surveyed by AmerisourceBergen’s Consulting team reported a gap in PIE—frequently citing product pricing, healthcare economic information, study results, and patient use projections, as types of information that are not adequately communicated by biopharma companies. If these gaps in PIE are closed, 91% of surveyed national payers agreed their formulary decision making ability would improve. Biopharma companies would also benefit from the market shaping and disease state education opportunities that PIE presents.

Designing Effective Strategies

When designing a strategy to facilitate pre-approval discussions with payers, it is critical for biopharma companies to understand what information payers find valuable and when they want to receive it to support their formulary decision making process.

In AmerisourceBergen’s research, most payers pointed to four types of information as extremely important to receive proactively prior to approval: credible study results, product pricing, indication, and product information. AmerisourceBergen also found that most payers (67%) preferred to receive pre-approval information four to 12 months pre-approval. However, biopharma companies may find it useful to disseminate pre-approval information even earlier depending on the product and therapeutic space. For example, more than a third of payers would like pre-approval information earlier for cell and gene therapies, followed by innovative therapies, rare disease, and oncology, compared to other categories. Earlier pre-approval communication will also help payers evaluate drugs receiving accelerated reviews and oncology agents gaining approval with Phase II data.

Closing the Information Gaps

Heightened collaboration among all stakeholders, including payers and biopharma companies, is critical to close the pre-approval information gaps and maximize the opportunities that PIE presents.

The FDA guidance provided biopharma companies a long-awaited path to engage payers in the pre-approval setting and more effectively plan for the availability of innovative new products. However, there is an opportunity to provide more concrete guidelines and create a pathway for payers and biopharma companies to engage in more robust pre-approval exchanges. A pending bill, the PIE Act of 2022 (included as Section 810 in the Food & Drug Amendments of 2022, H.R. 7667), which is expected to be voted on this fall would create a permanent safe harbor for biopharma companies to proactively conduct PIE with payers as identified in the current guidance. The bill also expands and clarifies the scope of permitted healthcare economic and scientific information communications between biopharma companies and payers. Passing this legislation would effectively eliminate some of the uncertainty that stakeholders face today and lead to more robust exchanges, which offer the potential to expedite coverage decisions for emerging therapies and accelerate patient access to the innovative products.