With the release of two guidance documents this week, the US Food and Drug Administration took significant steps to modernize how health care information is communicated. One guidance makes important improvements to expand the exchange of clinical and economic information for biopharmaceuticals, medical devices, and unapproved products and unapproved uses of existing products among biopharmaceutical manufacturers, payers and population-health decision makers. A second guidance outlines the communication of information consistent with, but not contained in, a product label, for communication to providers and the public.
These improvements were necessary because until recently, the exchange of information has not kept pace with the growing sophistication of the products available to treat conditions, and the ways health care is organized, delivered and reimbursed. Although section 3037 of the 21st Century Cures Act and a series of FDA draft guidances in 2017 added some clarity and detail about the exchange of health care economic information between biopharmaceutical companies and payers, health care decision-makers were looking for more concrete steps, particularly about how to exchange truthful and non-misleading information regarding investigational products and investigational uses to payers.
The final guidance released by FDA addresses this communications question as well as many of the concerns raised by the National Pharmaceutical Council through our longstanding research in this area and in public testimony and comments. The guidance document:
- Clarifies a broader range of organizations and individuals that can receive health care economic information (HCEI), such as state Medicaid programs. It also permits individuals who have multiple responsibilities, such as caring for patients and advising product coverage and reimbursement, to receive HCEI when carrying out their professional coverage and reimbursement responsibilities.
- Broadens the generally-accepted scientific practices FDA will consider as competent and reliable scientific evidence (CARSE).
- Permits pre-FDA approval exchange of information for both unapproved, investigational products and unapproved, investigational uses for approved products.
- Ensures disclosures encourage transparent and timely communications without being overly prescriptive.
- Exempts reporting requirements for risk-sharing and value-based confidential contractual terms that include HCEI between biopharmaceutical companies and payers.
- Clarifies differences in criteria and interpretation across multiple FDA guidance documents.
In coming years, as more complex treatments and medical innovations are developed, the need for data and information to guide health care decisions, and the ways we organize, deliver and reimburse health care will only increase. The guidance documents reflect positive changes that could pave the way for more value-based contracts, more efficient coverage determinations and robust health care decision-making.
NPC has long been engaged in this communications issue, conducting peer-reviewed research, surveying payer and provider information needs and hosting conferences to identify illustrative examples of the challenges in exchanging certain types of information. In addition, NPC has been an active contributor in identifying good research practices for conducting observational and modeling studies. NPC also participated in three forums hosted by the Academy of Managed Care Pharmacy that resulted in recommendations to foster the exchange of health care economic information and pre-approval information between payers and the biopharmaceutical industry.