NPC Submits Comments to FDA on Exchange of Clinical and Economic Information

To achieve our shared goal of a high-performing, value-based health care system, informed and evidence-based decisions are needed. Greater efficiency and better care requires more information exchange—not less—about which treatments work best for whom and under which care settings.

In comments submitted today to the Food and Drug Administration (FDA), the National Pharmaceutical Council (NPC) outlined ways to improve how the exchange of clinical and economic information between biopharmaceutical manufacturers, payers, and population-health decision makers is regulated. Although Section 114 of the Food and Drug Administration Modernization Act of 1997 (FDAMA Section 114) created a pathway to enable communications between payers and biopharmaceutical manufacturers, lack of further guidance from the FDA to clarify these provisions created uncertainty among stakeholders as to the types of information that can be exchanged, as well as with whom that information can be shared. It was only recently that Section 3037 of the 21st Century Cures Act and an FDA draft guidance offered additional clarity and detail about the exchange of information. FDA sought public comment on these changes.

NPC’s comments echoed remarks delivered by NPC Vice President for Comparative Effectiveness Research Jennifer Graff, PharmD, during the FDA’s November 2016 public hearing on manufacturer communications. The comments submitted today focused on six key areas:

• Clarify by including a broader range of organizations and individuals who can receive health care economic information (HCEI). When communications laws were first enacted, many stakeholders making population health recommendations, delivering care, and managing costs did not exist. Today, new care delivery models such as accountable care organizations, provider groups that share risk for patient costs and health, and technology assessment organizations such as clinical practice guideline groups and value assessment bodies all utilize HCEI in their decision-making processes. These additional organizations should be included as examples of appropriate audiences for HCEI.
  
  Additionally, there are many individuals who advise or inform the selection of drugs for population-based health decisions but may not be employees of the health plan or on the pharmacy and therapeutics committee. These individuals, acting in their roles to advise or inform the selection of drugs for population-based health decisions, also need access to HCEI.
   
• Broaden the generally accepted scientific practices recognized as competent and reliable scientific evidence (CARSE); confirm endpoints desired in a value-based payment environment are permissible. There are a number of generally accepted research standards that are in use to ensure that evidence is truthful and non-misleading. These standards were developed in partnership with health plans and researchers and/or endorsed by other professional societies and organizations—the same individuals who will develop and apply HCEI in coverage decisions. FDA should recognize these standards and best practices.
  
  In addition, payers and providers use many different outcomes and sources of information, such as clinical treatments or comparisons to other treatments, when making drug selection or coverage decisions. In today’s value-based environment, payment for payers and providers is increasingly linked to quality of care measures. For this reason, information on treatment performance against quality measures should be considered permissible types of HCEI.
   
• Permit pre-approval exchange of information for both investigational products and indications for approved products. Under the Affordable Care Act and state mandates, health plans are required to submit health plan rates 6-9 months before the start of the next plan year. To inform these rates, health plans begin evaluating plan design and formularies 12-18 months in advance (e.g., a full calendar year prior to open enrollment). In many cases, payers need to take into account therapies and new indications (e.g., use in a different type of cancer) that have could be approved by the FDA during the plan year. Restricting the information that can be shared could result in unpleasant scenarios such as a lack of reimbursement for newly approved treatments for patients, overestimates of use and high member premiums for consumers, unexpected budgetary pressures for health plans and inability to engage in value-based payment models among health systems. Planning information is needed for both new products and new indications for medications.
   
• Ensure disclosures encourage transparent and timely communications without being overly prescriptive. From time to time, additional information, such as research methodology or description details about a study population, is needed to put HCEI in context and to assess its rigor and credibility. NPC recommends that disclosures about this contextual information are based on the generally accepted good practices for the study design and the format of dissemination. Transparency of the study limitations and methods can be optimally provided through study documents (e.g., publication, analysis plan, etc.) rather than within the HCEI communication.
   
• Grant a promotional submission safe harbor to risk-sharing and value-based contracting HCEI discussions. Under risk-sharing agreements and value-based contracting, biopharmaceutical manufacturers and payers agree to link coverage and reimbursement levels to a drug’s effectiveness and/or how frequently it is utilized. Yet current regulations have made it challenging for manufacturers and payers to share the kind of information required to effectively develop these agreements. These types of agreements are based on business to business communications. Contracting discussions should be granted safe harbor from promotional submission requirements to avoid improper disclosure of confidential contract terms between manufacturers and payers.
   
• Clarify differences in criteria and interpretation across multiple FDA guidance documents; and highlight the need for the FDA to lead cross-agency interpretation of off-label communications. There are differences in the language that FDA has used in several guidance documents governing communications. Clarification of the relationship between these guidance documents can reduce ambiguities. Many other government agencies have enforcement oversight of biopharmaceutical communications. The FDA should seek to lead coordination across other agencies with the goal of having other agencies acknowledge the agency’s leadership on these communication issues.

As NPC noted in its comments, “The communication of health care information is now more important than ever. The products available to treat conditions, the ways health care is organized, delivered and reimbursed, and the information sources and analytic processes available have become more sophisticated. Now is the time for regulations and guidance for communication to evolve in parallel.”

NPC has long been engaged in this communications issue, conducting peer-reviewed research 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. More recently, NPC participated in two 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.