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Health Care Economic Information Communications to Payors for Medical Devices

This guidance addresses how medical device manufacturers can communicate health care economic information (HCEI) to payors, formulary committees, and similar entities. It covers both approved/cleared devices and unapproved devices/uses. The guidance aims to help manufacturers provide truthful, non-misleading information while enabling payors to make informed coverage and reimbursement decisions.

  1. Establish internal review process to ensure HCEI is truthful, non-misleading and based on competent and reliable scientific evidence
  2. Develop templates for HCEI communications that include all required elements:
    • Study design and methodology
    • Limitations and generalizability
    • Risk information
    • Required statements and disclosures
  3. Create process to track and provide follow-up information for communications about unapproved products/uses
  4. Train relevant staff on requirements for HCEI communications and appropriate audience
  5. Maintain documentation of scientific evidence supporting HCEI claims
  6. Implement process to review and update HCEI communications when new information becomes available
  7. Establish procedure to ensure appropriate disclosures of financial/affiliation biases
  8. Create system to track and respond to payor requests for additional information
  9. Develop process to ensure consistency between HCEI communications and FDA-required labeling
  10. Maintain records of all HCEI communications for reference

Key Considerations

Labelling

  • Must include FDA-required labeling for approved/cleared devices
  • Must include clear statement if product/use is not approved/cleared
  • Must include prominent statement disclosing approved/cleared indications when discussing unapproved uses

Safety

  • Must disclose important risk information associated with approved use
  • Must disclose additional risk information related to clinical assumptions that vary from FDA-required labeling

Other considerations

  • ISPOR: International Society for Pharmacoeconomic and Outcomes Research guidelines
  • ISPE: International Society for Pharmacoepidemiology guidelines
  • PCORI: Patient-Centered Outcomes Research Institute guidelines
  • AHRQ: Agency for Healthcare Research and Quality guidelines

Original guidance

  • Health Care Economic Information Communications to Payors for Medical Devices
  • HTML / PDF
  • Issue date: 2018-06-13
  • Last changed date: 2024-11-12
  • Status: FINAL
  • Official FDA topics: Medical Devices, Administrative / Procedural, Drugs, Biologics
  • ReguVirta summary file ID: 1beb00d610cbfedc031fa8881b4020cc
This post is licensed under CC BY 4.0 by the author.