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.
Recommended Actions
- Establish internal review process to ensure HCEI is truthful, non-misleading and based on competent and reliable scientific evidence
- Develop templates for HCEI communications that include all required elements:
- Study design and methodology
- Limitations and generalizability
- Risk information
- Required statements and disclosures
- Create process to track and provide follow-up information for communications about unapproved products/uses
- Train relevant staff on requirements for HCEI communications and appropriate audience
- Maintain documentation of scientific evidence supporting HCEI claims
- Implement process to review and update HCEI communications when new information becomes available
- Establish procedure to ensure appropriate disclosures of financial/affiliation biases
- Create system to track and respond to payor requests for additional information
- Develop process to ensure consistency between HCEI communications and FDA-required labeling
- 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
- HCEI must be based on competent and reliable scientific evidence
- Must include study design and methodology information
- Must disclose limitations and generalizability of analyses
- Must include sensitivity analyses
- Must disclose financial/affiliation biases
- For unapproved products/uses:
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
- Device Labeling Requirements and Content for Premarket Approval Applications
Related references and norms
- 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
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