Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.

Issued by

National Cancer Institute (NCI)

Purpose

Through this Notice of Special Interest (NOSI), the National Cancer Institute (NCI) announces the availability of financial support through administrative supplements to medical device small businesses interested in participating in the Early Payor Feedback Program during the Q-submission meeting with the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). The funds are intended to cover expenses associated with the development of documentation required to engage with payor organizations and the FDA during the Q-submission meeting. 

Background

Early engagement with key stakeholders, including patients, clinicians, regulators, and payors, is essential for the commercial success of a medical device. Notably, reimbursement, particularly payor coverage determinations, is sometimes overlooked by companies. Even if a medical device successfully passes the regulatory process, poor or no reimbursement coverage can hinder its integration into medical practice. Therefore, it is vital that medical device companies integrate and develop regulatory, clinical research, and reimbursement strategies in parallel during product development to ensure successful market access and adoption.
Following the FDA’s approval, public and private payor organizations that pay for healthcare and professionals who provide healthcare (providers) decide whether to cover, pay for, and use the medical device. However, the data provided by the medical device manufacturers to the FDA is often insufficient to satisfy the requirements of payors for positive coverage determinations. In many cases, the amount and rigor of clinical data required for a favorable coverage determination exceed the requirements for regulatory approval. In addition to safety and efficacy or analytical and clinical performance (for in vitro diagnostics) data, payor organizations require information on risk-benefit analysis, clinical outcomes, and cost-effectiveness to support coverage decisions. Medical device companies often focus their pivotal clinical trials on satisfying the FDA's requirements and neglect the evidentiary needs of payors that support reimbursement, resulting in a delay in coverage, payment, and patient access to the medical devices following FDA approval. To address this issue, the FDA’s Center for Devices and Radiological Health (CDRH) Payor Communication Task Force has established the Early Payor Feedback Program (https://www.fda.gov/about-fda/cdrh-innovation/medical-device-coverage-initiatives-connecting-payors-payor-communication-task-force). The program is intended to facilitate early communication between manufacturers and payors to potentially shorten the time from FDA approval to coverage decisions, thereby improving patient access to novel medical devices.

The Early Payor Feedback Program is a voluntary program that offers a unique platform for medical device manufacturers to interact with payor organizations early in the product development process to obtain payor input on pivotal clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. These interactions with payor organizations can occur during the Q-submission meeting with the FDA or in an independent meeting. By engaging with the FDA and payor organizations earlier in the product development process, medical device manufacturers can design their pivotal clinical trials to capture data that meets both regulatory and reimbursement requirements. This approach can significantly improve the chances of obtaining regulatory and reimbursement approvals efficiently, ultimately enabling patients to access safe, innovative, and effective medical devices.

Payor organizations include government payors, such as the Centers for Medicare & Medicaid Services (CMS), private health plans, health technology assessment groups, and others that provide input into coverage, procurement, and reimbursement decisions. For more information on the list of payor organizations participating in the Early Payor Feedback Program, visit https://www.fda.gov/about-fda/cdrh-innovation/medical-device-coverage-initiatives-connecting-payors-payor-communication-task-force.

Manufacturers developing novel devices, which may be first-of-a-kind PMAs or De Novo, including breakthrough-designated devices that do have clear coverage pathways, are eligible to apply for the Early Payor Feedback Program.

Medical device manufacturers interested in participating in the Early Payor Feedback Program must submit a request to the FDA to invite one or more payor organizations to attend the FDA Q-submission meeting. For information on submission instructions, visit https://www.fda.gov/about-fda/cdrh-innovation/medical-device-coverage-initiatives-connecting-payors-payor-communication-task-force. It is recommended that companies seeking payor feedback during the FDA Q-submission meeting should submit their Early Payor Feedback Program request before submitting the Q-submission to CDRH. Once the request is received, the FDA will work with the selected payor organization(s) to confirm their interest and availability. The Q-submission meeting will include both the FDA and any selected and interested payor organizations, allowing both parties to provide feedback on clinical trial design and data-gathering plans. Such feedback can significantly benefit companies in designing an effective clinical trial protocol that meets all requirements for successful market access and adoption.

NOTE: The Early Payor Feedback Program is a voluntary opportunity for medical device manufacturers and payor organizations. A medical device manufacturer's decision to participate or not participate in the Early Payor Feedback Program will not alter the regulatory and evidentiary standards the FDA uses for decision-making.

For questions or additional information on the Early Payor Feedback Program, email: [email protected]
 

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date: Applications to this NOSI can be submitted on a rolling basis after the first available due date, July 1, 2024. This administrative supplement program is a two-year pilot that will end on June 30, 2026. Please note that the current parent administrative supplement funding opportunity that this NOSI relates to (PA-20-272) expires on January 24, 2025. This NOSI will relate to the reissue of the parent supplement funding opportunity after January 24, 2025, until July 1st, 2

• 026.
• For funding consideration, applicants must include “NOT-CA-24-050” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Applicants should begin the supplement application abstract by stating, “This application is being submitted in response to the Notice of Special Interest (NOSI) identified as NOT-CA-24-050.”
• Eligibility: 
  
  • The applicant must hold an active NCI SBIR OR STTR Phase II grant for developing technologies regulated by CDRH.
  • The parent award must be active and not be in no-cost extension at the time of application. 
  • At the time of the supplement application, grantees must have at least six months remaining in their parent award.
  • Preference will be given to administrative supplement applications where a Q-submission meeting with FDA/CDRH was proposed in the parent grant award. 
  •  
• Project Period: The project period requested should be adequate to complete the proposed supplemental work but should not exceed one year from the proposed start date of the supplement.
• Budget: Individual requests can be no more than $50,000 in direct costs. The funds can be used to obtain support from Contract Research Organizations or regulatory or reimbursement consultants to prepare the documentation needed to support a Q-submission meeting request with the FDA and payors. Label the requested cost  in the ‘F. Other direct costs’ budget category on one of the lines from 8-17.
• Page Limit: The Research Strategy section of the application is limited to 6 pages. Applicants must incorporate all the following elements in their Research Strategy:
  • Brief description summarizing the merit of the proposed work, including:
    • Significance
    • Value proposition
    • Commercial potential
    • Innovation
  • Milestones achieved and progress made during the current award period.
  • Address the need for the supplement and how the supplement will fit into the commercial development plan.
    • Detailed scope of work, including goals, tasks, milestones, and timeline. 
  • Discuss briefly how the proposed supplement addresses the goals of this NOSI listed below:
    • Creating a combined regulatory and reimbursement strategy early in the product development process.
    • Understanding the requirements of both payors and the FDA to design clinical trials that are efficient and effective in achieving positive outcomes.
    • Accelerating the development of the product towards commercialization more efficiently.

Note: All applicants are strongly encouraged to discuss their Administrative Supplement request in advance with the Program Director listed on the parent award's ‘Notice of Award’. The purpose is to receive pre-submission feedback on the scope of the proposed supplemental work, and to assess its suitability with this program.

Administrative Evaluation Criteria 

NCI SBIR program staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed work. Additionally, program staff will evaluate applications using the following factors:

• The relevance of the proposed activities to the parent grant and original work scope.
• Satisfactory progress toward achieving the aims of the parent grant, as appropriate to the project's current stage.
• Impact of the proposed work to advance the technology forward to meet the next key development milestones.
• An appropriate and well-described supplement plan to accomplish the goals of the Early Payor Feedback Program within the proposed time frame. 

Inquiries

Please direct all inquiries to:

Swamy Tripurani, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5867
Email: [email protected]

Xiang-Jian Lou, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5226
Email: [email protected]