![]() ![]() We recommend adding a row that includes describes the dossier ability to communicate the value of a product.We recommend the Format use consistent terminology with the FDA guidance documents. Further, as noted in footnote 57, the final FDA guidance does not to supersede the draft guidance for Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices when payors make unsolicited requests to firms. Proactive and reactive communications are not defined elsewhere in AMCP Format nor the FDA final guidance. We recommend replacing the terms proactive and reactive communication with solicited and unsolicited requests to ensure consistency with the FDA guidance.To aid this, we suggest these modifications or clarifications: ![]() Clarity in the descriptions will help to inform users and reviewers reviewing at-a-glance descriptions. ![]() NPC appreciates the comparisons outlined in Table 1 describing pre-approval information dossiers, post-approval dossiers, and new indication dossiers. In addition, are the terms pre-approval information dossier, post-approval dossier, and new indication dossier helpful in being able to convey this information? Do these definitions properly convey the current state of communications based upon the FDA guidance? In particular, please provide feedback on whether Table 1 is helpful in conveying requirements in a concise manner. This section also outlines the communication process between manufacturers and HCDMS. Question 2: General Definitions and Considerations: AMCP has updated definitions upon new FDA guidance. Clarity in the information ultimately considered (or disregarded) in the budgeting, forecasting, and coverage determinations can improve the evidence developed and communicated. Developing efficient and high-quality evidence to meet the varying needs of diverse stakeholders, including health care decision-makers is a time and resource-intense activity. We recommend additional work to ensure the process facilitates clear, transparent, bi-directional communication rather than a uni-directional submission of information. New and innovative medicines bring value to patients and our health system. NPC applauds the Format’s recognition of the need for bi-directional exchange of timely, quality, and relevant clinical and economic information between biopharmaceutical manufacturers and health care decision-makers. Question 1: Please provide feedback on whether the role of the Format is accurately conveyed based on current Food and Drug Administration guidance and the current state of communications between manufacturers and payers. Ensure consistency with the FDA Final Guidance.Highlight the need to include caveats regarding the availability of evidence at various points in a product’s lifecycle, and.Underscore the importance of bi-directional rather than unidirectional feedback,.Our comments address the questions outlined by AMCP and emphasize three issues: While the 2018 FDA final guidance provides an important step forward to modernize health care communications, parallel efforts to operationalize the pathways to exchange of high-quality and robust information between biopharmaceutical manufacturers and health care decisionmakers determining coverage are needed. As a health policy research organization dedicated to the advancement of good evidence and science, we are pleased to see the Format’s revision and alignment with the 2018 Food and Drug Administration (FDA) Guidance Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities. The National Pharmaceutical Council (NPC) commends the Academy of Managed Care Pharmacy (AMCP) and the Format Executive Committee on the revised AMCP Format for Formulary Submissions Version 4.1. Re: AMCP Format for Formulary Submission Version 4.1: Call for Comments Individual Treatment Effects & Personalized Access.Patient Centered Formulary & Benefit Design.Rutgers-NPC 2023 Health Policy & Communications Fellowship. ![]()
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