OBJECTIVES: Develop a pragmatic PPEF that facilitates incorporation of patient input on drug’s value into payer drug coverage decision-making process in the U.S, in the context of RD.

METHODS: Literature review and content analysis encompassing value assessment frameworks (VAFs), ethical decision making (EDM) and corporate social performance (CSP) theories were performed and integrated with qualitative telephone interviews of 24 payer and RD patient stakeholders to contextualize the factors influencing the current payer decision-making process, lack of incorporation of patient input into that process and the ways to improve the process while considering patient input in drug formulary deliberations, and formulate PPEF.

RESULTS: Review of VAF literature revealed suboptimal use of patient preferences and input on drug’s value, and inadequate use of VAFs by payers to aid formulary decisions. Issue-contingent, neurocognitive, and sensemaking EDM models were identified to contextualize the influence of moral issue/intensity/intent/behavior on ethical decisions. Wood’s CSP model and issue-contingent model were identified to contextualize the importance of principles/processes/outcomes, in the context of external stakeholder perceptions/needs, to improve credibility/trust/loyalty and reputation. Payer/patient interviews highlighted these aspects and identified the utility of RD patient’s direct input and ways to solicit and use such input. Correspondingly, PPEF was constructed encompassing following sequential steps: (1) conduct environmental assessment, (2) solicit patient stakeholder input (via formal/informal channels), (3) mandatorily review patient preferences/input, (4) incorporate patient input into formulary review materials via dedicated section, (5) make ethical and robust formulary decisions leveraging all evidence, (6) select/train committee members and standardize process, and (7) engage in transparent stakeholder communication (to publicize patient input channels and committee decisions; assess feedback/satisfaction). PPEF is a cyclical process of assess-engage-act-communicate-assess.

CONCLUSIONS: PPEF could enable payers to formally solicit and consider patient input in their formulary decision-making process, enhance customer perception of payer’s patient-centricity and reputation, influencing credibility, trust and customer retention.