OBJECTIVES

To understand how recent legislation and guidance, including the 21^st Century Cures Act-Section 3037 and FDA Draft Guidance, has impacted the proactive communication of healthcare economic information (HCEI) and to assess the importance of preapproval information exchange without HCEI (PIE) and with HCEI (PIE/HCEI) from the payer’s perspective.

METHODS

Payers (N=44) were recruited via a web-based platform and completed a 28-item online survey between 12/22/17-1/5/18.

RESULTS

The majority of respondents (68%) represented managed care organizations. Post-approval proactive HCEI was rated as somewhat or very important for decision-making (84%); respondents’ perceptions about the importance of PIE/HCEI was more varied (39% very/extremely important; 30% not very/not at all important). More than half (64%) perceived a gap between available and needed post-approval HCEI. A gap between available and needed PIE was noted by 45% of respondents. The majority of payers (80%) reported that they sometimes/rarely received HCEI communications; receipt of PIE was also uncommon (64% rarely or never). An increase in HCEI and PIE communication over the past year was noted by 43% and 39% of respondents, respectively. Regarding type of PIE, payers considered indication sought (82%), clinical trial results (84%), anticipated timeline for FDA approval (80%), and product pricing (86%) as very or extremely important. Almost all (95%) respondents would prefer to receive PIE within 1 year of the product’s anticipated approval. Further, 47% of respondents would most prefer that a medical science liaison communicate PIE.

CONCLUSIONS

New legislation and regulations pertaining to the proactive communication of HCEI and PIE may have prompted an increase in such communication by manufacturers in the past year. More frequent and relevant communications between manufacturers and population health decision makers may be helpful to improve formulary decision making and ultimately treatment decisions for patients in need of therapy.