One of my favorite childhood memories was watching space shuttle launches from NASA Kennedy Space Center. It was inspiring to see the astronauts prepping for their journey, the countdown and of course the amazing launch into space!
But it got me thinking… although launch is the most exciting part,
what key preparation steps were required to ensure success?
From what I learned, the process of engagement starts in advance along with extensive testing, as every launch is unique and requires team communication, engagement, and preparation to ensure optimal lift-off.
This main concept applies to the opportunity the pharmaceutical industry has now to provide health care economic information (HCEI) to payers in the preapproval setting. Payers want early information for budget planning and formulary coverage decisions which will accelerate policy development for improving patient access to innovative new health therapies and technologies.
Recently AESARA published research based on phone interviews with ten US managed care representatives, all respondents noted they would like to see “early dossiers” and the majority reported an optimal range from 3 to 9 months prior to a new product’s PDUFA to review preapproval information2. Other research has corroborated similar findings and cited that population health decision makers have three key drivers for prioritizing preapproval information discussions: (a) size of target patient population, (b) magnitude of the new budget impact, and (c) expected speed of regulatory approval3.
Based on this access, focused field medical and/or commercial teams from pharmaceutical/biotech manufacturers can and should be sharing their new product economic budget impact or cost-effectiveness models. From my experience being in industry – this often does NOT happen until primarily at or after launch. Why? There are several reasons:
New product pricing is not known or disclosed until after approval.
The incorporation of simple scenario analyses with different price bands or assumptions can help address this.
Product registration remains paramount and research to generate HCEI is not routinely collected or prioritized.
HEOR researchers should be involved early and integrated into product development to identify appropriate endpoints for clinical trials, conduct real world studies, and develop economic models to project total costs of care.
Internal review committees need to understand the significance of HCEI 502(a) materials for access and reimbursement needs vs. those related to health care provider promotional requirements.
This presents an opportunity to leverage external HCEI experts and resources to create an internal approach to HCEI communication based on the FDA Payer Guidance to bridge the gap between approval and reimbursement.4
From my experiences in field medical/HEOR, when sharing HCEI prior to approval improvements were seen in forecasting, reducing uncertainties and most importantly allowing an opportunity to “pressure-test” and gather feedback. Gathering early insights to share with HEOR and access teams allowed for better adoption and customization to meet payer needs and to ensure a successful launch and excitement similar to a spaceship lift-off!
Do you want to help accelerate formulary coverage decisions to improve patient access to new therapies? Do you know what you want to communicate but face more internal operational (development and review) challenges?
1. Kennedy Space Center, Mission and Shuttle Process
2. Hogue S et al. Unmet Needs Exist in Payer Communications – Are Digital Solutions The Answer? Poster Presentation at ISPOR Annual Meeting 2019; NO, LA.
3. Brixner D et al. “Preapproval Information Exchange” JMCP 25(2); February 2019
4. Pham SV. “How Important is FDA’s Payer Communication Guidance to Industry?” DIA September 2018. Accessed online September 3, 2019
Please feel free to share your comments below on your experiences of successes, challenges, or questions in abilities to share HCEI in preapproval information exchange with payers.
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