This blog post is sponsored by Xcenda, part of AmerisourceBergen.
In the first of a two-part series on early engagement with payers, Dr. Patti Peeples, CEO of HealthEconomics.Com, sat down with Allen Lising, Managing Director of FormularyDecisions at Xcenda to discuss how this innovative platform is used to facilitate the early and ongoing exchange of information between qualified, active payers and life sciences companies.
This blog addresses the challenge of payers’ growing need for pre-approval information, now further hindered by the COVID-19 pandemic, and how Xcenda’s FormularyDecisions can be used early in drug development to engage payers continually through the development cycle for more successful market access.
Stay tuned for a companion blog featuring a case study of a biotechnology company launching a product in a new therapeutic space, and how they used FormularyDecisions for competitive intelligence, brand visibility, and a mutually beneficial exchange of information with payers, to better shape their product story.
Dr. Peeples: The COVID-19 pandemic has prompted life sciences organizations to quickly pivot their payer strategic approach and tactical implementation. Engaging payers has never been more essential and their demand for information early in drug development continues to increase. What insights has Xcenda uncovered to help manufacturers understand what payers want, when they want it, and how can it be delivered in this new environment?
A. Lising: Even before COVID, we were seeing increased desire by payers to get clinical and economic product information earlier in the approval process. The FDA has provided guidance for this dialogue (referred to as pre-approval information exchange – PIE), allowing the communication of clinical and health care economic information (HCEI) on therapies in development between U.S. population health decision-makers and drug manufacturers before regulatory approval. The impact of the pandemic seems to have escalated that need as they seek information that facilitates earlier planning, budgeting, and forecasting.
We’ve identified this growing need through our associates’ interactions with payers and biopharma, and it is underscored by a recent survey of Xcenda’s proprietary Managed Care Network. Results from the survey showed that about one in three national payers request product pricing information at least one year in advance of anticipated approval, and 40% request patient utilization projections more than 12 months pre-approval. Given this opportunity, the next challenge is facilitating this pre-approval information exchange.
Dr. Peeples: What information are payers seeking in the pre-approval period?
A. Lising: The majority of payers need more information regarding anticipated approval timeline, incidence and prevalence, clinical study outcomes, and expected range for product price, among others. They desire this as much as 18-24 months before regulatory approval2. Seven out of 10 payers believe that closing the PIE gap would result in improved decision-making3.
Dr. Peeples: Looking at the other side of the coin, what information are manufacturers seeking from payers in the pre-approval stage?
A. Lising: While the needs vary by company, product, and strength of manufacturer-payer relationship, most manufacturers are looking for insights related to unmet treatment needs, relevant comparators to consider in trial design, formulary design and access restrictions for current treatments, and evidence needed by payers to secure favorable formulary position. Discussions also center around clinical and real-world study design, patient perspectives on their product and that of competitors, importance of quality metrics, and economic impact. They are seeking to find agreement on a value story and understand where interests align with healthcare decision-makers.
Dr. Peeples: You’ve made a compelling case that early dialogue is important to both the manufacturer and the payer. What solutions exist to facilitate this two-way information exchange, particularly during this time when face-to-face meetings are so challenging?
A. Lising: FormularyDecisions has been the go-to solution that provides payers and manufacturers with the evidence and information they want, when they want it.
FormularyDecisions is a secure, online platform that facilitates the bi-directional exchange of information between life sciences companies and over 2,100 qualified, active payers in a decision-making role. From pre-approval to post-launch, subscribers can gain exclusive insights into what payers think of their product, maximize brand visibility, and utilize feedback to better inform market access strategies.
FormularyDecisions fills an important need in this COVID-challenged environment and has seen exponential growth over these last several months. It allows manufacturers, regardless of the stage of product development or the size of their managed markets team, to engage critical decision-makers virtually, thus overcoming the hurdle of limited face-to-face interaction. In this time of uncertainty, this is a much-needed solution for both the manufacturer and the payer.
Dr. Peeples: Specifically what information is available to a manufacturer who subscribes to FormularyDecisions to inform their market access strategies during early drug development?
A. Lising: Both pharma and payers work in a rapidly evolving landscape. FormularyDecisions offers a solution that provides ongoing interactivity over the drug development life cycle. At any stage from Phase 2 through commercialization, pharma delivers evidence-based product information to payers, and payers can provide feedback on that information. The platform allows us to gather payer insights through surveys, polls, and analytics that reflect what they are viewing, their perceptions on the sponsor product relative to competitors, as well as other insights. Key roles that benefit from access to these critical insights include Market Access, Health Economics & Outcomes Research (HEOR), Medical Affairs, Clinical Development and Product Marketing.
Insights that are accessible via FormularyDecisions include:
- Key factors driving preferred reimbursement
- Information gaps payers perceive in the manufacturer’s evidence
- Which product evidence sources are accessed most by payers
- Which payer groups reviewed product evidence, including competitor evidence
- Payer value ratings for your product and competitor products
- Analytics on payer usage of manufacturer proactive and reactive materials and platform-generated evidence
- Institute for Clinical and Economic Review (ICER) report access, and importance of value frameworks in payer reviews
Dr. Peeples: What options are available to subscribing manufacturers?
A. Lising: Three major components of FormularyDecisions that are available to full subscribers include:
|Manufacturer Resource Center: Provide supporting documents in a continuous fashion to entire FormularyDecisions community of 2,100 active payers.|
|AMCP eDossiers: Payers have immediate access to product dossiers with ability to review the document and provide feedback. Manufacturers have ability to view dossier usage analytics, including length of time payer spends on various sections and receive feedback on strength of value story.|
|Landscape Insights: Provides visually impactful dashboard metrics on payer activity, including product perception and how it ranks versus competitors.|
Dr. Peeples: What resources are available in FormularyDecisions to help a smaller manufacturer?
A. Lising: A common challenge for manufacturers, particularly those who are small to mid-size, is a lack of payer-facing associates to engage with important payer stakeholders. FormularyDecisions removes this barrier. Regardless of manufacturer size, payer engagement – actually payer two-way information exchange – is at one’s fingertips.
In the next blog, we will share a case study of how a small biotech gained valuable insights, which they used to their advantage, and established a level of access and information previously only available to larger teams and organizations.
Dr. Peeples: How can someone find out more about FormularyDecisions?
Get your product in front of 2,100 payers.
Explore FormularyDecisions, the revolutionary
online platform where you can:
- Continually engage with and get real-time feedback from the largest active online U. S. payer community;
- Increase your level of payer engagement regardless of manufacturer size or scope of managed markets team;
- Gain product, therapeutic area, and competitor insights;
- Improve product visibility throughout the development life cycle;
- Understand how payers are using product evidentiary information to refine your value story, thus improving success of market access; and,
- Make effective, evidence-based decisions to improve strategic plans.
1No author listed. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval. J Manag Care Spec Pharm. 2017 Jan;23(1):105-112. doi: 10.18553/jmcp.2016.16366.
2Mitchell M, Fazio L, Duhig AM. Effectively Communicating Pipeline Information to Drive Payers’ Attention. Xcenda AmerisourceBergen slide presentation available at https://www.xcenda.com/effectively-communicating-pipeline-information. Accessed from the internet on August 18, 2020.
3No author listed. Managed Care Trends Report: Healthcare Economic Information (HCEI) and Pre-Approval Information Exchange (PIE) Payer Survey. 2020 (Spring). Xcenda AmerisourceBergen slide presentation available by request.