The Situation
A global biopharma company had recently completed clinical trials to obtain approval for a new indication for their existing biologic. Because it was a unique and relatively rare indication and treated a condition that is difficult to recognize, the client requested our help to define a payer strategy that would provide them with brand differentiation as well as profitable payer access. This client’s brand challenges were numerous, however, to accomplish their stated goals we focused our engagement on three main questions.
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What is the current awareness of the unique indication among key payer audiences?
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How, if at all, do key payer audiences see this new indication as distinctly different from other similar but clinically different indications?
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What are the steps required to establish a clinical niche for the indication among key payer audiences?
For the client’s clinical investment to provide an adequate ROI, payers would need to receive and believe a clear and compelling message around:
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Successfully treating a disease with low awareness
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Establishing the need for a distinctly different diagnosis
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Introducing a clinical treatment unique to a brand in a crowded market
The client’s brand benefit needed proper context relative to the competitive agents – primarily to motivate payers but also to create space in a therapeutic category with complex treatments and contracted drug programs.
The Solution
We quickly identified and leveraged engagement opportunities within an industry association to conduct survey research among its members. We developed an extensive survey that captured an array of metrics including: payer attitudes, behaviors, indication awareness, and disease education, as well as created an opportunity to leverage the association programs to achieve market access investigational goals. The survey included respondents from nationally recognized payers, PBMs, and IDNs, including formulary decision-makers within these organizations. The survey was completed by over 70 association members, revealing that only 22% had aided awareness of the indication of interest, and only 21% viewed the indication as distinctly different from a similar but clinically different indication. Through our partnership with the association, we were able to survey the respondents and report back results with recommendations within eight weeks.
The Results
By focusing a strategy on the key market research findings, we were able to help this client advance and develop their payer approach to address unmet market needs. With little to no disease awareness among payers, disease education became a cornerstone of our client’s success. Payers needed to recognize the uniqueness of: first, the patient diagnosis and second, the treatment’s efficacy established by our client’s brand and demonstrated in the clinical trials. With disease awareness and understanding, and our client’s exclusive indication and treatment impact, payers recognized the need to find niche solutions for access and availability for this defined group of patients. Payers listed and detailed the additional disease category in medical policy based on the unique indication and the scientific literature. Win-win formulary positions were created by most payers to establish a unique market for our client’s brand to preserve their formulary access while allowing them to maintain the integrity of their current contracts.
Profitably managing a product through its lifecycle in highly competitive therapeutic markets presents an abundance of challenges. Pharmaceutical executives must be able to address these challenges to maximize their brand’s value even after the patent expires. Continuing to invest in clinical development in a brand’s waning years can be risky and must at minimum provide an opportunity to leverage an untapped or niche market that provides adequate ROI and ensures payer access to pay off. Once the brands in the competitive market basket have demonstrated efficacy profiles and treatment pathways are established in medical policy, many payers and formulary decision-makers may be reluctant to accommodate changes for additional indications, particularly if it's to treat uncommon or obscure disease states.