Sean and Carolyn argue that planning for a successful drug launch must begin early—often well before Phase III. In this article, they present a six-step framework to help manufacturers align clinical development with payer expectations, patient needs, and real-world access dynamics.
To learn more, view their latest webinar: Meet the Expert: Developing Your Commercial Strategy in Phases II-III.
Read on for Sean and Carolyn’s insights.
Starting with the End in Mind: How Pharma Can Build a Smarter Path to Commercialization
By Sean Wagner, VP of Client Partnerships, MMIT and Carolyn Zele, Advisor, Solution Consulting, MMIT
Today, one-third of pharma companies start market access planning in Phase I, and 80% start by Phase III. Manufacturers were once reluctant to invest in market research during development, when an asset’s future is uncertain. But the questions raised by early access planning are pivotal for your business, as their answers will drive decisions about your asset’s viability.
In Phases II and III, manufacturers should follow these steps to lay the groundwork for commercialization:
1) Develop Your Value Story: First, think about how your trials will feed market access. Is progression-free survival a key indicator for payers? Should you collect other patient outcomes data in Phase IIB? What are common treatment complaints? Is cost avoidance a potential benefit to payers?
Answering such questions requires research on what matters most to payers and HCPs. In turn, addressing their concerns in your trial design enables the collection of essential outcomes data to fuel your value story. One of our most strategic clients began developing its PIE deck at the start of Phase II, which helped it identify the precise endpoints required for creating a compelling value story.
2) Map the Patient Journey: In early clinical trials, manufacturers should focus on epidemiology. How large is your potential patient population? Where are these patients located, and what are their unmet needs? By Phase II, your team should revisit how a patient is diagnosed and treated. How can you address diagnostic roadblocks and treatment delays?
For uncommon disease states, delays are often caused by a lack of physician knowledge about symptoms. If your product requires testing that is not routinely ordered, you’ll need to educate physicians about when testing is indicated—and ensure these tests are covered. By understanding what access looks like today, your team can better understand your product’s differentiation.
3) Leverage Analogs: In early development, strategic manufacturers analyze analogs for their drug. By selecting appropriate analogs with similar differentiators, your team can study market reactions. What did their launch curve look like, and did they meet access projections? How restrictive were payers for analogs within your indication?
Historic fly-on-the-wall research can also show how payers reacted to developers’ PIE presentations. Which data points did they most want to see? Make your own product’s value story stickier by knowing exactly which elements mattered to payers in the past.
4) Conduct Pricing Studies: Identifying the best price for a new asset requires multiple pricing studies. By analyzing the correlation between analog access and pricing, your team can settle on a price to test with payers and institutions. For a minimal investment, you can even preview reactions from national and regional payers and PBMs.
If payer pushback indicates this price will result in restrictive prior authorizations, a pricing study can help you find a price band that will not require contracting to offset restrictions. Pricing analysis goes hand-in-hand with value proposition planning, as it can reveal which Phase III outcomes actually warrant a higher price point. By the time your first Phase II study concludes, you should already know which price makes sense for the market.
5) Segment Payers and Providers: Segmentation is critical, as no manufacturer has the bandwidth to create 700+ individual payer strategies. Prioritize outreach by bucketing payers into early and late adopter categories, selecting from hundreds of parameters to better understand payers’ relative size, impact, restrictiveness, and speed. Which payers have new-to-market blocks, and which will make immediate decisions?
Provider segmentation is also important, as the needs of IDN network providers are different from those in independent networks. How are physicians incentivized or penalized for their prescription decisions?
6) Create a Distribution Strategy: Manufacturers often use the same distribution channels and sites of care their competitors use, because they are a known entity for all involved. Do specific specialty pharmacies need to be part of your network? If your product disrupts the current paradigm, you’ll need to ensure that all players are prepared to facilitate product flow.
For example, if you’re launching a physician-administered product in a market dominated by retail pharmacy distribution, make sure that neither payers nor pharmacies are working against you. Do payers have policies in place to restrict buy-and-bill? What is the specialty pharmacies’ role in the process of fulfillment and billing? Ensuring patient access may involve aligning incentives to minimize disruptions.
While every launch is different, it’s never too early for manufacturers to begin preparing for commercialization. With a few targeted investments in Phases II and III, your team can reverse-engineer a successful go-to-market plan for your new asset.
To hear more insights on early market access planning from Sean and Carolyn, watch their webinar Meet the Expert: Developing Your Commercial Strategy in Phases II-III.
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