For pharma companies, securing favorable coverage for a new asset is far more complicated than it used to be. Indications are more competitive, and the market is full of specialized niche therapies for smaller patient populations. While market access data has never been easy to parse, we’ve seen an evolution in the amount and type of information that’s needed to understand a product’s positioning.
A decade ago, our pharma clients were interested primarily in coverage binaries: is a product covered, or not? Restricted, or not? While tier placement remains important, manufacturers have become increasingly focused on the nuances of policy criteria. Is the product’s coverage generally more restrictive than its FDA label, and what is the rationale behind those restrictions? How many covered lives are impacted by these access barriers?
More recently, however, even this level of granularity has proven insufficient. Payer policies are more layered than in the past, and manufacturers struggle to unearth the relevant details for their products vs. their competitors. It’s often difficult to determine what’s driving payer decision-making: what specific language in this medical policy prompted a coverage shift?
Widespread Need for Market Access Education
As true market access expertise is a rare commodity, many pharma companies turn to data vendors for help with their queries.
For example, clients who rely on MMIT’s Analytics ask us approximately 1,000 clarifying questions each month—a number which quadruples in January, April, July and October, when updates occur. These requests vary widely in nature, from a client who wants confirmation that an anticipated coverage win is now in effect to a client who wants to understand exactly what constitutes a step edit for a particular plan.
As our clients dive deeper into the data points and policy fields of market access, they always want to know more: not just what a therapy’s coverage looks like, but what it means in the context of the indication, channel, launch timing, etc. Often, our clients also want to access information that is not available or supported in the public domain, because the information they do have is hard to interpret.
Let’s look at some of the scenarios that generate the most client questions at MMIT:
Urgent need for change confirmation: Once a therapy is on the market, manufacturers monitor coverage data very carefully, as they want to capitalize on big wins to drive provider interest. They also want to know which restrictions have been placed on their product, especially in comparison with competitors. Monitoring regions and sub-populations in which a brand is disadvantaged helps to inform their contracting strategies and payer conversations.
However, the lag time between when a payer says it’s making a formulary change and the moment this change is reflected in the published data can often take several weeks. In that interim, pharma companies are anxiously awaiting evidence of the change in both their coverage data resource and their pull-though promotional tools. Will the policy update be accurate? Are there any unforeseen issues or delays?
Depending on the disease state, manufacturers might need payer changes confirmed immediately. In rare disease and oncology, for example, time is of the essence, as the manufacturer needs to be able to identify patients and get them started on treatment as soon as possible.
Products unlisted on formularies: More and more payers are choosing not to cover new products on their formularies. This trend is happening in parallel with a separate trend: the gradual increase in both the frequency and duration of new-to-market blocks. According to our data, 56% of all covered lives in the U.S. were impacted by new-to-market blocks last year, up from 51% in 2021.
When a pharma company’s new product is unlisted on a payer’s formulary, it raises a lot of questions that a market access team is usually unable to answer on its own. Without proprietary payer data and unpublished formulary documentation, it’s impossible to research and map a comprehensive benefit design.
Manufacturers are left with lots of questions about how their unlisted product will be covered on a particular channel: will Medicare patients need to go through the medical exception process? What about patients with commercial insurance? Will they be charged a higher copay share?
Market access experts provide clarity regarding how reimbursement will function with an unlisted product. They might find that although a drug is not listed on any formulary, it will be processed as a tier 3 product for certain plans and tier 2 for others. They might offer insights into how a payer handles its unlisted generic drugs vs. its unlisted branded drugs.
Unknown impact of regulatory changes: After the Inflation Reduction Act passed, many of our clients wanted to know how its provisions would impact their business. For example, how would the selection of certain drugs for Medicare price negotiation impact products in the same class? While regulatory questions vary in scope from manufacturer to manufacturer, almost all require additional research.
For example, many of our clients with new products in a protected class—products for which states must provide at least some degree of coverage—are perplexed about how there can be restrictions on their products. They want to know if those restrictions are legal. This information can be found in the data, but parsing it out requires a longer journey of data discovery than most market access teams want to attempt on their own.
Product launches in unfamiliar indications: Moving into a previously unfamiliar market basket often necessitates greater market access expertise. While a manufacturer has likely completed extensive pre-launch research, it’s difficult to understand what’s most important in an unfamiliar space until the product is live and gaining traction.
Market access advisors can help manufacturers better understand what strategies will work for this market basket in particular. Which competitors matter most? Will a national or a regional strategy prove more effective? By conferring with an expert who’s already familiar with the typical coverage and utilization management tactics at play within this indication, manufacturers can get ahead of the data—and begin operating more strategically.
The Art of Simplifying Qualitative and Quantitative Data
For pharma, payer coverage and restriction data is pivotal for launch, but it’s not just for understanding uptake. Manufacturers use this data for many purposes, from creating forecasting models to informing their brand logic and commercialization strategies.
As market access continues to evolve, pharma companies might need to rethink how they interact with coverage data. Instead of pulling information on an as-needed basis, they will likely need a more proactive approach, where relevant data is surfaced for them and pushed their way. For example, they might get a biweekly message about all recent updates in their space, from a competitor’s label expansion to newly published policies or criteria restrictions.
The future of market access research will look more like an ongoing, two-way conversation than a solitary slog through the data. Pharma companies will embrace the vendors that provide consultative, concierge service to help navigate the complexities of market access.
Learn more about MMIT’s Analytics Pro solution and services bundle, which provides bi-weekly market snapshots, office hours, and expedited answers to client queries from a dedicated market access advisor.
