Imagine that it’s senior year of high school, and you show up to chemistry class completely unprepared for the midterm exam—a midterm that’s worth half of your grade. Instead of studying the periodic table, you spent the previous evening rehearsing your choir solo. And while extracurriculars are important, messing up a few lyrics during the fall recital won’t have the same ramifications on your GPA and college opportunities as bombing that chemistry test.
Luckily, we’re far removed from the days of overlooked midterms, yet we can’t help but think of a similar situation—albeit one with much higher stakes—playing out over and over again in the pharma industry. As manufacturers work to develop lifesaving drugs, they aren’t doing their homework to ensure that patients will be able to access their drugs at launch. Instead, they’re focusing on aspects of commercialization that, while important, won’t matter much if their therapy can’t make it into the hands of patients in the first place. And the repercussions—millions in lost revenue, lack of patient access to much-needed treatment, etc.—are far more devastating than a low test score.
This issue is especially prevalent among pharma companies launching into already crowded markets. Take the competitive overactive bladder (OAB) space: It’s estimated that more than 23% of adults in the U.S. suffer from OAB—an opportunity that did not go unnoticed by pharma. Now, there are roughly a dozen products currently indicated to treat overactive bladder. However, we continue to see manufacturers enter this space only to find themselves fighting an uphill battle against already established products, many of which are helmed by major players with recognizable brands and significant resources.
Moreover, pharma companies continue to come under fire from payers, who, in an effort to curtail continuously rising healthcare costs, are placing increased scrutiny on a drug’s cost-effectiveness and overall clinical value. In today’s landscape, if you have a novel product—even a truly great one—but are entering a crowded market, clinical benefits alone aren’t enough to ensure coverage.
What do manufacturers need to know?
Pharma companies can no longer afford to show up for the exam without having cracked open the textbook. Success hinges on preparation; companies that launch products without a thorough understanding of the market they’re entering and the historical barriers to access will fail to get their drug to the patients who need it, no matter how promising their product profile.
To succeed at launch, pharma companies need a data-driven market access strategy—one that’s built out during the research and development phase through to post-launch. Ideally, a market access strategy should be rolled out after Phase II or Phase III trial results are available.
Here’s what manufacturers need to know ahead of and during launch, and why it matters:
- The coverage landscape:In 2019, 45% of commercial payers had policies that did not cover newly approved drugs at launch, according to Managed Markets Insight & Technology (MMIT) data. To successfully launch a product into a crowded space, understanding how payers have covered competitor products is perhaps the most important element of success. Do payers already have a preferred drug on the market? What kind of restrictions (prior authorization, step therapies, etc.) are in place for these competitors? What are payers basing their coverage decisions on? What do the policies look like at large national plans and PBMsWhen manufacturers gather this information at the outset, they can use it to build out more effective commercial strategies. For example, these insights can be used to identify payers that are likely to restrict access based on past behavior. Segmenting these payers will allow commercial teams to target them early—ideally 12 to 18 months before launch—and start having access discussions. As a result, sales reps will be able to focus their energy on these critical accounts instead of spinning their wheels in the field.Furthermore, tracking changes in the coverage landscape at launch—for your product and your competitors’ products—will enable sales teams to fine-tune their strategies as they go and pivot when needed to ensure optimal coverage.
- Existing pricing and contracting:Learning about how competitor products are priced and the existing contracting activity within your therapeutic category is key for appropriately forecasting—and meeting—your launch goals. Manufacturers need to know whether their drug’s price is more or less than therapies already on the market, what kind of rebates and discounts are in place, whether there’s a specialty threshold, if pricing impacted the uptake of competitor brands, etc. Furthermore, understanding if and how payers are implementing utilization management techniques to manage access to similar brands is key for setting expectations at launch.Once armed with that info, manufacturers can use it to test various pricing and contracting scenarios in a simulated pharmacy and therapeutics (P&T) session, which can shed light on payers’ perception of value, how health plans might evaluate costs, and what level of rebating may be necessary. Moreover, manufacturers can look into options such as value-based contracting to determine if an alternative approach is needed to help influence coverage decision making.
- Provider behavior:Knowing providers’ preferences within a therapeutic area and which factors lead them to write scripts for existing products is a valuable part of a well-thought-out launch strategy. Are they prescribing a competitor drug because of its efficacy data? Or because of a health plan’s coverage policy? Do physicians prefer surgical options within this therapeutic area? Do they have a preference for oral products vs. injections?The earlier that this information is uncovered, the better equipped manufacturers are to price, contract, and frame their messaging appropriately. This will lead to more productive pre-commercialization conversations with payers to educate them on the clinical benefits of a product and for manufacturers to understand how their product will likely be received. Similarly, insight into provider behavior can help manufacturers determine if certain strategies, like patient assistance programs, would influence physicians’ decision making and, therefore, lead to better coverage.
While an A+ product launch is reliant on many factors, leveraging deep competitive intelligence and understanding potential barriers to access will allow pharma companies to better position their products at launch. But data alone isn’t enough. Manufacturers need to incorporate it into their go-to-market strategies early on in order to succeed within a crowded market and, ultimately, help patients get timelier access to therapy.
When it comes to ensuring long-term, repeatable launch success, will you barely squeak by with a passing grade, or are you prepared to set the curve?
This article was originally published in the March 2022 issue of Life Science Leader.