Drugmakers Should Engage Early and Often With Payers, Patients Before Launch

Having a successful product launch and securing payer coverage come well before FDA approval of a drug. But some drugmakers face an uphill battle after launch because they fail to engage with both payers and patients in a timely fashion, as well as provide them with truly useful information.

To engage payers effectively, pharma companies should individualize their value propositions with a focus on what’s important to each one rather than a one-size-fits-all tactic, says Dominic Galante, M.D., chief medical officer at Precision AQ. He also recommends that manufacturers think beyond traditional pricing models and “adopt flexible pricing strategies and innovative reimbursement models that align with payer budgets and value-based care initiatives.”

One of the biggest mistakes manufacturers can make is forgoing collaboration among health economics and outcomes research (HEOR), market access, clinical and regulatory teams, and instead operating in silos. “The world is changing fast,” particularly with shortened product lifecycles because of the Inflation Reduction Act (IRA), says Mike Ciarametaro, managing director in policy at Avalere. Companies must understand that there is a limited window of opportunity and “proactively align clinical development with payer expectations — ensuring their trial design reflects real-world outcomes and economic value from the start.”

To have effective clinical trials, they should engage payers early to understand what kind of information they need, recommends Mina Allo, Pharm.D., managing director in market access at Avalere. “I’ve seen companies come to payers with clinical trial data that’s scientifically rigorous but misses the mark on what matters for coverage decisions, such as economic impact at the PMPM [per member per month] and total cost of care levels, real-world effectiveness and line of business implications.”

Avalere’s Jessica Cortez, principal in market access, agrees. “Payers are looking for clear, actionable evidence that helps them make coverage decisions that balance cost, clinical benefit and patient need.” And rather than simply presenting data, manufacturers should “educate payers on trade-offs, acknowledge uncertainties and work collaboratively to shape a sustainable access strategy.”

In order to integrate payer expectations into clinical trial design to optimize reimbursement success, both Ciarametaro and Allo recommend starting before pivotal trials are even designed. “Everything up to this point is about proving the molecule’s viability, but once you move into pivotal trials, those endpoints are what will be on the label and ultimately need to resonate with payers,” explains Ciarametaro.

Ongoing communication with payers is important and can be achieved by establishing advisory boards or panels, says Galante. Allo adds that “having a solid understanding of the competitive dynamics before, during and after launch will also be imperative to understand the totality of evidence and marketplace dynamics for the product.”

Trials also should reflect current clinical guidelines and standards of care, says Galante. They also should be flexible enough to “allow for modifications based on interim results, making the trial more efficient and relevant to payer needs.”

Perhaps most importantly, HEOR should be incorporated into trial design early on. “That means incorporating things like quality-of-life metrics, long-term cost impact and subpopulation data that capture a real-world audience early on, rather than scrambling to fill those gaps later,” says Allo. “Having robust economic models before or at time of launch are critical, and having robust, equitable RWE [real-world evidence] two years post marketing will help to solidify launch effectiveness and commercialization post launch.”

This, she asserts, is “a shift in mindset — thinking about payer evidence generation not as a separate function but as something that’s fully integrated into clinical development from the start. This includes considerations into formulation strategy, FDA filing strategy and continued pipeline indication sequencing for optimized access and commercial uptake early in the clinical development timeline and iterative considerations throughout as launch timelines become more solidified.”

Plug Evidence Gaps

Manufacturers can take various steps to make sure that payers don’t encounter evidence gaps that can lead to unfavorable formulary placement or even lack of coverage. One potential solution is piloting RWE “studies alongside clinical trials to provide additional data on the drug’s effectiveness, safety and long-term outcomes in everyday clinical practice,” says Galante.

Long-term follow-up studies can satisfy those payers that are skeptical of agents that the FDA approves via an expedited review, he states. And analyzing different patient subgroups within clinical trials can provide manufacturers with safety and efficacy data across various populations.

Ciarametaro points out that manufacturers need “a clear value proposition” based on “the nature of the therapeutic area” before launch. “For example, a first-to-market therapy would need to establish unmet need, while second- or later-to-market products should focus on clear differentiation in terms of outcomes or populations versus existing market entrants.”

According to Allo, drugmakers need to provide payers with “a clear picture of disease burden and unmet need” to make sure they understand the need for coverage of an agent. Patient-reported outcomes (PROs) that include “not just clinical efficacy but real-world impact on quality of life, hospitalizations and long-term costs” also are useful.

And having pre-approval information exchange (PIE) discussions three to 12 months before a product’s launch can help with formulary placement, she says, “with robust payer value proposition discussions touching on both clinical and economics within 30 to 60 days post launch to ensure they meet payers’ requirements to review and place products on formulary within three and six months, respectively. These are Medicare timelines that are typically used also for commercial plans, as pharmacy and therapeutics committees are typically joint efforts across lines of business.”

Don’t Forget Patient Engagement

Pharma also needs to strengthen patient communications for a successful launch. As with payers, early and ongoing engagement with patients and advocacy groups throughout both the development of an agent and after its launch is important, as is involving those stakeholders in clinical trials’ designs, maintains Galante. Patient-friendly protocols “minimize[e] the burden on participants and ensur[e] their ability to participate in a compliant and convenient manner,” he notes.

Also important, he says, is “transparent communication,” including potential benefits, as well as risks, of an agent. Incorporating digital tools and platforms and offering telehealth options can encourage engagement with participants. Educating patients and working with advocacy groups also help with market access, as well as with getting real-world data, which in turn can benefit payers in their coverage decisions.

Pinpointing “leakage points” in the patient journey from diagnosis to treatment helps address patient needs, points out Allo. She also agrees that working with patient advocacy groups is “imperative” in order to “to ensure the patient voice is not only listened to, but also acted upon, and can be a unique way to capture missing datapoints through registries that can augment RWE plans.”

Traditional patient engagement focuses on patient stories, not measurable outcomes, says Cortez. And payers may find PROs beneficial, but they “remain skeptical unless they tie directly to cost, adherence or health care utilization,” she contends. “Companies need to bridge that gap by ensuring patient-relevant data is also payer-relevant — demonstrating how improved quality of life translates into better long-term outcomes and lower costs.”

“When I sat in my payer shoes, I struggled with hearing the line that this particular product has such a small budget impact, and, therefore, shouldn’t be managed in any way,” says Allo. “The reality is we are in an environment where less than 20% of medications are driving more than 80% of the spend and trend payers are actively trying to manage. When pharmaceutical manufacturers come to payers with an approach that seeks first to understand and actually meets their evidentiary needs, greater collaboration and partnership can arise, ultimately impacting a patient’s ability to access their products.”

Ultimately, maintains Ciarametaro, it’s important to understand that “market access strategy isn’t just for high-cost specialty drugs with large patient populations. Even low-cost and orphan drugs need a rigorous approach. It’s not about the price of a single product — it’s about total budget impact. Think of it like a school of fish: One small fish isn’t a threat, but an entire school can be overwhelming. Payers are looking at the cumulative effect of new therapies on health care spending, and they can’t afford unchecked growth. Regardless of price point, any company bringing a new product to market must be prepared to answer how it fits into the broader cost equation.”