Blog payers

In today’s value driven healthcare environment, the final hurdle for any drug to thrive is no longer regulatory approval — it is now payer support. Even if a drug receives marketing authorization, if payers won’t reimburse for the drug, than doctors won’t prescribe it and patients won’t use it. We’ve seen many examples over the years of good drugs with suboptimal access to patients because payers didn’t get behind them. But it doesn’t have to happen. 

Early engagement strategies can help biopharma companies identify and dissipate the concerns payers may have about a new treatment option long before they come to market, thus improving the odds of their success. Payers want this kind of engagement, and the biopharma companies that incorporate interaction with them early in the development process are afforded more time and options to address concerns and achieve optimal access. 

Of the various early engagement strategies, payers are expecting more involvement in evidence development. Specifically, they want input into clinical trial design or supplement RWE development in Phases II and III, which have the largest impact on value generation. This engagement should ideally occur in three stages:

  1. Informal discussions about evidence
    At the earliest stage of development, when biopharma teams are defining what data they have and what gaps exist, they should meet informally with payers. The goal of these non-binding conversations is to identify the evidence that matters the most to payers, and what level of evidence they will require for coverage and reimbursement (i.e., surveys, observational studies, trial results). This is a vital first step to the engagement process, as not all gaps need to be filled. Understanding early on what evidence is most important to payers means researchers can focus their time and resources on those tasks that will deliver the greatest benefit to later-stage decisions makers. It is important to note that because these are non-binding discussions, payer requirements may change as the market evolves prior to launch, however the candid feedback collected and the trust developed as a result of these meetings brings far more benefits than risks.

  2. Formal advisory consultations
    At the later phases of development, research teams should meet with payer advisory boards to more formally discuss specific scientific evidence and differentiation including optimal sub-populations to inform positioning of the asset, and to garner advice that could potentially be binding. This can generate confidence among payers and biopharma for the pending drug, help researchers hone late stage decision-making, and build trust between the biopharma team and the payer agency.

  3. Formal binding consultations
    As the project moves into Phase III, biopharma should schedule more formal consultations with payer agencies to review the evidence around an asset, begin a conversation around the asset’s place in the treatment guidelines and pricing, ultimately improving the chance of garnering payer support once the drug is approved. 

Don’t be afraid 

Some biopharma companies are hesitant to participate in these early payer engagements, in part because they are afraid to show their hand before all of their evidence is thoroughly fleshed out. But waiting until the last minute creates unnecessary risks to the asset’s success and leaves little time for evidence remediation strategies that may be required. Most notably, not engaging payers as early as possible during the asset development process could result in potential delay of approval and/or coverage as evidenced by the Versatis example. 

Payers are often bewildered by decisions made by biopharmaceutical manufacturers when designing their clinical trials, choosing their comparators, or making certain safety and efficacy claims with mismatched evidence. This misalignment may be the result of pharmaceutical manufacturers designing their studies primarily for regulatory compliance while neglecting to fully consider the often older and sicker patient population payers are chiefly concerned with. 

Engaging payers early on can eliminate many of these blunders, and increase the odds that an asset will be embraced by payers, providers and patients alike.