In the Know: Pharma engages payers early in the drug development process

With market access for new treatments becoming more challenging due to limited budgets, increasingly payers are expecting more compelling evidence of a drug's value. To ensure payers understand how drugs can improve patient outcomes and demonstrate an economic benefit, pharmaceutical companies must make early payer involvement in clinical development an integral part of their go-to-market (GTM) strategy. FirstWord spoke with eight GTM experts about the stage of drug development pharma engages with payers and the outcome measures pharma uses to convey value to payers.

In the past, pharma did not engage payers until the end of the drug development process — sometimes initiating engagement just one year before anticipated regulatory approval. However, an expert said as the landscape has changed, companies are meeting with payers as early as the trial design phase. The experts said two factors have driven this trend:

1. Payers are playing a more prominent role in evaluating new therapies, likely due to more novel, expensive medicines entering the market.
2. The methods used by payers to assess the value of a new therapy vary across nations.

Because of these factors, pharma must work closely with payers as soon as possible to determine what criteria payers use to judge the potential benefits of a developmental drug. As a result, pharma can select endpoints most relevant to payers when designing clinical trials, which increases the likelihood of market access success.

One challenge noted by an expert is that reimbursement issues discussed early in the drug development process are not considered later in the development line after the landscape has changed. Therefore, it is advised that companies incorporate flexibility into any reimbursement plan made with payers.

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