Launch year rejection rates have climbed steadily, with durable payer rejections now affecting over 60% of new patients for many brands¹. Roughly one-third of U.S. drug launches failed to meet expectations, with market access, customer understanding and differentiation among the factors influencing launch performance².

Payers now exert unprecedented control over access to new therapies. As the brand leader, developing payer messaging should help them evaluate value, manage uncertainty and risk and prepare for coverage decisions, rather than simply increase awareness and more content than needed.

Understand Payer Audience and Their Needs

Payers assess therapies through multiple lenses:

1. Clinical Value
2. Health Equity
3. Unmet Need
4. Economic Impact
5. Operational Feasibility
6. Expected Utilization

Messaging should answer practical questions:

• Which patients are most appropriate?
• How does the therapy compare with available alternatives?
• What uncertainty or risk remains?
• What are the expected budget and access implications?

The Academy of Managed Care Pharmacy (AMCP) notes that formulary decisionmakers rely on clinical and economic evidence to inform coverage, reimbursement and policy decisions³.

Using an effectiveness framework will help address the practical questions from the payers’ point of view:

• Credible: grounded in clinical and economic evidence.
• Relevant: linked to payer decisions such as coverage, formulary placement and utilization management.
• Timely: delivered when payers are making planning or coverage decisions.
• Specific: clear about population, outcomes, comparators and economic assumptions.
• Behavior-aware: designed to reduce uncertainty and make evidence easier to evaluate.

Planning payer-facing communications may begin early as well and need clinical and economic information 12 to 18 months before FDA approval for planning, budgeting and forecasting. Additionally, emphasizing evolving clinical and economic information, anticipated indication, place in therapy and route of administration is critical for multiple audiences (4). The goal is to remove friction for a patient to adopt a life-changing therapy.

Launch phases:

12-24 months before launch

The focus should be understanding payer needs and evidence requirements by:

• identifying likely access barriers
• assessing evidence gaps
• defining the value story,
• determining which outcomes and economic measures are most relevant to decision-making
• promoting a PIE deck to field teams to engage with payer audiences

6-12 months before launch

The focus shifts to readiness that:

• refine the payer value narrative
• align messages to anticipated coverage questions
• prepare evidence resources that translate clinical data into decision-relevant insights.

Both clinical and economic evidence, including budget impact considerations, are relevant at this launch phase (4).

Launch

At launch, messaging should support real-world decision-making, aligned to the approved label, clearly explain the therapy's value and acknowledge any remaining evidence gaps.

Competitive Markets Versus Rare Disease

In highly competitive therapeutic areas, payer messaging must clearly explain differentiated value this product provides vs. current treatment options. Payers need to understand what is different, for which patients and why this therapy warrants consideration and recommendation. (1)

Rare disease launches often require a different messaging approach due to small patient populations and should place greater emphasis on disease burden, unmet need, natural history, evidence limitations and plans for continued evidence generation.

Practical Operating Model Delivers Message Effectiveness

A useful framework for payer communications is:

Start with the payer insight. Identify the behavior change needed. Build one message that addresses the belief shift. Deliver it at the right decision point, in the right format, and measure whether it improves understanding.

Launch success is becoming harder because access is more complex, reimbursement is slower or less reliable, and manufacturers are increasingly expected to prove value to payers and the broader health systems, who are under budget and capacity pressure.

As a brand leader, launching a new therapy encompasses balancing numerous, often competing priorities, and IQVIA Health Communications Group is here to serve as your strategic communications partner. IHCG represents a family of specialized communication agencies, who are dedicated to helping brand leaders turn data into belief-changing, behavior-aware messaging. Connecting evidence, affordability, therapeutic value, risk avoidance, with omnichannel sequencing so communications highlight economic value needed to engage the payer audience.

This blog is the third in a series exploring how to build launch readiness across four critical audiences: HCPs, KOLs, payers, and patients, and how an expert communications partner can make launch communications seamless.

Ultimately, launch success is measured by how effectively you prepare stakeholders to understand the unmet need, recognize the value of your therapy, and make confident decisions when launch day arrives.

Sources:

1. IQVIA Modern Launch in the US: https://www.iqvia.com/locations/united-states/library/publications/modern-launch-in-the-us

2. Drug launch success | Deloitte Insights

3. AMCP Format for Formulary Submissions 5.0; AMCP-Format-5.0-JMCP-web_0.pdf

4. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval - PMC