Creating a Gray Zone in Payer Messaging: Outflanking Comparability

Ira Studin, PhD, President, Stellar Managed Care Consulting

There is a theory in business that being second to market has its advantages. These include: first entrant having done the heavy lifting to educate the market; learning from the first entrant’s mistakes; and using the first entrant’s weaknesses to support the second entrant’s positioning.

From a pharmaceutical point of view, though, what if payers are not inclined to give the second entrant equal access? Adding a second agent might increase utilization beyond projections. Or payers may want to wait for more competition. Or there might be a rebate impact tied to the incumbent.

A typical payer threat to equal access for a second to market is the risk that safety/efficacy data are inadequate to escape the “comparable” bucket, reducing the decision to cost.

If the brand team for second to market has gotten feedback that equal access will be an uphill battle, the suggestion here is that the brand message should create a “gray zone” between itself and the incumbent, forcing payers out of a binary up or down mindset and elevating selected points that have merit on their own.

For this discussion, the gray zone can be thought of as a level playing field for some aspect of a brand’s clinical story that would otherwise fall under the umbrella of a potentially unfavorable equal access evaluation.

The idea of creating a gray zone in the payer message is to take the onus off of having to heavily discount for equal access and lean into clinical points that can’t simply be dismissed.

The argument here is that two steps in message development can create a gray zone where some piece of the later entrant’s clinical story can avoid being absorbed under a “not needed” decision:

• Conduct a payer decision criteria assessment.
• Expand the scope of clinical benefit.

Payer decision criteria assessment

There is a tendency in message development to let the science speak for itself. The challenge for a second or any later entrant is that unless there is an unmet need or opportunity to reduce costs, base case is the status quo. It’s been my experience that if there is no unmet need, payers treat products as a “may add” and leave it to finance.

This makes the messaging task for launch strategy two-fold: present the science but also change the payer decision playing field. To change the decision playing field, two questions could be helpful.

First, how can any gap in prescriber and payer thinking identify priorities where payer decision criteria are more accommodating? Second, how do payers understand standard of care and, aside from the primary endpoint, what data from a pivotal trial signal a new agent represents some degree of improvement?

Insight from both questions should help brand teams put the spotlight on data that stand apart from the “comparable, may add” bucket and elevate selected strengths.

Expand the scope of clinical benefit

This second step is to marshal secondary data that may not measure up to clinically meaningful benefit but do speak to gains payers can’t legitimately ignore. The points ahead illustrate empirical items that should command attention in the payer analysis.

Clinical trial design: Tougher patient population; diverse clinical study population; comorbidities in the study population; individual endpoints rather than a composite; health resource utilization.

Agent: Dosing and administration; percent of patients meeting primary endpoint at lower dose; durability of benefit; impact on polypharmacy; tolerability; discontinuation rate.

Gray zone in action

If equal access is uncertain, creating a gray zone by highlighting selected secondary data in the payer message can strengthen a brand’s case.

This example—with items payers don’t especially value— illustrates the gray zone effect: if incumbent causes nausea, headaches, and GI upset plus has burdensome dosing, while second to market has much more favorable tolerability and dosing, payers should see the latter’s potential for moving market share as one point favoring equal access.

Ira Studin, PhD, is President, Stellar Managed Care Consulting. He can be reached at istudin@stellarmc.com.