Abstract

RG+A’s client sought to optimize the post-launch value of their early stage respiratory asset by incorporating key payer perspectives into product strategy and trial design in support of high likelihood of reimbursement. RG+A used our Co-Creation approach to engage payers from our Health Payer Council community directly in the development of an optimal target product profile (TPP) and viable trial design to support the client’s post-launch objectives. RG+A identified cost containment from prevented hospitalizations to be a central issue for payers, and we made recommendations on a trial design that would support the development of both clinical and HEOR data along with insights into hospitalization reduction.

Background

A top-10 pharmaceutical company with an early-stage respiratory product sought to optimize the post-launch value of their asset by incorporating payer perspectives into their development strategy and clinical trial design. They engaged RG+A to assist in identifying key outcome parameters meaningful to payers for Phase II trials that would position them to enter Phase II with a well-characterized product with a strong likelihood of reimbursement.

Methodology

RG+A employed our Co-Creation approach consisting of three major phases to engage payers from RG+A’s Health Payer Council community directly in the development of five separate target product profiles (TPPs), and then tested and refined those TPPs with the payers to arrive at a viable trial design in support of the client’s objectives.

In the first phase, RG+A conducted qualitative telephone interviews with 22 health plan pharmacy and medical directors with the objective of characterizing the market to inform the development of the initial TPPs. The interviews covered likely areas of interest, level of interest in the product along with potential management and use, and key metrics for trial design, including trial outcomes, parameters, and impact of design on access.

Following the first phase, RG+A developed five different potential TTPs, one for each prospective area of payer interest, and split the sample into five monadic cells based on the TPP populations. The TPPs were then tested independently using a combination of synchronous and asynchronous online qualitative research. Again engaging 22 pharmacy and medical directors, RG+A’s exercise focused on gathering a detailed assessment of each TPP through a 30-minute interview, and then refining those TPPs through online bulletin boards to gain an understanding of strengths, weaknesses, and likely reimbursement. These activities were followed by 45-minute telephone interviews with five managed care executives to discuss elements of trial design.

In the final phase, RG+A conducted a set of synchronous chats followed by a convergence exercise to refine original draft materials into a more polished final document.

Key Challenges

1. Most respondents find it challenging to envision a future scenario with multiple elements in it and how they might behave in that scenario.
2. Many payers view marketing research as an opportunity to pre-negotiate later contracts by taking a more aggressive stand on price than they might in a “real world” situation.
3. At times in research, a payer may not have the time or impetus to fully think through an issue, and so provide an answer that is overly simplistic.
4. The relatively small number of actual decision makers in the payer community forces a scenario where the most reliable study plan will rely on excellent design instead of large sample size.

How the Design Addressed the Challenges

1. The multi-phase approach “stages” events over time in an iterative manner that includes lifelike tasks and pulls the respondent into the process.
2. Establishing a mix of individual and group events fosters group visioning.
3. Keyboard interviewing commands respondent’s full attention, avoids multitasking common on telephone.

RESULTS

In addition to the creation of an optimal TPP in alignment with the study objectives, RG+A found that payers were most interested in the cost-containment potential of the product that might be brought about by preventing hospitalizations. Further, payers could envision distinct target patient populations for the product. Both elements would be key aspects to support both trial design and needed health outcomes from potential Phase IV examination of the product.

GUIDANCE

Based on the findings, RG+A advised the client to develop a clinical program based on a single trial population and two sets of trials, and to select trial sites with high levels of real-world data integration that would facilitate the creation of clinical and HEOR data in a single set of trials.

We also recommended that the client recruit a clinical trial population determined by likelihood to experience one or more hospitalizations over twelve months after entering the study, thereby providing clear data about the reduction in exacerbations that was earmarked as critical to payers.

ACTION

The client incorporated RG+A’s recommendations into Phase II trial design and has now entered Phase III with a product that is differentiated to payers with a stronger likelihood of reimbursement.