Pricing & Market Access

Understanding the decision-makers, incentives, and processes that will set the price, access, and funding of a product is a critical step to successfully preparing for a new launch. CRA’s deep engagement with these issues allows clients to be up to date with the latest developments and likely future changes relevant for their products. This can range from the supranational (e.g., EUnetHTA), national (e.g., German AMNOG reforms), to local (e.g., US Medicare buy-and-bill) dynamics which may limit or drive a product’s commercial success.

Commercial success requires a clinical trial program that not only meets the needs of regulators, but also addresses the demands of payers and value assessors. CRA helps maximize the value of pipeline assets by identifying the most impactful clinical trial designs, endpoints, and outcomes to support the value proposition with skeptical payer audiences. We also develop post-launch evidence plans to leverage real-world, observational, and HEOR data to support ongoing access decisions which are critical in competitive therapy areas.

Pricing strategy is one of those most visible and politically sensitive decisions that life sciences companies need to make, and it has a clear impact on bottom-line performance. CRA’s rigorous, holistic approach can help bring confidence and clarity to decision-making on pricing. Our analyses can provide the foundation for indication and geographic launch sequencing to maximize an asset’s or franchise’s value over the lifecycle at global and local levels. We also support the implementation of pricing and contracting guidance to affiliate teams, capturing nuanced differences between countries’ archetypes, reimbursement channels, and payer segments (e.g., US PBMs and health plans).

The pace of scientific development means that many new products launch without full certainty on the scale, duration, or breadth of their effect. CRA frequently supports the development of innovative contracts and managed entry agreements (MEAs) to help bridge the gap between buyer needs for certainty and the potential value of new products. Our approach is closely integrated with negotiation strategy to keep the focus on value, minimize the default to price concessions, and provide tools for effective implementation by local teams.

In many therapy areas, multiple assets competing for different patient segments, sometimes in combination regimens, is increasingly the norm. CRA can help take a broader view of the price and access needed across a portfolio to optimize returns. This can include establishing principles for price relating to treatment stage and patient numbers, combination net pricing with internal or third-party backbone therapy, and setting price benchmarks for future product launches.

Rare/orphan, and potentially curative therapies are unique in their pricing dynamics. High price tags are typical, driven by the substantial clinical value across a small number of patient administrations. Our Rare Disease center of excellence is well-versed in these challenges and able to advise on engagement with all stakeholders to support success in these high-stakes negotiations, closely linking our expertise in policy and commercial strategy for rare/orphan disease.

Oncology is another area with a distinct pricing environment, with unique stakeholders and scrutiny but is often the arena for the latest scientific advances. CRA has extensive experience in helping oncology firms achieve value for their products.

What was once innovative has become table stakes as patient support programs have become both increasingly popular and necessary. However, not all programs are created equal as life sciences companies have evolved in the space to leverage new technology, streamline operational processes, and consider the total cost of patient care. CRA helps clients design socially-responsible, yet fiscally-sustainable, solutions that effectively address patient needs, mandatory and discretionary rebates, prescribing dynamics, and payer mechanisms such as accumulators and maximizers.

Price and access potential are major drivers of commercial forecasts and can be critical for the appropriate evaluation of an asset, platform, or company. CRA works on both buy- and sell-side assessments to provide valuable insights into the uncertain and time-pressured environment of investment decisions. We have an established process and have been retained by a number of large biopharmaceutical firms to deliver opportunistic assessments of potential acquisition targets.