The traditional route to pharmaceutical market access focuses on successful clinical trials and meeting regulators' safety and efficacy data requirements. In the past, this same data was sufficient for payers to determine that the drug was worth covering at the price point set by the manufacturer. But times have changed. With payers playing a more influential role in market access and the availability of data to provide a more accurate picture of how medications perform after approval, pharmaceutical manufacturers need to prove the real-world value of their brands.
An increasingly competitive market, the advent of specialty therapies, and the rise of value-based care have altered the dynamics of market access in the United States. The influence of insurers has escalated to the point that they are considered gatekeepers, acting as the middleman between patients and medication access. In fact, in a survey of pharmaceutical industry experts published in the Journal of Market Access and Health Policy, payers were named as the second most important stakeholder in market access following patients.
The market access role of payers - spanning from formulary tiering and drug utilization reviews to implementation of specific access barriers – translates to substantial impacts on treatment decisions, quality of care, and cost savings. Additionally, insurers are shifting toward value-based contracting in favor of volume-based agreements, particularly in the specialty drugs market.
As payer influence continues to evolve and grow, market access leaders need to provide payers with the full picture of the value their brands bring to healthcare delivery.
With healthcare costs under the microscope, pharmaceutical manufacturers have growing pressure to deliver clinical trial results in the real world. Real-world data (RWD) – data collected in the context of routine care delivery rather than with the controlled environment of a clinical trial – is playing a progressively more central role in drug decision-making. In today’s value-driven marketplace, RWD can be a gamechanger for pharmaceutical market access.
Potential sources for RWD include:
Electronic health records (EHRs)
Patient-reported outcomes (PROs)
Medical product and device registries
Condition-specific or disease registries
Environmental factors and social determinants of health
Real-world evidence (RWE), which the FDA defines as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data," can bridge gaps in evidence not addressed by clinical trials. In December 2021, the FDA issued guidance for evaluating RWD to support marketing applications after drug approval, such as a new indication.
While randomized clinical trials are still considered the gold standard for formulary decision-making, payers use real-world data to validate clinical trial results further and help make coverage decisions across therapeutic areas. Additionally, more and more payers are tying payment for treatment to both short- and long-term effectiveness measures. Health plans are also turning to RWD to gain insights into drug safety, utilization, costs, and value.
Pharmaceutical marketers have been using RWD for decades to inform their decision-making, respond to external stakeholders, and improve their brands’ market positioning.
With the evolution of data analytics, there are greater opportunities to provide RWD to payers around long-term efficacy, safety in real-world settings, head-to-head comparisons, cost analyses for formulary placements, medication use and adherence patterns, and patient-reported outcomes and experiences – ultimately demonstrating the actual value of a therapy.
In a 2017 Deloitte survey, more than half of life sciences companies polled planned to increase their RWE capabilities significantly. According to the findings, access to the right RWD was a common issue, and new channels for data, including external partnerships, would be needed to improve overall capabilities. The authors of the study pointed out that the FDA’s push to expand the use of RWE and “the growing imperative for life sciences companies to demonstrate product value is helping to drive commercialization strategies that result in broader insurance coverage, optimal pricing, and optimal formulary placement."
Achieving real-world insight from the point of care throughout the patient journey is ideal for demonstrating how your medication can improve outcomes and reduce costs. Life sciences companies should consider a commercialization partner that provides high-quality, timely, and actionable RWD to ensure a brand's post-approval market access.
With over 120 real-time data points across the patient access journey and customizable market access reports, Phil provides its life science company partners with RWD and insights to support their brand value to payers. Learn more about the Phil Platform here.
Our consultants will work with you to analyze your current channel strategy and make recommendations for how to improve patient access and increase the percentage of scripts getting covered by insurance.