The Role of Post-Market Studies in Market Access
Post-market studies are critical in responding to the increasing demand for data on economic and clinical value
As payers and providers continue to explore ways to reduce healthcare spending and improve patient outcomes, there is a growing trend to require more evidence of product safety and effectiveness across the product lifecycle. For manufacturers, the failure to develop such data can result in reduced formulary access and lower reimbursement by payers and providers.
In a previous article, I described how manufacturers can embed market access considerations into R&D. Bringing such considerations into product development helps ensure a compelling economic and clinical value story at launch. However, the work cannot stop there; new competitors enter the field, legacy products are displaced, and there is always opportunity to reinforce product strengths and chip away at weaknesses. Post-market studies to enhance reimbursement and increase product adoption are becoming a fixture across the product life cycle.
Some post-market studies rely on randomized clinical trials (RCTs) to support further indications. However, RCTs are based on narrow inclusion and exclusion criteria and often overlook what happens in real-world conditions. Payers, providers and regulators are interested in how products perform in a real-world setting and will make decisions on formulary inclusion or coverage based on available data. After market entry, manufacturers can generate real-world evidence (RWE) that leverages claims databases, EMR registries or observational studies to demonstrate how a product performs in segments outside of the clinical trial. Such studies can provide insight into hospitalization rates, drug utilization patterns, health outcomes, and overall treatment costs.
When anticipating market access challenges, manufacturers need to objectively evaluate barriers to access, and design studies to address them. While the specifics of study design will vary based upon the product, therapeutic area, and indication, here are three reasons manufacturers should conduct post-market studies:
Address payer concerns
Given continued pressure to demonstrate better patient outcomes at lower cost, payers are scrutinizing every cost outlay to identify ways to lower expenses. Their concerns with pharmaceuticals are that products don’t deliver the expected outcome for all patients, sometimes due to limitations of the drug, and sometimes due to patient adherence. With new product pricing setting records (and existing products sporting hefty price increases), such failures demand and get payer attention.
Post-market studies can be used to provide greater clarity on how products can help payers reduce costs, especially near-term costs (like office or ER visits as well as utilization of other products), and/or improve outcomes. Study data can provide insight into which patient subpopulations the product works best, tools or techniques for improving patient adherence, as well as cost savings that are a direct result of product use. This information lessens payer anxiety that they are spending money for products that don’t work as well as intended.
Also, when developing these studies, there is an opportunity to track and monitor how patients use products outside of a clinical trial setting. Monitoring how patients take products can provide insight into ways to improve overall patient adherence. Insights might suggest need for new formulations (e.g. patients splitting doses to address GI problems) or guidance to provide physicians to ensure optimal patient outcomes from the drug regimen.
Demonstrate competitive differentiation
Comparative studies are not yet required in the US for approval. That said, it’s increasingly important for manufacturers to research payer and provider perceptions regarding their products and the current standard of care. Those insights serve as the basis for designing post-market studies that address concerns and capitalize on opportunities. Post-market studies can identify opportunities to further demonstrate safety, tolerability or outcomes superiority, near- and long-term savings associated with a product’s use, and subpopulations where products work better. Such research can also identify additional indications that would further distinguish the product from its competition, and can open the door to combination diagnostics that confer meaningful competitive advantage.
Respond to regulatory requirements
In certain cases, the FDA requires companies to conduct observational studies once the product is on the market. Even a required study presents an opportunity to gather additional economic and clinical evidence that was not obtained in the original trials. Additional insights about how the product works and the subpopulations where it works best will give manufacturers more specific data to share with payers and providers that other manufacturers might not have. Since RCTs typically include a tightly controlled population, once products are used in the general population, side effects and other concerns that weren’t identified or seemed insignificant during clinical trials may be identified that limit patient willingness to take the product.
Post-market studies are a critical response to the market’s increasing demand for economic and clinical value. Moreover, well-designed post market studies can demonstrate a company’s commitment to ‘playing their part’ in improving health outcomes and reducing costs. Some manufacturers have already taken steps to revamp their use of post-market studies. Those that haven’t will need to do so quickly or be concerned about being left behind.
Rita E Numerof, PhD, is Co-founder and President of strategic management consulting firm, Numerof & Associates, Inc.