The pressure for biopharma companies to provide specific and nuanced data to demonstrate the value of their therapies has never been greater. Scientific data supporting safety and efficacy is no longer enough for a product to achieve approval and commercial success. In today’s healthcare economy, every stakeholder group in the value chain expects to see data that meets their unique needs, and when companies fail to provide this data, otherwise promising products can fall flat.
To avoid such risk, companies need to change the kinds of data they collect for their regulatory, clinical, market access, medical and commercial strategies, and how that data is used in the development process. Given that different stakeholders measure value in different ways, with each demanding a different set of cost-benefit input along the patient’s journey, the challenge is to efficiently build the optimized data package to meet all of their needs.
To ensure this information is captured and incorporated into the development process, companies need to factor stakeholder insights and expectations into the project plan earlier in the clinical trial process, and revisit these needs at every stage gate along the way. To do this, they need to embrace a more integrated, outcomes-based approach, where work streams from all of the scientific and commercial business units coalesce so that the data gathered can be incorporated into the next phase of the trial and used to build patient-value optimized assets surrounded by appropriate services, such as medical education, that will ultimately improve product performance and marketability.
Such collaborative integration of clinical and commercial functions ensures that teams gather the necessary evidence to support optimized value demonstration across stakeholders. In this way teams increase the chance that the asset will be value-priced, prescribed and used to maximize the return on their efforts.
Companies that want to pursue such internal optimization, should think about how to incorporate cross-functional team collaboration across the entire project lifecycle, focusing on what evidence of value is necessary at different stages. At a minimum teams should factor in the needs of individual stakeholders, including regulators, providers, payers, and patients — each of which will vary according to their role. When defining these needs and the evidence to support them, the following should be kept in mind:
- The Regulator’s need for evidence of an acceptable risk/benefit ratio is the initial and most fundamental hurdle to getting a drug to market.
- The value needs of the Provider, who focus on clinical efficacy, safety, ease of use, novelty, and economic drivers, must be met in order for the approved drug to be prescribed to the patient.
- The evidence requirements of the Payer must achieve a balance of quality and cost through demonstration of value to the patient. Along with proof of efficacy and improved quality of life compared to current treatments, teams will also need to include data about population budget impact, cost effectiveness, downstream cost offset, and direct cost impact. This balance of quality and cost must be met through specific and direct evidence for patients to receive access to the drug.
- Patient value requirements from the drug can include ease of use, effect on symptoms, side effects, and fit with other healthcare priorities and costs. This evidence is equally important as it will dictate the willingness of patients to take the drug as prescribed.
- Key influencers, including policy-makers, manufacturers, laboratories and site-of-care facilities will need to specifically be considered according to asset needs. All of these stakeholders impact how patients are treated, which creates on ever growing need for nuanced value demonstration.
Integrating commercial and clinical work streams to ensure the best evidence is collected across the clinical trial lifecycle, isn’t merely a way to drive incremental efficiency. It may very well determine whether a drug achieves approval and commercial adoption -- or fails to get out of the gate. As the healthcare market has become more value-driven, there have been many incidences of drugs failing to meet commercial potential because they were not developed with the integrated stakeholder and system value needs in mind. The makers of tofacitinib for example, failed to solicit payer feedback early enough in clinical development and as a result the manufacturer was unable to differentiate the product
resulting in it being priced as a biologic; or the makers of ziv-aflibercept, who failed to solicit the input of the provider community which led to a claims that the drug was overpriced
. In both of these cases, revenues were severely impacted as a result of these failures.
Such failures should act as stark reminders of just how difficult the value demonstration process has become, and reinforce the value of integrated asset value processes. It is a key business strategy that will support the ongoing need to evolve the way we prove and communicate the value proposition of new products going forward.