Market access update
Market access update
Understanding commercial and market access risks and opportunities at an early stage in biopharmaceutical product development is essential for optimizing commercial success. Several decisions are made in the early stages of clinical development that have key implications for entering markets successfully. These center on ascertaining the product value for stakeholders, identifying the right trial design, understanding the data to collect outside of clinical trials, and when to engage clinicians and patients with the right messages to shift the standard of care. The decisions will directly impact the value story for payers who, as the landscape becomes more complex, are looking for more nuanced and detailed information on the product value.
The products entering the market today are often complex and may leverage novel biomarkers and target smaller patient populations. Many therapies will be first-in-class with novel modes of action. However, for payers, as well as regulators, healthcare professionals, and patients, a new mode of action is not a value driver. Instead, the evidence package must translate this into clear clinical outcomes.
Market access functions have an important role to play in contributing to early decision‑making during the clinical development lifecycle. By working cross‑functionally, they can ensure that the clinical evidence generated to support regulatory approval for a drug is also sufficient and appropriate to support value‑based pricing and reimbursement success.
Market access centers around an intricate network of stakeholders, including patients, clinicians, payers, and regulators. For example, before healthcare professionals can prescribe drugs to patients, payers need to have a comprehensive understanding of how the therapy is prescribed, its expected outcomes, and its advantages over other available therapies.
Key challenges for biopharmaceutical teams include differing stakeholder expectations and the complex relationships between stakeholder groups, which often have overlapping needs and evidence priorities. Drug developers need to take a holistic view and prioritize assets that demonstrate clinical, economic, and patient‑relevant value to this range of stakeholders.
For example, there is often pressure from regulators to approve drugs earlier while payers may feel the evidence packages are compromised in terms of the ability to provide robust and compelling evidence. This has led to a rise in the need for real‑world evidence to complement and validate trial outcomes and contextualize the reimbursement decision with the goal of reducing payer uncertainties about how they prioritize and manage their spend.
With the demand for more and improved healthcare, budget scrutiny leads to increasingly complex managed entry or risk‑sharing agreements. In the USA, political and public concern around the price of pharmaceuticals comes with a heavy degree of pressure to do something about it. Prices are being challenged globally, and there is a growing focus on achieving better value.
To overcome these concerns and drive commercial success, biopharmaceutical companies must consider several stakeholders in all major decisions from the outset of development. Having those discussions early is critical to the success of the asset and should include an analysis of the needs of a broad range of stakeholders, not just regulatory agencies or even clinicians, but with a particular emphasis on the payer.
Involving market access teams in the development of the target product profile (TPP) ensures the value propositions are relevant to a holistic group of stakeholders, including the payer. The TPP should consider several core factors, including unmet patient and healthcare provider needs and clinical and economic value. This can then serve as a decision‑making guide for pipeline planning, product positioning, and other key areas.
However, this approach requires cross‑functional teams to develop an organized and methodical strategy so they can provide this holistic view efficiently and effectively.
PRMA Consulting, part of the Policy, Access, Value, and Evidence capability at Fishawack Health, has developed PRMA Healthcheck®, a digital application designed to maximize asset value at every stage of development. The application comprises a structured four‑step approach that identifies and communicates market access opportunities and risks for the asset through the lens of a payer, considering treatment landscapes, pricing outlooks, and payer needs.
Key benefits include early and effective cross‑functional collaboration and the identification of core activities that will mitigate risks and maximize opportunities. Ultimately, the application facilitates optimal market access potential by driving value‑based clinical development.
The four main steps involved in the PRMA Healthcheck® assessment are: a situation analysis to identify payer value drivers, a heatmap to assess evidence risks and opportunities, the identification of key drivers of market access success, and a roadmap of the activities required to optimize market access. This systematic approach has already been used in almost 150 asset assessments and has yielded excellent results for developing a holistic understanding of product value from the early stages of clinical development.
Contact us to find out why applying a payer lens early in the value assessment of pipeline assets is essential for driving commercial success.
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