In the second in a series on increasing market access influence during early pipeline planning, Andrea Hamlin, Director, highlights some of the stakeholders who can influence market access, summarizes 4 key trends in the policy, access, value, and evidence landscape, and highlights the need to right size your approach to market access to influence decision-making in early clinical development.
PRMA Consulting is now Avalere Health
Market access is influenced by a number of different stakeholders across the product lifecycle – it is a complicated matrix
To some extent, market access is the business of anyone in the company involved throughout the lifecycle of an asset. However, depending on role, individual goals and priorities differ as can the view on the definition of value. This makes for a complicated matrix that can be challenging to negotiate for the market access team.
Not only are internal stakeholders important, but market access is influenced by a number of external stakeholders. For example:
Regulatory agencies can evolve their views around the evidence package needed to get a label, as we saw in the recent initiative to encourage the use of real-world evidence (RWE). On the process side, we also see regulatory agencies collaborating with each other to evolve methodologies for innovative medicines, for example in Project ORBIS. All of these aspects will influence the evidence package and how clinical value is being demonstrated.
Payers in some markets are consolidating assessment processes; for example, through the upcoming joint clinical assessments in Europe. The methods used by the agencies also continue to evolve, not only technically but also in bringing new elements into consideration, such as the inclusion of cost-effectiveness data in Spain.
Clinicians are known to shape health technology assessment (HTA) thinking in helping understand complex treatment landscapes which constantly evolve, and additionally, there is an increase in joint decision-making with patients, which can also shape the evidence needed to demonstrate value. There are several initiatives to increase the patient involvement in drug development and in HTA and reimbursement processes.
All of this highlights market access as integral in the matrix of stakeholders, both in and outside the company, requiring manufacturers to take a holistic view of value and prioritize assets that will have the evidence to demonstrate clinical value to best support commercial success.
4 key trends in the increasingly complex and challenging policy, access, value, and evidence landscape
The policy, access, value, and evidence landscape continues to evolve and is increasingly complex and challenging; here are 4 key trends:
01. Different stakeholder perspectives on evidence
As noted earlier, there is a growing disconnect between the evidence that regulators and payers expect. While noble in ambition, the drive to approve drugs earlier can compromise the ability to provide the robust and compelling evidence that payers demand.
02. Increasing role of real-word evidence (RWE)
In part due to shorter-term data, there is an increased requirement for RWE to validate trial outcomes and contextualize the reimbursement decision problem in a drive to reduce payer uncertainties about their eventual spend. For years, randomized controlled trial data was king, but RWE is increasingly being used to supplement randomized controlled trial data as part of the value proposition. Just recently, the FDA released guidance as part of a framework for evaluating RWE to support the approval of a new indication for an already-approved drug.
03. Budget scrutiny
With the demand for more and improved healthcare, budget scrutiny leads to increasingly complex managed entry or risk-sharing agreements and, in the US, political and public concern around the price of US pharmaceuticals comes with a heavy degree of pressure to do something about it. Prices are being challenged globally, and there’s a growing focus on achieving better value.
04. Value-based prices
Considering payers have a significant influence and impact on healthcare professionals via controlling access to your drugs, which generate your revenue, you need payers to understand how to prescribe your therapy, what outcomes to expect, and why your product is more valuable to a particular patient population than somebody else’s.
The implication for market access is the increasing pressure to be making well-planned and informed decisions through a payer lens to drive positive market access outcomes. This requires market access functions to contribute to early decision-making during the development of pipeline assets. Such consultation ensures that the clinical evidence generated at drug approval is also sufficiently robust to inform value-based pricing and reimbursement success.
Right sizing your approach to market access to influence early clinical development
A commitment to market access needs to be intrinsic to drug launch success – so what is limiting the ability of market access to influence key decisions early?
We hear from our clients that it is essentially a challenge of available time, resources, and having a clear, robust process that can be consistently applied.
Not surprisingly, resources and priorities are often constrained in global and regional teams, limiting the ability to provide meaningful input into clinical development; additionally, to gain meaningful input you want a quick, robust, and structured process. This needs to be agile to accommodate strategic and tactical adjustment and allow for alignment and cross-functional coordination with the overall brand strategy. And finally, that process needs to consistently deliver a best-in-class market access perspective across the product lifecycle.
So how do you right-size your approach to market access to ensure that you provide the informed insights to decision-making process in the early clinical development of a drug? How do you accommodate the input required for in-licensed assets, which is often needed in a very short timeframe? How do you prioritize your resources? Watch the free on-demand webinar to find out more.