Market access strategy is an integral part of the clinical development process to ensure success in global healthcare markets and vital access to patients
Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel
In clinical development, it’s easy to underestimate the critical role that market access plays in the commercial success of a product. Understandably, organizations instead focus on the regulators, and the steps needed to secure eventual approval. However, ensuring the development plan is aligned with a well-planned market access strategy is essential to help the therapy actually reach the intended patients and realize its true commercial potential following regulatory approval. This is particularly crucial considering that payers and other key stakeholders demand compelling information on a drug’s/device’s value as well as justification of its pricing.
In this four-part blog series, I will address what can be done to optimize your market access planning, and why all that effort is really worth it.
Driving successful drug, medical device or diagnostic tool development: Efficacy, safety…and market access?
Achieving favorable market access is crucial in today’s highly competitive, cost-and-value conscious healthcare industry, but it’s also not easy. The days of launching a product, smoothly securing positive formulary coverage, and letting the sales force be the primary driver of commercial success are long gone.
Challenges are coming from all quarters. In the US, for example, regulators are looking for ways to reduce costs and promote competition while increasing patient access to life-saving medicines and devices (such as through the FDA’s 2018 Biosimilars Action Plan). Payers, for their part, are demanding ever more data — from information on a drug’s comparative - and/or cost-effectiveness compared to alternative treatments to long term outcomes and real world evidence (RWE). Indeed, in some instances, payers have elected to exclude newly launched drugs or devices from their formularies at launch, effectively depriving a portion of patients access to these new medicines or technologies and truncating the product’s market potential.
Outside the US, the situation is no simpler. Health Technology Assessment (HTA) agencies may determine that you’ve chosen an inappropriate comparator for their market and decide that you cannot be accurately evaluated. Alternatively, they might scrutinize your clinical trial population and decide to only reimburse for a subset of the regulator-approved label. This shifting, challenging global landscape means it is critical to show compelling evidence that market access requirements are being met. Merely demonstrating efficacy and safety for regulatory approval is insufficient to launch a new drug or device successfully. Payers are interested in clinical effectiveness and cost-effectiveness of a new drug or device.
Despite the growing importance of market access, however, the main priority for smaller, emerging biotechs still tends to be gaining regulatory approval. Although this is understandable in the high-stakes environment of the biopharmaceutical industry, it means that there is often ‘too little, too late’ invested in planning for market access. As I consider next, this can have a particularly detrimental effect on emerging biotechs.
Why emerging biotechs can’t afford to overlook market access
Given the tremendous time, effort and money invested in the development of new therapies, overlooking the importance of market access during drug/devices development can result in a significant underperformance of the product once it launches. With current estimates for bringing a drug to market as high as $2.7 billion, risking commercial performance is unsustainable and can have dire consequences for businesses. This is particularly true for smaller companies that have likely invested all their available funds into developing an asset.
Regardless of whether a company plans to out-license an asset or commercialize it themselves, failure to incorporate careful and early market access planning into development drastically increases the risk of a sub-optimized commercial potential for the product.
It is therefore of paramount importance that companies embed market access planning early into asset development; the value of careful planning will only grow as many countries, in the face of budgetary pressures and rising healthcare costs, are presenting increasing access and pricing challenges to successful product commercialization. In the US, for example, these challenges include the rise of various value frameworks and assessors, expansion of the use of payer drug formulary exclusion lists, increasingly more stringent medical benefit management, growing public pressure for greater price transparency and stricter pricing scrutiny, and the threat of government price negotiation and international price referencing, among other trends.
So, how can smaller companies address market access challenges posed by payers, HTA agencies, and other stakeholders in the global healthcare ecosystem? After all, these companies are increasingly critical drivers of innovation in the biopharmaceutical industry—a recent review of drugs launched in 2018 found that emerging biopharma originated and launched 42% of these new therapies (up from 26% in 2017).
Customized market access planning, introduced early, using specific tools, tactics, and expert guidance, can significantly benefit the clinical development programs of emerging biotechs and medtechs by addressing not only the needs of the regulators, but also payers and other market access stakeholders.
In part 2 of this series, I will elaborate on the critical role of market access planning in clinical development and the essential considerations for your market access plan.
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About Michael S. Pass
Michael S. Paas is an experienced market access executive and commercial strategy leader, with expertise across US and global markets. He has served in senior executive roles in market access and pricing in several leading biopharmaceutical companies, and led the US practice of a life sciences strategy consultancy, advising firms on market access, pricing and commercial strategy solutions. Michael is currently an executive with AbbVie. The views expressed here are his own, and do not represent that of current or former employers.