Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel
In my previous post, I established the importance of market access strategy in the clinical development process and why emerging biotechs cannot afford to overlook it.
Click on the button if you missed Part 1 or want to revisit it.
It is imperative to start developing your strategy with market access due diligence and value story creation early in the product development (at least by phase II of drug development or the proof-of-concept phase of a device development). Impactful market access planning involves designing your clinical programs so they sufficiently address the evidence needs of market access stakeholders, patients, and regulators. This means demonstrating the value of your therapy to payers and HTA agencies by generating compelling and robust clinical trial data against appropriate comparators, augmented where possible and helpful with real-world evidence, health economic arguments, economic models and/or relevant patient-reported outcomes.
The choices you make in development can either position you well to navigate the interests and requirements of these market access stakeholders or set you up for failure along a variety of dimensions, including:
- Limited or no reimbursement
- Protracted negotiations that delay reimbursement
- Severely curtailed access population
- Sub-optimal pricing (including list, and especially net, pricing)
- Reputational damage
A comprehensive market access plan helps to optimize the potential of the product across multiple markets, by navigating amongst three key, interconnected elements that payers and HTA agencies influence, manage or determine, and companies seek to navigate:
- Price: both list and net product pricing, as well as anticipated budget impact and affordability
- Volume: the patient population that will have reimbursed access to the product, and any hurdles that payer agencies may impose to achieving access
- Time: how long it takes to achieve reimbursed access in the market
To demonstrate the value of your drug or device, it’s critical that you provide compelling evidence that speaks to the needs and interests of payers and HTA agencies across the first two elements while minimizing the third.
Essential considerations for your market access plan
Examples of development decisions that have significant market access ramifications, and that should be carefully considered during market access planning, include:
- Choice of active trial comparator(s)
- The trial patient population, numbers of patients, inclusion and exclusion criteria
- Trial design, duration, and relevant primary and secondary endpoints
- Dosing regimen and frequency
- Use of patient recorded outcomes
- Collection of real-world evidence
- Any diagnostic biomarkers to be used alongside the clinical program
Launching a product globally involves satisfying the unique requirements of multiple HTA agencies and payers in different markets. Market access, pricing, and reimbursement decisions are made country by country, which differs from some regulatory and market authorization decisions. In the case of the EU, for example, regulatory approvals for drugs are made by EMA for the entire European Union, while each market makes its own determinations on pricing, access, and reimbursement. However, careful market access planning is needed to help ‘thread the needle’ between the different markets within the EU, helping optimize not only the launch sequence for the product but also its overall commercial trajectory.
Market access considerations and implications become even more intricate for assets that aim to grow their set of indications over time, as frequently occurs in many disease areas, notably in oncology, and in devices. Given the complexities of a global launch, and to ensure the greatest chance of commercial success, it is vital to integrate the payer’s perspective alongside that of the regulator’s throughout the development process.
In part 3 of this series, I will discuss how to harness the value of market access planning to maximize the commercial success of your drug and minimize risk.
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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.|