Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel
In crafting your market access strategy, it can be valuable to follow these five best practices:
- Start planning as early as possible in the drug or device development process, to give yourself enough time to make informed, optimal decisions, and adjust your strategy when needed;
- Plan for global markets and seek early advice from payers and HTA agencies, where possible. There are many different agencies and payers to think about when you launch globally, so it’s vital to ensure you are sufficiently addressing the requirements of the priority markets. Even if you do not plan to commercialize by yourself in countries outside the US, careful, early market access planning with key global markets in mind can maximize the attractiveness of your asset to potential licensors or partners;
- Allocate sufficient resources for market access. Work with experienced market access expert(s) in early-to mid-stage development to perform preliminary access and pricing assessments and gather information to shape your development program;
- Refine your development program to address access needs. Combine reviews of prior HTA and payer decisions with direct research to test target profile scenarios and value argumentation. Instead of guessing what payers might want to see, investigate it thoroughly, and determine how to incorporate the feedback;
- Foster close collaboration between market access, brand, and development teams to gain useful insights and market intelligence for adjusting your program as it progresses.
Planning to maximize the potential of your novel therapeutics or technologies
The biopharmaceutical and medtech industries are increasingly recognizing the importance of market access planning and the need to evolve with the changing healthcare landscape. Although showing evidence of the efficacy and safety of a new drug or device is essential to gain regulatory approval, it is just as essential to demonstrate its value and benefits to payers and HTA agencies globally, who often prioritize somewhat different elements and considerations than the regulators. Failure to do so risks ending up with patients unable to get your drug or device, and a lack of return on your investment.
To help realize the full therapeutic potential of your medicine or technology and ensure it is accessible to the patients who need it most, incorporate market access planning as early as possible during the drug/device development process. By doing so, you can better identify challenges ahead of time and increase your chances of success.
Francis Kendall and Ursula Garczarek from Cytel, explore the new drug development paradigm and discuss the promising real-world evidence applications in an on-demand webinar.
Read previous blogs in this series:
Why is market access strategy crucial to succeed?
The critical role of market access planning in clinical development
Harnessing the value of market access planning
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.|