Author: Michael S. Paas, Market Access & Commercialization Expert, Executive at AbbVie and Guest Author at Cytel
Addressing the myriad of considerations required for market access planning can be complex and time-consuming, so it is vital to give yourself enough time to make informed decisions. As such, starting to plan your market access strategy at least by early phase II or the proof-of-concept phase of device development can help you inform the design of the clinical program in such a way to ideally generate evidence credible and compelling to payer and HTA stakeholders, as well as regulators, in order to maximize the commercial success of your drug or device.
Planning early also gives you the opportunity to make adjustments along the trajectory of development as you gain new information and insights about the asset itself, as well as about the payer and competitive environment.
How market access planning can help minimize risk
A well-planned market access strategy can be incredibly beneficial for risk management. It can provide you with a clear map of the hurdles you will have to overcome to meet the requirements of HTA agencies and payers, as well as potential approaches to mitigate these challenges when they arise. It also reduces the likelihood that unforeseen risks will pop up and delay or jeopardize the launch and commercial success of your drug or device.
Minimizing risk is especially important for emerging biotechs and medtechs, as these smaller companies have a lot to lose if their lead asset(s) fail to make it on to the market. Poor market access planning could lead to the erosion of the perceived future value of an asset and deter potential licensing partners or acquirers. In the worst-case scenario, small biotech/medtech companies may have to shut down altogether if their main asset fails commercially.
Consider, for example, a decision earlier this year by the UK’s National Institute for Health and Care Excellence (NICE), and recently reconfirmed, not to fund the newly approved antimigraine drug, Aimovig (erenumab), the first in a new class of antibody-based CGRP inhibitors. The NICE draft guidance focused on trial design, specifically on how Aimovig’s trial programs had excluded certain patient populations who would be most clinically in need of treatment and the lack of sufficient evidence of long term efficacy. These concerns led the appraisal committee to conclude that the drug is not cost-effective.
As we have seen, getting a new drug or device approved is only half the battle in clinical development. Without a comprehensive market access plan in place or gathering the types of evidence that payers and HTA agencies wish to see, a promising drug or technology can still hit a brick wall commercially without adequate payer support. This denies patients access to much-needed medicines and technologies and leaves a substantial amount of money on the table.
By now, it should be clear that prioritizing market access needs to become a key focus for emerging biotechs and medtech startups—but how can you ensure your market access planning is optimal and maximizes your chance of success? Watch out for the final part of this blog series for the answer.
Read previous blogs in this series:
Biotechs and Medtechs, don’t forget your market access strategy (part 1of 4): Why is market access strategy crucial to succeed?
Biotechs and Medtechs, don’t forget your market access strategy (part 2 of 4): The critical role of market access planning in clinical development
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.
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Don’t miss the final part of this market access blog series!