3 Keys to Unlock Market Access – Part 2
Posted by: Joe Martinez, RPh, PDE, PPC
In last week’s blog, we identified the three keys required to unlock market access. These include:
1) building and refining an overall market access strategy
2) developing and creating compelling clinical and medical evidence
3) effectively communicating the value that matters to your internal and external stakeholders
We also explored how to devise an effective market access strategy based on real cases studies.
Today, we turn to the second key: clinical and medical evidence. So, why is this so important to market access?
The answer: There is a definite shift going on from specific RCT (randomized controlled trial) data towards evidence-based medical information for real world data. Evidence-based data now provides the foundation for value-based pricing strategies for both payers and sellers. The discussions between payers and their pharma/biotech providers ultimately result in crucial decisions being made that have a direct impact on market access and ultimately, the levels of reimbursement. In short: evidence-based medical information can and will be a game changer going forward.
Considering, here are 5 tips to help create the necessary elements for evidence-based data and to guide payer and provider discussions to a successful conclusion.
1) Build the basis for economic value of your brand by establishing a clear communication channel between clinical and medical.
Dialogue is important and early dialogue is essential. Moreover, it is always best to align the goals of the Medical Affairs/Health Outcomes team with the Clinical Operations team early on in the development process. “Early on” may mean phase 2 or phase 2b as compared to scurrying around at phase 3b with only six months to provide outcomes data for a formulary review committee meeting.
2) Focus value propositions on quantifiable worth that matters to the decision-maker.
3) Ensure that the medical strategy supports market access and is aligned with the commercial strategy
4) Collect and analyze payer decision-making criteria and insights
5) Anticipate what health outcomes data will be needed and be ready to supply it to the payer decision-makers, even before the request is made.
Again, relevant and insightful health outcomes data is the basis of any productive discussion between medical affairs teams and payers. This is why the data must be appropriate and credible. It must also provide strong support for product claims of being an efficacious, efficient and cost effective treatment for patients, while causing minimum hassle for the prescriber and payer. Moreover, the evolution of health care also dictates the need to plan globally and to prioritize market access support, country by country.
Addressing a “Clinical Disconnect”
I recently spoke with a Chief Medical Office (CMO) of an up and coming medical procedure company with a product/procedure in phase 2 trials. It became apparent during our conversation that there was a serious disconnect between their clinical and medical affairs departments and the needs of the latter were not being met. To remedy this, the company must begin generating the medical outcomes data. This is not only important but also very necessary to the big picture because while scientific data may be clinically relevant, it may not be medically significant to the payer or decision-maker.
Another point: the company will be engaged in its next funding round within the next six months. The available clinical trial data will indeed influence just how many millions of dollars of equity investment capital will be secured. With this in mind, in addition to collecting clinical efficacy and safety data, we recommended to the CMO that the company develop health outcomes data and begin preparing to track patients on a longitudinal basis over time. These suggested changes meant only minor but strategic adjustments to their existing plan.
I am pleased to share that our recommendation was accepted and the company now has a strategic medical database in place that will grow over time. This medical database will yield significant outcomes and utilization reports that can support many important initiatives including peer-reviewed journal articles, future clinical trial protocol designs, fundraising and let’s not forget, the point of this blog – market access which drive revenues.
So, what to do next? Effectively communicate the value that matters to your internal and external stakeholders. This is the topic of next week’s blog.