Introduction
Market Access is critical to commercial success, so the whole organisation needs to be upskilled in developing products that people will pay for. In some therapeutic areas, such as oncology, marketing authorisation can be sought as early as phase II, therefore company-wide alignment on PMA strategy must be reached early during the product R and D phase. Key to this is ensuring company-wide training is given such as e-learning or webinars, incorporating non-PMA professionals, that teaches fundamentals of PMA (what is it and how it can be achieved) so challenges can be communicated effectively and commercial success achieved.
Market access is critical to commercial success
Market access activities require an interdisciplinary approach so teams across the whole organisation must work collaboratively. Non-PMA professionals require a basic understanding of market access, to establish a common language so team members can help understand and support the organisation’s experts to drive product value and be aligned on the companies approach and decision-making.
For instance, a payer value proposition requires input from different internal functions:
- Clinical experts ensure relevant data is included to communicate the product’s value to payers
- The marketing team ensures the value messages align with commercial messaging and brand positioning
- Health economics and outcomes research (HEOR) teams support on the economic value of the product
- Medical and medical affairs engage with key opinion leaders, gain competitive-intelligence, and ensure the patient journey is clearly mapped
A successful MA strategy will initiate activities early in a product’s development
Clinical uncertainty associated with launch of oncology drugs at phase II needs MA activities to be initiated early. In Europe, for new oncology medicines, the European Medicines Agency (EMA) are more flexible in their evidence requirements and willing to accept phase II trial data (3). The benefit of this is it allows faster patient access, however the limited clinical evidence means it is challenging for payers to make access decisions due to clinical uncertainty. To address this, internal teams are being involved increasingly earlier in drug development. For example, HEOR involvement can ensure that clinically relevant endpoints and comparators favoured by payers will be included in clinical trials. Furthermore, attendance at payer advisory boards can achieve optimised value dossiers through close interactions with payers and HTA bodies pre-launch. To support P&MA teams with this early interaction, different functions within the organisation are required to formulate a product’s data package. To optimise favourable access decisions and manage clinical uncertainty at time of launch, PMA culture needs to be embedded in the organisation from as early as R&D phase.
Basic market access training is critical for company-wide alignment
time where attention can be retained. Further to this, webinars can be recorded providing a useful resource to refer too. A blended approach of theory, case studies and practical exercises or discussion will not only teach a basic understanding but allow non-PMA professionals to understand its application to real-world situations. Training will identify key points necessary to understand how early evidence outcomes can impact commercial strategy decisions, allow a more holistic view of the challenges and highlight the importance of non-PMA professional’s role in a collaborative company-wide approach to MA strategy. This will lead to effective interactions with payers and physicians, consistent communication of the product’s value and ultimately an effective MA strategy that will achieve commercial success.
Conclusion
A successful market access approach involves company-wide alignment from as early as R&D, thus PMA knowledge should be embedded in company culture. Non-PMA professionals require a common language to communicate challenges effectively for internal communications and align on the companies approach to driving product’s value in external exchanges. This is fundamental to achieving commercial success. Virtual webinars or e-learnings can address key learnings at a time that is convenient for employees and low-cost to the organisation.
Sources:
- https://www.fiercepharma.com/pharma/runaway-train-drug-launch-prices-have-grown-20-annually-more-decade-and-its-time-congress
- https://www.fiercepharma.com/pharma/half-drugs-launched-last-15-years-failed-to-meet-wall-street-s-expectations-report
- https://www.annalsofoncology.org/article/S0923-7534(19)35358-X/fulltext