Market Access (MA) is the process that ensures that a new technology gets fast and sustained access into the market at the right price and for the right patients, who would gain a major benefit from it.
So a deep understanding of each of the bolded words is critical to be successful for any market access challenge.
- THE PROCESS
Market access is impacted by both internal and external processes:
0. Innovation/ Discovery process; there is a big difference between bringing to the market a newly developed (invented) medical device and bringing to the market a newly discovered drug (which would cost up to USD 2,8 billions in R&D, according to most recent studies); however, in both scenarios a series of ‘decision gates’ exist in order to guide investment throughout technology development and manage the associated costs of R&D linked to the likelihood of success.
1. Almost every company has its own launch readiness process which involves virtually every function in the new technology launch preparation, including (and further to market access), regulatory, medical, legal, commercial, marketing, finance, public affairs, patient advocacy, communication, etc.; all functions aim to the same objectives: ensure the best access conditions for the new technology and prepare a successful commercial launch.
2. Payers do have processes: at National level — this includes HTA (full or partial), Pricing, Positioning and Reimbursement conditions approval (including Value-Based Pricing where applicable) and at Regional level (Italy, Spain, Sweden among others) as well as atLocal level (Local Health Units), including Drugs and Therapeutics committees. Sub -National bodies will make decisions based on (yearly) budget availability and positioning of the technology (also by adopting Regional Recommendations or restrictive formulary inclusion decisions).
On the other hand, also Market Access needs good processes in place, linking:
- MA Environment Assessment, which includes a. knowledge of healthcare systems in different countries and what their requirements are; b. understanding of disease management and unmet needs; c. understanding of which clinical evidence seems to have mostly…