Not only the requirements for the approval of a drug are constantly increasing, but the conditions for reimbursement or reimbursement levels are also becoming more stringent.
Particularly with the tremendous increase in cost pressures on health care systems following the pandemic, payers are trying to further raise the bar for an appropriate reimbursement amount for (not only) new drugs.
If the drug manufacturers do not incorporate these requirements into their considerations and generally into their strategic approach at an early stage, i.e. at the latest when planning the phase III trials, the achievement of an adequate reimbursement will only be a matter of luck.
In addition, it must already be taken into account that an EU benefit assessment (“EU-HTA”) has come into force, which will become active from January 2025 – initially for ATMP’s and cancer drugs, then from 2028 also for the orphan therapeutics and from 2030 also for all other drugs that are newly launched on the market.
The above-mentioned EU-HTA will apply to all EU member states and even if 2030 still seems to be a very long time away, the orphan drugs must already be considered now at the latest. The oncologics and ATMPs are already in the situation that they have to prepare for regulations whose exact application they cannot know by now – they are simply not yet defined. And if you have to calculate an average time from the beginning of the planning of a phase III trial to the approval of about 4-5 years, 2030 also seems to be suddenly quite close!
This is because the pivotal study to be conducted also forms an essential basis for the benefit assessment; it is mandatory that its requirements be taken into account.
Despite all still existing uncertainties: the cornerstones of the benefit assessment are defined and the procedure as well! Therefore, even now – subject to certain limitations – it is important and possible to integrate as careful an analysis as possible of the expected evaluation parameters into the planning.
My Offer to You:
- Consulting on specific issues and approaches as well as strategic alignment of studies
- Interim management as head of pricing and/or strategic market access
- Support in the planning and implementation of strategic market access processes from a pricing perspective
- Interim management for the establishment of a strategic pricing & market access department