Planning for successful registration, approval and reimbursement is in the plan of every development team. Appropriately, early planning is focused on clinical trial design with the appropriate endpoints to meet regulatory requirements. Planning for success very much revolves around the clinical trials, execution, and timely completion. Yet there’s a lot more involved when designing your program for success. Often planning for market access may not begin until the phase 3 studies are underway. Teams need to evolve beyond a siloed development team approach, to early strategic planning involving a broader group of stakeholders across your organization. Early planning for downstream early access to medicines is a required element of being ready for patient and prescriber demand. Incorporating budget-holder perspective early and consider evidence requirements to support value demonstration is an important aspect of successful planning.
Many companies have been evolving towards incorporating pre-approval access into a multi-stakeholder end of Phase 2 planning. As efficacy and safety data for a compound mature, asset teams will make an assessment as to whether pre-approval access is appropriate and will be granted. It may not be appropriate for every medicine, hence the early discussions around decision criteria are so important. Importantly, decisions about outcomes data collection in pre-approval programs must be part of the equation. This varies by country and must be taken into account when weighing pro and con. Equally important is the decision on whether early interactions with HTA bodies are planned, and the timing, both informal and formal.
Early Access Care can help you navigate this landscape and mature a best strategy for cross-company stakeholder planning for early access programs. Contact us (firstname.lastname@example.org) to begin your asset planning with the end in mind.