The Nice Accelerated Access Review, How Does It Compare to the Dutch Conditional Reimbursement Pathway?

The National Institute for Health and Care Excellence (NICE) Accelerated Access Review (AAR) aims to speed up access to innovative drugs, devices, and diagnostics for UK patients. Since 2006, the Netherlands has had a similar pathway in place: conditional reimbursement. This study compares the proposed NICE AAR with the established Dutch pathway and provides an overview of data requirements and likely changes to evidence packages that manufacturers will need to consider. Review of the proposed NICE AAR and existing Dutch conditional pathway methodology. The NICE AAR is still early in development and 5 propositions have been put forward: putting the patient centre stage, getting ahead of the curve (accelerate and manage entry into the health system for emerging products), supporting innovators, galvanising the National Health Service (be an active partner in promoting innovation), and delivering change. The Dutch conditional pathway covers all innovative pharmaceuticals, outpatient care, and medical devices, in cases where clinical benefits and cost-effectiveness cannot yet be proven. After approval there is a 4-year time period during which the drug is reimbursed and real world evidence is gathered to prove effectiveness. If after 4 years effectiveness has not been proven, the pharmaceutical will no longer be reimbursed, with the exception of slow-developing diseases, slow-acting medications, and orphan products. Using an accelerated access or conditional pathway is of great benefit to patients and manufacturers: patients gain access to new pharmaceuticals faster and manufacturers have more time to evaluate effectiveness. However, as has become evident from the Dutch pathway, there can be challenges. For example, reimbursement is not revoked after 4 years in practice, mainly due to ethical considerations and public pressure. This leads to more pressure on pharmaceutical budgets. Learning from other countries with similar processes can increase the efficiency of NICE’s AAR implementation.