OBJECTIVES:

Biopharmaceutical manufacturers have traditionally opted for negotiations involving direct confidential discounts to payers in order to gain patent access. However, with higher prices and concomitant clinical uncertainty associated with innovative therapies, manufacturers may be able to expedite time to access by offering MEA upfront during pricing negotiations than contemplating as a fall back option.

METHODS:

A non-systematic review of literature supplemented by DRG’s proprietary MEA Database was used to construct a list of MEAs involving high-cost oncology products implemented in recent years in Italy, Spain, and UK. to access was derived from published literature for each country.

RESULTS:

We reviewed 17 cases (majority of which were first-in-class products) where high priced oncology products reached patients faster than the median time to access in their respective countries based MEAs. Nine products (53%) were launched in UK, six (35%) in Italy, and two (12%) in Spain. All MEAs in UK involved manufacturer-led evidence development element, potentially highlighting the payer uncertainty around the clinical data. MEAs allowed reaching patients faster by almost 100 days compared to its median time to access, across these countries. For more innovative technologies (such as, cell therapies), access was 125 days faster on an average. The greatest number of days saved was 209 days, indicating payer acceptance of MEAs as a critical driver for patient access.

CONCLUSIONS:

Engaging payers early in the negotiation process may optimize a faster time to access for high cost oncology products. MEAs may save manufacturers time in the right conditions such as high unmet need in therapy area, difficulty in agreeing on the right level of discounts, and willingness of manufactures and payers to engage in an MEA.