OBJECTIVES: Disease-modifying therapies targeting early stages of Alzheimer’s disease (AD) are poised to enter the EU5 (France, Germany, Italy, Spain, United Kingdom) markets, where they will need to convince cost-conscious EU5 payers that they are worthy of investment amidst extensive generic presence. This research explored the EU5 market access challenges that emerging DMTs in AD will face.

METHODS: Across the EU5, 10 payers who influence reimbursement nationally or regionally were interviewed, and 254 neurologists were surveyed in 2017. Secondary research analyzed HTA reviews conducted by national and regional HTA agencies in the EU5.

RESULTS: While surveyed neurologists express a willingness to prescribe emerging agents, a reticence to treat pre-AD patients seems evident. Interviewed payers stress that, despite the limited efficacy of existing therapies, all emerging brands must unequivocally show robust superiority on disease progression and symptom relief-over the standard of care to secure positive HTA ratings, favorable pricing negotiations, and optimal access across the EU5. This is especially important in Germany, where there is a strict focus on specific endpoints and subpopulation analysis. Payers also agree that showing a reduction in the overall costs of AD, such as delaying nursing home placement, will constitute a key lever across the EU5. Payers and prescribers note that generic competition will most likely challenge uptake of emerging DMTs; they further warn that the market entry of innovative DMTs will likely herald tight monitoring of detailed prescribing parameters to ensure cost-effective prescribing. However, payers stress that manufacturer assistance with biomarker testing, via companion diagnostics or help with funding and access to testing facilities, will undoubtedly curry favor.

CONCLUSIONS: Although the superiority bar may be low for landmark DMTs, the HTA bar is high. Manufacturers are encouraged to build savvy pricing strategies, formulate compelling justifications of cost-effectiveness, and consider budget implications to optimize market access.