OBJECTIVES: Advanced Therapy Medicinal Products (ATMPs) are therapies expected to cure, halt or slow progression of many disabling diseases among which Alzheimer’s disease (AD). Stem cell therapies targeting AD are in development. Our objective is to evaluate ATMPs Drug budget impact (DBI) on Health Insurance (HI) in AD assuming various efficacy profiles. METHODS: A Markov model was developed to compare two strategies: Standard of care (SoC) and ATMPs for a representative cohort of AD patients over a 5-year period, with 1-month cycle-length. Model input data, SoC costs and quality-adjusted life-year (QALY) data were derived from published sources. We assumed that one procedure allows achieving the outcome. Five efficacy scenarios were tested to evaluate the cost of ATMP procedures assuming an ICER threshold of 30,000£/QALY. DBI was computed by multiplying the procedure cost by AD prevalence in the United Kingdom. RESULTS: In the first and second scenarios, 100% and 50% patients were cured respectively with a DBI of 72,132,071,000£ and 37,357,245,000£. In the third and fourth scenarios, probabilities of progression were reduced by 50% and 33% leading to respective DBI of 1,435,420,500£ and 1,895,457,500£. In the fifth scenario, patients did not progress further and the DBI was 2,839,051,000£. CONCLUSIONS: About 1000 ATMPs are in development of which 65 already in phase III. These therapies are expected to cure, halt or significantly slow down the progression of chronic and severely disabling diseases. If these therapies successfully reach the market they will bring unprecedented clinical and social benefits to patients and the society. However they are likely to severely impact the National Health Service (NHS) budget thus threatening sustainability of the healthcare system. Without deep policy changes in the pharmaceutical interventions pricing, the sustainability of health systems in the EU Member States will be severely threatened.