The Health Act 2013 requires reimbursement decisions to be made about new drugs by the health payer, and revised every 3 to 5 years. At present these decisions are based on estimates of market share projections and on (often limited) clinical trial data. A large number of cancer drugs, and treatments for rare diseases are funded through the High-Tech Drug scheme (which has increased in spend from €52 million in 2000 to €500 million in 2014.) Post reimbursement, the usage of drugs is tracked by the High-Tech prescription database. Outcome data for patients has been linked with this database and thus provides observational real-world evidence on the effectiveness of the interventions.
The proposed research, in consultation with stakeholders and patient groups: (i) Develops an approach to the synthesis of the evidence contained in the existing large databases together with randomized controlled trial data.
(ii) Informs the pharmacoeconomic evaluation process within the NCPE in terms of appropriate comparators, likely budget impact and real-world compared to clinical trial effectiveness for a given class of drugs.
(iii) Facilitates the re-evaluation of drugs in the High-Tech scheme.
This project brings together statistical and data analytical expertise in order to better inform the choices the Irish state makes in treating its population. The proposal will further develop statistical methodology to allow us to combine data from observational cohorts with randomized controlled trial evidence which will better estimate the efficacy of interventions.
