This report examines the importance and history of HTA evaluations for additional uses for cancer drugs after their initial approval. Included are the ten cancer drugs approved by the EMA during 2003–2005. Decisions by France’s HAS, NICE and Aetna in the US are analysed.

This publication examines the importance and history of HTA evaluations for additional uses for cancer drugs after their initial approval.
 
The cohort of cancer drugs included are the ten approved by the EMA during 2003–2005. This time period was chosen based on the assumption that cancer drugs on the market for eight years or more are likely to have been approved for additional indications. New indications, for example, may be for use in a different cancer, disease stage, treatment stage, treatment regimen, or patient population or subpopulation.

The decisions of three entities were included in the study: the Haute Autorité de Santé (HAS) in France, NICE in England and Wales, and Aetna, a private health insurance company in the US. These three were selected to suggest how assessment approaches might differ in interpreting value.

The value of a particular medicine, as this study illustrates well, may not be evident at the time of first approval and value can vary both over time and by indication. This may result in pricing and reimbursement decisions that fail to adequately reward important innovation and so discourage future innovation, to the detriment of society. Public policy options for addressing this challenge include, for example, pricing that varies by indication, and consideration of potential expanded use as part of the initial deliberations, and decisions about pricing and reimbursement.