A new OHE Consulting Report examines the importance and history of HTA evaluations for additional uses for cancer drugs after their initial approval. The potential value of a new medicine is not likely to be fully known at the time of marketing approval. New uses can expand both the therapeutic and financial value of a particular medicine. In a new study, OHE Consulting seeks to describe and quantify such ‘value expansion’ for a cohort of cancer drugs.

A new OHE Consulting Report examines the importance and history of HTA evaluations for additional uses for cancer drugs after their initial approval.

The potential value of a new medicine is not likely to be fully known at the time of marketing approval. New uses can expand both the therapeutic and financial value of a particular medicine. In a new study, OHE Consulting seeks to describe and quantify such ‘value expansion’ for a cohort of cancer drugs.

The cohort of cancer drugs included are the ten approved by the EMA during 2003–2005[1]. 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.

Seven of the ten drugs experienced value expansion after initial approval. For both NICE and HAS, a positive decision was more likely the greater the estimated gain in overall survival. HAS assessments of these ten cancer drugs resulted in reimbursement for 93% of the drugs, although this was at fairly low levels for more than 60%. In comparison, 63% of NICE appraisals resulted in a recommendation against use in the NHS. The statistics for Aetna are more difficult to interpret because the company may elect to reimburse for uses that have not been officially approved by the FDA and decisions affect only about 7% of the US population.

The study also tracks changes over time in price, volume and sales for the five medicines associated with the largest number of value expansions: Alimta, Avastin, Erbitux, Tarceva and Velcade. IMS data for 2004 through the end of Q3 2013 were used. Overall, prices, volume and sales were lower in the UK than in France and the US. Not surprisingly, additional licensed indications produced higher sales. However, for France and the UK, special access mechanisms muddy the water somewhat. France’s Temporary Authorisations for Use system in some cases has produced increases in use before an HAS decision; in the UK, sales for some cancer medicines increased after the 2010 introduction of the Cancer Drugs Fund even in the face of unfavourable NICE recommendations. 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.

[1] Alimta, Avastin, Busilvex, Erbitux, Faslodex, Litak, Lysodren, Tarceva, Velcade, Zevalin

The full report is available for download from the OHE Consulting website.

Download: Rejón-Parrilla, J.C., Hernández-Villafuerte, K., Shah, K., Mestre-Ferrandiz, J., Garrison, L.  and Towse, A., 2014. The expanding value footprint of oncology treatments. Consulting report. London: Office of Health Economics.

For additional information about this study and OHE Consulting, please contact Jorge Mestre-Ferrandiz.