The document discusses the expanding value of oncology treatments over time. It analyzes 10 cancer drugs approved by the EMA between 2003-2005 to see how their value expanded beyond initial indications. Seven of the 10 drugs gained additional approved uses over time. Health technology assessment bodies need to recognize how product lifecycles affect value, especially for cancer drugs, as innovations may be demonstrated through expanding uses over time. This has implications for designing health technology assessment systems.

1. The Expanding Value Footprint of Oncology Treatments
Rejon-Parrilla, J.C., Hernandez-Villafuerte, K., Shah, K., Mestre-Ferrandiz, J., Garrison, L. and Towse, A.
Email: jmestre-ferrandiz@ohe.org
1. BACKGROUND
•Drugs used in the treatment of cancer patients tend to be more expensive than those in most other therapeutic areas
•At the time of initial regulatory approval, the health outcome gains from the use of new cancer drugs are often seen as being quite modest
•Challenging HTA environment due to high costs of cancer drugs, combined with limited evidence about their impact on key health outcome measures in real-world setting
•Many new cancer drugs have a therapeutic potential well beyond their initial indication
References
•Boston Consulting Group. (2007) Continued development of approved biological drugs: A quantitative study of additional indications approved post launch in the United States. Boston: Boston Consulting Group.
•Shah, K.K., Mestre-Ferrandiz, J., Towse, A. and Smyth, E.N. (2013) A review of health technology appraisals: Case studies in oncology. International Journal of Technology Assessment in Health Care. 29(1), 101-109.
2. AIMS
•Provide a better understanding of how changes in the use of an oncology medicine can affect its aggregate value
3. METHODS
•Examine a cohort of 10 oncology medicines approved by the EMA between 2003 and 2005
•Assess how HAS/NICE/Aetna have assessed value expansions
•Analyse IMS data for five medicines (2004 – 2013)
4.RESULTS
Our analysis support previous analyses; seven of the 10 medicines in the cohort sample have additional value expansions following initial indication HAS assessments: no highest possible ASMR rating of level I
5. DISCUSSION
Results for both HAS and NICE seem to suggest a positive association between gains in overall survival and recommendation decisions NICE’s ‘end-of-life’ policy treatments appears to be leading to more positive decisions for cancer products, and the CDF provides access for medicines not recommended by NICE Advocates for flexible, indication-specific pricing for medicines in order to better reflect their expanding value over time. However, few HTA systems allow for flexible pricing schemes in principle, and almost none do in practice
6. CONCLUSION
Need for health systems and policy makers to recognise how product life-cycle considerations affect the value of medicines, and in particular, oncology medicines Since HTA processes for branded, innovative medicines generally aim to give greater rewards to more significant innovations, it is important to understand that the innovativeness of a given product can be demonstrated in terms of the ways in which its value expands across over time The issues raised in this report should be considered when designing new HTA systems
Acknowledgments This report was commissioned by Eli Lilly and Company, Global Public Policy. It is available at: www.ohe.org We are grateful for the contributions of the Lilly Global Steering Group: Dan Ball, David Grainger, Gary Lee Geipel, Jim Murray and Dan Mytelka – all of whom provided helpful feedback on our interim analyses and earlier drafts of this report. We also wish to thank Phill O’Neill for his contributions to the analysis of the IMS data; and to Lesley Cockcroft for her review of the earlier draft. We are grateful to IMS Health for allowing us access to the IMS database. Any errors in analysis remain the responsibility of the authors
Mixed picture in terms of the correlation between NICE/HAS recommendations and sales in the UK/France
NICE’s end-of-life policy and the Cancer Drugs Fund played an important role in England and Wales