REIMBURSEMENT DECISION LANDSCAPE FOR METASTATIC BREAST CANCER THERAPIES- A COMPARISON OF FACTORS LEADING TO FAVORABLE AND UNFAVORABLE RECOMMENDATIONS ACROSS LEADING HTA AGENCIES

Author(s)

Banerjee P, Gupta J, Kumar P, Kapoor A, Mazumder D
Optum Global Solutions, Noida, India

OBJECTIVES: To compare the reimbursement recommendations and rationale for decisions for metastatic breast cancer therapies across seven HTA agencies. METHODS: We assessed HTA reports published by AHRQ, HAS, IQWiG, NICE, PBAC, pCODR and SMC for metastatic breast cancer therapies. Decisions were categorized as positive, negative or deferred, and recommendation summaries were analyzed to identify clinical and economic factors affecting decisions. RESULTS: Thirty-nine HTA reports were identified, of which 46% had a positive recommendation. No relevant HTA reports were published by AHRQ. Highest positive decisions were provided by pCODR (80%), all being conditional on improving cost-effectiveness to an acceptable level. Major factors driving positive decisions were overall survival (OS) benefit for IQWiG and pCODR; acceptable efficacy and safety for HAS; and cost-effectiveness versus relevant comparator(s) for NICE, PBAC and SMC. Highest percentage of negative decisions was provided by NICE (75%). HAS cited lack of survival benefit (OS or progression-free survival) or quality-of-life improvement, or unacceptable safety profile for negative decisions; whereas, pCODR and IQWiG mainly considered lack of OS benefit and inappropriate comparators.  Negative decisions by NICE, PBAC and SMC were mainly due to economic modelling issues that resulted in high ICERs. NICE also considered lack of quality-of-life benefit and unacceptable safety profile for negative decisions. Major economic modelling issues across HTA agencies included inappropriate extrapolation of immature OS data, carry-over of benefit into post-treatment states, improper cross-over adjustment, non-inclusion of adverse event-related disutilities and costs, underestimation of post-progression utility and costs, overestimation of comparator drug costs, and underestimation of resource use costs. CONCLUSIONS: The study findings indicate that manufacturers should consider providing data supporting OS benefit versus relevant comparators. Also, a robust economic model including sensitivity analysis to adjust for uncertainties, and incorporating appropriate cost and utility values could be beneficial to gain access in CEA markets.

Conference/Value in Health Info

2015-05, ISPOR 2015, Philadelphia, PA, USA

Value in Health, Vol. 18, No. 3 (May 2015)

Code

CN4

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

Oncology

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