REIMBURSEMENT RECOMMENDATIONS FOR CANCER PRODUCTS WITHOUT STATISTICALLY SIGNIFICANT OVERALL SURVIVAL DATA- A REVIEW OF CANADIAN PCODR DECISIONS

Author(s)

Heyland K1, Samjoo IA2, Grima DT1
1Cornerstone Research Group, Burlington, ON, Canada, 2Cornerstone Research Group Inc., Burlington, ON, Canada

OBJECTIVES: Overall survival (OS) data for cancer products is an important endpoint to payers.  This study sought to examine (1) what proportion of positive reimbursement recommendations by the pan-Canadian Oncology Drug Review (pCODR) occurred despite unavailable statistically significant overall survival data, and (2) the proportion of negative recommendations that noted a lack of overall survival data as a contributing factor.  METHODS: Recommendations publicly accessible at www.pcodr.ca and reimbursementdecisions.com were reviewed for the period 13 July 2011 - 9 December 2013. RESULTS: During this time period, 28 submissions containing 32 oncology-specific indications were deliberated on by the pCODR committee.  Of the eight indications that received a negative recommendation, only one had statistically significant overall- and progression-free survival data. A total of 24 indications received positive recommendations.  Of these, two were based on single-arm Phase II clinical trials.  The remaining 22 positive recommendations were based on randomized controlled trials (RCTs), with 19 including OS as an endpoint.  Seven of these 19 indications had statistically significant OS data based on the most recent data cut included in the manufacturer’s submission to pCODR, while the remaining 12 either did not have statistically significant OS data or the OS data were immature (i.e., median OS not yet reached) at the time of submission. More than half of the 12 submissions with non-significant OS trial data allowed cross-over in the trial (n=9) thereby potentially confounding the clinical benefit of the active therapy.  Of the 19 positive recommendations which had an RCT design and assessed OS as an endpoint, progression-free survival (PFS) was statistically significant with or without additional clinically or statistically significant secondary endpoints. CONCLUSIONS: This study highlights that positive pCODR recommendations may be made in the absence of a clear OS benefit, provided strong PFS and or additional endpoint data exist.

Conference/Value in Health Info

2014-05, ISPOR 2014, Palais des Congres de Montreal

Value in Health, Vol. 17, No. 3 (May 2014)

Code

PCN189

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Oncology

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