CLINICAL AND BUDGET IMPACT OF USING A TEST TO DETECT KRAS MUTATIONS IN METASTATIC COLORECTAL CANCER PATIENTS IN THE UNITED STATES

Author(s)

Cheng I1, Hertz D2, Huang J1, Poulios N3
1Roche Molecular Systems, Inc., Pleasanton, CA, USA, 2GfK Custom Research, Wayland, MA, USA, 3Roche Molecular Systems Inc., Pleasanton, CA, USA

OBJECTIVES: Anti-epidermal growth factor receptor (EGFR) therapies are ineffective in tumors with KRAS mutations in exon 2 codons 12 and 13. Thus, guidelines have recommended determination of KRAS mutation status in metastatic colorectal cancer (mCRC).  Both the cobas® KRAS Mutation Test (cobas® test, currently available as Research Use Only in the US) and the therascreen KRAS RGQ PCR Kit (therascreen test) detect KRAS mutations in exon 2; cobas® test detects twelve mutations and therascreen test detects seven mutations in exon 2. We estimated the potential clinical and budgetary impact of using the cobas® test versus therascreen test in the mCRC setting. METHODS: A budget impact model comparing the clinical and economic outcomes of using the cobas® test versus therascreen test was developed from the US payer perspective. We assumed 42,000 annual cases of mCRC patients. Model inputs were obtained from literature, whereas testing and treatment costs were calculated from CMS reimbursement rates. KRAS test sensitivity reflected the test’s ability to detect mutations in codons 12 and 13; specificity was assumed to be the same for both tests. The model calculated the average cost for mCRC patients over 5 years, using median time on treatment and median overall survival. Based on current practice patterns, the proportion of patients receiving KRAS testing before 1st-line, 2nd-line, and 3rd-line therapy were 42%, 32%, and 26%, respectively. RESULTS: Adopting the cobas® test resulted in a reduction of 289 patient-months lost due to non-optimal care (i.e. by avoiding anti-EGFR therapies in mutant positive patients) and an improvement in median overall survival.  Adopting the cobas® test generated a total of $2.3 million in cost savings and an average decrease of $7 per mCRC patient per month. CONCLUSIONS: Using the cobas® test with improved sensitivity was associated with a reduction of patient-month lost and a decrease of healthcare costs in mCRC patients.

Conference/Value in Health Info

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

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

Code

PMD17

Topic

Economic Evaluation

Topic Subcategory

Budget Impact Analysis

Disease

Oncology

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