Rationale: The 70-gene signature (MammaPrint®, MP) is a prognostic test which guides treatment decisions in patients with early breast cancer. After level 1A evidence for clinical utility of MP has been proven, cost-effectiveness data is important to inform reimbursement. Research objectives: To compare cost-effectiveness of adding MP to clinical risk assessment versus clinical risk assessment alone for the US and EU. Clinical risk was assessed by Adjuvant Online! (AOL) as described in Cardoso et al. NEJM 2016. We used prospective survival data from the large randomized phase 3 trial 'Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy' (MINDACT). Methods: We used a Markov decision model to estimate the expected costs and outcomes (quality adjusted life years; QALYs) for MP versus AOL in early breast cancer patients from a payers perspective in the US and a societal perspective in the EU over a 5 year time horizon. Five year breast cancer overall- and distant metastasis free survival was calculated based on the MINDACT population (n=6,693). Utility scores were collected by means of the EuroQol-5D in the pilot phase of MINDACT(the first n=800 MINDACT patients). Cost data were for the US based on published insurance claim data, for the EU on published health care- and societal costs. The cost-effectiveness was calculated for: (1) total early stage breast cancer population, (2) clinical high risk population and (3) clinical high risk group in the ER+/HER2- population. Finally, budget impact for a high-low range of different countries was calculated, as the application and costs of chemotherapy can be highly variable between countries. Results: For all groups (1,2,and 3) in the US, using MINDACT survival data and insurance claim data, adding MP to AOL saved costs and gained more QALYs compared to AOL alone (total costs per patient $42,223 vs $45,566 and 4.035 vs 4.031 QALYs respectively). Thus, a small difference in quality adjusted life years (0,0041) was observed, whereas a large difference in costs ($3,342) renders MP a highly cost-effective test (less costly & more effective in 64% of the cases). The largest cost-benefit effect was seen for group 3. The cut-off point for MP being cost-effective in the total population (group 1) is when the chemotherapy costs (and consequences) together are above $30,000. In the US, with approximately 250,000 new breast cancer patients per year, and a cost saving of $3,342, annual budget savings are expected to be $836M. Similar results for the Netherlands (15,000 breast cancer patients per year), reveal a cost difference of $300 per patient, and overall annual budget savings are expected to be $4,5M. Conclusion: Adding MP to clinical risk assessment is highly cost-effective compared to clinical risk assessment alone, based on the MINDACT survival data and US insurance claim data, for all above mentioned groups. When costs for chemotherapy (and consequences) exceed $30,000, MP is cost-effective for the total early breast cancer population. When costs for chemotherapy (and consequences) are below $30,000, the MP is cost-effective for the clinical high risk early breast cancer group. The separate results for EU countries will follow.
|Publication status||Published - 2018|
|Event||40th San Antonio Breast Cancer Symposium 2017 - San Antonio, United States|
Duration: 5 Dec 2017 → 9 Dec 2017
Conference number: 40