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CLEOPATRA Phase 3 Study to Find HER2-Positive Metastatic Breast Cancer Treatment

April, 04, 2023 | Breast Cancer

KEY TAKEAWAYS

  • Pertuzumab was added to the TH regimen in metastatic breast cancer patients in the phase 3 CLEOPATRA study.
  • A partitioned survival model-based cost-utility analysis compared pertuzumab with TH versus TH alone.
  • Pertuzumab increased average life years, quality-adjusted life years, and total direct costs.
  • The incremental cost-effectiveness ratio for PTH compared to TH was $29,867, and the Colombian health system’s payers.
  • One-way sensitivity analysis showed pertuzumab cost as the critical variable causing model uncertainty.

Patients with human epidermal growth factor receptor 2 overexpression and metastatic breast cancer benefit from adding pertuzumab to the standard treatment plan of docetaxel plus trastuzumab (TH). Nonetheless, this enhancement may result in a high cost for the health care system in a country with a middle-income level like Colombia. Hence, a comparison of the efficacy of TH and the pertuzumab plus TH (PTH) strategy is essential. The costs and benefits were analyzed using a partitioned survival model. The CLEOPATRA trial provided each strategy’s progression-free survival and overall survival curves. A discount rate of 5% was applied to cost and quality-adjusted life-years over a 30-year time horizon.

National tariffs were used to determine the total direct expenses. The power, water, and heat all came from the outside. Deterministic and probabilistic sensitivity analyses were used to assess the model’s uncertainty.

The willingness to pay was set at USD 5,180. The average discounted price for TH was $24,109, while the average discounted price for PTH was $60,846. Quality-adjusted life-years were 3.28 and 4.51, while average life-years were 5.78 and 8.38 for these treatments. There was a $29,867 save compared to the baseline. According to a univariate sensitivity analysis, the price of pertuzumab was the primary driver of model uncertainty. In the probabilistic sensitivity analysis, the likelihood that PTH is economically viable is 0.0724. Patients with human epidermal growth factor receptor 2-positive metastatic breast cancer are unlikely to have a financial return on investment from including pertuzumab in the TH regimen in the Colombian healthcare system.

Source:https://pubmed.ncbi.nlm.nih.gov/36183606/

Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT00567190

Guevara-Cuellar CA, Parody-Rúa E, Rengifo-Mosquera MP, Del Mar Conde-Crespo M, Nuñez-Castro JM. Cost-Effectiveness Analysis of Pertuzumab Plus Trastuzumab and Docetaxel Compared With Trastuzumab and Docetaxel in the Adjuvant Treatment of Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer in Colombia. Value Health Reg Issues. 2022 Nov;32:109-118. doi: 10.1016/j.vhri.2022.08.002. Epub 2022 Sep 29. PMID: 36183606.

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