Cost-Effectiveness of Ribociclib for Hormone Receptor–Positive HER2-Negative Advanced Breast Cancer

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The international health impact of breast cancer is profound. Widely recognized as the most common cancer affecting women worldwide, in the United States in 2020 there were an estimated 276,480 new breast cancer cases and 42,170 related deaths.1

Patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative breast cancer constitute approximately 70% of breast cancers.2 The recommended standard treatment for patients with HR-positive, HER2-negative advanced breast cancer is endocrine therapy.3,4 However, while it is considered an effective primary or secondary therapy and is generally well-tolerated, the majority of patients receiving this type of treatment eventually develop endocrine resistance, and breast cancer progresses to disease advancement.5

Ribociclib, a novel selective small-molecule inhibitor of CDK4/6, received approval when combined with an endocrine-based therapy as a first- or second-line therapy for postmenopausal patients with HR-positive, HER2-negative advanced or metastatic breast cancer. Ribociclib has shown significant improvements in progression-free survival and overall survival of postmenopausal patients with HR-positive and HER2-negative advanced breast cancer.

Given its high cost, there is a pressing need to further investigate the economic value of ribociclib. Therefore, Yang and colleagues investigated the cost-effectiveness of ribociclib for postmenopausal patients with HR-positive and HER2-negative advanced breast cancer.

A comprehensive Markov model was developed to estimate the cost-effectiveness of ribociclib combined with fulvestrant and compare it with placebo plus fulvestrant as first-line treatment for HR-positive, HER2-negative advanced breast cancer. Variables were estimated based on the 4-week treatment cycle schedule of the MONALEESA-3 study, a randomized phase 3 trial that evaluated ribociclib combined with fulvestrant in postmenopausal, HR-positive, HER2-negative advanced breast cancer patients who had received 1 line of previous endocrine treatment for advanced disease.6 The estimate for quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs) were calculated based on a 10-year time interval.

To reveal the US payer perspective, direct treatment costs were estimated. To verify the robustness of the model, both 1-way and probabilistic sensitivity analyses were conducted. It was determined that fulvestrant plus ribociclib increased the treatment cost by $382,172, and provided 0.47 QALYs, compared with fulvestrant alone, which corresponded to an ICER of $813,132/QALY. According to the researchers, this is the first Markov model–based study investigating the cost-effectiveness of ribociclib plus fulvestrant compared with placebo plus fulvestrant in postmenopausal female patients with HR-positive, HER2-negative advanced breast cancer. Even under the most favorable assumptions, using sensitivity analyses, ribociclib was unlikely to be cost-effective. The chance of cost-effectiveness at a willingness-to-pay threshold of $150,000/QALY, when the cost of ribociclib was <$1384, was >50%. Furthermore, ribociclib was not cost-effective based on additional subgroup analyses. Therefore, the researchers concluded that for treating postmenopausal patients with HR-positive, HER2-negative advanced breast cancer, at current drug prices, ribociclib is unlikely to be cost-effective. To provide more favorable economic outcomes, its cost would need to decrease, despite the clinical benefits of ribociclib.

Source:

Yang J, Han J, Tian M, et al. Cost-effectiveness of ribociclib for hormone receptor-positive HER2-negative advanced breast cancer. Cancer Manag Res. 2020;12:12905-12913.

References

  1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70:7-30.
  2. Waks AG, Winer EP. Breast cancer treatment: a review. JAMA. 2019;321:288-300.
  3. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375:1738-1748.
  4. Baselga J, Campone M, Piccart M, et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012;366:520-529.
  5. Chlebowski RT. Changing concepts of hormone receptor-positive advanced breast cancer therapy. Clin Breast Cancer. 2013;13:159-166.
  6. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382:514-524.

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