The cost-effectiveness of nivolumab versus docetaxel in patients with previously treated non-small cell lung cancer (NSCLC) was estimated in a cohort-based, partitioned survival model with three health states (progression-free, progressed disease, and death) and a time horizon of 15 years. The base-case model was developed using extrapolations of progression-free survival (PFS) and overall survival (OS) data from the CheckMate 017 and 057 randomized trials, and 2015 Swedish unit costs. An annual discount rate of 3% was applied. Base-case time-on-treatment was based on PFS (CheckMate 017) or time-to-treatment discontinuation (CheckMate 057), depending on whether PFS was a close proxy for time-on-treatment. Data extrapolations from CheckMate 017 and 057 were validated against external trial and registry data. Model utilities were derived from CheckMate 017 and 057 with UK weights (base-case) and Swedish weights (scenario analysis). Uncertainty was assessed using sensitivity analyses adjusted for clinical, utility, and cost data. Outcomes included incremental cost per quality-adjusted life-year (QALY) gained. The base-case model showed that nivolumab was associated with QALY gains of 0.72 (squamous) and 0.81 (non-squamous) versus docetaxel at an incremental cost of 734,573 SEK (€69,174) and 999,032 SEK (€94,078), respectively. This resulted in an incremental cost per QALY gained for nivolumab versus docetaxel of 1,013,697 SEK (€95,459) and 1,231,664 SEK (€115,985) in squamous and non-squamous NSCLC, respectively. Scenario analysis utilizing Swedish utility weights resulted in slightly lower incremental cost per QALY gained of 855,505 SEK (€80,562) (squamous) and 1,165,401 SEK (€109,745) (non-squamous). Deterministic sensitivity analysis showed that utility weights, treatment costs, discount rates, and body weight were key drivers of cost-effectiveness. Overall, the model showed that cost-effectiveness was driven by nivolumab price, but nivolumab remained cost-effective in squamous and non-squamous NSCLC in accordance with previous appraisals by the Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket) and New Therapies Council in Sweden. Published: Online December 2019.

No abstract

Aims: Nivolumab has been approved for advanced squamous and non-squamous non-small cell lung cancer (NSCLC) following platinum-based chemotherapy in both Canada and Sweden. We aimed to determine the value-for-money of nivolumab versus docetaxel in a Canadian and Swedish setting based on 5-year data. Methods: These cost effectiveness analyses used partitioned survival models with three mutually exclusive health states: progression-free, progressed disease, and death. All clinical parameters were derived from two registration phase 3 randomized trials, CheckMate 017 and CheckMate 057, with a minimum follow-up of 5 years. Treatment duration was based on time-on-treatment data from the clinical trials. Costs were derived from published sources. The primary outcomes of the analyses were quality-adjusted life-years (QALYs), life-years gained, and incremental cost-effectiveness ratios (ICERs). The model input parameters for each analysis were chosen in line with guidance from the respective HTA authorities. Results: From a Canadian payer perspective, the ICERs were CAN$140,753 per QALY in the squamous population, and CAN$173,804 per QALY in the non-squamous population, assuming a 10-year time horizon and a 5% discount rate for both costs and outcomes. Sensitivity analyses demonstrated that changes to the discount rates for outcomes had the highest impact on the ICERs. In the Swedish analysis, the ICERs were SEK568,895 per QALY in the squamous population and SEK662,991 per QALY in the non-squamous population, assuming a 15-year time horizon, a 3% discount rate, and a 2-year maximum treatment duration for nivolumab. Sensitivity analyses demonstrated that the ICERs were most sensitive to changes in the discount rate for outcomes. Conclusion: These updated analyses, based on more mature trial data with a minimum follow-up of 5 years, generate more favorable ICERs versus the previously submitted HTA assessments that resulted in approval of nivolumab for patients with previously treated NSCLC in Canada and Sweden.

No abstract

comparison cohort) who were the same age, race, and gender were identified and matched. A random index date was chosen to minimize selection bias. Patients in both cohorts were required to be at least age 18 years, with continuous medical and pharmacy benefits 1-year pre-and 1-year post-index date. One-to-one propensity score matching (PSM) was used to compare health care costs and utilizations during the follow-up period, between the diseased and comparison cohorts, and adjusted for baseline demographic and clinical characteristics. Results: After risk adjustment by PSM, a total of 19,079 patients in each cohort were matched. Significantly more breast cancer patients had inpatient admissions (23.77% vs. 12.56%, p< 0.0001) and long-term care (7.77% vs. 6.60%, p< 0.0001), other service (99.88% vs. 87.86%, p< 0.0001) and pharmacy visits (77.80% vs. 68.85%, p< 0.0001), compared to those without breast cancer. Breast cancer patients also incurred significantly higher inpatient ($2,141 vs. $1,537, p< 0.0001), long-term care ($7,471 vs. $5,335, p< 0.0001), other service visit ($23,592 vs. $14,780, p< 0.0001) and pharmacy costs ($3,379 vs. $2,787, p< 0.0001) compared to those in the comparison cohort. ConClusions: Breast cancer patients in the Medicaid program incurred substantially higher health care resource utilization and costs compared to those without the disease.

No abstract

Background: Tamoxifen and raloxifene are two selective receptor modulators (SERMs) that have been shown to reduce the risk of developing breast cancer in women at increased risk of the disease. Both drugs are infrequently used in the general U.S. population. Increased knowledge about the risks and benefits of SERM use for breast cancer risk reduction does not lead to increased uptake of chemoprevention. We know little about what influences decision-making regarding breast cancer risk reduction with SERMs. Methods: To better understand what influences SERM decision-making for breast cancer risk reduction we conducted a survey study assessing social, environmental, and psychological factors that may influence a woman's decision. Women who talked to a health care provider (HCP) about SERM use (N=1,023) received a questionnaire immediately after the HCP visit that asked about the counseling session, sociodemographics, experiences with breast cancer, breast cancer risk, and risk perception. After its completion a second survey was administered that inquired about issues surrounding medication intake such as attitudes about taking medicines in general, trust in pharmaceutical companies, and in their HCP. A statistical comparison of survey responses was performed between those who decided to take a SERM and those who decided not to take a SERM. Logistic regression was used to determine a key set of independent factors associated with the decision. Results: Of the 1,023 women, 716 made a decision about SERM intake (70%) and were included in the study. Of those, 324 (45%) decided to take a SERM and 392 (55%) decided not to take a SERM. Of SERM users 89.8% received a recommendation to take a SERM by the HCP compared to 44.4% of non-users. Only 15.7% of SERM users reported never having had a breast biopsy compared to 26.3% of non-users. Overall, SERM users had a higher breast cancer risk, risk perception, and worry about getting breast cancer. In multivariate analysis 11 factors were identified as having independent association with SERM use, including: recommendation from HCP, attitudes and perceptions regarding medication intake, influenced by someone's breast cancer diagnosis, breast cancer worry, trust in HCP, a diagnosis of atypical hyperplasia, and others' experiences with SERM intake. Women who had one or more first degree relatives with breast cancer were less likely to take a SERM. Neither breast cancer risk nor risk perception influenced SERM decision-making. Discussion: Factors that influence SERM decision-making are related to women's personal experiences with breast cancer, their HCP, and attitudes towards medications. Conclusions: Social, environmental, and psychological factors proved to be more important for SERM decision-making than breast cancer risk or risk perception. In addition to presenting risks and benefits in counseling, the importance of personal experiences and attitudes for decision-making need to be considered to understand and support women's decision-making on SERM use for breast cancer risk reduction. SUPPORT: U10CA37377, -69974; -180868, -180822; -189867. Citation Format: Holmberg C, Bandos H, Fagerlin A, Bevers TB, Battaglia TA, Wickerham DL, McCaskill-Stevens W. Results from NRG oncology/NSABP protocol DMP-1: Women's decision-making in breast cancer risk reduction. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P6-10-01.

pembrolizumab) were reviewed nearly twice as frequently (35.8%) as TKIs (16.7%). All immunotherapies, except durvalumab, were evaluated by all studied countries, with a majority of decisions published as favorable (58.1%). High cost of immunotherapies was commonly cited as the reason for unfavorable decisions, while increased evidence for clinical benefit in patient subpopulations was often requested for mixed and neutral decisions. Conclusions: More than half of all HTA decisions were categorized as favorable. Immunotherapies were among the most commonly evaluated NSCLC treatments. Further emphasis on developing and evaluating robust health economic and clinical data is necessary as the landscape shifts towards precision medicine.