Economic evaluation of nivolumab for the treatment of second-line advanced squamous NSCLC in Canada: a comparison of modeling approaches to estimate and extrapolate survival outcomes. and showed that lung cancer patients taking immunotherapy drug pembrolizumab as first-line therapy fared much better than those who got chemo. When we assumed an HR of 0.64 (the lower end of the 95% CI) for the risk of death, the ICER decreased to $249300 per QALY (Figure 3B). Accessed October 9, 2020. For the first time in more than three decades, it has been demonstrated that the addition of immunotherapy to chemotherapy improved the survival of patients with extensive-stage SCLC, thereby immunotherapy plus chemotherapy established a new . We used Amua software (version 0.3.0) to perform the analysis. Having a good and consistent relationship with your primary care provider can be essential to preventing the onset of chronic disease for early detection. US Food and Drug Administration . Our arsenal of monoclonal antibodies is rapidly growing, as scientists continue to look for new targets to attack different types of cancer cells. Nafees B, Lloyd AJ, Dewilde S, Rajan N, Lorenzo M. Health state utilities in nonsmall cell lung cancer: an international study. However, a series of small differences in model construction and variable choice may explain the differences in ICERs between our study and previous research. Both use drugs to stop the cancer from growing, but they achieve this in different ways. Utility estimates were derived from prior literature (30). ) reveal that compared with chemotherapy, N+I had a higher probability of being cost-effective at a willingness-to-pay threshold above $238,000 per QALY for all patients, $245,000 per QALY for patients with PD-L1 1%, and $187,000 per QALY for patients with PD-L1<1%. Figure3 Immunotherapy can be given alone, or in combination with other types of cancer treatments. Dynamic Changes of Health Utility in Lung Cancer Patients Receiving Different Treatments: A 7-Year Follow-Up. Combination Therapy of Mithramycin A and Immune Checkpoint Inhibitor for the Treatment of Colorectal Cancer in an Orthotopic Murine Model. Following Granting of Indian Patent, Indaptus Therapeutics - GlobeNewswire If patients received immunotherapy as the second-line therapy, nivolumab was selected for three groups because it was most popularly used in the trials. Patients entered the Markov model in the stable disease state; they could then remain in the stable disease state or experience toxic effects, disease progression, or death. Ipilimumab with nivolumab was the most effective strategy (10.69 life-years and 9.25 QALYs for the third line; 10.69 life-years and 9.44 QALYs for the first line) in comparison with nivolumab (8.21 life-years and 6.76 QALYs for the third line; 8.21 life-years and 7.00 QALYs for the first line), trifluridine and tipiracil (0.74 life-years and 0.07 QALYs), and mFOLFOX6 and cetuximab (2.72 life-years and 1.63 QALYs). NCCN guidelines for treatment of cancer by site: nonsmall cell lung cancer. Results: FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC. The site is secure. If we took this issue into consideration and assumed that every non-squamous NSCLC patient received pemetrexed maintenance therapy after pemetrexed plus carboplatin, the ICERs of N+I versus chemotherapy for all patients, patients with PD-L1 1%, and patients with PD-L1 < 1% would become $212,823, $220,670, and $200,814 per QALY, respectively, which were still higher than the willingness-to-pay threshold value. The findings suggest that first-line treatment with nivolumab-ipilimumab combination therapy is not cost-effective at current prices despite clinical trial data indicating that this therapy increases overall survival among patients with advanced nonsmall cell lung cancer. 2020. Study concept and design: S-CY and S-YW. Ramsey SD, Bansal A, Fedorenko CR, et al.. Financial insolvency as a risk factor for early mortality among patients with cancer. Health utility values are summarized in the Table along with their respective literature sources.39,42,43,44 An annual discount rate of 3% was applied to all costs and QALYs. eCollection 2023. N+I+chemotherapy, as compared with N+I, had a higher probability of being cost-effective at a threshold above $838,000 per QALY for all patients. Per the CheckMate 227 protocol, certain patients could continue receiving immunotherapy after disease progression if they met prespecified criteria; therefore, we conducted a sensitivity analysis in which patients who experienced disease progression continued to receive immunotherapy for up to 2 years regardless of disease progression. Economic evaluation of therapeutic cancer vaccines and immunotherapy: a systematic review. Courtney PT, Yip AT, Cherry DR, Salans MA, Kumar A, Murphy JD. However, the proportion of deaths attributable to other comorbidities in patients with metastatic NSCLC was only about 6% (33), and our modeled overall survival was similar to the trial results. 2020. UpToDate. Side effects from immunotherapy drugs may include: Fatigue Skin rash Itching Zhang X, Wu T, Cai X, Dong J, Xia C, Zhou Y, Ding R, Yang R, Tan J, Zhang L, Zhang Y, Wang Y, Dong C, Li Y. Rarer but more serious side effects can include infusion reactions and autoimmune reactions. Our study found both higher incremental costs and lower incremental effectiveness (as measured by QALY) for nivolumab-ipilimumab combination therapy compared with these other studies, which produced substantially higher ICERs in our analysis. Some can stimulate your immune system to recognize cancer cells and work harder to vanquish them. When we assumed that all patients alive at the end of the study (42 months) were cured of disease, the ICER decreased to $317300 per QALY. Surgery versus stereotactic body radiation therapy for stage I nonsmall cell lung cancer: a comprehensive review, Recurrence after surgery in patients with NSCLC. The respective ICERs for patients with PD-L1 1% were $246,584 per QALY and $1,092,784 per QALY. Skin irritation around the injection site. The study model was sensitive to the cost and duration of immunotherapy. government site. The proportion of patients in the CheckMate 227 clinical trial who received maintenance pemetrexed was not published. FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression 1%). Some blood cancers can also respond well to immunotherapy. This phenomenon, known as pseudoprogression, isnt uncommon for immunotherapy, and it doesnt mean that the treatment isnt working. Tringale KR, Carroll KT, Zakeri K, Sacco AG, Barnachea L, Murphy JD. Conclusions Progression and survival data were extracted from the reported Kaplan-Meier curves using previously described methods.19,21,22 Model validation is shown in Figure 2 and eTable 1 in the Supplement, with model-predicted survival overlying the Kaplan-Meier estimates from the CheckMate 227 clinical trial. Indaptus Therapeutics has evolved from more than a century of immunotherapy advances. That means it is better at finding and attacking cancer cells. Cost-Effectiveness Analysis of Nivolumab Plus Ipilimumab vs. Abbreviations: AWP, average wholesale price; NA, not applicable. Disclaimer. Carboplatin: drug information. The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fonc.2021.760686/full#supplementary-material, National Library of Medicine Conflict of Interest Disclosures: Dr Kumar reported having equity in Sympto Health outside the submitted work. Analysis of stage and clinical/prognostic factors for lung cancer from SEER registries: AJCC staging and collaborative stage data collection system, Trends in the incidence, treatment, and survival of patients with lung cancer in the last four decades, Survival and prognostic factors of nonsmall cell lung cancer patients with postoperative locoregional recurrence treated with radical radiotherapy. Accessed October 9, 2020. Supplementary Figure2 This study has several limitations. Cost-effectiveness of immune checkpoint inhibitors for - PubMed The probability was 0.4% for patients with PD-L1 1% and 10.6% for patients with PD-L1 < 1%. ) (6, 7). For instance, in chemotherapy (and radiation) treatments, targeted tumors may start shrinking immediately. These attacks on healthy cells may causes some of chemotherapys more well-known side effects, such as hair loss and nausea. 1 Immunotherapy has already led to major advances in the treatment of many types of cancers, and has been approved as a first line of treatment for several. the contents by NLM or the National Institutes of Health. ). JAMA Network Open. Further, instead of simply assigning docetaxel as the second-line chemotherapy for all groups (17), we explicitly modeled the subsequent treatment based on the trial data. Research has shown that immune checkpoint inhibitor (ICI) monotherapy for patients with tumor programmed death-ligand 1 (PD-L1) expression 50% (1), and a single-agent ICI in addition to chemotherapy (24) or bevacizumab plus chemotherapy (5) for patients regardless of PD-L1 levels improved overall survival and progression-free survival. In contrast to the base-case results on the CheckMate 227 trial, N+I was weakly dominated by N+I+chemotherapy in all patients and patients with PD-L1 1%, and N+I no longer dominated N+I+chemotherapy in patient with PD-L1 < 1%. Immunotherapy for Lung Cancer: Types, Side Effects & More The second study51 also found slightly lower ICERs when comparing nivolumab-ipilimumab combination therapy with chemotherapy ($107404 per QALY vs $172589 per QALY, respectively) and used a willingness-to-pay threshold of $150000 per QALY. muscle pain or joint pain. Federal government websites often end in .gov or .mil. Researchers are currently working to lessen the serious side effects of CAR T-cell therapy, and I'm hopeful that this will become an increasingly safe and viable option in the years to come. Chongqing T, Sini L, Xiaohui Z, Liubao P, Ye P, Shuxia Q, Liting W, Meiyu W, Xiaomin W. Front Pharmacol. Cost-Effectiveness Analysis of Pembrolizumab Versus Chemotherapy as First-Line Treatment in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 Tumor Proportion Score 1% or Greater, First-Line Nivolumab Plus Ipilimumab vs Sunitinib for Metastatic Renal Cell Carcinoma: A Cost-Effectiveness Analysis. This is a relatively new treatment (currently there are only three CAR T-cell therapies approved in the United States) and some people have had very serious side effects from it. Understanding the difference between immunotherapy and chemotherapy is the first step towardmaking the right decision and finding the best treatment options available. Federal government websites often end in .gov or .mil. We concomitantly compared the two front-line treatments and chemotherapy by abstracting the efficacy and safety data from phase 3 randomized trials (6, 7), and incorporated time-dependent transitional probabilities during the follow-up period for disease progression; thus, our simulation model was able to accurately reflect the effectiveness estimates. colorectal neoplasms; cost-benefit analysis; immunotherapy; ipilimumab; nivolumab. Using this sequencing process, scientists look for unique genetic attributes of the cancer to see if the patient might respond well to a targeted new drug, or perhaps be eligible to join a clinical trial that's testing a new therapy. We conducted sensitivity analyses using the chemotherapy group in CheckMate 9LA trial as the reference. Similar ICER results were also recognized in two previous studies (17, 18). Impact of cytotoxic T lymphocytes immunotherapy on prognosis of colorectal cancer patients. Cost-Effectiveness of Pembrolizumab in Combination With Chemotherapy Versus Chemotherapy and Pembrolizumab Monotherapy in the First-Line Treatment of Squamous Non-Small-Cell Lung Cancer in the US. The incremental cost-effectiveness ratio (ICER) of N+I versus chemotherapy was $239,072 per QALY, and $838,198 per QALY for N+I+chemotherapy versus N+I. Subscribe to the CRI email newsletter. and transmitted securely. Generally, if you have health insurance, you can expect to pay 10 to 15 percent of chemo . "Chemotherapy is a reactive approach. Furthermore, N+I+chemotherapy was dominated by N+I for patients with PD-L1 < 1%. As with most treatments, immunotherapy comes with possible side effects, including: Chills. CAR-T cell therapy is a kind of immunotherapy. However, neither checkpoint inhibitor therapy was cost-effective in comparison with trifluridine and tipiracil (nivolumab ICER, $153,000; ipilimumab and nivolumab ICER, $162,700) or mFOLFOX6 and cetuximab (nivolumab ICER, $150,700; ipilimumab and nivolumab ICER, $158,700). Cost-Effectiveness of First-Line Versus Second-Line Pembrolizumab or Chemotherapy in Patients With Microsatellite-Instability-High/Mismatch Repair-Deficient Advanced Colorectal Cancer. Its effectiveness has also been proven against types of cancer that have been historically resistant to chemotherapies and radiation treatments. Given the increases in health care spending over time, we acknowledge that the willingness-to-pay threshold of $150,000 per QALY might be under-estimated. The transition probabilities for these events were derived from CheckMate 227 data. A cost-effectiveness analysis of nivolumab versus docetaxel for advanced nonsquamous NSCLC including PD-L1 testing, Modelled economic evaluation of nivolumab for the treatment of second-line advanced or metastatic squamous nonsmall-cell lung cancer in Australia using both partition survival and Markov models, Nivolumab versus docetaxel for previously treated advanced nonsmall cell lung cancer in China: a cost-effectiveness analysis. Another potential limitation is the heterogeneous array of resources used to inform estimations about costs and health utilities. That's not to say there are no side effects with immunotherapies. Healthline. The immune system helps your body fight infections and other diseases. 8600 Rockville Pike As the movement toward value-based practice, our comparison between N+I+chemotherapy and N+I has important clinical implication. Immunotherapy: precision medicine in action. Received 2020 Nov 30; Accepted 2021 Mar 12. Nivolumab: drug information. Knowing more about each can help you talk with your treatment team and make decisions about your care. When we adjusted our model so that all patients receiving nivolumab-ipilimumab continued to receive combination immunotherapy beyond disease progression and for up to 24 months, the ICER of nivolumab-ipilimumab therapy increased to $551900 per QALY. We also evaluated cost-effectiveness among patients with PD-L1levels of 50% or higher in a separate sensitivity analysis. As a library, NLM provides access to scientific literature. Learn about common signs and symptoms that indicate you should seek emergency care. The site is secure. Insinga RP, Vanness DJ, Feliciano JL, Vandormael K, Traore S, Ejzykowicz F, et al.. However, our model was not particularly sensitive to assumptions about cost or health utility, which suggests that including more accurate estimations would be unlikely to change our results. Immunotherapy can boost the immune response in the body as well as teach the immune system how to identify and destroy cancer cells. TreeAge Pro Healthcare software, version 2020 R1.2 (TreeAge Software, LLC) was used to construct and analyze our Markov models. Accessed October 9, 2020. 29 Broadway, Floor 4 Treatment with nivolumab-ipilimumab combination therapy was associated with an increase in overall cost of $201900 and improved effectiveness of 0.50 QALYs compared with chemotherapy, yielding an ICER of $401700 per QALY. The researchers used a higher willingness-to-pay threshold ($150000 per QALY) and concluded that nivolumab-ipilimumab combination therapy could be considered cost-effective among patients with a PD-L1level of less than1%. Cost-Effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Braithwaite RS, Meltzer DO, King JT, Jr., Leslie D, Roberts MS. What Does the Value of Modern Medicine Say About the $50,000 Per Quality-Adjusted Life-Year Decision Rule, Reporting Net Survival in Populations: A Sensitivity Analysis in Lung Cancer Demonstrates the Differential Implications of Reporting Relative Survival and Cause-Specific Survival. If your treatment plan includes immunotherapy, knowing how it works and what to expect can often help you prepare for treatment and make informed . Like chemotherapy, cancer immunotherapy can be expensive. 2023 Jan 16;13:1122669. doi: 10.3389/fonc.2023.1122669. We applied a lifetime horizon, half-cycle correction and an annual discount rate of 3% (21) for costs and QALYs. The value and cost of immunotherapy cancer treatments. 2020. Help with costs Summary Medicare covers immunotherapy treatment for cancer. Accessed October 9, 2020. Please enable it to take advantage of the complete set of features! Sarcomas: Unique Cancers that Merit Further Attention and Research, CRIs Wear White Luncheon Raises Over $30,000, Why Do We Get Cancer? In accordance with the Checkmate 227 protocol, patients who were receiving upfront chemotherapy in our base case model also received treatment until disease progression, development of unacceptable toxic effects, or 3 months (4 chemotherapy cycles) of treatment time, whichever occurred first. In order to destroy cancerous tumors, chemotherapy is intended to attack rapidly dividing cells within the body, which may include both cancerous and non-cancerous cells, such as hair follicles and the lining of the gut. Treatment with nivolumab-ipilimumab combination therapy was associated with an increase in effectiveness of 0.50 QALYs from 1.18 QALYs for chemotherapy to 1.68 QALYs for nivolumab-ipilimumab combination therapy. If cost of nivolumab plus ipilimumab reduced to $23,912, the ICER would be $182,253 per QALY for patients with PD-L1 1% and $145,802 per QALY for patients with PD-L1 < 1%. Associated Costs of Grade 3 to 4 Treatment-Related Adverse Events, eTable 3. The analyzed outcomes included survival (life-years), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). The analysis was conducted from the U.S. health care sector perspective and a willingness-to-pay threshold of $150,000 per QALY was selected (20). ; Swiss Group for Clinical Cancer Research . Costs vary based on several factors : The type of immunotherapy you receive How often you take immunotherapy Your insurance status and coverage For example, Keytruda is an immunotherapy drug used to treat several kinds of cancers. Cost-effectiveness of pembrolizumab in combination with chemotherapy versus chemotherapy and pembrolizumab monotherapy in the first-line treatment of squamous nonsmall-cell lung cancer in the US. In this study, first-line treatment with nivolumab-ipilimumab combination therapy was not found to be cost-effective at current prices despite clinical trial data indicating that this regimen increases overall survival among patients with advanced NSCLC. Immunotherapy for Cancer - NCI Treatment effectiveness was measured in quality-adjusted life-years (QALYs), which is a weighted aggregate of health utilities over time. Wang H, Huang L, Gao P, Zhu Z, Ye W, Ding H, Fang L. BMJ Open. Platinum-doublet chemotherapy was allowed to be used for a maximum of 12 weeks, whereas nivolumab plus ipilimumab could be continued for a maximum of 2 years according to the trial design. After a patient completes a course of chemotherapy or radiation, there's often the lingering worry that cancer will return. Chemotherapy and Immunotherapy. This website uses tracking technologies, such as cookies, to provide a better user experience.
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