Raymond C Chang, Joanna Huang, James Hurst, Daniel Reck, Kat Khachatourian, Michael H Shannon
{"title":"Benefits of dapagliflozin in chronic kidney disease for US commercial payers: A cost-offset analysis.","authors":"Raymond C Chang, Joanna Huang, James Hurst, Daniel Reck, Kat Khachatourian, Michael H Shannon","doi":"10.18553/jmcp.2024.30.8.834","DOIUrl":"10.18553/jmcp.2024.30.8.834","url":null,"abstract":"<p><strong>Background: </strong>One in 7 adults have chronic kidney disease (CKD), which is associated with high morbidity and mortality and substantial health care costs, especially in more advanced disease. Our data from a US commercial payer show rising per-member-per-year costs for renal and cardiac complications associated with CKD.</p><p><strong>Objective: </strong>To predict the clinical and economic impact of treatment with or without dapagliflozin from the perspective of a US commercial payer using a cost-offset model (COM).</p><p><strong>Methods: </strong>The COM used real-world cost and member count data from a US employer-sponsored commercial payer and results of the double-blind, randomized, phase 3 Dapagliflozin and Prevention of Adverse Outcomes in CKD clinical trial (NCT03036150) to predict the incidence of clinical events, including a greater than or equal to 50% decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, and hospitalization for heart failure, and their associated costs over a 3-year period. The COM compared a hypothetical scenario of the experience with or without dapagliflozin in members with CKD stages 2-4, aged younger than 65 years.</p><p><strong>Results: </strong>In the simulated populations of 130 members, the COM projected 9 events of a greater than or equal to 50% decline in estimated glomerular filtration rate for the experience with dapagliflozin vs 15 events for the experience without dapagliflozin (6 fewer events; number needed to treat [NNT] = 20, amounting to estimated cumulative cost offsets of $0.57 million [M] over a 3-year period). The COM projected similar results for end-stage kidney disease (8 events with dapagliflozin vs 14 events without dapagliflozin; NNT = 24, amounting to $1.92 M in cumulative cost offsets) and for hospitalization for heart failure (13 events with dapagliflozin vs 33 events without dapagliflozin; NNT = 7, amounting to $0.79 M in cumulative cost offsets). These projections translated to total mean, cumulative cost offsets of $3.89 M for all clinical events evaluated over the 3-year period (36.6% reduction with dapagliflozin vs without dapagliflozin), and net mean, cumulative cost offsets of $2.58 M over the 3-year period (24.2% reduction with dapagliflozin vs without dapagliflozin) after factoring in a discounted wholesale acquisition cost for dapagliflozin expenditure ($1.31 M over 3 years). Thus, the net mean, cumulative cost offsets were $19,843 per member over 3 years, representing a 197% return on investment for dapagliflozin expenditure.</p><p><strong>Conclusions: </strong>Results of our COM suggest that dapagliflozin can reduce clinical events and their associated costs over a 3-year period when compared with a scenario without dapagliflozin. Cost offsets increased with each year, indicating that US commercial payers can substantially reduce costs associated with CKD morbidity and mortality.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 8","pages":"834-842"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293758/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jyotirmoy Sarker, Jeffrey A Tice, David M Rind, Steven D Pearson, Surrey M Walton
{"title":"The impact of capping health system cost savings on the projected cost-effectiveness of etranacogene dezaparvovec compared with factor IX prophylaxis for the treatment of hemophilia B.","authors":"Jyotirmoy Sarker, Jeffrey A Tice, David M Rind, Steven D Pearson, Surrey M Walton","doi":"10.18553/jmcp.2024.30.8.868","DOIUrl":"10.18553/jmcp.2024.30.8.868","url":null,"abstract":"<p><p>This viewpoint discusses cost-effectiveness estimates for EtranaDez, a gene therapy for hemophilia B, using the Institute for Clinical and Economic Review's (ICER) framework for single and short-term therapies (SSTs). EtranaDez offers long-term benefits from a single administration, in contrast to the high costs and frequent dosing required by current factor IX prophylaxis. However, the projected gains in health from EtranaDez are small relative to the cost implications of the therapy, and consequently, how the cost offsets associated with EtranaDez are counted has a substantial impact on assessing its cost-effectiveness. Strategies for assessing cost offsets used in the ICER SST framework include a 50/50 cost-sharing model between the health care system and the manufacturer and a cap of $150,000 annually on health care cost offsets. Results from the standard full cost-offset analysis as reported by ICER depicted EtranaDez as a dominant therapy with substantial cost savings compared with factor IX prophylaxis. However, while considering the ICER SST framework, particularly the $150,000 annual cap scenario, the cost-effectiveness was significantly reduced. The incremental cost-effectiveness ratio varied notably between these scenarios, challenging the conventional perception of value of gene therapy in health care. These cost-sharing scenarios highlight the potential of the ICER SST framework to help curtail inefficient health care spending. In cases in which the cost of existing treatment is exceedingly high, the application of such frameworks would improve efficiency in resource allocation, fostering a balance between incentives for innovation and economic sustainability in managed care systems.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 8","pages":"868-872"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
David Choi, Autumn D Zuckerman, Svetlana Gerzenshtein, Katherine V Katsivalis, Patrick J Nichols, Marci C Saknini, Megan P Schneider, Paige Taylor, Stacie B Dusetzina
{"title":"A primer on copay accumulators, copay maximizers, and alternative funding programs.","authors":"David Choi, Autumn D Zuckerman, Svetlana Gerzenshtein, Katherine V Katsivalis, Patrick J Nichols, Marci C Saknini, Megan P Schneider, Paige Taylor, Stacie B Dusetzina","doi":"10.18553/jmcp.2024.30.8.883","DOIUrl":"10.18553/jmcp.2024.30.8.883","url":null,"abstract":"<p><p>Insurer or self-insured employer's plans are increasingly using copay accumulator, copay maximizer, and alternative funding programs (AFPs) to reduce plan spending on high-priced prescriptions. These programs differ in their structure and impact on patient affordability but typically decrease the insurer or self-insured employer's financial responsibility for high-priced drugs and increase the complexity of specialty medication access for patients. The aim of this primer is to describe the structure of copay accumulator, copay maximizer, and AFPs to improve understanding of these cost-shifting strategies and help clinicians and patients navigate medication access and affordability issues to minimize treatment delays or non-initiation.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 8","pages":"883-896"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293768/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Considerations for US coverage and reimbursement: Which digital health products to evaluate? Findings from a modified Delphi study.","authors":"Jennifer S Graff","doi":"10.18553/jmcp.2024.30.8.854","DOIUrl":"10.18553/jmcp.2024.30.8.854","url":null,"abstract":"<p><strong>Background: </strong>The rapid growth of digital health tools, including digital applications, wearables, sensors, diagnostics, digital therapeutics (DTx), and prescription DTx, offers new ways to treat patients and close gaps in care. Payers need transparent, credible, and efficient processes to differentiate products for potential reimbursement from the larger universe of digital health products.</p><p><strong>Objective: </strong>To identify areas of agreement, disagreement, and rationale for payers to determine which digital health products should be evaluated for formulary consideration and to develop generalizable criteria for health care decision-makers developing policies and approaches for digital health products.</p><p><strong>Methods: </strong>Experts from the Academy of Managed Care Pharmacy DTx Advisory Group Payer Evaluation subcommittee rated whether a pharmacy and therapeutics committee, health technology assessment group, or an innovation center within a health plan or pharmacy benefit manager should consider 14 hypothetical products for potential formulary coverage. Using a 4-step modified Delphi approach, experts rated whether it was appropriate for a payer to evaluate each product on a scale of 1 (strongly disagree) to 9 (strongly agree). Quantitative agreement was assessed using terciles of responses, medians, and the distribution of appropriateness scores. The corresponding discussions are summarized to identify generalizable criteria for payers to consider as they develop approaches to determine which digital health products to evaluate.</p><p><strong>Results: </strong>Among the 14 hypothetical products, 4 achieved quantitative agreement that payers <i>should</i> evaluate the product. 5 products had quantitative disagreement, and the remaining were indeterminant. Payers were most likely to review a product if it (1) was reviewed by the US Food and Drug Administration, (2) required a prescription, (3) was intended to be paid for using premium dollars, (4) treated rather than diagnosed or monitored a clinical condition, (5) had a low clinical opportunity cost, and (6) could address population health metrics.</p><p><strong>Conclusions: </strong>The rapid availability of digital health and DTx options can be daunting for health care decision-makers when determining which products to evaluate. These generalizable criteria can help payers develop a more efficient process.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 8","pages":"854-859"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gary Oderda, Diana Brixner, Joseph Biskupiak, James Harnett, Chieh-I Chen, Ruben G W Quek
{"title":"Evolving oncology care management trends in the United States: A survey among health care decision makers.","authors":"Gary Oderda, Diana Brixner, Joseph Biskupiak, James Harnett, Chieh-I Chen, Ruben G W Quek","doi":"10.18553/jmcp.2024.30.8.825","DOIUrl":"10.18553/jmcp.2024.30.8.825","url":null,"abstract":"<p><strong>Background: </strong>There is limited knowledge of how US managed care professionals view and prioritize quality metrics/performance measures, care models, alternative payment models, and clinical pathways in oncology settings.</p><p><strong>Objective: </strong>To characterize payor perspectives on, and the use of, oncology clinical pathways and performance measures in their reimbursement/access decision-making process.</p><p><strong>Methods: </strong>A survey was implemented via SurveyMonkey software and distributed electronically to a national sample of the Academy of Managed Care Pharmacy (AMCP) Market Insights Panel members from July 11 through August 5, 2022. The survey was created by a steering committee based on literature reviews of the current and future oncology care landscapes. The survey consisted of 47 questions, including those to establish respondents' position, responsibilities, and demographics. The results are presented as descriptive statistics for 7 key questions that covered the perceptions and use of quality metrics/performance measures, alternative payment models, and oncology care pathways as prioritized by the steering committee.</p><p><strong>Results: </strong>Among the 695 AMCP panel members who were sent the survey, 73 responded (response rate 10.5%), 54 were eligible to continue, and 31 completed the entire questionnaire; the low response rate may limit generalizability of the survey results. Specific oncology clinical and economic measures of performance were currently used (70%-88%) but generally received less endorsement for future use (39%-49%) except for chemotherapy during end of life, which was considered for future use by 80% of respondents but was only currently used by 31%. Benchmarking was the primary reason for the use of performance measures; only 27% used these to inform value-based agreements. Real-world data tracked by respondents' institutions primarily focused on managed care and pharmacy utilization (39%-85%), with patient-reported and clinical outcomes tracked by only 17%-34%. Almost one-third (31%) did not use clinical oncology pathways, and among those who did, fewer than half (48%) reported that their organization tracks whether treatment decisions agree with the oncology care pathways, and only 26% reported feedback to oncology providers on how often their treatment decisions agree with the pathways. When considering alternative payment models, patient-related components received lower rankings in importance than clinical relevance, actionability, and costs.</p><p><strong>Conclusions: </strong>Variation among payors regarding current trends in oncology care management, including on the importance of patient-centric outcomes and the use of oncology clinical pathways, suggests the need to focus on value-based health care and greater uptake of oncology clinical pathways.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 8","pages":"825-833"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293761/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Oralee J Varnado, Michelle Vu, Erin Buysman, Gilwan Kim, Gayle Allenback, Margaret Hoyt, Helen Trenz, Feng Cao, Lars Viktrup
{"title":"Health care resource utilization and direct costs incurred over 24 months after initiating galcanezumab or standard-of-care preventive migraine treatments in the United States.","authors":"Oralee J Varnado, Michelle Vu, Erin Buysman, Gilwan Kim, Gayle Allenback, Margaret Hoyt, Helen Trenz, Feng Cao, Lars Viktrup","doi":"10.18553/jmcp.2024.30.8.792","DOIUrl":"10.18553/jmcp.2024.30.8.792","url":null,"abstract":"<p><strong>Background: </strong>Health care resource utilization (HCRU) and direct costs incurred over 12 months following initiation of galcanezumab (GMB) or standard-of-care (SOC) preventive migraine treatments have been evaluated. However, a gap in knowledge exists in understanding longer-term HCRU and direct costs.</p><p><strong>Objective: </strong>To compare all-cause and migraine-related HCRU and direct costs in patients with migraine initiating GMB or SOC preventive migraine treatments over a 24-month follow-up.</p><p><strong>Methods: </strong>This retrospective study used Optum deidentified Market Clarity Data. The study included adults diagnosed with migraine, with at least 1 claim for GMB or SOC preventive migraine therapy (September 2018 to March 2020), with continuous enrollment for 12 months before and 24 months after (follow-up) the index date (date of first GMB or SOC claim). Propensity score (PS) matching (1:1) was used to balance cohorts. All-cause and migraine-related HCRU and direct costs for GMB vs SOC cohorts were reported as mean (SD) per patient per year (PPPY) over a 24-month follow-up and compared using a Z-test. Costs were inflated to 2022 US$.</p><p><strong>Results: </strong>After PS matching, 2,307 patient pairs (mean age: 44.4 years; female sex: 87.3%) were identified. Compared with the SOC cohort, the GMB cohort had lower mean (SD) PPPY all-cause office visits (17.9 [17.7] vs 19.1 [18.7]; <i>P</i> = 0.023) and migraine-related office visits (2.6 [3.3] vs 3.0 [4.7]; <i>P</i> = 0.002) at follow-up. No significant differences were observed between cohorts in other all-cause and migraine-related events assessed including outpatient visits, emergency department (ED) visits, inpatient stays, and other medical visits. The mean (SD) costs PPPY were lower in the GMB cohort compared with the SOC cohort for all-cause office visits ($4,321 [7,518] vs $5,033 [7,211]; <i>P</i> < 0.001) at follow-up. However, the GMB cohort had higher mean (SD) PPPY all-cause total costs ($24,704 [30,705] vs $21,902 [28,213]; <i>P</i> = 0.001) and pharmacy costs ($9,507 [12,659] vs $5,623 [12,605]; <i>P</i> < 0.001) compared with the SOC cohort. Mean (SD) costs PPPY were lower in the GMB cohort for migraine-related office visits ($806 [1,690] vs $1,353 [2,805]; <i>P</i> < 0.001) compared with the SOC cohort. However, the GMB cohort had higher mean (SD) PPPY migraine-related total costs ($8,248 [11,486] vs $5,047 [9,749]; <i>P</i> < 0.001) and migraine-related pharmacy costs ($5,394 [3,986] vs $1,761 [4,133]; <i>P</i> < 0.001) compared with the SOC cohort. There were no significant differences between cohorts in all-cause and migraine-related costs for outpatient visits, ED visits, inpatient stays, and other medical visits.</p><p><strong>Conclusions: </strong>Although total costs were greater for GMB vs SOC following initiation, changes in a few categories of all-cause and migraine-related HCRU and direct costs were lower for GMB over a 24-month fol","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 8","pages":"792-804"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Understanding racial disparities in health care expenditures for cervical cancer.","authors":"Jerusha Daggolu, Marjan Zakeri, Sujit Sansgiry","doi":"10.18553/jmcp.2024.30.8.873","DOIUrl":"10.18553/jmcp.2024.30.8.873","url":null,"abstract":"<p><strong>Background: </strong>Cervical cancer demonstrates a notable efficacy in treatment, evidenced by a 92% 5-year survival rate among cases diagnosed at a localized stage. In 2020, the estimated annual national expenditure for cervical cancer care amounted to $2.3 billion in the United States. Limited real-world data are available for racial disparities in health care expenditures for cervical cancer.</p><p><strong>Objective: </strong>To evaluate racial disparities associated with annual health care expenditures among patients diagnosed with cervical cancer in the United States.</p><p><strong>Methods: </strong>A retrospective observational cohort study of annual health care expenditures in patients with cervical cancer diagnosed during 2014-2019 was performed using the Medical Expenditure Panel Survey data. In addition to the descriptive weighted analysis, an unadjusted analysis of the annual health care expenditure was conducted. An adjusted linear regression model with log transformation of the outcome variable was used to evaluate the total annual health care expenditure as well as expenditures by category across the racial groups.</p><p><strong>Results: </strong>Overall, 826 patients with cervical cancer were identified from the Medical Expenditure Panel Survey during 2014-2019. The majority were classified as White patients (81.2%) and in the age group of 45-64 years (44.65%). On average, the total annual health care expenditure was $11,537 (95% CI = $9,887-$13,186) among the White cohort, $10,659 (95% CI = $6,704-$14,614) among the African American cohort, and $8,726 (95% CI = $6,113-$11,340) among the Hispanic cohort. After adjusting for covariates, the average total annual health care expenditure for the Hispanic cohort was 35% of the total health care expenditure of the White cohort (<i>P</i> < 0.001) and 46% of the African American cohort's health care expenditure (<i>P</i> = 0.02). Specifically, adjusted costs of office-based and outpatient visits for the Hispanic cohort were 47% (<i>P</i> = 0.009) and 57% (<i>P</i> = 0.005) lower than for the White cohort, respectively. The total annual home health care expenditure for the African American cohort was 49% lower than White patients (<i>P</i> = <i>0.03</i>), and the Hispanic cohort's total expenditure, excluding prescription medicines, was 57% lower than African American patients (<i>P</i> = 0.02).</p><p><strong>Conclusions: </strong>This study provides valuable information regarding the health care disparities that need to be addressed among certain minority races. Reducing the disparities in health care spending across racial groups should be included as a crucial element in tackling well-established health care inequities.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 8","pages":"873-881"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293762/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Terry Richardson, Brian P Vickery, Ruchi Gupta, Fred Goldstein, Michael Kobernick, Vivien Chan, Susan Wescott, Gaurang Gandhi, Tonya Winders
{"title":"Navigating the landscape of food allergies: Insights and perspectives from the AMCP Market Insights Program.","authors":"Terry Richardson, Brian P Vickery, Ruchi Gupta, Fred Goldstein, Michael Kobernick, Vivien Chan, Susan Wescott, Gaurang Gandhi, Tonya Winders","doi":"10.18553/jmcp.2024.30.8-a.s1","DOIUrl":"10.18553/jmcp.2024.30.8-a.s1","url":null,"abstract":"<p><p>AMCP convened a panel of clinical and managed care experts to identify insights regarding the prevalence, clinical manifestations, and management approaches for immunoglobulin E-mediated food allergies. This article aims to summarize expert perspectives on health care system challenges and areas of agreement concerning the management of food allergies, and to advance payers' understanding of their role in supporting health care for patients with food allergies. Food allergy management requires dietary modification and is associated with significant patient and caregiver burdens. Emerging therapies provide hope for those living with food allergies but will likely lead to a rise in health plan pharmacy expenses. In considering the value of new treatments, it is important to consider the total cost of care and the value of preventing anaphylaxis and enhancing the patient's quality of life. Several challenges remain in identifying the appropriate patient population for treatment with newer agents and in optimizing treatment outcomes. Addressing health disparities will require standardized clinical protocols, better access to specialized allergy care, and management of comorbid conditions.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"30 8-a Suppl","pages":"S1-S10"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Patrick P Gleason, Benjamin Y Urick, Landon Z Marshall, Nicholas Friedlander, Yang Qiu, R Scott Leslie
{"title":"Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes.","authors":"Patrick P Gleason, Benjamin Y Urick, Landon Z Marshall, Nicholas Friedlander, Yang Qiu, R Scott Leslie","doi":"10.18553/jmcp.2024.23332","DOIUrl":"10.18553/jmcp.2024.23332","url":null,"abstract":"<p><strong>Background: </strong>In 2014, the US Food and Drug Administration approved the first glucagon-like peptide-1 (GLP-1) receptor agonist product, liraglutide injection, for obesity treatment. Many GLP-1 obesity treatment clinical trials report significant weight loss and medication adherence at more than 85%. Little is known about the real-world GLP-1 obesity treatment adherence, persistence, and switch rates.</p><p><strong>Objective: </strong>To measure GLP-1 therapy persistence, adherence, and switch rates in a real-world cohort of members without diabetes using these drugs for obesity treatment.</p><p><strong>Methods: </strong>Integrated pharmacy and medical claims data from 16.5 million average monthly commercially insured membership were used to identify obese members without diabetes newly initiating GLP-1 therapy between January 1, 2021, and December 31, 2021. Members were required to be continuously enrolled 1-year before and after the GLP-1 therapy start date and aged 19 years of age or older. Persistence was measured as no greater than or equal to 60-day gap with allowance for GLP-1 switching. Adherence was measured as the proportion of days covered (PDC) and members with a PDC greater than or equal to 80% were considered adherent. GLP-1 product switching was also assessed descriptively.</p><p><strong>Results: </strong>4,066 commercially insured obese members without diabetes that newly initiated GLP-1 therapy met all study criteria. The mean age was 46 years, and 81% were female. Overall, GLP-1 persistence was 46.3% at 180 days and 32.3% at 1 year. The highest and lowest persistence rates at 1 year were observed for semaglutide (Ozempic) at 47.1% and liraglutide (Saxenda) 19.2%, respectively. Average PDC during the 1-year assessment was 51.0% with 27.2% adherent to therapy and 11.1% switched GLP-1 drugs.</p><p><strong>Conclusions: </strong>This GLP-1 weight loss treatment real-world analysis, among obese individuals without diabetes, found poor 1-year persistence and adherence and low rates of switching between products. These findings will aid in assessing products cost-effectiveness, understanding obesity care management program needs, forecasting future GLP-1 use and cost trends, and negotiating GLP-1 pharmaceutical manufacturer value-based purchasing agreements.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"860-867"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140876592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Inmaculada Hernandez, Emma M Cousin, Olivier J Wouters, Nico Gabriel, Teresa Cameron, Sean D Sullivan
{"title":"Price benchmarks of drugs selected for Medicare price negotiation and their therapeutic alternatives.","authors":"Inmaculada Hernandez, Emma M Cousin, Olivier J Wouters, Nico Gabriel, Teresa Cameron, Sean D Sullivan","doi":"10.18553/jmcp.2024.24153","DOIUrl":"10.18553/jmcp.2024.24153","url":null,"abstract":"<p><strong>Background: </strong>The Centers for Medicare and Medicaid Services (CMS) are currently negotiating prices with pharmaceutical manufacturers for the first 10 Part D drugs selected for Medicare drug price negotiation. Non-publicly available data, including the net prices of selected drugs and their therapeutic alternatives, will play a central role in the determination of the maximum fair prices (MFPs).</p><p><strong>Objective: </strong>To estimate price benchmarks involved in the derivation of the starting point of the CMS initial price offer for the 10 drugs selected for Medicare price negotiation.</p><p><strong>Methods: </strong>For the 10 drugs selected for negotiation, we reported (1) the list price, (2) the net price after manufacturer discounts, (3) the maximum negotiated price based on the minimum statutory discount, and (4) the ceiling of the MFP, estimated as the lowest of the latter 2. We also estimated net prices for therapeutic alternatives to the selected drugs. Net prices were estimated using peer-reviewed methodology that isolates commercial discounts negotiated between payers and manufacturers from mandatory discounts under government programs. All price benchmarks were estimated at the product level, for 30-day equivalent dosing, using 2021 data.</p><p><strong>Results: </strong>6 products (apixaban, rivaroxaban, empagliflozin, sacubitril/valsartan, etanercept, and insulin aspart) had therapeutic alternatives with lower net prices, which will be integrated with clinical benefit data in the derivation of initial price offers. The other 4 products (ustekinumab, ibrutinib, sitagliptin, and dapagliflozin) had therapeutic alternatives with higher net prices than the drugs selected for negotiation. For ibrutinib and ustekinumab, prices based on the minimum discounts were considerably lower than the estimated net prices and will likely set the starting point of the initial price offer. For dapagliflozin and sitagliptin, the starting point of the initial price offer will likely resemble their existing net prices.</p><p><strong>Conclusions: </strong>Our analyses identify different negotiation scenarios for the first 10 drugs selected for Medicare price negotiation, based on key elements involved in the derivation of the initial price offer. Our analyses can help improve transparency in the negotiation process, because the CMS is not required to reveal the information used in the derivation of price offers.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"762-772"},"PeriodicalIF":2.3,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11293770/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141437017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}