Background: Obesity rates in the United States have continued to grow, impacting health care costs and utilization among employer-based commercial insurance coverage. Many employers are now considering offering weight management programs and coverage of obesity treatments. Employers want to better understand the potential value of their investment dollars, given the delayed realization of health benefits from weight loss.
Objective: To provide insights into the duration of employment for employees with obesity, this study aimed to observe whether there was a difference in employee retention based on diagnosis of obesity.
Methods: A retrospective, observational descriptive study was conducted using an administrative claims database with over 50 million commercial lives. The study analyzed medical claims and enrollment data from 2014 to 2023 for self-insured employers. Individuals were categorized into obesity and nonobesity cohorts based on diagnosis codes. Retention rates were assessed using a Kaplan-Meier estimator, with statistical significance evaluated via a log-rank test.
Results: Among self-insured employer subscribers (employees who subscribe to their employer's insurance), subscribers with obesity had higher retention rates than those without (49% vs 26% at 5 years; 30% vs 14% at 10 years; P < 0.0001). This pattern was consistent across age bands and gender, with the highest retention observed in subscribers aged 30-49 years and subscribers who were male. Industry-specific analysis showed that subscribers with obesity in manufacturing, financial/insurance/real estate, and service/public administration had the highest retention, whereas the lowest retention was observed in retail. Subscribers with obesity-related comorbidities had a retention rate up to 10 percentage points higher at year 5 and 5 percentage points higher at year 10 compared with the overall obesity diagnosis cohort. Additionally, those with dependents diagnosed with obesity also showed higher retention compared with those with dependents who were not diagnosed with obesity (P < 0.0001).
Conclusions: The study found a higher employee retention in subscribers who had a diagnosis for obesity compared with those who did not. This information could help employers estimate the potential long-term costs and benefits regarding weight management programs and coverage of obesity treatments.
Background: The 2028 incorporation of Part B drugs into the Medicare Drug Price Negotiation Program, established by the Inflation Reduction Act (IRA), introduces several unique challenges. The Centers for Medicare & Medicaid Services (CMS) final guidance for Initial Price Applicability Year (IPAY) 2028 indicates that both traditional fee-for-service Medicare and Medicare Advantage encounter data will be used to identify eligible Part B drugs. Furthermore, the newly enacted One Big Beautiful Bill Act of 2025 (OBBBA) also has implications for which drugs are selected because of its expanded "Orphan Drug Exclusion" criteria.
Objective: To predict 15 drugs likely to be selected for IPAY 2028.
Methods: Using CMS's 2020-2023 Part D and Part B Spending by Drug datasets and 2024 Average Sales Price Pricing Files, we projected 2024 expenditures for Part D and B drugs separately via regression models for utilization and pricing trends. Utilization and pricing were multiplied to estimate 2024 gross expenditures. Exclusion criteria were then applied, consistent with the IRA, OBBBA, and final CMS guidance, to arrive at 50 Part B and 50 Part D negotiation-eligible products. We selected 15 IPAY 2028 products based on their ranked combined Parts B and D 2024 projected gross expenditures.
Results: The 15 selected drugs had projected 2024 expenditures above $800M, with 8 biologics and 7 small molecule drugs, and 7 Part B and D products and 8 exclusively Part D products. OBBBA significantly alters eligibility, delaying eligibility for 5 products and excluding at least 3 products from future negotiations.
Conclusions: Part B drugs will be negotiated for the first time in IPAY 2028. Policy changes, such as the OBBBA, exclude several high-cost products from negotiation. These policy decisions have major implications for how the Drug Price Negotiation Program targets high-spend drugs and achieves meaningful savings for the Medicare program.
Background: In the United States, rIX-FP, rFIXFc, and rFIX are approved as treatment options for people with hemophilia B (PwHB). Although clinical trials have demonstrated the efficacy and safety of each product, real-world data can help to understand their use and treatment outcomes in the absence of direct head-to-head trials.
Objective: To assess real-world factor IX (FIX) consumption and bleeding outcomes for PwHB receiving rIX-FP, rFIXFc, or rFIX prophylaxis.
Methods: Retrospective, deidentified medical record information for PwHB with moderate or severe hemophilia B (FIX activity ≤5%) treated with rIX-FP, rFIXFc, or rFIX prophylaxis for at least 12 months was obtained from Hemophilia Treatment Centers in the United States between 2020 and 2023. FIX consumption was calculated using the most recently prescribed dosing frequency and dosage. Annualized bleeding rate (ABR), annualized spontaneous bleeding rate, and annualized joint bleeding rate were calculated based on the number of bleeding events over the observation period. Generalized linear models adjusting for covariates were used to test the statistical significance of the differences of consumption and ABR among the products.
Results: Overall, 213 PwHB (53% with severe disease) aged 12 years and older were included for main analysis, with a mean age (range) of 32.7 (12-84) years. PwHB treated with rIX-FP prophylaxis had significantly lower mean FIX consumption compared with those receiving rFIXFc (45.8 vs 65.4 IU/kg/week; P = 0.0003) and rFIX (95.7 IU/kg/week; P < 0.0001). The mean dosing interval was 10.2, 7.3, and 5.2 days for rIX-FP, rFIXFc, and rFIX, respectively. Mean ABR was significantly lower in PwHB receiving rIX-FP compared with the other 2 products (rIX-FP vs rFIXFc: 1.2 vs 2.1; P = 0.0119; rIX-FP vs rFIX: 1.2 vs 2.3; P = 0.004). Mean annualized spontaneous bleeding rate was 0.4, 1.0, and 0.7 for rIX-FP, rFIXFc, and rFIX, respectively. Mean annualized joint bleeding rate was 0.7, 1.1, and 1.2 for rIX-FP, rFIXFc, and rFIX, respectively. The pattern of results for PwHB of all ages (including those aged <12 years, N = 50) were similar to those reported for PwHB aged 12 years and older. In a subgroup of 16 PwHB who switched to rIX-FP from a previous FIX product, mean FIX consumption was significantly reduced after switching to rIX-FP (49.0 vs 94.2 IU/kg/week; P = 0.0004). Mean ABR was also significantly reduced after switching to rIX-FP (3.2 vs 1.7; P = 0.0009).
Conclusions: In this retrospective study, rIX-FP prophylaxis was associated with lower FIX consumption and potentially improved protection against bleeds compared with prophylactic treatment with rFIXFc and rFIX.
Background: Nonadherence to self-administered biologic therapies increases risk for disease flares and adverse outcomes in inflammatory bowel disease (IBD).
Objective: To use machine learning and Medicare fee-for-service claims to create models predictive of medication nonadherence.
Methods: This study included Medicare fee-for-service beneficiaries with at least 2 IBD claims separated by 30 days between 2017 and 2021 and analyzed claims data from 2021. Beneficiaries with missing data or fewer than 3 self-administered biologic dispenses (adalimumab, certolizumab, golimumab, ustekinumab) on different dates in 2021 were excluded. Beneficiary-level nonadherence was defined as a proportion of days covered less than 0.8, and dispense-level nonadherence as dispenses occurring more than 5 days after previous supply elapsed. Sixteen machine learning models were trained, and model performance was evaluated based on area under the receiver operating characteristic curve (AUC) scores, accuracy, F1 score, positive and negative predictive value (P/NPV), sensitivity, and specificity.
Results: A total of 10,160 beneficiaries met inclusion and exclusion criteria. Subsequently, 64,197 dispense transactions were observed, with 8,547 (13.3%) considered nonadherent. Prior nonadherence was strongly associated with current dispense nonadherence (odds ratio, 2.65; 95% CI, 2.53-2.78). The random forest dispense-level model had fair predictive performance (AUC 0.739, accuracy 85.4%, sensitivity 17.7%, specificity 95.8%, PPV 39%, NPV 88.3%, F1 score 0.243). The bagging dispense-level model performed comparably with higher sensitivity (AUC 0.714, accuracy 74.9%, sensitivity 51%, specificity 78.6%, PPV 26.8%, NPV 91.3%, F1 score 0.351).
Conclusions: Machine learning models trained on Medicare fee-for-service claims data had fair predictive performance identifying nonadherent dispenses. The bagging model, which minimizes false negatives, may be most appropriate for future clinical decision support tools.
Background: Despite broad recommendations in older adults, uptake for the 2-dose recombinant zoster vaccine (RZV), which protects against herpes zoster (ie, shingles), has historically been low in the United States among those aged 50 years and older. By recommending RZV, health care providers play a critical role in encouraging shingles prevention among older adults. A vaccine prescription may reinforce a recommendation, but understanding the extent and associated characteristics of uptake following prescription is needed.
Objective: To describe RZV uptake following an RZV prescription among US adults aged 50 years and older.
Methods: RZV uptake following a prescription among adults aged 50 years and older in the United States was assessed from 2017 to 2023 using administrative claims data linked with electronic health records. Patient demographic and clinical characteristics, provider characteristics, and health system factors were presented descriptively and compared between those with and without RZV administration following a prescription. A Cox proportional hazards model assessed associations between patient, provider, and health system factors and RZV administration following an RZV prescription.
Results: Of the 8,715 patients with an RZV prescription included, vaccine uptake following prescription was generally high: 71% of patients received at least 1 RZV dose following prescription, of which 82% were administered in a pharmacy setting. Among prescriptions with a known provider specialty source, 91% were written by primary care physicians or internal medicine providers. Factors such as Medicare Advantage with Part D coverage (vs commercial insurance), household income of at least $75,000 (vs <$40,000), and having an immunocompromising or autoimmune condition were associated with higher rates of RZV administration following a prescription.
Conclusions: Receipt of RZV is likely following a healthcare provider's recommendation, as shown by the high uptake observed among adults who received RZV prescriptions in this study. Additional efforts are needed to ensure full adherence with provider recommendations for herpes zoster prevention.
Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) effectively reduce hypoglycemia and offer additional clinical benefits such as weight loss. However, their high costs impose a significant economic burden on both patients and payers. Health care expenditures associated with GLP-1 RA use have not been adequately examined in previous studies.
Objective: To examine the excess expenditures (total, payer, and out-of-pocket) associated with GLP-1 RA use compared with nonuse among adults with diabetes in the United States.
Methods: The study design was cross-sectional using data on adults (aged ≥18 years) with diabetes from multiple years (2016, 2018, and 2020) of the Medical Expenditure Panel Survey. Any GLP-1 RA use was derived from prescription medication files. Dependent variables included total, payer, and out-of-pocket health care expenditures. Excess expenditures associated with GLP-1 RAs were estimated using a multivariable generalized linear model (GLM) with gamma distribution and log link. The model adjusted for age, sex, race and ethnicity, social determinants of health, obesity, physical activity, and comorbid conditions.
Results: The study sample consisted of 7,670 adults with diabetes, representing approximately 28.6 million individuals in the United States. Overall, 7.5% of adults with diabetes used GLP-1 RAs, with rates increasing from 4.3% in 2016 to 10.6% in 2020. GLP-1 RA users had higher total ($22,029 vs $15,165, P < 0.001), payer ($20,023 vs $13,758, P < 0.001), and out-of-pocket ($2,006 vs $1,407, P < 0.001) expenditures compared with nonusers. Multivariable GLMs indicated that GLP-1 RA users incurred an adjusted excess of $5,417 (P < 0.001), $4,764 (P < 0.001), and $436 (P = 0.001) for total, payer, and out-of-pocket expenditures, respectively.
Conclusions: One in 13 adults used GLP-1 RAs. GLP-1 RA users had greater overall, third-party, and out-of-pocket expenditures. These findings underscore the growing economic impact of GLP-1 RA use and highlight the importance of developing strategies that balance the proven clinical advantages of GLP-1 RAs against their financial burden.
Background: Bipolar I disorder (BP-I) is a chronic and recurrent mental health disorder, broadly characterized by patients who alternate between the extremes of the mood spectrum: mania or hypomania; and depression. In 2015, the total estimated annual cost of BP-I in the United States reached more than $200 billion, approximately 2.5 times higher than the general population, largely driven by the increased use of acute health care services. Long-acting injectable antipsychotics such as aripiprazole were developed to significantly reduce patient burden for treatment adherence compared with oral formulations, to allow consistent dosing and improved outcomes. Previous real-world evidence studies have shown the benefits of starting aripiprazole once-monthly injection (AOM) at an early stage in patients diagnosed with schizophrenia; however, the effect of early initiation in the BP-I population remains unknown.
Objective: To evaluate the impact of initiating AOM 400 mg (AOM 400) in adults at an early stage (<180 days) following a diagnosis of BP-I compared with late initiation (>365 days) in a real-world setting, via a retrospective analysis using claims data from the MarketScan Medicaid database.
Methods: Study outcomes included the numbers of emergency department, hospitalization, outpatient, and pharmacy visits, together with the associated costs over a 1-year time horizon. A generalized linear model was used to compare the annualized costs associated with early, intermediate, and late initiators of treatment, using late initiators as the main reference group.
Results: Among 866 patients diagnosed with BP-I (median age, 36 years), 161 early initiators had significantly lower risks of emergency department visits (incidence rate ratio = 0.76; 95% CI, 0.61-0.94) and outpatient pharmacy visits (incidence rate ratio = 0.82; 95% CI, 0.73-0.93) compared with 591 late initiators. Early initiators also incurred lower pharmacy visit costs ($18,787 vs $23,503; P = 0.03) and lower medical costs ($13,898 vs $18,277; P = 0.01). Overall, early initiators incurred much lower total health care costs than late initiators during the follow-up ($31,086 vs $40,599, respectively; P < 0.001). Early initiators also incurred significantly lower total health care costs than intermediate initiators ($31,086 vs $40,892; P = 0.01).
Conclusions: This real-world study demonstrates that early initiation of AOM 400 among patients living with BP-I may offer a significant advantage of lower health care resource utilization and associated costs when compared with late initiation.
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