Real-world persistence and adherence to glucagon-like peptide-1 receptor agonists among obese commercially insured adults without diabetes.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Real-world outcomes and direct care cost before and after elexacaftor/tezacaftor/ivacaftor initiation in commercially insured members with cystic fibrosis.

BACKGROUND: Cystic fibrosis (CF) is a chronic, progressive genetic disease caused by mutations in the CF transmembrane conductance regulator (CFTR) gene resulting in a dysfunctional CFTR protein. Elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) is a triple combination oral drug therapy with an annual cost greater than $300,000 and available to nearly 90% of the CF population based on age and genotype. Limited real-world direct medical cost offset data are available for ELX/TEZ/IVA among commercially insured individuals. OBJECTIVE: To describe and compare total cost of care and health care resource utilization (HRU) 180 days before and 180 days after first ELX/TEZ/IVA drug claim among CFTR modulator treatment-naive, commercially insured members. METHODS: This study was a retrospective analysis of integrated pharmacy and medical claims data from 17.9 million commercially insured members. A 180-day prestudy and 180-day poststudy design was used to compare outcomes prior to and following ELX/TEZ/IVA initiation. Study inclusion was limited to members with first ELX/TEZ/IVA claim (index date) between October 21, 2019, and December 31, 2021, continuously enrolled 180 days before and 180 days after index date, and no CFTR-modulator drug claim 180 days prior to index date. Total paid amounts from medical and pharmacy claims after network discounts (defined as total cost of care), HRU, and pulmonary exacerbation events were summarized using descriptive statistics and compared using Wilcoxon signed rank test. RESULTS: 494 members newly initiating ELX/TEZ/IVA met inclusion criteria. Prestudy to poststudy mean member total cost of care increased from $58,180 to $198,815 (difference: $140,635; P < 0.001). Mean member medical benefit costs decreased from $28,764 to $12,484 (difference: -$16,280; P < 0.001), whereas mean member pharmacy benefit costs increased from $29,416 to $186,331 (difference: $156,915; P < 0.001). Mean member inpatient hospitalizations (62% absolute reduction; P < 0.001), emergency department visits (43% absolute reduction; P < 0.01), and pulmonary exacerbation events (44% absolute reduction; P < 0.001) were significantly lower in the postperiod compared with the preperiod. CONCLUSIONS: Among members with CF newly initiating CFTR modulator with ELX/TEZ/IVA, mean member total cost of care increased 3-fold despite significant and meaningful reductions in pulmonary exacerbation events, HRU, and medical benefit spend. Pharmacy benefit spend outpaced medical benefit spend at a rate of $9.64 to $1 in the 180 days following ELX/TEZ/IVA initiation. Real-world data should be used to objectively measure the clinical and economic benefits of costly medications, such as CFTR modulators, to align price with value. DISCLOSURES: Drs Marshall, Espinosa, Starner, and Gleason are employees of Prime Therapeutics. The study was funded by Prime Therapeutics.

Real-world Treatment Patterns and Reasons for Therapy Selection in Patients with Advanced Hepatocellular Carcinoma in US Oncology Practices.

BACKGROUND: The treatment landscape for advanced hepatocellular carcinoma (aHCC) is rapidly expanding beyond tyrosine kinase inhibitors (TKIs) in the first-line (1L) setting, with multiple TKIs and immune-checkpoint inhibitors (ICIs) now being evaluated in combination. Real-world evidence describing current treatment patterns and reasons for 1L and 2L treatment selection in aHCC is sparse. PATIENTS AND METHODS: A retrospective cohort study with a cross-sectional survey element was conducted using Cardinal Health's Oncology Provider Extended Network. U.S. medical oncologists identified adult aHCC patients initiating 1L systemic therapy between January 1, 2017 and July 31, 2019 and abstracted data from patient medical records. Data included provider characteristics, patient demographics and clinical characteristics, treatment regimens, and physician rationale for treatment regimen choice. RESULTS: A total of 44 medical oncologists provided data on 284 aHCC patients. The median age at 1L initiation was 61.5 years, and the majority were male (78%) and white (66%). Nearly half (47%) initiated 1L treatment in 2019, 34% were ECOG performance status 2+, and 63% were Child-Pugh Class B/C. Among the 284 aHCC patients, TKIs were used by 94% of patients in the 1L setting, comprised predominantly of sorafenib (54%) and lenvatinib (38%). ICIs were most common among the 90 patients (66%) who received 2L treatment. CONCLUSION: In the community-oncology practice setting, nearly all aHCC patients received sorafenib or lenvatinib in the 1L setting, while the majority of patients received an ICI in the 2L setting. With recent ICI approvals in aHCC, this marks the beginning of an increased use of ICIs in the 1L setting.

Direct oral anticoagulant prescription trends, switching patterns, and adherence in Texas Medicaid.

OBJECTIVES: To compare prescription trends, costs, switch patterns, and mean adherence among oral anticoagulants in the Texas Medicaid population. STUDY DESIGN: Secondary analysis of Medicaid prescription claims data. METHODS: All oral anticoagulant prescriptions for patients aged 18 to 63 years with 1 or more prescription claims for an oral anticoagulant from July 1, 2010, to December 31, 2015, were included in utilization and expenditure trend analyses. Switch patterns and adherence, measured by the proportion of days covered (PDC), were analyzed over 1 year for patients newly initiated on oral anticoagulant therapy. RESULTS: Over the 5.5-year study period, direct oral anticoagulant (DOAC) use increased steadily and the proportion of oral anticoagulant prescription expenditures accounted for by DOACs increased substantially. By December 2015, DOACs accounted for one-third of anticoagulant prescription claims and more than 90% of total oral anticoagulant prescription expenditures. The mean cost per prescription was 30 times higher for DOACs than warfarin. A higher proportion of patients with a DOAC as an index drug switched drugs. The overall mean ± SD PDC was 0.71 ± 0.21, with no significant differences among patients on dabigatran, rivaroxaban, and apixaban. Using a PDC cutoff point of 0.80 to indicate adherence (vs nonadherence), 42% of patients were categorized as adherent. CONCLUSIONS: Texas Medicaid prescription data show a gradual increase in DOAC use with a rapid increase in prescription expenditures. Further exploration of the causes of higher switch rates among DOAC initiators compared with warfarin initiators and nonadherence to DOACs is needed to understand the challenges related to DOAC adoption in practice and to improve patient outcomes.

Frequency and economic impact of comorbid cardiac conditions with multiple sclerosis.

BACKGROUND: Fingolimod, an oral immunomodulatory therapy approved to treat multiple sclerosis (MS) is contraindicated in patients with certain cardiac conditions, yet the frequency of these conditions in patients with MS is not known. This study assessed the frequency and economic impact of cardiac conditions among hospitalizations of patients with MS. OBJECTIVE: To determine the frequency and economic impact of selected comorbid cardiac conditions among hospitalizations of patients with a diagnosis of MS. METHODS: This was a retrospective, discharge-level cohort study of hospital discharge data from 2006-2010. The frequencies of cardiac conditions of interest (based on contraindications to fingolimod in the prescribing information) were reported among all discharges with a diagnosis of MS. Two cohorts were defined: (1) MS with cardiac condition of interest and (2) MS with no cardiac condition of interest. The mean adjusted cost per discharge and incremental cost per hospital day were reported. RESULTS: Among 136,542 discharges with a diagnosis of MS, 9.2% (n = 12,504) had a comorbid cardiac condition of interest based on contraindications to fingolimod in the prescribing information. Heart failure (59.4%), myocardial infarction (17.2%), and occlusion of cerebral arteries (12.4%) were the most common cardiac conditions. The mean adjusted cost per discharge was significantly higher for the MS with cardiac condition cohort compared with the MS with no cardiac condition cohort ($17,623 vs. $11,663, P less than 0.0001). The incremental cost per hospital day was $6,479 for the MS with cardiac condition cohort.  CONCLUSIONS: The presence of comorbid cardiac conditions among hospital discharges in patients with MS is substantial and associated with higher hospitalization costs. Health plans should give consideration to the overlapping presence of these diseases when determining coverage criteria for immunomodulatory therapies and designing clinical programs for MS.