Direct cost and healthcare resource utilization of patients with migraine before treatment initiation with calcitonin gene-related peptide monoclonal antibodies by the number of prior preventive migraine medication classes.

OBJECTIVE: This study compared all-cause direct cost and healthcare resource utilization (HCRU) among preventive migraine medication (PMM)-naïve patients and patients with up to 3 PMM category switches before initiating calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs). METHODS: This was a retrospective analysis of the IBM Marketscan database. Patients who initiated injectable CGRP mAbs between May 2018 and December 2019 (index period) were included in 4 groups based on the number of prior non-CGRP PMM classes used during the 24-month pre-index period: P0 = none; P1 = one; P2 = two; P3 ≥ three. All-cause direct cost and HCRU for groups were compared without adjustment and after generalized propensity score (GPS) matching. RESULTS: Of the 23,288 patients included (mean age ± standard deviation [SD] 45.4 ± 12.0 years), 85.6% were females, and the mean Charlson Comorbidity Index was 0.69 ± 1.2. P3 group had the highest average annual unadjusted total healthcare costs per patient ($50,274±$76,629); the highest costs attributed to procedure/imaging-related expenses ($20,105±$36,401) and pharmacy ($11,633±$29,763). P0 group had the lowest cost ($25,288±$41,427). Pairwise comparison of GPS matched costs showed significantly greater average annual direct costs per patient in the P3 group vs. P0 (p = .003), P1 (p = .014), and P2 (p = .021) groups. GPS matched HCRU also increased with the number of prior PMM classes used. Anti-epileptics (48.9%) were the most commonly used PMM class, with triptans (75.2%) being the most common acute medication class. CONCLUSIONS: Total direct healthcare cost and HCRU increased significantly with increasing use of PMM classes with the greatest cost difference existing between the P0 and the P3 groups.

Medications used for the prevention of migraine (PMM) are underused as they might cause adverse effects, intolerance, or may lack efficacy. This leads to the discontinuation of the current treatment and switching to other treatments. Calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) are a new class of drugs for the prevention of migraine. Since 2018, four CGRP mAbs have been approved for use in the prevention of migraine. It is known that patients who use more preventive migraine treatments incur greater total direct (caused by a number of medical visits or increased healthcare resource utilization, surgery, drugs, equipment, etc.) annual healthcare costs and healthcare resource utilization (HCRU) in patients with migraine. In the current study, the annual average direct cost and HCRU were compared between patients who had not used preventive medicine and patients who had used 1, 2, or ≥3 preventive medicines for migraine before starting CGRP mAbs. We observed that the healthcare costs and HCRU increased with the use of a higher number of preventive medicines for migraine. Patients who started using injectable CGRP mAbs after at least 3 preventive medicines had the highest healthcare costs and HCRU compared with other groups.

Budget impact of lasmiditan for the acute treatment of migraine in the United States.

BACKGROUND: Three novel acute treatments for migraine-lasmiditan, ubrogepant, and rimegepant-were approved by the FDA in 2019 and 2020 for adults with migraine with and without aura. American Headache Society guidance recommends that these novel acute treatments be considered for patients who are contraindicated to or fail to respond or tolerate oral triptans, the current standard of acute care. OBJECTIVE: To estimate, from a US commercial plan perspective, the budget impact of adding lasmiditan as an option to a formulary that already includes ubrogepant and rimegepant. METHODS: Epidemiologic data were drawn from US Census data, the American Migraine Prevalence and Preventive study, and the first wave of the OVERCOME US survey, a web-based survey that included 21,000 patients with migraine. A model with a 3-year time horizon was built assuming that demand for the novel acute treatments would not vary based on whether lasmiditan is included in the formulary. The model examined a variety of populations, in particular beneficiaries with previous use of 1 or more oral triptans or contraindicated to triptans and beneficiaries with previous use of 2 or more oral triptans or contraindicated to triptans. Primary outcomes were the incremental differences in total cost and average cost per member per month (PMPM) between scenarios with and without lasmiditan. One-way sensitivity analyses with model parameters that were varied by plus or minus 15% were conducted to assess the effect of key parameters on the incremental total cost over 3 years. RESULTS: The addition of lasmiditan to a formulary that already includes ubrogepant and rimegepant resulted in a total savings of -$927,657 (-1.5% compared with the scenario without lasmiditan) over a 3-year time horizon in the population with previous history of using 1 or more oral triptans or contraindicated to a triptan. In the population with previous history of using 2 or more oral triptans or contraindicated, the addition of lasmiditan resulted in a total budget impact of -$466,518 (-1.3%) over a 3-year time horizon. Most of the cost savings was attributable to reductions in drug acquisition cost. Savings in total costs resulted in average incremental cost per PMPM of -0.03 and -$0.01, respectively. CONCLUSIONS: The addition of lasmiditan to the formulary as a novel acute treatment option for migraine alongside ubrogepant and rimegepant resulted in lower budget impact on a 3-year time horizon from a US commercial payer's perspective. This result is important to US commercial payers as they seek to incorporate the emerging novel acute treatments for migraine into their benefit designs. DISCLOSURES: This work was funded by Eli Lilly and Company. Milev and Sun are employed by Evidera, which received funding from Eli Lilly and Company for work on this project. Pohl, Mason, Njuguna, and Loo are employees and stockholders of Eli Lilly and Company.

Demographic and clinical characteristics of prevention-eligible patients with migraine in the US: a linked national survey and administrative claims database study.

OBJECTIVE: To characterize burden of migraine in prevention-eligible patients compared with prevention non-eligible patients in the United States (US). Receipt of preventive therapy was also examined among prevention-eligible patients. METHODS: This retrospective study utilized data from the 2017 US National Health and Wellness Survey linked with medical and pharmacy claims. Patients aged ≥18 years who self-reported experiencing migraine and had confirmed evidence of migraine (≥1 medical or pharmacy claim) were included. Prevention eligibility was based on number of headache days in the past 30 days (prevention-eligible: ≥4 and prevention non-eligible: <4). Descriptive statistics summarized study variables; bivariate and multivariable analyses were conducted to examine the association of prevention-eligibility status with outcomes. RESULTS: Analyses included 450 patients, 291 (65%) prevention-eligible, and of these 56 (19%) received preventive therapy. Overall, patients were 42.98 ± 14.51 years old; 84% were female. Prevention-eligible patients reported significantly more migraine headache days in the past 6 months (29.27 ± 37.96 vs. 8.61 ± 7.88), had lower mental component summary scores (35.80 ± 2.73 vs. 37.90 ± 2.96), and more presenteeism (47.30 ± 2.98% vs. 37.90 ± 2.60%), overall work impairment (46.30 ± 2.87% vs. 37.90 ± 2.55%) and activity days missed due to migraine (8.16 ± 3.05 vs. 3.82 ± 1.58) than prevention non-eligible patients (all p<.001). Prevention-eligible patients receiving preventive therapy reported more migraine headache days during the past month (9.21 ± 7.99 vs. 6.06 ± 7.10; p=.002) and activity days lost due to migraine (18.39 ± 28.08 vs. 10.69 ± 21.43, p=.015) than those not receiving preventive therapy. CONCLUSIONS: Prevention-eligible patients experience greater burden due to migraine, including more headache days, worse health-related quality-of-life, and greater work and activity impairment than prevention non-eligible patients.

Economic burden and risk factors of migraine disease progression in the US: a retrospective analysis of a commercial payer database.

AIMS: To evaluate the prevalence and risk factors of migraine progression and to assess the incremental burden of migraine progression on healthcare systems. MATERIALS AND METHODS: Adult patients were required to have a migraine diagnosis in IQVIA's US adjudicated claims database between 1 January 2012 and 30 June 2016, continuous enrollment ≥12 months before and after the index date (i.e. the first observed migraine diagnosis), and ≥1 additional migraine diagnosis claim during the 12-month post-index period. A previously-developed algorithm identified patients with prevention-eligible episodic migraine (EM). All-cause healthcare resource utilization (HCRU) and costs were evaluated at baseline, over the follow-up period and pre/post progression from prevention-eligible EM to chronic migraine. Cox proportional hazards models were used to evaluate risk factors associated with progression. RESULTS, LIMITATIONS, AND CONCLUSIONS: Of the 125,436 patients with prevention-eligible EM that were initially identified, 5,790 (4.6%) were further identified as progressed. Patients who progressed had higher healthcare costs and higher medication use at baseline compared to patients that did not progress. Mean (SD) all-cause total costs per patient per month were $1,790 ($3,788), significantly higher in the post-progression period compared to $1,414 ($2,456) in the pre-progression period in patients who progressed (p < .0001). Younger age, female sex, initial diagnosis by a neurologist, chronic pain, and use of triptans and/or non-specific acute medications were all significant progression risk factors. Results are limited by the use of a heterogeneous population (incident, prevalent, treated, and untreated patients), coding biases, and lack of information on non-prescription drug utilization and plan limits. Limitations aside, there are substantial HCRU and cost burden associated with migraine progression. Younger age, female sex, and the use of specific drug classes are likely to increase migraine disease progression risk.

Relationship between Progression-free Survival and Overall Survival in Randomized Clinical Trials of Targeted and Biologic Agents in Oncology.

Introduction: With a gap in a full understanding of the mechanisms by which survival is extended for patients with cancer who are treated with novel biologic and targeted agents, there is the risk that discordant progression-free and overall survival outcomes are observed due to poor clinical trial design or biases in the interpretation of data. This study was designed to examine the role of study quality and design on the outcomes observed with biologic and targeted agents. Methods: A review of studies in clinicaltrials.gov supplemented with a literature review in OVID Medline was conducted to identify all randomized trials of a biologic/targeted agent versus a non-biologic/targeted comparator in oncology that report both median overall and progression-free survival outcomes. Details of the study, design, population, drugs, and outcomes were extracted. Study quality was evaluated using the PEDro scale. Data were summarized using SPSS 22.0.0.0. Results: A total of 192 unique studies of 206 pairwise comparisons between a biologic/targeted and comparator were identified. The average absolute magnitude of post-progression survival (difference between OS and PFS) was 9.7 months for biologic/targeted therapy and 9.8 for the comparator. A total of 64 comparisons (31.1%) showed an increase in OS and decrease in PFS, or vice versa, and 25 (12.1%) showed a magnitude of more than 4 months difference between the delta of OS and delta of PFS between the biologic/targeted and comparator arms. Average study quality was high overall (7.7/10), and was comparable for studies with directional differences (7.2/10) as well as for those with the greatest magnitude in post-progression survival (7.4/10). Conclusion: This review and analysis specifically examined small PFS benefit with large OS benefit as well as small OS benefit with large PFS benefit, including differences in direction of PFS and OS outcomes. No evidence was identified that these are the result of poor study design, but may rather be due to the mechanism of action, specific disease, and population under study. Further work is needed to understand the mechanism of action of novel biologic/targeted agents to better understand their interaction with the tumor microenvironment.