A recent study of the fully human monoclonal antibody erenumab was designed to evaluate real-world evidence on the impact of erenumab on acute medication usage and health care utilization (HCRU) among migraine patients. The Health Economics and Outcomes Research analyst team, tasked by Novartis and managed by Lujia Zhou, KMK Consulting, Inc., conducted a retrospective analysis which demonstrated a significantly reduced medication use and HCRU in a real-world setting. Their findings were published in the article “Impact of erenumab on acute medication usage and health care utilization among migraine patients: a US claims database study” authored by Stewart J. Tepper, Juanzhi Fang, Pamela Vo, Ying Shen, Lujia Zhou, Ahmad Abdrabboh,
Mrudula Glassberg and Matias Ferraris in the Journal of Headache and Pain.
The study leveraged real-world data from the US Optum’s de-identified Clinformatics® Data Mart, working with data from 3,171 identified migraine patients initiating medication between May 1, 2018 and September 30, 2019. The KMK analyst team deployed a pre-post study design for this assignment. As stated in the article, this pre-post design model was chosen for this impact evaluation because “the proper analysis of impact requires a counterfactual of what those outcomes would have been in the absence of the intervention. A pre-post study measures the occurrence of an outcome before, and again after, a particular intervention is implemented. It has the strength of temporality to be able to suggest that the outcome is impacted by the intervention.”
Using an examination of the use of acute medications overall and at different drug class levels along with HCRU, the study looked at patients who were at least 18 years of age and had taken a minimum of three doses of erenumab in the 6-month post-index period. The patients also needed to have continuous medical/pharmacy coverage in the 12-month pre- and 6-month post-index periods. The impact of erenumab was examined on a composite endpoint of three possible events:
- Outpatient visit with a diagnosis of migraine and an associated acute medication claim within 7 days of the visit
- Hospital admission with a primary diagnosis for migraine
- Emergency room visit with a primary diagnosis for migraine
The findings demonstrated that the use of erenumab was associated with less acute medication use and HCRU, significantly reducing the burden of migraine on patients and the health care system. Specifically, the composite outcome showed that
- The mean number of events decreased from 1.03 to 0.77 (rate ratio: 0.75; 95% CI: 0.71 to 0.79; P < 0.0001)
- There was a decrease in the proportion of patients with any of the three events was also observed (52.7% vs. 39.5%, P < 0.0001).
The study results clearly established that acute medication use, including the number of claims of each medication, the % of patients who received acute medication and HCRU were significantly decreased with a minimum of three doses of Erenumab.