P-011 - (Poster #11) Economic Burden of Chronic Low Back Pain Patients Transitioned from Oral Schedule II Short-Acting Opioids to Belbuca or Oral Schedule II Long-Acting Opioids: A Retrospective US Commercial Claims Analysis

Chronic low back pain (cLBP) is a musculoskeletal condition associated with chronic pain, muscle tension, or stiffness that is usually located between the lower ribs and the gluteal fold. It has been estimated that cLBP lifetime prevalence among the US population was 40%, increasing with the patients’ age. The quality of life of patients diagnosed with cLBP may be significantly impacted, often disrupting normal social functioning, and impacting the ability to complete daily activities, leading to high economic burden and productivity loss. The most recent data suggests that total cLBP-related healthcare costs will reach $1.8 billion within the first year of diagnosis. A real-world evidence study conducted in the US estimated that annual healthcare costs among cLBP patients treated with Belbuca® or buprenorphine patch ranged from $33,000 to $35,000 per patient, emphasizing the high economic burden.

Purpose/Objectives:

A previously conducted US real-world evidence study assessed healthcare costs and resource utilization among cLBP patients treated with Belbuca® or buprenorphine patch formulations. It was found that Belbuca® treatment did not yield a significant change in healthcare costs, while a significant increase was noted in the buprenorphine patch cohort. Belbuca® was associated with significantly lower rates and numbers of any-cause and cLBP-related emergency department (ED) visits, while outpatient visit and hospitalization rates were similar. There is a lack of studies that compares the economic burden of cLBP patients treated with Belbuca® vs. other opioids.

The objective of this retrospective claims study was to assess and compare healthcare costs and resource utilization among cLBP patients previously treated with oral schedule II (CII) short-acting opioids (SAO). The study assessed outcomes in patients who initiated treatment with Belbuca® compared to those who started on oral CII long-acting opioids (LAO).

Methods:

This retrospective study was conducted using the Merative MarketScan® insurance claims database of commercially insured US patients from January 2019 to December 2023. Using the national drug codes, the first date of a prescription with Belbuca® or oral CII LAO was set to be the index date. The observational period covered a 6-month pre-index period and a 12-month follow-up period. Patients were required to be adults and to have at least two low back pain diagnoses and at least one SAO prescription in the pre-index period. Patients with a gap in healthcare coverage and with cancer and HIV diagnoses during the observational period were excluded. Switching from Belbuca® to the LAO treatment and vice versa was prohibited.

The main study outcomes were healthcare costs and resource utilization during the 12-month follow-up period. Any-cause and cLBP-related outcomes were assessed and sub-categorized by healthcare setting to reflect economic burden in outpatient, ED, and inpatient settings. Propensity-score matching (PSM) with a 1 to 1 matching ratio was employed to balance differences in patients’ characteristics and minimize their impact on study outcomes.

Results:

The non-matched sample consisted of 3,350 patients (1,331 Belbuca® patients and 2,019 LAO patients). After the PSM, 964 Belbuca® patients were matched to 964 LAO patients without any differences observed in demographic and clinical characteristics.

Prescription costs associated with all dispensed medications were significantly higher among patients treated with Belbuca® compared to LAO patients ($10,417 vs. $8,238, p=0.007). There were no differences between the cohorts in any-cause outpatient ($16,069 in Belbuca® vs. $15,111 in LAO, p=0.505), ED ($2,406 in Belbuca® vs. $2,763 in LAO, p=0.308), and inpatient healthcare expenditures ($8,885 in Belbuca® vs. $10,551 in LAO, p=0.303). Despite prescription costs being higher in Belbuca® patients, total healthcare costs were similar between the cohorts, and no statistical difference was observed ($37,778 in Belbuca® vs. $36,663 in LAO, p=0.670). Regarding cLBP-related healthcare expenditures, similar expenditures were also noted between Belbuca® and LAO cohorts, with total cLBP-related costs of $5,881 vs. $6,134 (p=0.785). Similar healthcare costs were observed in other cLBP-related sub-categories (all p-values ≥0.050).

All patients in the Belbuca® cohort (100.0%) and 99.9% in the LAO cohort had any-cause outpatient visits, with a significantly higher number of visits among patients treated with LAO (33.1 vs. 35.4, p=0.038). A higher proportion of LAO patients had any-cause ED visits compared to Belbuca® (36.9% vs. 41.6%, p=0.036), without a statistical difference in the number of ED visits. Similar rates of any-cause hospitalizations were observed (16.6% in Belbuca® vs. 18.8% in LAO, p=0.210), with a significantly higher number of hospitalizations among LAO patients (0.2 vs 0.3, p=0.041). There were no differences in the rates of cLBP-related outpatient and ED visits, while the rate of cLBP-related hospitalizations was significantly lower in Belbuca® patients (3.5% vs. 6.1%, p=0.008). The numbers of outpatient and ED visits associated with cLBP were similar among the study cohorts (11.0 in Belbuca® vs. 11.8 in LAO, p=0.073 and 0.1 vs. 0.1, p=0.661, respectively). LAO patients had a statistically higher number of cLBP-related hospitalizations than Belbuca® patients (0.04 vs. 0.08, p=0.013), with a longer hospital stay (0.14 days vs. 0.33 days, p=0.023).

Conclusions/Implications for future research and/or clinical care:

This retrospective insurance claims study of commercially insured cLBP patients previously treated with oral CII SAO found that healthcare expenditures were comparable between those transitioned to Belbuca® and oral CII LAO. Despite significantly lower prescription costs in the oral CII LAO cohort, total any-cause healthcare costs were similar compared to the Belbuca® cohort during the 12-month period after Belbuca® or LAO treatment initiation.

It was observed that Belbuca® patients had a significantly lower rate of any-cause ED visits and significantly lower numbers of any-cause outpatient visits and hospitalizations. The rate of hospitalizations associated with cLBP was significantly higher among LAO-treated patients, with a higher number of hospitalizations and longer hospital stay than in Belbuca® treated patients.

The main limitations are associated with the nature of insurance claims database and coding systems obstacles. Also, it was challenging to precisely define the cLBP, as there is a lack of specific codes describing low back pain chronicity and severity.

This real-world evidence study provided a comprehensive overview of healthcare costs and resource utilization among cLBP patients and demonstrated significant benefits of Belbuca® over LAO treatment. This was reflected in lower rates of outpatient, ED, and inpatient visits, while maintaining similar per-patient healthcare expenditures.