Healthcare Cost and Resource Use in Chronic Low Back Pain Patients Treated with Belbuca® and Buprenorphine Transdermal Patches: A Retrospective US Commercial Claims Analysis

Abstract Title: Healthcare Cost and Resource Use in Chronic Low Back Pain Patients Treated With Belbuca^® and Buprenorphine Transdermal Patches: A Retrospective US Commercial Claims Analysis

Background:

Chronic low back pain (cLBP) is one of the leading causes of disability in the US, with every third patient experiencing moderate-to-severe chronic pain. Due to a great impact on quality of life, cLBP patients are usually heavily treated, leading to a high economic burden from the payer’s perspective.¹ Opioids are commonly prescribed as an effective treatment option, but their use is frequently followed by severe and serious adverse events.² However, buprenorphine’s efficacy and safety characteristics have the potential to result in an improved risk-benefit profile compared to other opioids for long-term chronic pain management.³

Buprenorphine products designed as buccal film and transdermal patch formulations are designed to ensure a greater bioavailability to avoid an extensive hepatic CYP3A4 metabolism.⁴

This retrospective US insurance claims analysis aimed to explore and compare total and disease-related healthcare cost changes in cLBP patients treated with Belbuca^® buccal film or buprenorphine transdermal patches (BTPs) observed before and after the treatment initiation. Additionally, healthcare cost and resource use differences between the study cohorts were also assessed.

Purpose/Objectives:

The study was performed on Merative MarketScan^® commercial claims captured from January 01, 2018 to December 31, 2021. Belbuca^® and BTP prescriptions were identified by the relevant national drug codes. The index date was the date of the first Belbuca^® or BTP prescription. Patients were observed 6 months prior (pre-index) and 12 months after (follow-up) the index event.

The study population consisted of adult cLBP patients treated with Belbuca^® or BTP. Age was determined on the index date, and cLBP was defined as at least 2 low back pain diagnoses over the pre-index period. Patients were also required to have continuous healthcare coverage and no opioid use disorder during the observational period. Switching between Belbuca^® and BTP treatments was not allowed.

Demographic characteristics of the study sample were assessed on the index date, while patients’ clinical characteristics were observed during the pre-index period. Propensity-score matching (PSM) analysis using the nearest-neighbor algorithm was performed to minimize the selection bias and ensure a homogenous pool of cLBP patients. Population characteristics (demographic and clinical) were used as a basis for the matching process.

Healthcare costs were calculated within the whole follow-up period for any-cause, particularly for cLBP-related services, and stratified by the healthcare setting. Healthcare cost trends in each cohort were observed during periods of equal duration, thus the pre-index period and the first 6 months of the follow-up, to ensure a valid within-group comparison. Between-group analysis was performed over the same periods.

Resource consumption outcomes of interest were the number of outpatient, emergency department (ED), and hospitalization visits, as well as the total duration of hospital stay. Healthcare resource utilization was observed over the follow-up period and compared between Belbuca^® and BTP patients.

Continuous variables were analyzed with an independent sample t-test (between-group differences) and reported as mean values with standard deviation. The healthcare cost difference between the pre-index and 6-month follow-up periods was assessed using paired sample t-test. Categorical variables were analyzed with the chi-square test of independence and summarized as numbers and proportions of the sample.

Method:

Out of 17,439 patients prescribed Belbuca^® or buprenorphine patch, 2,307 patients have been identified in a final non-matched sample. After PSM analysis, the final sample of matched patients consisted of 1,416 patients (708 patients in both cohorts).

Healthcare cost changes were analyzed within each cohort 6 months before and 6 months after the first buprenorphine prescription. The observed raise in prescription costs in both cohorts was anticipated due to the buprenorphine treatment initiation. Otherwise, Belbuca^® was associated with a trend of stable any-cause and cLBP-related total healthcare costs, inpatient, and outpatient cost categories. A significant benefit in terms of cost-savings was observed in the cLBP-related ED costs ($56 cost saving, p=0.025). On the contrary, the use of BTPs led to a cost raise in any-cause ($3,989, p< 0.001) and cLBP-related total healthcare costs ($1,337, p=0.043) after the treatment introduction. The raise in expenditures after the BTP initiation was mostly driven by the increases in any-cause outpatient ($1,734, p< 0.001) and inpatient ($1,648, p=0.057) costs.

Healthcare expenditures were similar between the cohorts in the pre-index period. The only significant difference was captured in any-cause outpatient costs ($7,979 in Belbuca^® and $6,332 in BTP, p=0.027). However, this difference diminished over the 6-month period after buprenorphine initiation ($7,542 in Belbuca^® and $8,066 in BTP, p=0.471). During the 6-month follow-up period, Belbuca^®-treated patients had significantly lower cLBP-related ED costs ($29 vs. $73, p=0.038) and cLBP-related total healthcare costs ($2,909 vs. $4,124, p=0.047) than BTP-treated patients. cLBP-related inpatient and outpatient cost categories were also lower in the Belbuca^® cohort, but statistical significance was not reached.
There were no observed differences between the study cohorts in terms of any-cause and cLBP-related outpatient visits, inpatient visits, and length of hospitalization stay during the 12-month period after buprenorphine treatment initiation. The main benefits of Belbuca^® treatment were noted within the ED setting, with fewer patients having at least one any-cause ED visit (36.3% vs. 42.5%, p=0.017) and at least one cLBP-related ED visit (4.7% vs. 7.3%, p=0.034) than patients receiving BTP. The Belbuca^® cohort also had fewer ED visits across the total sample related to any condition (0.8 vs. 1.1, p=0.011) and to cLBP (0.06 vs. 0.09, p=0.042) than the BTP cohort.

Results: Belbuca^® showed more favorable healthcare cost trends than BTPs, and was associated with significantly lower cLBP-related total healthcare costs after buprenorphine initiation. The benefits of Belbuca^® treatment during the follow-up were mostly observed in the ED category. In the ED healthcare setting, Belbuca^® was associated with significantly lower cLBP-related costs, less any-cause and cLBP-related visits, and fewer patients with at least one admission than BTPs. These study findings indicate that Belbuca^® use in cLBP patients may lead to more efficient cLBP management versus treatment with BTPs, whilst accompanied by lower use of healthcare resources.

Conclusions: [1] Stevans JM, Delitto A, Khoja SS, et al. Risk Factors Associated With Transition From Acute to Chronic Low Back Pain in US Patients Seeking Primary Care. JAMA Netw Open. 2021;4(2):e2037371. doi:10.1001/jamanetworkopen.2020.37371
[2] Chou R, Turner JA, Devine EB, et al. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015;162(4):276-86. doi:10.7326/m14-2559
[3] Webster L, Gudin J, Raffa RB, et al. Understanding Buprenorphine for Use in Chronic Pain: Expert Opinion. Pain Med. 2020;21(4):714-723. doi:10.1093/pm/pnz356
[4] Poliwoda S, Noor N, Jenkins JS, et al. Buprenorphine and its formulations: a comprehensive review. Health Psychol Res. 2022;10(3):37517. doi:10.52965/001c.37517

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