Limited Access to On-Label Formulations of Buprenorphine for Chronic Pain as Compared with Conventional Opioids

Abstract

Importance Buprenorphine is a Schedule III analgesic that is recommended as the firstline long-acting opioid for the treatment of chronic pain due to its ceiling effect on respiratory depression, adverse effect profile, and analgesic efficacy. However, prescription drug coverage policies commonly require that patients try and fail multiple Schedule II conventional opioids before approval of on-label use of buprenorphine for chronic pain. Design A retrospective review was performed looking at coverage of buprenorphine in the forms of Butrans and Belbuca. Patient denial letters, web searches of insurance and pharmacy benefit managers (PBMs), and an online tool (formularylookup.com) were used to assess the coverage and availability of buprenorphine for chronic pain. Results Unrestricted access to Butrans was reported for 42% of commercial lives and 11% of Medicare lives in all locations. Unrestricted access to Belbuca was reported for 53% of commercial lives and 23% of Medicare lives in all locations. Oxycodone immediate-release has unrestricted access for 84% of commercial plans and 97% of Medicare plans. Morphine extended-release has unrestricted access for 62% of commercial lives and 65% of Medicare lives. Conclusions and Relevance There are >17,000 prescription opioid–involved deaths each year in the United States. By substituting buprenorphine as the firstline treatment for chronic and even acute pain, there may be fewer prescribed conventional opioids in the United States. Schedule III buprenorphine formulations for chronic pain should be given unrestricted access for appropriate patients before considering a Schedule II opioid as a public health priority.

Complex Persistent Opioid Dependence with Long-term Opioids: a Gray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes

“…12,13 Compared with other opioids like morphine, oxycodone, or fentanyl, access to buprenorphine for LTOT patients with chronic pain has been restricted by many insurance plans. 39 It is important to remove the barriers to access to buprenorphine treatment for CPOD given that over 10 million US adults are likely on LTOT. It is unknown how many of these patients on LTOT may be experiencing worsening pain or difficulty with opioid taper due to CPOD.…”

Buprenorphine Buccal Film for Chronic Pain Management

“…The Schedule III classification of buprenorphine by the US Drug Enforcement Administration confirms its enhanced safety profile and reduced abuse potential [77]. As a result, buprenorphine should be considered a first-line treatment for chronic pain in appropriate patients identified by risk/benefit analyses [62]. The increased bioavailability (46-65%) and extended available dose range (75-900 μg) of buprenorphine buccal film compared with that of the buprenorphine transdermal system support its preferential consideration for chronic pain treatment.…”

“…Buprenorphine buccal film has advantages over the transdermal formulation and is considered by many practitioners to be a preferential treatment option over Schedule II opioids on the basis of efficacy and safety demonstrated by clinical studies [44][45][46]62]. This review article is thus focused on the buccal formulation, with the primary objective of providing an overview of the clinical studies that have examined buprenorphine buccal film as a resource for clinicians who are seeking alternative treatments for chronic pain.…”

Frontline Perspectives on Buprenorphine for the Management of Chronic Pain

“…Many prescription drug coverage policies require therapeutic trials of multiple Schedule II opioids to fail before issuing an approval for payment of buprenorphine for chronic pain. 48 This suboptimal or limited coverage and reimbursement has resulted in a significant access hurdle to buprenorphine treatment for chronic pain, despite its being regarded as a relatively safer and effective opioid. 5 Although a US Drug Enforcement Agency (DEA) X-waiver was never required for prescribing buccal or transdermal buprenorphine for chronic pain, much confusion on this topic has resulted in additional access barriers.…”