How will the new long-acting buprenorphine treatment option and changing government rules affect the opioid treatment market?
Report Available:March 2, 2017
Blueshift’s initial research found the opioid dependence treatment market on the verge of a major disruption. Due to the opioid addiction epidemic, government rules and regulations are allowing physicians to expand the number of patients they treat. Additionally, new and emerging long-acting buprenorphine treatments are becoming available that will offer physicians and patients more treatment options. Still, the future of treating opioid dependency with these new drugs and treatment rules is unclear, as are the expectations for success of the companies involved. Timing of adoption, cost of treatment, patient desire for treatments, and treatment efficacy are all issues that will need attention.
- Opioid dependence to prescription or illicit drugs has become a worldwide public health problem. In the United States, the problem is described as an epidemic and overdose deaths from opioids, including prescription opioids and heroin, have more than quadrupled since 1999. Overdoses involving opioids killed more than 28,000 people in 2014. Over half of those deaths were from prescription opioids. Ninety-one Americandeaths occur every day as a result of opioid overdose.
- In an effort to expand treatment opportunities for opioid-dependent patients, the U.S., Department of Health and Human Services (HHS) hasexpanded the maximum number of patients being treated for opioid dependency by a physician from 100 to 275. To further expand treatment opportunities, HHS now allows nurse practitioners (NPs) and physician assistants (PAs)tocomplete the required training and seek to prescribe buprenorphine for up to 30 patients beginning in early 2017.
- New buprenorphine delivery systems are becoming available that are implantable or injectable and last a week, a month, or six months, in the case of TTNP and Braeburn Pharmaceutical’s recently-approved Probuphine. The drugs are expected to offer the advantage of lowering the potential for misuse, diminishing the effects of physical dependency to opioids, increasing safety in cases of overdose, and eliminating the daily visit to a methadone clinic. Two new post-Phase 3 drugs that could hit the market later this year or in early 2018 are INDV’s RBP-6000, which is a monthly depot injection, and CAM2038 by Braeburn and CAMX, which is a weekly and monthly subcutaneous buprenorphine injection.
- During TTNP’s Q3 earnings call, management indicated that since the FDA approval of Probuphine, Braeburn has trained 2,400 healthcare professionals in 50 states and Puerto Rico on how to insert and remove the ProNeura implant, and has obtained third-party coverage for Probuphine from large and regional insurance companies, as well as coverage under Medicare, Medicaid and the Department of Veterans Affairs. Management noted that adoption of Probuphine has been slowed by time-consuming paperworkwhich has created alonger-than-desired sales cycle. Braeburn is devoting resources to this procedure in an effort to streamline the process.
- Blueshift April 8, 2016, report found that long-acting implantable and injectable buprenorphine is expected to become an important tool and gain a significant foothold in treating opioid-addicted patients over time.All 15 sources acknowledged the clinical value of treating stable patients with long-acting buprenorphine. Sources’ expectations for market penetration varied, but two (a physician and an addiction treatment professional) expected buprenorphine to claim 20% to 25% share.Weekly and monthly treatments likely will be more widely used than the six-month dosage of long-acting buprenorphine.
How will the market evolve as it migrates from the daily dose to the long-acting depot-based drug? What are timing expectations for adoption of the long-acting buprenorphine treatments? What is the TAM for long-acting buprenorphine? What are the possible roadblocks and headwinds to adoption? What will insurers and third-party payers do regarding long-acting buprenorphine? What will adoption look like for the weekly, monthly, and six-month options? Which companies will stand out above others with their treatment options? To answer these and other questions, Blueshift will issue a market research report by gathering data from independent sources in the following areas: Physicians, Nurse Practitioners (NPs) and Physician Assistants (PAs), Pain management opioid sales channel, Addiction treatment specialists, Third-party payers, and Industry specialists.
Companies: Camurus AB (CAMX), Indivior PLC (INDV),Titan Pharmaceuticals Inc. (TTNP)
Research Begins: Feb. 13, 2017