Braeburn Pharmaceuticals’ Probuphine® Implant Receives J-Code by Centers for Medicare & Medicaid Services
Princeton, N.J.—January 13, 2017—Braeburn Pharmaceuticals, Inc. today announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common Procedure Coding System (HCPCS) code, or permanent J-code, for Probuphine, the first and only six-month buprenorphine implant for the maintenance treatment of opioid addiction. The new J-code (J0570) became effective January 1, 2017 and coincides with the activation of a new field force to drive the next phase of Probuphine adoption.
“With patients and providers urgently needing access to evidence-based treatment for opioid addiction, we are pleased that CMS granted a J-code for Probuphine,” said Behshad Sheldon, President and CEO, Braeburn Pharmaceuticals. “We anticipate that the new code and our expanded commercial team will advance adoption of Probuphine and broaden access for appropriate patients with opioid use disorder.”
HCPCS codes are used by healthcare professionals to identify services and procedures for which they bill public or private health insurance programs. The codes included in the HCPCS set, which is based on the American Medical Association’s Current Procedural Terminology, are maintained by CMS and universally accepted by all payers.
Probuphine is the only six-month treatment for opioid dependence that delivers buprenorphine continuously using Titan Pharmaceuticals’ (NASDAQ: TTNP) ProNeura™ technology. Probuphine is placed under the skin of the upper arm during a short outpatient office procedure and is removed in a similar manner. Probuphine is available through a closed distribution system. Qualified healthcare providers can register for Probuphine training at www.probuphineREMS.com or by calling 1-866-397-8939. Probuphine is available in all 50 U.S. States; people interested in finding a provider in their area can visit www.probuphinerems.com/probuphine-locator.
Probuphine Indication and Important Safety Information
PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent).
PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support.
PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet or generic equivalent.
WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL
Risk Associated with Insertion and Removal
Insertion and removal of PROBUPHINE are associated with the risk of implant migration, protrusion, expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion.
Because of the risks associated with insertion and removal, PROBUPHINE is available only through a restricted program called the PROBUPHINE REMS Program. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing PROBUPHINE implants. Patients must be monitored to ensure that PROBUPHINE is removed by a healthcare provider certified to perform insertions.
Please see additional Important Safety Information in the Package Insert that can be found at probuphine.com or by following this link http://probuphinerems.com/wp-content/uploads/2016/02/final-approved-pi.pdf.
About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges. Braeburn’s commercial product, Probuphine® (buprenorphine) implant was approved by the FDA in May 2016. Braeburn’s investigational product pipeline consists of long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia. Braeburn’s pipeline products are at various stages of clinical development and include weekly and monthly CAM2038, subcutaneous injection depot formulations of buprenorphine, being investigated in opioid addiction and pain, BB0417 buprenorphine/granisetron injectable for acute pain, and BB0817, six-month risperidone implant being investigated in schizophrenia. More information on Braeburn can be found at www.braeburnpharmaceuticals.com.
Sherry Feldberg for Braeburn Pharmaceuticals MSLGROUP 781-684-0770 firstname.lastname@example.org