Sublocade – A New Once-Monthly Injection for the Treatment of Opioid Use Disorder

CMS, FDA, Medicare, Medicare Set-Aside Blog, Medicare Set-Asides, MSP News, Opioids on February 5, 2018
Posted by Katherine Bales, RN, JD

The opioid crisis continues to be one of the most talked about issues facing the health care community, and the nation as a whole, having been declared a national public health emergency. In response, pharmaceutical companies have been actively working on ways to treat the crisis with the development of alternative treatment methods.

The FDA recently approved the first and only once-monthly injectable buprenorphine extended release formulation for subcutaneous injection to treat moderate to severe opioid use disorder. The drug, trade name Sublocade, is expected to be available in the United States sometime in the first quarter of 2018 with a reported wholesale acquisition cost of $1,580 per monthly dose. Manufactured by Indivior, Sublocade is intended to be administered by healthcare professionals as part of a complete treatment program, which includes psychosocial support, in patients who have initiated treatment with a transmucosal buprenorphine containing product followed by dose adjustment for a minimum of seven days. In an opioid blockade study, most patients who received Sublocade achieved complete blockade of drug liking effects for an entire month providing a sustained rate of medication release over a one month period. In clinical trials, the overall safety of Sublocade, given by healthcare providers, was consistent with the known safety profile of transmucosal buprenorphine except for injection site reactions, none of which were reported as serious and with only one participant stopping treatment.

Prescription use of Sublocade for the treatment of opioid dependence under the Drug Addiction Treatment Act (DATA, 21 U.S.C. 823(g)) is limited to healthcare providers who meet certain requirements and notify the Secretary of Health and Human Services of their intent to prescribe Sublocade. Distribution of Sublocade will be restricted in an attempt to prevent the direct distribution of the medication to patients due to the possible risk of serious harm or death that could result from intravenous self administration. Indivior worked closely with the FDA to include appropriate warnings and precautions, and healthcare providers and pharmacies that order and dispense Sublocade, must be certified in the Sublocade Risk Evaluation and Mitigation Strategy program.

The American Society of Addiction Medicine is one group that supports development and manufacturing of medications that aid in the treatment of addiction as no one treatment modality is appropriate for every patient. The opioid crisis affects nearly 12 million people nationwide and the workers’ compensation arena has been particularly impacted by opioid use disorder. The treatment and recovery from opioid addiction is complex, access to treatment and development of new ways to treat the crisis supports the goal of fighting against the chronic relapsing disease of opioid addiction. Sublocade is just one weapon that may be coming to your workers’ compensation claim in the near future.