FDA Approves Once-Monthly Buprenorphine Injection

The FDA has approved Sublocade, the first once-monthly injectable buprenorphine product for moderate-to-severe opioid use disorder (OUD) in patients who have initiated treatment with a transmucosal (absorbed through mucus membrane) buprenorphine-containing product.

The following language is extracted from the FDA’s press release for Sublocade:

Sublocade is indicated for patients that have been on a stable dose of buprenorphine treatment for a minimum of seven days. Sublocade can provide a new treatment option for patients recovering from OUD who may value the benefits of a once-monthly injection compared to other forms of buprenorphine, such as tablets, implants, or film that dissolves in the mouth, reducing the burden of medication adherence.

The drug is injected by a health care professional under the skin, forming a depot of buprenorphine that is released over time. Sublocade should not be administered intravenously, as the depot could cause blockage, tissue damage, or embolus, which can lead to death. In clinical trials, Sublocade provided sustained therapeutic plasma levels of buprenorphine over the one-month dosing interval. Common side effects include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site and abnormal liver function tests.

Sublocade should be used as part of a complete treatment program that includes counseling and psychosocial support. Regular adherence to medication-assisted therapy (MAT) with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids.

For further information, read the FDA press release.


Tags: FDA, product approvals, opioid, opioids, buprenorphine, opioid use disorder, opioid-use disorder


Dr. Silvia Sacalis Discusses Specialty Drug Trends with WorkCompWire

Healthesystems VP of Clinical Services, Silvia Sacalis, PharmD, recently appeared in WorkCompWire, an online news service focused on workers’ comp, discussing clinical decision-making as it relates to specialty drug trends in workers’ comp.

Dr. Sacalis was featured in the Leaders Speak series, offering her expertise on how to weigh the high cost of specialty drugs against the significant clinical benefits they potentially offer injured workers. The article “The Specialty Drug Decision – Weighing Outcomes and Cost” addressed the often complex decision regarding the appropriateness of specialty medications in the treatment of workplace injury, covering topics such as hepatitis C and HIV, osteoarthritis, and other relevant conditions.

Read the article in full online at WorkCompWire.


Tags: Specialty, specialty drugs, HIV, HCV, hepatitis, WorkCompWire


New Study Ties Medical Marijuana to Reduced Opioid Use

The Public Library of Science (PLOS) recently published a study from the University of New Mexico that found a strong correlation between medical marijuana program enrollment and reduced opioid use in patients with chronic pain.

The study tracked 37 habitual opioid using chronic pain patients who were enrolled in New Mexico’s Medical Cannabis Program (MCP) between 2010 and 2015, comparing them to a group of 29 patients with similar health conditions who did not enroll in the MCP. The state’s Prescription Monitoring Program was used to monitor opioid usage over a 21-month period to measure opioid cessation and reduction.

Patients enrolled in MCPs were 83.8% likely to reduce daily opioid usage, while other patients were only 44.8% likely to reduce daily opioid usage. MCP enrolled patients were also 40.5% likely to cease filling opioid prescriptions entirely, compared to 3.4% of other patients. Finally, MCP patients reduced their daily opioid prescription doses by an average of 47%, versus 10.4% for non-MCP patients. Survey responses from MCP patients indicated improvements in pain reduction, quality of life, activity levels, and concentration after one year of enrollment in MCPs.

This study joins others that indicate medical marijuana programs may be linked to a reduction in opioid use. In July of 2016, data from Medicare Part D enrollees revealed that the use of prescription opioids decreased significantly in states with medical marijuana programs, while a June 2016 study from the University of Michigan found that medical cannabis use was associated with a 64% decrease in opioid use. Furthermore, the Journal of the American Medical Association (JAMA) found in 2014 that states with medical cannabis laws had a 24.8% lower mean annual opioid overdose mortality rate compared with states without medical cannabis laws.

For further information on this most recent study from the University of New Mexico, visit PLOS online.


Tags: Marijuana, medical marijuana, cannabis, medical cannabis, opioid, opioids


2018: The Year of Telemedicine?

Effective January 1, 2018, telemedicine services in Colorado will no longer face certain preauthorization requirements in workers’ compensation claims due to recent fee schedule updates from the Division of Workers’ Compensation. Healthcare providers will now be able to follow applicable Medicare payment policies and billing provisions for workers’ comp patients.

For quite some time, the topic of telemedicine entering workers’ compensation has been discussed, and it appears 2018 may be a big step forward as more states take action.

During the 2017 International Association of Industrial Accident Boards and Commissions (IAIABC) Convention in October, South Carolina regulators announced plans to reexamine telemedicine in their next iteration of fee schedule updates in April 2018. Furthermore, back in September, the Texas Division of Workers’ Compensation proposed an informal working draft of rules that would expand the accessibility of telemedicine services to injured workers. The proposed rules state that healthcare providers would have to follow applicable Medicare payment policies and billing provisions, and so far the informal rules have received enough traction that a formal rule will soon be released.

It’s no secret that a state as big and influential as Texas could impact more states to act on telemedicine in workers’ comp, and while telemedicine has initially been slow in entering the workers’ comp sphere, it has made great strides entering the larger healthcare sphere.

The National Telehealth Policy Resource Center revealed earlier this fall that 48 states and the District of Columbia provide reimbursement for some form of telemedicine in Medicare fee-for-service systems, an increase from 29 states at the beginning of this year. Furthermore, 44 states introduced over 200 telehealth-related pieces of legislation in 2017.

With this level of activity, it is hard to doubt that telemedicine’s impact on workers’ compensation will soon increase, especially as the market continues to grow. A recent report from IHS Technology found that the world market for telehealth and remote patient monitoring was worth $521.1 million in 2015, with 36.4 million virtual consults in North America and Western Europe. Meanwhile, market research estimates that the telemedicine market will increase around 16.3% through 2025, reaching $78.3 billion.

While the American College of Occupational and Environmental Medicine (ACOEM) guidelines give preference to in-person examinations, they recognize that in certain cases telehealth is a more viable alternative, such as in rural locations with health professional shortages, and in cases of severe, impassible weather. The Official Disability Guidelines recognize telehealth’s use in treating pain, diabetes, mental health disorders, and common occupational injuries such as sprains and cuts. Telemedicine has also been found to work well for monitoring chronic conditions, which could be beneficial in workers’ comp for the management of comorbidities, and there is great evidence that telemedicine works well for triage, physical rehabilitation, and drug therapy management.

While there are many valid concerns regarding the use of telemedicine in workers’ compensation patients, it seems inevitable that a larger implementation of telemedicine services is on the horizon, an implementation that industry stakeholders will soon need to prepare for while lawmakers continue to draft and debate legislation that empowers telemedicine.


Tags: Telemedicine, telehealth, Texas, Colorado, South Carolina


New RxInformer Clinical Journal Now Available

RxInformer is a trusted source for information on trending and influential topics in workers’ compensation with in-depth articles and infographics authored by a veteran team of clinicians, policy experts, and other industry thought leaders.

The Winter 2017 of RxInformer journal issue covers diverse topics such as:

  • Clinical decision points related to specialty medications in workers’ comp
  • The changing dynamic of age among injured worker populations and the related impact on pharmacy management
  • The latest research exploring non-opioid pain pathways in the body
  • An overview of the FDA’s reexamination of their opioid policies
  • A perspective on the use of Virtual Reality in physical therapy
  • More

Read these stories online now at RxInformer.


Tags: RxInformer, clinical journal, Healthesystems, specialty drugs, specialty, pathway, pathways, age, FDA