The Opioid Crisis: What is The Government Doing About It? Part 5 – Improving the Quality of Research on Pain and Addiction

CMS, Opioids, Rx/Pharmacy on February 15, 2019
Posted by Complex Claims Division

This blog series is devoted to better understanding the efforts our Federal government is undertaking to combat the opioid epidemic in America. Last year, the Department of Health and Human Services (HHS) announced a five-part strategy that will be utilized to combat the opioid epidemic. In previous posts, we have focused on the first four parts of the strategy which include (1) increasing availability to addiction treatment services; (2) improvements in public health data and reporting as a means to drive more effective solutions for the ever-expanding opioid crisis; (3) the promotion of healthy, evidence-based methods of pain management and (4) increasing the availability of overdose-reversing drugs.

In this post, we’ll examine the fifth and final prong of HHS’ five-part strategy, which focuses on improving the quality of research on pain and addiction to inform clinical practice and reduce opioid prescribing. The hope is that in turn, these efforts will help to combat the opioid crisis by making opioids less ubiquitous in society.

In April 2016, the Centers for Disease Control (CDC) published a guideline for the prescribing of opioids for chronic pain[1] The guideline includes many factors for prescribers to consider in the treatment of pain, as well as best practices for the use of opioids. As an example, the CDC’s guideline includes a preference for nonpharmacologic therapy and non-opioid pharmacologic therapy for the treatment of chronic pain. The guideline also includes a preference for immediate-release opioids rather than extended-release opioids when initiating opioid therapy for chronic pain.

In 2017 and 2018, Federal funding for pain and opioid research increased significantly. In October of 2017, the National Institutes of Health announced funding for a study called ACT NOW. ACT NOW stands for Advancing Clinical Trials in Neonatal Opioid Withdrawal syndrome. The goal of ACT NOW was to develop best practices for the treatment of infants who suffer from opioid withdrawal syndrome.

In November of 2017, the results of a study funded by the National Institute on Drug Abuse were published in the Lancet.[2] The study involved 570 opioid-dependent adults, who were randomly assigned to one of two treatment groups. One group received treatment with a buprenorphine/naloxone combination product (Suboxone), and the other group received treatment with an extended-release naltrexone product (Vivitrol). Researchers expected that it would be more difficult to initiate treatment in the Vivitrol group, since Vivitrol requires full detoxification prior to the initiation of treatment. Many patients abandon treatment before full detoxification is achieved. This expectation proved to be correct, since fewer patients were able to initiate treatment with Vivitrol compared to Suboxone (72.1% vs. 94.1%). This difference also contributed to higher 24-week relapse rates in the Vivitrol group compared to the Suboxone group (65.4% vs 56.8%). However, among the 474 participants who were able to initiate medication therapy, the 24-week relapse rates were similar (52.0% for Vivitrol vs. 55.6% for Suboxone). Other study endpoints – number of days of abstinence, negative urine testing and time to relapse – generally favored Suboxone. Five fatal overdoses occurred during the study, three in the Suboxone group and two in the Vivitrol group. Overdose rates in the study – both fatal and non-fatal – were significantly lower than what would be expected in an opioid-dependent population. This supported the conclusion that medication therapy protects against overdose.

Over the next few years, it is likely that we will start to see the results of these and other studies being incorporated into clinical protocols for the treatment of chronic pain and opioid dependency, and in turn Workers’ Compensation Medicare-Set Asides (WCMSAs).  In our experience, we have not seen Vivitrol regularly included in WCMSAs, but it is not uncommon to see Suboxone included if the medication is being prescribed by a primary treating physician for the treatment of opioid dependence.  Moreover, in 2018, it was not uncommon to see Suboxone included in WCMSAs as brand name.   That could change as the generic version of Suboxone film was approved by the FDA in June, 2018 for the treatment of opioid dependence, as utilized in the study.  However, recent litigation has been launched in an effort to impede the release of the generic of the film, which we will be closely monitoring.  

This concludes our in-depth look into the government’s Five Part Strategy for addressing and combating the opioid crisis.  We are optimistic that the five components, as we have discussed here on our blog [3] will continue to draw the necessary attention needed to begin to reverse the national crisis  we have witnessed with opioids.  Moreover, we are hopeful that CMS will follow stride and implement changes into the voluntary WCMSA review program, which will appropriately reflect the government’s five-part strategy.