On Sept. 27, the Commission on Combating Drug Addiction and the Opioid Epidemic met with government, nonprofit and pharmaceutical industry leaders to discuss how innovations in pain management and drug treatment can be used to address the U.S. opioid problem.
The testimony from pharmaceutical company representatives highlighted impressive advancements in treatments for pain and addiction. Several companies discussed work on injectable buprenorphine (a drug used to treat opioid use disorders) that could be taken on a monthly basis, as opposed to daily. Such long-acting formulations are in demand for the certainty they provide in ensuring medication delivery and their ability to minimize the divergence of buprenorphine to the black market. Other notable advancements included a non-opioid drug for post-surgical pain management; a non-opioid drug for treating the opioid withdrawal process; a heroin vaccine; and “digital medicines,” drugs that contain ingestible sensors that allow doctors to monitor how patients take and respond to medications. While the efficacy of many of these new treatments remains untested, they signal that the pharmaceutical community is on its way to developing medical interventions that could help stem the opioid epidemic.
Pharmaceutical representatives were eager to discuss their respective companies’ latest drug innovations, which are an important part of responding to the opioid epidemic. But the larger message from the industry was clear. Despite medical advancements, there are two major barriers to advancing prevention of and treatments for opioid use disorder (OUD): the U.S. Food and Drug Administration’s slow approval processes for clinical trials and new drugs, and limitations on care imposed by the health insurance industry.
Nearly every pharmaceutical representative in the meeting stressed that the FDA must prioritize development of non-opioid pain medications and new formulations of medication-assisted treatment (MAT) therapies. Among the recommendations industry leaders shared with the commission were for the FDA to grant priority review to non-opioid and abuse deterrent pain management drugs, to waive filing fees for studies of non-opioid pain treatments and to incentivize investment in drug development by designating non-opioids to the “breakthrough” drug category. Implicit in these recommendations is the need for more funding for the FDA approval process. More resources are needed if the agency is expected to speed the clinical trial and drug review processes while still performing its primary function of protecting public safety.
FDA leaders probably are aware of the criticism that the agency’s review process is too slow, and likely recognize the need to get non-opioid pain drugs and more effective MATs to the market quicker. Recently, the agency, along with the National Institutes of Health (NIH), formed a public-private partnership with pharmaceutical companies to cut in half the time needed to make new non-addictive pain management medications and medications to treat addiction available to the public. The partnership, which was announced on Sept. 18, is brand new and, while much applauded, has not yet had the opportunity to demonstrate its effectiveness. If funds are not appropriated to facilitate the partnership, its chances at success will surely be lower.
The commission meeting identified the health insurance industry as a crucial actor in the opioid epidemic response, one that so far has done more to exacerbate the problem than to alleviate it. This criticism was not limited to private payers, but also included the Centers for Medicare and Medicaid Services (CMS), which many third-party insurers use as a model for their own care reimbursement standards.
One major obstacle is the limited access to pain medications that carry lower risks of addiction for patients. As The New York Times reported, insurance companies often make it difficult or impossible for patients to receive such pain medications because they are more expensive than traditional opioids. Insurers also typically place restrictions on MAT that run counter to patients’ best interests but that keep costs low for insurers, such as requiring patients to show that other treatment modalities have failed before they can obtain a buprenorphine prescription or placing arbitrary limits on its use. The insurance industry was also criticized for its continued noncompliance with the Mental Health Parity Act, which requires insurers to provide the same amount of coverage for substance use and mental health treatment as it does for other medical conditions; as the Opioid Commission recognized in its interim recommendations, compliance and enforcement remain low.
For the pharmaceutical companies working to develop new MAT therapies and non-addictive pain medications, the reluctance of insurers to cover these new drugs is a considerable barrier not only to patient access but also to further drug development. In particular, reimbursement systems that do not compensate care providers for the additional time needed for non-opioid pain management incentivizes the continued use of opioids, limits patient access to beneficial medications and discourages outside investment in underused pain management alternatives.
Research and development of non-addictive, non-opioid pain medications that can bring relief to the 25 million Americans who suffer from chronic pain is critical to stemming new incidences of OUD. Further development of MAT therapies is also needed to address the approximately 2.6 million current incidences of OUD. Testimony from pharmaceutical representatives demonstrates that efforts are underway to address both of these needs. But it is also apparent that even as the science and technology for addressing pain and addiction are improving, current policies prevent effective use of these new tools. While the FDA seems to recognize the importance of accelerating approval of clinical trials and new drugs for pain management and addiction treatment, it needs additional resources to accomplish this goal. Insurance companies must accept their role in responding to the opioid epidemic by eliminating barriers to drug treatment and providing mental health and substance use health care coverage that is on par with other medical benefits.
Let’s also not forget the motives of the pharmaceutical industry. All of the pharmaceutical representatives at the commission meeting stressed their organizations’ desire to create non-addictive drugs that can relieve patients’ pain and treat drug dependence. But the pharmaceutical industry also bears a large share of responsibility for the overprescribing of opioid painkillers that contributed to the current epidemic. While it may be in the public interest for the FDA to accelerate its drug approval process and for insurance companies to expand coverage, these recommendations are also clearly in the interest of an industry that likely views the opioid epidemic as a financial opportunity. Right now, the public interest in combating the opioid epidemic and the industry’s goal of profiting from expanding the use of non-opioid pain medications and new MAT therapies seem to coincide. But if in the future we learn that a different response is needed, do not expect the industry to support policy changes that do not align with their bottom line.
Katharine Neill Harris, Ph.D., is the Alfred C. Glassell, III, Fellow in Drug Policy at the Baker Institute. Her current research focuses on state sentencing policies for drug offenders and the legalization of medical and recreational marijuana.