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Sen-Jam Pharmaceutical Reports the Positive Effect of Payer Options and Expanded Coverage for Individuals with Opioid Use Disorder

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HUNTINGTON, N.Y., Aug. 30, 2018 (GLOBE NEWSWIRE) -- The Opioid Epidemic is an incredibly complex and multifaceted problem facing America. We wanted to investigate the developments in medications, funding, and therapy programs for opioid addiction on the national and state levels.  One of the leading problems contributing to the Opioid Epidemic is that people who want to quit their opioid pain medication often cannot due to painful opioid withdrawal syndrome. In response, state and federal governments have increased funding for opioid withdrawal therapy. I have identified Vermont and Massachusetts as two states with high prevalence of opioid use disorder (OUD) as well as extensive healthcare coverage. The combination of crisis and funding means that these states have the pressure necessary for innovation in medication-assisted treatment (MAT) as well as the resources necessary to make it possible. The healthcare environment in these states has produced innovative care management structures that prove beneficial for long term OUD recovery.

The National Safety Council 2018 Report on the Progress of State Efforts to Combat the Opiod Crisis
The National Safety Council 2018 Report on the Progress of State Efforts to Combat the Opiod Crisis



State Level Comparison of Relative Buprenorphine Use and Public Funding
State Level Comparison of Relative Buprenorphine Use and Public Funding



Background on MAT

Most people experience severe withdrawal symptoms when they stop taking opioids that restrict their ability to get off of the medication. In response to widespread opioid dependence and overdose deaths, health professionals may prescribe medication-assisted treatment (MAT), which combines behavioral therapy and medications to treat substance use disorders. These medications relieve withdrawal symptoms and psychological cravings. Methadone, buprenorphine and naltrexone are used to treat opioid dependence and addiction to short-acting opioids such as heroin, morphine, and codeine as well as semi-synthetic opioids like oxycodone and hydrocodone. Methadone and buprenorphine have a significantly lower induction hurdle, the ability to initiate therapy, than naltrexone (Vivitrol).  However, methadone has a higher addiction potential than buprenorphine. The therapy must be administered with careful supervision at federally certified opioid treatment programs or clinics.

Traditionally, there has been a deficit in the number of buprenorphine prescribers, largely because doctors were required to attend an 8-hour training course and buprenorphine was not necessarily covered by a person's insurance.  However, in recent years, federal and state restrictions on buprenorphine have lessened due to the rise in the opioid crisis. Thus, buprenorphine has gained traction as a more accessible opioid withdrawal therapy.

Buprenorphine is a breakthrough therapeutic because it is the first medication that can be prescribed and given to individuals in a doctor's office. According to the Drug Addiction Treatment Act of 2000, doctors can now prescribe buprenorphine in a variety of settings including community hospitals, health departments, and prisons. In 2013, Suboxone (a buprenorphine-naloxone tablet) sales were $1.55 billion – more than those of Adderall and Viagra combined that year.

The sales of Buprenorphine and usage of MAT may be at an all time high because states have taken action and implemented OUD treatment programs across the country. The National Safety Council (NSC) conducted an extensive review of OUD literature, state legislation and data to create a report on the status of the opioid crisis1. The paper evaluates each state's progress in fighting this epidemic, based on the number of these six key actions achieved:

  1. Mandating prescriber education
  2. Implementing opioid prescribing guidelines
  3. Integrating prescription drug monitoring programs into clinical settings
  4. Improving data collection and sharing
  5. Treating opioid overdose
  6. Increasing availability of opioid use disorder treatment

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The NSC used these indicators to score states that are "failing", "lagging", or improving with regard to combatting the opioid crisis. State progress in this report was based on best available data as of Dec. 31, 2017. Nevada and New Mexico were the only two states this year that met all six key actions and no state met zero key actions. Although the country as a whole is making great strides, efforts vary greatly from state to state. Some states like Florida, Ohio and Kentucky focus primarily on gathering data and decreasing the number of opioid prescriptions. Others like Massachusetts and Vermont place a greater focus on MAT availability and prescriber education.

Overall, the NSC explains that none of these indicators is a solution in itself. Prescriptions like buprenorphine and methadone keep physical cravings at bay so that patients may focus on addressing psychological issues and reconnect to social support networks. That said, many drug treatment programs address the psychological and social aspects of addiction, but do not include medication as a necessary component. "If people leave rehab without MAT, they are more likely to die than if they hadn't completed rehab," Dr. Kelly Clark of CleanSlate addiction treatment centers says. "We need to develop a structured, standard model of care and then adapt it for each person. A full assessment and individualized treatment should be a core piece of best practices." Success of programs like those Dr. Clark describes often depends on public private partnerships. This kind of funding traditionally depended on the states, but has seen more federal attention since the Affordable Care Act was passed.

MAT Funding

In a 2016 report by the IMS Institute2, it was revealed that only 1 in 10 people who need drug and alcohol treatment receive it. Not everyone who needs treatment wants it, but enough do to create long waiting lists across the country. In West Virginia, the state with the highest rate of overdose deaths, there are a mere 171 beds for detox and 151 for longer-term residential treatment. In New Hampshire, another state with astronomical OUD rates, Medicaid patients wait as long as six weeks for a publicly funded residential bed. The small subset of users who have private insurance can generally gain quick access to facilities that cost up to $10,000 a week.

Medicaid expansion under the Affordable Care Act (ACA) significantly increased access to MAT treatment centers across the country.  Nationwide, public funding accounts for about 32% of total buprenorphine prescriptions, significantly more than before 2010. Soon, the number of beds in New Hampshire is expected to more than double thanks to new state and federal funding. OUD admissions to specialty treatment facilities increased 18% in expansion states.

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/644ac4bb-1a65-472f-9469-360bfb212e90

Although ACA Marketplace states broadened access to MAT, some other states have obtained waivers to access Medicaid expansion and used the additional funding for local plans to mitigate the opioid crisis. Of particular interest in this category are Vermont and Massachusetts. Each state provides some of the greatest access to MAT in the country. The two states spend more than any other state per capita on buprenorphine. Vermont, in particular, covers almost 70% of requests for buprenorphine, indicating that the state has successfully increased the number of buprenorphine prescribers, versus the National Average of 24%. Vermont may have high buprenorphine utilization, but OUD coverage in hospitals lags well behind Massachusetts. In 2015, Vermont public payers covered 54% of all opioid-related hospital discharges. In Massachusetts that same year, public payers covered 76% of all opioid-related hospital discharges. Vermont's emphasis on buprenorphine versus Massachusetts' focus on hospital intake of OUD patients indicates where these states prioritize care for OUD individuals.

OBOT Models in Vermont and Massachusetts MAT System

The cause behind these states' high buprenorphine need and MAT coverage may be that both Massachusetts and Vermont have become leaders for OUD care across the country. The common theme between these states is the success of their office-based opioid treatment program (OBOT) models: The Vermont Hub and Spoke and the Massachusetts Collaborative Care Model.

Massachusetts' initiative to disseminate the office-based opioid treatment was developed in Boston Medical Center. In 2007, the state voted to expand the implementation of the OBOT to fourteen community health centers (CHCs) beginning in 2007. The Massachusetts Collaborative Care Model for the buprenorphine therapy, in which nurses work with physicians, play a central role in the evaluation and monitoring of patients. The OBOT model consists of 1) screening and assessment of the patient's appropriateness for office-based treatment; 2) MAT induction; 3) stabilization; and 4) maintenance.

Vermont uses a similar OBOT model within its Hub and Spoke Model3. The "hubs" offer the screening, high-intensity MAT, and stabilization. The "spokes" maintain a person's recovery through sustaining MAT, community support, and counseling services.  Today, Vermont's nine hubs serve some 3,000 patients; most have unstable lives and/or co-occurring mental illnesses.
Vermont has had surprisingly more success than Massachusetts. Vermont's per capita cost incurred by the opioid crisis was less than two-thirds that of Massachusetts ($1,919 versus $3,151), a relatively effective system for Vermont4. Since the implementation of the Hub and Spoke Model, the system has seen a 92% drop in drug use, 89% decrease in emergency department visits, and 90% reduction in both illegal activities and police stops/arrests.

Multifaceted Approach to OUD

What is consistent among Massachusetts and Vermont, other than expansive healthcare coverage and high OUD rates, is that innovation started at the ground level5. Dr. John Brooklyn in Burlington, Vermont conceived the Hub and Spoke Model. Massachusetts' OBOT structure expanded from Boston Medical Center. People within each system observed patients and realized that addiction was similar to any other chronic condition. The disease required multifaceted teams to care for both the acute and long-term needs of individuals, so that they did not drop out of the system.

Katie Marvin, M.D., a primary care physician in Vermont who runs one of the spokes at a federally qualified health clinic in Stowe, noted that she collaborates the sheriff's department, recovery centers, mental health specialists, hospitals, and the health department to form a community-wide approach to prevention, treatment, recovery, and law enforcement. For example, the MAT coordinator — originally a nurse assigned to her practice and now a social worker — has helped the sheriff assess and triage patients. "We are working together for the people in our towns and families who need help and answers," Marvin says. Without an individualized care team, these complex individuals were slipping through the cracks of the healthcare system.

Although Vermont and Massachusetts have some of the highest cost nationwide for OUD, their investment in treatment may soon pay off. In one study, patients with opioid use disorder who received MAT had slightly lower total health care spending, on average, than those who had other forms of treatment for opioid addiction. It will take time to realize whether OBOT care management of OUD will save states money, but there are likely overall savings to states from lower rates of incarceration and higher rates of employment.
Vermont and Massachusetts have become the country's standard for effective OUD treatment6. The Center for Medicaid and CHIP Services (CMCS) is working to create a Medicaid incentivized program designed after these states' OBOT healthcare structures.

This report was researched and written by Katherine McDonough, Graduate Intern, Sen-Jam Pharmaceutical.  Kate can be reached at kate@sen-jam.com.

About Sen-Jam Pharmaceutical

Sen-Jam Pharmaceutical's Mission is to Create Value by Developing Novel Pharmaceutical Solutions for Large Unmet Needs using the 505(b)2 development pathway and Selling or Licensing these Assets.  Sen-Jam's Exulta® product line is based on Opioid Free Pain Relief with GI Protection for Extended Use.   Sen-Jam Pharmaceutical is focused on providing a new therapeutic solution to the Opioid Crisis.

For more information, visit www.sen-jam.com  or contact  Christine@sen-jam.com.

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1 Prescription Nation 2018: Facing America's Opioid Epidemic. National Safety Council, 27 June 2018, http://www.nyscouncil.org/wp-content/uploads/2013/12/RxNation-2018-web.pdf.

2 Use of Opioid Recovery Medications. IMS Institute for Healthcare Informatics. Accessed 1 Aug. 2018.

3 Brooklyn, J. R., & Sigmon, S. C. (2017). Vermont hub-and-spoke model of care for opioid use disorder: development, implementation, and impact. Journal of addiction medicine11(4), 286.

4 Newman, Katelyn. "The Per Capita Cost of the Opioid Crisis." U.S. News and World Report, 20 Mar. 2018.

5 Hostetter, M., & Klein, S. (2017). In focus: Expanding access to addiction treatment through primary care. Transforming Care: Reporting on Health System Improvement Retrieved from http://www.commonwealthfund.org/publications/newsletters/transforming- care/2017/september/in-focus

6 Mikow, Asher. Overview of Medication-Assisted Treatment Clinical Pathway and Rate Design Approach. The Center for Medicaid and CHIP Services, Feb. 2017, https://www.medicaid.gov /state-resource-center/innovation-accelerator-program/iap-downloads/reducing-substance- use-disorders/mat-overview.pdf.

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