- As COVID-19 puts millions of Americans in recovery at risk for mass relapse, Coalition of U.S. advocates, providers and manufacturers announce a Call to Action to eliminate barriers to access for FDA authorized digital therapeutics for substance use disorder
WASHINGTON & BOSTON & NORWALK, Conn.--(BUSINESS WIRE)--A Coalition of leading addiction and mental health advocacy groups and stakeholder organizations today announced the launch of the Recovery Access Coalition to address the barriers to accessing potentially life-saving digital therapeutics authorized by the U.S. Food and Drug Administration (FDA) to treat substance use disorder, like prescription digital therapeutics (PDTs). Members of the Coalition include Advocates for Opioid Recovery, Global Recovery Initiatives Foundation, the Kennedy Forum, the National Council for Behavioral Health, Shatterproof, and Young People in Recovery. Pear Therapeutics, Inc. is a member and sponsor of the initiative.
Digital therapeutics, including PDTs, have a critical role to play for people in recovery, especially in today’s newly complicated treatment environment. Under current circumstances, the advantages of digital therapeutics to people with substance use disorder treatment needs, and their clinicians, are significant. Digital therapeutics can treat people without physical proximity, extend care over distances, promote deeper connection between people and their care team, and empower people to strengthen their self-assessment skills and better navigate their care.
“Addiction is a disease that thrives in isolation,” said former U.S. Rep. and founder of The Kennedy Forum, Patrick J. Kennedy. “Because of social distancing, COVID-19 has already put millions who live in recovery from substance use disorders, including opioid use disorder, at extreme risk. The inability to regularly access traditional forms of care will only compound the problem—thus an urgent need for more remote treatment options.”
The Recovery Access Coalition is advocating for Medicare coverage of FDA authorized digital therapeutics at the federal level, for Medicaid coverage at the state level, and for broad coverage across the commercial health insurance market. According to the Coalition, policymakers have the rare opportunity to embrace a clinically validated, FDA-authorized therapeutic solution that already exists and is made for the challenges and demands of the moment.
In March, the Substance Abuse and Mental Health Services Administration (SAMHSA) cited that nearly 58 million Americans are living with mental and/or substance use disorders, announcing, “The current national crisis of COVID-19 will certainly contribute to growth in these numbers.”1 Since the beginning of COVID-19, suspected overdose submissions display an average increase of 20% when compared to the same time-period during the previous year.2 As many as 75,000 Americans could die because of drug or alcohol misuse and suicide as a result of the coronavirus pandemic, according to an analysis conducted by the national public health group Well Being Trust.3
"We need access to innovative solutions that create connectivity and engagement with evidence-based addiction treatment programs. This is especially important in times when one can’t be physically present," said Kevin Roy, Chief Policy Officer of Shatterproof. "Now, more than ever, is the time for widespread access and coverage of remote treatment options and supports, like prescription digital therapeutics.”
“COVID-19 has ushered in a new era of remote health care delivery,” said Corey McCann, M.D., Ph.D., President and CEO of Pear Therapeutics. “Supporting broad access to digital care solutions, like our own FDA authorized prescription digital therapeutics, is consistent with this urgent and necessary sea change in provision of treatment and care. As policymakers respond to the massive impacts created by COVID-19, widespread access to safe, effective, remote addiction treatment must not be overlooked – especially as the nation readies for a potential second wave of the pandemic in the fall.”
About the Recovery Access Coalition
The Recovery Access Coalition aims to eliminate barriers to access for FDA authorized digital therapeutics for substance use disorder. Specifically, the Coalition is seeking policy changes in Medicare, Medicaid, and the commercial insurance market to authorize coverage for digital therapies, including prescription digital therapeutics (PDTs), for substance use disorder treatment. Our goal is to increase policymakers’ awareness of the dire need for digital therapy for substance use disorder, educate policymakers about the value, safety, and efficacy of digital therapeutics in providing needed treatment digitally and promote greater patient access to – and adoption of – FDA authorized digital therapeutics for substance use disorder. For more information, visit the Recovery Access Coalition at www.recoveryaccesscoalition.org.
About Advocates for Opioid Recovery
Advocates for Opioid Recovery (AOR) is a nonprofit organization that supports survivors and co-survivors of opioid use disorder (OUD) by breaking down the ideological, legislative, and regulatory barriers to evidence-based care and support. Founded in 2016 with bipartisan advisors former Speaker of the House Newt Gingrich, former U.S. Representative Patrick J. Kennedy, and Van Jones, AOR is dedicated to advancing evidence-based addiction treatment and recovery systems. For more information, visit www.opioidrecovery.org and follow us on Facebook, Twitter, and LinkedIn.
About Global Recovery Initiatives Foundation
The Global Recovery Initiatives Foundation (GRI) is the first and only national community foundation dedicated to building a philanthropic source of funding for organizations to expand their capacity to provide people with SUD recovery support services. GRI supports organizations using evidence-based programs that have demonstrated success in philanthropy leaders to invest in recovery-focused nonprofit initiatives; reducing the stigma around substance use disorders and recovery; and deploying public, private, and pop culture resources to strengthen the field of recovery. For more information, visit: https://globalrecoveryinitiatives.org/
About The Kennedy Forum
Founded in 2013 by former Congressman Patrick J. Kennedy (D-R.I.), The Kennedy Forum leads a national dialogue on transforming the health care system by uniting mental health advocates, business leaders, and government agencies around a common set of principles, including full implementation of the Federal Parity Law. Launched in celebration of the 50th anniversary of President Kennedy’s signing of the landmark Community Mental Health Act, the nonprofit aims to achieve health equity by advancing evidence-based practices, policies, and programming for the treatment of mental health and addiction. The Kennedy Forum’s “Don’t Deny Me” campaign educates consumers and providers about patient rights under the Federal Parity Law and connects them with essential appeals guidance and resources. To learn more about The Kennedy Forum and donate, please visit www.thekennedyforum.org.
About the National Council for Behavioral Health
The National Council for Behavioral Health is the unifying voice of America’s health care organizations that deliver mental health and addictions treatment and services. Together with our 3,326 member organizations serving over 10 million adults, children and families living with mental illnesses and addictions, the National Council is committed to all Americans having access to comprehensive, high-quality care that affords every opportunity for recovery. The National Council introduced Mental Health First Aid USA and more than 2 million Americans have been trained.
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst™, for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.
Shatterproof is a national nonprofit organization dedicated to reversing the addiction crisis in United States by transforming addiction treatment, shattering stigma of addiction, advocating for federal and state policy change and payer reform, and supporting and educating the community. For more information about Shatterproof visit www.shatterproof.org.
About Young People in Recovery
Young People in Recovery (YPR) is a national peer recovery support service organization with over 54 chapters nationwide. YPR aims to improve access to resources such as housing, education and employment that sustain long-term recovery, particularly for youth and young adults. YPR envisions a world where all young people have the resources they need to thrive in recovery from addiction to drugs and alcohol. YPR’s mission is to provide the life skills and peer supports to help people recover from substance use disorder and reach their full potential. YPR was founded in 2010 by young people in recovery (under age 30) who wanted to help others. YPR embraces all pathways to recovery including 12-step, faith-based, medication-assisted and individuals who do not identify with any particular treatment or recovery philosophy.