Just six months after a Maryland task force called for an increase in effective treatments to combat opioid and heroin addiction amid a sharp rise in overdose deaths, the state Department of Health and Mental Hygiene (DHMH) is instead creating barriers to treatment that will exacerbate the tragedy caused by this raging epidemic.
Suboxone Film, also known as buprenorphine film, is an effective and well-tolerated medication that is widely prescribed to treat opioid addiction. Since it became available three years ago, it has become one of the most commonly prescribed opioid addiction treatments in Maryland; it works and is easy to take. Yet DHMH is precipitously removing this medication from the Maryland Medicaid Pharmacy Preferred Drug List (PDL) as of July 1. After then, it will only be covered if prescribing physicians first go through an arduous prior authorization process. DHMH will replace Suboxone on the list with relatively little-used Zubsolv Tablets, which will become the only opioid addiction medication available without the prior authorization hurdle.
Why? What rationale justifies this action? A letter sent to DHMH last month by Baltimore City Health Commissioner Leana Wen opposing the change sheds some light:
"I have heard anecdotally that incidents of buprenorphine film being smuggled into jails have increased. I understand this is an important issue that needs to be addressed; however, addressing this problem by removing films from the PDL is irresponsible and unnecessary. This narrow potential for misuse should be addressed directly through increased security measures, not through sweeping regulatory changes that will impact the lives and recovery of many individuals living in the community."
The scope of the smuggling problem is unknown. Prison doctors are not allowed to prescribe Suboxone for inmates addicted to opiates, so it is reasonable to assume that some people are treating their addiction through self medication. The corrections system could choose to begin providing medication-assisted opiate addictions treatment, eliminating the need to bring in the drug illegally. Regardless, it is highly unlikely that this change will eliminate the smuggling problem, as Dr. Wen noted, if that is the issue. We have seen no evidence that Zubsolv has less smuggling potential. However, we know this change will damage public health.
Without Medicaid reimbursement, Suboxone Film, a well-tolerated medicine will be virtually unavailable for the most vulnerable patients, resulting in a serious restriction of access to treatment.
The directives from the state to the providers came out late last month with an effective date of July 1. Why this haste in light of the potential public health risks? It is not clear. The DHMH Advisory letter to providers provides no rationale for the change, and we know many letters were sent by medical associations and others urging DHMH to reject this change. Why not add the new drug to the preferred drug list and expand treatment options? Why remove the one drug most preferred by the treatment community? Why do it so quickly, putting patients at risk?
What is clear is this: Next week, doctors have to tell their patients that they must change their medication. To many patients who have struggled for years with addiction, this change will be baffling and difficult. The new medication might not work as well for them. Dosages will need adjustment. For many patients in early recovery, recovery is tenuous. The medication change will be a major barrier. There is a real possibility that many will fail to make the transition; they will join the ever increasing overdose death statistics in Maryland.
Dr. Wen said it will have "disastrous" effects.
"Changes in medication formulation can and will lead to relapses, overdoses, and deaths," she wrote in her letter. "Public policies should encourage and support recovery, not create barriers to it."
Removing Suboxone Film from the Medicaid list of preferred drugs is not good medicine. Thousands of people will be at risk, and there is no publicly-stated valid rationale for restricting treatment. We urge the DHMH to be consistent with the state task force recommendations: Delay this change and have an open process to determine the best path for Maryland to increase treatment options for this devastating disease.
Deborah Agus is executive director of Behavioral Health Leadership Institute (BHLI); her email is firstname.lastname@example.org. Dr. Leonard Feldman is an associate professor of internal medicine and pediatrics at the Johns Hopkins School of Medicine and president of BHLI's board; his email is email@example.com. Scott Nolen is the director for Open Society Institute-Baltimore's Drug Addiction Treatment Program; his email is firstname.lastname@example.org.