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By Athena Mandros

A couple of months ago, we wrote about the recent approvals by the U.S. Federal Drug Administration (FDA) for innovative apps and medical devices in the complex consumer space (see The Emerging Digital Treatment Era). But there is also an impressive list of approved and soon-to-be-approved novel medications and new medication formulations. Keeping an eye on this pipeline of innovations is important for executives of payers, health plans, and provider organizations alike. Medications are now 10% of U.S. health care spending and integral to many care management plans.

To look at the new medications for mental health, addiction treatment, and cognitive disorders, our team completed a review of recently approved medications in this space and the pipeline of pending medications. This review is now available in a new market intelligence report: The FDA Pipeline For Medications For Behavioral & Cognitive Conditions: A 2018 OPEN MINDS Update. What did we find? Over the past six years, there were only a handful FDA approvals of new medications for these conditions. But, there are currently at least 245 drugs in the approval pipeline – with 42 in late stage trials.

When we looked at the past approvals and the future pipeline, we found two strategic takeaways: more consumer options are likely to become available and medication adherence is the focus of innovative medication formulations.

More consumer options likely to become available The 245 medications in the current approval pipeline should result in a number of new medications coming to market in the next few years. Of those medications in the pipeline, 42 (17%) were in Phase III clinical trials (The success rate for medications at phase three is 49% for psychiatric medications, see Drugs, Devices, and the FDA: Part 1: An Overview of Approval Processes for Drugs and Clinical Development Success Rates 2006-2015.) Of those medications, 33 were for mental health conditions, six for addiction disorders, and nine for cognitive impairment. These new medications will provide consumers with new treatment options—treatment options that will need to be addressed by health plans and clinical professionals.

Medication adherence is the focus of innovative formulations When we reviewed FDA approval of innovative medication formulations for already approved medications (as opposed to new medications), some of the most interesting approvals were focused on improving medication adherence. The approaches ranged from long-acting injectables, to implants that deliver a steady dose of medication, and to digital tracking technology that knows when the consumer takes the medication. Some of the notable innovative formulations include:

  1. Probuphine by Braeburn Pharmaceuticals and Titan Pharmaceuticals – an implant for opioid addiction (FDA Approves Six-Month Implant For Opioid Addiction Treatment)
  2. Sublocade by Indivior – a long-acting injectable for opioid addiction (FDA Approves Sublocade, A Once-Monthly Buprenorphine Injection)
  3. Abilify MyCite by Otsuka – a pill for schizophrenia with digital sensor that alerts the individual and key stakeholders when medication is taken( FDA Approves Abilify MyCite® (Aripiprazole Tablets With Sensor), A Pill With Digital Sensor To Track Oral Antipsychotic Ingestion)
  4. Aristada by Alkermes – a long-acting injectable for the treatment of schizophrenia (FDA Approves Aristada Long-Acting Injectable Antipsychotic)
  5. Ablify Maintena by Otsuka– a long-acting injectable for the treatment of schizophrenia (FDA Approves Sale Of Abilify Maintena Extended-Release LAT)

In addition to these recently approved innovative formulations, there are a number of new formulations for behavioral health at the Phase III clinical trial stage related to addiction and mental health that are injectables, transdermal patches, and implants. The reasons for the focus on medication adherence is clear—relapse and recidivism due to non-adherence with recommended disease management protocols is responsible for a large proportion of hospital utilization (see Medication Non-Adherence Doubles Risk of Rehospitalization for Schizophrenia Patients and Medication Adherence Reduces ER & Inpatient Expenses By 34% For Complex SMI Consumers).

For more, don’t miss our new report, The FDA Pipeline For Medications For Behavioral & Cognitive Conditions: A 2018 OPEN MINDS Update. Our report has a complete list of all medications approved for behavioral health and cognitive conditions over the past six years, a list of all medications in Phase III clinical trials (along with their indication), a list of long-acting medications in the pipeline, and information on the companies that are developing each medication. And, you can check out these resources on the issues around medications in the treatment of behavioral and cognitive conditions:

And for even more, join us on August 14th at The 2018 OPEN MINDS Management Best Practices Institute in Long Beach, California for the summit, Designing & Implementing Innovative Treatment Programs: An OPEN MINDS Executive Summit & Showcase led by Annie Medina, MBA, ACNP-BC, Senior Associate, OPEN MINDS.


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