Of the many developments in the complex consumer market, anticipating the likely market effects of new treatments is the most difficult. The difficulty is all in that pesky “time lag”—it takes 15 to 20 years from science to service (see Failure To Launch). There are three new mental health medications that caught my eye as having big benefits for consumers—Esketamine nasal spray, Brexanolone injection for intravenous use, and SEP-363856 (in development for schizophrenia).
Esketamine nasal spray—On March 5, 2019, the FDA approved the use of SPRAVATOT, an esketamine nasal spray for treatment-resistant depression. Specifically, esketamine is a “non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist” (see FDA Advisory Panel Recommends Approval Of Esketamine Nasal Spray For TRD). The drug was found to be more effective in reducing suicide ideation in 24 hours than a sedative (see Ketamine Shown More Effective In Reducing Suicidal Thoughts Than Sedatives). Notably, the Department of Veterans Affairs has been at the forefront of the adoption of esketamine, but recently declined widespread support of the medication (see VA declines broad coverage for new J&J depression drug touted by Trump).
Brexanolone injection for intravenous use—Also in March, the FDA approved Zulresso, or brexanolone, for postpartum depression. Zulresso is the first drug to be approved for this indication. Zulresso is administered as a continuous IV infusion over a total of 60 hours, or 2.5 days. The treatment must be administered by a health care professional in a certified health care facility (see FDA Approves Zulresso, First Drug For Postpartum Depression).
SEP-363856—In May, the FDA granted breakthrough status to SEP-363856 for the treatment of schizophrenia. SEP-363856 offers a new approach to the treatment of schizophrenia including the potential to be the first agent for the treatment of schizophrenia that does not bind to the dopamine 2 (D2) receptor. Schizophrenia has been found to be present in increased D2 messenger molecules (mRNA) in the frontal cortex. Traditional schizophrenia treatments either bind to D2 in direct relation to their clinical potencies, or hinder normal dopamine neurotransmission, as in the case of partial dopamine agonists (see FDA Grants Breakthrough Designation To Novel Schizophrenia Medication).
These are interesting new scientific developments now available (or soon to be available) to consumers. But my question is how and how long will it really take these to get to consumers? I reached out to my colleagues at OPEN MINDS, George Braunstein and Greg Downing, D.O., Ph.D., to learn more about what these new treatment options mean for practice. Their take is that the adoption and actual use of these (or any) new treatments is dependent upon many factors—expanded professional education, updated service delivery processes and procedures, and enhanced shared decisionmaking processes.
Expanded professional education—As with any new technology or service line adoption, updating clinical staff education to include these new treatment options is essential for success. This starts with overarching communication at all levels of the organization and ends with adopting best practice education models to make sure that both culture and training are aligned. Dr. Downing explained:
As health care executives, what steps can you take to embrace new therapies and clinical evidence and bring them into clinical practice? First, the most important role CEOs and senior leaders can do is to openly promote and embrace new interventions in their communications. Creating a culture of innovation starts with consistent communication from the board room to the consumer encounter and it’s critical that message comes from the top. This sets the expectation that your organization strives for improvement and the best care options possible. Often, it is this organizational attitude that leads to forming centers of excellence.
Innovation means change in practice models and here are some steps to hasten adoption. First, establish a clinical champion in your organization who is familiar with the characteristics of the new modality. This go-to source could be a pharmacist, experienced practitioner, or even a consumer engagement officer. The champion is responsible for creating an internal buzz with key facts on the intervention that present the ideal objectives of where the intervention fills a gap and key steps toward the practice adoption will be their role.
Secondly, identify a key consumer population or subgroup as the starting point for a pilot cohort for adoption – a dozen or two consumers who can help your institution learn the feedback and how the new intervention fits in the real-world aspects of their condition or illness. Clinical trials experience is only a piece of the adoption path.
Third, establish a focus on the consumer adoption pathway. Consumer info sessions, lay audience information sheets, and conversations with providers can help inform internal goals and expectations.
Fourth, collect data to track adoption rates and results and, importantly, that includes impressions of the consumer experiences. This information supports evidence for conversations with payers and consumer advocates.
Fifth, use existing monthly meetings and communication channels with providers to bring new clinical guidelines, clinical study results, and new services to their attention.
Finally, celebrate success! If a new treatment product or service is achieving favorable responses, leaders should highlight this achievement and encourage embracing the next innovation opportunity.
Updated service delivery processes and procedures—In most provider organizations, a fundamental step that needs extra attention is to build new decision support for what treatment to use, the operational processes to deliver the treatment, and the billing processes to be reimbursed. Mr. Braunstein explained:
If your organization has an effective leadership team, including medical leadership, then you are going to have the pieces in place that you need. If you don’t, if you have gaps in leadership, you’ll get into trouble when new treatment modalities come on the market that require new protocols.
For these new medications, for example, a designated team member, usually with pharmacy input should create policies and procedures for the use and implementation. Then all clinical managers, including nursing, psychology and social work should notify staff of the availability and appropriate use of a new medication. If that medication requires new clinical procedures, such as observing a consumer after a dosage is administered or follow-up blood work, the clinical team should have a set of procedures to choose the treatment, deliver it, and support proper billing.
If they are appropriately using the processes that are already set up, it’s easier. If the management team sets up good processes from the start, there isn’t extra work. The same is true of setting up the billing. They get notified on whether there is anything that needs to be done differently. Usually in documentation there isn’t anything new, but in the billing, if there is something different then that must go through and again, management should have processes to identify that they have a new med or set of billing codes.
If a provider organization doesn’t have these types of standard processes, it is a failure of management. If you know what you are doing, those processes are in place. If you don’t know, new processes and protocols can catch you off guard.
Shared decisionmaking processes—Finally both Mr. Braunstein and Dr. Downing noted that the availability of new medications need to be integrated into the array of treatment options available to consumers. And this wide range of options is part of clinical decision support tools for clinical professionals and consumer-facing shared decisionmaking processes and tools. Any new approach to clinical decisionmaking, specifically if it comes with the need for incorporating more data, more quickly, means investing in a faster decision support process. More responsibility for individual care coordination and population health management means all new service options, including medications, will need to be managed to higher quality at lower cost.
For more on OPEN MINDS coverage of novel treatments check out:
- FDA Grants Breakthrough Device Status To NightWare App To Stop PTSD Nightmares
- Blackthorn Therapeutics Announces Close Of $76 Million Series B Financing
- Catasys, Inc. Announces Artificial Intelligence Solution To The Loneliness Epidemic
- Addiction Labs Of America Developing Pharmacogenetics Test For Cannabis & Cannabidiol
- Karuna Secures $68 Million To Support Schizophrenia Treatment Development
- Food & Drug Administration Approves Purdue Pharma Subsidiary’s Attention-Deficit/Hyperactivity Disorder Treatment
- Servier, Neurochlore Initiates Trial To Evaluate Bumetanide In Children With Autism Spectrum Disorder
- Alkermes Receives Complete Response Letter From U.S. Food & Drug Administration For ALKS 5461 New Drug Application
- Pear Therapeutics Raises $64 Million, Launches Prescription App For Opioid Use-Related Addiction Disorder
- BioXcel Therapeutics Reports Positive Human Proof-Of-Concept Data For Acute Treatment Of Agitation In Individuals With Alzheimer’s Disease
For even more on this topic, join us at The OPEN MINDS Management Best Practices Institute in Long Beach, California on Wednesday August 14 for the session: “Best Practices In The Shift To Virtual Health: How To Integrate Digital Treatment Tools Into Programs & Treatment Models” featuring Sandra Stein, M.D., Medical Director of Care Integration, Banner University Health Plans and David Heffron, Vice President, Operations, Telecare Corporation.