Upcoming changes to Medicare Part D further cap out-of-pocket costs

Starting on 1-1-2025, out-of-pocket expenses for people enrolled in Medicare Part D will be capped at $2,000. “It’s the first time in the history of the Medicare program that people have a cap on how much they could have to pay out of pocket,” said Meena Seshamani, M.D., the director of the federal Center for Medicare, in an interview with AARP.

The $2,000 cap includes deductibles, copayments and coinsurance. 80.4% of those on Medicare are enrolled in Part D. It’s important to know Part D does not include Part B drugs, (such as injections patients get at doctors’ offices), plan premiums, or drugs not covered by your insurance plan (it is estimated that 59% or more of Medicare prescription drug plans now cover VMAT2 inhibitors for TD treatment).

Also starting in 2025, the Medicare Prescription Payment Planrequires all Part D plans to offer enrollees the option of paying out-of-pocketcosts in monthly payments instead of all at once at the beginning of the year.This doesn’t reduce the total cost of prescription drugs, but it can help withbudgeting. Patients can opt into the plan by contacting their insurance company.

The most notable Part D change in 2025 is the elimination ofthe ‘donut hole,’ or coverage gap. Instead, plans may have annual deductiblesup to $590.00. After meeting these deductibles, patients will have copaymentsuntil their total out-of-pocket spending reaches $2000.

With such big changes to Medicare Part D, it’s likely there will also be changes in monthly premiums, copayments and covered drugs. That’s why it’s important for consumers to compare plans during open enrollment (starts on October 15) and find the ones that best meet their health and financial needs.

Read more on the Inflation Reduction Act’s changes to Medicare, and the AARP article.

Breakthrough antipsychotic that promises no TD risk nears finish line for FDA approval

On September 26, 2024, the FDA is scheduled to decide whether a new antipsychotic drug, KarXT®, will become the first of its kind not to block dopamine receptors to treat psychosis. KarXT, developed by Karuna Therapeutics (acquired by Bristol Myers Squibb in March), is one of a handful of antipsychotics that target muscarinic receptors instead. Currently, traditional antipsychotics primarily target D2 receptors to treat psychosis, which can lead to tardive dyskinesia and other side effects that cause almost three-quarters of patients to abandon treatment with them. KarXT reduces dopamine activity in the brain but does so by acting on the M1-M4 muscarinic receptors instead of dopamine receptors.

Researchers have been trying to bring muscarinic-type antipsychotics to market for over forty years but have been stymied by side effects. With recent advances in precision pharmacology and targeting, this looks to be much less of an issue.

If approved, KarXT will be the first new type of antipsychotic on the market in decades. But KarXT has some competition. At last count, at least four other pharmaceutical companies are testing various types of muscarinic receptor drugs, including Neurocrine Biosciences, AbbVie, Terra Biosciences and Neumora Therapeutics Ltd.

If KarXT is approved, it would be indicated for treatment of schizophrenia, which has a dire need for better treatment options. Because demand is high, revenues for schizophrenia drugs could reach $7.11 billion by 2028. However, M1-M4 receptor-targeted antipsychotics will have blockbuster market potential if they become FDA-approved for the treatment of mood disorders as well. A 2022 analysis of 33 studies into the role of muscarinic receptors in depression and bipolar disorder showed muscarinic antagonists to have robust antidepressant effects. While these findings are not definitive, muscarinic receptor interventions hold promise in terms of efficacy, safety and tolerability in the treatment of schizophrenia, mood disorders, and the behavioral and psychiatric symptoms of Alzheimer’s Disease.

With fewer side effects, muscarinic receptor-targeted drugs will likely improve patient adherence and long-term outcomes. This new generation of antipsychotics could mark the end of TD as we know it.

For further reading, refer to the following informative articles and studies:

Golden age of muscarinic acetylcholine receptor modulation in neurological diseases: https://pubmed.ncbi.nlm.nih.gov/39143241/

Overview on new wave of antipsychotics https://www.pharmavoice.com/news/bms-karxt-schizophrenia-approval-abbvie/724512/

Systematic review of 33 studies regarding muscarinic receptor drugs in people with mood disorders: https://pubmed.ncbi.nlm.nih.gov/36269510/

Antipsychotics block dopamine D2 receptors in pancreas, too?

A recent study published in the June 2024 edition of the journal Diabetes from the University of Pittsburgh points to a promising new approach to reducing the risk of diabetes associated with antipsychotic medications.[i] This study builds on previous findings that antipsychotics, in addition to blocking D2 receptors in the brain, block D2 receptors in other parts of the body such as the pancreas. This organ, that produces and secretes hormones such as insulin and glucagon are crucial in balancing blood sugar.

The study presents evidence in support of combining antipsychotics with chemicals that directly counter those effects. This new approach could limit serious metabolic side effects.

“Antipsychotics don’t just stop working below the neck,” said research author Zachary Freyburg, M.D., Ph.D. “Maintaining glucose metabolism requires the brain to be in constant contact with the rest of the body. Next generation antipsychotic drugs can be modified as a new strategy to control dysglycemia [abnormal blood sugar levels] and diabetes.”

Currently, Freyburg and his collaborators are in the early stages of studies to determine whether the therapeutic effects of antipsychotics are preserved when combined with molecules that block peripheral D2 receptors such as those in the pancreas.

Dr. Freyburg concluded, “We hope that our research builds awareness about the importance of communication between the brain and the rest of the body in maintaining physiological functions and reminds clinicians that they should also consider that drugs designed to act on targets in the brain, like psychiatric medications, may also have significant actions outside of the brain…”

View the research abstract, Development of novel tools for dissection of central versus peripheral dopamine D2-like receptor signaling in dysglycemia, and press release.

[This report concludes NOTD’s three-part series on new research into the metabolic effects of antipsychotics.]

[i] Bonifazi, A., Ellenberger, M., Farino, Z. J., Aslanoglou, D., Rais, R., Pereira, S.,Mantilla-Rivas, J. O., Boateng, C. A., Eshleman, A. J., Janowsky, A., Hahn, M.K., Schwartz, G. J., Slusher, B. S., Newman, A. H., & Freyberg, Z. (2024). Development of Novel Tools for Dissection of Central Versus Peripheral Dopamine D2-Like Receptor Signaling in Dysglycemia. Diabetes, 73(9),1411–1425. https://doi.org/10.2337/db24-0175

The Clinician’s Tardive Inventory (CTI): Testing a New Way to Measure TD

The burden tardive dyskinesia (TD) places on the lives of patients, families, and to a certain extent, caregivers, cannot be overstated. The challenge for healthcare providers has been the limitations of currently utilized clinician-rated TD measurement scales such as the well-established AIMS examination.

To address these limitations, a group of researchers developed and tested the Clinician’s Tardive Inventory (CTI), a more comprehensive instrument that measures clinical signs alongside their functional impact on patients’ quality of life. The results were published in the Jan. 2024 issue of Journal of Clinical Psychiatry.[i]

A movement disorder neurologist developed an outline for the new method of measurement. This was followed by a steering committee of five neurologists and two psychiatrists who made multiple revisions with the goal of making the CTI user-friendly for clinicians of various expertise levels and to facilitate documentation of TD exams.

The CTI assesses and rates abnormal movements in various body parts such as the eye, eyelid, face, tongue, mouth, jaw, limbs and trunk as well as more complex movements, and abnormal vocalizations.

The CTI also rates frequency of symptoms from 0 to 3 ranging from absent to constant. Functional impact in areas like activities of daily living (ADL), social impairment, symptom distress, and physical harm a re-rated 0 to 3 (ranging from unawareness to severe impact).

Using video recordings of TD examinations, the researchers studied the CTI for reliability and consistency. The new tool showed “fair to excellent” reliability in the rating of both TD symptoms and functional impairment. Test-retest reliability ratings were “fair to very good.”

The study’s conclusion is that the CTI is a promising new tool with proven reliability in assessing clinical signs and functional impact, but challenges remain in the domain of “symptom bother.” Therefore, a further validation study is warranted.

The abstract of the January 2024 Journal of Clinical Psychiatry article is available here: https://pubmed.ncbi.nlm.nih.gov/38270545/

[i] Trosch RM, Comella CL, Caroff SN, Ondo WG, Shillington AC, LaChappelle BJ, Hauser RA, Correll CU, Friedman JH. The Clinician’s Tardive Inventory (CTI): A New Clinical Tool for Documenting and Rating Tardive Dyskinesia. J Clin Psychiatry.2024 Jan 24;85(1):23m14886. doi: 10.4088/JCP.23m14886. PMID: 38270545.

New Coating Added to Antipsychotic Mitigates Weight Gain in Study

5/28/2024—New research from the University of South Australia shows that antipsychotics reformulated with a strategically engineered coating mitigate the unwanted side effect of weight gain. Researchers tested lurasidone (Latuda®), a second-generation antipsychotic, in rodent studies. Using a coating of tiny shell particles made from the dietary fiber inulin, and bioactive medium-chain triglycerides, researchers found the triglycerides to increase drug absorption, while the inulin boosts the diversity, abundance and activity of the gut microbiome to reduce unwanted weight gain.

Although human studies are still needed, researcher Dr. Paul Joyce is optimistic. “Because we are not developing new drugs, rather, reformulating them, the new therapies can be fast-tracked for clinical use, so we could expect them within the next few years rather than the 10-15 years needed for new drug molecules to be approved by regulatory bodies.”

View the Science Daily article.

This is the second installment of NOTD’s coverage of the latest research into antipsychotic-associated high blood sugar, weight gain, and diabetes.

New Ingrezza® Sprinkle granules provide TD treatment for those with difficulty swallowing

On April 30, 2024, Neurocrine Biosciences announced that the Food and Drug Administration (FDA) approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA for the treatment of adults with Tardive Dyskinesia (TD) and chorea associated with Huntington’s Disease (HD). Ingrezza Sprinkle provides an alternative administration option for those who experience dysphagia (difficulty swallowing) or would prefer not to take a pill.

This is great news for those with TD as TD often causes difficulty swallowing. Like the original formulation of Ingrezza, Ingrezza Sprinkle offers simple once-daily dosing in three effective dosage strengths (40 mg, 60 mg and 80 mg). The contents of the capsules can be easily sprinkled over soft food for oral administration. For more information on the side effects and safety of Ingrezza and Ingrezza Sprinkle, visit: the online Medication Guide.

Antipsychotic-associated weight gain and diabetes: New research offers hope for prevention and treatment

Individuals who take antipsychotics have higher rates of obesity and 2-3 times the risk for diabetes (Holt, 2019). A University of Toronto study has discovered that the root of the problem may lie with how antipsychotics affect the part of the brain that manages glucose metabolism.  

Historically, it has been thought that blood sugar from ingestion of foods such as refined carbohydrates were solely controlled by release of the hormone insulin by the pancreas. However, this new research demonstrates that the hypothalamus in the brain is responsible for more than half the regulation of glucose metabolism in the body.  

Interviewed in a University of Toronto department of psychiatry newsletter, here’s how Drs. Pereira and Hahn, who led the research team, summed up the results of their study: “Our most important finding is that antipsychotics block the ability of the brain to sense sugar and adjust glucose metabolism in the rest of the body. This may be one mechanism through which antipsychotics cause high blood sugar and diabetes.”

Researchers used a new technology combining biology and tissue analyses with computer science called “bioinformatics” that identified pathways through which antipsychotics interfere with the brain’s ability to detect and regulate glucose.

“We will soon be starting new studies to look at various interventions to prevent the negative effects of antipsychotics on glucose sensing by the brain. We hope that the new interventions we research can be brought to use quickly so that the quality of life and life expectancy of patients taking antipsychotics can improve.”

View the research abstract and full interview online.

This is the first installment of NOTD’s coverage of the latest research into antipsychotic-associated high blood sugar, weight gain and diabetes.  

Holt, R. I. G. (2019). Association between antipsychotic medication use and diabetes. Current Diabetes Reports, 19(10), 96. https://doi.org/10.1007/s11892-019-1220-8 

TD Advocacy Update: Federal telehealth bill to include guidance on TD screening

We are anticipating that Congress will pass legislation at the end of this year to extend COVID-era telehealth benefits for those on Medicare for two more years. While COVID helped revolutionize healthcare by bringing it into most people’s homes, telehealth can make it difficult for practitioners to properly screen for drug-induced movement disorders like TD.

That’s why NOTD has been advocating to Federal law makers that practitioners who care for those taking antipsychotics should receive guidance regarding screening for movement disorders in a telehealth environment. The current bill making its way through Congress includes language explaining the importance of periodic screening for medication-induced movement disorders, best practices for screening for these disorders via telehealth, and clarification regarding how to account for screening in evaluation and management code selection. (Thanks to Neurocrine Biosciences’ Government Affairs Division for their efforts in this regard.)

By including this TD-related education/guidance with the telehealth bill, we will hopefully mitigate the impact that telehealth can have on thorough TD screening and diagnosis. 

Integrated AIMS reminders to assist in early detection and treatment of TD

Amalgam Rx, a healthcare tech company, has developed software that embeds AIMS assessment reminders in the electronic health records of patients at risk of developing Tardive Dyskinesia. TD experts generally advise that the Abnormal Involuntary Movement Scale, or AIMS, be given to patients taking antipsychotics and other dopamine-blocking medications every six months and more frequently if at a high risk for TD. Amalgam Rx’s reminder prompt is triggered when patients are seen who need regular AIMS screenings. At present, it is thought the AIMS test is underutilized, and that TD often goes undiagnosed, with approximately 60% of sufferers unaware they have the condition. The Amalgam Rx AIMS reminder tool will aid in early detection and diagnosis for patients. More information is available at: https://amalgamrx.com/aims/ and on-demand webinar

FDA approves new single-tablet strengths of once-daily AUSTEDO® XR

5/30/24 – Following the U.S. Food and Drug Administration’s (FDA) approval of once-daily AUSTEDO XR (deutetrabenazine) extended-release tablets in February 2023, the FDA has approved new single-tablet strengths of AUSTEDO XR. AUSTEDO XR is now available as one pill, once-daily across a range of effective doses: 24, 30, 36, 42, 48 mg/day tablet strengths offering flexibility to tailor individual treatment regimens for effective and tolerable TD and HD chorea symptom control. In addition, AUSTEDO XR can be taken with or without food. For more information on side effects and safety of the XR and standard AUSTEDO drugs, visit: Medication Guide.

New antipsychotic that doesn’t block dopamine receptors could be approved this September

KarXT (xanomeline-trospium) is a new antipsychotic drug in Phase 3 testing that acts on the muscarinic receptors instead of directly blocking dopamine receptors. For those concerned with developing TD, this is good news because the central theory of TD development entails blocking of the D2 dopamine receptors. KarXT still decreases dopamine availability in the brain by activating muscarinic receptors instead. If KarXT is approved by the FDA it would be the first antipsychotic since their first use in the 1950s (in the U.S.) that wouldn’t act by blocking dopamine receptors which can cause involuntary movements. KarXT is being developed by Karuna Therapeutics and is scheduled for an FDA decision on September 26, 2024. 

Teva Pharmaceuticals presents first real-world data from IMPACT-TD Study at Psych Congress Elevate 2024

An interim analysis of 286 patients with varying levels of TD severity reported that TD has a multidimensional impact, even on patients with mild TD. Clinician-reported IMPACT-TD findings show: “98% of patients experience the impact of TD in some aspect of their quality of life; 83% of patients experience moderate to severe impact across various quality of life domains, including social (59%), psychological/psychiatric (70%), physical (53%) and vocational/ educational/recreational (57%); 54% and 61% of patients with “very mild” and “mild” TD severity based on CGIS-TD (Clinical Global Impression of Severity of TD), experience moderate to severe impact on their quality of life. Review more key findings from this important ongoing study.

NOTD joins forces with NAMI Citrus County for in-person TD lecture/screening event

Bill Cote, Sr. Director of NOTD, provided a TD Talk to members of the National Alliance of Mental Illness (NAMI), Citrus County, FL on May 14 from 7pm-8pm. The event was held at the county’s local YMCA and included in-person screenings for attendees by psychiatric nurse practitioner Andrew Wargo PMHNP-BC of Concord Health based in Clearwater, FL.