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Recent FDA-approved drugs of interest to underwriters

January 22, 2025|IntelliScript Team

Our clinical team continually updates our SaaS tools so you can confidently assess mortality or morbidity risk, even when you’re seeing a new therapeutic for first time.

Ohtuvayre (ensifentrine): A novel treatment for COPD

Matt Glasow

Matt Glasow, PharmD, MBA

Senior Clinical Consultant

January 22, 2025 Updated

Ohtuvayre (ensifentrine, approved June 2024) is a first-of-its-kind, nebulized suspension taken twice daily for the maintenance treatment of chronic obstructive pulmonary disease (COPD).

Ohtuvayre (pronounced “oh-too-vare”) has a novel mechanism of action as a dual phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) inhibitor that helps to relax the muscles around the airways and decrease inflammation in the lungs. This dual mechanism of action helps to improve symptoms of COPD (e.g., wheezing, coughing, chest tightness, shortness of breath) and, based on clinical trial data, has been shown to improve overall lung function.

Underwriters should expect to see Ohtuvayre via Irix® Prescription Data in those with a diagnosis of COPD. Importantly, the clinical trials for this medication were performed in individuals with moderate to severe COPD, most of whom were on other inhaled medications to control COPD symptoms. Based on this studied population and recommendations found in the 2025 GOLD* guidelines, we would expect Ohtuvayre to primarily be used as an add-on medication to standard bronchodilator therapy (e.g., LAMA + LABA combination inhalers).

Anticipated relative mortality: High (>220%).

*Global Initiative for Chronic Obstructive Lung Disease

Kisunla (donanemab-azbt): Another treatment option for Alzheimer’s disease

Matt Glasow

Matt Glasow, PharmD, MBA

Senior Clinical Consultant

January 22, 2025 Updated

Kisunla (donanemab-azbt, approved July 2024) is a once-monthly, intravenous infusion indicated for the treatment of Alzheimer’s disease. The medication is similar to Leqembi, a medication originally FDA-approved in 2023. Both products are to be initiated specifically in patients with mild cognitive impairment or mild dementia.

Kisunla (pronounced “kih-suhn-lah”) works by targeting and reducing amyloid beta plaques in the brain, a defining feature of Alzheimer’s disease. Unlike Leqembi, Kisunla offers more convenient dosing intervals (every four weeks vs. Leqembi’s every two weeks) and may ultimately be stopped if amyloid plaques are removed. In terms of efficacy, additional trials are still ongoing to verify Kisunla’s long-term clinical benefit, but existing trials have shown that patients treated with Kisunla demonstrated a reduction in clinical decline compared to those on a placebo. It is important to note that this medication does not improve or cure the symptoms of Alzheimer’s, but rather it slows the progression.

Underwriters should expect to see Kisunla via Irix® Medical Data in those with a diagnosis of Alzheimer’s disease. Due to its high cost and the need for regular MRI monitoring (a minimum of five MRIs during treatment) as part of a safety precaution to check for amyloid related imaging abnormalities (ARIA, which commonly presents as swelling in the brain), the initial use of this medication is expected to be limited. Therefore, underwriters should continue to look for diagnoses found through medical claims, as well as other treatments addressing Alzheimer’s disease.

Anticipated relative mortality: High (>220%).

Cobenfy (xanomeline and trospium chloride): A unique treatment option for schizophrenia

Matt Glasow

Matt Glasow, PharmD, MBA

Senior Clinical Consultant

January 22, 2025 Updated

Cobenfy (xanomeline and trospium chloride, approved September 2024) is a first-of-its-kind, twice daily oral treatment for schizophrenia. This medication represents the first new approach (i.e., a new medication class) to treat schizophrenia in more than 30 years.

Unlike traditional schizophrenia treatments that target dopamine, Cobenfy (pronounced “co-ben-fee”) activates M1 and M4 muscarinic acetylcholine receptors in the central nervous system which are believed to play a role in the treatment of schizophrenia through its xanomeline component, while the trospium chloride helps mitigate peripheral side effects by blocking muscarinic receptors in the peripheral tissues. The dual mechanism of action offers a new therapeutic target and side effect profile, an important consideration as most available treatment modalities today (e.g., antipsychotic medications) are associated with considerable side effects such movement dysfunction, weight gain, increased blood sugar, etc.

The medication was approved based on two trials showing benefit when the medication was used over a five-week time span. Given the short duration of the trials, the medication is unlikely to gain significant market share until longer term trials are performed. In the cases the medication is used, underwriters should expect to see Cobenfy via Irix® Prescription Data in those with a diagnosis of schizophrenia. At this time, other medications (primarily antipsychotics) would likely also be found on the prescription profile alongside Cobenfy.

Anticipated relative mortality: High (>220%).

Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor): Another advancement in cystic fibrosis

Matt Glasow

Matt Glasow, PharmD, MBA

Senior Clinical Consultant

January 22, 2025 Updated

Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor, approved December 2024) is a once daily, oral tablet indicated for the treatment of cystic fibrosis (CF) in ages 6 and up with select genetic mutations common to individuals with this disease. This is a follow-up to Trikafta (approved 2019), a twice daily oral tablet that has become standard of care in eligible patients with CF.

Alyftrek (pronounced “ah-lif-trek”) combines three active ingredients to increase the activity of cystic fibrosis transmembrane conductance regulator (CFTR), a protein that maintains the balance of salt and water in the body. In those with CF the CFTR protein is defective or absent, causing buildup of mucus and symptoms such as chronic respiratory infections and digestive complications, which makes this protein an ideal target for drug therapy. Clinical trials compared Alyftrek to Trikafta,  and Alyftrek was found to have similar results when looking at lung function and superior results in its ability to reduce the amount chloride in sweat (a characteristic marker of CF).

Underwriters should expect to see Alyftrek via Irix® Prescription Data in those with a diagnosis of CF. Based on positive clinical trial data and more convenient dosing, it is likely that in time, Alyftrek will surpass Trikafta (which is produced by the same manufacturer) as the preferred agent for the treatment of CF in the indicated population. Although CF has historically been a major concern in underwriting, ongoing therapeutic advancements may prompt a reevaluation of how CF is handled in the insurance market.

Anticipate relative mortality: High (>220%).

Rezdiffra (resmetirom): A novel treatment for MASH

Kyle Schimek, PharmD, BCPS

Manager, Clinical Services

September 24, 2024 Updated

Rezdiffra (resmetirom, approved March 2024) is a first-of-its-kind, once-daily oral treatment indicated for metabolic dysfunction-associated steatohepatitis (MASH), a condition previously referred to as nonalcoholic steatohepatitis (NASH) that affects an estimated 1.5%–6.5% of U.S. adults.*

MASH is a form of fatty liver disease characterized by inflammation and cell death that can lead to fibrosis and cirrhosis. Rezdiffra is the first FDA-approved treatment for this condition and works by reducing liver fat accumulation through partial activation of thyroid hormone receptors in the liver and should be used in conjunction with diet, exercise, and/or therapies, including vitamin E and those focusing on weight loss. While additional trials are ongoing to verify Rezdiffra’s clinical benefit, existing trials have shown significantly more patients taking Rezdiffra achieved MASH resolution or an improvement in liver fibrosis compared to those on a placebo.

Underwriters should expect to see Rezdiffra via Irix Prescription Data in those with a diagnosis of MASH with moderate to advanced liver fibrosis. Because of its high cost and the potential need for a liver biopsy before beginning therapy, the initial use of this medication is expected to be low relative to the percentage of Americans with MASH/NASH. Therefore, underwriters should continue to look for diagnoses found through medical claims or records, as well as other treatments addressing risk factors for MASH such as those promoting weight loss and blood sugar control.

Anticipated relative mortality: High (>220%).

*Definition & Facts of NAFLD & NASH | NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases. 

Vafseo (vadadustat): A new oral agent to treat anemia due to chronic kidney disease

Kyle Schimek, PharmD, BCPS

Manager, Clinical Services

September 24, 2024 Updated

Vafseo (vadadustat, approved March 2024) is a once-daily oral treatment for anemia due to chronic kidney disease (CKD) in those who have been receiving dialysis for at least three months. This is the second oral option for anemia from CKD in those on dialysis, following the approval of Jesduvroq (daprodustat) in February of 2023. Both agents work to prevent the breakdown of hypoxia-inducible factor (HIF), which leads to enhanced production of red blood cells. These products have similar efficacy and safety profiles as erythropoiesis-stimulating agents (ESAs, such as Epogen/ epoetin alfa) in those on dialysis.

Underwriters should expect to see Vafseo via Irix Prescription Data as an alternative to ESAs in those experiencing anemia due to CKD while on dialysis. Medical Data claims associated with CKD and dialysis treatment are expected to accompany fills of Vafseo, while clear indicators of CKD on prescription profiles may be absent. Despite being approved earlier in 2024, this product likely won’t become available until early 2025.

Anticipated relative mortality: High (>500%).

Tryvio (aprocitentan): A novel treatment for resistant hypertension

Kyle Schimek, PharmD, BCPS

Manager, Clinical Services

September 24, 2024 Updated

Tryvio (aprocitentan, approved March 2024) is a once-daily oral treatment indicated for hypertension not controlled by other agents. By blocking the effects of endothelin on vascular smooth muscle, Tryvio helps to relax blood vessels (which lowers blood pressure) and can help decrease production of aldosterone, one of the hormones implicated in the causation of elevated blood pressure. This represents the first unique therapeutic pathway for an anti-hypertensive in nearly 40 years. Clinical trials found Tryvio helped to further reduce blood pressure in individuals with elevated readings despite being on at least three anti-hypertensive agents.

Underwriters should expect to see Tryvio via Irix Prescription Data as an add-on therapy in those with difficult-to-control hypertension, as inexpensive, first-line medications will likely be clinically preferred over a more expensive, brand name product. The medication is only approved for those already on multiple anti-hypertensives, although this may change over time as the manufacturer has indicated interest in researching its use in other conditions. Traditional therapies, such as ACE inhibitors (e.g., lisinopril), ARBs (e.g., losartan), thiazide diuretics (e.g., hydrochlorothiazide), and calcium channel blockers (e.g., amlodipine), continue to be preferred therapies for hypertension.

Anticipated relative mortality: Medium (180-220%).

Zepbound (tirzepatide): A new GLP-1 + GIP receptor agonist for chronic weight management

Derek Cole, PharmD

Clinical Consultant

April 26, 2024 Updated

Zepbound (tirzepatide, approved November 2023) is a subcutaneous injection given weekly for chronic weight management in patients who are obese, i.e., have a body mass index (BMI) of 30 or higher. Zepbound is also indicated for patients who are overweight, i.e., have a BMI of 27 or higher and have at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, cardiovascular disease).

Zepbound joins the ranks of other GLP-1 receptor agonists approved for chronic weight management, including Saxenda (liraglutide, approved December 2014) and Wegovy (semaglutide, approved June 2021), but differentiates itself by also working as an agonist on GIP receptors. Action on both GLP-1 and GIP receptors produces a synergistic effect, resulting in enhanced regulation of appetite and caloric intake. Of note, the active ingredient in Zepbound, tirzepatide, can also be found in Mounjaro (approved November 2022), which is used in the treatment of type 2 diabetes.

Underwriters should expect to see this medication via prescription fills for use in those who are obese, overweight, or trying to maintain their weight. Research has shown those who meet their weight goals but stop Zepbound are more likely to regain the weight they lost, which may lead to patients staying on this medication long term. Other factors should be considered when underwriting these cases, such as the presence of weight-related comorbid conditions referenced above.

Anticipated relative mortality: Low (<180%).

Opvee (nalmefene): A new nasal spray to treat opioid overdose

Derek Cole, PharmD

Clinical Consultant

April 26, 2024 Updated

Opvee (nalmefene, approved May 2023) is a single-dose nasal spray given for emergency treatment of known or suspected opioid overdose. Opvee is an opioid antagonist and is used similarly to others within this class (e.g., naloxone/Narcan). This new product improves ease of administration and, when compared to naloxone, provides a longer duration of action, giving patients and providers another option to combat overdoses. At this time, Opvee is only available via a prescription while naloxone is approved for over-the-counter purchase by the FDA.

Underwriters should expect to see this medication via prescription fills. It is important to note that fills of Opvee may be found on the profile of a ‘Good Samaritan’ and not always the intended recipient of the medication, as some state laws allow all opioid antagonists to be obtained by concerned family or friends. We encourage consulting with your legal team on how to best underwrite opioid antagonist medications as many states have restrictions on the ways information about these drugs can used in insurance underwriting.

Anticipated relative mortality: High (>220%).

Lantidra (donislecel-jujn): A novel treatment for type 1 diabetes

Derek Cole, PharmD

Clinical Consultant

April 26, 2024 Updated

Lantidra (donislecel-jujn, approved June 2023) is a novel cell treatment indicated for adults with type 1 diabetes who cannot effectively control their A1c due to repeated episodes of severe hypoglycemia.

Type 1 diabetes is a chronic autoimmune disease caused by destruction of pancreatic islet cells, requiring lifelong insulin administration. One common side effect of insulin is hypoglycemia, which can be dangerous and cause unresponsiveness or seizures in severe cases. Lantidra is made from donor pancreatic islet cells and given in a healthcare setting as a single infusion into the hepatic portal vein. A second or even third infusion may be given depending on a patient’s response, with the goal of stopping the need for insulin injections altogether.

Underwriters may see administration of Lantidra via medical claims data in type 1 diabetics with repeated episodes of hypoglycemia. Of note, because Lantidra consists of donor cells, immunosuppressants (e.g., tacrolimus, sirolimus) are required with administration and continued long term to prevent rejection of the treatment. Because of this, Lantidra is anticipated to be a last-line therapy for difficult-to-control type 1 diabetes.

Anticipated relative mortality: High (>220%). Given this medication is used for uncontrolled or difficult-to-control type 1 diabetes, the anticipated mortality for those given this therapy is expected to be on the high end of the spectrum for type 1 diabetes.

First oral agent for the treatment of postpartum depression: Zurzuvae (zuranolone)

Kim Sapre

Kimberly Sapre, DMSc, PA-C

Medical Consultant

December 15, 2023 Updated

Zurzuvae (zuranolone, approved August 2023) is a once-daily oral treatment given for one 14-day course for postpartum depression, the first oral agent approved by the FDA for this condition. While its mechanism is not fully understood, it is thought zuranolone functions similarly to the previously approved intravenous therapy for postpartum depression, Zulresso (brexanolone), by increasing the binding of GABA-A receptors in the brain to reduce symptoms of depression. Subjects in clinical trials saw improvement in symptoms in as little as three days, which is much quicker than most antidepressants on the market that work on different receptors in the brain.

Postpartum depression can be diagnosed during pregnancy, but it is more frequently diagnosed after delivery. Underwriters may expect to see fills of the medication on the applicant’s profile following delivery, but there should only be one 14-day course of the medication. Furthermore, other antidepressants (e.g., sertraline) may be prescribed in conjunction with or prior to the administration of zuranolone.

As an oral agent, Zurzuvae fills will show up in Prescription Data. Anticipated relative mortality: Low (< 100%)

A new agent to prevent symptomatic heart failure and cardiovascular death: Inpefa (sotagliflozin)

Kim Sapre

Kimberly Sapre, DMSc, PA-C

Medical Consultant

December 15, 2023 Updated

Underwriters may expect to see this medication prescribed after a recent hospitalization or an emergency department visit for the treatment of acute heart failure, or in those with the risk factors indicated above. Sotagliflozin will usually appear on an applicant’s profile after other medications that are used to treat heart failure and / or diabetes, such as beta blockers (e.g., carvedilol, metoprolol), hypertension medications (e.g., lisinopril, losartan), diuretics (e.g., furosemide, spironolactone), diabetes medications (e.g., metformin, semaglutide), etc. Finding sotagliflozin on the profile likely signals worsening of disease or, at a minimum, concern for cardiovascular problems in those with these significant risk factors.

While sotagliflozin is approved for the treatment of type 1 diabetes in some parts of Europe, safety concerns have prevented its approval by the FDA for that condition in the United States at this time.

Because it’s an oral agent, underwriters will spot Inpefa fills in Prescription Data. Anticipated relative mortality: High (>220%)

A new infusion for the treatment of Alzheimer’s disease: Leqembi (lecanemab-irmb)

Kim Sapre

Kimberly Sapre, DMSc, PA-C

Medical Consultant

December 15, 2023 Updated

Leqembi (lecanemab-irmb, approved January 2023) is an intravenous infusion given every two weeks for the treatment of early Alzheimer’s disease. Similar to Aduhelm (aducanumab-avwa, approved June 2021), lecanemab works by reducing the build-up of beta-amyloid plaques in the brain, one of the primary causes of Alzheimer’s disease responsible for impairing the brain cell’s functionality. In clinical trials, lecanemab was shown to only modestly slow both cognitive decline and loss of ADL (activities of daily living) function when compared to placebo. While it may slow or delay symptoms, it does not cure or reverse Alzheimer’s disease and is not approved for those with severe disease.

Underwriters may expect to see this medication used in those with early forms of Alzheimer’s disease; however, based on the population who participated in clinical trials, eligibility to use the product may be limited. Additionally, its biweekly administration in a clinic or hospital as well as its high list price of around $26,000 per year may further limit its use when cheaper, more convenient options (e.g., donepezil, memantine) are already available on the market.

As an intravenous infusion, Leqembi will found in Medical Data. Anticipated relative mortality: Medium (180-220%)