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The Oral GLP-1 Race: Medical Breakthroughs Meet Financial Reality

by Rx Insights

The weight loss drug market is evolving rapidly as pharmaceutical companies advance their clinical trials for both oral and non-oral GLP-1 formulations. As Biopharmadive recently noted in an article, “The obesity drug race is far from over, with a plethora of companies vying for a piece of what’s expected to become a huge market in the years ahead. Analysts project that “incretin” drugs, like Novo’s Wegovy and Lilly’s Zepbound, could top more than $100 billion in yearly sales by 2030.” 

While these emerging treatments promise expanded therapeutic benefits for obesity-related conditions as well as improved efficiency in weight loss, they also pose challenges for employer-sponsored prescription plans already experiencing unprecedented utilization and cost increases from GLP-1s.  

Emerging Treatments in Clinical Trials 

These pharmaceutical companies are conducting extensive clinical trials for both oral and non-oral GLP-1 drugs, with each potential treatment still awaiting FDA approval: 

  • Novo Nordisk’s experimental oral drug, amycretin, currently in Phase 3 trials, has shown promise beyond weight loss. By targeting both GLP-1 and amylin receptors, it may offer additional benefits for cardiovascular health and metabolic disorders associated with obesity1.  
  • Eli Lilly’s orforglipron, advancing through Phase 3 trials, demonstrates potential benefits for obesity-related complications including fatty liver disease and sleep apnea2.  
  • Amgen’s MariTide (maridebart cafraglutide), in late-stage clinical trials, is being studied for potential impacts on obesity-related inflammation and metabolic syndrome, with a unique monthly dosing approach3.  
  • Other pharmaceutical companies, including Roche and emerging biotech firms, are conducting trials focusing on broader therapeutic applications for obesity-related conditions while improving tolerability4.  

The Implications for Plan Sponsors 

As these medications progress through clinical trials toward potential FDA approval, many current injectable users may transition to oral versions, while the improved accessibility could drive new patient adoption. This shift will likely intensify the financial pressure on prescription benefit plans. 

In response to these market dynamics, Benecard continues to develop innovative solutions to help manage rising costs of GLP-1 drugs while ensuring appropriate care. Our comprehensive approach includes specialized plan design features which were previously addressed in our three-part bulletin series “decoding the rising Rx trends.” 

Contact us to explore strategies for managing GLP-1 medication expenses while supporting employee health outcomes. 

Sources: 

“The Race for Oral Obesity Drugs: Multiple Phase 3 Trials Vying for Next-Gen Status,” Fierce Pharma. 

“GLP-1 Market Heats Up as Companies Vie for Next-Gen Obesity Drugs,” Outsourcing-Pharma. 

“Why Amgen’s MariTide Could Rival Eli Lilly and Novo Nordisk’s Obesity Drugs,” Business Today. 

“Four Oral GLP-1 Products in Phase III Trials as Race Intensifies,” Clinical Trials Arena. 

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Successfully Managing Rising Rx Costs Starts with Accurate Trends

by Rx Insights

In today’s market if you’re seeing prescription drug trend estimates in the single digits, you should know: those numbers don’t reflect reality. Some trend calculations may focus solely on manufacturer drug price inflation and therefore dramatically understate actual or true prescription benefit trends. To accurately project trends, additional critical factors must be considered:

  • Utilization Patterns – Prescription volume increases yearly as population age and chronic conditions become more prevalent and members simultaneously shift to newer, costlier alternatives. Medical advancements allow for earlier diagnosis which drives longer treatment duration and higher utilization.
  • Specialty and Non-Specialty Pipeline Impact – New to market drugs typically launch at premium price points as compared to existing products. These treatments often expand the treatable population while commanding unprecedented costs.

The Risk of Underestimating

When these factors are properly weighted, we consistently see trends in the mid to higher teens. When plans understate drug trends, they create severe budget shortfalls. This forces employers to make radical mid-year plan design adjustments or significantly increase contributions or benefit reductions the following year, all while making it increasingly difficult to secure stop-loss coverage in the following year without significant rate increases. 

Looking Ahead

While we can’t control drug prices, we can control how benefits are managed. That’s where Benecard Services is different. Instead of just chasing rebates and managing unit costs, we have aligned financial interests with our clients that focus on getting members the right medications while keeping costs in check. No conflicts of interest ― just patient-centered care that works.

With more specialty and GLP-1 drugs in the pipeline, these trends will only intensify. Contact us today at (800) 734-9528 or talktous@benecard.com to discuss how Benecard is helping employers tackle rising drug trends.

New Jersey state capitol building in Trenton

SHBP-Local Government’s Financial Crisis

by Rx Insights

The NJ State Department of Treasury released a report on May 20th confirming that the State Health Benefits Program for Local Government (SHBP-LG) has become financially unsustainable and needs immediate intervention to survive. The report also states that the School Employee Health Benefits Plan (SEHBP) is on the same trajectory and likely to follow the SHBP-LG’s deterioration.

The Immediate Financial Impact

A potential 26.5% increase could be applied as a combination of a mid-year rate increase in 2025 and/or factored into future renewals. This potential 26.5% increase is a culmination of the 7% premium rate increase required to repay the $120 million dollars still owed on a $258 million dollar loan and based on the SHBP-LG exhausting its claim stabilization reserves (CSR) which calls for an additional 19.5% increase.

This increase would be in addition to normal medical and prescription trends. The State’s consulting firm, Aon, projects prescription trends of 18% to 23% for 2026, with medical trends estimated at 8% to 10% based on current SHBP-LG data.  

What This Means for Plan Sponsors in the SHBP-LG

According to the Department of Treasury, immediate action is necessary for the SHBP-LG to survive. These actions require significant rate increases, forced plan design changes, and/or legislative actions. Plan sponsors should begin evaluating alternatives now to avoid compounding rate increases in 2025 and 2026 as well as potential plan design changes.  

Plan sponsors and their brokers should explore private carriers who can offer full risk protection and/or who can offer access to trusts or group purchasing organizations, which provide for greater stability by spreading the risk through such arrangements. While such quotes will likely show double-digit increases, private carriers do not carry the same financial burden as the SHBP does (i.e., debt burden and CSR requirement), which represents a considerable financial reduction for groups who transition sooner rather than later.

NEXT STEPS

Plan sponsors in the SHBP should obtain their most recent claim experience and census as soon as possible which will allow private carriers to provide the most accurate quotes.   If you are currently contracted with a broker, have them contact Benecard’s Vice President of Sales, Richard Van Noord, at (609) 651-5412 or Richard.VanNoord@benecard.com. If you do not have a broker, you can contact Richard directly to explore available solutions.

Everything You Need to Know About Shingles & the Shingles Vaccine

by News

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 8, 2024.
By Robin Foster HealthDay Reporter

Shingles can strike anyone who had chickenpox when they were young, and the intense pain that can accompany this body rash has sidelined many seniors. Here, one expert explains how and why shingles can surface, and what you can do to treat it, or better yet, avoid it. Shingles can happen at any age, but it most typically affects people over 50 who have stress and compromised immunity. “Shingles is caused by the varicella-zoster virus. It’s the same virus that causes chickenpox,” said Dr. Eugene Fellin, a family medicine physician at Penn State Health Medical Group – Fleetwood. “For most of us who grew up before the 1990s, when children began being immunized against chickenpox, we’ve been exposed to the virus and are at risk for shingles.”

How can shingles surface? After lying dormant in the nervous system for years, the virus can reemerge as shingles, which causes painful rashes that typically surface on the face or around the side of the torso, Fellin explained.

“It’s like a poison ivy rash that won’t go away,” he added in a Penn State news release.

“It can occur in, but along that same nerve root. A lot of times, people feel some tingling or a burning sensation prior to the rash actually breaking out,” Fellin noted. “When we’re looking for the rash, it will be in a string on the torso because the nerves wrap around the torso. You get a line around you, from the back to the front.”

“The other issue we worry about is if it breaks out on the face and involves the eye because this can lead to blindness,” Fellin said. “Shingles around the eye is considered dangerous, and an instant referral to an
ophthalmologist is always recommended.”

What can you take to treat shingles? Antivirals such as Valacyclovir can be prescribed, but they’re time-sensitive and need to be taken within 36 hours of the start of the rash because they work by slowing the spread of the virus, Fellin said.

While symptoms subside after three to five weeks, pain can sometimes return in the form of postherpetic neuralgia, he said. This long-term nerve pain occurs where the shingles rash appeared and can last for months or even years. Older adults are more likely to develop postherpetic neuralgia and have longer lasting and more severe pain, Fellin said. Luckily, there is something you can do to avoid shingles altogether: get vaccinated.

The U.S. Centers for Disease Control and Prevention recommends the Shingrix vaccine, given in two doses, with the second dose given two to six months after the first. People who get shingles can still receive the vaccine, which can lower the chances of another outbreak, Fellin noted.

Most family doctors and pharmacies stock the vaccine, which is covered by Medicare, he added. “Most insurance programs are covering it because it has been out long enough and shows a real benefit,” Fellin said in a Penn State news release. “There’s a lot of misinformation about vaccines circulating out there. My message is this: Don’t be afraid of this or any vaccine.”

SOURCE: Penn State Health, news release, Dec. 5, 2024

https://pennstatehealthnews.org/2024/12/the-medical-minute-shingles-and-its-shot-what-you-need-to-know-to-stay-healthy/

FDA’s Critical Role in Ensuring Safe and Effective Flu Vaccines

by NewsUncategorized

The flu (influenza) vaccine you get at your doctor’s office or pharmacy is the result of year-round work of highly skilled microbiologists, epidemiologists, physicians, and other public health experts. Sound complicated? It is.

As new strains of flu viruses emerge, the U.S. Food and Drug Administration closely coordinates with sister agencies and works with manufacturers to help the development of vaccines to protect from the flu, a disease that can cause severe illness.

The FDA and other parts of the U.S. Department of Health and Human Services are working to advance the development of new technologies for producing flu vaccines so we can better respond to influenza public health emergencies. All FDA-approved flu vaccines have been evaluated and determined to be safe and effective by the FDA.

There is often more than one type of flu virus circulating each season. So, vaccines are made to target the most likely viruses to circulate and cause illness in the U.S. during the upcoming flu season.

To find a flu vaccine near you, visit this page.

Source: FDA; Courtesy of Drugs.com

Ream More…

BIZENGRI

by NewsUncategorized

FDA Grants Accelerated Approval to Bizengri for NRG1+ Pancreatic adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer

Merus N.V. has announced that the U.S. Food and Drug Administration (FDA) approved Bizengri (zenocutuzumab-zbco). This is the first and only treatment indicated for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC); that are advanced, unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion; who have disease progression on or after prior systemic therapy.

These indications are approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Bizengri has a Boxed WARNING for Embryo-Fetal Toxicity and warnings for infusion-related reactions (IRRs), hypersensitivity and anaphylactic reactions, interstitial lung disease (ILD)/pneumonitis, and left ventricular dysfunction.

  • Bizengri is a bispecific antibody that binds to the extracellular domain of HER2 and HER3 expressed on the surface of cells, including tumor cells, inhibiting HER2:HER3 dimerization and preventing NRG1 binding to HER3.
  • The company plans to help appropriate patients gain access to Bizengri by providing resources and support based on each patient’s needs and situation.

Source: Meru N.V.

Read more…

YESINTEK

by NewsUncategorized

FDA Approves Yesintek, a Biosimilar to Stelara

Biocon Biologics Ltd, announced that the U.S. Food and Drug Administration (FDA) has approved Yesintek (ustekinumab-kfce), a biosimilar to the reference product, Stelara® (ustekinumab).

Yesintek, a monoclonal antibody, is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. As a human interleukin-12 and -23 antagonist, Yesintek is indicated in the treatment of:

Adult patients with:

  • moderate to severe plaque psoriasis (PsO) who are candidates for phototherapy or systemic therapy.
  • active psoriatic arthritis (PsA).
  • moderately to severely active Crohn’s disease (CD).
  • moderately to severely active ulcerative colitis.

Pediatric patients 6 years and older with:

  • moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
  • active psoriatic arthritis (PsA).

Source: Biocon Biologics Ltd.

Read more…

RAPIBLYK

by NewsUncategorized

FDA Approves Rapiblyk for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting

AOP Orphan Pharmaceuticals GmbH announced that the U.S. Food and Drug Administration (FDA) has granted regulatory approval for Rapiblyk (landiolol) in the hospital critical care setting for the treatment of the severe heart condition, supraventricular tachycardia. The approval is based on clinical studies which demonstrated that Rapiblyk (landiolol) enables rapid management of the heart rate with minimal reduction of blood pressure.

  • Rapiblyk approval in the U.S. represents an important milestone for patients experiencing supraventricular tachycardia, including atrial fibrillation and atrial flutter, who need rapid and short-term heart rate reduction. The approval will provide patients in the U.S. with a new treatment option.

Source: AOP Orphan Pharmaceuticals GmbH

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IMKELDI

by NewsUncategorized

FDA Approves Imkeldi Oral Solution for the Treatment of Certain Forms of Leukemia and Other Cancers

  • Shorla Oncology has announced that the U.S. Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, to treat certain forms of leukemia and other cancers, and it is designed to provide dosing accuracy.
  • Imkeldi can help slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia, myelodysplastic syndrome /myeloproliferative disease (MDS/MPD), and gastrointestinal tumors (GIST).
  • Imatinib mesylate is a tyrosine kinase inhibitor, approved by the FDA for use in certain forms of leukemia (such as acute lymphoblastic leukemia and chronic myeloid leukemia) and other cancers in adults and pediatric patients as young as one year old. Imatinib is available both generically and as a brand name, Gleevec tablets, which were approved in 2001.

Source: Shorla Oncology

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ATTRUBY™

by NewsUncategorized

FDA Approves Attruby to Reduce Cardiovascular Death and Cardiovascular-Related Hospitalization in Patients with ATTR-CM

BridgeBio Pharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Attruby™ (acoramidis), for the treatment of adults with cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalization.

The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of life.

  • Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. It mimics a naturally occurring “rescue mutation” of the TTR gene that targets the root cause of ATTR-CM.
  • Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.

Source: BridgeBio Pharma, Inc.

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