Reasons Patients Must Transition to Second-Line Obesity Medications

Soon, tens of thousands of Americans will be compelled to transition from well-known obesity medications to alternatives that are likely to yield less effective weight loss, thanks to decisions made by Health’s insurance providers.

This situation exemplifies the consequences of a clandestine agreement between a pharmaceutical company and an intermediary known as a pharmacy benefits manager (PBM), appointed by employers to manage prescription coverage for their workforce. While employers benefit from lower medication costs, employees find themselves restricted from accessing competitive healthcare options. This type of insurance denial has become increasingly prevalent in the last decade.

Caremark, part of CVS Health and one of the largest PBMs, has opted to eliminate coverage for Zepbound, despite research indicating its weight loss efficacy surpasses that of Wegovy.

These findings, which were first announced in December, were confirmed in an article published in the New England Journal of Medicine on Sunday. The study encompassed a significant clinical trial evaluating these drugs, funded by Eli Lilly, the producer of Zepbound. Previous research not funded by Eli Lilly reached similar conclusions.

Ellen Davis, a 63-year-old resident of Huntington, Massachusetts, is one of those affected by Caremark’s decision. “It’s as if the rug has been pulled out from under me,” she expressed.

After using Zepbound for a year, she lost 85 pounds and experienced significant health improvements, having retired after a 34-year tenure at Verizon.

In a letter addressed to Verizon, she stated, “This forces patients to transition to less effective medications without any justification for medical care.”

Verizon did not respond to inquiries.

Following Caremark’s announcement, word spread rapidly online. A physician’s assistant at a weight loss clinic in New Hampshire started a Change.org petition to urge the company to reconsider. As of Sunday afternoon, it had garnered over 2,700 signatures. Caremark is set to cease Zepbound coverage in July.

Doctors assert that both Wegovy, from Novo Nordisk, and Zepbound are effective medications; however, they prefer Zepbound for most patients. This shift greatly limits their ability to tailor obesity medication prescriptions to individual needs.

It remains unclear if the omission of Zepbound will enhance Caremark’s profit margins.

Executives from Novo Nordisk claim they are not attempting to obstruct Zepbound’s availability. They maintain that patients and healthcare providers should have the autonomy to select their preferred medications.

David Whitrap, a spokesperson for Caremark, stated that the firm’s objective was to reduce drug costs. He noted that the agreement would lower obesity drug prices for Caremark’s employer clients by 10-15% compared to the previous year.

“CVS Caremark has aimed to let PBMs competitors often put forth their best efforts. Our choice is to encourage competition among clinically similar products while providing the lowest net costs to our clients,” Whitrap commented.

When queried about studies highlighting Zepbound’s advantages, Whitrap indicated that both medications are highly effective, and that clinical trial outcomes frequently diverge from real-world results.

The actual pricing that employers pay for medications is usually confidential. The Health Transformation Alliance, a consortium of major employers, reports that the average monthly cost for a large employer falls between $550 and $650.

Without insurance, patients might spend approximately $500 monthly on their medications. Many recently lost cheaper alternatives when regulators halted the sale of generic versions that cost below $200 monthly.

Countless employers do not cover either Zepbound or Wegovy due to their high cost. Medicare excludes most drugs for obese patients, and the Trump administration recently declined to support the Biden administration’s proposal to expand coverage.

Caremark, along with two other PBMs, dominates 80% of the prescription market. Other players, like Cigna’s Express Scripts and UnitedHealth’s Optum Rx, have not implemented similar restrictions on weight loss medications.

Since 2012, major PBMs have increasingly employed strategies that disrupt patient care and complicate treatment plans. Medications have been abruptly removed from the PBM’s official list of covered drugs.

According to a drugmaker-funded analysis, the number of medications excluded from at least one PBM list surged from 50 in 2014 to 548 in 2022. This count reflects instances where patients were compelled to switch to entirely different drugs, not merely to a standard version or alternative replica.

Limitations fluctuate frequently, leaving patients uncertain about the reasons behind them. One PBM might cover a specific drug while another does not, but competing managers may do the reverse.

Exclusions are generally purported not to harm patients; in certain instances, they may even be beneficial if patients are nudged toward more effective medications.

However, some exclusions have prompted significant concern among patients and healthcare providers.

In 2022, Caremark compelled patients to switch from one widely utilized blood-thinning elixir to Xarelto, leading to anecdotal reports that patients experienced complications during their treatment change. A group of physicians criticized this move, and the company restored coverage for the elixir six months later.

Individuals with autoimmune diseases, such as arthritis, often face similar mandatory drug switches. Asthma patients are also experiencing transitions to alternate inhalers.

“We’ve witnessed numerous situations,” remarked Dr. Robin Cohen, an asthma specialist at Boston Medical Center.

Representatives on behalf of employers indicate that patients affiliated with Caremark have already reached out via calls and emails, inquiring about the potential impact on their prescriptions. While they may remain on the PBM’s drug list, they have not played an active role in shaping it.

Caremark’s changes are applicable only to specific private insurance beneficiaries whose employers selected the most prevalent drug list managed by PBMs. This movement excludes patients receiving a version of diabetes medication.

Patients can consider switching to Wegovy or three other weight loss alternatives.

Whitrap noted that Caremark provides a “case-by-case medical exception process for individuals who may require alternatives,” including patients who have previously utilized Wegovy and saw insufficient weight loss.

However, many individuals may not meet the criteria for the exemption. In a conversation, one patient expressed a desire for Zepbound specifically and was not interested in switching.

“I selected Zepbound in consultation with my physician,” stated Carl Hoode, 49, from Saugus, Massachusetts.

Some patients are contemplating using their own funds to continue Zepbound. For 28-year-old Victoria Bello of Syracuse, New York, the medication has provided significant health improvements, and she fears losing access to it.

“I wasn’t prepared for such a sudden change,” she remarked. “I’m concerned for my health and the potential setback in my progress.”

A study funded by Eli Lilly conducted direct comparisons of medications across 750 clinical trials over a span of 16 months.

Participants receiving high doses of Zepbound shed an average of 50 pounds, whereas those on Wegovy lost around 33 pounds. Though both medications are administered via injection and share side effects such as nausea, vomiting, diarrhea, and constipation, the frequency of these effects was generally comparable between the two drugs. A small proportion of patients in both groups discontinued medication due to side effects.

Both drugs function similarly but have critical differences. Wegovy mimics only a single appetite-regulating hormone, while Zepbound influences two. Researchers believe that engaging more hormones leads to greater weight loss.

Dr. Jason Brett, an executive at Novo Nordisk, indicated in a recent interview that the quantity of weight lost is just one aspect of obesity treatment. Both medications are associated with improved heart health, though only Novo Nordisk has obtained regulatory approval to market the drug with that claim.

Medical professionals contend that both options must remain accessible, as Wegovy may outshine Zepbound in terms of weight loss efficacy or having milder side effects.

Healthcare providers advocate for the availability of both medications due to the diverse responses patients exhibit when using either Wegovy or Zepbound.

Supporters of Caremark argue that their decision to restrict Zepbound is merely fulfilling their responsibilities.

Benefits managers engage with pharmaceutical companies to negotiate payments known as rebates, which ultimately reduce employers’ costs for prescription drugs. These negotiations can yield substantial fees for the biggest market players. Caremark stood to gain significant revenue from weight loss medications without needing to exclude Zepbound.

The weight loss pill market is thriving, with both Novo Nordisk and Eli Lilly vying for market share.

Caremark engaged both drug manufacturers regarding rebate amounts associated with making their products available. However, neither Novo Nordisk nor Eli Lilly disclosed specific amounts provided. Novo Nordisk maintains that it did not advocate for or pay to inhibit Zepbound’s availability, emphasizing that the exclusion was solely Caremark’s decision.

“We believe that patients and physicians should determine what’s in the best interest of the patient,” stated Lars Flugaard Jorgensen, CEO of Novo Nordisk. He elaborated to Wall Street analysts this month.

Elizabeth DeGalier, 56, of Rochester, Minnesota, shared that Zepbound had a transformative impact on her life, expressing her frustration over Caremark’s choice. “It appears they overlooked scientific evidence,” she remarked. “They were primarily motivated by financial considerations.”

She added, “I am apprehensive about the future. I rely on several other expensive medications. Will they also be discontinued?”