ICER Finds Insurers Struggled to Provide Fair Access for Obesity Drugs

Major payer coverage policies for 11 drugs often met fair access criteria, according to the Institute for Clinical and Economic Review’s (ICER) fourth annual Barriers to Fair Access assessment. Where insurers struggled to provide fair access was with several of the anti-obesity drugs, which include Wegovy, Saxeda, Qsymia and Contrave.

In fact, reviewers found there was a 70% alignment with ICER’s criteria for fair access — what the organization calls concordance — for Wegovy (semaglutide), a GLP-1 agonist, and Qsymia (phentermine and topiramate), an oral medication that helps to control hunger. Alignment in terms of cost sharing was rated as 81% for Wegovy, Qsymia and Mounjaro (tirzepatide), which is approved to treat type 2 diabetes.

Reviewers also found that 30% to 52% of obesity drugs were rejected due to non-coverage. KFF published the results of its annual survey of employer health benefits in October 2024. It found that just 18% of companies with 200 or more employees cover GLP-1 agonists, one class of medications used to treat obesity.

Sarah Emond

Many plans have policies in place for offering access to weight-loss drugs, but clients can opt out of that coverage, Sarah K. Emond, president of ICER, said in an interview.

“We tried to make clear the unprecedented potential budget impact challenge that is represented by these drugs, even though they look like a great deal from a long-term value perspective,” she said. “There are payers that just can't find a way to offer affordable access.”

For this analysis, ICER reviewed 11 formularies, covering 57 million people. These include 10 commercial payers and the formulary from the Veterans Health Administration. The formularies were selected based on information on the largest number of covered from MMIT Analytics Market Access Database.

ICER assessed 11 drugs that the organization had reviewed in 2022 for cost-effectiveness. For this analysis, reviewed assessed criteria that ICER has determined are cornerstones of fair access. Alignment for fair access was assessed based on cost sharing to patients and the lowest relevant tier, clinical eligibility not being more narrow than the FDA label, step therapy policies that meet standard for clinical appropriateness, and provider qualification restrictions.

The drugs assessed included:

• Mounjaro to treat type 2 diabetes
• Wegovy, Saxenda, Qsymia and Contrave (bupropion and naltrexone) to treat obesity
• Radicava ORS (edaravone) to treat amyotrophic lateral sclerosis
• Cosela (Trilaciclib) to treat chemotheray-induced neutropenia,
• Veozah (fezolinetant) to treat vasomotor symptoms of menopause
• Zynteglo (betibeglogene autotemcel), a one-time gene therapy to treat beta thalassemia
• Roctavian (valoctocogen roxaparvovec), a one-time gene therapy to treat hemophilia A
• Hemgenix (etranacogene dezaparvovec-drlb), a one-time gene therapy to treat hemophilia B

New this year was an exploratory analysis of consumer accessibility of the drugs assessed using data from IQVIA’s Market Access Library. ICER looked at prescriptions filled, rejected, abandoned, cash payments and out-of-pocket costs.

“Partnering with IQVIA gave us the opportunity to see what it feels like for patients from a cost perspective because that's been missing in previous reports,” Emond said. “We'd always used tiering as a very inadequate substitution for cost sharing, but knowing the range of costs that are coming out of pocket for patients for these drugs was also really instructive.”

Emond said there could be many different cost-sharing amounts for a single tier based on how the purchaser has structured the plan. “It can be a really big difference, and we weren’t able to see that when we were just looking at tiers,” she said. “The IQVIA data is not as granular when looking at specific formularies, but it gave us a sense of how much patients are paying out of pocket at the pharmacy counter for the drugs. Feedback from our working group over the years was that if we had any opportunity to get to the dollars that patients were paying, that would be a good contribution to the conversation about what represents fair access.”

Insurer’s Obesity Drug Coverage

The ICER review found that three formularies (Highmark, UnitedHealth, Health Care Service Corp) placed Wegovy and Qsymia on a non-preferred brand tiers with no other drugs in its class covered at the lowest tier.

In terms of clinical eligibility, one payer (Blue Shield of California) required that a patient has not undergone bariatric surgery within 12 months of receiving Qsymia, which is not part of the approved labeling or on clinical guidelines. The Veterans Health Administration included additional requirements for Wegovy, including documentation of prior use of orlistat not be adequate and specific BMI and conditions related to type 2 diabetes. These requirements, ICER said, do not align with clinical eligibility criteria. The Veterans Health Administration also implemented restrictive criteria for the use of Saxenda (liraglutide).

After the ICER review, Blue Shield of California changed one policy to be in align with the organization’s fair access policies. For example, effective October 2024, the plan no longer excludes patients who have undergone bariatric surgery within 12 months of receiving Qsymia.

But Blue Shield of California also made another change that makes Qsymia no longer in alignment with other ICER criteria. For example, effective September 2024, Blue Shield of California changed the tier placement for Qsymia, moving it from a tier 2 (preferred brand) to tier 3 (non-preferred brand). This means Qsymia is no longer on the lowest relevant tier. Because of this change, there is no obesity medication in the same class as Wegovy in the lowest tier.

Greater Transparency Efforts Needed

ICER reviewers also conducted an exploratory analysis of the transparency of information available to prospective plan members for the three gene therapies that were assessed: Zynteglo, Roctavian and Hemgenix. These three gene therapies were chosen based on the potential economic impact and because there was a likelihood that that prospective enrollees would consider coverage important in health plan selection.

ICER found that although most plans posted clinical eligibility criteria for these gene therapies, information on tiering and cost sharing was not widespread. ICER found that Elevance and Cigna provide cost-sharing details for Hemgenix and Roctavian. Three payers (Elevance, Highmark, and Cigna) provide publicly accessible information on cost sharing and tiering for Zynteglo.

Elevance, for example, were not covered and the full out-of-pocket responsibility would fall on the individual. Cigna also provided information regarding the cost sharing for each of the three gene therapies. But ICER officials note the language used could be confusing.

Additionally, four of the plans (Cigna, HCSC, Highmark, UnitedHealth) posted clinical criteria policies only within the portion of the website intended for providers where consumer may not look.

The National Pharmaceutical Council’s Chief Strategy Officer Kimberly Westrich says that although the report raises important concerns about patient access, it has numerous methodological limitations. "It shouldn’t be used to draw conclusions about whether payers are providing meaningful access to patients," she said. "For example, the report adopts a narrow scope, evaluating payer alignment with only 14 out of ICER’s 27 Fair Access Criteria. Additionally, the concordance analysis excludes policies for drugs that are non-formulary or excluded from coverage."

Emond says ICER is very clear about the limitations of the study and caution the readers not to not draw too many broad conclusions. "That said, we know of no other systematic approach to analyzing the fairness of insurance coverage policies tied to the fairness of drugs prices, and we believe this report offers important lessons for the system if we are to move toward fair price and fair access for all patients," she said.