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Genetics and genomics are starting to have an impact on cardiovascular care. Here’s what payers should consider when deciding whether to cover a gene expression test.

Five questions for payers to ask when deciding coverage of genomic tests

Beginning Jan. 1, 2025, Optum Rx will prefer a different set of Humira biosimilar on its commercial formularies. UnitedHealth Group’s pharmacy benefit manager (PBM), one of the three largest in the United States, is favoring Amgen’s Amjevita (adalimumab-atto) over Sandoz’s Hyrimoz (adalimumab-adaz) and Cyltezo (adalimumab-adbm).

Optum Rx still includes Humira (adalimumab) on its formulary, as a tier three product, and Amjevita the first Humira biosimilar to be launched in January 2023, is a tier two product. Both Humira and Amjevita are subject to prior authorization and quantity limits. Optum Rx is removing Hyrimoz, Cyltezo and the nonbranded adalimumab-adaz, based on a review by 

 effective Jan. 1, 2025, compared with January 2024 list. 

The preferred adalimumab biosimilars will include high-WAC (wholesale acquisition cost) and low-WAC Amjevita, with high-concentration doses, including formulations appropriate for pediatric patients, and access to all drug strengths. The high-WAC products provide rebates to insurers and employers.

“The decision addresses affordability for patients, including availability of manufacturer copay assistance programs, and significant cost reduction for plan sponsors,” an Optum Rx spokesperson said. “We will offer a path to coverage for those patients who require Humira for clinical reasons.”

Biosimilars have made headway in the U.S. market, delivering on their stated purpose of bringing down the cost of expensive biologics by creating competition to their brand-name reference drugs. But Humira biosimilars, with now 10 available on the market, crucial test of biosimilar market because Humira had the top selling prescription brand-name drug for years.

Related: Humira Biosimilars Got Off to a Slow Start. Has That Changed? | AMCP Nexus 2024

Initially, the sale of the Humira biosimilars was small as insurers and PBMs continue to include Humira on their formularies. Many Humira biosimilar manufacturers used a dual pricing strategy, with both high-WAC and low-WAC options. Although the low WAC prices were on average 81% lower than Humira’s price, at the end of 2023, there was only 3% adoption of biosimilars, experts have said. At least 

 that switching to the Humira biosimilars can resulted in overall cost savings.

Related: CVS Caremark Makes Changes in Diabetes Coverage for 2025

Now the tides turning, and some large PBMs have started to remove Humira from their formularies in favor of biosimilars. CVS Health and Evernorth, for example, have said that they would teaming up with manufacturers to launch private label versions of the biosimilar. In 2023, for example, CVS launched Cordavis, which 

 was a way to accelerate adoption of biosimilars and bring cost savings to payers and patients. The company also said Cordavis allows for manufacturing oversight and provides quality assurance.

 at the time that CVS Health was positioning itself for the 2025 Medicare part D market. Because of the Inflation Reduction Act, Fein said that high-list, high-rebate drugs may be less attractive.

Optum Rx has added several oncology medications to its formulary, including Augtyro (repotrectinib), a Bristol Myers Squibb drug that is used to treat patients with ROS1-positive non-small cell lung cancer and patients with solid tumors that have a NTRK gene fusion. For 2025, Augtyro will be a tier three specialty medication that requires prior authorization.

Another added oncology therapy is Truqap (capivasertib), which was approved in November 2023 to treat patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer. It was developed by Astek Pharmaceuticals and partner AstraZeneca. Trugap will be a tier three specialty medication that requires prior authorization.

But the PBM has removed for 2025 Kisqali Femara, which is ribociclib and letrolzole packaged together, from its 2025 formulary. Like Kisqali (which is on Optum Rx’s formulary list), Kisqali Femara is a treatment for early metastatic HR-positive, HER2-negative breast cancer. Femara is a hormone and reduces the amount of estrogen in the body and is approved as first line for women in breast cancer.

Among the drugs for central nervous system disorders, Optum Rx has added Abilify Asimtufii (aripiprazole) as a tier three product. Previously only Abilify Maintena and generic aripiprazole were included. Abilify Asimtufii (aripiprazole) and Abilify Maintena are long-acting maintenance treatments developed by Otsuka and Lundbeck. 

Optum Rx has included for 2025 MedinCell’s Uzedy (risperidone) extended-release injectable suspension, a subcutaneous, long-acting formulation of risperidone that uses SteadyTeq, which is able provide for the steady release of risperidone. It is a tier 3 product.

Beginning in January 2025, Optum Rx will remove from several Humira biosimilars from its formulary, including Hyrimoz (adalimumab-adaz), the unbranded Hyrimoz and Cyltezo (adalimumab-adbm).

Formulary Watch

Clinical

Optum Rx Switches Up Humira Biosimilar Coverage for 2025

In the first year on the market, the uptake of biosimilars for Humira (adalimumab) was low but there was lower net spending and prices on adalimumab, which was likely because of rebates from AbbVie, Humira’s manufacturer, according to a new analysis published today in 

“The fact that AbbVie offered higher rebates for Humira to maintain formulary position likely led to lower healthcare spending, and these rebates often offset premiums for patients,” Benjamin N. Rome, M.D., M.P.H., one of the researchers involved in the study, told 

. “But rebates are generally not passed along directly to patients who use medications, which means patients who used Humira may not have noticed any change in their out-of-pocket costs due to the rebates.”

Rome is an assistant professor of Medicine, at Harvard Medical School and a faculty member of the division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital.

Researchers, led by Rome and his colleagues — Aaron S. Kesselheim, M.D., J.D., M.P.H., and Anushka Bhasker, M.Phil., both also with the division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital — examined the use and spending on Humira and nine biosimilars.

They assessed the four quarters before and after the launch of the first biosimilar in January 2023. Amgen’s Amjevita (adalimumab-atto), launched in Janaury 2023, was the first Humira to come on the market. It was joined by eight others in 2023 and another, Simlandi (adalimumab-ryvk), in May 2024.

They measured the number of prescriptions dispensed using the IQVIA National Prescription Drug Audit. Sales data, net of rebates and discounts, were assessed from manufacturer financial filing. But sales data were only available for Humira and three biosimilars. Researchers calculated the net price and compared with Humira’s list price.

What they found was that the proportion of biosimilars increased from 0.03% in the first quarter of 2023 to 1.35% in the fourth quarter of 2023. Net sales for adalimumab were $5 billion in the fourth quarter of 2022 and decreased by 45% to $2.8 billion in the fourth quarter of 2023.

Net price per prescription declined by 43% from $5,007 in the fourth quarter of 2022 to $2,837 in the fourth quarter of 2023. In the fourth quarter of 2023, the net price per prescription for Humira was $2,798 and was lower than the biosimilars, which ranged from $3,452 to $4,793.

“Lower healthcare spending is a goal of biosimilar introduction, but low uptake raises concerns that manufacturers may withdraw from the market or avoid developing future biosimilars,” the authors wrote.

Rome said that in 2024 the three largest pharmacy benefit managers, starting with CVS Caremark, announced deals in which they co-branded their own biosimilar version with one of the biosimilar makers and started to prefer this version on their formulary.

“Thus, biosimilar uptake has increased in 2024 (after our study) but the effects on spending and out-of-pocket costs for patients are not yet clear,” he said. “It’s hard to predict, but it seems like the PBM co-branded biosimilars are the current approach by PBMs and payers and I'd expect that to continue.”

The Humira biosimilars, with now 10 available on the market, have been seen as a crucial test of biosimilar market because Humira had the top selling prescription brand-name drug for years. Humira and its biosimilars are used to treat several immune conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis, ulcerative colitis and Crohn’s disease.

“Humira is one of the first self-administered retail pharmacy biologics to face biosimilar competition,” Rome said. “So all of the concerns we’ve seen with the roll-out of Humira biosimilars are definitely warning signs for what we might see with future biosimilars, including Stelara.”

Stelara (ustekinumab), developed by Janssen, a Johnson & Johnson company, is a high-cost drug with a list price of $13,836 for one month’s supply. It generated $10.86 billion in revenue globally in 2023 compared with $6.4 billion the previous year.

Biosimilars of Stelara are expected to be launched in 2025. So far, six biosimilars have been approved, which treat patients with plaque psoriasis and psoriatic arthritis, as well as ulcerative colitis and Crohn’s disease.

Additionally, Evernorth has already indicated that it will offer a private-label biosimilar of Stelara. The interchangeable biosimilar will be produced for Evernorth’s affiliate private-label distributor, Quallent Pharmaceuticals, and will have a price that is more than 80% lower than the list price of Stelara.

In 2023, there was lower net spending and prices on adalimumab, which was likely because of rebates from AbbVie, Humira’s manufacturer, a new analysis finds.

Introduction of Biosimilars Led to More Rebates on Humira

Why consumer price transparency for medication is so important

Why Consumer Price Transparency for Medication is So Important

Quality measures are a tool to drive healthcare toward value-based care, and in diabetes care these measures can improve diabetes management and prevent downstream conditions, such as cardiovascular disease. However, there are multiple hurdles that healthcare organizations face when implementing quality measures for diabetes care, explained Sean M. Oser, M.D., M.P.H., associate professor in the Department of Family Medicine at the University of Colorado School of Medicine, in a 

There are many differences between recommendations for quality measures and reimbursement policies for covered services from different insurers. Although Oser suggested that these all need to be streamlined, in the interim, health systems and provider organizations should have a quality improvement program or team to help understand these requirements. The team can translate the requirements down to the practice level from the health plan or health system and gather data from the electronic health record (EHR) to turn it into an actionable report.

The ability to generate reports allows providers and health systems to track measurement and performance over time to see what progress, if any, is being made. He recommends ensuring there is transparency with stakeholders so they can also follow the progress or see where improvements are lagging. “There is a ton of data that we have available now to try to improve our performance on quality measures and to target where they are not being met,” Oser said.

Advanced EHRs have the capability to generate reports and identify care gaps in real time, too. Previously, when using paper records or older EHRs, Oser would have to search through them to find the latest laboratory results to see the patient’s hemoglobin A1C level or the date of their most recent eye exam. Now, when that data is entered into the EHR, care gaps are highlighted as soon as the patient’s chart is opened during the visit.

Communication is another important aspect of filling those gaps. Patients or providers might get letters from health plans indicating that a patient who has diabetes might not be taking their statin based on claims information, but Oser doesn’t view that communication as very actionable at the practice level. What has been more successful is using care managers or nurses at the health plan to reach out to patients directly to be their personal care manager. “Actual face-to-face — or at least person to person on a telephone — communication can be a whole lot more effective than some of those letters that are received,” he said.

Another area where data has evolved for the benefit of patients with diabetes is with continuous glucose monitoring (CGM), Oser noted. “We’ve relied for a very long time on hemoglobin A1C checks, and they remain extremely useful, but they’re not always right,” he said.

CGM measures glucose levels as frequently as every minute for up to 15 minutes depending on the system, and this data provides an average glucose level. Oser noted there is a small difference between average glucose and hemoglobin A1C. In the latter, the percent of the portion of the hemoglobin molecule that has glucose attached is being measured. While this is associated with average glucose levels, “it’s not a direct correlation,” he explained.

“CGM gives us the actual average glucose, which is what we’re really looking for in the first place,” Oser said. There are many reasons why a hemoglobin A1C level may be inaccurate, such as during pregnancy, in patients with chronic kidney disease, or in patients with variants of their hemoglobin, such as in sickle cell disease.

The National Committee for Quality Assurance recently changed the name of a measure from being based on hemoglobin A1C levels to glycemic management, which allows for a measure directly derived from CGM. Higher levels are associated with diabetic retinopathy, diabetic nephropathy, chronic kidney disease and more.

Traditionally, the thought is “the lower the A1C [level], the better,” Oser said. “But as we bring glucose levels down, it stands to reason that occasionally glucose levels will drop too low, and that can be very dangerous in the short term.”

Low levels are associated with seizures and severe hypoglycemia, but CGM devices can predict low glucose before it happens and sound an alert on the device to give the patient a chance to prevent hypoglycemia. “Since an alarming amount of hypoglycemia develops without any symptoms, CGM can be a real life-changer here,” Oser said.

However, CGMs also have a tremendous amount of raw data. The hope is that in the future, more EHR systems will be able to manage that raw data and produce insights the way CGM systems currently do. Reports from this data can also show how much time is spent within certain ranges and how much time is spent above or below the target range. The CGM data also show how much variability there is in glucose data.

A patient with a hemoglobin A1C level of 6.7% may have a lot of really high and really low glucose readings that averaged out to look like they are meeting the glycemic target. However, the CGM will provide the extra information that shows the patient is “experiencing pretty dangerous swings in glucose,” he said.

“It’s really revolutionized the way I care for people with diabetes when I feel CGM is appropriate, which is not in every case, but I’ll use it often and get a lot more information,” Oser said.

Oser says he follows up with the data from the CGM by engaging patients about their own care. One way he does this is by focusing on the things going well. If the CGM report has multiple measures and one met its target, he starts with that. For example, if someone’s average glucose level is always high, but they have no low glucose levels, Oser will explain how that is a positive. “I try really hard to avoid using language that is judging or leading,” he said. “Focusing on CGM, I’ve found, always gives me something to start with and always something to align with a patient to be able to let them know that this takes work."

There are also quality measures related to diabetes self-management, education and support (DSMES), which engage patients. Diabetes relies heavily on patient self-management, which involves taking all of the medications as prescribed, because patients often have multiple prescriptions; being mindful of what, when and how they eat; and paying attention to movement and exercise. “Often, people with diabetes are on blood pressure medications that can be impacted by diet as well as by activity,” Oser said. “So, everything is really interrelated. There’s a large burden of self-management. So DSMES programs can really help patients directly in those ways.”

Oser also discussed how quality measures can be adapted to address social determinants of health, comorbidities, socioeconomic challenges, or cultural, racial and ethnic differences. Data show African American and Hispanic patients are likely to have higher hemoglobin A1C levels than White patients despite having the same average glucose level. "There is an important cultural, ethnic, racial difference there where CGM, for example, which is measuring the glucose levels and can calculate the actual average glucose level, can get rid of that disparity,” he said.

Since getting to the physician’s office can be a challenge for some people who can’t take time off work or travel the distance, the CGM can eliminate some of those barriers by sending the data to the office. However, there are access challenges with CGM,even though coverage for CGM has been increasing and its cost has been coming down. Oser recommends having a CGM that the practice owns and can provide to the patient for episodic use. “There are [Current Procedural Terminology] codes, billing codes, for the activities around that [so] it’s an office-based charge instead of the patient having to pay a copay for supplies and for continuous use,” Oser said. “It’s also a really useful way for practices to become more engaged with and eventually more comfortable with CGM.”

Sean M. Oser, M.D., M.P.H., an associate professor in the Department of Family Medicine at the University of Colorado School of Medicine, discussed diabetes management and quality measures in a Managed Healthcare Executive K-Cast video series.

Diabetes Quality Measures Have Challenges But Also Successes

Women living in rural areas experience higher rates of menopausal symptoms — such as mood changes, sleep issues sand musculoskeletal pain — compared to women in urban and suburban communities.

A new, first-of-its-kind study published in 

 found that these symptoms occur particularly during the late menopause transition and post-menopause.

Women living in rural communities tend to face more health issues than those in urban communities, such as higher rates of anxiety, depression, obesity and heart disease.

However, there is limited research on how women in rural, suburban and urban communities experience menopause differently, according to study authors.

Menopause — a natural but sometimes burdensome stage in a woman’s life — can greatly affect her health and well-being. Many women (80%) experience symptoms such as hot flashes and night sweats, which can lead to poor sleep, memory issues and depression.

Menopause Challenges Across Rural, Suburban and Urban Communities

Rural women may have a more difficult time during menopause as they are more likely to deal with challenges including higher stress, financial problems, smoking and lower levels of education.

A new, first-of-its-kind study found that these symptoms occur particularly during the late menopause transition and post-menopause.

David Levison

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