Infant mortality rises in U.S. – how employers can help improve maternal outcomes

U.S. infant mortality rises

The Centers for Disease Control and Prevention (CDC) released preliminary data in November showing that infant mortality rose 3% to 5.6 infants per 1000 live births in 2022. This is in contrast to most developed countries, where infant mortality is three or fewer per 1000 live births.

The March of Dimes’ recent annual report on preterm births showed that they remained unchanged in 2022 (10.4% of all births, compared to 10.5% in 2021). Preterm birth was 1.5 times higher among Black deliveries compared to white births. Factors that the March of Dimes highlighted as risks include:

• Smoking (4.6% of births)
• Hypertension (2.9%)
• Obesity (34.3%)
• Diabetes (1.2%)
• Multiple births (3.2%)
• Previous preterm deliveries (3.9%)

The report points out that maternal mortality in the U.S. has risen from 17.4 deaths per 100,000 births (2018) to 32.9 deaths per 100,000 births (2021). Even though we spend $19,000 per delivery in the U.S., those giving birth today are more likely to die in childbirth than their mothers were.

Implications for employers:

• Employers can help improve maternal outcomes through:
  • Designing benefits to include affordable out-of-pocket costs, access to midwives and doulas, parental leave, and appropriate access to mental health services
  • Requiring that medical carriers provide timely, accurate information to members and employers about provider quality and outcomes
  • Advocating for value-based payment so that hospitals don't make higher margins from Cesarean section deliveries

Here’s an article we published earlier this year in Harvard Business Review offering guidance on what employers can do to make childbirth safer.

At-home testing can empower patients and improve outcomes

At-home testing has changed healthcare. First with pregnancy tests in 1976, and then with COVID-19 in 2021. Both eliminated the need to go to a medical provider.

At-home testing can give quicker answers, help reduce strain on the medical and pharmacy system and enable earlier diagnosis.

The world of at-home tests continues to expand. Here are promising new tests coming to market:

1. HIV testing
   • Home HIV tests can be done in less than 30 minutes at home or can be mailed to a lab. Offering testing in private can help us reach the U.S. goal of a 90% decrease in new HIV infections by 2030. Also, at-home tests can help prevent secondary infections.
   • Home testing can help monitor those on Pre-exposure Prophylaxis (PrEP), who should be tested for HIV every three months.
2. Other sexually transmitted infections (STIs)
   • The Food and Drug Administration (FDA) just approved an at-home urine or swab to test for the two most common sexually transmitted diseases: chlamydia and gonorrhea. Results take a few days because the test is mailed to a lab. Hopefully, the next generation of tests will give results at home.
   • Those who were exposed to STIs or have symptoms should see a provider promptly and treated regardless of the results of tests.
3. Home HPV (human papillomavirus) tests
   • This is not yet FDA approved for cervical cancer screening, but HPV tests are gradually replacing traditional pap smears for this purpose.
4. Home screening tests for colorectal cancer
   • Fecal immunochemical tests (FIT tests) are effective at screening for colorectal cancer and are recommended by the U.S. Preventive Services Task Force as an alternative to colonoscopies for those between ages 45 and 75. Patients should do them annually. They require no colon prep and are less expensive than other methods of screening for colon cancer, including colonoscopy, CT colonography and Cologuard tests.
   • As with all at-home tests, inadequate samples require retesting.
5. Upper respiratory disease
   • Provider offices currently offer testing for strep throat, influenza, respiratory syncytial virus (RSV) and COVID-19. They are now available for purchase online, although are sometimes only available in large quantities.

Implications for employers:

• At-home tests could help empower patients and enable earlier diagnoses for infectious diseases.
• Although out-of-pocket costs of at-home tests are often less than the cost of an office visit, most insurance plans won't provide coverage for them. Many health plan members will choose to self-pay for these.
• Employees can check with their flexible spending account (FSA) or health savings account (HSA) administrators to understand if these over the counter (OTC) tests are reimbursable.
• FIT tests are a promising way to increase screening rates for colorectal cancer.

GLP-1 medications are not likely to lower long-term medical costs

Early research shows glucagon-like peptide-1 (GLP-1) drugs will prevent heart attacks and strokes, delay progression of renal failure and progression to diabetes. These drugs, which include Ozempic, Rybelus, Zepbound and Wegovy, also cause weight loss. Many believe that if more people take them, we will see medical savings.

A pharmaceutical executive recently told the Financial Times that his company would be “flexible” in its pricing so more people would benefit from medications to treat obesity. Then, he suggested that his company would seek payment methods to “make it possible to adopt medicines upfront, [and] see the benefits and pay down the road.”

Even if the drugs were sold for far less than their current net prices, we are unlikely to see “net” medical savings from GLP-1 medications.

In fairness, there's little within medical care delivery, besides childhood vaccinations and birth control that lowers medical costs. In general, we are happy to pay for medical services that are cost-effective rather than cost-saving.

The Institute for Clinical and Economic Review (ICER) found last year that the medical costs of GLP-1 drugs over a lifetime would be $274,4000, while the medical costs saved would be $61,600. ICER has discounted future savings and future drug costs to account for the time value of money. But it didn't account for the fact that most of the savings from these medications will occur when people are on Medicare.

There are other studies of the cost effectiveness of GLP-1 medications. These are generally simulations, as the drugs haven’t been in widespread use long enough to see the “real world” impact on medical costs over years and decades.

• The SELECT study showing that GLP-1s decreased major adverse cardiac events required treating 100 people for three years to prevent 1.5 events. The cost of treating 100 people with GLP-1s for three years (after rebates and discounts) is about $2.7 million. Major adverse cardiac events are unlikely to cost enough each for the medical claims cost savings.
• An industry-funded simulation showed that 100,000 people treated for five years with a loss of 15% of body weight would lead to $85 million in lower medical spending. But the cost of the drugs would be about $900 million annually. So, cost savings is less than two cents per dollar spent on the medications.
• Researchers at University of Southern California built a microsimulation model that included all societal benefits, which were strongly influenced by $150,000 per quality-adjusted life year saved. In other words, there were no savings in the medical budget itself.
• A 2020 study found the drugs to be cost-effective, but not cost saving. The total estimated societal benefit of about $1.9 trillion to $2.5 trillion was about 10 times higher than total obesity-related medical expenses ($147 billion to $210 billion).

Implications for employers:

• Alternative payment models for anti-obesity medications could be key to making these medications affordable to a wider group of plan members who could see an improved quality of life.
• These alternative models could include subscriptions or deeper discounts in exchange for market exclusivity or increased access.
• Employers should be cautious about reimbursement models that would require back-loaded payments in exchange for drug effectiveness, as employers will likely not see enough medical savings to fund these payments.

Chantell Sell, PharmD, and I recently published an article about employer options given soaring costs of these medications in Human Resources Executive.

FDA challenges pharmaceutical patents

The Food and Drug Administration (FDA) has announced that it will challenge a series of drug company patents in a case that could lead to substantial savings for employer health plans.

Brand-name manufacturers are granted patents for new drugs, giving them market exclusivity, enabling them to charge high prices and reap large margins for a limited time. This exclusivity encourages investment in research on new drugs and helps boost innovation. However, pharmaceutical companies often claim a “thicket” of patents on their brand-name drugs, giving them a monopoly to sell their drugs for decades beyond their original patents. This is a special problem with delivery devices, like inhalers or pens for self-injection, where patents on elements of the medication other than a drug itself stymie generic competition.

Current regulations prohibit the FDA from approving a generic drug for 30 months if a brand-name company sues for patent infringement. Delisting patents could speed FDA approval of generics. Among the drugs where patents are being challenged are EpiPen (for allergic reactions), Restasis (for dry eyes) and many brand-name inhalers for lung disease, including Ventolin, Pro-Air, QVar, Symbicort, Atrovent and Spiriva.

Extending patent protection can lead to substantial extra profits for drug companies and dramatically increase costs for purchasers. For instance, Humira (an anti-inflammatory drug) had average revenue of $3.3 billion a year until its primary patent expired in 2016, and averaged revenue of $14.6 billion each year during its patent extension period from 2016 to 2023.

The U.S. has the highest brand-name drug prices in the world, but the lowest generic prices. This increases the importance of challenging patent extensions that delay availability of generics.

Implications for employers:

• This FDA action to challenge expired patents could eventually lead to billions of dollars in savings.
• Price relief from this effort won't be immediate, as it will take some time for these patent challenges to wind their way through the legal system.
• Stricter scrutiny of secondary patents coupled with Medicare price negotiations for high-cost drugs without competition could encourage pharmaceutical companies to spend more resources on new drug development and fewer resources on maximizing revenue from drugs close to the end of their patents.

Author

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Jeff Levin-Scherz, MD, MBA

Managing Director and Population Health Leader

Jeff is an internal medicine physician and has led WTW’s clinical response to COVID-19 and other health-related topics. He has served in leadership roles in provider organizations and a health plan and is an Assistant Professor at Harvard Chan School of Public Health.

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