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Our Take: 2021 in the rearview

Dec 19, 2021

Editor’s Note: Due to the upcoming holidays, Our Take will return on January 10. From all of us at Darwin Research Group, we wish you a happy holiday season and we’ll see you in 2022.

COVID-19 continued to monopolize the news, week after week, for the second year running. At this point, it’s hard to remember a time when it didn’t. And with the omicron variant poised to swiftly overtake delta as the dominant strain, it looks as though we’ll continue to read about the coronavirus awhile longer.

Still, it’s interesting to take a quick look back and see how much progress we’ve made (and lost) in the fight to end the pandemic and at the very least wrestle COVID-19 into an endemic disease.

Almost exactly a year ago, Pfizer and BioNTech received the first FDA authorization for a COVID-19 vaccine, followed a week later by Moderna. Officials were concerned about the logistics of distributing the vaccines. They also were concerned that too many people would refuse to get vaccinated.

Nonetheless, a sense of hope took hold that we might finally be turning the corner, and some semblance of life as we knew it way back in 2019 could return.

With help from the Department of Defense, FEMA, and countless individuals throughout the country, the federal government and the vaccine manufacturers rolled out the vaccines with remarkable speed. By mid-April, they were available to all adults, including Johnson & Johnson (J&J)’s single-dose vaccine, which had been authorized in late February.

(Eli Lilly’s antibody cocktail, a combination of the monoclonal antibodies bamlanivimab and etesevimab, had also been authorized in February, giving physicians another treatment that might stave off the most serious effects of the disease.)

Millions of people waited in long lines to get their first shot of a vaccine. A few weeks later, most of them waited in line again to get their second shot. The ranks of the newly vaccinated swelled. Then, the numbers began to slow and eventually leveled off.

Meanwhile, concerns had cropped up in other countries regarding AstraZeneca’s vaccine after more than 200 recipients developed severe blood clots that, in some cases, were fatal.

By April, public health officials in the U.S. were having similar concerns about J&J’s vaccine. Although only six cases of severe blood clots had been reported, the FDA and the CDC recommended pausing use of the vaccine while they investigated the cases. After finding that the benefits of the vaccine outweighed the risk, the agencies recommended resuming vaccinations 10 days later.

As of early July, the delta variant, first identified in India, had become the dominant strain of the coronavirus in the U.S. What many had hoped would be a summer of long-awaited reunions was instead rapidly evolving into another surge that threatened to overwhelm hospitals and health systems yet again — particularly in areas with low vaccination rates.

In an effort to stem the spread of the virus, health systems started instituting employee vaccine mandates, and the Biden administration shifted its strategy for getting people vaccinated, closing down the mass vaccination sites and focusing instead on neighborhood outreach efforts.

With the increase in delta cases — and mandates — vaccination rates began to climb again.

In August, the FDA authorized a third shot of both mRNA vaccines for immunocompromised individuals. The agency also granted full approval to Pfizer-BioNTech’s vaccine, dubbed Comirnaty. And it authorized Regeneron’s monoclonal antibody treatment REGEN-COV for use as post-exposure prophylaxis for COVID-19 in certain settings.

That same month, as Moderna completed the rolling BLA submission for full approval of its vaccine, the FDA and the CDC were investigating reports of a possible association between the Moderna vaccine and an increased risk of myocarditis in young people.

In September, with just 53% of Americans fully vaccinated, President Biden announced a new plan to reduce the spread of the virus. His plan included an emergency rule developed by the Department of Labor, as well as executive orders, that would mandate vaccinations for large swaths of the population. Two months later, when CMS and OSHA issued emergency regulations to set those mandates in motion, the pushback was immediate.

The various mandate-related lawsuits are still working their way through the legal system. As of this writing, a federal appeals court had just decided that the mandate for large private employers could proceed. The Supreme Court will most likely decide that case.

The FDA began authorizing booster doses for certain groups of people in September, starting with Pfizer-BioNTech’s vaccine. By November, the agency had authorized boosters for all three authorized vaccines and had expanded eligibility to include all adults. In October, the Pfizer-BioNTech vaccine was authorized for children ages 5 through 11.

By October, Merck and Ridgeback Biotherapeutics had their sights set on becoming the first to receive authorization for a COVID-19 pill. Interim trial results for their oral antiviral, molnupiravir, were impressive enough that an independent data monitoring committee recommended halting enrollment. A month later, the companies did receive authorization — in the U.K. It’s likely that the FDA will soon follow suit, since an advisory panel voted 13-10 to recommend authorization at the end of last month.

It looks like the U.K. — and probably the FDA as well — will also authorize Pfizer’s oral COVID-19 treatment, Paxlovid, in the days ahead. Interim trial results showed that Paxlovid reduced the risk of hospitalization or death by 89%. Based on recent laboratory experiments, Pfizer believes the drug will be effective against the omicron variant.

Wrapping up the coronavirus news, the FDA just recently authorized the use of AstraZeneca’s Evusheld in individuals who are at least 12 years old and meet certain other criteria, making it the first treatment to be authorized as a pre-exposure prophylaxis for COVID-19.

The vaccine mandates weren’t the only topic of controversy in health care news this year. The FDA’s accelerated approval of Biogen’s Aduhelm (aducanumab-avwa) in June kicked up quite a bit of dust, too.

And it wasn’t because the drug was the first new treatment to be approved for Alzheimer’s disease since 2003.

Rather, it was the lack of compelling clinical evidence to support the drug’s approval that generated all the buzz.

Even the FDA’s own advisory panel was decidedly against recommending the drug for approval. Not only did panel members cite the lack of evidence that Aduhelm can effectively treat Alzheimer’s disease. They also voiced concerns that the drug might cause harmful side effects, including amyloid-related imaging abnormalities, or ARIA, which most often presents as temporary swelling in the brain.

Several panel members resigned from the panel after the FDA approved the drug.

Biogen also raised some eyebrows when it set Aduhelm’s list price at $56,000 for a year of treatment. Based on the available clinical evidence, ICER said a fair price for the drug would be in the range of $2,500 to $8,300 a year.

With analysts estimating that 96% of Aduhelm’s market would be Medicare beneficiaries, the drug could easily cost Medicare many billions of dollars each year. CMS began an analysis in July to determine whether Medicare should have a universal coverage policy for Aduhelm, but the decision isn’t expected until next spring.

Initially, the FDA broadly approved the drug for patients with Alzheimer’s disease. Within weeks, the agency updated the label, limiting the use of Aduhelm to patients with early-stage disease.

Around the same time, a House committee started looking into both the FDA’s approval of the drug and Biogen’s pricing strategy. Dr. Janet Woodcock, acting chief of the FDA, also asked the Office of Inspector General to conduct an independent investigation of the drug’s approval — presumably to show that Biogen hadn’t influenced the FDA.

A number of the largest health systems and insurers said at first that they would wait for more clinical data to become available before making any decisions on the drug. Eventually, several insurers said they would not cover Aduhelm because it wasn’t considered medically necessary.

In November, when CMS announced a 15% increase in Medicare Part B premiums for 2022 — the largest in Medicare’s history, in terms of dollar amount — the agency attributed about half of the increase to contingency planning in case Medicare ends up covering Aduhelm.

Also in November, a 75-year-old woman died of ARIA while being treated with Aduhelm. Both the FDA and Biogen are investigating her death to determine if the drug was responsible.

Another big story occurred right at the start of the year, when Haven suddenly, and without any fanfare, called it quits.

Haven was the nonprofit joint venture that Amazon, Berkshire Hathaway, and JPMorgan Chase (Chase) launched in early 2018 with the mission of providing their 1.2 million U.S. employees with simplified health care at a reasonable cost.

In early January, CNBC first reported that Haven was disbanding. The company quietly posted a statement on its website saying it would end its independent operations at the end of February.

No specific reason was given, though there was plenty of speculation. It seems that while Haven arrived with a bang, it left without so much as a whimper.

Amazon didn’t waste any time mourning Haven’s demise. Of Haven’s three original founding companies, it appears that Amazon probably gained the most from any insights the venture may have yielded.

In mid-March, the online retailer announced the expansion of its virtual health service, Amazon Care, not only to all of its employees but also to other companies. Amazon had begun a pilot of the on-demand urged and primary care service for its own employees in the Seattle area just 18 months earlier.

Amazon Pharmacy, which Amazon launched a little over a year ago after buying PillPack in mid-2018, added two new features last May: the Amazon Prime prescription savings benefit, which Prime members can use to save on generic and brand-name drugs when paying without insurance, and another feature that lets customers with an Amazon Pharmacy account view their expected copay for medications.

Chase apparently took a few notes during the Haven days, too. The firm announced in May that it was launching Morgan Health, with the goal of improving “the quality, efficiency, and equity of employer-sponsored health care.”

According to Chase, Morgan Health would start by improving costs and the health care experience for Chase’s U.S. employees, The ultimate goal, however, is for Morgan Health to serve as a model for other employers.

Both Amazon and Chase seem to be attempting to do on their own what they didn’t achieve through Haven.

As for Berkshire Hathaway, CEO Warren Buffet said during last year’s annual shareholder meeting, “We found inefficiencies, and … we saved more than the other two partners because they knew their situation better. We found dumb things we were doing. So we got our money’s worth.”

Other notable stories in 2021

More than a dozen of the country’s largest health systems launched Truveta in February, with the goal of building a new data platform that uses artificial intelligence and machine learning, along with de-identified patient data, to “democratize care and advance health for all.” Last month, with 20 health systems now collaborating on the project, Truveta launched its clinical platform by sharing insights focused on breakthrough cases of COVID-19.

In February, Intermountain Healthcare, Presbyterian Healthcare Services, and SSM Health launched Graphite Health, a nonprofit, member-led enterprise with a focus on “health care interoperability challenges.” The new company is creating a standardized, interoperable data platform and app marketplace to facilitate the distribution of digital health solutions for its member health systems.

Humana became the sole owner of Kindred at Home by acquiring the remaining 60% interest from two private equity firms for $5.7 billion. After Kindred at Home’s home health business is integrated into Humana’s Home Solutions business, Humana said Kindred at Home would be called CenterWell Home Health.

The U.S. Supreme Court upheld the Affordable Care Act for the third time, by a vote of 7-2.

Startup Honor Technologies acquired Home Instead, a 27-year-old home care services provider with 1,200 franchises in the U.S. and service locations in 14 other countries. The combined entity represents more than $2.1 billion in home care services.

Walgreens is investing almost $1 billion in Shields Health Solutions, a specialty pharmacy services provider that partners with more than 70 hospitals and health systems. The transaction is expected to be completed in February, giving Walgreens an approximate 71% ownership stake.

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