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Tuesday, December 6, 2022

Medicare Advantage Plans Losing Their Edge for Patient Outcomes

 Amid years of Medicare Advantage's growing popularity, it was increasingly harder to argue that these private plans allow for better care over traditional Medicare, investigators found.

Within the model population of acute myocardial infarction (MI) patients, enrollment in Medicare Advantage was associated with a significant albeit modest reduction in adjusted 30-day mortality rates in 2009 as seen in, for example, people with ST-segment elevation MI (STEMI; 19.1% vs 20.6%).

However, a decade later, improved survival across the board meant that mortality rates no longer favored Medicare Advantage over traditional Medicare (e.g., 17.7% vs 17.8% in STEMI for 2018), according to Bruce Landon, MD, MBA, of Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, and colleagues.

They reported in JAMA that a gap in 90-day revascularization rates had also narrowed to nonsignificance by 2018. Nevertheless, the study showed that small advantages remained for acute MI patients with Medicare Advantage in terms of:

  • Greater postdischarge prescription fills (e.g., 91.7% vs 89.0% statin prescription fills after STEMI)
  • Lower ICU admission
  • Better odds of discharge to home rather than postacute facility
  • Reduced adjusted 30-day readmission rates

"These findings, considered with other outcomes, may provide insight into differences in treatment and outcomes by Medicare insurance type," Landon and colleagues wrote.

They opted to assess the two Medicare programs using a relatively uniform population with established diagnostic criteria, and the analysis relied on a national sample of over 2.2 million acute MI patients with Medicare from 2009 to 2018.

Notably, the year 2012 saw the introduction of penalties, applied only to traditional Medicare, for high rates of acute MI readmissions under the Hospital Readmissions Reduction Program. Landon's group suggested that the growth of accountable care organizations and value-based payment in traditional Medicare since then could have factored into the convergence in care between Medicare Advantage and traditional Medicare.

Another explanation, according to the authors, could be unmeasured residual differences between patient populations that would narrow over time as opportunities for selection fall with growing enrollment in Medicare Advantage.

Medicare Advantage, also known as Part C, offers older Americans a private alternative to original Medicare. These plans can be appealing for offering lower out-of-pocket costs and coverage of additional benefits (e.g., dental and fitness) despite the downsides of a constrained network of available physicians, and care delays related to prior authorization and referral to specialists.

"How does this study fit into our greater understanding of the Medicare Advantage program? Much of the literature shows that enrollment in Medicare Advantage is associated with lower use of health care services, particularly postacute care, greater performance of recommended preventive services, and higher scores for some measures of patient experience," though "it is not clear whether these associations will persist as the program grows to represent a larger share of the overall Medicare program," according to David Meyers, PhD, MPH, and colleagues from Brown University's School of Public Health, Health Services, Policy, and Practice in Providence, Rhode Island.

"The study by Landon et al, along with research over the last decade, suggests that the association between Medicare Advantage and higher quality of care is modest at best. At the same time, extensive research suggests that Medicare Advantage plans are overpaid due to structural factors in the program design. These factors include risk-adjustment, plans' upcoding of disease severity, and inflated bonus payments for quality performance," they noted in an accompanying editorial.

Patients have also complained of deception in the aggressive sales pitches for Medicare Advantage plans.

For the retrospective cohort study, Landon and colleagues used the MedPAR files of adults, ages 66 and older, continuously enrolled in both Medicare Part A and Part B for at least 1 year prior to and following a hospitalization for acute MI. Posthospital medication use was assessed using a 20% random sample of enrollees with Part D coverage.

Across groups stratified by STEMI versus non-STEMI and Medicare type, patients were in their mid- to late-70s on average in 2018. That year, under 42% of patients were women.

Medicare Advantage patients were more frequently Black or Hispanic and had disproportionately more people with diabetes than traditional Medicare, the authors reported.

Study limitations included its reliance on coding being accurate in administrative claims and the lack of consideration of plan-level variation within Medicare Advantage.

"It is important to note that the discharge location variable in MedPAR data may be inaccurate for Medicare Advantage enrollees, the MedPAR data are not complete and may underreport readmissions, there may be differential enrollment in Part D plans between Medicare Advantage and traditional Medicare that could confound the association between Medicare Advantage enrollment and higher receipt of statins, and any reductions in spending may be offset by higher payments overall to Medicare Advantage plans," Meyers and colleagues warned.

They cited predictions that the majority of Medicare beneficiaries will be enrolled in a private Medicare Advantage plan in 2023 -- reaching nearly seven in 10 beneficiaries by 2030.

Meyers' group urged more research on how Medicare Advantage can be redesigned to reduce overpayments and deliver care of value.


Disclosures

The study was supported by a National Institute on Aging (NIA) grant.

Landon disclosed relationships with, and/or support from, CVS/Aetna, NIA, the National Cancer Institute, the Agency for Healthcare Research and Quality, Physician Performance, the Beth Israel Lahey Performance Network, and Health Resources in Action.

Meyers disclosed support from Arnold Ventures, the Robert Wood Johnson Foundation, NIA, and the National Institute on Minority Health and Health Disparities.

Illumina loses its grip

 Illumina is appealing the European Commission’s determination that its merger with Grail must be dissolved, but that appeal is looking less and less likely to succeed.

Yesterday the Commission gave Illumina concrete instructions on how to split off its subsidiary, and despite its ongoing appeal Illumina is believed to be quietly exploring various exit options for the liquid biopsy-focused group. But this will be costly, and Illumina has already taken a $3.9bn write-down on the $8bn deal.

The Commission has not yet issued a formal divestment order – that is expected early next year – but it has told Illumina what steps to take to unwind the deal in the interim. Transitional measures, with which Illumina must comply until the deal is dissolved, include keeping Grail separate and viable, with no further integration.

To complete the dissolution Illumina must restore Grail’s independence, to the same degree it had prior to the completion of the transaction. Grail must be as viable and competitive after the divestment as it was before Illumina’s acquisition; and, most importantly, the divestment must be “executable swiftly and with sufficient certainty”.

This raises questions about the capitalisation level necessary for Grail to remain a viable liquid biopsy group after leaving the Illumina fold – either Illumina will have to generously fund Grail so it can be spun out as an independent group, or a deep pocketed buyer will have to step in.

And who would buy? The liquid biopsy market already plays host to several large companies with entrenched blood tests that are – unlike Grail’s flagship Galleri product – FDA-approved. It seems unlikely that any of these would want to pay top dollar for another, similar test. Groups that do not yet play in this segment can surely find a cheaper way into it.

Cautionary tale

The companies can seek a closed-door hearing and also submit a written response before the Commission issues a final decision in early 2023.

But there will be consequences for Illumina if it fails to comply with the Commission’s demands. The Commission can impose a fine of up to 10% of the company’s annual worldwide turnover, which would, on 2021 figures, amount to around $400m.

Illumina maintains that any divestment order should be halted until its appeal of the Commission’s prohibition has been settled by the European courts. And it is separately appealing a July 2022 decision by the General Court of the European Union, disputing the Commission’s jurisdiction to challenge the Grail deal.

Separately, the Commission is investigating Illumina for jumping the gun and closing the Grail merger without European authorisation. This remains ongoing.

Almost the only hope Illumina now has is that its appeal succeeds. If the two groups are forced to split in Europe, it seems impossible that they can continue to do business as a single entity elsewhere. There are legal challenges ongoing in the US too, where the FTC is investigating this deal.

It seems all but certain that this deal is going to cost Illumina even more than the $4bn it has already paid. This could become a cautionary tale for other groups tempted to close deals without regulators’ permission.

Timeline of a contested deal
DateEvent
Jan 10, 2016Illumina spins Grail out as a separate company
Mar 1, 2017Grail raises a $900m series B round, then the largest-ever VC funding deal
Sep 9, 2020Grail says it intends to float on Nasdaq
Sep 21, 2020Illumina announces its intention to acquire Grail
Mar 30, 2021FTC challenges the deal
Jun 16, 2021European Commission begins investigation of the deal
Aug 18, 2021Illumina closes the acquisition, keeping Grail as a separate business unit
Sep 1, 2022US administrative law judge rules that the deal is not anticompetitive
Sep 2, 2022FTC appeals administrative law judge's decision
Sep 6, 2022European Commission prohibits dealIllumina says it will appeal the Commission's decision
Nov 3, 2022Illumina says it took a goodwill impairment charge of $3.9bn related to the Grail segment
Dec 5, 2022European Commission outlines steps Illumina must take to divest Grail
Expected early 2023Formal European Commission divestment order
Source: company releases; SEC filings; the FTC; the European Commission. 

https://www.evaluate.com/vantage/articles/news/deals/illumina-loses-its-grip

US intel chief: Parents ‘should be’ concerned for kids’ privacy on TikTok

 Director of National Intelligence Avril Haines is warning parents about risks to their children’s data privacy on the social media platform TikTok, which is owned by the Chinese company ByteDance.

In an interview with NBC’s Andrea Mitchell at the Reagan National Defense Forum, Haines said it is “extraordinary” how adept the Chinese government is at “collecting foreign data.”

“And their capacity to then turn around and use it, to target audiences for information campaigns but also to have it for the future to use it for a variety of means,” she said.

When Mitchell asked if parents should be worried, Haines responded, “I think you should be.”

TikTok is one of the most popular social media platforms in the U.S., with tens of millions of users.

The video-sharing app is particularly popular among younger generations, fueling concerns about data collection from Beijing.

Last month, Federal Communications Commission (FCC) member Brendan Carr called for TikTok to be banned, saying it was impossible to say with confidence that personal data was not ending up in the hands of the Chinese Communist Party.

Carr was appointed to the FCC by former President Trump, who threatened to ban the app in 2020 if ByteDance didn’t sell it to an American company.

The Biden administration is in talks with TikTok to address national security concerns without a complete restructure, according to The New York Times.

Lawmakers have also repeatedly raised concerns about TikTok. Sen. Mark Warner (D-Va.), the chairman of the Senate Intelligence Committee, called the platform an “enormous threat” last month.

Despite the warnings, TikTok continues to be one of the most downloaded apps across the world.

Haines told NBC that it was “extraordinary how open we are as a society in the amount of information we put into public venues that can be accessed.”

https://thehill.com/policy/technology/3763428-us-intelligence-chief-parents-should-be-concerned-for-kids-privacy-on-tiktok/

Edwards cut to Hold from Buy by Stifel

 Target to $75 from $95

https://finviz.com/quote.ashx?t=EW&ty=c&ta=1&p=d

Equillium, Ono in Option and Asset Purchase Agreement for Development, Commercialization of Itolizumab

 Equillium grants Ono an option to purchase rights to itolizumab

Equillium to receive an upfront payment of approximately $26.0M (¥3.5B); eligible to receive up to approximately $138.5M (¥18.7B) in option exercise and milestone payments

Ono to fund Equillium’s continued research and development of itolizumab during the exercise period

Conference call and webcast today at 8:30 a.m. ET

Management will host a conference call to discuss the option and asset purchase agreement with Ono Pharmaceutical Co., Ltd. for analysts and institutional investors, at 8:30 a.m. ET today, December 6, 2022. To access the call, please dial (888) 350-3846 or (646) 960-0251 and, if needed, provide confirmation number 8770084. A live webcast of the call will also be available on the company’s Investor Relations page at www.equilliumbio.com/investors/events-and-presentations/default.aspx. The webcast will be archived for 180 days.

https://finance.yahoo.com/news/equillium-ono-pharmaceutical-announce-exclusive-120000241.html

COVID Rapid Antigen Test Distributed By Virax Gets Emergency Use Authorization in US

 Virax Biolabs Group Limited ("Virax" or the "Company") (Nasdaq: VRAX), an innovative biotechnology company focused on the prevention, detection, and diagnosis of viral diseases, announced today that their supplier has received an Emergency Use Authorization ("EUA") from the U.S. FDA for their Over-the-Counter COVID-19 Rapid Antigen Test (the "Test"). The Tests are ready for sale in the US by Virax. Additionally, another Point of Care Rapid Antigen test to be distributed by Virax is seeking an approval with Health Canada for Canadian distribution. The Tests have been eligible for sale in markets accepting the CE Mark since 2020.   

https://www.biospace.com/article/releases/covid-19-rapid-antigen-test-distributed-by-virax-biolabs-receives-emergency-use-authorization-in-the-united-states/

F-star: Data on CD137/PD-L1 Tetravalent Bispecific Antibody, at ESMO-IO 2022 Congress

 -f-Star Therapeutics, Inc. (NASDAQ: FSTX) (“F-star” or the “Company”), a clinical-stage biopharmaceutical company pioneering bispecifics in immunotherapy so more people with cancer can live longer and improved lives, today announced new clinical data from its potentially best-in-class clinical asset FS222, a CD137/PD-L1 targeting tetravalent bispecific antibody, at the European Society of Medical Oncology Immuno-Oncology (ESMO-IO) Annual Congress which is being held from December 7 - 9, 2022, in Geneva.

FS222 targets critical tumoral immune-suppressing pathways via PD-L1 checkpoint blockade and has exhibited important costimulatory effects through potent clustering and activation of CD137, which in turn, synergistically promotes T cell activation and enhanced cytotoxic T cell responses. In preclinical models, engagement of PD-L1 and CD137 by FS222 induced T cell proliferation and cytokine production that was associated with significant tumor regression compared to the combination of CD137 and PD-L1 targeting monospecific antibodies.

https://www.biospace.com/article/releases/f-star-therapeutics-presents-clinical-data-on-fs222-a-cd137-pd-l1-tetravalent-bispecific-antibody-at-esmo-io-2022-congress/