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Thursday, May 6, 2021

AHA Opposes UnitedHealth-Change Healthcare Merger; DOJ to Look Into

 Clinical laboratory information would be part of a “massive” transfer of data that may affect medical decision-making ‘to the detriment of consumers and healthcare providers’ the AHA stated in a letter to the DOJ

In yet another example of healthcare market concentration and consolidation where the big get bigger—sometimes at the expense of patients, physicians, and clinical laboratories—UnitedHealth Group (NYSE:UNH) announced in January the agreement that would enable it to acquire and merge Change Healthcare (NASDAQ:CHNG) with UnitedHealth Group’s (UHG’s) subsidiary OptumInsight. Many medical laboratories and anatomic pathology groups are clients of Change Healthcare.

Healthcare Finance reported that Nashville-based Change Healthcare “will join with OptumInsight to provide software and data analytics, technology-enabled services and research, advisory and revenue cycle management offerings, according to Optum parent company UnitedHealth Group.”

Change Healthcare says its Pathology Practice Revenue Cycle Management (RCM) services are used by more than 600 pathology and laboratory clients representing about 3,800 doctors. Perhaps this is why the American Hospital Association (AHA) has registered opposition to the proposed acquisition with the federal Department of Justice (DOJ).

In a letter to Richard Powers, JD, Acting Assistant Attorney General of the Antitrust Division at the DOJ, the AHA asked the DOJ to “conduct a thorough investigation of the proposed transaction because it threatens to reduce competition for the sale of healthcare information technology (HIT) services to hospitals and other healthcare providers, which could negatively impact consumers and healthcare providers.”

‘Substantial Antitrust Concerns’ Notes the AHA about the Merger

Optum, based in Eden Prairie, Minn., has approximately 5,000 hospitals and 300 health plans in its portfolio, according to Healthcare Finance. The health information technology and services firm offers data analytics, pharmacy care services, population health management, and more and is UHG’s fastest growing subsidiary, Modern Healthcare reported. UHG also owns UnitedHealthcare, the largest US health insurer.

When the AHA became troubled by UHG’s Optum/Change Healthcare plans, the national healthcare industry trade group asked the Antitrust Division of the DOJ to investigate the merger, noting in its letter to Powers that the merger “presents substantial antitrust concerns because the transaction agreement provides that the Parties will divest assets that generate hundreds of millions of dollars in revenue in order to obtain DOJ approval.”

In a US Securities and Exchange Commission report filed March 24, the DOJ announced it would extend its time to review the proposed acquisition, Becker’s Hospital Review reported.

Merger Could Affect Provider Reimbursement and Create Opportunity for Misuse of Patient Data

In its March 17 letter to DOJ’s Richard Powers, the AHA urged review of the proposed merger for these overarching reasons:

  • Possible loss of competition for services such as RCM and health IT services.
  • Likely repercussions from combining “massive” Optum and Change Healthcare data sets, which could be misused.

The marriage of Optum’s and Change Healthcare’s private patient data, the AHA portends, could possibly lead to altered decisions on patient care and claims processing and denials, Healthcare Finance reported.

Analysts told Healthcare Dive the merger would “consolidate Optum’s dominance in the data analytics space.”

In the AHA letter to the DOJ, Melinda Reid Hatton, JD, AHA Vice President and General Counsel, wrote, “The proposed acquisition would produce a massive consolidation of competitively sensitive healthcare data and shift such data from Change Healthcare, a neutral third party, to Optum.”

She continued, “Post-merger, Optum will have strong financial incentives to use competitive payers’ data to inform its reimbursement rates and set its competitive clinical strategy, which will reduce competition among payers and harm hospitals and other providers. 

“Optum’s proposed acquisition of Change Healthcare will reduce the competition between two similarly scaled competitors,” Hatton concluded.

Optum, Change Healthcare Say Their Goal is Better Outcomes

For their part, according to a UHG news release announcing the merger in January, Optum and Change Healthcare are intent on combining their technology and service companies for the purpose of improving “core clinical, administrative, and payment processes.”

“Optum and Change Healthcare share a vision for better health outcomes and experiences for everyone at lower cost,” an Optum spokesperson told Becker’s Hospital Review.

A UHG spokesperson told Healthcare Dive a separation of UnitedHealthcare and Optum businesses is in place.

The AHA’s letter acknowledged Optum’s inclusion of an “informational firewall,” but noted that it is not enough. “UHG has never demonstrated that firewalls are sufficiently robust to prevent sensitive and strategic information-sharing,” Hatton wrote.

The deal, which was originally expected to close in the second quarter of 2021, has a $13 billion valuation, Healthcare Dive reported. 

How Might This Affect Clinical Laboratories?

For clinical laboratories and pathology groups, the proposed merger could introduce questions about UnitedHealthcare’s access to information about how labs bill different payers other than UnitedHealthcare. 

Change Healthcare each year processes more than 87 million pathology and clinical laboratory procedures, for which it charges $4.4 billion, according to the company’s website. The services it provides are aimed at increasing clinical laboratory cash flow, patient revenue and billing, coding efficiency, and compliance, according to Change Healthcare.

Therefore, Change Healthcare—in serving labs and pathology groups—already has data about agreements on charges for tests and other prices labs have with different insurers, noted Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

“It’s only reasonable for lab leaders to be concerned—if this deal is made—about lab pricing and other information,” Michel said. “Could it be reviewed and possibly used by UnitedHealthcare to establish its own terms in its network contracts with clinical labs and pathology groups?”

Clinical laboratory leaders will want to monitor these events as DOJ receives more information and further examines the UHG Optum/Change Healthcare proposed merger. It will be interesting to see if opposition to the merger arises from other healthcare associations and professional groups.

https://www.darkdaily.com/aha-expresses-opposition-to-merger-between-unitedhealth-groups-optuminsight-and-change-healthcare-doj-agrees-to-look-into-the-13b-deal/

Cross Country Healthcare Q1 results, outlook

 Cross Country Healthcare, Inc. (the "Company") (Nasdaq: CCRN) today announced financial results for its first quarter ended March 31, 2021.

SELECTED FINANCIAL INFORMATION:

Variance

Variance

Q1 2021 vs

Q1 2021 vs

Dollars are in thousands, except per share amounts

Q1 2021

Q1 2020

Q4 2020

Revenue

$

329,241

57

%

53

%

Gross profit margin*

21.7

%

(190

)

bps

(350

)

bps

Net income attributable to common shareholders

$

19,448

1,031

%

322

%

Diluted EPS

$

0.53

$

0.59

$

0.40

Adjusted EBITDA*

$

26,733

480

%

132

%

Adjusted EBITDA margin*

8.1

%

590

bps

280

bps

Adjusted EPS*

$

0.58

$

0.59

$

0.39

Cash flows used in operations

$

(24,927

)

(245

)

%

(1,392

)

%

* Refer to accompanying tables and discussion of non-GAAP (Generally Accepted Accounting Principles) financial measures below.

"We entered the year on a very positive trajectory, with solid execution, higher productivity, and exceptional performance," said Kevin Clark, Co-founder and Chief Executive Officer for Cross Country Healthcare. He continued, "This was the single largest revenue quarter in our Company's history and was fueled by our passionate, tireless efforts to deliver the critical professionals needed across the country."

Outlook for Second Quarter 2021

The guidance below applies to management’s expectations for the second quarter of 2021.

Q2 2021 Range

Year-over-Year

Sequential

Change

Change

Revenue

$300 million - $310 million

38% - 43%

(9)% - (6)%

Gross Profit Margin*

22.0% - 22.5%

(140) bps - (90) bps

30 bps - 80 bps

Adjusted EBITDA*

$19.0 million - $21.0 million

64% - 81%

(29)% - (21)%

Adjusted EPS*

$0.37 - $0.42

$0.21 - $0.26

$(0.21) - $(0.16)


The Company will hold its quarterly conference call on Wednesday, May 5, 2021, at 5:00 P.M. Eastern Time to discuss its first quarter 2021 financial results. This call will be webcast live and can be accessed at the Company’s website at ir.crosscountryhealthcare.com or by dialing 888-566-1099 from anywhere in the U.S. or by dialing 773-799-3716 from non-U.S. locations - Passcode: Cross Country. A replay of the webcast will be available from May 5th through May 19th at the Company’s website and a replay of the conference call will be available by telephone by calling 800-510-0118 from anywhere in the U.S. or 203-369-3808 from non-U.S. locations - Passcode: 2021.

Moderna in Supply Agreement with Switzerland for Booster Vaccine

 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced a new supply agreement with the Swiss Federal Government for 7 million doses of booster vaccine in 2022, with an additional option for another 7 million doses for delivery during the second half of 2022 or first quarter of 2023. Purchase under this agreement is subject to regulatory approval of the booster vaccine candidate. Today’s announcement follows two earlier agreements between Switzerland and Moderna to supply a total of 13.5 million doses of the COVID-19 Vaccine Moderna. Swissmedic, the Swiss Agency for Therapeutic Products, authorized the COVID-19 Vaccine Moderna in Switzerland on January 12, 2021.

https://www.businesswire.com/news/home/20210506005563/en/Moderna-Announces-New-Supply-Agreement-with-Switzerland-for-7-Million-Booster-Vaccine-Doses-in-2022-and-Option-for-Additional-7-Million-Doses

Regeneron's COVID-19 therapy helps boost quarterly profit

 Regeneron Pharmaceuticals Inc reported a quarterly profit on Thursday that beat analysts' estimates, helped by a strong recovery in demand for its physician-administered eye drug Eylea as well as sales of its COVID-19 therapy.

The company's antibody cocktail, REGEN-COV, has been authorized in the U.S. for treating non-hospitalized COVID-19 patients.

With many nations reporting a resurgence in coronavirus infections and a slew of positive trial data on potential use of the antibody cocktail with a lower dose and as a preventive treatment, Regeneron is hoping to improve REGEN-COV's uptake.

On Wednesday, India granted emergency use authorization to the antibody cocktail, while Germany has said it is looking to broaden its use.

REGEN-COV posted sales of $438.8 million in the reported quarter, compared with $146 million in the fourth quarter.

Eylea sales, which took a hit last year as patients postponed visits to doctor's office due to the COVID-19 pandemic, jumped 17% to $2.17 billion.

On an adjusted basis, the company earned $9.89 per share in the first quarter, beating estimates of $9.00 per share, according to Refinitiv IBES data.

Sales rose 38% to $2.53 billion, missing estimates of $2.55 billion.

https://finance.yahoo.com/news/1-regeneron-quarterly-profit-rises-104454025.html

Orgenesis hits milestone with FDA OK of Tissue Genesis Icellator2 pilot trial

Orgenesis Inc (NASDAQ:ORGS) (FRA:45O) is poised to carry out the first-in-human trial of its Tissue Genesis Icellator2 to treat Acute Respiratory Distress Syndrome (ARDS) caused by the coronavirus (COVID-19) after receiving the go-ahead from the US Food and Drug Administration (FDA). 

The cell and gene therapies (CGTs) focused biotech described being granted the Investigational Device Exemption (IDE) approval for the pilot trial as a 'significant milestone' for the company. 

The FDA approval covers a study of 21 patients at one clinical site in the US.

The Tissue Genesis Icellator2 is a device, which can rapidly recover high yields of stromal and vascular cells (SVF) from a person's fat tissue, which can then be used therapeutically.

Published nonclinical and clinical evidence indicates that the SVF cells can potentially improve oxygenation, maintain T and B lymphocytes to support antibody production, and may induce an anti-inflammatory effect.

Orgenesis did note in the statement that the numbers of hospitalized patients in the US suffering from ARDS resulting from the virus had declined significantly in recent months. It said it will monitor current clinical needs before beginning this approved pilot trial.

"Orgenesis may consider amending its clinical development plan to target treatment of non-COVID-19 related ARDS or treatment of patients who have not recovered from prior COVID-19 infections (so called “long haulers”)," the company added.

Orgenesis' Point of Care platform is comprised of three enabling components - therapeutics, technology and network.

The company says it identifies promising new therapies and leverages its POCare Platform to provide a 'rapid, globally harmonized pathway' for these therapies to reach and treat large numbers of patients at lowered costs.

https://www.proactiveinvestors.com/companies/news/948717/orgenesis-reaches-milestone-with-us-fda-approval-of-tissue-genesis-icellator2-pilot-trial-948717.html

Merck, Eisai Get Priority Review for combo in Renal Cell, Advanced Endometrial Carcinoma

 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. The first set of applications (a supplemental Biologics License Application [sBLA] for KEYTRUDA and a supplemental New Drug Application [sNDA] for LENVIMA) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free survival (PFS), overall survival (OS) and objective response rate (ORR) data from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307). The second set of applications are for the treatment of patients with advanced endometrial carcinoma who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation, based on PFS, OS and ORR data from the pivotal Phase 3 KEYNOTE-775/Study 309 trial. These are the first applications to be submitted in the U.S. for this combination therapy based on Phase 3 clinical data. The FDA has set Prescription Drug User Fee Act (PDUFA) dates, or target action dates, of August 25 and 26, 2021, for the advanced RCC sNDA and sBLA applications, respectively, and September 3, 2021, for the advanced endometrial carcinoma applications.

“Advanced renal cell carcinoma and advanced endometrial carcinoma are aggressive cancers, and patients urgently need new treatment options that may help improve outcomes,” said Dr. Gregory Lubiniecki, Vice President, Oncology Clinical Research, Merck Research Laboratories. “We appreciate that the FDA has recognized this significant unmet need and the potential for the combination of KEYTRUDA plus LENVIMA in these patients by granting priority review for these applications.”

The applications in advanced RCC are based on results from the CLEAR study (KEYNOTE-581/Study 307), in which KEYTRUDA plus LENVIMA demonstrated statistically significant improvements in PFS, OS and ORR versus sunitinib. These data were presented in February at the virtual 2021 Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in the New England Journal of Medicine.

https://www.businesswire.com/news/home/20210506005287/en/Merck-and-Eisai-Receive-Priority-Review-From-FDA-for-KEYTRUDA%C2%AE-pembrolizumab-Plus-LENVIMA%C2%AE-lenvatinib-Applications-for-Advanced-Renal-Cell-Carcinoma-and-for-Advanced-Endometrial-Carcinoma

ICER, unconvinced by Biogen data, suggests low price for Alzheimer's med

 Clinical trial results used by Biogen to apply for U.S. approval of its experimental Alzheimer's drug aducanumab are "insufficient" to determine whether treatment would actually help patients, according to an influential nonprofit that assesses the value of new medicines.

Any benefit observed in human testing of the drug is highly uncertain, the Institute for Clinical and Economic Review said in a preliminary report released Wednesday, pushing back against several of Biogen's explanations for why two near identical late-stage studies of aducanumab had conflicting outcomes.

ICER's conclusions are another knock against the treatment, which has divided Alzheimer's researchers and doctors ever since Biogen controversially declared one of the trials a success just months after judging both unlikely to meet their goals. Aducanumab is now under review for at the Food and Drug Administration, with a decision on approval expected by June 7.

The FDA worked closely with Biogen to reinterpret the initial study findings using additional data following Biogen's March 2019 decision to discontinue both studies. But last November a panel of independent advisers to the agency overwhelmingly rejected Biogen and the FDA's case for aducanumab, creating new doubt about the result of the regulator's review.

ICER has been assessing aducanumab and its potential role in treating Alzheimer's since September, shortly before that advisory committee meeting. The group's report is not likely to factor directly in the FDA's decision, but represents a notable outside evaluation of the clinical evidence supporting aducanumab. ICER's view has become increasingly consequential among insurers, which are weighing the prospect of paying for a drug that could be used by millions of patients if approved.

"It was a really hard problem to try to figure out what happened here," said David Rind, ICER's chief medical officer, in an interview. "It's not just because the trials disagree but also the entire arc of the way the evidence was ultimately interpreted, from the early decision to stop the trials for futility to then go back and decide to look at the data again."

Biogen's main argument in favor of aducanumab centers on a theory that patients in the failed trial didn't receive enough exposure to the higher and seemingly more effective dose of the drug. In the successful study, Biogen claims, longer exposure resulted in better outcomes and a statistically significant difference between the drug and placebo.

Even then, the benefit claimed by Biogen translated to 22% less cognitive and functional decline than placebo, a relatively small effect that may not be considered clinically meaningful by all doctors.

In its report, ICER concluded that any effect from sustained exposure could not be unraveled from other factors, such as study participants who received placebo worsening over time. ICER also criticized a decision to exclude certain patients whose disease progressed rapidly from analyses that were used to explain the trials' differing results.

ICER did acknowledge Biogen's explanations are possible. But the group said "other explanations are equally or more likely." One alternative, ICER suggested in its report, "is that the differences between the trials are due to chance."

Critics, including several members of the FDA advisory committee that met last November, have emphasized this point and noted both Biogen and the regulator appear to be assuming the negative trial missed aducanumab's benefit, rather than being a true result.

"You have something that almost never happens with major randomized trials of drugs, which is a slew of analyses that weren't planned up front," said Rind. "Once you do that, you're potentially at risk that you're fishing for data."

Despite the uncertainty surrounding Biogen's data, ICER calculated the drug's cost effectiveness assuming an efficacy estimate derived from the two trials' results. Aducanumab would need to be priced between $2,500 and $8,300 per patient per year to meet ICER's thresholds for cost effectiveness, according to the group's reports. That's far less than the $50,000 per year price assumed by some analysts, which ICER noted "would not be reasonable."

ICER also calculated the cost-effective price for scenarios that assume "optimistic" and "conservative" treatment benefits. The former scenario relies only on the positive study results, in which case aducanumab could be priced between $11,100 and $23,100 and still be cost-effective. The latter assumes only patients with mild cognitive impairment benefit from treatment, reducing the cost-effective range to between $1,200 and $4,200.

Biogen has kept its plans for pricing aducanumab close, although it appears the company has decided on a number. "I think that we are there," company CEO Michel Vounatsos said on a recent earnings call.

https://www.biopharmadive.com/news/icer-biogen-aducanumab-price-alzheimers/599612/