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Tuesday, May 7, 2019

CMS may overpay Medicare Advantage plans by billions: Kaiser study

Many Medicare Advantage members already spend less on care and use fewer services before they sign up for their MA plans — a fact that may be leading the government to significantly overpay MA insurers, according to a new study.
Researchers at the Kaiser Family Foundation examined spending for people who switched to MA in 2016 and found the spent $1,253, or 13%, less on average on care the year before changing insurers.
These findings challenge the long-held assumption that care management strategies deployed by MA plans are what’s keeping spending low, as these beneficiaries were already spending less to begin with, according to the study.
It also raises questions about whether the Centers for Medicare & Medicaid Services should continue to base MA payments on traditional Medicare rates since that is leading the agency to overpay those insurers.
“The results suggest that favorable self-selection into Medicare Advantage plans is occurring, even among traditional Medicare beneficiaries with similar health conditions,” the researchers wrote.
For example, if the average difference in spending applied to 10% of MA plan members — or about 1.8 million enrollees in 2016 — it accounts for $2 billion in excess spending in just one year, according to the study.
CMS is expected to pay MA plan sponsors about $250 billion this year, a number that’s expected to grow as enrollment expands. About a third of Medicare beneficiaries are in an MA plan.
The KFF study dove into spending among beneficiaries with certain chronic conditions and found similar trends for those who jumped into MA in 2016. Beneficiaries with asthma, for example, spent on average $1,410 less in 2015 than their counterparts who stayed in traditional Medicare.
Spending was on average $1,517 less among people with breast or prostate cancer who switched to MA and $1,072 less for people with diabetes, the study found.
The potential overpayments increase alongside chronic conditions, according to the study. The average potential overpayment for beneficiaries with no chronic illnesses was $226, while it was $1,629 among beneficiaries with five or more chronic conditions.
In looking for targeted areas for potential savings, this would be a good place for CMS to start, the researchers said.
“This finding suggests that potential overpayments may be largest for the Medicare Advantage plans serving the sickest beneficiaries,” they said.

Regeneron star bispecific linked to 2 deaths — which was no help for its Q1 call

One of Regeneron’s star cancer drugs in the pipeline has run into trouble, and that’s contributing to some turbulence for the share price on Tuesday.

Regeneron execs chose to disclose in their Q1 call with analysts today that their closely watched bispecific REGN1979 was linked with two deaths from cytokine release syndrome in a small study involving 30 patients.
This bispecific hunts the B cell marker CD20 as well as the CD3 component of the T cell receptor, and Regeneron cancer research chief Israel Lowy spotlighted a 100% overall response rate at ASH late last year, with 8 complete responses and 2 partials among patients with follicular lymphoma. That’s very early-stage data from a tiny trial, but Phase I is the new Phase II in cancer research, and that kind of data always attracts attention in the field — particularly when it comes from a high-profile outfit like Regeneron.
SVB Leerink’s Geoffrey Porges was on the call, and reported back:
The trial had only enrolled 30 patients. Regeneron suggested the higher CRS toxicity was likely due to a heightened immune response, and noted the CRS was also seen in conjunction with increased tumor response. While the toxicity is a preliminary setback for the combination, Regeneron believe they can individually titrate doses and tune the sequence of drugs to help control the immune activation in a manner that captures the increased antitumor activity while limiting potential CRS. Management believe this tunability of dosing and sequencing is an advantage for their therapeutic approach versus CAR-T therapies.
But don’t look for Regeneron to back off. This company doesn’t back away from anything.
From Jefferies’ Biren Amin:
An update on REGN1979 CD20xCD3 bispecific is expected at 2 EU hematology mtgs in Jun ’19, including data on higher doses, LT follow-up, and efficacy in CAR-T failures. Mgmt intends to initiate 2 PII registrational studies for ‘1979, 1st in FL by mid-’19 and 2nd in DLBCL by YE ’19. A combo study of ‘1979 w/ Libtayo anti-PD-1 in 30 advanced lymphoma pts was also started….
Regeneron shares were down 6.5% late afternoon Tuesday, but that wasn’t just about any possible jitters about its bispecific. Increased R&D costs combined with flat Eylea sales — around the same time Novartis is expected to launch its rival brolucizumab — and a reduction in cash flow from its former partner Sanofi helped drive a miss on earnings per share and revenue.

Mylan downgraded to Market Perform from Outperform at Wells Fargo

Wells Fargo analyst David Maris downgraded Mylan to Market Perform from Outperform and lowered his price target for the shares to $22 from $33.

Axcella Health IPO: What You Need To Know

Axcella Health Inc. will issue more than 3.57 million shares on the Nasdaq under ticker AXLA, according to the firm’s S-1 filing. Priced between $20 and $22, the offering represents 15.5 percent of outstanding shares and is expected to bring in about $90.4 million.
Underwriters include Goldman Sachs, JPMorgan and SVB Leerink.
The company qualifies as an emerging growth company under the U.S. JOBS Act, which exempts management from certain SEC disclosure requirements.

The Company

The 11-year-old biotech company develops therapies for dysregulated metabolism.
In 2018, three of its six candidates generated positive results in non-IND clinical studies for hepatic insufficiency and non-alcoholic fatty liver disease (NAFLD). Axcella intends to launch a Phase 2b/3 clinical trial in the back half of 2020 for its lead candidate, AXA1665, in hepatic encephalopathy.
The lab has three other candidates in pre-clinical or non-IND studies targeting pediatric NAFLD, sickle-cell disease and limb immobilization-induced acute atrophy.

The Finances

In 2018, management recorded $36.07 million in net loss against the previous year’s rate of $30.94 million. Axcella has not yet generated revenue.
By the end of last year, it had accumulated $26 million in debt and received $197.8 million in stock sales to fund operations.

Applied Therapeutics IPO: What You Need To Know

Applied Therapeutics Inc. will issue 4 million shares on the Nasdaq under ticker APLT, according to the firm’s S-1 filing. Priced between $14 and $16, the offering represents 23.5 percent of outstanding shares and is expected to bring in about $73.6 million.
The underwriters include Citigroup, Cowen and UBS.
The company qualifies as an emerging growth company under the U.S. JOBS Act, which exempts management from certain SEC disclosure requirements.

The Company

The pharmaceutical company launched in 2016 to develop therapies for conditions with a high unmet need.
Its AT-001 candidate will enter a Phase 2/3 study this year for diabetic cardiomyopathy and continue early stage trials for diabetic peripheral neuropathy and acute myocardial infarction. Management estimates about 77 million patients suffer from the primary indication, a fatal heart fibrosis with no available treatment.
Meanwhile, AT-007 will enter a Phase 1 trial in 2019 for galactosemia, and AT-003 will begin a Phase 1 trial in 2020 for diabetic retinopathy.

The Finances

In 2018, Applied Therapeutics recorded a $16.52-million net loss. The previous year saw a loss of just $4.28 million.
Applied Therapeutics has not yet generated revenue.

Invitae reports Q1 EPS (47c), consensus (48c)

Reports Q1 revenue $40.6M, consensus $47.17M.
https://thefly.com/landingPageNews.php?id=2905271

Genomic Health expects to achieve double-digit revenue growth in FY19

The company said “In the Q1 we delivered more than 17% overall revenue growth and $13.0M in profit driven by significant growth across all key product areas. Our Q1 performance was very strong, based in part on the impact of the landmark TAILORx trial results, which are continuing to drive increased Oncotype DX Breast Recurrence Score test usage both in the U.S. and globally. We expect to achieve double-digit revenue growth for the year with continued growth across key products and look forward to the national reimbursement decision in Germany for the Oncotype DX breast cancer test.”
https://thefly.com/landingPageNews.php?id=2905275