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Friday, January 17, 2020

Analyst action, Jan. 17

Amedisys (NASDAQ:AMED) initiated with Outperform rating and $206 (14% upside) price target at Credit Suisse.
BeiGene (NASDAQ:BGNE) resumed with Overweight rating at Morgan Stanley.
Karyopharm Therapeutics (NASDAQ:KPTI) downgraded to Neutral with a $19 (1% upside) price target at Wedbush.
Syros Pharmaceuticals (NASDAQ:SYRS) downgraded to Neutral with a $9 (2% downside risk) price target at Wedbush.

Durect down premarket after split ad com vote on bupivacaine

DURECT (NASDAQ:DRRX) is down 13% premarket on light volume following yesterday’s 6-6 vote from an FDA advisory committee on bupivacaine extended-release solution for the treatment of post-surgical pain.
The company’s application is a resubmission. It received a CRL in February 2014 in response to its first filing citing the need for more safety data.

UnitedHealthcare maintains coverage of Vascepa

A representative of UnitedHealth Group Investor Relations confirmed via a direct message with the author that UnitedHealthcare’s coverage of Amarin’s (NASDAQ:AMRN) Vascepa (icosapent ethyl) will continue in 2020 with the same classification as 2019.
Shares up 1% premarket on light volume.

German drug assessment body not convinced by Bayer cancer drug Vitrakvi

Bayer’s Vitrakvi won European approval in September, the first drug in Europe to tackle tumors based on a rare genetic mutation regardless of where in the body the disease started.
Bayer has said it expected annual peak sales of more than 750 million euros ($836 million) from the drug. It needs a boost as many analysts regard the group’s drug development pipeline as too thin to make up for an expected decline in revenues from its two bestsellers from about 2024.
IQWiG – an independent authority that evaluates new drugs and plays an advisory role over what price German health services pay for them – in particular criticized the fact that the clinical trials lacked a comparative group that did not receive Vitrakvi.
EMA, for its part, has said it was swayed in favor of Vitrakvi by trials involving 102 patients that showed that the drug reduced the size of tumors in 67% of cases, and by the speed of tumor shrinkage.
Germany is the largest European pharmaceuticals market and the fourth biggest globally. Still, it has only slightly more than 10% the size of the U.S. market, where Vitrakvi was approved in late 2018.

‘List price’ for healthcare treatments in the U.S. may be misleading

The “list price” for healthcare treatments can vary wildly and may not reflect what will appear on a patient’s bill, a new study finds.
After reviewing listed prices for a particular therapy — radiation treatments for prostate cancer — researchers concluded that publicly-available price lists for cancer treatment may not help patients who want to shop around for the best deal.
Since 2019, hospitals have been required by the U.S. Centers for Medicare and Medicaid Services (CMS) to post prices online for the services they offer, in what is called a chargemaster.
“The prices we found were all over the map,” said Dr. Trevor Royce, an assistant professor of radiation oncology at the University of North Carolina at Chapel Hill and the study’s senior author. “And they were much higher than what Medicare typically pays.”
The point of making hospitals create a chargemaster was to facilitate comparison shopping and to foster competition, Royce said.
The problem with the system is that the list prices may not reflect what insurance companies are actually paying for services, Royce said. “They are not the true negotiated rates that the hospitals and insurance companies agree upon,” he explained. “Those numbers might be more meaningful, but that is not what is listed publicly because they are considered to be proprietary.”
While the CMS has tried to fix the problem by issuing a new rule that would force hospitals to post negotiated rates, that change may not be implemented any time soon, Royce said. “Several hospital groups have filed lawsuits in federal court to prevent it from becoming a reality,” he added.
To get a sense of whether the CMS rule mandating hospitals post prices would help patients, Royce and colleagues concentrated on a common treatment, radiation therapy for prostate cancer, and checked prices listed at National Cancer Institute designated cancer centers.
As reported in JAMA Oncology, of the 63 designated hospitals, 52 listed a price for the treatment the researchers were looking for. “We found prices were hard to find on websites and not at all uniform,” Royce said.
In fact, prices varied wildly, with the highest price 20 times that of the lowest: $399,056 versus $18,368. The average cost was $111,728.80, which is more than 10 times the $11,091 that Medicare pays.
The wide variation in prices didn’t surprise Amanda Starc, an associate professor of strategy at the Kellogg School of Management at Northwestern University in Chicago.
What you’ll pay generally depends on the deal your insurance company negotiated, said Starc, who wasn’t involved in the study. But there is a group of consumers for whom the numbers may have more meaning: those without insurance.
Without an insurance company to negotiate, consumers can end up with a bill for the amount shown in the chargemaster, Starc said.
As for shopping around, that’s not something everyone can do, Starc said. “If you’re looking at MRIs, you might be willing to travel a little further to get a less expensive MRI,” she added. “But that’s a little different from traveling for cancer services.”
The new study highlights the difficulty patients face trying to find out how much their care will cost, despite efforts by the CMS to make pricing more transparent, said Dr. Akila Viswanathan, interim director in the department of radiation oncology and molecular radiation sciences at Johns Hopkins Medicine in Baltimore.
“Royce and Colleagues’ article shows how much ‘mis’ informative price transparency can be for patients,” Viswanathan said in an email. “Information on price does not reflect the true cost of care, nor does it reflect the charges sent to a patient on a bill. Obtaining the true cost of care and the potential financial impact on a patient remains elusive despite price transparency.”
SOURCE: bit.ly/2uXsS5h JAMA Oncology, online January 16, 2020.

Novo Nordisk’s diabetes pill Rybelsus to be covered by Express Scripts

Novo Nordisk’s new diabetes pill, Rybelsus, will be covered by Express Scripts Holding Co, one of the largest U.S. pharmacy benefit managers, the Danish drugmaker said on Friday.

Pharmacy benefit managers act as middlemen in the drug supply chain, and negotiate discounts on drugs on behalf of health insurers.

Depending on the discounts drugmakers are willing to provide, pharmacy benefits managers make decisions about which drugs to include in coverage plans.

NMC independent committee taps FBI ex-boss Freeh in Muddy Waters fight

Private healthcare provider NMC Health, hurt by short-selling by Muddy Waters, said on Friday an independent review committee looking into the matter had hired FBI ex-boss Louis Freeh.

NMC, the United Arab Emirates’ largest private healthcare provider, launched an independent review of its finances last month after short-seller Muddy Waters questioned the value of its assets and cash balance while announcing a short position.
Since Muddy Waters’ claims were launched on Dec. 17, NMC has lost 2.4 billion pounds ($3.14 billion) of its share value, or 44%.
Its shares leapt 6.4% on Friday to 1,533 pence, leading London’s bluechip index, after news that Freeh, who probed BP oil spill claims payouts, would take charge of the investigation.
Short selling involves borrowing an asset and selling it with the aim of buying it back at a cheaper price for profit. Muddy Waters, founded by American Carson Block, is known in financial markets for declaring short equity positions on the basis of its in-house research.
Muddy Waters also questioned the value of NMC’s reported profits and debts. The short-seller also said in a research note that NMC’s asset purchase prices and capital expenditures were inflated.
NMC has called the report “false and misleading” and has defended its position.
The company suffered another setback after the attack by Muddy Waters as two major shareholders launched a discounted share sale in NMC earlier this month.
The healthcare firm’s vice-chairman Khaleefa Al Muhairi and its second-largest shareholder Saeed Al Qebaisi together sold NMC shares worth 375 million British pounds ($490.54 million) and a source told Reuters that the sale price factored in context around Muddy Waters.
FBI HEAVYWEIGHT
NMC said the independent committee has also hired Freeh’s risk management firm FGIS to look at the allegations.
“The committee chose Freeh Group to provide a completely independent, unbiased, comprehensive and transparent report that will address all of these allegations,” Jonathan Bomford, chairman of the independent review committee, said.
Freeh, who ran the Federal Bureau of Investigation from 1993 until June 2001, has handled multiple high-profile probes including possible misconduct by a lawyer involved in settlement payments to those affected by the Gulf of Mexico spill in 2010.
However, his tenure as director of the FBI also attracted criticism.
The strongest backlash of Freeh’s tenure came from the commission that investigated the Sept. 11, 2001 attacks on the World Trade Centre and the Pentagon.
The NMC committee intends to publish findings of its review before NMC reports its 2019 results.
Muddy Waters did not immediately respond to a request for comment outside U.S. business hours.