eHealth: Medicare Advantage premiums drop 33% during latest enrollment period

Medicare Advantage (MA) and Part D applications were up 87% during the open enrollment period between January and March compared to the same period last year, according to a new report from eHealth.

The report looks at the costs and reactions from enrollees of Medicare’s latest open enrollment period. During the first three months of this year, the average MA premium dropped 33% from $12 to $8 from 2018, and average out-of-pocket limits decreased 11%. The average monthly premium for Part D coverage decreased during this time as well from $26 to $25.

Chris Hakim, senior vice president and general manager of Medicare for eHealth, said the company has been tracking the downward trend on average MA premiums for some time. It was noted in eHealth’s previous report at the year-end annual enrollment period as well.

“This may be a sign of strong competition and increased efficiency in the Medicare Advantage market,” Hakim told FierceHealthcare.

More than half of respondents (53%) used open enrollment as an opportunity to switch from one MA plan with prescription drug coverage to another plan also with drug coverage.

During the time period, average deductibles for MA plans with prescription drug coverage decreased from $151 to $132, but deductibles for Part D plans increased from $292 to $308.

Currently, a person enrolled in an MA plan can leave the plan and return to original Medicare or join another Advantage plan during open enrollment. Prior to 2018, enrollees could not switch to a different MA plan during those months. Now that midyear options for enrollment are available, Hakim notes that there are several factors that might lead to more plan swapping among MA enrollees.

For example, Hakim notes that a lot of baby boomers are aging into Medicare, and this group is tech-savvy, careful with money and increasingly comfortable comparing options and enrolling online.

“The combination of more Medicare Advantage plans coming into the market and increased competition, increased transparency in cost and coverage, plus a more informed and tech-savvy buyer, there’s plenty of reason to think this is a trend that will continue,” he said.

Still, half of the respondents of this study had not previously been aware of the new open enrollment period before reviewing coverage options, and 38% learned about it only after contacting an agent or broker. In addition, 31% learned about it from a news source.

Hakim was surprised that half of the respondents who bought new coverage had visited Medicare.gov first but didn’t enroll there, and those that bought from eHealth instead noted they wanted help from a licensed agent. So how did consumers react to this year’s open enrollment period?

Respondents changed plans due to dissatisfaction with old insurers (22%), dissatisfaction with copays (15%) or because a preferred doctor was no longer in-network (12%).

“I think our report, combined with regulatory changes and encouragement from the federal government, suggests we’ll continue to see an expansion of Medicare Advantage plans in the market and increased enrollment by Medicare beneficiaries,” Hakim added. “With increased competition, we may continue to see decreasing average premiums. A big factor in those decreasing premiums is the popularity of $0 premium Medicare Advantage plans.

“While Medicare Advantage plans may not be the best match for everyone in every situation (some people prefer original Medicare with a Medicare Supplement plan), they work for a lot of people, and it’s no mystery why they’re so attractive,” he said.

https://www.fiercehealthcare.com/payer/ehealth-medicare-advantage-premiums-drop-33-during-latest-enrollment-period

Turning Point makes push to outdo Pfizer, Roche in targeted cancer therapy

• Turning Point Therapeutics, a San Diego-based biotech six weeks from its public market debut, unveiled fresh clinical results Friday that keep it on track to challenge Pfizer, Roche, and Eli Lilly in the fast-moving field of targeted cancer therapies.
• Expanded data from an early Phase 1/2 trial showed treatment with repotrectinib, Turning Point’s experimental tyrosine kinase inhibitor, caused tumors to shrink in nine of 11 lung cancer patients never treated with similar drugs, and seven of 22 previously treated.
• That latter group of patients is particularly important for the biotech. Drugs like Pfizer’s Xalkori are commonly used as initial treatment for people diagnosed with a type of non-small lung cancer driven by a mutation known as ROS1. Treatment resistance can develop for some, however, after which options are limited.

Turning Point raised nearly $200 million from an initial public offering last month, capitalizing on widespread enthusiasm for targeted cancer therapies.

Founded in 2013, the biotech aims to replicate the success of companies like Loxo Oncology and Ignyta, the targets of recent buyouts by Eli Lilly and Roche, respectively.

Both Loxo and Ignyta drew attention with drugs designed to home in on tumors spurred to grow by rare genetic mutations, posting encouraging data that lured their eventual pharma buyers. In the case of Loxo, positive results for patients with solid tumors harboring abnormal fusions of a gene called NTRK to other strips of DNA led to the approval of Vitrakvi (larotrectinib). Bayer acquired rights to Vitrakvi before Lilly’s acquisition.

Turning Point believes it can outdo its targeted cancer peers with repotrectinib, which it’s developing for NTRK positive as well as ROS1 positive cancers.

Friday’s data, which will be presented at the annual meeting of the American Society of Clinical Oncology, is the first look at repotrectinib that new investors in Turning Point have had since October.

Results among patients never treated with tyrosine kinase inhibitors, or TKIs, are from just 11 patients. But the response rates to repotrectinib appear on par at this early stage with those for Xalkori (crizotinib) and entrectinib in ROS1 positive lung cancer.

Notably, repotrectinib also looks active in individuals already treated with TKIs. A 2017 study of lung cancer patients given Xalkori found more than half of tumor specimens studied had developed resistance, mutating in response to treatment.

One type of genetic alteration, known as solvent front mutations, are particularly problematic for most of the TKIs approved or in development due to the way the drugs bind to the targeted kinase. According to Turning Point, repotrectinib’s design allows the drug to sidestep this type of resistance mutation, potentially making the drug a better candidate for patients who no longer respond to Xalkori or similar therapies.

The company’s claim is bolstered by having J. Jean Cui as founder and chief scientific officer. Cui worked for Pfizer from 2003 to 2013 and is described in Turning Point’s prospectus as an inventor for Xalkori and the pharma’s more recently approved lung cancer drug Lorbrena (lorlatinib).

Results presented Friday showed 32% of TKI-pretreated patients responded to repotrectinib, a rate that rose to 55% when only counting those patients who received what Turning Point sees as its therapeutic dose. In five study participants who tested positive for one of the more common resistance mutations, two experienced confirmed partial responses.

It’s worth noting, however, that none of the four patients previously treated with two or more TKIs responded.

Athena Countouriotis, Turning Point’s CEO, said the data give her confidence repotrectinib can stand out from its rivals.

“Patients will get tested and if they have solvent front mutations, I don’t believe physicians will give anything else other than repotrectinib,” Countouriotis said in an interview with BioPharma Dive.

Investors, however, didn’t appear as convinced. Shares in Turning Point fell by more than 15% Friday morning, bringing the company’s market value close to dropping below $1 billion.

Turning Point plans to start the Phase 2 portion of its study later this year, with plans to enroll up to 190 patients with ROS1 positive non-small cell lung cancer. Patients will be divided into three cohorts: those TKI-naive, those pretreated with 1 prior ROS1 TKI and those with 2 previous lines of ROS1 TKI therapy.

While repotrectinib’s activity in pretreated patients may give it a competitive edge, Countouriotis says the company’s plan is to go after both patient populations.

“The Phase 2 design accommodates multiple paths to approval,” she said.

The Food and Drug Administration has proved willing to consider accelerated approval for targeted drugs that show clear activity against genetically defined cancer types — although some are now wondering whether the bar has been set too low.

Vitrakvi, for example, was conditionally approved on strong response rate data from 55 patients. Turning Point could feasibly pursue a similar route to market.

Even if repotrectinib is approved, though, Turning Point will compete with much larger rivals. Pfizer earned more than $500 million from sales of Xalkori last year and is studying Lorbrena in ROS1 positive tumors. Roche expects a decision from the FDA on entrectinib by August and Lilly is advancing a successor to Vitrakvi in TRK positive cancer, another target of Turning Point’s.

Such powerful competitors are notable given the small number of patients involved. Turning Point estimates between 2% and 3% of patients with advanced non-small cell cancer have tumors positive for ROS1. Estimates by the investment bank Leerink put the second-line population at 1,900.

Investors may see an opportunity for Turning Point to be acquired as Loxo and Ignyta were before it.  For now, though, Turning Point thinks it can take on the challenge solo. “Our intention is to take repotrectinib all the way,” said Countouriotis.

https://www.biopharmadive.com/news/asco-19-turning-point-makes-push-to-outdo-pfizer-roche-in-targeted-cancer-therapy/555882/

Heritage charged in fed generic price fixing case

Heritage Pharmaceuticals Inc., a generic pharmaceutical company headquartered in Eatontown, New Jersey, was charged for conspiring with its competitors to fix prices, rig bids, and allocate customers, the Department of Justice announced today.

According to a one-count felony charge filed yesterday in the United States District Court for the Eastern District of Pennsylvania in Philadelphia, from about April 2014 until at least December 2015, Heritage participated in a criminal antitrust conspiracy with other companies and individuals engaged in the production and sale of generic pharmaceuticals, a purpose of which was to fix prices, rig bids, and allocate customers for glyburide, a medicine used to treat diabetes.  This charge is the third in the Department of Justice’s Antitrust Division’s ongoing investigation; Heritage’s former CEO and its former president were previously charged.

The Antitrust Division also announced a deferred prosecution agreement resolving the charge, under which Heritage admits that it conspired to fix prices, rig bids, and allocate customers for glyburide.  Under the agreement’s terms, Heritage will pay a $225,000 criminal penalty and cooperate fully with the ongoing criminal investigation.  The United States will defer prosecuting Heritage for a period of three years to allow the company to comply with the agreement’s terms.  The agreement will not be final until accepted by the court.

The Antitrust Division entered into the deferred prosecution agreement with Heritage based on the individual facts and circumstances of this case.  Among those facts and circumstances, the agreement specifically identifies the company’s substantial and ongoing cooperation with the investigation to date, including its disclosure of information regarding criminal antitrust violations involving drugs other than those identified in the criminal charge and the agreement.  According to the agreement, this cooperation has allowed the United States to advance its investigation into criminal antitrust conspiracies among other manufacturers of generic pharmaceuticals.  Other facts and circumstances identified in the agreement include: Heritage has agreed to resolve all civil claims relating to federal health care programs arising from its conduct; and a conviction (including a guilty plea) would likely result in the Office of the Inspector General of the Department of Health and Human Services imposing mandatory exclusion of Heritage from all federal health care programs under 42 U.S.C. § 1320a-7 for a period of at least five years, which would result in substantial consequences, including to American consumers.  The agreement can ensure that integrity has been restored to Heritage’s operations and preserve its financial viability while preserving the United States’ ability to prosecute it should material breaches occur.

In a separate civil resolution, Heritage has agreed to pay $7.1 million to resolve allegations under the False Claims Act related to the price-fixing conspiracy.  The government alleged that between 2012 and 2015, Heritage paid and received remuneration through arrangements on price, supply, and allocation of customers with other pharmaceutical manufacturers for certain generic drugs in violation of the Anti-Kickback Statute, and that its sale of such drugs resulted in claims submitted to or purchases by federal healthcare programs.  The drugs allegedly implicated in this scheme address a wide variety of health conditions, and include hydralazine, used to treat high blood pressure, theophylline, used to treat asthma and other respiratory problems, and glyburide.

https://www.justice.gov/opa/pr/pharmaceutical-company-admits-price-fixing-violation-antitrust-law-resolves-related-false

China's Fosun Slows Down Investment in U.S. Biotech Sector Due to Trade Issues

Continued Sino-American trade relation concerns are forcing one company to rethink its investment opportunities in the United States.
Kevin Xie, a spokesperson for China-based Fosun International, told Bloomberg that the conglomerate plans to limit its investments in U.S.-based biotech companies to “small stakes.” The cautious investment plan is a response to the increased scrutiny of Chinese investments in U.S. pharma and biotech by the federal government. Washington has been increasingly focused on Chinese investment in the United States, particularly in the areas involving intellectual property and biotech. Earlier this year, Congress almost unanimously passed an updated version of the review powers of the Committee on Foreign Investment in the United States. That review power though has raised concerns in companies like Fosun, particularly after the White House ordered the Chinese majority owner of Massachusetts-based healthcare company PatientsLikeMe to sell his stake, as well as the more recent issues with Chinese tech company Huawei Technologies.
“Trade friction has impacted our investments in the U.S., but not to the extent of stopping all deals," Xie told Bloomberg. “Companies in the U.S. still welcome investments and are willing to work with us, so we are making some changes in the wiggle room allowed under the law.”

As Bloomberg notes, Chinese investment in the U.S. pharmaceutical industry has been significant in recent years. Last year, China invested $2.8 billion in U.S. health care companies, a big jump from the $702.9 million in 2017, Bloomberg said. Some of the deals from 2018 include a team-up between BeiGene and SpringWorks Therapeutics to develop therapeutics that will target advanced solid tumors that contain RAS mutations, as well as other MAPK aberrations. Also last year, WuXi’s subsidiary Shanghai SynTheAll Pharmaceutical Co., Ltd., a contract development and manufacturing organization, secured a physical toehold in the United States, opening an operation site in San Diego that will provide process research and development as well as API manufacturing services for early phase clinical studies. WuXi also previously formed a partnership with Seattle-based Juno Therapeutics to develop treatments for cancer with the formation of a new Chinese company called JW Biotechnology Co., Ltd. The new Chinese company’s mission will be to build a cell therapy company in China.
China’s increased focus on investing in health care and becoming a global leader in the field has become a concern for Washington, particularly related to issues of intellectual property and patient data. Typically, the power of CFIUS has come into play when deals are involving billions of dollars, but as more Chinese money flows into the U.S. sector, the government is using the program more and more to scrutinize even the smallest of deals.

A 2017 report issued by the FBI noted that that intellectual-property theft by China costs the U.S. as much as $600 billion annually. Last year, two Chinese scientists pled guilty to stealing intellectual property from GlaxoSmithKline. Those trade secrets were going to be part of the foundation for setting up a company in China called Renopharma. Even researchers at vaunted colleges and cancer centers have come under scrutiny over funding from China or concerns of espionage. Emory University terminated some employees over funding from China the college said was not disclosed, while MD Anderson dismissed three ethnically Chinese scientistswho have been associated with espionage conducted by the government of China following an investigation conducted by the National Institutes of Health.

https://www.biospace.com/article/chinese-company-slows-down-investment-in-u-s-biotech-sector-due-to-trade-issues/

J&J: Will appeal $300 million punitive damages ordered in NY talc suit

Johnson & Johnson was ordered Friday to pay $300 million in punitive damages to a woman who blamed her rare asbestos-related cancer on the company’s talc-based products, the company confirmed Friday.

Friday’s decision brings the total award in the case to $325 million. The New York state jury earlier this month awarded $25 million to the woman, Donna Olson, 66, and her husband in compensatory damages.

“With this verdict, yet another jury has rejected J&J’s misleading claims that its talc was free of asbestos,” said Jerome Block, the lead trial attorney in the New York case. “The internal J&J documents that the jury saw, once more laid bare the shocking truth of decades of cover-up, deception and concealment by J&J of the asbestos found in talc baby powder.”

J&J faces more than 13,000 talc-related lawsuits. The consumer products company, which makes everything from Tylenol to Aveeno lotions, denies allegations that its talc causes cancer. It said numerous studies and tests by regulators worldwide have shown that its talc is safe and asbestos-free.

“This trial suffered significant legal and evidentiary errors which Johnson & Johnson believes will warrant a reversal on appeal,” J&J said in a statement to CNBC. “Decades of tests by independent experts and academic institutions repeatedly confirm that Johnson’s Baby Powder does not contain asbestos or cause cancer.”

J&J relaunched its iconic namesake baby product line last summer to reverse a decline in J&J’s baby care unit. While trusted for decades, the 124-year-old brand had fallen out of touch with consumers, namely millennial moms, who opted instead for cleaner, natural products from trendy upstart brands.

https://www.cnbc.com/2019/05/31/johnson-johnson-must-pay-300-million-punitive-award-in-talc-case-company-will-appeal.html

So-Young target raised at Canaccord

To $21 from $20; maintains Buy.

https://www.benzinga.com/stock/SY/ratings

Reata Pharmaceuticals target hiked by Citi

To $190 from $185; maintains Buy.

https://www.benzinga.com/stock/RETA/ratings