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Friday, November 4, 2022

Rain Therapeutics Experimental Cancer Therapy Shows Encouraging Tumor Regression

 

  • Rain Therapeutics Inc  announced preliminary data from Phase 2 basket trial evaluating milademetan for MDM2-amplified advanced solid tumors.
  • "Treatment with milademetan led to tumor regression in patients previously treated with a multitude of therapies across a range of cancers. We look forward to expanding this dataset as the trial continues to enroll," said Avanish Vellanki, co-founder & CEO.
  • Seventeen patients have been enrolled, 15 of whom have been dosed with milademetan. Ten patients were efficacy-evaluable.
  • Two unconfirmed partial responses (PRs) were observed with tumor regression of 34% and 30% (pancreatic and lung cancer, respectively).
  • Two patients exhibited promising activity with tumor regression of 29% and 27% (biliary tract and breast cancer, respectively), and the patients are continuing with the investigational therapy.
  • Safety profile to date is preliminarily consistent with prior Phase 1 trial of milademetan
  • Concurrently, Rain Therapeutics priced a registered offering of 6.86 million shares and 1.72 million non-voting shares at $5.83 per share, with gross proceeds of approximately $50 million

BioNTech spokesperson: Vaccine could initially be imported to China

 BioNTech would initially import its COVID-19 vaccine into China if approvals are granted, said a spokesperson for the company on Friday, after German Chancellor Olaf Scholz said during a visit to Beijing that China would allow expatriates to receive the German company's vaccine

https://finance.yahoo.com/news/corrected-biontech-spokesperson-vaccine-could-100208957.html

China stocks notch trillion-dollar gain on hopes of reopening, better U.S. ties

 Chinese markets soared and the yuan rose on Friday, with about a trillion dollars added to the value of Chinese stocks in week, as rumours and news reports fed hopes for twin relief in U.S.-China tension and China's tough COVID rules.

The Hang Seng .HSI surged 5.3% and notched its biggest weekly gain in 11 years. The Shanghai Composite .SSEC rose 2.4% for a 5.3% weekly gain, the largest in more than two years and China-sensitive assets around the world rose sharply.

Bloomberg News reported initial U.S. inspections of audit papers at U.S.-listed Chinese companies - a long-running point of regulatory tension and risk - finished ahead of time, raising hopes that the U.S. officials were satisfied.

"The optimism right now is basically a removal of certain types of uncertainties that have been lingering ... but the outlook is really mixed," said Peiqian Liu, China economist at NatWest Markets in Singapore.

Gains were broad, defying a downbeat mood in global markets weighed by the prospect of U.S. interest rates rising further than previously expected. Property and tech shares led the way.

Shares in online giants Alibaba 9988.HK and JD.com 9618.HK each rose more than 10% and the Hang Seng Tech index .HSTECH rose 7.5%. Property manager Country Garden Services 6098.HK rose 15% and an index of mainland developers .HSMPI rose 9%.

Technical factors, following months and months of relentless selling also helped the rebound, said Kenny Ng, a strategist at China Everbright Securities in Hong Kong.

Gains in value, across Hong Kong, Shenzhen and Shanghai over the week are approximately $1 trillion. However the Hang Seng remains down 30% this year against a 24% fall in world stocks .MIWD00000PUS. The Shanghai Composite is down 15% this year.

The rally extended to commodities markets with iron ore futures surging on Friday, and China-sensitive stocks listed in London and Europe.

Miners such Rio Tinto RIO.L and Anglo American AAL.L rose sharply along with luxury retails like LVMH LVMH.PA and Swiss jeweller Richemont CFR.S.

Changes to COVID policies have not been officially flagged. A foreign ministry spokesman said on Tuesday he was not aware of the situation, when asked about rumours on social media that China was planning a reopening from strict COVID curbs in March.

Bloomberg News also reported on Friday, citing unnamed people familiar with the matter, that China was working towards relaxing rules that penalise airlines for carrying COVID-positive passengers.

A foreign ministry spokesman later said he was and that China's COVID policies were consistent and clear.

"I do not see anything new that has changed the Hong Kong and China investment environment," said Frank Benzimra, head of Asia equity strategy at Societe Generale in Hong Kong.

"The only explanation I have is that the sell-off has been excessive post-Congress, valuation on some offshore names has been very distressed, and there is some bottom-fishing."

The currency joined in the rally, jumping more than 0.5% to touch a one-week high of 7.2340 per dollar.

https://www.nasdaq.com/articles/china-stocks-notch-trillion-dollar-gain-on-hopes-of-reopening-better-u.s.-ties

Schrodinger narrows guidance range

Total Revenue Growth of 24 Percent Over Third Quarter of 2021, Driven by Continued Progress Across Drug Discovery Portfolio

Full-Year 2022 Revenue Guidance Range Narrowed, with Mix Shifting Toward Drug Discovery

Phase 1 Clinical Trial of MALT1 Inhibitor, SGR-1505, Open for Patient Enrollment

New Preclinical Data for CDC7 Inhibitor, SDGR-2921, to Be Presented at American Society of Hematology 2022 Annual Meeting

"Despite the challenging macroeconomic and industry environment, our tightened total revenue guidance for 2022 remains within our original range," stated Geoff Porges, MBBS, chief financial officer at Schrödinger. "We consider our balanced business model to be one of our greatest strengths, and this quarter’s results reflect the growing contribution of our drug discovery portfolio to our operating results and overall value."

Webcast and Conference Call Information
Schrödinger will host a conference call to discuss its third quarter 2022 financial results on Thursday, November 3, 2022, at 4:30 p.m. ET. The live webcast can be accessed under "News & Events" in the investors section of Schrödinger’s website, https://ir.schrodinger.com/news-and-events/event-calendar. To participate in the live call, please register for the call here. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will receive the dial-in information. The archived webcast will be available on Schrödinger’s website for approximately 90 days following the event.

https://finance.yahoo.com/news/schr-dinger-reports-third-quarter-200000849.html

Cash for Colonoscopies: Colorado Tries to Lower Health Costs Through Incentives

 State employees in Colorado are being asked to be better consumers when shopping for health care services. And if they choose lower-cost and higher-quality providers, they could get a check in the mail for a portion of the savings.

It’s part of an initiative known as the Colorado Purchasing Alliance, through which employers in the state are banding together to negotiate lower prices for health care services. The state government is one of 12 employers that have agreed to join the alliance and will be the first to use the newly negotiated rates and consumer incentives.

The goal is to disrupt what’s considered a dysfunctional market for health care by encouraging employers and employees to make better choices and forcing health systems in the state — which have some of the highest prices and profits in the country — to cut their rates.

Since July 1, state employees have had access to the Healthcare Bluebook, which is an online tool, owned by a health data company of the same name, that ranks health providers by both costs and quality. Providers in the top 25% for quality are designated in green, the bottom 25% in red, and anyone in between in yellow. The same color scale is used for costs.

“If you go to a green-green provider, then we’ll send you a check,” said Josh Benn, director of employee benefits contracts for the Colorado government.

The checks can range from less than $50 for something like a mammogram to thousands of dollars for surgery. In most cases, the money helps offset the employee’s copayments, coinsurance, or deductible. But for preventive services like colonoscopies, which have no copay, it’s extra cash in the employee’s pocket.

The reward program is available only to employees who choose the state’s self-funded health plan, which is administered through Cigna, not the Kaiser Permanente option, which has a closed network of providers. Of the nearly 20,000 people, both employees and family members, on the Cigna plan, more than 1,200 used the tool in the first six weeks, conducting 4,500 searches.

“We could cut the network to the bone and really limit choice, but part of what I want to do is encourage people to make better decisions,” Benn said. “There are ways to curb health care spending without harming employees.”

Although it’s too early to tell how much the state will save through the program, Healthcare Bluebook estimates that employers save an average of $1,500 every time an enrolled member uses the online tool to choose a provider.

“And you wind up with fewer complications and sick days,” Benn said.

Larimer County, in northern Colorado, has been using Healthcare Bluebook since 2018 in its incentive program to counteract the high prices it was paying for employees’ care under its self-funded plan. With little competition, the local health systems were charging county employees nearly double the prices in Denver, just two hours to the south.

“We have one particularly dominant health care system here that knows they are the system of choice, just based on market reputation, and they are willing and able to charge accordingly,” said Jennifer Whitener, benefits manager for the county.

Whitener recalled one employee who needed a hip replacement and found a free-standing orthopedic surgery center that cost $20,000 less than a hospital-owned facility and had higher quality ratings.

“Being able to share information in terms of how you can shop for health care and that not everyone is charging the same price for everything, and — oh, there’s actually a difference in quality depending on where you go — has been eye-opening,” she said.

Over the first four years, the county paid out an average of $15,000 in rewards per year. The county calculated that for every $1 it spends to offer Healthcare Bluebook to its employees, it saves $3.50.

Andrea Bilderback, a health promotion and outreach specialist with the county, used the tool when deciding where to have a mammogram and a colonoscopy after recently turning 40. She wound up getting a check for $100 for the colonoscopy and $35 for the mammogram, neither of which had any out-of-pocket costs. She and her husband used the funds for a date night, a welcome respite for the parents of a 1½-year-old boy.

“It was like free money,” Bilderback said.

Such incentives have been used with varying degrees of success across the country. Self-Insured Schools of California, a purchasing alliance that represents 450 school districts in the Golden State, implemented a similar system years ago. Officials compared the prices they paid for five common procedures — arthroscopies, cataract surgeries, colonoscopies, upper GIs, and endoscopies — at hospitals versus free-standing surgery centers. They found that surgery centers were generally much cheaper and the care was often rated as better. The group capped the amount of money it would pay hospitals, leaving employees on the hook for any balance. If they went to a surgery center, there would be no cap.

For example, arthroscopies were capped at $4,500, so if a hospital charged $6,000, the patient could be billed for the remaining $1,500. But if that patient went to a surgery center, the plan would cover the entire cost, no matter the amount.

In the first year, starting Oct. 1, 2018, the new approach had shifted 54% of procedures from high-cost hospitals to lower-cost surgery centers, saving the school districts $3.1 million in health care costs.

“If you could pay $25,000 for a car or $75,000 and the only difference was the overhead of the dealership, why would you pay $75,000?” said John Stenerson, Self-Insured Schools of California’s deputy executive officer. “That’s kind of like what we do with medical pricing all the time.”

The Colorado alliance did a similar analysis of the 10 most frequent outpatient procedures paid for by its employer members. Even before negotiating any rates, those employers could cut their costs for those procedures in half by sending employees to surgery centers instead of hospitals. Surgery centers tend to charge less than hospitals for the same procedures, and hospitals often tack on a facility fee that increases costs for consumers and employers. A recent study found that costs for a range of orthopedic surgeries were an average of 26% lower at ambulatory surgery centers than at hospitals.

The cash-back incentive program is part of a broader effort by the Colorado alliance to lower health care costs for state employees and 12 other employers, mostly school districts and local governments. But the state employees are what give the alliance a sizable block of covered lives and greater negotiating power with doctors, hospitals, and other health providers.

Robert Smith, head of the Colorado Business Group on Health, which is spearheading the alliance, believes the purchasing-alliance model can revolutionize the health care market and use the power of the employers to drive down costs. Most companies, he explained, pay premiums to a health plan to cover their employees but allow those health plans to negotiate rates with hospitals, doctors, and other providers. It would be too complicated and time-consuming for most businesses to take on that role themselves.

Health-purchasing alliances, on the other hand, allow employers to band together and negotiate rates for a much larger group of employees, giving them greater market power to negotiate lower rates.

“Health care outcomes are not related to the price,” Smith said. “You can pay twice as much for some of the worst health care at one facility, and then you can get some of the best health care at half the price at another facility 10 miles away.”

But if employers changed the way they buy health care, it could create a competitive market, Smith said.

So far, most of the negotiated rates have been limited to providers in the populous Front Range region of Colorado that includes Denver, Fort Collins, and Colorado Springs. The alliance is trying to sign up providers in other areas, particularly in the western part of the state, but it might take three years or more to fully transition to the new model.

Purchasing alliances have been tried in other parts of the country with limited success. A report by the nonprofit Catalyst for Payment Reform found that such alliances often had early success but couldn’t survive, in part because of the reactions of the large health care systems. Those systems often undercut the pricing of purchasing alliances to drive them out of business.

So far, Smith has negotiated with free-standing ambulatory surgery centers, imaging facilities, and physician-owned clinics. But he has had little luck getting the larger health systems to play ball.

“If it’s disruptive enough that it affects their bottom line and they notice it,” said Benn, the state employee benefits director, “then, yeah, I think they’ll come to the table.”

https://khn.org/news/article/colorado-health-costs-incentives-purchasing-alliance/

Flu vaccine uptake low as influenza, RSV continue to spread: CDC

 Flu vaccine uptake is lower this year compared to last year even as the U.S. experiences a resurgence of respiratory viruses, the Centers for Disease Control and Prevention said Friday.

About 18.7 million flu vaccine doses have been administered to adults in pharmacies as of the week ending Oct. 15, 2022, compared with 19.9 million at the same last year, according to newly updated federal data.

Additionally, about 10.7 million doses have been given out to adults in doctors' offices compared to 14.7 million at this point in October 2021.

"For adults, we're about 5 million doses administered down behind where we were this time last year," Dr. Lynnette Brammer, lead of the CDC's Domestic Influenza Surveillance team, told reporters during a media telebriefing Friday. "And also, we're seeing about 5% fewer pregnant people having been vaccinated now compared to this time of year, and that worries us because flu shots help protect both the pregnant woman and the baby."

It comes as cases of influenza and respiratory syncytial virus, or RSV, continue rising. The viruses typically spread during winter, but experts have said the surges are occurring earlier than usual.

CDC data shows flu vaccine coverage among all children this year is at 24.8%, comparable to the same time last year at 25.2%.

However, Dr. José Romero, director for the CDC's Center for Immunization and Respiratory Diseases, said during the briefing that one reason for a high number of infections in children may be that many are being exposed to these viruses for the first time after two years of COVID-19 pandemic mitigation measures.

Data released by the CDC on Friday showed 20% of flu tests are coming back positive for influenza.

Additionally, there were 4,326 new hospital admissions for influenza the week ending Oct. 29 with a cumulative rate of 2.9 per 100,000. This is the highest rate at this point in the season since the CDC started tracking data during the 2010-2011 season.

What's more, over the month of October, weekly RSV cases have risen from 5,845 during the week ending Oct. 1 to 7,679 during the week ending Oct. 29, CDC data shows.

At least three states -- North CarolinaSouth Carolina and Texas -- have recorded pediatric flu deaths and children in Michigan and Virginia have died from RSV.

According to the CDC, between 100 and 500 pediatric deaths occur from RSV every year and flu seasons have seen between 37 to 188 pediatric deaths.

Romero encouraged Americans to get vaccinated against flu and to vaccinate their children. He added that children aged 8 and younger should get two doses if they have not received flu shots before.

"Parents and caregivers should be on the lookout for emergency warning signs for children and young infants," he said. "It's hard to tell the difference between influenza, COVID-19 and other respiratory viruses just by looking at symptoms alone."

CDC officials said they are ready to send personnel and supplies to any state that requests assistance due to overflowing hospitals, but no state has done so at this time.

https://abcnews.go.com/Health/flu-vaccine-uptake-low-influenza-rsv-continue-spread/story

Senate Report Decries Medicare Advantage Plan Marketing Deception

 Widespread Medicare Advantage (MA) marketing scams and deception often result in beneficiaries getting switched -- without their knowledge or consent -- to plans that don't cover their providers or their needs, according to a new report from the Majority Staff of the U.S. Senate Committee on Finance.

Committee Chairman Ron Wyden (D-Ore.) and fellow members give examples of "bait and switch" schemes, "aggressive" and "sneaky tactics," and "predatory actions," such as agents approaching seniors in grocery stores and giving out "false and misleading information," or distributing materials that falsely imply they're from Medicare or another federal agency rather than a private company.

Marketing Scams

The majority committee collected complaints from 14 states, Medicare advocacy organizations, and federally funded State Health Insurance Assistance Programs (SHIP), "painting a consistent national picture" of deceptive practices.

They noted that MA plan advertisements are not harmless. "Some people who fall victim to marketing and enrollment scams delay care because of confusion over their benefits and coverage instability. Many feel frustrated and embarrassed that they were scammed," they wrote.

"False and misleading marketing advertisements and fraudulent sales practices undermine access to care and the trust beneficiaries have in the Medicare program," they added.

David Weil, program manager for the SHIP-equivalent program in San Diego, agreed with the committee's report, noting that "the problem of misleading and false advertising has plagued the Medicare Advantage landscape for the 15 years I've been involved with the program."

"Coupled with unethical and unscrupulous brokers, complaints from beneficiaries always seem to spike in January and February after they discover that what they were told during the annual election period or thought would be the case turns out not to be true. Our counselors then find themselves trying to undo the harm and get them back on the path to positive health outcomes," he told MedPage Today.

Despite these deceptive practices, the Centers for Medicare & Medicaid Services (CMS), which has reviewing authority over MA marketing materials, made "only one enforcement decision" related to deceptive marketing practices since September 2017. That 2019 action, against Solis Health Plans of Miami, resulted in a fine of only $41,552.

Joe Namath Deception

The report singles out complaints regarding particularly disingenuous television ads advertising the "Medicare Coverage Helpline," which feature celebrities such as former football star Joe Namath.

"In the ad, Mr. Namath says, 'get what you deserve,' and 'the benefit that adds money back to your Social Security check.' After numerous lawsuits, the ad was recently updated to comply with current CMS regulations," the report noted. "However, it still fails to mention basic information about the MA program, including that not all providers are in-network and was only recently updated to mention that benefits vary by zip code."

Particularly troublesome for Tatiana Fassieux, an educator with California Health Advocates, a SHIP-affiliated program in Northern California, is the "explosion of new plans without premiums, deductibles, or even co-pays," which are proving to lack providers in clients' networks. The TV ads reach large geographic areas, and often enroll beneficiaries in plans with no providers in their county, thus saddling counselors with "the task of unraveling the mess."

"Even though CMS has placed more restrictions on TV and other media marketing for 2023, third-party marketers do not care!" she told MedPage Today.

A 2020 investigation by the House Committee on Energy and Commerce found that 14,000 third-party agents and brokers across 40 states were tied to the company sponsoring the helpline ads, TogetherHealth, a subsidiary of Benefytt Technologies, formerly known as Health Insurance Innovations, or HII.

According to the report, "HII's operation and business structure incentivizes third-party agents and brokers to actively target vulnerable consumers seeking comprehensive health coverage."

Through 1-800 calls and online plan finder tools, TogetherHealth generates "leads" for thousands of agents and brokers with the names of prospective MA beneficiaries in what the report called "a tangled web of actors that regulators must unravel to monitor and regulate MA plan marketing."

For example, in Missouri, "an elderly consumer in a long-term care facility and without the capacity to make her own decisions called the number advertised on television. During the call, she was switched from one plan to another."

The report specifically blamed the Trump administration for rolling back "commonsense marketing regulations" in 2018, when they limited the types of materials under regulation and removed the requirement that marketing materials include the consumer grievance and appeals process.

Those regulatory relaxations also removed the requirement that plans terminate unlicensed agents and brokers and notify the enrollee, making it more difficult for regulators to identify bad actors, the report said. It also prevented enrollees from knowing that they could be eligible for a special enrollment period to get into a more suitable plan if they had previously enrolled based on misinformation.

Additionally, on Jan. 19, 2021, 1 day before the end of Trump's presidency, his administration expanded allowable marketing activity into healthcare settings, including waiting rooms and common entryways.

The report did not mention one common problem many MA enrollees face when they realize they've been enrolled in a plan that does not provide the benefits they expected, or requires high co-pays or deductibles, such as hundreds of dollars in co-pays for each day of hospitalization. If, after a trial period of 1 year, they try to disenroll and apply for a supplemental plan to pick up those costs, their health conditions may lead to them being rejected, thus incurring $1,600 in deductibles for each day of hospitalization, as well as 20% co-pays for most other encounters.

Regulatory Fixes

The report recommended five actions to stop deceptive practices:

  • Reinstate requirements loosened during the Trump administration, such as reinforcing prohibitions against educational events and marketing events happening on the same day in the same place
  • Monitor disenrollment patterns and use CMS's enforcement authority to hold "bad actors" accountable
  • Require agents and brokers to review their clients' prescription drugs and regularly visit health providers to ensure that the plan meets beneficiaries' needs, considered "best practices"
  • Implement robust rules around MA marketing materials and close regulatory loopholes that allow cold-calling. CMS should prohibit MA plans from contracting with marketing organizations, agents, or brokers who design materials that include the use of Medicare in the business name, or suggest they are from Medicare. The agency should also prohibit MA plans from contracting with agents and brokers who purchase lists of leads, especially from online "bait and switch" ads. CMS should review its agent/broker compensation model "to ensure that agent/broker incentives align with a beneficiary's interests and do not distort the incentives for choosing" one plan over another
  • Support unbiased sources of information for beneficiaries, including sufficient resources for the SHIP and the Senior Medicare Patrol program, described as "valuable partners in ... identifying local and national actors who are misleading or deceiving beneficiaries"

A recent MedPage Today report showed how brokers earn double the commission for enrolling a beneficiary into an MA plan compared with traditional Medicare/Medigap plan.


https://www.medpagetoday.com/special-reports/features/101583