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Wednesday, October 13, 2021

Medicare Patients Don't Compare Plans

 More than seven in 10 Medicare beneficiaries didn't check or compare their health plans in 2018 for changes in drug plan pricing, Medicare Advantage plan costs, or provider networks for 2019 -- leaving them vulnerable to surprising price increases and reductions in the array of doctors their plans will cover.

That's according to a new report from the Kaiser Family Foundation (KFF), which also found that certain demographic groups who might benefit the most from comparison shopping were even less likely to check for changes in their plans.

For example, higher percentages of lower income or less well-educated patients, those in poorer health, residents in rural areas, or those in an older age bracket didn't look up their plans or survey their options for better, less expensive alternatives.

"This is a story that affects the majority of people on Medicare," report author Tricia Neuman, executive director of Medicare policy at KFF, told MedPage Today. "Most people simply do not compare their plans each year" during open enrollment, and end up surprised by changes they can't afford.

That trend is expected to continue this year, with 2022 open enrollment starting on October 15 and continuing through December 7.

The ramifications of the report's findings could be significant for physicians when beneficiaries suddenly find themselves unable to afford the drugs their doctors prescribed because the pricing structure (or "Tier" category) has changed. Or, they call their physicians desperately requesting cheaper alternatives that may not be as effective.

"Many patients, particularly those with serious medical problems, feel a close connection to their doctors, but may not realize that Medicare Advantage plans have provider networks that limit access to certain hospitals and doctors, and that provider networks may change from one year to the next," Neuman said.

In a separate poll released Tuesday, KFF revealed that one in five Medicare beneficiaries say they experience difficulty paying for their medications, including those with coverage plans. Also, for those seniors who are on four drugs or more, a quarter reported having difficulty affording them.

Deaths as a Result?

San Diego neurologist James S. Grisolia, MD, acknowledged the pressure doctors receive when angry, frightened patients ask that their prescriptions be changed to less expensive alternatives that don't exist. Some patients will alternatively skimp on doses or not refill prescriptions that cost a lot more.

"This happens now daily," he said, adding that "2022 will see patient deaths" because of it; for many conditions generics just don't work as well.

Particularly worrisome are brand-name seizure medications necessary for survival, for which some drug plans require co-payments in the hundreds of dollars each month, almost as if the patient didn't have any coverage at all, Grisolia said.

The neurologist blames the pharmaceutical industries' "institutionalized greed," and said that patient-focused disease-specific organizations are working on solutions such as more pharmaceutical support -- "but the cost of medication is frankly at a crisis level."

American Medical Association President Gerald E. Harmon, MD, said this about the KFF report: "Physicians want real-time prescription benefit information to help inform discussions with patients about drug selection to avoid coverage and cost barriers that could impact medication adherence."

That's being developed, he said, but as yet does not mesh or integrate with all electronic health record systems. Nor does it provide information for all patients to give doctors the tools they need to "guide useful discussions with patients about drug coverage and cost."

Mind-Boggling Choices

The report noted that a likely reason for beneficiaries not comparison-shopping is the array of choices. The average Medicare beneficiary has "33 Medicare Advantage plans and 30 Part D stand-alone prescription drug plans" to choose from -- a factor Neuman said is causing beneficiaries to be "overwhelmed."

They "don't realize there's a fair amount of variation" from plan to plan, she said. The plans are also terribly complicated with many moving parts. That's why, Neuman said, "it pays to shop."

The KFF report was based on an analysis of the Medicare Current Beneficiary Survey, which was conducted in 2019. Neuman said it sampled at least 10,000 of the 50.7 million beneficiaries who had the opportunity to change Part D, Medicare Advantage, or straight Medicare plans in 2018.

Doubling and Quadrupling Costs

Some Medicare beneficiaries who have looked up their Part D drug plan benefits, which were recently released through mailed notices or on the Medicare Plan Finder, are finding drastic price changes.

For example, a common Aetna SilverScript plan in California is nearly doubling its annual deductible from $250 to $480. It also is changing the pricing structure from a flat fee to a percentage for commonly prescribed Tier 3 drugs, which includes several brands of generic statins such as rosuvastatin and ezetimibe.

Instead of $104 for a 90-day supply of each of those two drugs, the plan will charge 17% of $925, or $157 for one, and 17% of $800-plus, or $136, for the other, according to this reporter's conversation with a plan supervisor about her own plan.

Those prices could increase in 2022, the supervisor said.

Additionally, a brand of an inhaler that now costs $105 for a 90-day supply will cost 17% of nearly $1,900, or $324.

Several counselors with that plan told this reporter they are bracing for calls from angry enrollees and are in training sessions on how to manage them.

A beneficiary in New York with Aetna SilverScript Choice also will see Tier 3 drugs go from $105 for a 90-day supply to 17% of the full price set by the plan. The less commonly prescribed but more expensive drugs in Tiers 4 and 5 will drop from 40% to 34% and from 27% to 25%, respectively.

Savvy Consumers Only

"The whole system is premised on active, savvy consumers reviewing and changing their coverage in order to get what is best for them, but obviously that doesn't happen," said David Lipschutz, senior policy attorney for the Center for Medicare Advocacy.

"The advertising we have seen in the last few years from the Medicare program promotes 'plans' without the nuanced distinction between Part D and Medicare Advantage plans, leaving many to think they should enroll in MA plans even if they are in traditional Medicare and doing just fine there," he said. "Insurance industry advertising is out of control."

A San Diego Medicare beneficiary and former business editor was asked to look up his changes in his Anthem Blue Cross MediBlue Rx Plus plan, and found that the monthly premium is increasing nearly four-fold, from $26.10 to $92, an increase he called "outrageous."

Tatiana Fassieux, education specialist at California Health Advocates, said calls from Part D beneficiaries indicate increasing premiums in most plans, with some doubling or more than doubling. And most plans are going to the $480 maximum for the deductible, she said.

Neuman and Lipschutz both suggested that one way to improve the situation is increased funding for State Health Insurance Assistance Programs, or SHIP, now supported by federal grants. Lipschutz said the Medicare program should engage in more outreach and education, and work harder to "scrub bias" that has consistently appeared in the thick, annual "Medicare & You" handbooks, whose paragraphs appear to steer patients toward Medicare Advantage plans over straight Medicare alone, or straight Medicare with a supplemental and a Part D plan.

Both mentioned that the array of choices can be mind-boggling to a senior citizen. "Sometimes there is such a thing as too much choice," Lipschutz said.

Lipschutz also mentioned the need for Medicare to eliminate underwriting requirements for beneficiaries who want to leave Medicare Advantage for traditional Medicare with a supplemental plan to pick up the beneficiary's 20% share of Part B costs. Those with certain conditions that supplemental plans consider "pre-existing," such as diabetes or hypertension, are frequently denied coverage. That change would enable beneficiaries to "actually have a 'choice,'" he said.

The KFF report broke down the data by plan type: 29% of 50.7 million Medicare beneficiaries overall compared plans while 71% did not; of 21.4 million Medicare Advantage enrollees, 32% compared plans while 68% did not and for those in straight Medicare, 27% compared plans while 73% did not.

Many said they never visited an official Medicare website or did not have access to the internet or had no one who could access it for them. Medicare's toll-free number and Medicare Handbook were also not widely used.

The KFF analysis also found a failure to compare plans among those in Medicare Advantage drug plans, i.e., 81% of 16.4 million enrollees, and for stand-alone Part D drug plans, 72% of 20.7 million enrollees did not compare plans.

https://www.medpagetoday.com/special-reports/exclusives/94997

Atara claims a remyelination signal

 A keenly awaited early-stage update on Atara’s ATA188 in aggressive forms of multiple sclerosis presented at Ectrims today have made for encouraging reading. Seven of 25 patients have seen sustained improvement on an important measure of disability, EDSS, with 11 remaining stable throughout the phase 1 portion of the study.

The company also presented new data on a biomarker called magnetisation transfer ratio (MTR), which is a measure of the density of myelin, the insulating sheath around nerves that is degraded in MS. Atara believes that a correlation can be seen between MTR and EDSS improvement in the new data, which could mean that ATA188 is promoting remyelination and driving the clinical benefit. Should this be confirmed in larger studies it would represent a big step forward.

A muted reaction from investors this morning – Atara shares were 9% lower in early trade – shows how overheated expectations had been, and points to the need for much more data before any of these claims can be substantiated.

The update concerned 18 subjects recruited into the open-label extension stage of the phase 1 portion of an ongoing trial, Embold. That study has already progressed to the phase 2 double-blind, placebo-controlled stage, from which Atara today promised an interim analysis in the first half of 2022.

This readout now becomes a big event for the company and this project. ATA188 is an allogeneic T-cell immunotherapy that targets Epstein-Barr virus-infected B cells and plasma cells; nearly all MS patients are positive for Epstein-Barr, and these infected cells drive an inflammatory cascade. ATA188 is thought to work by shutting down this inflammation and, perhaps, allowing the body to remyelinate damaged nerves.

On a call today Atara's chief executive, Pascal Touchon, emphasised that ATA188 requires no gene editing – no doubt in a nod to current safety concerns with gene-editing technology. Updated safety data today revealed no new issues, with no grade 4 or 5 events reported and no cases of cytokine release syndrome or graft versus host.

The data  

Results from the 24 subjects recruited into the phase 1 trial have previously been reported; the new data today concerned an update on these, as well as the 18 who elected to move into the trial extension, and were followed for up to 39 months.

At the latest data cut-off, nine patients had achieved sustained disability improvement either during the phase 1 portion, which lasted 12 months, or the extension. Seven of these did so via sustained EDSS improvement – an important regulatory endpoint.

11 patients remained stable throughout the study, and on a conference call Atara stressed that in this patient population of primary progressive MS stable disease should be considered a response. Four patients had confirmed disability progression.

On the MTR presentation, patients who achieved sustained EDSS improvement showed greater increases in MTR from baseline at 12 months. In general, an increase in MTR was associated with improvement in EDSS scores, Atara claimed.

Source: Atara company presentation.

There are caveats here, mainly concerning the small patient numbers and the relatively short time period of the trial. Important questions also remain around MTR as a biomarker, a measure has not been widely used in MS trials to date. Unknowns include whether there can be “noise” in the signal – for example, whether the reading can be affected by oedema or dehydration. What regulators might make of the biomarker is also unknown.

But Atara clearly believes that it is amassing evidence that ATA188 promotes remyelination, the ultimate goal for MS research. No project to date has shown clear evidence of this. Much more data are needed, but hopefully this is a step in the right direction.

https://www.evaluate.com/vantage/articles/news/trial-results/atara-claims-remyelination-signal

Moderna: Data suggests mRNA booster generates stronger antibody response after J&J shot

 People who received Johnson & Johnson's COVID-19 vaccine will have a stronger neutralizing antibody response if they get an mRNA shot as the second dose, Axios reported on Tuesday, citing a person who has seen data collected by the U.S. National Institutes of Health (NIH).

J&J has asked the U.S. Food and Drug Administration (FDA) to approve a shot of its own single-dose vaccine as the booster dose. The FDA's advisers are set to consider the need on Friday.

The NIH will present the mix-and-match data to the FDA panel on Friday, Axios said.

There were limitations to the NIH data, according to the report. Neutralizing antibodies only prevent the virus from entering cells and replicating, and the report said it was unclear how long the response will last.

The NIH, FDA and J&J did not immediately respond to Reuters' requests for comment.

Two-dose vaccines made by Pfizer Inc and its German partner BioNTech and Moderna Inc use the mRNA technology.

The health regulator's outside experts will also discuss the need for an additional dose of Moderna's vaccine on Friday.

Scientists at the FDA have said Moderna had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-Data-suggests-mRNA-booster-dose-generates-stronger-antibody-response-after-J-J-shot-Axio-36666239/

Biogen: People Treated With MS Therapies Achieve Antibody Response to Covid-19 Vaccine

 Biogen Inc. said it found that patients treated with the company's multiple-sclerosis therapies achieved an antibody response to Covid-19 vaccination.

The company Wednesday said preliminary results from a new analysis suggest that anti-CD20 and sphingosine 1-phosphate, or S1P, therapies may reduce the antibody response to Covid-19 vaccination. For all other classes evaluated in the analysis--including the broad range of MS therapies offered by Biogen--the antibody response to vaccination is consistent with the response of patients not being treated with an MS disease-modifying therapy, the company said.

Biogen said researchers looked at blood samples from 322 participants 28 to 90 days after their last Covid-19 vaccine dose, using data from a company-sponsored network in the U.S., Germany and Spain. About 92% of participants in the analysis received an mRNA vaccine, the company said.

https://www.marketscreener.com/quote/stock/BIOGEN-INC-4853/news/Biogen-People-Treated-With-MS-Therapies-Achieve-Antibody-Response-to-Covid-19-Vaccination-36668990/

Lilly: FDA Approves Verzenio in Some High-Risk Early Breast-Cancer Patients

 Eli Lilly and Co. on Wednesday said the U.S. Food and Drug Administration approved the expanded use of its cancer drug Verzenio in combination with endocrine therapy in certain patients with high-risk early breast cancer.

The Indianapolis drug maker said the approval covers the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of at least 20%.

Eli Lilly said Verzenio is the first and only CDK4/6 inhibitor approved for this patient population.

The FDA previously approved Verzenio for the treatment of certain types of HR+ HER2- advanced or metastatic breast cancer. Eli Lilly said the agency has now expanded the use of Verzenio in all indications, when given in combination with endocrine therapy, to include men.

https://www.marketscreener.com/quote/stock/ELI-LILLY-AND-COMPANY-13401/news/Eli-Lilly-FDA-Approves-Verzenio-in-Some-High-Risk-Early-Breast-Cancer-Patients-36669456/

Ardelyx Provides Corporate Update Following FDA Meeting

 Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that the company has met with the U.S. Food and Drug Administration (FDA) in a Type A meeting, but was not provided sufficient clarity on what constitutes "clinical relevance of the magnitude of treatment effect" and continues to await additional information regarding the path forward for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

"Given that we have conducted the requisite registration studies, which met all primary and key secondary endpoints with no safety or other identified issues, we continue to be extremely disappointed and surprised by the lack of clarity from the FDA on the next steps to resubmit our NDA," said Mike Raab, president and chief executive officer of Ardelyx. "In order to preserve our cash resources and extend our cash runway, we have made the extremely difficult decision to implement a restructuring plan that includes a significant reduction in force. We have retained key employees needed to continue to support the regulatory process and work to achieve our goal to gain approval for tenapanor for hyperphosphatemia. While a setback for our company, we believe the delay in approval represents a more significant hardship for patients who are being denied access to tenapanor, a much-needed, novel therapeutic alternative with a different mechanism of action. We remain dedicated to providing these underserved patients, of which 77% are unable to maintain target phosphorus levels despite active treatment with currently available therapies, another treatment option."

The company announced that on October 12, 2021, it began implementing a restructuring plan to further reduce operating costs and better align the company's workforce with the needs of its business following the receipt of a complete response letter (CRL) from the FDA on July 28, 2021, regarding the company's NDA for the control of serum phosphorus in adult patients with CKD on dialysis, and the results to date of the subsequent Type A meeting. The restructuring plan is expected to be completed in December 2021. In connection with the restructuring, the company estimates that it will incur aggregate restructuring charges of approximately $2.3 million, which will be recorded primarily in the fourth quarter 2021, related to severance payments and other employee-related costs. The company expects that the workforce reduction will decrease its annual cash compensation costs by approximately $18.1 million. At the end of the third quarter ended September 30, 2021, Ardelyx had $141.7 million in cash and cash equivalents (unaudited).

In July 2021, Ardelyx announced that it had received a CRL from the FDA regarding the company's NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis. According to the CRL, while the FDA agrees that "the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis," they characterize the magnitude of the treatment effect as "small and of unclear clinical significance." Additionally, the FDA noted that for the application to be approved, Ardelyx needs "to conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect on serum phosphorus or an effect on the clinical outcome thought to be caused by hyperphosphatemia in CKD patients on dialysis." There were no safety, clinical pharmacology/biopharmaceutics, CMC or non-clinical issues identified in the CRL.

While Ardelyx has yet to receive minutes from the Type A meeting held October 1, 2021, the discussion at the meeting did not provide clarification on the key requirements: the FDA's definition of clinical significance and relevant treatment effect.

https://www.knopnews2.com/prnewswire/2021/10/13/ardelyx-provides-corporate-update-following-type-meeting-with-fda/

Hochul apologizes to families of nursing home COVID victims in closed-door meeting

 Gov. Kathy Hochul on Tuesday held a closed-door meeting with relatives of nursing home residents killed by COVID-19 — and apologized to them for the pain caused by her predecessor, Andrew Cuomo’s, handling of the crisis, The Post has learned.

The families, led by Assemblyman Ron Kim (D-Queens), presented the governor with a list of demands, including elder-care reforms and that the state own up for its controversial directive believed to have increased the death toll among nursing home residents.

“At the very top of the meeting, after we introduced ourselves, she (Hochul) leaned in pretty hard and opened up with an apology to the families about what they had to go through as a result of these policies,” Kim said.

“It was obviously a private apology, but I think it really touched the families. That’s something they’ve been asking for — to be treated decently as human beings.”

a patient is loaded into an ambulance by emergency medical workers outside Cobble Hill Health Center in the Brooklyn
A patient is loaded into an ambulance by emergency medical workers outside Cobble Hill Health Center in Brooklyn.
AP Photo/John Minchillo, File

He added: “It was a genuine, empathetic moment that stood out to us.”

It was a stark change from the behavior of Cuomo’s lackeys, the lawmaker said.

“There wasn’t an inkling of dismissiveness or her saying that we don’t have the facts — as the previous governor used to be — there was no dismissiveness in her tone.”

The families and Kim, whose uncle died of suspected COVID-19 last year in a nursing home, had been requesting a sit-down with Hochul since she took over following Cuomo’s resignation in late August.

Haydee Pabey holds a picture of the deceased Elba Pabey as demonstrators gather for a rally decrying New York Governor Andrew Cuomo's handling of nursing homes during the previous years outbreak of COVID-19
Haydee Pabey holds a picture of the deceased Elba Pabey as demonstrators gather for a rally decrying former Governor Andrew Cuomo’s handling of nursing homes during COVID-19, March 25, 2021.
AP Photo/John Minchillo
Janice Dean attends the "Fox & Friends" naturalization ceremony for Veterans Day at Fox News Channel Studios on November 11, 2019 in New York City.
Janice Dean lost both her mother and father-in-law to COVID-19 in March and April 2020.
Roy Rochlin/Getty Images

The roughly hour-long meeting on Tuesday afternoon took place at the governor’s Manhattan offices and was “very emotional” with “lots of crying going on,” Kim said.

Other attendees included Alexa Rivera, whose sister Vivian Zayas founded the advocacy group Voices for Seniors after losing their mom Ana Martinez to COVID-19 in a nursing home, and Fox News meteorologist and elder-care advocate Janice Dean, who lost both her mother and father-in-law to the virus in March and April 2020, respectively.

“Even though it’s been 19 months, it still feels raw and fresh. We still feel like our family members just passed yesterday,” Rivera told The Post.

“For the first time since we began our quest for accountability on behalf of our families that died from Covid in nursing homes last spring, we met today with @GovKathyHochul,” Dean wrote on Twitter. “It was a small step but an important one to get answers. It would not have happened without @rontkim.”

The group requested an announcement from the state that the Department of Health’s March 25, 2020 mandate that nursing homes admit coronavirus patients had “led to thousands of untimely and unnecessary deaths.”

Other demands included:

  • That Hochul support a “bipartisan investigation with subpoena power into the nursing home crisis”;
  • That she release all remaining nursing home data and pending Freedom of Information Law requests;
  • That she direct the DOH to conduct a “re-audit” of all COVID-related nursing home deaths;
  • Pass a bill creating a nursing home victims compensation fund;
  • and that she dedicate a “nursing home victim memorial.”

“It was a good first meeting and they committed to continue to work with us on our requests,” Kim said, adding that governor’s staff also spoke with the group to discuss details of the requests following the face-to-face.

Assemblyman Ron Kim
Assemblyman Ron Kim led the families in presenting the governor with a list of demands.
James Messerschmidt for NY Post

NYPD detective Haydee Pabey, 54, who lost her 72-year-old mother Elba Pabey to COVID-19 in a nursing home, was also at the meeting — and was thankful for Hochul’s apology.

“I was in tears, I was a mess — everybody just started crying,” Pabey recalled. “But the governor opened up the meeting very welcoming and warm. It felt good. She apologized for the pain that we have endured. She did say that they will do the best they can.”

“It was hitting a brick wall with the last administration,” Pabey added. “We had no answers and no one would get back to us.”

Peter Arbeeny (L) and Daniel Arbeeny (R) holding a photo of their father Norman Arbeeny inside their father’s home at 128 Amity Street in Brooklyn, where their father passed away due to COVID-19.
Peter Arbeeny, left, and Daniel Arbeeny holding a photo of their father Norman Arbeeny inside their father’s home in Brooklyn, where their father passed away due to COVID-19.
Kevin C. Downs

Peter Arbeeny, 55, the owner of an air conditioning business who lost his 89-year-old dad Norman Arbeeny to the virus, also appreciated the apology, but was more cautious.

“It was a good first step for a new governor,” he said. “I won’t know what it means yet until we see these promises turned into actions.”

Still, Arbeeny said, a top priority for him was seeing a re-audit of nursing home deaths, and he told The Post that Hochul had committed to getting it done. Shortly before she took office, Hochul had promised that her administration would be “very transparent” when it comes to releasing documents pertaining to COVID-19 nursing home deaths 

Daniel arbeny on left, haydee Paybe, Ron Kim, Alexa Rivera in middle, Janice Dean, Sean dean, Peter arbeny on right
Daniel Arbeny, Haydee Paybe, Assemblyman Ron Kim, Alexa Rivera, Janice Dean, Sean Dean and Peter Arbeny.
Ron Kim

Kim said the gov’s legislative director would also be working with the group on a memorial and compensation fund.

He noted that Hochul seemed inclined to get another meeting on the books once the new health commissioner, Mary Bassett, comes in, following the resignation of Cuomo appointee Howard Zucker.

Zucker was a key figure in the Cuomo administration, whose March 25, 2020 directive is blamed for putting many of the casualties of nursing homes in harm’s way by mandating that COVID-19 infected patients be sent back to nursing homes from hospitals.

Dr. Howard A. Zucker, commissioner of the New York State Department of Health, speaks during a news conference on coronavirus vaccination at Suffolk County Community College on Monday, April 12, 2021
Dr. Howard A. Zucker resigned from his position as state health commissioner.
Michael M. Santiago/Pool via AP

He is also accused of helping Cuomo and his aides hide the pandemic’s true death toll across the state and in its nursing homes.

“One thing that is clear is as soon as the new commissioner of health comes in, she personally would like to participate in a follow up discussion,” Kim said.

“It’s important going forward that families have access, and an ability for them to shape policies that impact their families,” he added.

“Governor Hochul is committed to transparency and restoring trust in government, and she looks forward to working with Assemblymember Kim on these priorities,” said Hochul spokeswoman Hazel Crampton-Hays.

“On her first day in office, the Governor disclosed additional nursing home data, and she will continue to deliver transparency to New Yorkers on the impact of COVID-19 on nursing homes. Governor Hochul’s deep sympathy is with the families whose loved ones have been lost to the pandemic, and she appreciates Assemblymember Kim’s dedication to these important issues.”

https://nypost.com/2021/10/12/hochul-apologizes-to-families-of-nursing-home-covid-victims/