High-risk individuals should get priority access to Covid therapies. That isn’t happening

 Ms. S, a primary care patient in one of our clinics (M.L.B.), recently called in with loss of taste and a terrible cough, worse than her regular breathing problems. She said she had gone out to play bingo the past weekend with friends, her first outing in weeks. Two days later, one of her friends called and told Ms. S she had tested positive for Covid-19.

Ms. S was frightened — as an older woman with heart and lung conditions, getting Covid-19 posed a serious threat to her life, especially since she hadn’t yet received her booster vaccine. But she didn’t have a home test to check for Covid-19.

“What do I do now?” she asked.

The answer should have been, “Let’s get you tested for Covid, and if you’re positive, we’ll get you an infusion of Covid-fighting antibodies as soon as possible.”

But Ms. S already felt too sick to wait in line at the testing site or take a bus to the infusion center. She had no family to bring her a test or transport her. She would have to ride Covid out on her own, without the treatment that could reduce her chance of hospitalization or death by 85%.

This scenario has been playing out across the U.S. since November 2020, when monoclonal antibodies were authorized as the most effective treatment to prevent individuals diagnosed with mild Covid-19 from becoming seriously ill. But the supply has been severely limited, and getting treatment requires a positive Covid-19 test result and traveling to an infusion center no later than 10 days after symptoms start. Those are not easy tasks for individuals experiencing with Covid symptoms in the first place.

Anticipating the shortages in supply, federal guidelines have prioritized people who are the most likely to benefit from treatment — those at the highest risk of getting severely ill, like Ms. S. But has the limited supply of this lifesaving therapy reached these patients?

Research that we and several colleagues published on Friday in the Journal of the American Medical Association confirms the worst: Through August last year, those who most needed monoclonal antibody therapy were the least likely to get it. We analyzed data from about nearly 2 million Medicare patients diagnosed with Covid-19 between November 2020 and August 2021 and identified all who received antibody therapy. Ideally, those at highest risk of hospitalization or death, such as individuals like Ms. S with multiple chronic illness, and those over 65 years old would be first in line to receive treatment. Instead, we found that individuals with no chronic illness were five times more likely to receive antibody therapy than those with six or more chronic conditions, who represented more than 1 in 3 Medicare enrollees.

We also found that the likelihood of getting treatment varied substantially by region of the country. In the western U.S., less than 3% of eligible patients with Covid-19 received monoclonal antibody therapy, compared to 11% in the South. This fits with reports that states with lower vaccination rates seem to be embracing monoclonal antibodies as a central part of their strategy to fight Covid-19. Yet the Food and Drug Administration and the Centers for Disease Control and Prevention have made it clear that antibody treatment is not a substitute for vaccination.

Monoclonal antibody distribution by state

Quartile 1: 24.9% to 9.5%; Quartile 2: 9.4% to 6.3%; Quartile 3: 6.2% to 3.0%; Quartile 4: 3.0% to 0.7%PATRICK SKERRETT / STATSOURCE: CAROLINE BEHR AND MICHAEL BENNETT

The federal government has tried to fight this inequitable spread, taking over distribution from suppliers in September 2021 as demand started to grow. But inequities persisted in the winter of 2021 when federally coordinated distribution, based on Covid case counts and other factors, was in place. This system will collapse further as only one of three available monoclonal antibody products seems to be effective against the Omicron variant, further restricting an already limited supply. Emerging Covid therapeutics such as the oral antiviral Paxlovid, which the FDA has authorized for emergency use, and others on the horizon will likely face the same supply shortages as monoclonal antibodies.

How can these problems supply and distribution problems be fixed to ensure that new Covid-19 therapeutics don’t encounter the same serious pitfalls? A starting place is to educate both patients and physicians about who is eligible for these therapies (for example, those 65 and older or those with diabetes or heart disease) and the importance of rapid diagnosis. Speed is crucial in delivering antibody therapy, which should start as soon as possible after a positive test result and within 10 days of symptom onset. Monoclonal antibodies, as well as new antiviral treatments like Paxlovid, are effective only if taken as early as possible, underscoring the ongoing importance of improving access to testing — not only to limit the spread of Covid-19, but to improve access to treatment.

The mechanisms of distribution, on the federal and state levels, should ensure that supply is being distributed fairly at the local level ensuring that communities with the most vulnerable patients get an appropriate share of treatment. This is an example of a “last-mile” problem that requires close coordination between local health systems and state governments. There are both short- and long-term fixes to close the last mile of access, such as streamlining the process of getting infusion appointments in the short term and fostering the development of brick-and-mortar and mobile infusion sites for future waves.

More and better Covid therapeutics will continue to emerge and be in high demand. Without a concerted effort to ensure they are fairly distributed, those most in need of them will continue to be left behind.

Caroline Behr is a fourth-year medical student at Harvard Medical School. Michael Barnett is a primary care physician at Brigham and Women’s Hospital in Boston and an assistant professor of health policy and management at the Harvard T.H. Chan School of Public Health. The views expressed here are their own and do not necessarily reflect those of the institutions they are affiliated with.

https://www.statnews.com/2022/02/04/high-risk-individuals-priority-monoclonal-antibodies-covid/

CDC: Two dead from Listeria outbreak linked to Dole salads

 The Centers for Disease Control and Prevention (CDC) said two people have died from a Listeria outbreak linked to Dole salads.

An investigation by the CDC found that 17 people were ill, 13 had been hospitalized and two died across 13 states from the outbreak.

Although the investigation is still ongoing, the CDC has linked the outbreak back to Dole salads that were sold under 11 brand names.

Ahold, Dole, HEB, Kroger, Lidl, Little Salad Bar, Marketside, Naturally Better, Nature’s Promise, President’s Choice and Simply Nature sold the mixed greens, garden salads, Caesar kits and other salads linked to the illness, the agency said.

The items are under recall, with recalled items having “Best used if by” dates from Nov. 30, 2021 to Jan. 9 of this year.

In the upper-right hand corner of the packages of the recalled items, the letters  “B,” “N,” “W” or “Y” will be at the start of the product lot code, the CDC said. 

It is one of two investigations of Listeria outbreaks the agency is investigating. The other outbreak is linked to Fresh Expressed packaged salads.

The Hill has reached out to Dole for comment.

https://thehill.com/policy/healthcare/592821-cdc-two-dead-from-listeria-outbreak-linked-to-dole-salads

Cal. Inks Sweetheart Deal With Kaiser Permanente, Jeopardizing Medicaid Reforms

 Gov. Gavin Newsom’s administration has negotiated a secret deal to give Kaiser Permanente a special Medicaid contract that would allow the health care behemoth to expand its reach in California and largely continue selecting the enrollees it wants, which other health plans say leaves them with a disproportionate share of the program’s sickest and costliest patients. 

The deal, hammered out behind closed doors between Kaiser Permanente and senior officials in Newsom’s office, could complicate a long-planned and expensive transformation of Medi-Cal, the state’s Medicaid program, which covers roughly 14 million low-income Californians. 

It has infuriated executives of other managed-care insurance plans in Medi-Cal, who say they stand to lose hundreds of thousands of patients and millions of dollars a year. The deal allows KP to limit enrollment primarily to its previous enrollees, except in the case of foster kids and people who are eligible for both Medicare and Medi-Cal.  

“It has caused a massive amount of frenzy,” said Jarrod McNaughton, CEO of the Inland Empire Health Plan, which covers about 1.5 million Medi-Cal enrollees in Riverside and San Bernardino counties. “All of us are doing our best to implement the most transformational Medi-Cal initiative in state history, and to put all this together without a public process is very disconcerting.” 

Linnea Koopmans, CEO of the Local Health Plans of California, echoed McNaughton’s concerns.

Insurance plans got wind of the backroom talks when broad outlines of the deal were leaked days before the state briefed their executives Thursday.

Dr. Bechara Choucair, Kaiser Permanente’s chief health officer, argued in a prepared written response on behalf of KP that because it operates both as a health insurer and a health care provider, KP should be treated differently than other commercial health plans that participate in Medi-Cal. Doing business directly with the state will eliminate complexity and improve the quality of care for the Medi-Cal patients it serves, he said. 

“We are not seeking to turn a profit off Medi-Cal enrollment,” Choucair said. “Kaiser Permanente participates in Medi-Cal because it is part of our mission to improve the health of the communities we serve. We participate in Medi-Cal despite incurring losses every year.” 

His statement cited nearly $1.8 billion in losses in the program in 2020 and said KP had donated $402 million to help care for uninsured people that year.

Kaiser Permanente, the state’s largest managed-care organization, is one of Newsom’s most generous supporters and close political allies. 

The new, five-year contract, confirmed to KHN by administration officials and expected to be announced publicly Friday, will take effect in 2024 pending approval from the legislature — and will make KP the only insurer with a statewide Medi-Cal contract. It allows KP to solidify its position before California’s other commercial Medi-Cal plans participate in a statewide bidding process — and after those plans have spent many months and considerable resources developing their bidding strategies.

Other health plans fear the contract could also muddle a massive and expensive initiative called CalAIM that aims to provide social services to the state’s most vulnerable patients, including home-delivered meals, housing aid for homeless people, and mold removal from homes. Under its new contract, KP must provide some of those services. But some executives at other health plans say KP will not have to enroll a large number of sick patients who need such services because of how it limits enrollment.

Critics of the deal noted Newsom’s close relationship with KP, which has given nearly $100 million in charitable funding and grant money to boost Newsom’s efforts against homelessness, covid response, and wildfire relief since 2019, according to state records and KP news releases. The health care giant was also one of two hospital systems awarded a no-bid contract from the state to run a field hospital in Los Angeles during the early days of the covid pandemic, and it got a special agreement from the Newsom administration to help vaccinate Californians last year.

Jim DeBoo, Newsom’s executive secretary, used to lobby for KP before joining the administration. Toby Douglas, a former director of the state Department of Health Care Services, which runs Medi-Cal, is now Kaiser Permanente’s vice president for national Medicaid.  

Still, many critics agree that Kaiser Permanente is a linchpin of the state’s health care system, with its strong focus on preventive care and high marks for quality of care. Many of the public insurance plans upset by the deal subcontract with KP for patient care and acknowledge that their overall quality scores will likely decline when KP goes its own way.

Michelle Baass, director of the state Department of Health Care Services, said Medi-Cal had risked losing KP’s “high quality” and “clinical expertise” altogether had it been required to accept all enrollees, as the other health plans must. But she said KP will have to comply with all other conditions that other plans must meet, including tightened requirements on access, quality, consumer satisfaction, and health equity. 

The state will also have greater oversight over patient care, she said.  

“This proposal is a way to help ensure Kaiser treats more low-income patients, and that more low-income patients have access to Kaiser’s high-quality services,” Baass said. 

Though Kaiser Permanente has 9 million enrollees, close to a quarter of all Californians, only about 900,000 of them are Medi-Cal members. 

Under the current system, 12 of the 24 other managed care insurance plans that participate in Medi-Cal subcontract with KP to care for a subset of their patients, keeping a small slice of the Medi-Cal dollars earmarked for those patients. Under the new contract, KP can take those patients away and keep all of the money.

In its subcontracts, and in counties where it enrolls patients directly, KP accepts only people who are recent Kaiser Permanente members and, in some cases, their family members. It is the only health plan that can limit its Medi-Cal enrollment in this way. 

The new contract allows KP to continue this practice, but it also requires Kaiser Permanente to take on more foster children and complex, expensive patients who are eligible for both Medi-Cal and Medicare. It allows KP to expand its geographic reach in Medi-Cal to do so. 

Baass said the state expects KP’s Medi-Cal enrollment to increase 25% over the life of the contract. 

KP defended the practice of limiting enrollment primarily to its previous members, arguing that it provides “continuity of care when members transition into and out of Medi-Cal.” 

The state has long pushed for a larger KP footprint in Medi-Cal, citing its high quality ratings, its strong integrated network, and its huge role on the broader health care landscape.

“Kaiser Permanente historically has not played a very big role in Medi-Cal, and the state has long recognized that we would benefit from having them more engaged because they get better health outcomes and focus on prevention,” said Daniel Zingale, a former Newsom administration official and health insurance regulator who now advises a lobbying firm that has Kaiser Permanente as a client. 

But by accepting primarily people who have been KP members in the recent past, the health system has been able to limit its share of high-need, expensive patients, say rival health plan executives and former state health officials.

The executives fear the deal could saddle them with even more of these patients in the future, including homeless people and those with mental illnesses — and make it harder to provide adequate care for them. Many of those patients will join Medi-Cal for the first time under the CalAIM initiative, and KP will not be required to accept many of them.

“Awarding a no-bid Medi-Cal contract to a statewide commercial plan with a track record of ‘cherry picking’ members and offering only limited behavioral health and community support benefits not only conflicts with the intent and goals of CalAIM but undermines publicly organized health care,” according to an internal document prepared by the Inland Empire Health Plan. 

The plan said it stands to lose the roughly 144,000 Medi-Cal members it delegates to KP and about $10 million in annual revenue. L.A. Care, the nation’s largest Medicaid health plan, with 2.4 million enrollees in Los Angeles County, will lose its 244,000 KP members, based on data shared by the plan. 

The state had been scheduled on Wednesday to release final details and instructions for the commercial plans that are submitting bids for new contracts starting in 2024. But it delayed the release a week to make the KP deal public beforehand.

Baass said the state agreed to exempt KP from the bidding process because the standardized contract expected to result from it would have required the insurer to accept all enrollees, which Kaiser Permanente does not have the capacity to do. 

“It’s not surprising to me that the state will go to extraordinary means to make sure that Kaiser is in the mix, given it has been in the vanguard of our health care delivery system,” Zingale said.

Having a direct statewide Medi-Cal contract will greatly reduce the administrative workload for KP, which will now deal with only one agency on reporting and oversight, rather than the 12 public plans it currently subcontracts with. 

And the new contract will give it an even closer relationship with Newsom and state health officials.

In 2020, KP gave $25 million to one of Newsom’s key initiatives, a state homelessness fund to move people off the streets and into hotel rooms, according to a KHN analysis of charitable payments filed with the California Fair Political Practices Commission. The same year, it donated $9.75 million to a state covid relief fund.

In summer 2020, when local and state public health departments struggled to contain covid spread, the health care giant pledged $63 million in grant funding to help contract-tracing efforts.

KP’s influence extends beyond its massive charitable giving. Its CEO, Greg Adams, landed an appointment on the governor’s economic recovery task force early in the pandemic, and Newsom has showcased KP hospitals at vaccine media events throughout the state. 

“In California and across the U.S., the campaign contributions and the organizing, the lobbying, all of that stuff is important,” said Andrew Kelly, an assistant professor of health policy at California State University-East Bay. “But there’s a different type of power that comes from your ability to have this privileged position within public programs.”

https://californiahealthline.org/news/article/medicaid-kaiser-permanente-contract-newsom/

Lilly and Roche learn from Biogen’s mistakes

 When pharma companies have to remind investors to wait for confirmatory phase 3 results you can be sure that expectations had departed from reality. But this plea for patience was heard on two earnings calls yesterday – those of Roche and Lilly, both of which are nearing crucial readouts with their respective Alzheimer’s projects.

It was Biogen that had raised hopes of shortcuts to the Alzheimer’s market, of course; the beleaguered biotech also reported yesterday, laying bare the dismal repercussions of its pursuit of an approval without first generating real evidence of efficacy. No wonder Roche and Lilly are now backing away from such a strategy.

True, Roche had never sounded convinced about pursing accelerated approval for gantenerumab, but then the Swiss group has been struggling to generate strong signals from the project for years. It firmly walked away from this pathway yesterday, with the company’s head of pharma, Bill Anderson, insisting that the MAb had "to deliver two large, robust studies that are run to the end”.

“Physicians, patients, payers, want compelling evidence; in [Aduhelm’s] case they seem to be voting with their feet that they don’t have that yet,” he said in a clear swipe at Biogen.

Lilly had previously signalled a more aggressive approach to donanemab’s filing, emboldened by a well-received readout from Trailblazer-Alz last year. But in the wake of the CMS’s national coverage determination for Aduhelm, which applies to all amyloid-beta MAbs, it has decided to delay its accelerated approval submission, from this quarter to later in the year.

“The CMS draft NCD proposal … clearly reduces some of the ability to help patients faster than we were hoping for with the accelerated approval,” said Dan Skovronsky, Lilly’s chief science officer.

“What hasn't changed for us is the importance of the Trailblazer-Alz 2 readout,” he said, referring to the phase 3 trial due to yield topline results in mid-2023. If that study “provides positive confirmatory data we can't see a scenario where there's not global reimbursement, patient access and broad use of donanemab”.

On the horizon for the amyloid-beta space
Date	Project	Event
April	Aduhelm (and others)	Final NCD from CMS on US reimbursement
H2 2022	Donanemab; Lilly	Topline data from Trailblazer-Alz 4, H2H vs Aduhelm
Q3 2022	Lecanemab (BAN2401); Eisai and Biogen	Topline readout from phase 3 Clarity-AD
Q4 2022	Gantenerumab; Roche	Topline results from the ph3 Graduate programme
By YE 2022	N3pG 4; Lilly	Pivotal trials to start; amyloid-clearing project said to work similarly to donanemab but with potential for better dosing and administration
Mid-2023	Donanemab	Lilly to report topline data from ph3 Trailblazer-Alz 2
Source: company statements.

Lilly also seemed to level some criticism towards the CMS, saying it were “disappointed” with the position, because it negates any benefits patients can gain from the FDA’s accelerated approval pathway. Mr Skovronksy also warned that the NCD’s position could mean a slow launch for donanemab even if Trailblazer-Alz 2 was positive because it would take some months for the CMS to reconsider its position.

Lilly does not expect the final coverage decision, due in April, to change much, said Anne White, head of Lilly’s neuroscience division. The company is seeking confirmation from the CMS that should Trailblazer-Alz 2 succeed donanemab would be fully covered and a coverage decision “not be needed or appropriate”.

“We want that path for this coverage to be clearly laid out. We have been and will continue to meet with CMS to make our points known and to work through what that process is,” she said.

The CMS’s refusal to accept Biogen’s claims for Aduhelm’s efficacy have effectively scuppered the drug’s launch. The company reported a mere $1m of sales in the fourth quarter of 2021, up from $300,000 in the third quarter but still half of what the sellside was expecting. 

Biogen's chief executive, Michel Vounatsos, yesterday repeated his warning of having to take “aggressive steps” should the NCD remain in its current form. This means cuts and, probably, job losses. Realistically, however, until a planned phase 4 study called Envision yields data towards the end of this decade it is hard to see what Biogen can provide to change the CMS’s mind.

Wait for the data

As such, it falls to other amyloid-beta MAbs to support the class, and it could be another Biogen project that reports next. Phase 3 data on the Eisai-partnered lecanamab are due in the third quarter. Roche’s Graduate-1 and 2 studies will follow, the readout from which has shifted from the second half of this year to the fourth quarter, though the company denied that this was a delay.

An accelerated review submission has also been commenced for lecanemab, but with the CMS’s stance not expected to change it does raise the question why Eisai and Lilly are still pursuing this. 

Perhaps the slim chance that the CMS will loosen the purse strings makes it worthwhile. But it is becoming increasingly clear is that the Alzheimer’s disease market – at least where it concerns amyloid-beta MAbs – will take years to grow into anything substantial, if indeed there is a future here at all.

https://www.evaluate.com/vantage/articles/news/corporate-strategy/lilly-and-roche-learn-biogens-mistakes