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Saturday, July 3, 2021

Don't expand Medicare to cover dental benefits

 Congressional Democrats are currently considering expanding Medicare to cover dental services, but their plan fills the wrong gap. Though major unmet needs exist in dental care for the poor, the proposed expansion would cost an estimated $60 billion per year when fully phased in—four times more than what Medicaid currently spends on dental services—while doing little to make care more attainable to those who most need it. The proposal would also undermine the growth of Medicare Advantage, which has significantly increased the proportion of Medicare beneficiaries with dental coverage without imposing any such cost increase on taxpayers.

Despite its flaws, the proposal is rising to prominence. Senator Bernie Sanders has been pushing for Medicare to cover dental procedures for many years, and now can advance the plan as chairman of the Senate Budget Committee. Senate Majority Leader Charles Schumer (D-NY) is flirting with Sanders’s proposal as part of a potential $6 trillion spending package. If the legislation that passed the House in December 2019 as Section 601 of the H.R. 3 drug-price-control bill is any guide, the proposal would expand Medicare Part B to cover 80 percent of the cost of twice-yearly preventive dental care (oral exams, x-rays, cleanings) and basic procedures (fillings, extractions) and 50 percent of the cost of major dental services (root canals, crowns, dentures).

Gaps in dental coverage do exist. Though poor oral health can exacerbate or lead to other medical conditions, dental coverage was specifically excluded by statute from the traditional Medicare benefit, except where associated with major inpatient procedures. Whereas Medicare is responsible for 26 percent of hospital expenses, in 2019 it covered only 1 percent of dental costs.

Dental insurance is a recent phenomenon whose prevalence post-dates the creation of Medicare. As recently as 1962, only 0.5 percent of Americans had such plans. It was long thought to be a routine, low-variance expense for which individuals had less reason to pool risks to protect themselves from catastrophic costs. As employer-sponsored dental coverage is eligible for the same tax exemption as other health insurance, 66 percent of working-age adults, but only 34 percent of seniors, had such coverage in 2015.

But Medicare Advantage has since led to rapid gains in coverage for seniors. Such plans can attract enrollees by using whatever savings they generate in efficient procurement of medical services to offer supplemental benefits, including dental. The proportion of Medicare beneficiaries enrolled in Medicare Advantage has soared from 13 percent in 2005 to 43 percent in 2021; of these, 89 percent are enrolled in plans that cover preventive dental services, while 65 percent receive comprehensive dental coverage. In 2016, the Kaiser Family Foundation estimated that 18 percent of seniors received dental coverage through Medicare Advantage—already more than all other sources of coverage put together. This year, 38 percent of Medicare beneficiaries will receive dental coverage from Medicare Advantage. As a result, it’s likely that most seniors now have dental coverage, with Medicare Advantage benefits being spread more evenly across the income spectrum and offering the most generous coverage to low-income seniors.

Today, the distribution of unmet needs for dental care has more to do with income than with age. Sixty-five percent of seniors received dental care in the past 12 months, similar to the figure for working-age adults. Even before the rapid growth of Medicare Advantage, seniors were less likely to have untreated cavities than were working-age adults. Thirty-three percent of working-age adults with incomes under the Medicaid eligibility cutoff, compared with only 6 percent of seniors with incomes above that cutoff, cited financial barriers as a reason for failing to obtain needed dental care.

It is Medicaid that falls short of delivering adequate dental care to those it is supposed to be helping. Spending on dental services under Medicaid is highly concentrated on low-income kids, whom states are required to cover, and is typically slim or nonexistent for seniors, whom they are not. While 39 percent of children in 2015 received dental coverage under Medicaid, only 7 percent of adults did. Just 36 states currently cover preventative or restorative dental procedures under Medicaid for low-income adults, including seniors. In 2014, Medicaid payments for dental services averaged 40 percent of rates paid by private insurers. As a result, only 43 percent of dentists currently accept Medicaid patients, even when beneficiaries are nominally eligible.

Recent changes haven’t helped. As the Affordable Care Act’s expansion of Medicaid eligibility to childless adults was unaccompanied by increases in dental reimbursement rates, the increase in dental visits that it caused among childless adults seems to come at the cost of a decline in access to dental care among previously eligible adults. Medicaid’s dental benefits and reimbursement rates typically suffer retrenchment during periods when state budgets are squeezed.

The Democrats’ proposed dental benefit would cost more than four times the $14 billion that Medicaid currently spends on dental care every year—aid that would not be targeted to those who most need it. Though the proposal would assume the bulk of dental costs for wealthier seniors, substantial coinsurance would likely continue to deter poorer enrollees from seeking treatment. States may still be unforthcoming with the funds needed to help them.

A better solution is possible. Expressing opposition to a universal dental benefit under Medicare, the American Dental Association once stated: “Congress should target whatever limited federal resources are available toward robust and adequately funded Medicaid coverage for poor adults, which would include many seniors.” That’s the right approach—and the rapid growth of dental coverage for Medicare beneficiaries through Medicare Advantage, funded with efficiency gains rather than extra costs, only adds to its wisdom.

Sellas: Promising Data from Combination Trials in Ovarian Cancer, Mesothelioma

 Positive results from Sellas Life Sciences Group’s Phase I/II trial using galinpepimut-S (GPS) as a combination therapy with pembrolizumab (Keytruda®) were announced Wednesday, shortly after similarly positive news was issued from a combination study in which GPS was evaluated as a treatment for mesothelioma.

Although both trials are small – 11 and 4 persons, respectively – they are part of a broad strategy that involves multiple studies to investigate GPS as a therapy for several conditions. In that context, their results support each other and Sella’s overall effort to gather safety and efficacy data from diverse patient populations.

GPS is a Wilms Tumor-1 (WT1)-targeting peptide immunotherapeutic. For the ovarian cancer study, it was used in combination with the checkpoint inhibitor Keytruda® to treat patients diagnosed with second- or third-line WT1(+) relapsed or refractory platinum-resistant, advanced metastatic ovarian cancer. Of the 11 patients in this study, nearly 67% had failed second-line therapies or were refractory, and all were resistant to the standard of care platinum-based therapy. They were expected to survive 9 to 12 months.

An ad hoc analysis at 15-week follow-up showed that nearly 64% of the patients were stable or are responding to the combination therapy. More than nine months after their initial treatment, all 11 are still alive. Median overall survival, therefore, remains unknown.

Preliminary evidence from the Phase I trial of GPS administered as a combination therapy with nivolumab (Opdivo®) as a treatment for mesothelioma showed improvement in median survival of about half a year. Sellas reported median survival of 35.4 weeks after one month of GPS treatment, compared to 28 weeks for patients receiving standard of care (pemetrexed, a chemotherapy), for relapsed/refractory patients. This trial involved only four patients, however.

Such gains are “signals that a combination approach could have a benefit for patients,” Angelos Stergiou, M.D., Sc.D. h.c., president and CEO of Sellas, told BioSpace.

“The fundamental news from the mesothelioma study is that it seems to be safe and tolerable,” Stergiou said. “We went after a very serious disease state and showed a meaningful survival rate, even in the one patient with the sarcoma-toid variant.” That patient was diagnosed with Stage IV cancer and, so far, has survived 25 months – several months longer than usual for those receiving standard of care. (The expected survival for this patient under standard of care treatment was 12 to 18 weeks.)

“We expect to have follow-up data by the end of the year in a large patient sample,” he added.

“Sellas specializes in immunotherapy focused around the development of Wilms Tumor 1 antigen, which was designated as the number one immunotherapy target by the National Cancer Institute,” he said.  WT1 antigen is expressed in the cell nuclei of 75% of mesotheliomas and 93% of ovarian serous carcinomas, for example. There are approximately 20 tumor types that overexpress WT-1 antigen, thus suggesting GPS could have substantial application.

GPS is made of four peptide chains. Two of those (CD4+ and CD8+) induce a strong innate response against the WT1 antigen and access multiple HLA types. When administered, therefore, the immune system recognizes and destroys cancer cells and can continue to do so, targeting recurring tumors and residual cancer cells. Consequently, Stergiou said, “Patients can stay in remission longer and, hopefully, this will translate into longer overall survival.”

In most cases, GPS is not envisioned as a stand-alone therapy. “GPS, when used alone, isn’t built to debulk tumors,” he said. Instead, it works synergistically with immunotherapies – notably, Opdivo® and Keytruda® – that modulate the hostile tumor microenvironment. Then, when GPS is injected, “GPS increases the antigen-specific effector T cells and shepherds them, focusing the immune response to specific epitopes for optimal T cell response,” Stergiou said.

Based on that mechanism of action, GPS may have potential as a monotherapy for patients who are in complete remission. That hypothesis is being tested in the ongoing Phase III study of AML patients.

“Our lead program (currently in Phase III) is in acute myeloid leukemia for patients in their second remission,” Stergiou said. Earlier, Phase II data, showed notably longer survival rates for patients in their second complete remission – 21 months for those receiving GPS therapy versus 5.4 months for those receiving standard of care treatment.

The Phase III program began in January. It is a 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance period to investigators’ choices of therapy in ALS patients who have achieved complete remission after second-line antileukemic therapy, and who are ineligible or unable to participate in stem-cell transplantation. Ultimately, Sellas plans to enroll 116 patients across 50 clinical sites in the U.S. and Europe.

https://www.biospace.com/article/sellas-reports-promising-data-from-combination-trials-in-ovarian-cancer-and-mesothelioma/

Can cell therapy treat muscular dystrophy? German billionaire's anti-aging startup aims to find out

 Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?


Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professors Gabsang Lee and Kathryn Wagner. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.


The startup is the second portfolio company unveiled by Cambrian Biopharma, the anti-aging portfolio company launched last year by ATAI co-founder Christian Angermayer. (The first was the now public cancer startup, Sensei Bio). Cambrian is taking the approach ATAI took to psychedelic therapies, bringing a broad range of related companies under a single roof, and applying it anti-aging therapies, said CEO and co-founder James Peyer.


They’ve invested in several technologies that could slow or reverse the effects of aging, such as boosting mitochondria or regenerating tissue. But they’re applying them first in diseases where they could have a more immediate impact.


For muscular dystrophies, Vita will try to take the same strategy that CRISPR Therapeutics and other gene editing companies have used for genetic blood disorders such as sickle cell disease. This is not a simple task: Doctors have decades of experience removing and replacing a patient’s blood cells — and over a decade of experience engineering those cells — but it’s not as if you can just extract all of a patient’s muscle cells and then put them back.


Accordingly, companies such as AskBio and Sarepta devised ways of correcting muscle cells in vivo, strapping healthy genes onto (mostly) harmless viruses and administering them to patients as gene therapy. That process, though, has faced a number of hurdles: The genes involved don’t fit well onto the viruses used for gene therapy and the viruses don’t reach all the muscle. Early clinical trials yielded mixed results.


Peyer said Vita doesn’t need to replace all a patient’s muscle cells. Instead, they’ll take cells from a patient’s blood, turn them into stem cells in the lab, use CRISPR to correct the disease-causing mutations and finally manipulate them into a class of cells called myosatellite cells. These cells are responsible for producing mature muscle cells.


Vita, led by first time CEO Doug Falk and Hopkins professor Peter Anderson as CSO, believes that they can inject these cells into different parts of the body, where they will produce healthy muscle cells that can replace the damaged ones.


“We have this amazing data in mice that they reintegrate into the muscles,” Peyer told Endpoints News. “And in the mice can improve time on a treadmill or grip strength… It’s really awesome functional outcomes.”


Vita will look to start a clinical trial next year for limb girdle dystrophy, where they will compete with a gene therapy from Sarepta. But even if the therapy works, Peyer acknowledged there will be steep limitations.


For one, it’s not clear how long the cells will last. And although the approach might work to replenish muscle cells in the limbs, there are no myosatellite cells in the heart. For many patients with muscular dystrophy, including those with Duchenne, it’s degeneration in these vital muscles that ultimately brings the worst symptoms and death.


“Yeah,” Peyer said, “That’s why we’re not starting immediately DMD.”

https://endpts.com/can-a-cell-therapy-treat-muscular-dystrophy-a-german-billionaires-anti-aging-startup-is-trying-to-find-out/

ICER revises its view of Aduhelm’s price – but not by much

 The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company.

The cost-effectiveness watchdog has revised its calculation of a fair price range for Aduhelm (aducanumab) upwards, but only by a small amount.

Biogen would still have to cut the $56,000 list price for a year’s treatment with the drug by 85% to 95% to reach ICER’s new $3,000 to $8,400 range, up marginally from the $2,500 to $8,300 range set in its earlier draft analysis.

The only reason for the change is that the FDA-approved labelling for the drug requires fewer MRI scans per patient than were carried out during clinical trials of the anti-amyloid antibody.

That’s small comfort for Biogen, given that US lawmakers have launched an investigation into Aduhelm’s price as well as the sequence of events that led to the drug’s approval despite questions about its clinical benefit.

The Kaiser Family Foundation recently estimated that of prescribed at full price, Medicare could spend $57 billion or more per year on Aduhelm – more than Medicare Part B outpatient cover spends on all other drugs combined.

Discussing the latest update, ICER’s chief medical officer David Rind acknowledged that the first effective therapy with Alzheimer’s will warrant “a very high price in the US health system,” but the non-profit group is adamant that Aduhelm does not fit the bill.

“After months of delving into the data, and working with patient groups, clinical experts, and the manufacturer to gain their perspectives, our judgment remains that the evidence on aducanumab is insufficient to be able to demonstrate that patients get benefits that would outweigh the risks and harms of this treatment,” he said.

Biogen’s price would only be in the acceptable range of $50,000 to $70,000 per year for a hypothetical therapy that – when given as a maintenance therapy – could completely halt the progression of dementia in people with Alzheimer’s.

ICER’s assessment has been challenged by a number of groups including the Alzheimer’s Association which challenges its decision to “blend” data from the two phase 3 trials submitted in support of Aduhelm’s approval, and for overplaying the side effects of the antibody which it says are “manageable”.

It isn’t defending Biogen’s price though, describing it earlier this month as “unacceptable” and for many patient “an insurmountable barrier to access”.

Biogen – and other amyloid drug developers Eli Lilly and Genentech – also took issue with ICER’s methodology, including the way it has calculated cost per quality adjusted life year (QALY) figures – a widely used measure of cost-effectiveness used by health technology assessment (HTA) agencies.

They also said the analysis failed to take into account the wider burden of Alzheimer’s on society as a whole.

Biogen will have an opportunity to defend its pricing of Aduhelm at an ICER-sponsored meeting scheduled for 15 July that will hear representation from the company, neurologists, patients, the Alzheimer’s association, payer organisations and former FDA Commissioner Mark McLellan.

https://pharmaphorum.com/news/icer-revises-its-view-of-aduhelms-price-but-not-by-much/

Merck partners neuroloop on bioelectronic device for inflammation

 Merck KGaA has joined forces with a unit of medtech firm B Braun – neuroloop – on a way to treat inflammatory diseases using neurostimulator devices.

The German drugmaker will work with startup neuroloop on bioelectronics, put simply the harnessing of electrical stimulation to treat human disease, with a focus on chronic conditions like arthritis and inflammatory bowel disease.

neuroloop – a spinout of Freiburg University in Germany formed in 2016 – has been working to date on using its device as an implant to lower blood pressure, among other applications. The Merck collaboration will concentrate on using the device alongside anti-inflammatory drug therapies.

Merck chief executive Belén Garijo said that these kind of neurostimulator approaches “show great promise in helping to improve therapeutic outcomes and efficiency for patients with chronic inflammatory diseases.”

The tie-up with neuroloop and B Braun will bring together their expertise in this area with Merck’s knowhow in “electronics, medicines and drug delivery,” he added.

The German startup has developed a cuff electrode that allows selective stimulation of fibres in the vagus nerve, which carries an extensive range of signals from the body to the brain and vice versa.

One hypothetical neural circuit – known as the ‘inflammatory reflex’ – is thought to ferry sensory information about inflammation to the brain as well as anti-inflammatory signals back to the cells in tissues.

An open-label, proof-of-concept study looking at a vagus nerve-stimulating implant as a therapy for rheumatoid arthritis was published in 2016, showing that the device was able to reduce the production of inflammatory cytokines in the body and finding some evidence of reduced disease severity.

The approach sounds simple in principle, but neuroloop chief executive Michael Lauk cautioned that “identifying the specific disease relevant nerve signal patterns and subsequently modulating these signals via stimulation are major challenges in the field of bioelectronics.”

“Together with the strong preclinical and clinical expertise of Merck and our platform which enables multi-channel selective stimulation, we are well positioned to potentially solve these crucial challenges and offer neurostimulator treatment to patients suffering from chronic inflammatory diseases,” he added.

Merck and its partners are hoping to have initial data from trials of the bioelectronic device by the end of 2022 , which will then be used to establish a clinical development plan with an eye on getting approvals in major markets like Europe and the US.

The drugmaker – which has made bioelectronics a key research area along with other pharma companies like GlaxoSmithKline – says novel bioelectronic devices also have the potential to monitor disease conditions.

https://pharmaphorum.com/news/merck-partners-neuroloop-on-bioelectronic-device-for-inflammation/

Medicaid expansion didn't lead to changes in hospitalizations in safety-net facilities: Study

 The Affordable Care Act’s Medicaid expansion did not lead to patients migrating from safety-net hospitals to other facilities, underpinning a major goal of the initiative, a new study found.

The study conducted by Boston Medical Center and published in the Journal of the American Medical Association Wednesday comes as the Biden administration has made improving access to care and erasing racial and ethnic minority coverage gaps a major priority.

“While we thought that the expansion of Medicaid might lead some racial/ethnic minority patients to transfer their care to non-safety-net hospitals, where specialty care services might often be more accessible, our study results demonstrate that was not the case,” said Karen Lasser, the lead study author, in a statement.

Researchers looked at discharge data from 11 states that expanded Medicaid under ACA and six that did not. All the states had 18.2 million Medicaid and uninsured patient discharges, with nearly 60% from states with expanded Medicaid and 40.6% in non-expansion states, a release on the study said.


The study found no significant changes in safety-net hospitalizations among Medicaid or uninsured patients in states that did and did not expand Medicaid. There were also no major changes among racial and ethnic minority groups or among low-income patients.

“It is possible that patients are satisfied with the care they receive and benefit from services that may be unavailable in other settings, such as assistance with insurance, interpretation and case management,” the study said.

But another theory is that the “persistence of structural racism and residential segregation prevents patients from transferring care to non-[safety-net hospitals],” the study said. “Extending health insurance coverage alone appears insufficient to reduce hospital segregations by race/ethnicity or socioeconomic status.”

The study could inform the Biden administration’s efforts to close racial and ethnic disparities in healthcare. The Department of Health and Human Services is exploring new requirements including hospitals to produce race and ethnicity data as part of payment models.

The White House is also making moves to get 12 holdout states to sign up for Medicaid expansion. The American Rescue Plan Act raised the federal matching rate by 5% for Medicaid payments for newly expanded states.

https://www.fiercehealthcare.com/hospitals/study-medicaid-expansion-didn-t-lead-to-changes-hospitalizations-safety-net-facilities

Stephens starts HealthEquity at Overweight, target $100

 

  • Stephens initiated coverage of HealthEquity (HQY) with an Overweight rating and $100 price target. The firm believes as the largest health savings account custodian, HealthEquity is well positioned to benefit from industry growth trends as higher-deductible health plans are becoming more of the norm. The firm sees near and longer-term catalysts that should drive above-peer top and bottom line growth.