US Treasury Secretary Scott Bessent met with insurance regulators to talk about their exposure to private credit as the increasingly complex ties between the two sectors fuels mounting regulatory scrutiny.
The meeting Thursday with the National Association of Insurance Commissioners, a standard-setting body composed of state insurance regulators, also focused on the off-shoring of life insurance and annuities reserves through reinsurers, the Treasury Department said in a statement.
The head of the International Energy Agency is urging Canada to move more quickly to develop and export its energy resources, warning that market conditions will only favor the country for so long.
Typically, countries buy energy based on price. But in the aftermath of the Iran war, “there will be an energy security risk premium,” Fatih Birol, the IEA’s executive director, told a policy conference in Toronto on Thursday. As a result, “the most important resource, or card, that Canada has today is trust.”
Targeting an inflammatory pathway in diabetic macular edema (DME), in addition to angiogenesis, led to greater improvement in visual acuity and retinal anatomy, a randomized trial showed.
Single-agent ranibizumab (Lucentis: Genentech/Roche) improved best corrected visual acuity (BCVA) by 9.4 letters at 44-48 weeks, which increased to 12.8 letters with the addition of the interleukin (IL)-6 inhibitor vamikibart. Central subfield thickness (CST) declined by an average of 192 µm with ranibizumab alone, increasing to 202 µm when vamikibart was added. More patients treated with the combination had large improvements in BCVA (≥15 letters), normalization of CST (<325 µm), and resolution of macular edema.
The combination was associated with more intraocular inflammation and elevated intraocular pressure (IOP), but cataract events occurred in a similar proportion of patients in the two treatment arms, reported Roger Goldberg, MD, of Bay Area Retina Associates in Walnut Creek, California, at the Association for Research in Vision and Ophthalmology meeting.
A separate trial of vamikibart monotherapy in DME showed the IL-6 inhibitor improved visual acuity and CST, independent of VEGF inhibition, although the improvements were less than those observed with single-agent ranibizumab.
"IL-6 inhibition, in conjunction with an anti-VEGF, really offers an opportunity to help our DME patients, in terms of best corrected visual acuity and in terms of CST," said Goldberg. "We did see, in the combination arm, issues around intraocular inflammation... . But I think [the two trials] taken together show that IL-6 inhibition offers a distinct benefit that's isolated from VEGF blockade alone. There's an ongoing phase I trial investigating a single molecule, a bispecific antibody, targeting both VEGF and IL-6 in patients with DME, with a single injection."
During a discussion that followed the presentation, an unidentified member of the audience noted that even with the addition of a second drug, a substantial proportion of patients did not meet generally accepted criteria for response.
"I think IL-6 will be an important step forward, but we know that DME is a heterogeneous, complex, multifactorial disease," said Goldberg. "A single silver bullet, VEGF inhibition, works great but isn't for all of our patients. I don't think the IL-6 silver bullet, just targeting that one pathway, is going to be enough for all of the patients because not all of the patients have IL-6-mediated inflammation."
"What are the biomarkers we can look for to help us better personalize medicine and give patients the exact therapy that they need?" he continued. "I do think we will get there. Having multiple tools in our toolbox is going to be part of the solution to giving patients personalized medicine and treatment that's going to be best for that patient."
Baseline BCVA also should be considered when evaluating treatment response, said Arshad Khanani, MD, of Sierra Eye Associates in Reno, Nevada, who presented findings from the monotherapy trial. Patients with higher baseline BCVA have less room for improvement. More questions will arise and have to be addressed as the field moves forward.
"I think this really is a pivotal moment for our field, to have a validated new MOA [mechanism of action] for our patients with diabetic macular edema," said Khanani. "As the field evolves, is it just two pathways? Is it more than two? What do we need to target?"
Inflammation and DME
Increasingly, the field of ophthalmology has recognized inflammation as a key contributor to DME. Historically, corticosteroids have been used to mitigate the effects of inflammation, but the drugs have well-known safety issues, said Goldberg. VEGF inhibition remains standard of care for DME, but an unmet clinical need exists for well-tolerated treatments that can target inflammation in DME.
IL-6 is elevated in ocular fluids of patients with DME and has a pivotal role in DME pathogenesis, including vascular leakage, leukocyte infiltration, and chronic inflammation.
Vamikibart is a recombinant humanized anti-IL-6 antibody specifically designed for intravitreal delivery, said Goldberg. In a phase I trial vamikibart demonstrated rapid and sustained suppression of IL-6 in the aqueous humor of patients with uveitic macular edema.
Goldberg reported findings from the phase II BARDENAS trial involving patients with type 1 or 2 diabetes and center-involving DME with CST ≥325 µm. The patients were randomized to vamikibart and ranibizumab every 4 weeks or ranibizumab alone. Investigators randomized a total of 187 patients, and the primary endpoint was the change in BCVA during weeks 44-48 in previously untreated patients (n=124).
Baseline characteristics for the untreated subgroup included a mean age of 61-62, majority male (59-67%), mean BCVA 62-64 letters, and mean CST of 482-502 µm.
The primary analysis showing a 3.4-letter improvement in BCVA during weeks 44-48 met prespecified criteria for statistical significance (P=0.0625, prespecified P=0.1). More patients in the combination arm had at least a 15-letter improvement (44.7% vs 28.6%). The difference in CST improvement did not achieve statistical significance, but more patients in the combination arm had CST <325 µm (85.1% vs 71.4%).
Treatment-related ocular AEs occurred more often in the combination arm (10 related to vamikibart, six to ranibizumab) versus ranibizumab monotherapy (four), and more patients stopped one or both drugs in the combination arm (10 vamikibart, eight ranibizumab) than in the monotherapy arm (one).
Intraocular inflammation occurred in nine patients in the combination arm, and two patients developed retinal occlusive vasculitis, versus none treated with single-agent ranibizumab.
Single-Agent Vamikibart
Khanani reported findings from the phase II ALLUVIUM trial evaluating three dosing levels of vamikibart and single-agent ranibizumab. The primary endpoint was change in BCVA in previously untreated patients (n=259) at weeks 44-48. The trial was not designed as a direct comparison of vamikibart and ranibizumab but to evaluate the efficacy of the IL-6 inhibitor.
The primary analysis showed patients randomized to vamikibart had BCVA improvement of about five to seven letters across the three dose levels. The improvement averaged 13 letters in the ranibizumab arm. Across the three vamikibart dosing groups, 15-23% of patients had at least a 15-letter improvement in BCVA (40% in the ranibizumab arm).
An analysis of all patients (N=394), regardless of treatment history, showed BCVA improvement of three to five letters with vamikibart. Across the three doses of vamikibart, 10-18% of patients had at least a 15-letter improvement in BCVA.
Vamikibart treatment led to CST improvement of 50-70 µm in previously untreated patients, 33-40% of whom had resolution of DME, defined as CST <325 µm. Results were similar in the all-comer analysis.
Disclosures
Both studies were supported by Roche/Genentech, and company employees participated in the studies.
Goldberg submitted an extensive list of financial disclosures, including a relationship with the study sponsor.
Khanani submitted an extensive list of financial disclosures, including a relationship with the study sponsor.
Daniel M. Blumberger, M.D. daniel.blumberger@camh.ca, Fidel Vila Rodriguez, M.D., Shawn M. McClintock, Ph.D., Kevin E. Thorpe, M.Math., Amer M. Burhan, M.B.Ch.B., Karen Foley, M.D., Michelle S. Goodman, Ph.D., … Show All … , and Zafiris J. Daskalakis, M.D.
https://doi.org/10.1176/appi.ajp.20250955
In this interview, Stephen Parente, PhD, MPH, chair of health finance at the University of Minnesota, who served on the U.S. Council of Economic Advisers during both the first Trump administration and the Biden administration, says he likes high-deductible plans because people need to "have some skin in the game."
"A serious event like a cancer diagnosis, they might be out $10,000, but the lion's share of recovery that will cost $300,000 will be paid," he said. "My benchmark is that if the out-of-pocket payment is less than the base model Kia, then we're okay."
What has been the greatest contributor to high healthcare costs in the U.S.?
Parente: Probably the greatest contributor is the relatively higher prices that we have in the U.S. compared to most other countries. It's well documented that many of our providers ... get paid more than others. And there are also more of our folks [that have jobs] in the healthcare industry than in other places. That probably contributes to the lion's share of it.
Has physician pay contributed to high costs?
Parente: It has ... but with a big caveat. If you look at the average salary for an internal medicine physician ... it might be a little higher in the U.S. compared to most other industrialized countries, say Germany or France. But where there really is a difference is in the specialties. So there are not many instances where physicians say, even in Switzerland, would be earning more than a million dollars, whereas in the U.S., that's quite common, whether it's orthopedics, anesthesiology, radiology, oncology. They're really vital specialty areas, but they're also ones that have a much higher net payment to physicians than most others.
Have administrative costs contributed to high costs?
Parente: It definitely is a factor. I wouldn't say it's the most overwhelming factor. It's hard to quantify these things in different countries.
Just through our insurance system and third-party payments, whether or not it's through Medicare or Medicaid, we pay more to process the money that keeps our healthcare system operational. Whereas if you look at the U.K. or other countries, there's a central budget model. It's collected through taxation. People are paid salaries. There might be some elements of public insurance that's associated with it. But they're generally government-run and a little more efficient.
One thing to keep in mind, too, is while we say Medicare is very efficient, it's important to understand that Medicare itself does not pay any claims. Medicare contracts out all of its claims payments to this entire ecosystem of private health insurers and has since its inception in 1967. And that cost is never adequately accounted for when we talk about all the administrative savings that, say, a Medicare-for-All plan would have.
What is the best solution you've heard for lowering the cost of healthcare?
Parente: I think people need to ... have some skin in the game. They need to have some coverage for something that's serious and catastrophic. They need to have some coverage for preventive care. But by-and-large ... people should be paying out of their own pockets.
I'm a big fan of high-deductible health plans. They are, by their design, more affordable because it's just like car insurance. If you have a higher deductible car insurance policy or homeowners policy, your premium is less. They're more affordable. But there are rules in the Affordable Care Act that say that even if you have a high-deductible policy, there still needs to be coverage, pre-deductible, for office visits and certain preventive services and tests. I actually worked on policy so that in addition to primary coverage, secondary coverage -- meaning if I have diabetes, I can get insulin pre-deductible for free or at a very low cost -- that was something that came about 5 or 6 years ago, but it's not talked about quite as much.
Those types of things typically put into check this issue that I and other economists talk about, moral hazard, where it's like the benefit designs are too generous if they have first-dollar coverage all the way through. It's just a statistical fact that if you have a high-deductible health plan, the premiums will be less, consumers will be more engaged. A serious event like a cancer diagnosis, they might be out $10,000, but the lion's share of recovery that will cost $300,000 will be paid. My benchmark is that if the out-of-pocket payment is less than the base model Kia, then we're okay.
[It has to be] combined with price transparency. If we're actually going to have this work like a market and give people the incentives to shop for things ... the Trump administration and the Biden administration, too, has tried to make that information more available. It's just that we haven't really gotten to that point where what we see on Amazon or Expedia allows us to buy things as easily as what we see in the marketplace today. But it's coming, I'm hoping.
Would greater transparency in pricing help bring costs down?
Parente: Greater transparency at the margin can definitely bring costs down for consumers. Full disclosure, I've worked in this space wearing three different hats -- an academic hat, a government hat, and an entrepreneur hat. I actually have an app that anyone can use called MyMedVita. What we've tried to do is take what CMS defines as shoppable services -- there are 70 of them. This is where the money could be saved. Those shoppable services account for about 10% of spend in healthcare dollars.
The truth is, most consumers are just not used to thinking this way. ... They don't think of it the way we think about shopping for lawnmowers or anything else. But what I'm hoping is, eventually ... let's appeal to the digital natives while they're young and they're shopping and they're relatively healthy and they don't need that coronary artery bypass. Let's see if they get it and then tell their friends and family, why are you paying so much money? Check out this [app] instead.
As an academic and someone who's been evangelical about this, what frustrated me was that I played a role in getting that data out there, but just saw that no one was using it for years.
Would having a single payer help control costs?
Parente: I think a single payer would probably help control [costs], but the question is how that single payer is going to operate. The most extreme illustration of a single payer controlling costs is the British National Health Service. ... A certain percent of GDP [gross domestic product] is allocated. There are different ways that the money is incentivized with general practitioners, but for the most part, it's a central budget model. It's predictable. But there's also the potential for rationing as well, depending upon where people flex in their budget.
The other model people talk about is Medicare for All. Taxation comes in, money goes out. The question then becomes, if it is that system, how generous is the design? Is it first-dollar coverage or are there other criteria for it? The thing that people have to understand about Medicare for All is that if it truly operates under the Medicare fee-for-service rules, it's a very expensive system to operate because there is no medical management. There's no utilization management. There's no disease management that you'd see in managed care, by law. It sticks to the original 1967 statute that more or less says the physician's decision is sacrosanct.
Another opportunity is instead of Medicare for All, do Medicare Advantage for All. That would effectively take the system that we have now that people are generally comfortable with, put them into a bid structure for their plans, have performance metrics, have some utilization management, and probably would work better. Then again, there's a question of budget constraints that people have to worry about too.
Will artificial intelligence (AI) be able to help control healthcare costs?
Parente: I think AI has potential to help control costs. There are certainly some ways that AI can play a role to help consumers navigate benefits and other things better. But there are still some realities that FDA has not really weighed in on, [such as] to what extent AI can replace a practitioner.
I think what people are most excited is about drug discovery, new innovations, things that people haven't seen before. And there we have a problem because to make these things work, like a large language model, the more data, the better to find those edge cases that really show something that really might be never seen before. And our data, while it's electronic for healthcare, doesn't move that freely. You know, this is where the hospital systems that invest in Epic or something else like that are more or less closed wall systems. There is the possibility, you know, Epic allows for the data to be linked, but it's not ubiquitous.
We as a culture are very concerned about privacy of our data, particularly medical data. Other cultures are not. And so not naming countries per se, but to the extent that the data flows more freely to a large language model that looks at all medical records and imaging, and ours doesn't, that could be a strategic disadvantage to us.
https://www.medpagetoday.com/special-reports/features/121027
Starting in July, Medicare beneficiaries may be able to get a GLP-1 prescription for weight loss for $50 a month. It's a notable shift for Medicare, which has long been barred from covering weight loss treatments.
The drugs, such as semaglutide (Wegovy) and tirzepatide (Zepbound), are effective but can be expensive without insurance coverage. They're available in injection or pill form. Even with discounts, current cash prices typically range from $149 to $699 per month.
About half of GLP-1 users say these drugs were difficult for them to afford, according to KFF polling. A quarter said they were "very difficult" to afford.
But the new Medicare benefit comes with caveats, particularly around clinical guidelines and what happens when the short-term program ends.
What Is This Program?
The initiative, announced by CMS, is a short-term pilot program known as the Medicare GLP-1 Bridge. It will run from July 1, 2026, through Dec. 31, 2027. It's meant to "bridge" the gap before a longer-term program that might -- or might not -- begin in 2028.
The pilot program will offer coverage for the following GLP-1 medications approved for weight loss: the pill and injectable formulations of semaglutide, the KwikPen formulation of tirzepatide, and the orforglipron (Foundayo) pill.
Who Can Participate?
To get access to these weight loss medications, a patient must be enrolled in Medicare Part D, which covers prescription drugs. After that, eligibility is based mainly on body weight and health status. People will qualify if they have a body mass index (BMI) of 27 or higher and have a condition such as heart disease or prediabetes, among others. People with BMIs of 35 or higher automatically qualify. About 40% of American adults are clinically obese, with a BMI of 30 or higher, according to the CDC.
How the Program Works (It's a Bit Unusual)
This is not a typical Medicare benefit. Even though Part D enrollment is required, the Bridge program itself works differently.
Instead of going through the regular Part D plan, patients will need a prior authorization. Doctors will need to send the prescription to a central system run by CMS contractor Humana, using a system already in place for another Medicare drug program. Doctors don't need to be enrolled as Medicare providers to write a prescription or submit a prior authorization request under this program. Once they get approval, patients will pay the flat $50 copayment at the pharmacy when they pick up the prescription.
What Are the Benefits?
The cost savings could make these drugs accessible to patients who simply couldn't afford them before. Even with discounts, the prices can be daunting without insurance coverage. TrumpRx, a new government website, provides links to direct-to-consumer prescription drug discounts for patients not using their health insurance. On that site, semaglutide injectables range in price from $199 for a lower dosage for the first 2 months to $399 for a higher dosage. The KwikPen formulation of tirzepatide costs up to $699 per month. At the highest dosages, the daily semaglutide pill for weight loss costs up to $299 while orforglipron tops out at $349.
Most people who use these drugs will need a higher dose to maintain weight loss. The Bridge program is unique in that it offers a predictable $50 copayment that does not go up as dosages increase.
What Are the Downsides?
Like many pilot programs, there are trade-offs. The $50 copay will not count toward the Part D deductible, nor does it count toward the $2,100 annual out-of-pocket cap on prescription drug costs. The pilot program will also end in December 2027. Most studies have shown that many people who stop using the GLP-1 drugs regain weight they lost while taking them.
Still Obstacles for Those With Low Incomes
If a patient receives a low-income subsidy, also known as the Medicare Extra Help program, they cannot use that assistance for the drugs covered by the GLP-1 Bridge program. For beneficiaries accustomed to paying a $5 or $10 copay for their pharmaceuticals, a $50 copay could still be a big financial barrier.
"Fifty dollars a month sounds like a great deal compared to paying the discounted prices through TrumpRx and these other direct-to-consumer options, but it's a lot of money for somebody who's living on a $750-a-month Social Security check," said Juliette Cubanski, PhD, MPH, deputy director of the Program on Medicare Policy at KFF, a health information nonprofit that includes KFF Health News.
The $50 Copay Is Only for Weight Loss
Patients already taking one of these medications for a qualifying condition -- such as type 2 diabetes, cardiovascular disease risk reduction, or sleep apnea -- will continue to get it through their regular Part D plan. That means they'll pay the plan's price, which may be higher than the $50 Bridge copay, meaning the same drug could cost different amounts depending on the reason it is prescribed.
Patients already on GLP-1 drugs for weight loss may qualify for the Bridge program. Prescribers will need to attest that the patient met the clinical criteria when they first started the medication. For example, if a patient started a GLP-1 drug in September 2024 with a BMI of 37 but in July 2026 they've lost weight and now have a BMI of 34, the prescriber should attest in the prior authorization request that they met the BMI criteria of 35 or over when the GLP-1 therapy started.
What Happens After 2027?
The Trump administration had proposed a two-step approach to expand coverage of GLP-1 medications for obesity in Medicare. The Bridge program was initially planned to last 6 months -- after that, the idea was to launch a longer-term program that would shift the cost of the drugs from the government to insurers. A recent study found the long-term program would have cost insurance companies billions of dollars in the first year. Not enough insurers signed on for the voluntary plan by the April deadline, so CMS instead announced it would extend the Bridge program to 18 months, with a new end date of December 2027.
The move will give insurance companies more data on how many people with Medicare get GLP-1 drugs during the Bridge program and more time to negotiate with the Trump administration.
But extending the Bridge program will be "really expensive" for Medicare, Cubanski said, because the program heavily subsidizes the cost of the drugs.
"There's no sense right now of the cost of the Bridge model, but it is likely to be billions of dollars a year in additional spending for Medicare," Cubanski said.
The cost to Medicare will depend largely on how many people use the Bridge program. CMS has not provided any projections publicly, but a previous KFF analysis estimated that in 2020 close to 14 million Medicare beneficiaries were overweight or obese.
"This will just cost additional money, and we don't know how much, because they haven't disclosed it," Cubanski said.
https://www.medpagetoday.com/publichealthpolicy/medicare/121154
