Analysts shrug

Unless you were under a rock, you saw yesterday’s news that Medicare negotiated a better deal than the private market for some of the program’s top-selling drugs.

Why it matters: 

So what? How meaningful is that difference, and what will the longer-term effects be?

  • Some seniors will likely pay less out of pocket for drugs (that’s a whole topic that we’re not going to get into right now), and that obviously matters to patients. But how pharma interprets the negotiated prices and reacts to them will have a huge impact on future drug development.

Our thought bubble: 

Democrats are thrilled, Republicans are appalled. The drug industry is complaining publicly but telling investors everything is fine.

  • For all of the uproar this law caused when it was passed, the financial world’s reaction to today’s rollout made everything seem pretty good — for now (more on that below).

Between the lines: 

The announced prices — an overall 22% reduction in net spending but no details on individual drugs’ net price reductions — are less drastic than some feared.

  • “There are strong price reductions, but it also shows there is plenty of room for the industry to continue to make some profits on these drugs,” Vanderbilt’s Stacie Dusetzina said.

Analysts are reacting much more neutrally than the politicians.

  • In a note titled “CMS Spins, Pharma Wins (Relatively),” Raymond James analyst Chris Meekins wrote that “the impact is far less than politicians proclaimed and the industry as a whole seems to be managing this fine so far.”
  • And in a note titled “Sigh of Relief,” Leerink analysts concluded that “22% is not as bad as anticipated earlier this year,” though recent earnings calls had assuaged fears somewhat.

Where it stands: 

No one knows for sure the net prices of Part D drugs, much less what they would have otherwise been in 2026. But there are some estimates, and Medicare’s negotiated rate is generally lower than those estimates.

The big picture: 

If there’s anything everyone agrees on, it’s that America’s high drug prices make up a grossly disproportionate bulk of pharma’s revenue compared with the rest of the world’s.

  • Critics — which include many politicians from both parties! — say all that means is that America is getting ripped off.
  • Pharmaceutical companies and some experts say that this subsidization allows drug companies to keep searching for and investing in new therapies despite too-low prices in other countries.

Regardless, that tasked the administration with figuring out how much of a revenue haircut — or a subsidy reduction — drug companies could take without sacrificing the new drugs we want them to continue bringing to market.

  • So far, that haircut seems to be pretty manageable.
  • “We’ve shown that it can be done successfully and the sky doesn’t fall,” said Harvard’s Aaron Kesselheim. “It’s not surprising to me that the markets haven’t come crashing down, because I think this process was not set up to bankrupt the pharmaceutical industry.”

There are several reasons why the outcome of negotiations over this particular group of drugs may not say much about future outcomes.

  • Many of them were already about to get generic competition, which may not be the case for drugs selected down the road. Most of them are already highly rebated.
  • And the number of drugs any given company is receiving a negotiated price for will likely go up over time, as more drugs enter the program each year.
  • “The financial impact will be a lot worse when companies have many drugs negotiated rather than just one or two in ’26 that are going off patent anyway,” said Leerink’s David Risinger.

Plus, positive earnings calls may not reflect the full picture.

  • “Over time, will they adjust and make money? Big pharma — of course. It’s small pharma … that’s getting severely impacted,” said Joe Grogan, the former director of the United States Domestic Policy Council in the Trump administration.
  • “They’re figuring out how to continue to make money, but it doesn’t alter the fact that it upset their R&D expenditures and their R&D plans, and it’s going to leave fewer therapies and fewer treatments down the road,” he added.
  • “Medicine development is a long and complex process, and the negative implications of these changes will not be fully realized for decades to come,” said PhRMA CEO Steve Ubl in a statement before the rates were released.

And perhaps the biggest wild card of all: Different administrations could take different approaches — and nothing requires any given administration to be consistent.

  • “They have flexibility to negotiate harder in coming years, and maybe they didn’t want to poke pharma in the eye too hard in the first year,” Risinger said.
  • “The problem is it’s unpredictable so it’s hard to forecast,” former FDA commissioner Scott Gottlieb told me. “These will ultimately be political decisions, and as much as CMS says there’s a process and a formula, there isn’t.”

The bottom line: 

For now, it looks like the Biden administration found a way to save the government some money — it helped me to consider how I’d think about a 22% sale in my personal life — without really upsetting the drug market.

  • That balance may not be reproduced going forward.

What to watch when Medicare releases first negotiated drug prices

The confidential nature of the Biden administration’s drug price negotiations has made the process and outcome of the long-sought Democratic policy goal something of a mystery.

Why it matters: 

The administration is expected to announce the results of those negotiations this week, and there’s plenty of speculation about the actual savings that will be realized starting in 2026 — and how aggressive the Biden administration got on pharma in an election year.

Where it stands: 

Drugmakers have indicated that the negotiated prices for this first 10 drugs won’t have much impact on their projected bottom lines.

  • But the results could hint at what’s to come in subsequent rounds, as the number of drugs up for negotiation expands, possibly to include blockbuster GLP-1 weight-loss drugs.

Context: 

The Centers for Medicare and Medicaid Services last summer chose 10 drugs that account for some of the highest total costs for Medicare, including Bristol Myers Squibb and Pfizer’s blood-thinner Eliquis and Boehringer Ingelheim’s diabetes drug Jardiance.

  • CMS and drugmakers have been going back and forth since February on how to price the drugs. Meanwhile, the pharmaceutical industry and its allies have mounted a series of so far unsuccessful legal challenges to stop the talks.

Here are some key unanswered questions ahead of the announcement, expected Thursday morning:

What information will CMS release about the final drug prices? Analysts, policy experts and industry groups told Axios they’re watching for whether Medicare officials announce specific levels of savings they achieved on each drug.

  • If Medicare does announce levels of savings, it’ll matter whether they measure those against drugs’ current list prices, which are typically higher than what patients actually pay, or another figure that takes into account existing rebates and discounts, said TD Cowen analyst Rick Weissenstein.
  • Statutorily, Medicare officials have to release the final prices for the selected drugs by Sept. 1 and justify those prices by March 1.
  • “What data CMS chooses to release is a big question mark,” said Chris Meekins, an analyst at Raymond James.

How will pharmacy benefit middlemen and prescription drug insurance plans react to the new prices? 

Medicare Part D insurers must cover all 10 selected drugs, but the Inflation Reduction Act doesn’t specify where they need to place the drugs on their formularies.

  • That could potentially lead to drug middlemen and insurers giving competing products more favorable placement on their formularies, said Lindsay Bealor Greenleaf, who leads federal and state policy at ADVI Health, which consults for pharmaceutical and biotech manufacturers.
  • CMS will require plans to justify their decision if they move the drugs to different tiers or add more restrictive utilization management tools, per KFF.

How will investors and drugmakers react? 

The release of the maximum fair drug prices could clarify how risk-averse large pharmaceutical companies need to be in future acquisitions of smaller biotech companies, said John Stanford, executive director of Incubate, the life sciences investor lobbying group.

How will Medicare-negotiated prices compare with international drug prices? 

Branded drugs typically come with higher price tags in the United States than elsewhere in the world.

  • “I think it’s going to be very instructive to see how much the purchasing power of CMS gets us in terms of reduction,” said Anna Kaltenboeck, who leads the prescription drug reimbursement work at consulting firm ATI Advisory.

What’s next: 

Negotiated prices will go into effect Jan 1., 2026. CMS will announce as many as 15 additional drugs for the second round of negotiation by Feb. 1, 2025.

How Do Democrats and Republicans Rate Healthcare for 2024?

https://mailchi.mp/burroughshealthcare/april-16-9396870?e=7d3f834d2f

It feels as though November 5, 2024 is far away, but for both Democrats and Republicans, the election is now. On the issue of healthcare, the two parties’ approaches differ sharply.
 


Think back to the behemoth effort by Republicans to “repeal and replace” the Affordable Care Act six years ago, an effort that left them floundering for a replacement, basically empty-handed. Recall the 2022 midterms, when their candidates in 10 of the tightest House and Senate races uttered hardly a peep about healthcare.
 
That reticence stood in sharp contrast to Democrats who weren’t shy about reiterating their support for abortion rights, simultaneously trying hard to ensure that Americans understood and applauded healthcare tenets in the Inflation Reduction Act.
 
As The Hill noted in early August, sounds like the same thing is happening this time around as America barrels toward November 2024. The publication said it reached to 10 of the leading Republican candidates about their plans to reduce healthcare costs and make healthcare more affordable, and only one responded: Rep. Will Hurd (R-Texas).


 
Healthcare ‘A Very Big Problem’


 
Maybe the party thinks its supporters don’t care. But, a Pew Research poll from June showed 64% of us think healthcare affordability is a “very big problem,” superseded only by inflation. In that research, 73% of Democrats and 54% of Republicans thought so.


 
Chuck Coughlin, president and CEO of HighGround, an Arizona-based public affairs firm, told The Hill that the results aren’t surprising.
 
“If you’re a Republican, what are you going to talk about on healthcare?” he said.
 
Observers note that the party has homed in on COVID-lockdowns, transgender medical rights, and yes, abortion.


 
Republicans Champion CHOICE


 
There is action on this front, for in late July, House Republicans passed the CHOICE Arrangement Act. Its future with the Democratic-controlled Senate is bleak, but if Republicans triumph in the Senate and White House next year, it could advance with its focus on short-term health plans. They don’t offer the same broad ACA benefits and have a troubling list of “what we won’t cover” that feels like coverage is going backwards to some.
 

Plans won’t offer coverage for preexisting conditions, maternity care, or prescription drugs, and they can set limits on coverage. The plans will make it easier for small employers to self-insure, so they don’t have to adhere to ACA or state insurance rules.


 
CHOICE would let large groups come together to buy Association Health Plans, said NPR, which noted that in the past, there have been “issues” with these types of plans.
 
Insurance experts say that the act takes a swing at the very foundation of the ACA. As one analyst described it, the act intends to improve America’s healthcare “through increased reliance on the free market and decreased reliance on the federal government.”


 
Democrats Tout Reduce-Price Prescriptions


 
Meanwhile, on Aug. 29, President Joe Biden spoke proudly in The White House: “Folks, there’s a lot of really great Republicans out there. And I mean that sincerely…But we’ll stand up to the MAGA Republicans who have been trying for years to get rid of the Affordable Care Act and deny tens of millions of Americans access to quality, affordable healthcare.” 
 
Current ACA enrollment is higher than 16 million.

 
He said that Big Pharma charges Americans more than three times what other countries charge for medications. And on that date, he announced that “the (Inflation Reduction Act) law finally gave Medicare the power to negotiate lower prescription drug prices.” He wasn’t shy about saying that this happened without help from “the other team.”
 
The New York Times said it feels this push for lower healthcare costs will be the centerpiece of his re-election campaign. The announcement confirmed that his administration will negotiate to lower prices on 10 popular—and expensive drugs—that treat common chronic illnesses.


 
It said previous research shows that as many as 80% of Americans want the government to have the power to negotiate.


 
The president also said that “Next year, Medicare will select more drugs for negotiation.” He added that his administration “is cracking down on junk health insurance plans that look like they’re inexpensive but too often stick consumers with big hidden fees.” And it’s tackling the extensive problem of surprise medical bills.
 
Earlier, on August 11, Biden and fellow Democrats celebrated the first anniversary of the PACT Act, legislation that provides healthcare to veterans exposed to toxic burn pits while serving. He said more than 300,000 veterans and families have received these services, with more than 4 million screened for toxic exposure conditions.


 
Push for High-Deductible Plans


 
Republicans want to reduce risk of high-deductible plans and make them more desirable—that responsibility is on insurers. According to Politico, these plans count more than 60 million people as members, and feature low premiums and tax advantages. The party said plans will also help lower inflation when people think twice about seeking unneeded care.
 
The plans’ low monthly premiums offer comprehensive preventive care coverage: physicals, vaccinations, mammograms, and colonoscopies, and have no co-payments, Politico said. The “but” in all this is that members will pay their insurers’ negotiated rate when they’re sick, and for medicines and surgeries. Minimum deductible is $1,500 or $3,000 for families—and can be even higher.
 
Members can fund health savings accounts but can’t fund flexible spending accounts.
Proponents cite more access to care, and reduced costs due to promotion of preventive care. Nay-sayers worry about lower-income members facing costly bills due to insufficient coverage.
 

Republican Candidates Diverge on Medicaid
 

The American Hospital Association (AHA) doesn’t love these high deductible plans. It explained that members “find they can’t manage the gap between what their insurance pays and what they themselves owe as a result,” and that, AHA said, contributes to medical debt—something the association wants to change.


 
An Aug. 3 Opinion in JAMA Health Forum pointed out other ways the two parties diverge on healthcare. For example, the piece cited Biden’s incentives for Medicaid expansion. In contrast, Florida Governor Ron DeSantis, a Republican presidential candidate, has not worked to offer Medicaid to all lower-income residents under the ACA. Former Governor Nikki Haley of South Carolina feels the same, doing nothing. However, former New Jersey Governor Chris Christie has expanded it, as did former Vice President Mike Pence, when he governed Indiana.


 
Undoubtedly, as in presidential elections past, healthcare will be at least a talking point, with Democrats likely continuing to make it a central focus, as before.

American healthcare: The good, bad, ugly, future

https://www.linkedin.com/pulse/american-healthcare-good-bad-ugly-future-robert-pearl-m-d-/

Albert Einstein determined that time is relative. And when it comes to healthcare, five years can be both a long and a short amount of time.

In August 2018, I launched the Fixing Healthcare podcast. At the time, the medium felt like the perfect auditory companion to the books and articles I’d been writing. By bringing on world-renowned guests and engaging in difficult but meaningful discussions, I hoped the show would have a positive impact on American medicine. After five years and 100 episodes, now is an opportune time to look back and examine how healthcare has improved and in what ways American medicine has become more problematic.

Here’s a look at the good, the bad and the ugly since episode one of Fixing Healthcare:

The Good

Drug breakthroughs and government actions headline medicine’s biggest wins over the past five years.

Vaccines

Arguably the most massive (and controversial) healthcare triumph over the past five years was the introduction of vaccines, which proved successful beyond any reasonable expectation.

At first, health experts expressed doubts that Pfizer, Moderna and others could create a safe and effective Covid-19 vaccine with messenger RNA (mRNA) technology. After all, no one had succeeded in more than two decades of trying.

Thanks in part to Operation Warp Speed, the government-funded springboard for research, our nation produced multiple vaccines within less than a year. Previously, the quickest vaccine took four years to develop (mumps). All others required a minimum of five years.

The vaccines were pivotal in ending the coronavirus pandemic, and their success has opened the door to other life-saving drugs, including those that might prevent or fight cancer. And, of course, our world is now better prepared for when the next viral pandemic strikes.

Weight-Loss Drugs

Originally designed to help patients manage Type 2 diabetes, drugs like Ozempic have been helping people reverse obesity—a condition closely correlated with diabetes, heart disease and cancer.

For decades, America’s $150 billion a year diet industry has failed to curb the nation’s continued weight gain. So too have calls for increased exercise and proper nutrition, including restrictions on sugary sodas and fast foods.

In contrast, these GLP-1 medications are highly effective. They help overweight and obese people lose 15 to 25 pounds on average with side effects that are manageable for nearly all users.

The biggest stumbling block to their widespread use is the drug’s exorbitant price (upwards of $16,000 for a year’s supply).

Drug-Pricing Laws

With the Inflation Reduction Act of 2022, Congress took meaningful action to lower drug prices, a move the CBO estimates would reduce the federal deficit by $237 billion over 10 years.

It’s a good start. Americans today pay twice as much for the same medications as people in Europe largely because of Congressional legislation passed in 2003.

That law, the Medicare Prescription Drug Price Negotiation Act, made it illegal for  Health and Human Services (HHS) to negotiate drug prices with manufacturers—even for the individuals publicly insured through Medicare and Medicaid.

Now, under provisions of the new Inflation Reduction Act, the government will be able to negotiate the prices of 10 widely prescribed medications based on how much Medicare’s Part D program spends. The lineup is expected to include prescription treatments for arthritis, cancer, asthma and cardiovascular disease. Unfortunately, the program won’t take effect until 2026. And as of now, several legal challenges from both drug manufacturers and the U.S. Chamber of Commerce are pending.

The Bad

Spiking costs, ongoing racial inequalities and millions of Americans without health insurance make up three disappointing healthcare failures of the past five years.

Cost And Quality 

The U.S. spends nearly twice as much on healthcare per citizen as other countries, yet our nation lags 10 of the wealthiest countries in medical performance and clinical outcomes. As a result, Americans die younger and experience more complications from chronic diseases than people in peer nations.

As prices climb ever-higher, at least half of Americans can’t afford to pay their out-of-pocket medical bills, which remain the leading cause of U.S. bankruptcy. And with rising insurance premiums alongside growing out-of-pocket expenses, more people are delaying their medical care and rationing their medications, including life-essential drugs like insulin. This creates a vicious cycle that will likely prolong today’s healthcare problems well into the future.

Health Disparities

Inequalities in American medicine persist along racial lines—despite action-oriented words from health officials that date back decades.

Today, patients in minority populations receive unequal and inequitable medical treatment when compared to white patients. That’s true even when adjusting for differences in geography, insurance status and socioeconomics.

Racism in medical care has been well-documented throughout history. But the early days of the Covid-19 pandemic provided several recent and deadly examples. From testing to treatment, Black and Latino patients received both poorer quality and less medical care, doubling and even tripling their chances of dying from the disease.

The problems can be observed across the medical spectrum. Studies show Black women are still less likely to be offered breast reconstruction after mastectomy than white women. Research also finds that Black patients are 40% less likely to receive pain medication after surgery. Although technology could have helped to mitigate health disparities, our nation’s unwillingness to acknowledge the severity of the problem has made the problem worse.

Uninsurance

Although there are now more than 90 million Americans enrolled in Medicaid, there are still 30 million people without any health insurance. This disturbing reality comes a full decade after the passage of the Affordable Care Act.

On Capitol Hill, there is no plan in place to reduce the number of uninsured.

Moreover, many states are looking to significantly rollback their Medicaid enrollment in the post-Covid era. Kaiser Family Foundation estimates that between 8 million and 24 million people will lose Medicaid coverage during the unwinding of the continuous enrollment provisions implemented during the pandemic. Without coverage, people have a harder time obtaining the preventive services they need and, as a result, they suffer more chronic diseases and die younger.

The Ugly

An overall decrease in longevity, along with higher maternal mortality and a worsening mental-health crisis, comprise the greatest failures of U.S. healthcare over the past five years.

Life Expectancy

Despite radical advances in medical science over the past five years, American life expectancy is back to where it was at the turn of the 20th century, according to CDC data.

Alongside environmental and social factors are a number of medical causes for the nation’s dip in longevity. Research demonstrated that many of the 1 million-plus Covid-19 deaths were preventable. So, too, was the nation’s rise in opioid deaths and teen suicides.

Regardless of exact causation, Americans are living two years less on average than when we started the Fixing Healthcare podcast five years ago.

Maternal Mortality

Compared to peer nations, the United States is the only country with a growing rate of mothers dying from childbirth. The U.S. experiences 17.4 maternal deaths per 100,000 live births. In contrast, Norway is at 1.8 and the Netherlands at 3.0.

The risk of dying during delivery or in the post-partum period is dramatically higher for Black women in the United States. Even when controlling for economic factors, Black mothers still suffer twice as many deaths from childbirth as white women.

And with growing restrictions on a woman’s right to choose, the maternal mortality rate will likely continue to rise in the United States going forward.

Mental Health

Finally, the mental health of our country is in decline with rates of anxiety, depression and suicide on the rise.

These problems were bad prior to Covid-19, but years of isolation and social distancing only aggravated the problem. Suicide is now a leading cause of death for teenagers. Now, more than 1 in every 1,000 youths take their own lives each year. The newest data show that suicides across the U.S. have reached an all-time high and now exceed homicides.

Even with the expanded use of telemedicine, mental health in our nation is likely to become worse as Americans struggle to access and afford the services they require.

The Future

In looking at the three lists, I’m reminded of a baseball slugger who can occasionally hit awe-inspiring home runs but strikes out most of the time. The crowd may love the big hitter and celebrate the long ball, but in both baseball and healthcare, failing at the basics consistently results in more losses than wins.

Over the past five years, American medicine has produced a losing record. New drugs and surgical breakthroughs have made headlines, but the deeper, more systemic failures of American healthcare have rarely penetrated the news cycle.

If our nation wants to make the next five years better and healthier than the last five, elected officials and healthcare leaders will need to make major improvements. The steps required to do so will be the focus of my next article.