We Americans pay more for prescription medications than just about anywhere else on the globe. And Big Pharma keeps jacking prices higher.

So when someone puts the brakes on, it’s worth noting. The successes so far are spotty, but worth knowing about, especially as drug prices become an issue in the upcoming election.

Efforts to help the millions of diabetic Americans afford their life-sustaining insulin are paying off, at least for older folks. Federal officials have capped the cost of insulin at $35 a month. For now, that gives relief only to patients 65 and older covered by Medicare.

The need for this price curb is rife with irony, because the drug’s discoverers a hundred years ago declined their right to patent the drug and thereby gave up the chance to make individual fortunes. They said then that insulin provides such a benefit it should be made and sold at the lowest cost possible.

Big Pharma in recent years has flouted that charitable intent. Drug makers have moved in dubious lockstep to tinker with the insulin molecule, claiming to make the medication more effective than before. Minor tweaks also allowed the industry to make new intellectual property claims (patents and the like) and, in turn, spike prices. Further, the many parties in the industry — notably middlemen who manage drug benefits for insurers and large companies — jumped in with their own pricing moves.

The net result: The medication fast has become unaffordable to too many, leading patients to skimp on or even forgo insulin. That has been harmful, even lethal. The outcry over insulin profiteering and how it added to the financial ruin of Americans with a chronic illness has proven impossible for Big Pharma to quell.

It has led some insurers, states, and finally the federal government (Congress and the White House) to impose a $35-a-month cap on insulin costs via Medicare. Experts estimate that more than 35 million of us have diabetes, and half of the 7 million Americans who require insulin are old enough to qualify for the federal health coverage for seniors.

Because of medication rebates, insurance coverage, and other factors, it is not easy to determine the average benefit of the Medicare insulin cap on seniors’ pocketbooks. The sums are a point of partisan political wrangling. Still, it is worth noting that average insulin costs had hit as much as $6,000 or so annually ($500 per month) in 2019.

Yes, but … Critics emphasize that the insulin price cap is not universal and fails to help younger diabetics who need the med. Lawmakers on the Hill have promised repeatedly — but not brought up for a vote — measures to prod Big Pharma to slash insulin costs, though a continuing outcry has prompted some price reductions.

Just as insulin is a lifesaver for diabetics, so inhalers are critical for people with breathing disorders. But here’s an interesting coincidence. Just as a U.S. Senate committee started zeroing in on why American patients, notably young ones, must pay much higher prices than their European peers for inhalers, multiple manufacturers agreed to a $35-a-month cap on these breathing medications.

Besides the young, this move, advocates say, will significantly benefit the health and finances of the underinsured and uninsured.

As CNBC explained of the need for inhalers:

“People with chronic lung conditions that affect their breathing, such as asthma or chronic obstructive pulmonary disorder, or COPD, most commonly use inhalers. They can use daily inhalers to prevent or manage their symptoms and fast-acting inhalers at times when their breathing worsens, like during an asthma attack. An estimated 25 million Americans have asthma, while around 16 million suffer from COPD. Many of those patients rely on inhalers to help them breathe, and some end up having to ration those products due to price …”

The budget-busting cost of inhalers for those with asthma or COPD had drawn the ire of the Senate Committee on Health, Education, Labor, and Pensions. The lawmakers noted that patients in this country, for example, paid $319 to GlaxoSmithKline for a multidose Advair inhaler, while their peers in Britain were charged $26 for the same product. AstraZeneca’s multidose Breztri Aerosphere inhaler cost U.S. patients $645 versus $49 in the U.K.

Senators and their investigators asked not only why drug makers had such marked price differences but also why Big Pharma pushed doctors and patients to switch to newer inhalers — those with higher costs and more recent and longer-lasting patent protections beneficial to makers.

Yes, but … Parents and pediatric specialists have expressed anxiety about problems with daily inhalers for kids with asthma. The maker of a widely used med for this condition pulled its branded product from the market, saying a generic equivalent is an available substitute. This action was tied to changes in Medicaid rebate rules, effectively requiring the drug maker to pay more if their product’s price increased.

Patients have found, though, that the prescription generic is more expensive, less widely covered by insurers, especially in lists of approved drugs that get updated periodically. Specialists note that the branded product, unlike the generic, had a mask-like attachment, making the drug easier to administer in kids.

More than a million patients older than 65 got what may have been a significant financial surprise at the start of the new year. They may find this little-known part of their Medicare coverage will be even bigger in 2025.

As part of the Inflation Reduction Act (IRA) that became law in 2022, federal rules affecting senior drug coverage, aka Medicare Part D, changed.

Starting in 2024, as the New York Times reported, “an annual out-of-pocket cap of $3,300 will take effect, because people covered under Part D are no longer required to pay 5% of the cost of brand-name drugs once they reach that level of spending. Another provision penalizes drug companies for price increases that exceed the rate of general inflation. And the [law] expands eligibility for financial assistance with Part D costs for low-income seniors.”

Before digging into what all this means, the newspaper also reported this:

“In 2025, there will be two more important changes: A beneficiary’s total out-of-pocket spending will be capped at $2,000, and people will be able to spread their out-of-pocket costs throughout the year by setting up a monthly payment plan with their Part D insurance companies.”

Here’s the financial bottom line for these changes, as the New York Times noted:

“The new caps on out-of-pocket costs will save thousands of dollars for those who take high-cost drugs for conditions such as cancer and multiple sclerosis. In many cases, Medicare beneficiaries have been paying tens of thousands for their medicines. In 2020, 1.4 million people who didn’t receive a low-income subsidy had annual out-of-pocket costs of $2,000 or more, according to KFF, which focuses on health policy. ‘The prescription drug reforms in this law mark the most substantial changes to the Medicare D program since the drug benefit launched in 2006,’ said Tricia Neuman, senior vice president of KFF.”

KFF, a nonprofit, nonpartisan foundation focusing on healthcare issues, has found in its public opinion polling that few seniors or Americans in general knew about or understood the potentially dramatic savings that patients will experience because of recent Medicare rule changes.

For 1 million or more individuals, these can amount to hundreds or even thousands of dollars annually, with one consumer group reporting a patient had $15,000 more in his pocket due to the changes. A family member of a friend of this newsletter saw a $9,000 savings this year and anticipates more in ’25, a big burden lifted in paying for cancer care.

The rule changes also boosted federal aid for the Part D plans for older patients with lower incomes, the New York Times reported.

KFF has posted online a detailed description of the Medicare changes, as well as its expert analyses on how they affect federal spending and individuals, and how programs will roll out. Patients can check with their doctors, hospitals, and insurers to see how they might benefit from the medication-cost cap. (They should have seen some of its benefits already). It also may be worth checking how the increased benefit in ’25 might result in further savings. It never hurts to get a little good news, right?

Yes, but … Advocates may have won some recent battles on behalf of older patients in the Medicare program. But much more work still must be done.

For context, seniors take more prescription drugs than others, with KFF finding that “more than half of adults 65 and older (54%) report taking four or more prescription drugs compared to one-third of adults 50-64 years old (32%) and about one in 10 adults 30-49 (13%) or 18-29 (7%).”

Seniors also fork over more money for drugs. A health policy institute at Georgetown University reported that “annual average out-of-pocket prescription drug expenditures for all adults are $177, but people age 65 and older pay much more for their medications. People aged 65 to 79 pay $456 out-of-pocket. People aged 80 and older pay even more.”

Affordability issues affect significant numbers of us all, KFF has found in its regular medical care opinion surveys. They show that one in five respondents reporting that they have not filled a prescription or took an over-the counter drug instead (21%), and 12% who say they have cut pills in half or skipped a dose because of the cost.

It’s almost incomprehensible to think that the nation’s largest payer for prescription drugs has been legally prevented from negotiating with Big Pharma over its nosebleed prices. That’s changing now.

As part of the already-described Inflation Reduction Act, federal officials for the first time ever have started to dicker with Big Pharma over the prices for a handful of costly, popular drugs, which taxpayers foot the bill for under the Medicare program.

As the nonpartisan, nonprofit KFF Health News organization reported: The price negotiations now under way are “for 10 brand-name medications that lack generic equivalents. Those drugs include the blood thinners Eliquis and Xarelto; the diabetes drugs Januvia, Jardiance, and NovoLog; Enbrel, for rheumatoid arthritis; the blood-cancer drug Imbruvica; Entresto, for heart failure; Stelara, for psoriasis and Crohn’s disease; and Farxiga, a drug for diabetes, heart failure, and chronic kidney disease.”

The Congressional Budget Office estimates that, over time, negotiating the cost of these meds will save taxpayers tens of billions of dollars, helping to reduce an exploding federal deficit.

Big Pharma waged a furious battle against allowing any price negotiations by the federal government, arguing with its allies that such moves would harm patients by making it tougher for the industry to make the sizable research and development investments to produce innovative life-saving medications.

These arguments by drug makers, of course, have been hotly disputed by respected, independent research. Studies have found that the industry has dropped more money on advertising, marketing, and stock buybacks than on drug research and development. Big Pharma also now sinks too much of its dough into tweaking existing high-cost drugs to maximize profits without offering significant improvements as to how they preform for patients.

Yes, but … Critics and advocates agree that “bending the price curve” on prescription drug costs will not be fast or easy. Proponents of price negotiations want to expand the number of costly meds that officials can dicker over. It is unclear if a new administration would keep campaigning for this, or, negotiations or, indeed, to be aggressive in seeking to slash prescription drug costs at all.

During the coronavirus pandemic, Americans became all too familiar with a manufacturing buzz term: the supply chain.

Problems in this critical area have cropped up in a big way with prescription drugs.

The number of shortages of needed medications has hit record highs in the first quarter of this year, experts say. As USA Today reported:

“In the first quarter of the year, 323 drugs were running low, surpassing the 2014 high of 320, according to data provided by the American Society of Health-System Pharmacists (ASHP) and the University of Utah Drug Information Service. Since 2001, the groups have tracked shortages using voluntary reports from practitioners and patients that are confirmed by drug makers.

“Both basic and life-saving drugs are in short supply, from oxytocin and chemotherapy medications to prescriptions for attention deficit hyperactivity disorder (ADHD) medications. The data does not explain how many patients are affected.

“From 2016 to 2020, the average drug shortage impacted more than half a million consumers, with many being older adults ages 65 to 85, the Department of Health and Human Services shared in a report to Congress last May.”

The newspaper noted that the Federal Trade Commission and the Department of Health and Human Services “announced in February that they will investigate whether drug wholesalers and companies that buy medicines for health care providers are partly responsible for the shortages. The departments will examine whether the groups have cut the prices of generic drugs to prevent manufacturers from profiting, to halt production and to discourage rival suppliers.”

U.S. patients, to their great distress, have discovered that Big Pharma has sought to cut its costs by increasing the manufacture of drugs overseas. The top offshore sites for pharmaceuticals and medical products include places like China and India.

Concerns have grown about U.S. regulators’ capacity to monitor and oversee foreign drug making to ensure the quality, safety, affordability, and access of products in critical demand in this country.

The issue has grown even more complicated due to increasing tensions between China and the United States, with the New York Times reporting high concern in Washington, D.C., about the national security implications of offshore pharmaceutical and medical manufacturing. As the newspaper reported:

“A Chinese company targeted by members of Congress over potential ties to the Chinese government makes blockbuster drugs for the American market that have been hailed as advances in the treatment of cancers, obesity, and debilitating illnesses like cystic fibrosis. WuXi AppTec is one of several companies that lawmakers have identified as potential threats to the security of individual Americans’ genetic information and U.S. intellectual property. A Senate committee approved a bill in March that aides say is intended to push U.S. companies away from doing business with them.

“But lawmakers discussing the bill in the Senate and the House have said almost nothing in hearings about the vast scope of work that WuXi does for the U.S. biotech and pharmaceutical industries — and patients.”

While patients, doctors, hospitals, medical researchers, policy makers, and politicians express increasing concern about drugs and the overseas supply chain, fixes won’t be cheap, easy, or fast, experts say.

Concerned about medical care? The fall election really matters

If you’re concerned about the affordability and availability of medical services in this country, the ballot box in November will provide a crucial tool for you.

If you’re not already registered to vote or you’re looking for elections-related resources, online information is available by clicking on the hyperlink if you’re in the District of Columbia, Virginia, or Maryland.

A national group also may provide helpful election information: Vote.org.

Your health and spending, and that of your loved ones, as well as your experiences with medical providers, will be shaped by the decisions you make in the privacy of a voting booth. These issues can be complicated and fraught. Take the time to research issues carefully, please, relying on facts, evidence, and sources that are clear, public, transparent, and credible. Beware of misinformation.

The partisan divide, alas, is huge on many health and medical matters. Zero Republicans in the House or Senate voted in favor of the Inflation Reduction Act, the big law that prompted several of the drug price changes described in this newsletter. The Senate Committee that pressed drug makers to cap inhaler costs is led by a Democratic majority and is chaired by an independent who caucuses with Senate Democrats.

It also may be important for voters to note that the president, when he was the nation’s No. 2, fought for broadening health insurance coverage via the Affordable Care Act. As president, he pushed during the coronavirus pandemic to expand and fix aspects of Obamacare, so that record numbers of Americans now have coverage. The number of uninsured Americans has hit a record low during the current administration.

During the predecessor’s term, the number of Americans without health coverage increased and the former president campaigned to repeal the ACA. He has said he would renew his efforts to kill Obamacare if elected again, though he has revised that position. He promised throughout his term to offer an ACA alternative and a comprehensive health care plan for the nation. He did neither.

The ex-president made much about meeting with Big Pharma executives early in his term but backed away from confronting them about cutting drug prices. As his four years in office waned, he sought to impose a federal rule tying prices of two dozen costly drugs to prices charged in 25 other countries. That “most favored nations” plan was blocked by a federal judge and later withdrawn by the current president, who took a different approach with the bill that Congress passed.