Category: Drugs and technology

  • Gray hair? It could be a thing of the past

    Gray hair? It could be a thing of the past

    If your hair is grey or would be grey if you didn’t color it, you are part of a club that includes nearly half of all people worldwide. Gray hair is generally unavoidable by the time you’re 50, and most people start graying at a far younger age, reports Erin Blakemore for National Geographic. But, before long, gray hair could be a thing of the past.

    Why does our hair turn gray? According to the National Institutes on Health, melanocyte stem cells, which give our hair color, produce new cells that enable us to retain our hair color. These stem cells occupy hair follicles at the base of each strand of hair. But, as we get older, the stem cells die off. When they do, our hair begins to lose its color and turns gray.  

    Stress also can cause our stem cells to die off. It can speed up the process of our hair losing its pigment and turning gray.

    Consequently, more than one in five people live with half a head of gray hair by the time they are 50.  A significant majority of women dye their hair in order to look younger. But, men do not dye their hair as much, likely in part because silver-haired men tend to “look good” as compared with silver-haired women, who are often seen as “old.”

    One study found that women who let their hair go gray, make up for the time and money they save from not dyeing it by investing in other ways to look good.

    The future of gray hair: It’s very possible that women will be able to keep their natural youthful hair color in the not too distant future. With melanocyte-producing stem cells, their hair color might not fade. 

    Here’s more from Just Care:

  • Medicare Advantage insurers increasingly use step therapy for cancer drugs, delaying care

    Medicare Advantage insurers increasingly use step therapy for cancer drugs, delaying care

    A study by Avalere reveals that health insurers are increasingly delaying and denying drugs to cancer patients through the use of step therapy, reports Noah Tong for Fierce Healthcare.

    The American Cancer Society Cancer Action Network (ACSCAN) released a paper that demonstrates Medicare Advantage insurers are weaving step therapy into their prior authorization requirements. Sometimes, enrollees don’t even realize it. Step therapy is a means by which insurers require patients to use a less costly treatment before receiving a more costly one, such as requiring an X-ray before approving a CT scan or MRI.

    Some say that requiring prior authorization for cancer drugs helps ensure safety. Prior authorization can also save patients money. But, what the Medicare Advantage insurers are doing is troubling. Patients and doctors are too often unaware of what the insurers are requiring. In particular, delays in treatment are concerning.

    Kisqali and Verzenio are two breast cancer drugs for which Medicare Advantage insurers often require step therapy. They won’t cover these drugs unless other less costly drugs are shown to be ineffective. One concern is “embedded step therapy,” which could hide an insurer’s use of step therapy. It might not be included in an insurer’s Part D list of covered drugs.

    In the year between 2023 and 2024, overall, Medicare Advantage insurers used step therapy more often for breast cancer drugs and hepatocellular carcinoma, according to the American Cancer Society.  Medicare Advantage insurers required step therapy as much as 95 percent of the time. They did not appear to require it for biosimilar drugs Kanjinti and Trazimera.

    The bigger insurers tend to require step therapy more of the time than the smaller insurers. If the issue is truly safety, they should be using step therapy with the same frequency.

    To date, the Centers for Medicare and Medicaid Services, CMS, which oversees the Medicare Advantage plans, has allowed insurers to decide for themselves when to use prior authorization. Some use it a lot more than others, at times delaying and denying urgently needed care inappropriately.

    Prior authorization determinations should be standardized across all Medicare Advantage plans. Without standardization, people cannot meaningfully distinguish among MA plans. Moreover, MA plans can wrongly deny or delay care with little if any accountability.

    Here’s more from Just Care:

  • CVS plans to raise Medicare Rx premiums a lot in 2025

    CVS plans to raise Medicare Rx premiums a lot in 2025

    In an op-ed for MarketWatch, Brett Arens’s Roi warns about rising Medicare Part D premiums.

    The CFO at CVS is alerting people that Medicare Part D premiums will increase significantly in 2025. How much of that increase amounts to more profits for CVS? It’s already profiting from pocketing pharmaceutical company rebates instead of passing them on to its Part D enrollees in the form of lower out-of-pocket costs.

    A series of articles over the last few years highlight tactics CVS uses to maximize profits. For example, it sometimes makes its Part D enrollees buy brand-name drugs, for which CVS earns more. So, it’s no surprise that CVS is planning another premium hike. Premiums will be “much, much higher” says Thomas Cowhey, the CFO.

    CVS knocked up Part D premiums 20 percent this past year. This time round, the higher premiums will allow CVS to protect its profits from rising costs resulting from the $2,000 out-of-pocket cap for Part D coverage that goes into effect in 2025.

    CVS believes that more people will be filling their prescriptions once Part D has a $2,000 out-of-pocket cap. Costs will no longer be a barrier for some, after they spend $2,000 out of pocket. The question then becomes how many people have $2,000 to spend to reach that out-of-pocket cap when they need to?

    As of now, about one in seven people with Medicare say they are not filling their prescriptions because of the cost.

    Some analysts believe that the new $2,000 out-of-pocket cap in Part D will steer more people into Medicare Advantage plans. Medicare Advantage plans almost always include prescription drug coverage in their premiums. Medicare Advantage plans are likely to look less expensive than Traditional Medicare, where people would have to buy a stand-alone Part D prescription drug plan.

    Here’s more from Just Care:

  • Will the administration step in to curb prices on drugs developed with taxpayer dollars?

    Will the administration step in to curb prices on drugs developed with taxpayer dollars?

    For more than 30 years, the federal government has failed to rely on the Bayh-Dole Act to reduce the cost of prescription drugs developed with taxpayer dollars. US Senator Elizabeth Warren, along with many advocates, is urging the Department of Commerce to finalize a policy that would specify the federal government’s right to seize prescription drug patents funded by the government on drugs with prices deemed to be “too high.” Partrick Wingrove reports for Reuters on where things stand.

    In early December 2023, the Biden administration said it would issue a policy for taking patents from drug manufacturers when their drug prices were excessive. The policy would give the federal government “march-in rights.” Essentially, the government could give other manufacturers the license to manufacture drugs developed with federal dollars, which are priced too high.

    Not surprisingly, the US Chamber of Commerce is trying hard to keep the policy from people implemented. Rather than accepting that the policy would promote innovation and drive competition, it makes the tired argument that the policy will keep pharmaceutical companies from developing new drugs. As a rule, the pharmaceutical companies use their power to make new versions of the same blockbuster drugs rather than to develop new drugs to meet unique and important health care needs. Exceptions are few and far between.

    To determine whether a drug’s price is excessive, the government will look at who can afford it and whether the high price of the drug exploits a health or safety issue.

    Under the new policy, the government would consider a list of factors, including whether only a narrow set of patients can afford the drug, and whether drugmakers are exploiting a health or safety issue by hiking prices.

    Here’s more from Just Care:

  • If you use an inhaler, your out-of-pocket costs should come down soon

    If you use an inhaler, your out-of-pocket costs should come down soon

    As of Saturday June 8, many people in the US will pay $35 a month out of pocket for their asthma medications, reports NBC News. AstraZeneca and Boehringer Ingelheim have agreed to limit people’s out-of-pocket costs for inhalers. GlaxoSmithKline says it will also limit people’s out-of-pocket costs but not until next year. The cap does not apply to people with Medicare.

    People in other developed countries pay far less than Americans for their inhalers. Americans have been paying 13 times what Brits pay for AstraZeneca inhalers, $645 as compared to $49. Teva charges Americans $286 for their inhalers and Germans $9.

    And, we’re talking millions of Americans are paying insane costs for inhalers. Twenty-seven million Americans suffer from asthma. Five million of them are children.

    Today, even with insurance, many Americans cannot afford their asthma medicines. Costs for insured people with asthma can easily be $350 a month in the US, when you fold in the cost of additional medications such as albuterol.

    Black Americans are more at risk than white Americans. Black Americans have far worse health outcomes. Black children with asthma are 4.5 times more likely to end up in the hospital and 7.6 times more likely to die because of their asthma.

    If you have insurance: Your pharmacy should adjust the price of your inhalers to $35 a month, if it participates in the pharmaceutical companies’ programs.

    If you don’t have insurance or your pharmacy is not participating in the program: You can visit your drug company’s website online and sign up for a $35 copay card.

    It’s still not clear whether people who use multiple medications for their asthma will have to pay $35 a month for each asthma medicine. Some people need a rescue inhaler in addition to a maintenance inhaler.

    It’s great that some pharmaceutical companies have agreed voluntarily to lower people’s asthma medicine costs. But, it’s terrible policy that pharmaceutical corporations can charge pretty much what they will for their drugs, and we have to rely on their voluntary gestures for our drugs to be affordable. Right now, too many Americans are forced to choose between their child’s inhaler and food or rent.

    Here’s more from Just Care:

  • FTC cleaning up junk patents on 20 brand-name drugs

    FTC cleaning up junk patents on 20 brand-name drugs

    Pharmaceutical companies don’t only get to set their prices on brand-name drugs, they can flood the FDA with patents to keep those brand-name drugs without generic competition for extensive periods of time. Thankfully, the Federal Trade Commission (FTC) is challenging what it is calling “junk” patents on 20 brand-name drugs, Bruce Gil reports for Quartz. The goal is to clean up the mess in the drug patent arena, allow generic drugs to enter the market sooner, and bring down drug prices.

    Ozempic is one of the 20 drugs that the FTC claims has junk patents. If not undone, it will take longer for generic alternatives to compete with it. Novo Nordisk will be able to continue to charge insanely high prices for Ozempic. The FTC is also disputing the patents on Saxenda and Victoza.

    As a rule, a drug patent extends for 20 years beginning when the drug manufacturer files the patent. Once the manufacturer files the patent, it can charge what it pleases for a drug.

    Manufacturers tend to file patents as early as they can, usually even before requisite clinical trials are completed and their drugs are approved. They then file more patents as a way to extend their ability to control the price of their drugs.

    The manufacturers claim they need to recoup their research and development investments. But, substantial evidence suggests that these investments do not justify the prices.

    Junk patents generally support small changes to a drug, such as how they are manufactured or how they are taken, e.g., orally or by injection. With Ozempic, the FTC challenge is to a patent on its “injection device with torsion spring and rotatable display.” By having this device listed in the FDA’s Orange Book, Novo Nordisk gets 30 months of additional exclusivity on its drug.

    But, even if the FTC wins its challenges on these 20 brand-name drugs and they are removed from the FDA’s Orange Book, the manufacturers can sue companies for violating their patents. Through these lawsuits, the pharmaceutical companies can continue to quash competition.

    Some say that the FDA needs more time to review patent applications in order to nip them in the bud and deny them where appropriate. One study finds that if those determining whether patents should be issued were given 50 percent more time, more patents would be denied and Americans would spend about $5 billion less each year for drugs.

    Here’s more from Just Care:

  • CVS profits from manufacturing its own generic drugs

    CVS profits from manufacturing its own generic drugs

    CVS has become the sixth largest corporation in America, owning not only a chain of pharmacies, but health insurance company Aetna, and Pharmacy Benefit Manager (PBM), Caremark, among other big businesses. To maximize profits, CVS offers many private label products. To increase those profits further, CVS has begun to sell its own prescription drugs, reports David Wainer for the Wall Street Journal.

    Bottom line, CVS believes that selling its own biosimilars will generate handsome profits. CVS can steer its customers to these generic drugs through its Pharmacy Benefit Manager or PBM, which determines the drugs on many insurance companies’ formularies, including Aetna’s. In the process, CVS can put competitor manufacturers with lower-cost biosimilars out of business.

    The Cordavis unit of CVS Health – lord knows how CVS came up with the name—works with drug manufacturers to create the biosimilars CVS sells. Biosimilars are the generic version of biologicals, prescription drugs made from living cells. The biosimilar market is booming as more blockbuster biologicals, such as Humira, lose their patents.

    Beginning shortly, Humira will no longer be available on CVS formularies. CVS will offer its biosimilar. Similarly, Cigna, which has its own PBM, Express Scripts, will take Humira off its formulary and instead offer its private label biosimilar. For now, the cost will be low for patients, 85 percent lower than Humira’s list price, with no out-of-pocket costs to patients.

    CVS projects that the biosimilar market will grow exponentially in the next five years to $100 million. It was not even $10 million just two years ago. CVS will steer its customers away from brand-name biologicals to its biosimilars and profit big time in the process. Over time, will patients save money and how much? That’s largely up to CVS, an untenable truth.

    The bigger question is how will patients fare as biologicals are replaced by biosimilars? It’s not at all clear; at least for now, it is out of government hands. PBMs, such as CVS Caremark, can and will use their power to determine which drugs people use and at what cost in order to maximize their profits. Before long, some say it’s likely that there will be no prescription drug price competition, only strategies among the PBMs and insurers to maximize profits.

    Here’s more from Just Care:

  • Will insulin ever be affordable in the US?

    Will insulin ever be affordable in the US?

    The pharmaceutical industry is all too powerful in the US. Not only does it spend a lot of money contributing to policymakers’ political campaigns and lobbying them to ensure pharmaceutical companies keep their monopoly drug pricing power, they employ huge numbers of Americans. Not surprisingly, no one in Congress has proposed opening our borders to prescription drug imports–the easiest way to bring drug prices down quickly for everyone in the US. And, Senate Majority Leader Chuck Schumer can’t even make good on his promise to lower insulin copays for everyone in the US, reports Rachel Cohrs Zang for Stat News.

    Two years ago, Senator Schumer announced to a crowd that he was going to ensure the Senate voted to limit insulin costs for every insured American to $35 a month. Since then, he has said it was a “high priority.” But, he has not yet acted.

    Importantly, the Inflation Reduction Act does lower these costs for people with Medicare, but only for people with Medicare. Ideally, federal legislation would protect everyone from high drug costs, including people without health insurance. And, it would require the government to negotiate drug prices. Protecting insured Americans from high insulin costs is a toe in the door, at best, and still it would be a major feat for the Democrats.

    Senator Schumer’s office was unwilling to speak to a reporter about why the Senator has not yet held a vote on legislation that would limit the cost of insulin for insured Americans. Notably half of states have laws limiting these costs. And, pharmaceutical companies have said that they are making it easier to qualify for their programs that help pay for insulin costs.

    Better access to lower cost insulin for more Americans might explain Schumer’s reluctance to move forward with legislation to cover everyone, but it’s not a compelling reason. As recently as August 2022, one in seven diabetics were struggling to pay for their insulin. For sure, hundreds of thousands, if not millions, of Americans are still struggling to pay for insulin. More likely, Schumer doesn’t want to take on the opposing forces or propose legislation that undercuts other legislation to lower insulin costs that his fellow Senators are proposing.

    Politically, Schumer has good reason to take on the insulin issue. Six states that the Democrats would like to win in November –Ohio, Pennsylvania, Michigan, Wisconsin, Nevada, and Arizona–do not provide residents with low-cost access to insulin. And, low-copay insulin could be a winning issue for the Democrats. Pharmaceutical companies don’t mind low copays as they would not affect insulin prices.

    But, the forces opposing low-copay insulin are mighty. Republicans, for one. Patient advocates, for two, because Schumer’s proposal would not lower the cost of insulin, only make it more affordable, shifting costs, and not help people without health insurance.

    Here’s more from Just Care:

  • Medicare Part D drug coverage stunts are rampant

    Medicare Part D drug coverage stunts are rampant

    When it comes to Medicare Part D prescription drug coverage, one thing’s for sure: Medicare Part D coverage stunts will continue without an overhaul. Insurers have way too much room to drive up drug costs for enrollees in order to profit handsomely. Cheryl Clark reports for MedPage Today that Medicare Payment Advisory Commission (MedPac) Commissioners are surprised by the huge variation in generic drug prices and availability among different Part D drug plans. It’s no surprise, it’s the “free market” run amok.

    Commissioners considered why one generic drug can cost someone with Part D coverage $1.06 at one pharmacy and $102 at a different pharmacy, sometimes even the same pharmacy chain. What goes into generic drug pricing? Lots of unknown factors in addition to the cost of manufacturing and dispensing the drug and the pharmacy’s costs. (But, you can be sure it’s all about insurer profits.)

    About 20 percent of Medicare spending on prescription drugs is for generics, and generics represent about 90 percent of the drugs that Part D plans fill. Generics are costing more and more.

    Some basic generic drugs, including cardiovascular drugs, are just plain “out of stock.” The big PBMs can’t even say when they will have these drugs in stock. Is it a supply chain issue? (Editor’s note: A David Dayen story in TAP reveals that 323 drugs are in short supply, many more than in the past, endangering people’s health and lives.)

    MedPac Commissioners want to know more about Medicare Part D, as if we need to know more to fix a multi-headed drug cost problem. The biggest players have so much power that they can keep drugs off the market if that helps them financially. A while back, I reported on a story about CVS not selling certain generic drugs because they profited more from only making the brand-name alternatives available.

    “Tying arrangements” are another cog in the pharmaceutical supply and price wheel. These agreements allow drug wholesalers and pharmacies to set the amount of a brand-name drug discount to the amount of generic drugs a pharmacy buys and the price it pays. Wholesalers can then charge more for generic drugs and give bigger discounts on brand-name drugs.

    In addition, bigger pharmacy chains can bargain for lower costs than independent pharmacies. They can also pay less for the same drug from wholesalers. The manufacturers might be charging the same price for a drug, but the wholesalers do not.

    And, the Part D the insurers don’t help matters, designing formularies that benefit their bottom lines and often cost their enrollees more. For more on the challenges of getting your drugs covered through Part D, check out this post from last week.

    Bottom line: You cannot assume that you are getting your drugs at the lowest cost through your Part D drug plan. You need to shop around. Too often you can pay a lot less without using your insurance. One MedPac Commissioner explained that with “irrational drug prices … beneficiaries in the know have to strategize multiple means to access their meds. GoodRx over here and a mail order for Mark Cuban over there, a patient assistance program over there, and the many other methods that … bypass the local pharmacist.” Of course, those not in the know, often the most vulnerable, pay more than they should.

    The Commissioner expounds on the problem: “It’s bad enough that the plans can dramatically change what medicines they cover and what costs for each year with different utilization management tools. But then to have multiple sources of the least expensive drug is just too much for older adults and adults with disabilities.” What’s worse, as I understand it, Part D plans can change the medicines they cover and their costs throughout the year.

    Michael Chernew, MedPac Chair, appeared not to be aware of this longstanding issue with Medicare Part D drugs, both generic and brand-name. He suggested that it was challenging to determine a way to fix the problem, even though every other wealthy nation has done so through negotiated drug prices.

    Here’s more from Just Care:

  • Will FDA approval of Wegovy to treat heart conditions mean more people with Medicare can fill a weight-loss prescription?

    Will FDA approval of Wegovy to treat heart conditions mean more people with Medicare can fill a weight-loss prescription?

    The FDA recently approved Wegovy, a weight-loss drug, to treat overweight people with heart conditions. Will that mean that more people with Medicare will get their weight-loss drugs covered? Maya Goldman reports for Axios on what the Centers for Medicare and Medicaid Services (CMS), which oversees Medicare, as well as the insurers offering Medicare Part D prescription drug coverage, are considering.

    At the moment, CMS has not decided whether Medicare will cover Wegovy as a treatment for overweight people with heart conditions. To date, Medicare has not covered any weight-loss drugs simply for the purpose of helping people lose weight. But, Medicare does cover weight-loss drugs as a treatment for people with diabetes.

    Medicare, by law, covers only treatments for medically reasonable and necessary services. CMS does not consider treatment for weight loss as reasonable and necessary. Treatment for a heart condition, much like treatment for diabetes, is very different.

    About 40 percent of people with Medicare have heart conditions. That’s more than 24 million people. And, likely a sizeable number of them are overweight. So, Medicare might end up covering Wegovy for them.

    Of note: Wegovy costs about $1,200 a month. Covering it for even four million more people will likely cause Medicare spending to balloon. Fortunately, people with Medicare should not see their costs balloon. Beginning in 2025, people’s annual out-of-pocket costs for covered prescription drugs will be capped at $2,000.

    For now, insurers offering Medicare Part D prescription drug coverage are waiting for CMS to rule on the conditions under which Medicare will cover Wegovy. Part D insurers could, of course, decide to cover Wegovy without waiting for CMS, but that would cost them a bundle. Their Medicare payments for this year are already set.

    Here’s more from Just Care: