Kaiser Health News

This Panel Will Decide Whose Medicine to Make Affordable. Its Choice Will Be Tricky.

Published

12 months ago

May 25, 2023

by Markian Hawryluk
Thu, 25 May 2023 09:00:00 +0000

Catherine Reitzel's multiple sclerosis medication costs nearly $100,000 a year. Kris Garcia relies on a drug for a blood-clotting disorder that runs $10,000 for a three-day supply. And Mariana Marquez-Farmer would likely die within days without her monthly $300 vial of insulin.

At best, a Colorado panel of medical and pharmacy experts seeking to cut the costs of expensive drugs will be able to help only one of them.

Starting this summer, the state's Prescription Drug Affordability Board will choose up to 18 high-cost drugs for review over the next three years to determine if the medications are unaffordable and whether to cap what health plans and consumers pay for them.

But with hundreds of expensive drugs to choose from, the board members face tough decisions about who will get help now and who will have to wait.

Do they tackle drugs with extremely high costs taken by only a handful of patients, or drugs with merely very high costs taken by a larger group? Should they consider only out-of-pocket costs paid by consumers, such as for insulin, whose copays Colorado caps at $50 a month, or the total cost of the drug to the health system? Will they weigh only drug prices, or will they try to right social wrongs with their choices?

And what does “affordable” even mean?

“That question alone is a lot harder to answer than it might seem at face value,” said Jennifer Reck, project director for the National Academy for State Health Policy's Center for State Prescription Drug Pricing. “You immediately get into how utterly complex our drug supply chain is, how opaque it is, how many different prices there are,” she said.

Maryland was the first state to establish a drug affordability board in 2019, but funding challenges and the pandemic have slowed its progress. Colorado passed a bill creating its board in 2021 and has already moved ahead of Maryland in the process. Washington followed in 2022 but is still in its early phases of implementation.

Maine, New Hampshire, Ohio, and Oregon have also established boards, but they lack the power to limit drug payments. And at the federal level, the Inflation Reduction Act of 2022 included a provision requiring the Health and Human Services secretary to negotiate prices with drug companies for a small number of the most costly medications covered by Medicare.

It's taken years for the Colorado and Maryland board members to create all the rules and regulations to govern their work before getting to the point of looking at specific drugs.

“It's just a long, tortuous government process to get things up and running,” said Gerard Anderson, a professor of health policy and management at Johns Hopkins University, and a member of Maryland's board. “You basically have to dot every ‘i' and cross every ‘t' in order not to get sued.”

Setting Priorities

On May 12, Colorado released its first list of hundreds of drugs eligible for review, mostly because they each cost more than $30,000 for a course of treatment. Next month, they'll release a dashboard ranking those drugs according to the board's priorities. The dashboard can also be used to examine which drugs have the highest price tags, which have had the largest increases in price, and which the state spends the most on. That would allow the board to begin affordability reviews this summer and set payment limits for the first four to eight drugs sometime in 2024. But board members will first have to set their priorities, and those could change from year to year.

“Maybe one year we focus on the impact to the system, and another year we focus on out-of-pocket costs, and one year we focus on a lifesaving drug that has smaller utilization,” said Lila Cummings, director of the Colorado board.

Such approaches could pit one group of patients against others looking for cost relief. But Cummings said not all groups are eager to see payment limits.

“Some of them said, ‘We want the board to focus on our drugs,' and others said, ‘Please leave us alone,'” she said.

That reluctance likely reflects the close ties that some patient groups have with the manufacturers of their medications, including receiving funding from the drugmakers.

“We have seen cases in public hearings — it seems counterintuitive or surprising — where a patient group, instead of being thrilled that they might have access to the drugs at a lower price, instead are arguing against upper payment limits,” Reck said. “But in most cases, there's a pretty clear financial connection to drug manufacturers.”

Maryland has also received input from patient groups as it finalizes its regulations.

“So far it has not been, ‘Pick me! Pick me! Pick me!'” Anderson said. But that could change once the Maryland board begins its affordability reviews this fall.

The drug that Garcia, 47, of Denver, takes did not make the board's list. Diagnosed with four bleeding disorders, including von Willebrand disease, he needs the medication Humate-P, made by CSL Behring, to replace one of the clotting factors missing in his blood. This winter, driving home from his job at the airport, Garcia hit a patch of black ice, spun out, and careened into a concrete barrier at 75 mph. He needed the expensive medication every day for the first five days after the accident, and then every other day for a full month.

“It's not like I can just sit there and say no to this medication, because my bleeds get so bad,” he said.

According to Perry Jowsey, executive director of the National Hemophilia Foundation's Colorado chapter, about 300 to 400 individuals are being treated for von Willebrand disease in Colorado. That's far fewer than the roughly 10,000 Coloradans with MS or the 74,000 who manage their diabetes with insulin.

“In my shoes, I would target what would help the most people,” Garcia said. “You have to find a balance, especially starting out. You're not going to be able to help everyone.”

The Colorado and Maryland boards will rely on data from state databases that show how much various public and private health plans pay for drugs. That data, however, doesn't capture what uninsured patients pay, and it doesn't give any insight into how much manufacturers pay for research and development.

“The goal is not to stifle innovation,” Anderson said. “But we can't get any public data, so we have to ask the pharmaceutical industry, and they're not required to give us the data.”

The boards want to ensure that patients like Reitzel still have access to new and better therapies. Reitzel, 38, of Highlands Ranch, was diagnosed with multiple sclerosis in 2008 and has switched medications several times seeking one whose side effects she could tolerate. “They're all terrible in their own special way,” she said.

In 2021, she began taking a relatively new drug from Biogen and Alkermes called Vumerity, which was included on Colorado's list of eligible drugs. But the cost of a three-month supply was nearly $24,000, including a copay of more than $7,000. Biogen provides up to $20,000 in annual copay assistance through a debit card she can use at the pharmacy. But now her health plan no longer credits those payments toward her deductible. It makes it almost impossible for her to meet the $25,000 out-of-pocket maximum under her plan.

“Primarily for this reason, I am no longer taking any medication,” Reitzel said, “and have to only hope my disease does not progress.”

Colorado legislators passed a bill to require health plans to count copay assistance programs toward patients' deductibles for drugs with no generic equivalents, but that provision does not take effect until 2025.

Insulin as an Outlier?

Just a couple of years ago, insulin may have been a higher priority for drug affordability boards, but now it's not so clear. Both Colorado and Maryland have established insulin copay caps that provide pocketbook relief, at least for patients with coverage. And manufacturers are making their own moves to lower insulin prices. That could prompt the boards to bypass insulin and concentrate their limited resources on other high-cost drugs.

Copay caps do not lower the actual cost of insulin but instead spread it among members of the health plan through higher premiums. The Colorado copay caps don't help new state residents and initially did not help those without insurance, either. Both of those hurdles would have applied to Marquez-Farmer when she moved from California to Colorado Springs a couple of years ago.

“I got married to my husband during covid because I didn't have insurance,” she said. “I loved him, and it all worked out, but a big reason for me to marry him was because I would not be able to afford insulin.”

Marquez-Farmer, 34, said that while insulin may not be the most expensive drug on the market, many Coloradans, particularly those from marginalized communities who have higher rates of diabetes, struggle to afford it.

“I'm not saying the other medicines are not important, because obviously they are,” she said. “The reality is there's more people who are being affected by not being able to afford their insulin and a lot of people who are dying because of them rationing insulin.”

Andrew York, executive director of the Maryland board, said the payment limits should be viewed as a last resort, a tool that can be used when other cost-control measures haven't worked.

“The goal is for folks to never be able to say that they can't afford their insulin. And I think we may get there soon enough just because of how much is happening in that space,” he said. “So if that's the case, then maybe boards don't need to use the upper payment limit tool.”

At least one form of insulin was included on Colorado's list of drugs eligible for review, but not the most commonly taken brand-name insulins. That precludes the Colorado board from addressing insulin costs more broadly.

The pharmaceutical industry has pushed back against the concept of payment limits, warning that drugmakers could pull out of states that set payment limits.

“The boards are acutely aware of this discussion point. The interest and the purpose of these boards is to increase access to the drugs, not decrease it,” York said. “But there's kind of this game theory element of: How will manufacturers react?”

Reck discounted the notion that a payment limit would prompt a manufacturer to abandon a profitable market.

“Unfortunately, it's kind of a scary message and it can be impactful on patients,” she said.

By: Markian Hawryluk
Title: This Panel Will Decide Whose Medicine to Make Affordable. Its Choice Will Be Tricky.
Sourced From: kffhealthnews.org/news/article/this-panel-will-decide-whose-medicine-to-make-affordable-its-choice-will-be-tricky/
Published Date: Thu, 25 May 2023 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/a-trans-teen-no-longer-feels-welcome-in-florida-so-she-left/

Post Views: 351

Related Topics:Featured Health Kaiser Health News News

Up Next

When an Anti-Vaccine Activist Runs for President

Don't Miss

A Trans Teen No Longer Feels Welcome in Florida. So She Left.

Kaiser Health News

Journalists Delve Into Climate Change, Medicaid ‘Unwinding,’ and the Gap in Mortality Rates

Published

1 day ago

May 4, 2024

Staff Editor

Sat, 04 May 2024 09:00:00 +0000

KFF Health News senior correspondent Samantha Young discussed Medicaid and climate change on KCBS Radio's “On-Demand” podcast on April 29.

Click here to hear Young on KCBS
Read Young's “AC, Power Banks, Mini Fridges: Oregon Equips Medicaid Patients for Climate Change“

KFF Health News contributor Andy Miller discussed Medicaid unwinding on WUGA's “The Georgia Health Report” on April 26.

Click here to hear Miller on “The Georgia Health Report”
Read Phil Galewitz' “Millions Were Booted From Medicaid. The Insurers That Run It Gained Medicaid Revenue Anyway.“

KFF Health News Nevada correspondent Jazmin Orozco Rodriguez discussed mortality rates in rural America on The Daily Yonder's “The Yonder Report” on April 24.

——————————
Title: Journalists Delve Into Climate Change, Medicaid ‘Unwinding,' and the Gap in Mortality Rates
Sourced From: kffhealthnews.org/news/article/journalists-delve-into-climate-change-medicaid-unwinding-and-the-gap-in-mortality-rates/
Published Date: Sat, 04 May 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/oh-dear-baby-gear-why-are-the-manuals-so-unclear/

Post Views: 42

Kaiser Health News

Oh, Dear! Baby Gear! Why Are the Manuals So Unclear?

Published

2 days ago

May 3, 2024

Staff Editor

Darius Tahir
Fri, 03 May 2024 09:00:00 +0000

Since becoming a father a few months ago, I've been nursing a grudge against something tiny, seemingly inconsequential, and often discarded: instructional manuals. Parenthood requires a lot of gadgetry to maintain a kid's health and welfare. Those gadgets require puzzling over booklets, decoding inscrutable pictographs, and wondering whether warnings can be safely ignored or are actually disclosing a hazard.

To give an example, my daughter, typically a cooing little marsupial, quickly discovered babyhood's superpower: Infants emerge from the womb with talon-strength fingernails. She wasn't afraid to use them, against either her parents or herself. So we purchased a pistachio-green, hand-held mani-pedi device.

That was the easy part. The difficulty came when we consulted the manual, a palm-sized, two-page document.

The wandlike tool is topped with a whirring disc. One can apparently adjust the speed of its rotation using a sliding toggle on the wand. But the product manual offered confusing advice: “Please do not use round center position grinding,” it said. Instead, “Please use the outer circle position to grinding.” It also proclaimed, “Stay away from children.” In finer print, the manual revealed the potential combination of kids and the device's smaller parts was the reason for concern.

One would hope for more clarity about a doodad that could inadvertently cause pain.

Later, I noticed another warning: “If you do not use this product for a long time, please remove the battery.” Was it dangerous? Or simply an unclear and unhelpful yet innocuous heads-up? We didn't know what to do with this information.

We now notice shoddy instructions everywhere.

One baby carrier insert told us to use the product for infants with “adequate” head, neck, and torso control — a vague phrase. (The manufacturer declined to comment.)

Another manual, this one online and for a car seat — a device that's supposed to protect your kid — informed readers with words and images that a model baby was “properly positioned” relative to the top of the headrest “structure” when more than one inch from the top. Just pixels away, the same model, slumped further down, was deemed improperly positioned: “The headrest should not be more than 1” from the top of her head,” it said, in tension with its earlier instructions. Which was it, more than one inch or not? So we fiddle and hope for the best.

I acknowledge this sounds like new-parent paranoia. But we're not entirely crazy: Manuals are important, and ones for baby products “are notoriously difficult to write,” Paul Ballard, the managing director of 3di Information Solutions, a technical writing firm, told me.

Deborah Girasek, a professor of social and behavior sciences at the Uniformed Services University of the Health Sciences, told me that for decades, for the young and middle-aged alike, unintentional injury has been the leading cause of death. That's drownings, fires, suffocation, car crashes. The USU is a federal service academy training medical students destined for the armed services or other parts of the government.

Some of these deaths are caused by lack of effective communication — that is, the failure of instruction about how to avoid injury.

And these problems stretch from cheap devices to the most sophisticated products of research and development.

It's a shortcoming that's prompted several regulatory agencies charged with keeping Americans healthy, including the Consumer Product Safety Commission, the Food and Drug Administration, and the National Highway Traffic Safety Administration, to prod companies into providing more helpful instructions.

By some lights, they've had success. NHTSA, for example, has employees who actually read manuals. The agency says about three-quarters of car seats' manuals rate four or five stars out of five, up from 38% in 2008. Then again, our car seat's has a five-star rating. But it turns out the agency doesn't evaluate online material.

Medical product manuals sometimes don't fare too well either. Raj Ratwani, director of MedStar Health's Human Factors program, told me that, for a class he teaches to nurses and doctors, he prompted students to evaluate the instructions for covid-19 tests. The results were poor. One time, instructions detailed two swabs. The kit had only one.

Technical writers I spoke with identified this kind of mistake as a symptom of cost cutting. Maybe a company creates one manual meant to cover a range of products. Maybe it puts together the manual at the last moment. Maybe it farms out the task to marketers, who don't necessarily think about how manuals need to evolve as the products do.

For some of these cost-cutting tactics, “the motivation for doing it can be cynical,” Ballard said.

Who knows.

Some corners of the technical writing world are gloomy. People worry their jobs aren't secure, that they're going to be replaced by someone overseas or artificial intelligence. Indeed, multiple people I spoke with said they'd heard about generative AI experiments in this area.

Even before AI has had its effect, the job market has weighed in. According to the federal government, the number of technical writers fell by a third from 2001, its recent peak, to 2023.

One solution for people like us — frustrated by inscrutable instructions — is to turn to another uncharted world: social media. YouTube, for instance, has helped us figure out a lot of the baby gadgets we have acquired. But those videos also are part of a wild West, where creators offer helpful tips on baby products then refer us to their other productions (read: ads) touting things like weight loss services. Everyone's got to make a living, of course; but I'd rather they not make a buck off viewers' postpartum anxiety.

It reminds me of an old insight that became a digital-age cliché: Information wants to be free. Everyone forgets the second half: Information also wants to be expensive. It's cheap to share information once produced, but producing that information is costly — and a process that can't easily or cheaply be replaced. Someone must pay. Instruction manuals are just another example.

——————————
By: Darius Tahir
Title: Oh, Dear! Baby Gear! Why Are the Manuals So Unclear?
Sourced From: kffhealthnews.org/news/article/baby-product-instruction-manuals-confusing-technical-writing/
Published Date: Fri, 03 May 2024 09:00:00 +0000

Post Views: 23

Kaiser Health News

California Floats Extending Health Insurance Subsidies to All Adult Immigrants

Published

2 days ago

May 3, 2024

Staff Editor

Jasmine Aguilera, El Tímpano
Fri, 03 May 2024 09:00:00 +0000

Marisol Pantoja Toribio found a lump in her breast in early January. Uninsured and living in California without legal status and without her family, the usually happy-go-lucky 43-year-old quickly realized how limited her options were.

“I said, ‘What am I going to do?'” she said in Spanish, quickly getting emotional. She immediately worried she might have cancer. “I went back and forth — I have [cancer], I don't have it, I have it, I don't have it.” And if she was sick, she added, she wouldn't be able to work or pay her rent. Without health insurance, Pantoja Toribio couldn't afford to find out if she had a serious condition.

Beginning this year, Medi-Cal, California's Medicaid program, expanded to include immigrants lacking legal residency, timing that could have worked out perfectly for Pantoja Toribio, who has lived in the Bay Area city of Brentwood for three years. But her application for Medi-Cal was quickly rejected: As a farmworker earning $16 an hour, her annual income of roughly $24,000 was too high to qualify for the program.

California is the first state to expand Medicaid to all qualifying adults regardless of immigration status, a move celebrated by health advocates and political leaders across the state. But many immigrants without permanent legal status, especially those who live in parts of California where the cost of living is highest, earn slightly too much money to qualify for Medi-Cal.

The state is footing the bill for the Medi-Cal expansion, but federal law bars those it calls “undocumented” from receiving insurance subsidies or other benefits from the Affordable Care Act, leaving many employed but without viable health insurance options.

Now, the same health advocates who fought for the Medi-Cal expansion say the next step in achieving health equity is expanding Covered California, the state's ACA marketplace, to all immigrant adults by passing AB 4.

“There are people in this state who work and are the backbone of so many sectors of our economy and contribute their labor and even taxes … but they are locked out of our social safety net,” said Sarah Dar, policy director at the California Immigrant Policy Center, one of two organizations sponsoring the bill, dubbed #Health4All.

To qualify for Medi-Cal, an individual cannot earn more than 138% of the federal poverty level, which currently amounts to nearly $21,000 a year for a single person. A family of three would need to earn less than $35,632 a year.

For people above those thresholds, the Covered California marketplace offers various health plans, often with federal and state subsidies, yielding premiums as low as $10 a month. The hope is to create what advocates call a “mirror marketplace” on the Covered California website so that immigrants regardless of status can be offered the same health plans that would be subsidized only by the state.

Despite a Democratic supermajority in the legislature, the bill might struggle to pass, with the state facing a projected budget deficit for next year of anywhere from $38 billion to $73 billion. Gov. Gavin Newsom and legislative leaders announced a $17 billion package to start reducing the gap, but significant spending cuts appear inevitable.

It's not clear how much it would cost to extend Covered California to all immigrants, according to Assembly member Joaquin Arambula, the Fresno Democrat who introduced the bill.

The immigrant policy center estimates that setting up the marketplace would cost at least $15 million. If the bill passes, sponsors would then need to secure funding for the subsidies, which could run into the billions of dollars annually.

“It is a tough time to be asking for new expenditures,” Dar said. “The mirror marketplace startup cost is a relatively very low number. So we're hopeful that it's still within the realm of possibility.”

Arambula said he's optimistic the state will continue to lead in improving access to health care for immigrants who lack legal residency.

“I believe we will continue to stand up, as we are working to make this a California for all,” he said.

The bill passed the Assembly last July on a 64-9 vote and now awaits action by the Senate Appropriations Committee, Arambula's office said.

An estimated 520,000 people in California would qualify for a Covered California plan if not for their lack of legal status, according to the labor research center at the University of California-Berkeley. Pantoja Toribio, who emigrated alone from Mexico after leaving an abusive relationship, said she was lucky. She learned about alternative health care options when she made her weekly visit to a food pantry at Hijas del Campo, a Contra Costa County farmworker advocacy organization, where they told her she might qualify for a plan for low-income people through Kaiser Permanente.

Pantoja Toribio applied just before open enrollment closed at the end of January. Through the plan, she learned that the lump in her breast was not cancerous.

“God heard me,” she said. “Thank God.”

This article was produced by KFF Health News, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

——————————
By: Jasmine Aguilera, El Tímpano
Title: California Floats Extending Health Insurance Subsidies to All Adult Immigrants
Sourced From: kffhealthnews.org/news/article/california-legislation-medicaid-subsidies-all-adult-immigrants/
Published Date: Fri, 03 May 2024 09:00:00 +0000

Did you miss our previous article…
https://www.biloxinewsevents.com/bird-flu-is-bad-for-poultry-and-dairy-cows-its-not-a-dire-threat-for-most-of-us-yet/

Post Views: 34