Kaiser Health News
A Move to Cut Drug Prices Has Patients With Rare Diseases Worried
by Markian Hawryluk
Wed, 30 Aug 2023 09:00:00 +0000
For people with cystic fibrosis, like Sabrina Walker, Trikafta has been a life-changer.
Before she started taking the drug, she would wind up in the hospital for weeks at a time until antibiotics could eliminate the infections in her lungs. Every day, she would wear a vest that shook her body to loosen the mucus buildup.
One particularly bad flare-up, known as a pulmonary exacerbation, had her coughing up blood in 2019, so she was put on the newly approved breakthrough medication.
Within a month, her lung function increased by 20%, she said, and her health improved. Before she started taking Trakafta, she could count on three to four hospitalizations a year. Over the four years on the medication, she has been hospitalized only once.
“I was spending hours a day doing airway clearance and breathing treatments, and that has been significantly reduced,” said the 37-year-old Erie, Colorado, mother. “I've gained hours back in my day.”
Now she runs and hikes in the thin Colorado air and works a full-time job. Other patients have seen similar gains with the drug therapy, allowing many to resume regular lives and even take themselves off waiting lists for a lung transplant. Yet Walker and scores of other Colorado patients with cystic fibrosis are worried they could lose access to that transformative medication.
A state board charged with addressing the affordability of the most expensive prescription drugs has chosen Trikafta among its first five drugs to review, and it could move to cut the medication's average in-state annual price of approximately $200,000, accounting for both insurers' contributions and patients' out-of-pocket costs. Drugmakers, including Trikafta's maker, Vertex Pharmaceuticals, have said payment limits could hurt innovation and limit access, stoking panic among patients that the drug might no longer be sold in Colorado.
Two of the drugs chosen by the state board, the rheumatoid arthritis treatment Enbrel and the psoriasis medication Stelara, also appear on the initial list of 10 drugs for which Medicare will negotiate prices. Any federally negotiated price reductions won't go into effect until 2026, and it's unclear how that effort will affect the Colorado board's work in the interim.
The Colorado board's choice of drugs to review elucidates one of the thorniest questions the board must wrangle with: Would lowering the price tag for rare-disease medications lead manufacturers to pull out of the state or limit their availability? State officials contend that the high cost of prescription drugs puts them out of reach for some patients, while patients worry that they'll lose access to a life-changing therapy and that fewer dollars will be available to develop breakthrough medications. And with affordability boards in other states poised to undergo similar exercises, what happens in Colorado could have implications nationwide.
“It just puts Trikafta as a whole at risk,” Walker said. “It would start here, but it could create a ripple effect.”
Cystic fibrosis is a genetic condition that causes the body to produce thick, sticky mucus that clogs the lungs and digestive system, leading to lung damage, infections, and malnutrition. It is a progressive disease that results in irreversible lung damage and a median age of death of 34 years. There is no cure.
The rare disease affects fewer than 40,000 people in the U.S., including about 700 in Colorado. That means research and development costs are spread across a smaller number of patients than for more common conditions, such as the millions of people with heart disease or cancer.
Officials from Vertex Pharmaceuticals declined a request for an interview. But company spokesperson Sarah D'Souza emailed a statement saying that “the price of this medicine reflects its value to patients, the small number of people living with CF, the billions of dollars Vertex has invested to date to develop the first medicines to treat the underlying cause of CF, and the billions more we are investing in CF and other serious diseases.”
Setting an upper payment limit, the company said, could hinder access to drugs like Trikafta and curtail investment in scientific innovation and drug discovery.
State officials counter that Vertex and other drugmakers are resorting to fear-mongering to protect their profits.
Colorado Insurance Commissioner Michael Conway said that whenever the state talks about saving people money on health care, the affected entity — be it a hospital, insurance company, or drug manufacturer — cries foul and claims there will be an access problem.
“This is just, from my vantage point, the pharmaceutical industry trying to scare people,” he said.
Colorado's Prescription Drug Affordability Board has been working for more than a year to sort through 604 drugs eligible for review, with 17 data points for each, to create a prioritized list. In the end, they decided to focus this year only on drugs that had no brand-name competition or generic alternatives that could lower costs.
Besides Trikafta, Enbrel, and Stelara, the board will review the affordability of the antiretroviral medication Genvoya, used to treat HIV, and another psoriasis treatment, Cosentyx.
Of those five, Trikafta had the highest average annual costs but the lowest five-year increase in price and the fewest patients taking it.
The board's review of the five drugs will happen over its next three to four meetings this year and early next year, allowing all stakeholders — including patients, pharmacies, suppliers, and manufacturers — to provide feedback on whether the drugs are indeed unaffordable and what a reasonable price should be. Any cost limits wouldn't take effect until next year at the earliest.
The board looked at what patients were paying out-of-pocket for their medicines, using a database that captures all the insurance claims in the state. But that data did not account for patient assistance programs, through which manufacturers reimburse patients for out-of-pocket costs. Such programs boost manufacturer sales of drugs because insurance covers most of the cost, and patients otherwise might not be able to afford them.
Through the first half of the year, Vertex reported profits of $1.6 billion, with 89% of its revenue coming from Trikafta (marketed as Kaftrio in Europe). At the beginning of the year, Vertex decreased copay assistance for people with cystic fibrosis, in what the company said was a response to insurers' limiting patients' ability to apply copay assistance to their deductibles.
Lila Cummings, director of the Colorado board, said its staff could not find any entity that collects data on patient assistance programs, so those figures were not available to the board. Once they begin reviewing the individual medications, board members will dig into what extra financial help patients are getting. Cummings also said the board is hoping manufacturers will convey in good faith what might prompt them to leave the Colorado market.
When Trikafta came up second on the Colorado board's prioritized list of drugs eligible for review, patients and advocacy groups flooded the board with pleas to leave pricing for the medication and other drugs for rare diseases untouched.
“People are scared,” Walker said. “If you look at all the drugs out there, it's one that has been so transformational that I think it will go down in history for how positively it's impacted our population as a whole.”
According to the Cystic Fibrosis Foundation, lung exacerbations dropped 65% and lung transplants dropped 80% after the drug's approval. More patients have been able to work, attend school, or start a family. Clinicians have reported a baby boom among patients who take Trikafta.
A study published this year showed that two-thirds of people with cystic fibrosis struggled with finances, experiencing debt, food insecurity, or trouble paying for household or health expenses. The survey was conducted in 2019, before the FDA approval of Trikafta.
Years ago, the Cystic Fibrosis Foundation invested in Aurora Biosciences, later acquired by Vertex Pharmaceuticals, to promote development of cystic fibrosis therapies. The foundation completed the sale of its royalty rights in 2020.
Mary Dwight, chief policy and advocacy officer for the Cystic Fibrosis Foundation, said the board should “ensure its review of Trikafta accounts for the overall value this drug has for someone with CF, including the impact on an individual's long-term health and well-being.”
There is no guarantee that the Colorado board will take action on Trikafta. State officials have stressed that board members are solely focused on improving access and wouldn't jeopardize the availability of the medication.
“We have a history of being able to save people money on health care that doesn't lead to access problems,” Conway said. “We're not talking about these companies losing money at all; we're talking about making it more affordable so that more Coloradans can get access to the pharmaceutical needs that they have.”
But Walker remains unconvinced.
“They had so much testimony on their call and they still selected Trikafta,” she said. “Everyone was just saying how important this drug is, and it didn't matter. It still got pushed through.”
By: Markian Hawryluk
Title: A Move to Cut Drug Prices Has Patients With Rare Diseases Worried
Sourced From: kffhealthnews.org/news/article/a-move-to-cut-drug-prices-has-patients-with-rare-diseases-worried/
Published Date: Wed, 30 Aug 2023 09:00:00 +0000
Kaiser Health News
Journalists Delve Into Climate Change, Medicaid ‘Unwinding,’ and the Gap in Mortality Rates
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.
- Click here to hear Rodriguez on “The Yonder Report”
- Read Rodriguez' “City-Country Mortality Gap Widens Amid Persistent Holes in Rural Health Care Access”
——————————
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/
Kaiser Health News
Oh, Dear! Baby Gear! Why Are the Manuals So Unclear?
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
Kaiser Health News
California Floats Extending Health Insurance Subsidies to All Adult Immigrants
Jasmine Aguilera, El TÃmpano
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.Â
——————————
By: Jasmine Aguilera, El TÃmpano
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/
-
SuperTalk FM3 days ago
Driver’s education set to become mandatory in Mississippi as bill passes
-
SuperTalk FM6 days ago
Festival merger in Leland sets up one major event for Mississippi Delta
-
SuperTalk FM2 days ago
State approves $160M to expand Highway 7 to four lanes in Lafayette County
-
Mississippi Business4 days ago
Geartek expanding operations in Alcorn County
-
SuperTalk FM6 days ago
PERS bill set to phase in employer rate increase heads to governor’s desk
-
Mississippi News5 days ago
Two women accused of shoplifting across southeast captured in Mississippi
-
Mississippi News3 days ago
Altercation at Mississippi police department leads to officer-involved shooting
-
Mississippi Today6 days ago
Podcast: The contentious final days of the 2024 legislative session