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California Picks Generic Drug Company Civica to Produce Low-Cost Insulin




SACRAMENTO, Calif. — Gov. Gavin Newsom announced the selection of Utah residents on Saturday Generic manufacturer Civica to produce low-cost insulin for California, an unprecedented move that delivers on its promise of using state government direct competition with the dominant branded drug manufacturers.

“People shouldn’t be forced into debt to get life-saving prescriptions,” Newsom said. “Californiaans will have access to some of the cheapest insulins available, helping them save thousands of dollars each year.”

The contract with a Acquisition cost of 50 million dollars That Newsom and his Democratic lawmakers approved last year calls for Civica to manufacture state insulin and make the life-saving drug available to every Californian who needs it, regardless of insurance coverage, through mail order and at local pharmacies. But insulin is just the beginning. Newsom said the state will also try to manufacture the opioid overdose-reversing drug, naloxone.

Allan Coukell, Civica’s senior vice president of public policy, told KHN that the nonprofit drugmaker is also in talks with the Newsom administration to potentially make other generic drugs, but declined to elaborate, saying the company focus on making cheap insulin widely available first.

“We are very excited about this partnership with the State of California,” said Coukell. “We don’t want 100% of the market, but we do want 100% of people to have access to fair insulin prices.”


As insulin costs for consumers have skyrocketed, Democratic lawmakers and activists have urged the industry to rein in prices. Just a few weeks after President Joe Biden Big Pharma attacked for raising insulin prices, the three drugmakers that control the insulin market — Eli Lilly and Co., Novo Nordisk, and Sanofi — announced they would do so reduce the list prices of some products.

Newsom, who previously accused the pharmaceutical industry of showering Californians with “prices heaven” argued that the introduction of the state’s generic drug label CalRx, will increase competition and put pressure on the industry. Administration officials declined to say when California’s insulin products would be available, but experts say it could be as early as 2025. Coukell said the federally-labeled drug is yet to be approved by the FDA, which may take about 10 months.

The Pharmaceutical Research and Manufacturers of America, which champions branded companies, blasted California’s move. Reid Porter, PhRMA’s senior director of state public affairs, said Newsom just wanted to “pick up political points.”

“If the governor wants to meaningfully influence what patients pay for insulin and other drugs, he should broaden his focus to others in the system who often make patients pay more than they do for drugs,” Porter said, blaming pharmaceutical intermediaries. so-called pharmacy benefit managers who negotiate with manufacturers on behalf of insurers about rebates and rebates on medicines.

The Pharmaceutical Care Management Association, representing pharmacy performance managers argued in turn that the drug companies are to blame high prices.


But drug pricing experts say pharmacy utility managers and drug manufacturers share the blame.

Newsom administration officials say inflated insulin costs are forcing some to pay up to $300 a vial or $500 for a box of injectable pens, and too many Californians with diabetes are skipping or rationing their medications. This can lead to blindness, amputations, and life-threatening conditions such as heart disease and kidney failure. almost 10% of California adults have diabetes.

Civica is Development of three types of generic insulin, known as a biosimilar, which will be available in both vials and injection pens. They are expected to be interchangeable with branded products such as Lantus, Humalog and NovoLog. Coukell said the company would make the drug available for no more than $30 per vial, or $55 for five injectable pens.

Newsom said the state’s insulin will save many patients $2,000 to $4,000 a year, though critical questions about how California would get the products into the hands of consumers remain unanswered, including how pharmacies, insurers and retailers will would convince them to distribute the drugs.

Newsom also secured last year $50 million seed capital to build a facility to manufacture insulin; Coukel said Civica is considering building a plant in California.


California’s move, though never attempted by a state government, could be blunted by recent industry decisions to cut insulin prices. In March, Lilly, Novo Nordisk and Sanofi promised to cut prices, with Lilly offering a vials at $25 per month; Novo Nordisk promising significant reductions bring the price of a certain generic vial to $48; And Sanofi is also lowering priceswith a bottle priced at $64.

The governor’s office said that insulin would cost the state $30 per vial to manufacture and distribute and would be sold at that price. The government argues that this will prevent the egregious cost shifting that occurs in traditional pharmaceutical price games.

Drug pricing experts said generic drug production in California could fall further cost of insulinand benefit people with high-deductible or uninsured health insurance plans.

“This is an extraordinary move in the pharmaceutical industry, not just for insulin but potentially for all types of drugs,” said Robin Feldman, professor at the College of the Law at the University of California, San Francisco. “It’s a very difficult industry to disrupt, but California is ready to do just that.”

This story was produced by KHNwhich published California Healthlinean editorially independent service California Health Care Foundation.




How Have Costs Associated With Obesity Changed Over Time?




The analysis examines the costs associated with obesity for individuals with large employer private insurance, using data from Merative MarketScan’s commercial claims and encounters database from 2011 to 2021. Pocket spending as people without an obesity diagnosis. The analysis also examines the costs of common surgical and pharmacological treatments for obesity.

The analysis is available via the Peterson-KFF Health System Trackeran online information center that monitors and evaluates the performance of the US health care system.

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Catholic Church issues trans care guidelines for Catholic hospitals




Catholic bishops in the United States have issued guidelines aimed at blocking Catholic hospitals from offering care for gender transition, a move that LGBTQ advocates say is damaging to the physical and emotional health of transgender people within the church could.

The 14-page teaching note, titled “Moral Limits to Technological Manipulation of the Human Body,” provides guidelines for changing a person’s gender, particularly in adolescents. The document, released Monday, says Catholic hospitals “may not perform any surgical or chemical procedures aimed at converting the sexual characteristics of a human body into those of the opposite sex, or engage in the development of such procedures.”

Related: Catholic health organizations may refuse care for trans people, court rulings

Transgender Catholics have received mixed reactions across the US church. Some have found acceptance in certain communities and rejection in certain dioceses, including those that prevent church personnel from using trans people’s preferred gender pronouns. Bishops’ recent guidance on Catholic medical centers could prevent trans people from getting the medical care they need, said Francis DeBernardo, executive director of the New Ways Ministry, which works to promote greater LGBTQ acceptance in the church.

Catholic hospitals make up a sizable portion of the US healthcare system, and in some communities they are are the only option. The Catholic Health Association, which includes more than 600 hospitals and 1,400 long-term care and other healthcare facilities across the United States, says more than one in seven US hospital patients receive care in a Catholic facility.


“These decisions are made at a much higher level without knowing the individuals involved and the individual cases,” DeBernardo said. “When transgender people are not allowed or restricted from transitioning in ways they see fit, it can lead to depression, anxiety, or even self-harm, including suicide.”

The bishops’ guidelines “are not going to change much” when it comes to the care of transgender patients in Catholic hospitals, said Rev. Charlie Bouchard, CHA’s senior director of theology and sponsorship. Transgender people continue to be always admitted to Catholic hospitals and treated with dignity and respect, but may not receive all the gender-affirming care they demand because of the church’s theological and moral teachings, he said.

“As we look at the bishops’ document, we remember that we have a history of caring for the marginalized and we view transgender people very strongly as a marginalized group,” he said.

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Catholic hospitals see transgender patients with a variety of health needs, from broken bones to cancer treatments and heart attacks, Bouchard said, adding that the hospitals would not perform cosmetic procedures like reconstructive surgeries, hysterectomies, or treatments like sterilizations on request unless there is a medical need for them.


He said Catholic hospitals also train staff to be respectful of transgender patients: “When a patient checks in, we ask staff to be respectful of questions. We want to validate transgender people as individuals and provide them with spiritual care and psychological counseling.”

Bouchard said Catholic hospitals “base healthcare on science and continue to follow science when it comes to transgender people.”

“But we don’t deal with ideology,” he said. “We treat patients who are really suffering. There are things out there regarding gender fluidity that we don’t agree with. But as Catholic hospitals we are subject to the same standard of care as other hospitals.”

DeBernardo disagreed, saying that the bishops’ doctrinal guidelines hurt rather than heal people by ignoring science.

“The bishops’ unwillingness to confront any evidence from the scientific community or the experiences of transgender people is neither good theology nor acceptable pastoral care,” he said.


Related: Minnesota governor signs executive order protecting gender-affirming care

DeBernardo said he sees hope with many more Catholics in the pews showing a greater understanding of the lives of transgender people. He pointed to instances of Catholic parents supporting their transgender children against restrictive policies in Catholic schools, including bans on puberty blockers and preferred pronouns on campus and in parishes.

Christine Zuba, a transgender woman living in New Jersey, said she feels accepted in her local community but is upset that the national church “continues to deny our existence and our need for health care.” Zuba said she was disappointed to see that transgender people weren’t even mentioned in the 14-page document.

“I feel unconditionally accepted in my community just the way I am,” she said. “But that is missing in our hierarchy. There is no willingness to engage with us and understand our lives.”

Zuba said she looks forward to more engagement and interaction in some dioceses. In Davenport, Iowa, Bishop Thomas Zinkula formed a gender committee that called on Catholics to “listen to those on the fringes” and called serving LGBTQ people — particularly trans people — “a life’s work.” In a column published in Catholic Messenger, Zinkula said he was haunted by the story of a transgender youth who attempted suicide after being refused communion.


“This should never happen again,” he wrote.

Zuba said she would like to see that kind of commitment to listening and learning in the upper echelons of the church.

“All we ask is that you listen to us as a group and as individuals,” she said. “Open your hearts and try to understand.”

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Anxiety, Depression Climbing Among People with IBD




March 24, 2023 – Joshua Denton was diagnosed with ulcerative colitis as a junior in college. Not only was he concerned about a new health diagnosis, but how it might change the rest of his life.

His initial fear was “having something that is technically considered incurable”. Next came the daily challenges of living with Inflammatory Bowel Disease (IBD).

“There’s just a level of concern about what your quality of life is going to be like. Will it ever be like that again, will it get better or worse over time?” said Denton, now a 37-year-old aerospace project manager in Dallas.

People with IBD report higher rates of anxiety, depression and other life problems compared to 6 years ago, according to an American Gastroenterological Association (AGA) survey of more than 1,000 people.

At the same time, many healthcare providers believe patients’ mental health needs are being met, according to an accompanying survey of more than 100 healthcare professionals who treat Crohn’s disease and ulcerative colitis.


So why the inequality? People with IBD are sometimes reluctant to talk to their doctor about relationship issues or difficulties at work, saying they don’t want to be a burden, said Laurie A. Keefer, PhD, a psychologist and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York City, specializing in helping people with IBD develop coping skills and resilience.

Doctors sometimes don’t want to ask questions that might be inappropriate or make people feel uncomfortable. “There’s a lot of good intentions on both sides,” Keefer said. “But I think there’s a real disconnect, which actually needs to happen.”

Survey results showed that 36% of people with IBD report anxiety and 35% report depression. This reflects a steady increase in anxiety and depression diagnoses since 2017 The national anxiety rate is 19% and for depression, 8%, according to a 2017 report by the National Alliance on Mental Illness.

what is the connection

There are likely two reasons that explain why anxiety and depression are more common in people with IBD, Keefer said. It is increasingly recognized that these conditions share inflammatory pathways with autoimmune diseases, particularly pathways associated with the brain and gut.


“The second problem is that these conditions themselves cause depression because there’s so much to deal with,” she added. “You don’t feel good when you stop going out and doing things, and for some people that really just manifests as depression.”

The risk of depression can also increase when someone’s IBD is active. Keefer said, “When you’re sick and you’re in bed and you’re not at work and you don’t see your friends, you get more and more depressed.”

The survey also reveals the impact IBD can have beyond mental well-being — including challenges in relationships, in the workplace, and in educating others about the conditions. AGA used the results as the basis for a new resource called My IBD Life.

“The idea is to really simplify the conversation about the emotional toll of IBD,” Keefer said. My IBD Life features real people with IBD sharing tips on how to talk to friends and family about these challenges, how to manage their work-life balance, and how to travel. “Many of my patients don’t take vacations that require them to fly by plane.”

The campaign also focuses on helping younger people, as IBD is generally diagnosed when people are in their teens or early 20s. “The mental health needs of young adults are high and they are increasing post-COVID,” Keefer said. “These are also people who are trying to get their lives together and then the disease sweeps over them.”


Unpredictability increases fear

Kamila guides was diagnosed at the age of 12 and has had Crohn’s disease for more than 20 years. She shared some challenges beyond the IBD itself.

“Relationships are always important — try to figure out when you’re having that conversation with Crohn’s,” she said. It can be especially difficult for people who have had their colon removed and are living with a colostomy bag. “How do you talk to someone about this in a relationship or even before sex?”

Joint errands can also induce anxiety, Denton said. “There are things that people with normally functioning bodies take for granted. I have to think, “Hey, can I go to the store and buy groceries without worrying about going to the bathroom or having an accident?” ‘Can I go on a date and eat and drink comfortably – and not eat anything that’s going to trigger a flare-up?’”

There can be issues with friends and family who don’t understand the urgency of always being near a bathroom, said Guiden, a digital marketing expert at JPA Health, a public relations and marketing agency that has helped develop it the My IBD Life campaign.


Keefer, who is also an advisor to the campaign, said that “a lot of GI disorders, not just Crohn’s disease and ulcerative colitis, come with a lot of unpredictability that can increase anxiety.” Uncertainty is what separates IBD from many other chronic conditions.

What do you need a break for?

Employers cannot understand the need for time off. People with IBD may be reluctant to ask for time off from the office to avoid being seen as unable to work. For Guiden, it was college professors who were unwilling to forego her absence if she missed class because of her IBD.

“Communication is very important to having a chronic illness and getting the housing you need. Also, don’t be afraid to escalate if necessary,” Guiden said.

The campaign also aims to help providers take a more active role in fighting IBD beyond the physical symptoms. Many providers in the survey said they felt less able to treat the emotional issues than the physical aspects of IBD.


education and awareness

“The subject can be very uncomfortable for a lot of people, including myself at times, admittedly, and it leads to a kind of self-censorship,” Denton said. He’s trying to figure out how much his conversation partner wants to know about his personal IBD challenges.

At the same time, he added, “Anyone you meet who doesn’t know about IBD is an opportunity to educate.”

This is another way the My IBD Life website can help. If someone is uncomfortable discussing the details or IBD, those affected can refer others to this resource. That way, Denton said, people can take their time and learn as much as they want about living with Crohn’s disease or ulcerative colitis. The personal stories shared on the site really “humanize” IBD.

Keefer agreed. “The campaign really breaks down patients’ common emotional concerns and offers them real tips and tricks based on real patients and providers. It’s a very evidence-based guide, but also very practical, tangible information for patients.”


The patient survey, with responses from 1,026 people aged 18 to 59 years with IBD, was conducted from June 27 to July 5, 2022. The provider survey, with responses from 117 gastroenterologists, was conducted at the same time.

IBD and inequality

The survey also found that different communities may experience the challenges of IBD in different ways. For example, one question asked respondents to rate my experience on a scale of 0 to 10, with 0 representing “not applicable” and 10 representing “very good,” the following: “My IBD journey was enhanced by my race , ethnicity and culture influences , sexual orientation, gender identity and/or age.”

The average rating of all 1,026 respondents was 3.57. However, People of Color gave this statement a 4.5 and Black patients gave it a 4.7.

“I will not attempt to speak for those behind the survey, but I will speak through the lens of myself, who is an IBD patient and also part of a non-profit organization Color of Crohn’s and Colitis Foundationa nonprofit organization focused on improving medical access and equitable resource-based treatment for black and brown IDB patients,” said Denton.


“Unfortunately, it’s rooted in a bit of systemic discrimination,” referring to the historical treatment of black and brown patients, he added. Topics include equal access to care and treatment, and participation in clinical trials that are more representative of the United States population. “Certain things have very little to do with who we are as actual individuals and have a lot more to do with the structure of the medical environment.”

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