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KHN senior correspondent Angela Hart discussed California’s contract with Civica to make lower-cost insulin on KQED’s “Forum” on March 23. She also discussed California’s potential plan to use Medicaid funding to cover up to six months of rent for low-income enrollees on KCBS’ “State of California” on March 22.
KHN South Carolina correspondent Lauren Sausser discussed prior authorization on WNHN’s “The Attitude With Arnie Arnesen” on March 21.
KHN Montana legislative fellow Keely Larson discussed Montana’s vaccine exemption legislation on the Montana Free Press’ “The Session” on March 20.
KHN Midwest correspondent Bram Sable-Smith discussed insulin costs on NPR’s “Weekend Edition Saturday” on March 18.
Sen. Bernie Sanders, who rose to national prominence criticizing big business in general and the pharmaceutical industry in particular, claimed the spotlight Wednesday on what might at first seem a powerful new stage from which to advance his agenda: chairmanship of the Senate health committee.
But the hearing Sanders used to excoriate a billionaire pharmaceutical executive for raising the price of a covid-19 vaccine showed the challenges the Vermont independent faces.
Though its formal name is the Committee on Health, Education, Labor, and Pensions (HELP), the panel Sanders chairs has little if any authority over drug prices. In the Senate, most of that leverage lies with the Finance Committee, which oversees Medicaid, Medicare, and Obamacare.
As far as drug prices go, the platform Sanders commands is essentially a bully pulpit. So Sanders was left to bully his way toward results. And while some committee Republicans sympathized with his complaints, others bristled at his approach.
By the end of the hearing, seeming to acknowledge the limits of his power, the former presidential candidate was pleading with Moderna chief executive Stéphane Bancel for a relatively modest concession on vaccine pricing.
The CEO made no promises. Then again, pulpit proclamations can lead to corporate action, even if delayed and informal; in the weeks following President Joe Biden’s State of the Union call for cheaper insulin, the companies that make it drastically cut their prices.
Sanders began Wednesday’s hearing with his usual fire and brimstone.
“All over this country people are getting sicker, and in some cases dying, because they can’t afford the outrageous cost of prescription drugs, while companies make huge profits and executives become billionaires,” Sanders thundered.
Bancel had won his place in the witness chair with federal assistance. Moderna, which was founded in 2010 and had not brought a drug to market before the pandemic, received billions in government funds for research, guaranteed purchases, and expert advice to help develop and produce its successful covid vaccine. The payoff has been handsome. As of March 8, Bancel held $3 billion in Moderna stock. He also held options to buy millions of additional shares.
Government research and support are foundational to many of the expensive drugs and vaccines in use today. But Bancel made himself the perfect foil for Sanders when he announced in January that Moderna planned to increase the price of its latest covid shot from about $26 to $110 — or as much as $130.
Denouncing greed, Sanders expounded on his dream of a system in which the government fully funds drug development — and in exchange controls drug prices. “Is there another model out there where, when a lifesaving drug is made, it becomes accessible to all those who need it?” he asked. “What am I missing in thinking that it’s cruel to make a medicine that people can’t afford?’”
Sanders’ overt moralizing and harsh attacks on big business make him an outlier in the Senate, even in his own party. Yet distaste for soaring drug prices extends across the aisle. On the HELP Committee, at least, Republican politicians seem about evenly split between populist and pro-business takes on the problem, showing both the possibilities and the pitfalls that Sanders faces.
Sen. Mike Braun (R-Ind.) expressed disgust with the lack of transparency in the health care system and called Moderna’s planned price hike “preposterous.” Sen. Roger Marshall (R-Kan.) called it “outrageous.”
Sen. Rand Paul (R-Ky.), who often bucks mainstream GOP views and has expressed rancor for the biomedical establishment, claimed Bancel was downplaying vaccine injuries to make money. (Paul vastly exaggerated those risks.)
Ranking member Bill Cassidy (R-La.), who has pledged to work with Sanders, responded to the chairman’s opening remarks with both a hedge and a warning. “I’m not defending salaries or profits,” Cassidy said, but he added that he hoped the hearing’s goal wasn’t to “demonize capitalism.”
Only Sen. Mitt Romney (R-Utah), a former private equity executive, came heartily to Bancel’s defense. “If I’m an investor, I have to expect that if a product I’m backing works, I get to make an awful lot of money,” he said. “I’ve heard people say, ‘That’s corporate greed.’ Yeah, that’s how it works.”
Sanders’ idealized vision of the pharmaceutical industry is, in any case, moot. Even the Biden administration, which successfully browbeat insulin makers into drastically lowering prices in March, revealed this week it would not use “march-in” rights to lower the price of a cancer drug, Xtandi, developed with government-licensed patents.
March-in rights were established in the 1980 Bayh-Dole Act, which enabled companies to license federally funded research and use it to develop drugs. But federal courts and administrations have consistently said the government can seize a product only if the license holder has failed to make it available — not because the price is too high. The administration did, however, announce a review of whether price might be considered in future march-in decisions.
Sanders said before the hearing that he was “extremely disappointed” with the Xtandi decision. But he was ultimately realist enough to aim his bully pulpit at a lower target. Late in Wednesday’s hearing, Sanders pushed for a minimal gimme from Moderna. “Will you reconsider your decision to quadruple the price of your vaccine to the U.S. government and its agents?” he asked politely.
Bancel dodged, saying pricing was more complex now that Moderna faced an uncertain market, had to fill separate syringes with its vaccine, and needed to sell and distribute the vaccine to thousands of pharmacies, where previously the government did all that work. Later, he left open the possibility that negotiations could drive down the price paid by some government agencies or private insurers.
For all the theatrics of such hearings and the mix of opinions among the senators, interrogations of figures like Bancel may help inspire a shift in how the National Institutes of Health “does business in giving away its science to the private sector,” said Tahir Amin, co-executive director of I-MAK, a nonprofit that advocates for equitable access to medicines.
“You have to prosecute it so you at least get these public comments on record,” Amin said. Eventually, he said, this type of hearing could lead to a recognition that, ‘Hey, we need to do this.’”
Despite the HELP Committee’s lack of direct jurisdiction over drug prices, said John McDonough, a Harvard professor who was senior adviser for health reform on the HELP Committee from 2008 to 2010, Sanders “uses his position of authority and influence to draw attention to this in a way that has been helpful.”
KHN correspondent Rachana Pradhan contributed to this report.
Medicare Advantage, the private-sector alternative to original Medicare, now enrolls nearly half of all Medicare beneficiaries. But it remains controversial because — while most of its subscribers like the extra benefits many plans provide — the program frequently costs the federal government more than if those seniors remained in the fully public program. That controversy is becoming political, as the Biden administration tries to rein in some of those payments without being accused of “cutting” Medicare.
Meanwhile, President Joe Biden has signed a bill to declassify U.S. intelligence about the possible origin of covid-19 in China. And new evidence has emerged potentially linking the virus to raccoon dogs at an animal market in Wuhan, where the virus reportedly first took hold.
This week’s panelists are Julie Rovner of KHN, Margot Sanger-Katz of The New York Times, Jessie Hellmann of CQ Roll Call, and Joanne Kenen of the Johns Hopkins Bloomberg School of Public Health and Politico.
Among the takeaways from this week’s episode:
The Biden administration recently changed the formula used to calculate how much the federal government pays private Medicare Advantage plans to care for patients with serious conditions, amid allegations that many of the health plans overcharge or even defraud the government. Major insurers are making no secret about how lucrative the program can be: Humana recently said it would leave the commercial insurance market and focus on government-funded programs, like its booming Medicare Advantage plans.
The formula change is intended to rein in excess spending on Medicare — a huge, costly program at risk of insolvency — yet it has triggered a lobbying blitz, including a vigorous letter-writing campaign in support of the popular Medicare Advantage program. On Capitol Hill, though, party leaders have not stepped up to defend private insurers as aggressively as they have in the past. But the 2024 campaign season could hear the parties trading accusations over whether Biden cut Medicare or, conversely, protected it.
The latest maternal mortality rates released by the Centers for Disease Control and Prevention show the problem continued to worsen during the pandemic. Many states have extended Medicaid coverage for a full year after women give birth, in an effort to improve care during that higher-risk period. But other problems limit access to postpartum care. During the pandemic, some women did not get prenatal care. And after the fall of Roe v. Wade, some states are having trouble securing providers — including one rural Idaho hospital, which announced it will stop delivering babies.
The federal government will soon declassify intelligence related to the origins of the covid pandemic. In the United States, the fight over what started the pandemic has largely morphed into an issue of political identity, with Republicans favoring the notion that a Chinese lab leak started the global health crisis that killed millions, while Democrats are more likely to believe it was animal transmission tied to a wet market.
And in drug price news, Sanofi has become the third major insulin maker (of three) to announce it will reduce the price on some of its insulin products ahead of a U.S. government policy change next year that could have cost the company.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
During a four-hour hearing last week that could eliminate nationwide access to a common and widely used abortion pill, federal Judge Matthew Kacsmaryk, of the Northern District of Texas, signaled his conservative Christian beliefs early and often.
Speaking from the bench in a courtroom in Amarillo, Texas, Kacsmaryk repeatedly used language that mimicked the vocabulary of anti-abortion activists. It also reflected the wording of the lawyers seeking to overturn the FDA’s two-decade-old approval of mifepristone, one of the drugs in the two-pill regimen approved for early pregnancy termination.
Each time a lawyer from the Department of Justice, representing the FDA, referred to “medication abortion,” Kacsmaryk returned to the language of conservative Christian activists, using monikers like “chemical abortion” and “mail-in abortion,” phrases at odds with conventional medical terminology.
The stakes in the case, Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, are high: Abortion rights advocates fear that Kacsmaryk, an appointee of then-President Donald Trump and a former lawyer at the First Liberty Institute, a conservative Christian legal group, could rule within days to force manufacturers to pull mifepristone from the market nationwide. If that happens, clinics and obstetricians and gynecologists across the country will be able to prescribe only misoprostol, the second drug in the two-pill regimen, for miscarriages and early abortion care. Misoprostol is still extremely safe but less effective and comes with more side effects.
The ruling would be unprecedented in the history of approved drugs and could affect the health care of millions of women, even those in states where abortion is still legal.
“One conservative judge is impacting the rights of women in California and New York,” said Greer Donley, an associate professor of law at the University of Pittsburgh Law School and expert on reproductive health law. “The endgame is to stop as many abortions as possible by any means necessary.”
When the conservative majority on the Supreme Court eliminated the federal right to abortion, Justice Brett Kavanaugh, a Catholic, wrote that the court was not outlawing abortion throughout the United States. “On the contrary,” Kavanaugh wrote, “the Court’s decision properly leaves the question of abortion for the people and their elected representatives in the democratic process.”
But in the nine months since the announcement of the decision in Dobbs v. Jackson Women’s Health Organization, Christian legal groups have made their strategy clear: eliminate abortion nationwide by filing lawsuits in federal courts that make scientific claims, unsupported by mainstream medical organizations, to raise doubts about the safety of abortion pills and contraception.
These legal decisions, which conservatives might once have decried as “judicial activism,” are partially necessary because abortion rights continually poll positively, with voters even in solidly conservative states like Kansas and Kentucky refusing to enact bans.
“After Dobbs, there have been more and more efforts to move things away from the popular majority and into the hands of judges like Kacsmaryk,” said Mary Ziegler, a law professor and abortion historian at the University of California-Davis School of Law. “Because voters are not sold on fetal rights and because the only way to a national ban on abortion is likely to come from the conservative courts,” she said.
Ziegler added of anti-abortion campaigners, “They don’t want solutions that work only in Tennessee and Texas.”
The strategy of casting doubt on established and accepted science is not new in conservative circles, nor is it limited to abortion.
For decades, conservative Christian legal groups have introduced scientific uncertainty where there had been none: Claims that abortion causes breast cancer or infertility are unsupported by medical and scientific research but nevertheless made their way into state laws, requiring physicians in certain states to tell patients about risks from abortion that do not exist.
And in a recent opinion that ended birth control access for teens without parental consent in Texas, the same judge as in the mifepristone case — Kacsmaryk — exaggerated the health risks of prescription birth control in his decision, asserting that states have an interest in protecting the health of girls.
“Several popular methods of birth control carry serious side effects,” Kacsmaryk wrote, later quoting from Planned Parenthood educational material that read, “Complications are rare, but they can be serious. In very rare cases, they can lead to death.”
That case, Deanda v. Becerra, was filed by a Christian father who cited religious objections to a federal family planning program. And in the mifepristone case, fundamentalist Christian groups have argued that the drug is unsafe, despite ample research and decades of use testifying to the contrary.
Alliance Defending Freedom, which describes itself as the world’s largest legal organization committed to protecting “God’s design for marriage and family,” is pushing to outlaw abortion pills. Erik Baptist, an attorney for the group, said in a statement following the March 15 hearing that the “the FDA’s approval of chemical abortion drugs over 20 years ago has always stood on shaky legal and moral ground.”
He added, “It’s time for the government to do what it’s legally required to do: protect the health and safety of vulnerable women and girls.”
Conservative legal groups like ADF have been savvy about exploiting small wins in the courts and building on them, such as the 2007 decision Gonzales v. Carhart, which upheld a federal ban on a rarely used method of abortion.
The decision had minimal practical impact, as the procedure in question was rarely performed, but it established an important legal principle: When scientific uncertainty arises in legal disputes — is a medical procedure, device, or medication safe or not? — legislatures get to decide.
“The court said when there is scientific uncertainty the tiebreaker goes to the legislature,” said Ziegler.
But there is little question that mifepristone is safe: More than 5.6 million women have successfully used medication abortion since 2000, according to the FDA. In 2008, the Government Accountability Office investigated the FDA’s approval of mifepristone and concluded the process was consistent with FDA regulations.
In the courtroom, Baptist acknowledged that no court had ever ordered the FDA to remove a drug from the market over the agency’s objections, and legal observers say there remains a huge question whether the court can order the secretary of the Department of Health and Human Services, who oversees the FDA, to do so.
But Laurie Sobel, an associate director for women’s health policy at KFF, who listened to the hearing in a Dallas courtroom, said anti-abortion attorneys argued that the mailing of abortion medications strips states of their ability to protect women and children. (The hearing, which Kacsmaryk did not, initially, publicly announce, was not streamed to the public, and the court has yet to release a transcript.)
But Jessica Ellsworth, an attorney representing Danco Laboratories, a manufacturer of mifepristone, told the court that abortion remained legal in all states because it was allowed for preventing a patient’s death or serious bodily injury. Using mifepristone is the safest method of abortion, she argued, noting the judge’s decision in the case could ban it in every state.
“If Kavanaugh said, ‘We’re going to send it back to the states to be decided by their elected representatives,’ this is the exact opposite,” said Donley.
Kacsmaryk appeared ready to grant a preliminary injunction in favor of anti-abortion groups, asking ADF’s Baptist what kind of remedy he was seeking.
Baptist responded, “The court has an interest in preventing dangerous drugs from entering the marketplace.” He added, “Any relief you grant must be complete. The harm of chemical drugs knows no bound.”
SACRAMENTO, CA. — El gobernador Gavin Newsom anunció el sábado 18 de marzo que se había seleccionado al fabricante de medicamentos genéricos Civica, con sede en Utah, para producir insulina de bajo costo para el estado, una medida sin precedentes que cumple su promesa de poner al gobierno estatal en competencia directa con las versiones de marca de las farmaceúticas que dominan el mercado.
“La gente no debería verse obligada a endeudarse para obtener recetas que salvan vidas”, dijo Newsom. “Los californianos tendrán acceso a algunas de las insulinas más económicas disponibles, lo que les ayudará a ahorrar miles de dólares cada año”.
El contrato, con un costo inicial de $50 millones que Newsom y los legisladores demócratas aprobaron el año pasado, estipula que Civica produzca insulina de marca estatal y ponga el medicamento a disposición de cualquier californiano que lo necesite, por correo y en las farmacias locales, independientemente de si tenga o no seguro de salud.
Y la insulina es solo el comienzo. Newsom dijo que el estado también buscará producir naloxona, el fármaco que revierte las sobredosis de opioides.
Allan Coukell, vicepresidente sénior de políticas públicas de Civica, le dijo a California Healthline que el fabricante de medicamentos sin fines de lucro también está en conversaciones con la administración de Newsom para producir potencialmente otros medicamentos genéricos. Pero se negó a dar más detalles y dijo que la compañía se enfoca primero en hacer que la insulina económica esté ampliamente disponible.
“Estamos muy entusiasmados con esta asociación con el estado de California”, dijo Coukell. “No buscamos tener el 100% del mercado, pero sí queremos que el 100% de las personas tenga acceso a insulina a un precio justo”.
A medida que los costos de la insulina para los consumidores se han disparado, los legisladores y activistas demócratas han pedido a la industria que los controle. Apenas unas semanas después que el presidente Joe Biden atacara a las grandes farmacéuticas por aumentar los precios de la insulina, los tres fabricantes de medicamentos que controlan ese mercado, Eli Lilly and Co., Novo Nordisk y Sanofi, anunciaron que reducirían drásticamente los precios de lista de algunos productos.
Newsom, quien anteriormente acusó a la industria farmacéutica de estafar a los californianos con “precios altísimos”, argumentó que el lanzamiento de la marca de genéricos estatal, CalRx, sumará competencia y ejercerá presión sobre la industria.
Funcionarios de la administración no dijeron cuándo estarían disponibles los productos de insulina de California, pero expertos dicen que podría ser tan pronto como en 2025. Coukell remarcó que el medicamento de marca estatal aún requerirá la aprobación de la Administración de Drogas y Alimentos (FDA), lo que puede demorar unos 10 meses.
La Pharmaceutical Research and Manufacturers of America, que cabildea en nombre de las empresas de marca, criticó la medida de California. Reid Porter, director senior de asuntos públicos estatales de PhRMA, dijo que Newsom solo “quiere sumar puntos políticos”.
“Si el gobernador quiere tener un impacto significativo en lo que los pacientes pagan por las insulinas y otros medicamentos, debería expandir su enfoque a otros en el sistema que a menudo hace que los pacientes paguen más por los medicamentos”, dijo Porter, culpando a las empresas intermediarias, conocidas como administradores de beneficios de farmacia, que negocian con los fabricantes en nombre de las aseguradoras para reembolsos y descuentos.
La Pharmaceutical Care Management Association, que representa a estos administradores, argumentó a su vez que son las compañías farmacéuticas las culpables de los altos precios.
Expertos en precios dicen que los administradores de beneficios farmacéuticos y los fabricantes de medicamentos comparten la culpa.
Funcionarios de la administración Newsom dicen que los costos inflados de la insulina obligan a algunos a pagar hasta $300 por vial o $500 por una caja de plumas inyectables, y que demasiados californianos con diabetes se saltan o racionan sus medicamentos. Esto puede provocar ceguera, amputaciones y afecciones potencialmente mortales, como enfermedades cardíacas e insuficiencia renal. Casi el 10% de los adultos de California tienen diabetes.
Civica está desarrollando tres tipos de insulina genérica, conocida como biosimilar, que estarán disponibles tanto en viales como en plumas inyectables. Se espera que sean intercambiables con productos de marca, incluidos Lantus, Humalog y NovoLog. Coukell dijo que la compañía pondría a disposición el medicamento por no más de $30 por vial, o $55 por cinco plumas inyectables.
Newsom dijo que la insulina estatal le ahorrará a muchos pacientes entre $2,000 y $4,000 al año, aunque siguen sin respuesta preguntas críticas sobre cómo California pondrá los productos en manos de los consumidores, incluida la forma en que persuadiría a las farmacias, las aseguradoras y los minoristas para que distribuyan los medicamentos.
El año pasado, Newsom también obtuvo $50 millones en capital inicial para construir una instalación para fabricar insulina; Coukell dijo que Civica está explorando la construcción de una planta en California.
El movimiento de California, aunque nunca antes lo había intentado un gobierno estatal, podría verse afectado por las recientes decisiones de la industria para reducir los precios de la insulina. En marzo, Lilly, Novo Nordisk y Sanofi se comprometieron a reducir los precios. Con Lilly ofreciendo un vial a $25 por mes, Novo Nordisk prometió importantes reducciones que llevarían el precio de un vial genérico particular a $48, y Sanofi fijó un vial a $64.
La oficina del gobernador dijo que le costará al estado $30 por vial para fabricar y distribuir insulina y se venderá a ese precio. Si lo hace, argumenta la administración, “evitará el atroz cambio de costos que ocurre en los juegos de precios farmacéuticos tradicionales”.
Expertos en precios de medicamentos dijeron que la producción de genéricos en California podría reducir aún más los costos de la insulina y beneficiar a las personas con planes médicos con deducibles altos o sin seguro.
“Este es un movimiento extraordinario en la industria farmacéutica, no solo para la insulina, sino potencialmente para todo tipo de medicamentos”, dijo Robin Feldman, profesor de la Facultad de Derecho de la Universidad de California en San Francisco. “Es una industria muy difícil de quebrantar, pero California está lista para hacer precisamente eso”.
SACRAMENTO, Calif. — Gov. Gavin Newsom on Saturday announced the selection of Utah-based generic drug manufacturer Civica to produce low-cost insulin for California, an unprecedented move that makes good on his promise to put state government in direct competition with the brand-name drug companies that dominate the market.
“People should not be forced to go into debt to get lifesaving prescriptions,” Newsom said. “Californians will have access to some of the most inexpensive insulin available, helping them save thousands of dollars each year.”
The contract, with an initial cost of $50 million that Newsom and his fellow Democratic lawmakers approved last year, calls for Civica to manufacture state-branded insulin and make the lifesaving drug available to any Californian who needs it, regardless of insurance coverage, by mail order and at local pharmacies. But insulin is just the beginning. Newsom said the state will also look to produce the opioid overdose reversal 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 produce other generic medications, but he declined to elaborate, saying the company is focused on making cheap insulin widely available first.
“We are very excited about this partnership with the state of California,” Coukell said. “We’re not looking to have 100% of the market, but we do want 100% of people to have access to fair insulin prices.”
As insulin costs for consumers have soared, Democratic lawmakers and activists have called on the industry to rein in prices. Just weeks after President Joe Biden attacked Big Pharma for jacking up insulin prices, the three drugmakers that control the insulin market — Eli Lilly and Co., Novo Nordisk, and Sanofi — announced they would slash the list prices of some products.
Newsom, who has previously accused the pharmaceutical industry of gouging Californians with “sky-high prices,” argued that the launch of the state’s generic drug label, CalRx, will add competition and apply pressure on the industry. Administration officials declined to say when California’s insulin products would be available, but experts say it could be as soon as 2025. Coukell said the state-branded medication will still require approval from the FDA, which can take roughly 10 months.
The Pharmaceutical Research and Manufacturers of America, which lobbies on behalf of brand-name companies, blasted California’s move. Reid Porter, senior director of state public affairs for PhRMA, said Newsom just “wants to score political points.”
“If the governor wants to impact what patients pay for insulins and other medicines meaningfully, he should expand his focus to others in the system that often make patients pay more than they do for medicines,” Porter said, blaming pharmaceutical go-between companies, known as pharmacy benefit managers, that negotiate with manufacturers on behalf of insurers for rebates and discounts on drugs.
The Pharmaceutical Care Management Association, which represents pharmacy benefit managers argued in turn that it’s pharmaceutical companies that are to blame for high prices.
Drug pricing experts, however, say pharmacy benefit managers and drugmakers share the blame.
Newsom administration officials say that inflated insulin costs force some to pay as much as $300 per vial or $500 for a box of injectable pens, and that too many Californians with diabetes skip or ration their medication. Doing so can lead to blindness, amputations, and life-threatening conditions such as heart disease and kidney failure. Nearly 10% of California adults have diabetes.
Civica is developing three types of generic insulin, known as a biosimilar, which will be available both in vials and in injectable pens. They are expected to be interchangeable with brand-name products including Lantus, Humalog, and NovoLog. Coukell said the company would make the drug available for no more than $30 a 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 it would persuade pharmacies, insurers, and retailers to distribute the drugs.
Last year, Newsom also secured $50 million in seed money to build a facility to manufacture insulin; Coukell said Civica is exploring building a plant in California.
California’s move, though never been tried by a state government, could be blunted by recent industry decisions to lower insulin prices. In March, Lilly, Novo Nordisk, and Sanofi vowed to cut prices, with Lilly offering a vial at $25 per month; Novo Nordisk promising major reductions to bring the price of a particular generic vial to $48; and Sanofi also slashing prices, with one vial pegged at $64.
The governor’s office said it will cost the state $30 per vial to manufacture and distribute insulin and it will be sold at that price. Doing so, the administration argues, “will prevent the egregious cost-shifting that happens in traditional pharmaceutical price games.”
Drug pricing experts said generic production in California could further lower costs for insulin, and benefit people with high-deductible health insurance plans or no insurance.
“This is an extraordinary move in the pharmaceutical industry, not just for insulin but potentially for all kinds of drugs,” said Robin Feldman, a professor at the University of California College of the Law-San Francisco. “It’s a very difficult industry to disrupt, but California is poised to do just that.”
Jessica Layman estimates she has called more than 150 doctors in the past few years in her search for someone to prescribe opioids for her chronic pain.
“A lot of them are straight-up insulting,” said the 40-year-old, who lives in Dallas. “They say things like ‘We don’t treat drug addicts.’”
Layman has tried a host of non-opioid treatments to help with the intense daily pain caused by double scoliosis, a collapsed spinal disc, and facet joint arthritis. But she said nothing worked as well as methadone, an opioid she has taken since 2013.
The latest phone calls came late last year, after her previous doctor shuttered his pain medicine practice, she said. She hopes her current doctor won’t do the same. “If something should happen to him, there’s nowhere for me to go,” she said.
Layman is one of the millions in the U.S. living with chronic pain. Many have struggled to get opioid prescriptions written and filled since 2016 guidelines from the Centers for Disease Control and Prevention inspired laws cracking down on doctor and pharmacy practices. The CDC recently updated those recommendations to try to ease their impact, but doctors, patients, researchers, and advocates say the damage is done.
“We had a massive opioid problem that needed to be rectified,” said Antonio Ciaccia, president of 3 Axis Advisors, a consulting firm that analyzes prescription drug pricing. “But the federal crackdowns and guidelines have created collateral damage: patients left high and dry.”
Born of an effort to fight the nation’s overdose crisis, the guidance led to legal restrictions on doctors’ ability to prescribe painkillers. The recommendations left many patients grappling with the mental and physical health consequences of rapid dose tapering or abruptly stopping medication they’d been taking for years, which carries risks of withdrawal, depression, anxiety, and even suicide.
In November, the agency released new guidelines, encouraging physicians to focus on the individual needs of patients. While the guidelines still say opioids should not be the go-to option for pain, they ease recommendations about dose limits, which were widely viewed as hard rules in the CDC’s 2016 guidance. The new standards also warn doctors about risks associated with rapid dose changes after long-term use.
But some doctors worry the new recommendations will take a long time to make a meaningful change — and may be too little, too late for some patients. The reasons include a lack of coordination from other federal agencies, fear of legal consequences among providers, state policymakers hesitant to tweak laws, and widespread stigma surrounding opioid medication.
The 2016 guidelines for prescribing opioids to people with chronic pain filled a vacuum for state officials searching for solutions to the overdose crisis, said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School.
The dozens of laws that states passed limiting how providers prescribe or dispense those medications, she said, had an effect: a decline in opioid prescriptions even as overdoses continued to climb.
The first CDC guidelines “put everybody on notice,’’ said Dr. Bobby Mukkamala, chair of the American Medical Association’s Substance Use and Pain Care Task Force. Physicians reduced the number of opioid pills they prescribe after surgeries, he said. The 2022 revisions are “a dramatic change,” he said.
The human toll of the opioid crisis is hard to overstate. Opioid overdose deaths have risen steadily in the U.S. in the past two decades, with a spike early in the covid-19 pandemic. The CDC says illicit fentanyl has fueled a recent surge in overdose deaths.
Taking into account the perspective of chronic pain patients, the latest recommendations try to scale back some of the harms to people who had benefited from opioids but were cut off, said Dr. Jeanmarie Perrone, director of the Penn Medicine Center for Addiction Medicine and Policy.
“I hope we just continue to spread caution without spreading too much fear about never using opioids,” said Perrone, who helped craft the CDC’s latest recommendations.
Christopher Jones, director of the CDC’s National Center for Injury Prevention and Control, said the updated recommendations are not a regulatory mandate but only a tool to help doctors “make informed, person-centered decisions related to pain care.”
Multiple studies question whether opioids are the most effective way to treat chronic pain in the long term. But drug tapering is associated with deaths from overdose and suicide, with risk increasing the longer a person had been taking opioids, according to research by Dr. Stefan Kertesz, a professor of medicine at the University of Alabama-Birmingham.
He said the new CDC guidance reflects “an extraordinary amount of input” from chronic pain patients and their doctors but doubts it will have much of an impact if the FDA and the Drug Enforcement Administration don’t change how they enforce federal laws.
The FDA approves new drugs and their reformulations, but the guidance it provides for how to start or wean patients could urge clinicians to do so with caution, Kertesz said. The DEA, which investigates physicians suspected of illegally prescribing opioids, declined to comment.
Smith has experienced pain in her left leg since a nerve was cut during surgery years ago. But in December her pharmacy stopped filling her prescriptions for painkillers.(Andy Miller / KHN)
The DEA’s pursuit of doctors put Danny Elliott of Warner Robins, Georgia, in a horrible predicament, said his brother, Jim.
In 1991, Danny, a pharmaceutical company rep, suffered an electric shock. He took pain medicine for the resulting brain injury for years until his doctor faced federal charges of illegally dispensing prescription opioids, Jim said.
Danny turned to doctors out of state — first in Texas and then in California. But Danny’s latest physician had his license suspended by the DEA last year, and he couldn’t find a new doctor who would prescribe those medications, Jim said.
Danny, 61, and his wife, Gretchen, 59, died by suicide in November. “I’m really frustrated and angry about pain patients being cut off,” Jim said.
Danny became an advocate against forced drug tapering before he died. Chronic pain patients who spoke with KHN pointed to his plight in calling for more access to opioid medications.
Even for people with prescriptions, it’s not always easy to get the drugs they need.
Pharmacy chains and drug wholesalers have settled lawsuits for billions of dollars over their alleged role in the opioid crisis. Some pharmacies have seen their opioid allocations limited or cut off, noted Ciaccia, with 3 Axis Advisors.
Rheba Smith, 61, of Atlanta, said that in December her pharmacy stopped filling her prescriptions for Percocet and MS Contin. She had taken those opioid medications for years to manage chronic pain after her iliac nerve was mistakenly cut during surgery, she said.
Smith said she visited nearly two dozen pharmacies in early January but could not find one that would fill her prescriptions. She finally found a local mail-order pharmacy that filled a one-month supply of Percocet. But now that drug and MS Contin are not available, the pharmacy told her.
“It has been a horrible three months. I have been in terrible pain,” Smith said.
Many patients fear a future of constant pain. Layman thinks about the lengths she’d go to in order to get medication.
“Would you be willing to buy drugs off the street? Would you be willing to go to an addiction clinic and try to get pain treatment there? What are you willing to do to stay alive?” she said. “That is what it comes down to.”
President Joe Biden’s fiscal 2024 budget proposal includes new policies and funding boosts for many of the Democratic Party’s important constituencies, including advocates for people with disabilities and reproductive rights. It also proposes ways to shore up Medicare’s dwindling Hospital Insurance Trust Fund without cutting benefits, basically daring Republicans to match him on the politically potent issue.
Meanwhile, five women in Texas who were denied abortions when their pregnancies threatened their lives or the viability of the fetuses they were carrying are suing the state. They charge that the language of Texas’ abortion ban makes it impossible for doctors to provide needed care without fear of enormous fines or prison sentences.
This week’s panelists are Julie Rovner of KHN, Shefali Luthra of The 19th, Victoria Knight of Axios, and Margot Sanger-Katz of The New York Times.
Among the takeaways from this week’s episode:
Biden’s budget manages to toe the line between preserving Medicare and keeping the Medicare trust fund solvent while advancing progressive policies. Republicans have yet to propose a budget, but it seems likely any GOP plan would lean heavily on cuts to Medicaid and subsidies provided under the Affordable Care Act. Democrats will fight both of those.
Even though the president’s budget includes something of a Democratic “wish list” of social policy priorities, the proposals are less sweeping than those made last year. Rather, many — such as extending to private insurance the $35 monthly Medicare cost cap for insulin — build on achievements already realized. That puts new focus on things the president has accomplished.
Walgreens, the nation’s second-largest pharmacy chain, is caught up in the abortion wars. In January, the chain said it would apply for certification from the FDA to sell the abortion pill mifepristone in states where abortion is legal. However, last week, under threats from Republican attorneys general in states where abortion is still legal, the chain wavered on whether it would seek to sell the pill there or not, which caused a backlash from both abortion rights proponents and opponents.
The five women suing Texas after being denied abortions amid dangerous pregnancy complications are not asking for the state’s ban to be lifted. Rather, they’re seeking clarification about who qualifies for exceptions to the ban, so doctors and hospitals can provide needed care without fear of prosecution.
Although anti-abortion groups have for decades insisted that those who have abortions should not be prosecuted, bills introduced in several state legislatures would do exactly that. In South Carolina, those who have abortions could even be subject to the death penalty. So far none of these bills have passed, but the wave of measures could herald a major policy change.
Also this week, Rovner interviews Harris Meyer, who reported and wrote the two latest KHN-NPR “Bill of the Month” features. Both were about families facing unexpected bills after childbirth. If you have an outrageous or exorbitant medical bill you want to share with us, you can do that here.
Plus, for “extra credit,” the panelists suggest health policy stories they read this week that they think you should read, too:
Walgreens has announced it will stop dispensing the abortion pill mifepristone in 21 states where Republican attorneys general threatened legal action against the company, which is the nation’s second-largest pharmacy chain.
KHN senior correspondent Sarah Varney joined PBS NewsHour co-anchor Amna Nawaz in a report on the move and its ramifications for women in those states, many of which have outlawed or severely restricted abortion. In four — Alaska, Iowa, Kansas, and Montana — Walgreens could legally sell the pills but has said it will not.
Other pharmacies such as CVS, Rite Aid, Costco, Walmart, and Kroger also face legal action.
To otherwise obtain the medication, Varney said, women could seek “a telehealth appointment with someone outside of the state” or “you could order from an online pharmacy.”
But, she noted, the move by Walgreens restricts access to the drug for “women in what is typically a very time-sensitive situation.”
Midwest KHN correspondent Bram Sable-Smith discussed the Eli Lilly news on insulin prices on “PBS NewsHour” and insulin prices on Slate’s “What Next” on March 1.
KHN contributor Andy Miller discussed Georgia’s legislative wrap-up including Medicaid work requirements on Georgia Public Broadcasting’s “Lawmakers” on Feb. 28. He also discussed health care for foster children on WUGA’s “The Georgia Health Report” on Feb. 3.
Senior KHN correspondent Julie Appleby discussed how the end of the public health emergency will affect costs for covid-19 vaccines, treatments, and masks on KMOX’s “Health Matters” on Feb. 25.
KHN correspondent Cara Anthony discussed the youngest victims of gun violence and those who dig their graves on America’s Heroes Group on Feb. 25.
KHN contributor Eric Berger discussed distracted driving laws and why Missouri still doesn’t have one on St. Louis Public Radio’s “St. Louis on the Air” on Feb 24.
