Tagged Pharmaceuticals

More Marijuana Legislation Focusing On Making Changes To Criminal Justice System, Helping Those Harmed By War On Drugs

“For me, the social justice piece of it is much larger than, I think, the taxing and regulating — although that is important,” said New York Assemblywoman Crystal Peoples-Stokes. News on marijuana comes from Oregon, Massachusetts, Oklahoma, Ohio and Florida, also.

Staggering Prices Slow Insurers’ Coverage Of CAR-T Cancer Therapy

Patients whose blood cancers have failed to respond to repeated rounds of chemotherapy may be candidates for a new type of gene therapy that could send their cancers into remission for years.

But the two approved therapies, with price tags of hundreds of thousands of dollars, have roiled the insurance approval process, leading to delays and, in some cases, denials of coverage, clinicians and analysts say.

The therapy involves collecting patients’ own T cells, a type of white blood cell, genetically modifying them, and then infusing them back into patients, where they hunt down and kill cancer cells. Known as CAR T-cell therapy, it has been called a “living drug.”

Two drugs, Kymriah and Yescarta, were approved last year to treat patients whose blood cancers haven’t responded to at least two other rounds of treatment. Kymriah is approved for people up to age 25 with a form of acute lymphoblastic leukemia, the most common cancer in children. Kymriah and Yescarta are both approved for adults with advanced lymphomas.

Researchers report that some critically ill patients who received the therapy have remained cancer-free for as long as five years.

“This is what patients need,” said Dr. Yi Lin, a hematologist who oversees the CAR-T cell practice and research for the Mayo Clinic. “With the likelihood of getting patients into durable survival, we don’t want to deny them the therapy.” She said she receives no personal financial support from the drugs’ makers.

But it comes at a cost. The drugs are hugely expensive. Kymriah and Yescarta cost $373,000 to treat adults with advanced lymphomas, while Kymriah costs $475,000 to treat acute lymphoblastic leukemia in children and young adults. In addition, many patients experience serious side effects that can land them in a hospital intensive care unit for weeks, pushing treatment costs more than $1 million.

All of this gives government and private insurers pause.

Most commercial insurers are covering CAR-T therapies now, but they do so on an individual basis, writing single-patient agreements each time, said cancer experts. Large insurers that are already familiar with  complicated therapies like stem-cell transplants are getting speedier at handling CAR-T treatment requests, they said. But that’s not always the case at smaller or regional plans, where delays can add weeks to the approval process.

“A request for CAR-T may end up with somebody on the payer authorization team who doesn’t understand the technology or the urgency of the request, when somebody has only weeks or months to live,” said Stephanie Farnia, director of health policy and strategic relations at the American Society for Blood and Marrow Transplantation.

Farnia is in contact with many of the more than 50 medical centers that are authorized to provide treatment. The process of getting to a treatment center and evaluated for therapy is involved, she said, “to then be substantially delayed due to paperwork is incredibly frustrating” for patients.

Medicare and Medicaid often pose greater coverage challenges than do private insurers, according to insurance experts.

Some Medicaid programs don’t cover the treatment, said Dr. Michael Bishop, director of the cellular therapy program in the hematology-oncology section at the University of Chicago. Medicaid, the state-federal health program, covers children in low-income households and some adults.

“Medicaid has been very tough,” he said. “Certain states just deny coverage, even states with balanced budgets.”

Matt Salo, executive director of the National Association of Medicaid Directors, said states have to evaluate the cost as well as the drugs’ effectiveness. “Medicaid is a finite pot of money, and it’s stretched threadbare even on a good day,” he said.

People who are on Medicare, the health insurance program for people age 65 and older and some people with disabilities, typically haven’t faced coverage denials to date, clinicians say. But the government’s reimbursement rates are raising concerns for providers.

Last spring, Medicare announced payment rates for providers who administer Yescarta and Kymriah on an outpatient basis. The payments would more than cover the costs of the drugs. Medicare beneficiaries’ out-of-pocket costs would be capped at $1,340 plus their Part B deductible, if it hasn’t been met, the agency said.

The problem with this plan: Facilities typically provide treatment on an inpatient basis, because of the potential for severe, systemic side effects.

“There’s a lot of toxicity and questions about whether it can even be provided in an outpatient setting,” said Gary Goldstein, the business manager at the blood and marrow transplant program at Stanford Health Care in Stanford, Calif.

For inpatient care, “CAR T-cell therapy … would be paid at a much lower amount compared to outpatient hospital use,” according to officials at the Centers for Medicare & Medicaid Services.

The agency is considering how to handle payment for inpatient CAR-T care for the upcoming fiscal year that starts in October. For now, some medical centers are absorbing whatever Medicare doesn’t pay.

“How can you tell a patient who’s 66, ‘If only you’d gotten lymphoma when you were 64’? Goldstein asked.

But the current approach can’t continue indefinitely, he said.

“Even if there aren’t any centers that are making that decision today, if coverage doesn’t change for Medicare, it absolutely is going to be a problem tomorrow,” said Goldstein.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

FDA Wants To Be Granted Expanded Authority To Intervene In Drug Shortages

While the number of drugs in shortage is down from a peak several years ago, many supply interruptions are lasting much longer — sometimes well over a year. Right now, there’s not much the agency can do, but FDA Commissioner Scott Gottlieb says he wants to get more aggressive in protecting patients from the shortfalls.

Pfizer CEO Has Knack For Making A Profit, But He Misplayed The Optics Of Raising Prices In Current Atmosphere

Like clockwork, Pfizer has been raising prices every six months, flying under the radar because most pharma companies were doing the same. But then the company caught the attention of President Donald Trump, and everything changed. In other pharmaceutical news: Novartis ditches antibiotics research; a patient advocacy group highlights a New Jersey candidate’s ties to high prices; and an experimental epilepsy drug moves forward toward approval.

Podcast: KHN’s ‘What The Health?’ ACA Under Fire. Again.

Democrats in the Senate are gearing up to fight President Donald Trump’s nominee to the Supreme Court, U.S. Circuit Judge Brett Kavanaugh. They argue he is not only a potential threat to abortion rights, but also to the Affordable Care Act.

Meanwhile, the Trump administration continues its efforts to undermine the workings of the Affordable Care Act. This week, officials announced a freeze on payments to insurers who enroll large numbers of sicker patients, and another cut to the budget for “navigators” who help people understand their insurance options and enroll for coverage.

This week’s panelists for KHN’s “What the Health?” are:

Julie Rovner of Kaiser Health News

Margot Sanger-Katz of The New York Times

Anna Edney of Bloomberg News

Julie Appleby of Kaiser Health News

Among the takeaways from this week’s podcast:

  • One reason Democrats are rallying around the health issue rather than the abortion issue is that there is more unity in their caucus over health than abortion. Also, the two key Republican senators who support abortion rights — Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) — also voted against GOP efforts to repeal the Affordable Care Act last year.
  • The Trump administration’s action on risk-adjustment payments sent yet another signal to insurers that the federal government does not necessarily have their backs and is willing to change the rules along the way.
  • The Trump administration says it wants to cut to payments for navigators because they are not cost-effective. But the navigator money does not come from taxpayers or government sources. It is paid from insurance industry user fees. These funds also go to support ACA advertising — which has also been cut. However, the user fees have not been reduced. In theory, reducing these fees could provide savings that could be passed on to consumers.
  • After being called out on Twitter by Trump, drugmaker Pfizer this week announced it would delay some already-announced price increases on about 100 of its drugs. It is worth noting that the president used his bully pulpit and gained some success. The six-month delay will mean that consumers will not experience an increase in cost at the pharmacy for at least that time period. But it still raises questions.
  • The Trump administration worked to block a World Health Organization resolution to promote breastfeeding. But while this seemed a clear case of promoting the interests of infant formula companies over public health experts, there was pushback from some women who say they are unable to breastfeed and feel stigma when they opt for formula instead. On the other hand, formula can be dangerous in developing countries without easy access to clean water.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too:

Julie Rovner: Politico Agenda’s “The One Big Winner of the Obamacare Wars,” by Joanne Kenen

Julie Appleby: The New York Times’ “Doctor, Your Patient Is Waiting. It’s a Red Panda,” by Karen Weintraub.

Anna Edney: Politico’s “CMS Quit Test of Pricey Cancer Treatment Amid Concerns Over Industry Role,” by Sarah Karlin-Smith and David Pittman

Margot Sanger-Katz: HuffPost’s “Trump Administration May Be Preparing A New Obamacare Sabotage Effort,” by Jonathan Cohn

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Podcast: KHN’s ‘What The Health?’ ACA Under Fire. Again.

Democrats in the Senate are gearing up to fight President Donald Trump’s nominee to the Supreme Court, U.S. Circuit Judge Brett Kavanaugh. They argue he is not only a potential threat to abortion rights, but also to the Affordable Care Act.

Meanwhile, the Trump administration continues its efforts to undermine the workings of the Affordable Care Act. This week, officials announced a freeze on payments to insurers who enroll large numbers of sicker patients, and another cut to the budget for “navigators” who help people understand their insurance options and enroll for coverage.

This week’s panelists for KHN’s “What the Health?” are:

Julie Rovner of Kaiser Health News

Margot Sanger-Katz of The New York Times

Anna Edney of Bloomberg News

Julie Appleby of Kaiser Health News

Among the takeaways from this week’s podcast:

  • One reason Democrats are rallying around the health issue rather than the abortion issue is that there is more unity in their caucus over health than abortion. Also, the two key Republican senators who support abortion rights — Sen. Susan Collins (R-Maine) and Sen. Lisa Murkowski (R-Alaska) — also voted against GOP efforts to repeal the Affordable Care Act last year.
  • The Trump administration’s action on risk-adjustment payments sent yet another signal to insurers that the federal government does not necessarily have their backs and is willing to change the rules along the way.
  • The Trump administration says it wants to cut to payments for navigators because they are not cost-effective. But the navigator money does not come from taxpayers or government sources. It is paid from insurance industry user fees. These funds also go to support ACA advertising — which has also been cut. However, the user fees have not been reduced. In theory, reducing these fees could provide savings that could be passed on to consumers.
  • After being called out on Twitter by Trump, drugmaker Pfizer this week announced it would delay some already-announced price increases on about 100 of its drugs. It is worth noting that the president used his bully pulpit and gained some success. The six-month delay will mean that consumers will not experience an increase in cost at the pharmacy for at least that time period. But it still raises questions.
  • The Trump administration worked to block a World Health Organization resolution to promote breastfeeding. But while this seemed a clear case of promoting the interests of infant formula companies over public health experts, there was pushback from some women who say they are unable to breastfeed and feel stigma when they opt for formula instead. On the other hand, formula can be dangerous in developing countries without easy access to clean water.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too:

Julie Rovner: Politico Agenda’s “The One Big Winner of the Obamacare Wars,” by Joanne Kenen

Julie Appleby: The New York Times’ “Doctor, Your Patient Is Waiting. It’s a Red Panda,” by Karen Weintraub.

Anna Edney: Politico’s “CMS Quit Test of Pricey Cancer Treatment Amid Concerns Over Industry Role,” by Sarah Karlin-Smith and David Pittman

Margot Sanger-Katz: HuffPost’s “Trump Administration May Be Preparing A New Obamacare Sabotage Effort,” by Jonathan Cohn

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.

Distributors Funneled Equivalent Of About 260 Opioid Pills For Every Person Into Missouri During 5-Year Period

The findings come from a congressional investigation into drug distributors and their potential failure to report suspicious prescription activity. The report, in particular, focused on the disparity between what AmerisourceBergen and McKesson flagged. The two distributors shipped nearly identical volumes of opioids to Missouri, but the number of suspicious orders each company reported were nowhere close: 224 from AmerisourceBergen and 16,714 from McKesson.

Distributors Funneled Equivalent Of About 260 Opioid Pills For Every Person Into Missouri During 5-Year Period

The findings come from a congressional investigation into drug distributors and their potential failure to report suspicious prescription activity. The report, in particular, focused on the disparity between what AmerisourceBergen and McKesson flagged. The two distributors shipped nearly identical volumes of opioids to Missouri, but the number of suspicious orders each company reported were nowhere close: 224 from AmerisourceBergen and 16,714 from McKesson.

Alzheimer’s Drug Results Send Stocks Soaring, But Experts Temper Expectations After String Of Failures Against Disease

Biogen and Eisai announced that the drug slowed the progression of Alzheimer’s disease and reduced the amount of clumps of a protein called beta amyloid that build up in the brains of patients. The data cheered even skeptics that have been burned by decades of failed Alzheimer’s drugs. But they did warn about getting too excited, as the study is preliminary.

Alzheimer’s Drug Results Send Stocks Soaring, But Experts Temper Expectations After String Of Failures Against Disease

Biogen and Eisai announced that the drug slowed the progression of Alzheimer’s disease and reduced the amount of clumps of a protein called beta amyloid that build up in the brains of patients. The data cheered even skeptics that have been burned by decades of failed Alzheimer’s drugs. But they did warn about getting too excited, as the study is preliminary.

Podcast: KHN’s ‘What The Health?’ Whither Work Requirements?

A federal District Court judge in Washington, D.C., has — for now — blocked Kentucky’s proposal to add a work requirement for much of its adult Medicaid population. The decision, while far from final, is likely to prompt lawsuits from advocates in other states where the Department of Health and Human Services has approved similar proposals.

Also this week, HHS released updated enrollment information about those purchasing health insurance in the individual market. Despite efforts by the Trump administration and Republicans in Congress to depress enrollment by cutting outreach and canceling federal payments to insurers, the number of people who actually paid their first month’s premium was up slightly in 2018, compared with 2017.

This week’s panelists for KHN’s “What the Health?” are: Julie Rovner of Kaiser Health News, Stephanie Armour of The Wall Street Journal, Anna Edney of Bloomberg News and Joanne Kenen of Politico.

Among the takeaways from this week’s podcast:

  • While the overall number of people buying coverage in the health law’s exchanges rose, the number of people not getting help with their premiums fell for the third-straight year. While some consumers may have found other coverage (through Medicare or jobs), rising premiums have been a problem.
  • The court decision blocking Kentucky’s Medicaid work requirement does not necessarily preclude other states’ work requirements from going forward. But the decision is likely to spark lawsuits in those states that have already had their work programs approved by HHS.
  • The window for bipartisan action on health care costs on Capitol Hill has closed. The Justice Department’s decision to join the state attorneys general lawsuit on preexisting conditions was likely the last straw. Issues surrounding coverage of preexisting conditions will now likely dominate the political discussion leading up to the midterm elections this fall.
  • Two things worth noting from the month of June. First, the recent court decision on risk-corridor payments to insurers seems to be a significant blow to the industry. Also, the Trump administration announced a major reorganization of Cabinet-level agencies. Although this is a common step for an administration, and something that rarely moves beyond “pie-in-the-sky” discussions, this one seems to be encapsulating the debate about the safety-net and social welfare programs.

Read the latest on the Bill of the Month series:

“Father’s And Son’s Injuries Lead To The Mother Of All Therapy Bills,” By Stephanie O’Neill.

If you have a medical bill you’d like NPR and KHN to investigate, you can submit it here.

Plus, for “extra credit,” the panelists recommend their favorite health stories of the week they think you should read, too:

Julie Rovner: Kaiser Health News’ “Unlocked And Loaded: Families Confront Dementia And Guns,” by JoNel Aleccia and Melissa Bailey

Stephanie Armour: NPR’s “Rising Cost of PrEP to Prevent HIV Infection Pushes It Out of Reach for Many,” by Shefali Luthra and Anna Gorman

Anna Edney: The New York Times’ “Emergency Rooms Run Out of Vital Drugs, and Patients Are Feeling It,” by Katie Thomas

Joanne Kenen: The Washington Post’s “College Students Are Forming Mental-Health Clubs — and They’re Making a Difference,” By Amy Ellis Nutt

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunesStitcher or Google Play.