FDA approves first advanced cancer therapy - Axios
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FDA approves first advanced cancer therapy

Elaine Thompson / AP

The FDA has approved the first advanced therapy to attack cancer. The brand-name drug, Kymriah, made by pharmaceutical giant Novartis, can be used for children and young adults who have a certain form of leukemia.

Why it matters: It's a major approval that has the potential to change how cancer is treated, although the eligible patient population appears small for now. "We're entering a new frontier in medical innovation with the ability to reprogram a patient's own cells to attack a deadly cancer," FDA Commissioner Scott Gottlieb said in a statement.

What the drug does: It's commonly known as a CAR-T therapy, and it's a hot research area across several drug companies (and is the prize of Gilead's $11.9 billion buyout of Kite Pharma from this week). CAR-T modifies a patient's immune cells, which are then infused back into the patient to kill cancer cells.

The price: $475,000 for a one-time treatment, according to a conference call with Novartis executives. The company also said it will only accept payments if patients respond to the drug within the first month. David Mitchell, president of advocacy group Patients For Affordable Drugs, met with Novartis yesterday to talk about "how to arrive at a fair price for its new CAR-T drug," but said the meeting was "disappointing."

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Murkowski backs ACA individual mandate repeal

Photo: Jose Luis Magana / AP

Sen. Lisa Murkowski, a moderate Republican who broke ranks over the summer to vote against GOP plans to repeal the Affordable Care Act, has written an op-ed declaring her support for a repeal of the ACA's individual mandate. She writes, "I believe that the federal government should not force anyone to buy something they do not wish to buy in order to avoid being taxed."

Why it matters: The Senate tax plan includes a repeal of the mandate, which helps stabilize insurance markets by incentivizing healthy people to buy coverage. This may be a signal Murkowski intends to vote yes on the plan.

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Tobacco companies will start running anti-tobacco ads

After a protracted legal battle, tobacco companies will begin running court-ordered ads next week about the health risks of smoking. The campaign of "corrective statements," mandated by a federal judge in 2006, includes a year of TV spots and roughly four months of full-page ads in 50 newspapers.

Why now? These ads have been the subject of litigation for nearly 20 years. They're the product of a lawsuit the Justice Department filed in 1999, which was decided in 2006, then appealed, before the ads themselves were finalized earlier this year. And though the spots will run widely, both TV and newspaper advertising have lost a lot of their reach since this all began.

The details: The "corrective statements" tobacco companies must make cover five topics:

  • The U.S. death toll of cigarettes and the diseases they cause
  • The addictiveness of nicotine
  • The fact that "light" and "low tar" cigarettes are not safer
  • That cigarettes are designed to be addictive
  • The adverse health effects of secondhand smoke

Beginning next week, print ads will run in the Sunday editions of 50 daily newspapers. The television spots must run for 52 weeks, in prime time, on the major networks.


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AmerisourceBergen eyes $815 million buyout of H.D. Smith

AmerisourceBergen is acquiring a competitor for $815 million. Photo: George Widman / AP

AmerisourceBergen said Monday it will acquire H.D. Smith, a smaller, independent drug wholesaler, for $815 million in cash. It would further consolidate the drug distribution industry, as AmerisourceBergen, McKesson and Cardinal Health control about 85% of the market.

Looking ahead: The Federal Trade Commission might scrutinize the deal closely, considering H.D. Smith is the second-largest drug wholesaler outside of the big three. AmerisourceBergen has struggled to hold a profit due to declining generic drug prices, and several cities and municipalities have accused the company and others of making the opioid epidemic worse by not properly monitoring where painkillers were going.

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Alex Azar made millions in the drug industry

Alex Azar (left) made millions from his drug industry stint. Photo: Katsumi Kasahara / AP

Alex Azar, President Trump's nominee to replace Tom Price as Health and Human Services secretary, is worth as much as $20.6 million, according to new federal disclosures analyzed by the Associated Press. Most of that fortune was made while Azar was at pharmaceutical giant Eli Lilly & Co.

Go deeper: Congress still needs to confirm Azar. The biggest questions surrounding him involve his history with the drug industry and what he'd do to change the U.S. drug pricing system.

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Cost of opioid epidemic raised to $504 billion

Discarded hypodermic needles at an encampment where opioid addicts shoot up along the Merrimack River in Lowell, Mass. Photo: Charles Krupa / AP

"The White House says the true cost of the opioid drug epidemic in 2015 was $504 billion, or roughly half a trillion dollars," per AP's Darlene Superville:

"[T]he Council of Economic Advisers says the figure is more than six times larger than the most recent estimate. The council said a 2016 private study estimated that prescription opioid overdoes, abuse and dependence in the U.S. in 2013 cost $78.5 billion."

  • "The council said its estimate is significantly larger because the epidemic has worsened, with overdose deaths doubling in the past decade, and that some previous studies didn't reflect the number of fatalities blamed on opioids, a powerful but addictive category of painkillers."
  • "The council also said previous studies focused exclusively on prescription opioids, while its study also factors in illicit opioids, including heroin."
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Corporate lawsuit over drug savings pulls in another party

Express Scripts' feud with Anthem is roping in Optum, a competitor. Photo: Jeff Roberson / AP

Anthem and Express Scripts are embroiled in lawsuits, each accusing the other side of being a bad business partner. And now court documents show Optum, a health care company owned by UnitedHealth Group, is getting dragged into the mix.

Why it matters: This is more than just a corporate brouhaha in a far-off courtroom. Three massive health care companies are spending consumers' premium dollars on legal teams to fight over prescription drug rebates — an issue that continues to pinch people's wallets when they pick up their medicine.

The details: Health insurer Anthem originally sued pharmacy benefit manager Express Scripts in March 2016 for $15 billion, alleging Express Scripts was reaping "an obscene profit windfall" from negotiations with drug makers and was not passing enough savings back to Anthem. Express Scripts countersued and said Anthem was not acting in good faith.

New legal filings detail how UnitedHealth got involved with the two feuding parties.

  • After Anthem sued Express Scripts, Anthem reached out to OptumRx, UnitedHealth's pharmacy benefit manager and a competitor to Express Scripts.
  • Anthem wanted Optum to provide a "pricing proposal" of drug savings in case Anthem decided to end its contract with Express Scripts, according to Optum, which obliged with the request.
  • But Express Scripts said Anthem and Optum created the proposal solely as a way to justify the alleged $15 billion worth of damages.
  • Express Scripts demanded Optum reveal internal documents and analyses to understand how Optum made the proposal.
  • Optum handed over the pricing proposal, which outlined the services and prices Optum was offering Anthem, but has not provided the "highly confidential" documents.
  • Express Scripts said Optum has acted "to both harm a competitor...and ingratiate Optum with a potential future client." (Anthem is partnering with CVS on its own pharmacy benefit manager.)
  • Optum countered that Express Scripts "concocted a conspiracy theory" and has no legal grounds to obtain internal processes from a competitor.
The bottom line: The lawsuits are full of mud-slinging but also confirm the contracts between health insurers and pharmacy benefit managers are incredibly complex and lucrative documents. Anthem, Express Scripts and Optum did not comment.
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Individual mandate is important, but underperforming

Experts almost universally agree repealing the individual mandate is bad for the marketplace. Photo: Carolyn Kaster/AP

Experts across the political spectrum generally agree that the Affordable Care Act's individual mandate is both necessary for market stability, and probably not working as well as its authors intended.

The bottom line: Almost everyone agrees that repealing the mandate now, without a replacement, will make insurance markets function substantially worse than they are today. But many experts believe other policies might be just as effective, if not more so, at getting healthy people into the system and thus moderating premium increases.

While there's disagreement about how effective the mandate has been, most people I talked to acknowledge that it's not working as well as originally intended, and some conservative health wonks think there are more effective ways of getting more young, healthy people into the market.
  • "There is real uncertainty about the precise magnitude of the effects of repealing the mandate—as there is about almost any change in public policy—but little uncertainty that doing so would result in many more uninsured and a worse health care system," said Matt Fielder of the Brookings Institution.
  • "The mandate wasn't very strictly enforced, the penalty is pretty low by most people's standards, and it comes a year after dropping coverage, if it comes," Joe Antos of the American Enterprise Institute told me.
  • "Putting aside whether the mandate is actually effective, insurers think it is effective—and in many ways that's what counts. If insurers think it's effective, then they won't jack up premiums—which means it is effective," the Center for American Progress Topher Spiro said.
  • Potential alternatives include auto-enrolling people into coverage, imposing a penalty on those who don't have continuous coverage when they sign up, creating a federal reinsurance pool to offset the cost of sick enrollees, increasing the mandate penalty.
What we know about the mandate's effectiveness:
  • Enrollment through the ACA's exchanges has been lower than predicted. There are many potential reasons for this, but the mandate being a weak incentive is one.
  • S&P Global estimated last week that repealing the mandate would result in 3 to 5 million more uninsured people than the status quo — a far cry from the 13 million predicted by the Congressional Budget Office.
  • Yet, as Brookings' Matt Fiedler points out, the uninsured rate among people who are too wealthy for the ACA's premium subsidies fell by around one-third as the ACA took effect. "That trend is very hard to explain unless the mandate has had a significant effect on insurance coverage decisions since these individuals are not eligible for subsidies or Medicaid expansion."
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California hospital system destroyed antitrust evidence

Nurses protest outside a Sutter Health hospital in 2007. Photo: Paul Sakuma / AP

Sutter Health, a California-based network of hospitals and doctors, knowingly destroyed massive amounts of evidence that were relevant to a lawsuit that accuses the not-for-profit system of anticompetitive practices and price-gouging, Chad Terhune reports for California Healthline. Sutter said it made a "mistake," but a judge said Sutter was, at best, "grossly reckless."

Why it matters: It's a damning revelation against a large hospital system, and it's worth watching to see if there will be any penalties. Hospitals and doctors have consolidated rapidly over the past decade, which experts say has contributed to rising health care costs.

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Big changes proposed for Medicare insurers, drugs

CMS Administrator Seema Verma rolled out a new Medicare proposal. Photo: Evan Vucci / AP

The federal government unveiled a new proposal late Thursday that would make some rather large changes to Medicare Advantage and the Part D drug program in 2019. The 713-page rule covers a lot, but there are two nuggets worth highlighting.

Part D: Health insurers and pharmacy benefit managers "rarely" pass along to consumers the discounts they extract from drugmakers, the Centers for Medicare & Medicaid Services said. Now, the agency is asking for help to design a policy that would require Medicare drug plans to pass some of those savings onto consumers when they are actually buying their medicine.

  • Why it matters: This would potentially lower what people pay at the pharmacy counter, but it wouldn't change how drugs are priced in the first place. Insurers and pharmacy benefit managers likely will argue against it.

Medicare Advantage: By law, Medicare Advantage insurers have to spend at least 85% of premiums on health care. Money they spend trying to combat fraud is not counted toward that 85%. CMS' proposal would change that.

  • Why it matters: It's a big win for insurers. They've wanted this for a long time, and it could immediately boost their profits because an administrative expense could be lumped into what they have to spend on health care services.
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Poll: Independents say it's Trump's fault if ACA enrollment numbers are bad

The latest tracking poll from the Kaiser Family Foundation finds that answers to blame if enrollment in Affordable Care Act coverage drops this year, like everything in health care/politics/life, comes down to partisanship. The overwhelming majority of Democrats would blame President Trump for weakening the ACA; the overwhelming majority of Republicans would blame Democrats for writing a flawed law.

Reality check: Enrollment and competition began to decline last year, before Trump was even elected. But the steps Trump has taken since then have made those problems substantially worse.

Reproduced from the Nov. 2017 Kaiser Health Tracking Poll; Chart: Axios Visuals