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Biden asks to expand Medicare drug price negotiations

Presented by Better Medicare Alliance: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Mar 08, 2024 View in browser
 
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By Lauren Gardner and David Lim

Presented by

Better Medicare Alliance

With Robert King

Driving The Day

President Joe Biden delivers the State of the Union address with Vice President Kamala Harris and House Speaker Mike Johnson, R-La. looking on.

President Joe Biden told Congress on Thursday night that he intends to lower prescription drug prices. | Shawn Thew/AP Photo

BIDEN: CUT MORE DRUG PRICES — President Joe Biden made an assertive bid in his State of the Union address Thursday to expand his administration’s policies to lower drug prices.

“Americans pay more for prescription drugs than anywhere else in the world,” he said. “It’s wrong, and I’m ending it.”

The speech offers a vision of how Biden plans to govern if he were to secure a second term, with an expansion of policies in the 2022 Inflation Reduction Act as a key focal point.

Here’s what the president proposed:

Expand drug price negotiations: Biden seeks to dramatically increase the number of drugs subject to Medicare price negotiations to 50 a year, up from 20.

CMS is negotiating with the makers of 10 drugs, with the final prices set to be announced by Sept. 1 and go into effect in 2026. Without a change, the number of eligible drugs will increase to 15 in 2027 and 2028 and to 20 every year thereafter.

“They’re making a lot of money, guys, and they’ll still be extremely profitable,” Biden said of the drug industry.

He added that the expansion would save taxpayers another $200 billion over the next decade.

Extend the prescription drug cost cap: Starting next year, older Americans on the Medicare prescription drug program would pay no more than $2,000 out of pocket.

Biden seeks to expand that cap to those on commercial plans, too.

It remains unclear how such an expansion would work, as insurers would have to cover any costs over the cap.

Expand the insulin cap: Biden once again called for the IRA’s $35 monthly co-pay cap for Medicare beneficiaries to be extended to those on private plans.

This idea has gotten bipartisan support in the Senate but has yet to gain traction in either chamber.

BUT DRUGMAKER LITIGATION CONTINUES — Meanwhile, a crucial hearing in a courtroom in Trenton, New Jersey, took place hours before the State of the Union address. The hearing was about drugmakers’ ongoing legal efforts to halt the price negotiations.

Outside counsel for Bristol Myers Squibb, Janssen, Novartis and Novo Nordisk and Department of Justice attorneys made their case at the U.S. District Court for the District of New Jersey.

The unusual setup — the companies each have their own lawsuit, persuaded a district court judge to consolidate oral arguments into one hearing since the arguments in the suits overlap. It offers the most comprehensive opportunity to date for a federal judge to opine on the industry’s various constitutional and statutory challenges to the IRA’s drug pricing provisions.

The four lawsuits argue the negotiations program violates the First, Fifth and Eighth amendments, as well as the nondelegation doctrine and the law governing administrative procedures the government must follow when writing regulations.

Judge Zahid Quraishi, a Biden appointee, signaled some skepticism of the drugmakers’ claims that agreeing to the government’s final price offer would harm drug research investment, quipping that pharma companies are not “Mother Teresas” developing drugs for free.

But he prodded both sides to defend their positions for and against the program in a nearly four-and-a-half-hour day that the judge said went well beyond the parties’ briefs.

Oral arguments are “often redundant” and “a waste of time,” Quraishi said. “Absolutely, that was not the case today.”

It’s unclear when the judge will issue his decision. The next deadline in the negotiations process is Sept. 1, when both sides will agree to the final prices.

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. ICYMI: The government’s program to provide free at-home Covid-19 tests through USPS will be suspended today.

Send news and tips to Lauren Gardner (lgardner@politico.com or @Gardner_LM) or David Lim (dlim@politico.com or @davidalim).

 

A message from Better Medicare Alliance:

Healthcare organizations urge the Centers for Medicare and Medicaid Services to promote Medicare Advantage stability: “Over 69% of Hispanic seniors choose Medicare Advantage for the affordable, quality care it provides. NHMA and our 50,000 licensed Hispanic physicians join BMA’s call for a final rate notice that promotes a strong, stable Medicare Advantage program and advances health equity for our nation’s seniors.” – Dr. Elena Rios, President and CEO of the National Hispanic Medical Association (NHMA). Learn more.

 

DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The stakes are high as America's health care community strives to meet the evolving needs of patients and practitioners, adopt new technologies and navigate skeptical public attitudes toward science. Join POLITICO’s annual Health Care Summit on March 13 where we will discuss the future of medicine, including the latest in health tech, new drugs and brain treatments, diagnostics, health equity, workforce strains and more. REGISTER HERE.

Eye on the FDA

In this Sept. 16, 2014 file photo, a sign telling customers that they can get a flu shot in a Walgreen store is seen in Indianapolis.

After a decade of being vaccinated against four strains of influenza, Americans will only need to be protected against three strains for the next flu season. | Darron Cummings/AP

U.S. MOVES TOWARD 3-IN-1 FLU SHOT — The FDA’s independent vaccine advisers unanimously voted this week to green-light a trivalent flu vaccine for next winter’s respiratory virus season.

The 2024-2025 flu season will be the first in about a decade without a shot targeting four strains of the virus now that one of its lineages appears to have stopped circulating.

 

JOIN US ON 3/21 FOR A TALK ON FINANCIAL LITERACY: Americans from all communities should be able to save, build wealth, and escape generational poverty, but doing so requires financial literacy. How can government and industry ensure access to digital financial tools to help all Americans achieve this? Join POLITICO on March 21 as we explore how Congress, regulators, financial institutions and nonprofits are working to improve financial literacy education for all. REGISTER HERE.

 
 
In Congress

SANDERS PRAISES INHALER MAKER — Senate HELP Committee Chair Bernie Sanders (I-Vt.) lauded Boehringer Ingelheim for its plan unveiled Thursday to cap the monthly out-of-pocket cost of its inhalers at $35 a month and lower the list price of some of its products.

“These are very positive steps in the right direction,” Sanders said. “Today, I am calling on the three other major manufacturers of inhalers to take similar action. And they are AstraZeneca, GlaxoSmithKline and Teva.”

ICYMI: In January, Sanders and Sens. Tammy Baldwin (D-Wis.), Ben Ray Luján (D-N.M.) and Ed Markey (D-Mass.) opened an investigation into the prices charged by several manufacturers of asthma and chronic obstructive pulmonary disease inhalers.

Around the Agencies

PEDIATRIC RSV SHOT 90 PERCENT EFFECTIVE — An early report released by the CDC on Thursday found that nirsevimab, a long-acting monoclonal antibody to protect against respiratory syncytial disease, is 90 percent effective against RSV-associated hospitalization in infants.

But the delayed availability of the shots, which weren’t distributed until after RSV’s seasonal start; supply shortages throughout the fall; and the low number of infants who got the injection may limit generalizing these results to all babies who received the shot, researchers warned.

 

A message from Better Medicare Alliance:

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In the Courts

PhRMA APPEALS — The next stop for a PhRMA-backed bid to kill Medicare drug price negotiations is the conservative-leaning Fifth Circuit.

On Wednesday, the National Infusion Center Association, the Global Colon Cancer Association and PhRMA appealed a ruling in their lawsuit. The appeal comes less than a month after a lower court dismissed the challenge.

“We disagree with the district court’s legal assessment and have appealed the decision,” PhRMA spokesperson Nicole Longo said in a statement. “We continue to believe the IRA’s price setting provisions are unconstitutional.”

Jogging your memory: In early February, Senior District Judge David Alan Ezra of the U.S. District Court for the Western District of Texas dismissed the groups’ lawsuit on the grounds that it was filed in an improper venue.

 

DON’T MISS POLITICO’S HEALTH CARE SUMMIT: The stakes are high as America's health care community strives to meet the evolving needs of patients and practitioners, adopt new technologies and navigate skeptical public attitudes toward science. Join POLITICO’s annual Health Care Summit on March 13 where we will discuss the future of medicine, including the latest in health tech, new drugs and brain treatments, diagnostics, health equity, workforce strains and more. REGISTER HERE.

 
 
WHAT WE'RE READING

The House cleared on Wednesday a six-bill government funding package, sending the package that funds the FDA to the Senate, POLITICO’s Caitlin Emma and Jennifer Scholtes report.

Eli Lilly, maker of weight-loss drug Ozempic, is launching an ad a few days before the annual Oscars ceremony in Hollywood, criticizing people without an obesity diagnosis who take the drug, USA Today’s Adrianna Rodriguez reports.

Pharma Moves

The Reagan-Udall Foundation for the FDA added two people to its board: Dr. Pietro Antonio Tataranni, PepsiCo chief medical officer, and Dr. Reed Tuckson, managing director at consultancy Tuckson Health Connections.

Document Drawer

The FDA issued final guidance on the premarket safety notification process for new dietary ingredients in food and dietary supplements.

 

A message from Better Medicare Alliance:

Leaders from agilon health agree: proposed changes to Medicare Advantage put the stability of the program at risk.

"The strength and stability of the Medicare Advantage program are essential to our ability to drive value through better care, lower costs, and a focus on real outcomes." – Kevin Spencer, M.D., Chief Clinical Officer at agilon health

Learn more about patient and provider organizations who support keeping Medicare Advantage stable for over 32 million beneficiaries.

 
 

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David Lim @davidalim

Lauren Gardner @Gardner_LM

 

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