Tuesday, October 22, 2024

Harris: Accelerate Medicare drug negotiations

Presented by Express Scripts by Evernorth: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Oct 22, 2024 View in browser
 
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By David Lim

Presented by 

Express Scripts by Evernorth
Driving The Day

Vice President Kamala Harris holds microphone.

Vice President Kamala Harris proposes expanding Medicare's drug price negotiation program. | Francis Chung/POLITICO

DRUG-PRICING PUSH — Vice President Kamala Harris wants more drugs to be negotiated by Medicare, but her plan to implement an expansion if elected president remains unclear.

Her campaign website lends some clues: She wants to expedite the negotiations to lower drug prices for Americans. Drug-pricing experts say that likely means adding more drugs each year to what’s laid out in the Inflation Reduction Act or potentially drawing name-brand drugs into price talks after a shorter period of time on the market.

The Harris campaign did not respond to questions about the policy proposal.

Both approaches would require Democrats to regain control of both chambers of Congress, according to Stacie Dusetzina, a health policy professor at Vanderbilt University Medical Center.

There is a legislative starting point. A House Energy and Commerce Committee Democrat spokesperson pointed to the Lowering Drug Costs for American Families Act — introduced last year by Energy and Commerce Committee ranking member Frank Pallone (D-N.J.), Ways and Means Committee ranking member Richard Neal (D-Mass.) and Education and the Workforce Committee ranking member Bobby Scott (D-Va.).

That bill would increase the number of drugs selected for negotiation each year from 20 to 50 starting in 2029, extend negotiated prices to those with private health insurance and apply the IRA’s restrictions on increasing drug prices faster than inflation to people with private health plans.

A recent Congressional Budget Office report estimated that increasing the number of drugs negotiated each year would reduce average drug prices by 0.1 to 3 percent, making negotiated prices available to merchants would cut them 1 to 3 percent and requiring drugmakers to pay inflation rebates on drug price hikes in the private market, not just to those on Medicare would reduce them 1 to 3 percent.

“To the extent that the negotiation program is expected to save money, expansions of the program, at least within Medicare, serve as a potential pay-for for other priorities that parties may have,” said Rachel Sachs, a law professor at Washington University, and former senior adviser in the HHS Office of the General Counsel in the Biden administration.

Craig Garthwaite, a professor at Northwestern University and economist who focuses on health care, said the program’s most consequential change would be introducing drugs to price talks sooner in their lifespan. But he argued that Democrats should wait a few years to understand how prices set by the program have impacted biopharmaceutical investment before making further changes.

“I don’t think we’ve fully seen even the initial effects of the IRA, and we’re talking about changing the policy,” Garthwaite said.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Why do we exist in a world where your author is forced to root for the Yankees in the World Series?

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

 

A message from Express Scripts by Evernorth:

In 2023, four in five Express Scripts by Evernorth patients spent less than $250 a year out-of-pocket for all their medications. Yes, despite the median annual price of new drugs to market soaring to an average of $300K. That's not a middleman. That's an advocate. Express Scripts is advocating to make medications more affordable. Learn how here.

 
In the courts

A sign for Eli Lilly sits outside their corporate headquarters in Indianapolis on April 26, 2017.

Eli Lilly is suing three companies for selling copycat versions of its popular weight-loss and diabetes drugs. | Darron Cummings/AP

ELI LILLY SUES — Three companies selling compounded or research-grade versions of its popular diabetes and weight-loss drugs are being sued by Eli Lily in a trio of district courts — the latest skirmish in the brewing legal battle over compounded versions of the popular medicines.

The Indianapolis multinational claims that illegal marketing of copycats of its GLP-1 tirzepatide products puts patients at risk.

Compounding pharmacies, medical spas and telehealth providers stepped up copycat product offerings of tirzepatide and semaglutide — the ingredient behind Novo Nordisk’s Ozempic and Wegovy — when both went into shortage in 2022.

But tirzepatide came off the FDA’s shortage list earlier this month, prompting the company to renew efforts to shut down providers it said are siphoning away Lilly customers while jeopardizing patient safety.

MangoRX said in a press release that it “believes it has strong arguments against Eli Lilly’s claims and intends to vigorously defend itself in this matter.”

Pivotal Peptides and Genesis Lifestyle Medicine did not respond to a request for comment.

Research Corner

MANAGING HIGH DRUG COSTS — Various strategies such as co-payment cards and patient assistance programs intended to help patients manage high drug costs demonstrate the U.S. drug delivery and reimbursement system is “ complex, fragmented, and inefficient,” Harvard Medical School researchers write in JAMA.

They examined co-payment cards, patient assistance programs, pharmacy coupons, direct-to-consumer pharmacies, public assistance programs, international online pharmacies and real-time prescription-benefit tools.

“While these strategies provide tangible solutions for clinicians to help patients access medically appropriate but costly medications, they do not address the root causes of high drug prices,” wrote Drs. Hussain Lalani, Catherine Hwang, Aaron Kesselheim and Benjamin Rome.

 

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Pharma Moves

The National Academy of Medicine elected 100 new members , the organization announced.

Document Drawer

The CDC’s Advisory Committee on Immunization Practices meets Wednesday and Thursday to discuss pneumococcal, influenza, chikungunya, respiratory syncytial virus, meningococcal and Covid-19 vaccines. Read the draft agenda here.

The FDA is extending by 30 days the comment period for its draft guidance on chemical analysis for biocompatibility assessment of medical devices until Dec. 19.

WHAT WE'RE READING

The Arkansas Supreme Court ruled Monday that votes for a medical marijuana expansion initiative will not count in a 4-3 decision, POLITICO’s Mona Zhang reports.

Many former FDA lawyers have gone on to advise or litigate for the tobacco industry, The Examination’s Kathryn Kranhold reports.

Many pharmaceutical industry executives are not donating directly to candidates this electoral season, instead opting to give to company political action committees, STAT’s Rachel Cohrs Zhang reports. But those who did give to individual politicians favored Democrats.

Gilead is withdrawing its accelerated approval of Trodelvy for the treatment of bladder cancer following negative clinical trial results, BioPharma Dive’s Jonathan Gardner reports.

 

A message from Express Scripts by Evernorth:

Want to know something unhealthy? The median annual price of a new drug reached $300K in 2023. Yes, $300,000. Yet millions of Americans paid less than $250 a year out-of-pocket for all their medications combined. How? Express Scripts by Evernorth. Express Scripts by Evernorth is the primary line of defense for millions of Americans against rising health costs – advocating every day to make their medications more affordable and accessible. And they’re not stopping anytime soon. That’s not a middleman. That’s an advocate.

See how Express Scripts is advocating to make medication more affordable for millions here.

 
 

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