Friday, October 4, 2024

PBM vibe check

Presented by The Council for Citizens Against Government Waste: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Oct 04, 2024 View in browser
 
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By Lauren Gardner and David Lim

Presented by 

The Council for Citizens Against Government Waste

With Carmen Paun

Driving The Day

Rep. Jake Auchincloss questions witnesses during a hearing.

Rep. Jake Auchincloss introduced a bill with Rep. Diana Harshbarger that would reform some of pharmacy benefit managers' practices. | Alex Brandon/AP

DEAL TO BE HAD, BUT WHICH? Legislation to rein in practices by pharmacy benefit managers has long been considered a contender for inclusion in an end-of-year legislative package after it was left out of a springtime spending measure. But which party controls the White House — and one or both chambers of Congress — will likely determine whether members try to “clear the decks” before January or hold out hope for a better deal next year.

For nearly two years, Congress has grappled with how to reform the drug-pricing middlemen, the practices of which critics say hamper patient access to medicines and drive up prices. Meanwhile, PBMs argue they’re the only entity negotiating with the pharma industry, which ensures market competition.

Health lobbyists aren’t writing off a possible deal. But one told Prescription Pulse that Hill staff is itching to move on from the issue, while another wondered whether the Federal Trade Commission’s PBM lawsuit “takes the wind out of Congress doing anything.”

Plus, the House-passed bill is one of many proposed to put guardrails around the industry, signaling that, while there might be consensus in Congress around taking action on PBMs, lawmakers aren’t necessarily united on what that should look like.

Another take: Rep. Jake Auchincloss (D-Mass.) introduced his own PBM bill with GOP Rep. Diana Harshbarger of Tennessee in July with an eye toward year-end negotiations.

“We need to focus efforts on building bipartisan support for tough reforms because what I don't want to have happen is ‘transparency’ and then move on. That would be a win for PCMA, and we must prevent that,” he told Lauren, referring to the Pharmaceutical Care Management Association, the PBM lobbying group.

Auchincloss said he wants to see Congress “delink” PBMs’ service fees from a drug’s list price and, “ideally,” as many provisions as possible from his bill, which would prohibit PBMs from steering patients to pharmacies they own and tie pharmacy reimbursements to the national average drug acquisition cost.

Rep. Brett Guthrie (R-Ky.), chair of the Energy and Commerce Health Subcommittee, said he would press for PBM legislation next Congress, even if something passes in December.

“If I get to be chair of this committee, we will continue down the path to PBM reform,” he said. “This is just a bite at the apple.”

Over the Hill: Sen. Tim Kaine (D-Va.) vented his frustration during a September hearing on Novo Nordisk’s GLP-1 drug prices that PBM legislation approved by the Senate Health, Education, Labor and Pensions Committee had yet to advance despite an 18-3 vote.

“As a committee with wide ideological difference, when you get a vote that overwhelming, you should do it,” he said later in an interview. “I like passing legislation that goes right at pharmaceutical companies with things like negotiated pricing, but I don't like leaving PBMs without the same level of scrutiny.”

IT’S FRIDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your host who’s a parent is once again grappling with hand, foot and mouth disease in her household.

Send tips and ideas (for stories and for avoiding illness) to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).

 

A message from The Council for Citizens Against Government Waste:

The 340B Drug Pricing Program was enacted in 1992 to help low-income and uninsured patients access affordable medications. But the law has deviated far from its goal and failed those it was meant to serve. Bad actors have hijacked the program and exploited its loopholes for their own profit. Congress must get back to work and enact legislation to provide affordable medication to those who should get the benefits. Learn more about 340B reform.

 

Cows | Getty Images

Dairy cows are being pointed to as the culprits behind two confirmed cases of bird flu in humans in California. | Getty Images

ANOTHER TWO CASES — Two California dairy workers exposed to cows infected with avian flu tested positive for the virus, the state’s public health department said Thursday.

The latest infections bring the number of documented human bird flu cases in the U.S. since April to 16. The individuals contracted conjunctivitis, or pinkeye, and had mild symptoms.

The California Department of Health said the risk to the public remains low, but people who work with infected animals are at “higher risk of getting bird flu.”

Eye on the FDA

LILLY GLP-1 SHORTAGE ENDS — The FDA declared this week that tirzepatide, the GLP-1 used in Eli Lilly’s blockbuster diabetes and weight-loss drugs, is no longer in shortage, Lauren reports.

But pharmacy groups warn that acquiring stock will continue to be difficult as supply-chain kinks work themselves out, and compounders say their limited ability to now make product copies could put patients in a pinch.

“Patients currently taking compounded GLP-1s will likely be switched to the FDA-approved versions, which could potentially raise additional shortages of these products,” American Pharmacists Association spokesperson Ross Hemminger said.

The Alliance for Pharmacy Compounding shared an image with reporters of an Arlington, Va.-based pharmacist’s distribution portal showing that no doses of Mounjaro are available for purchase.

“FDA may say the shortage is resolved, but it’s not — not if ‘resolved’ means pharmacies can access the drug and dispense it to patients,” APC CEO Scott Brunner said.

The other GLP-1: A Novo Nordisk spokesperson said all doses of Ozempic and Wegovy, its semaglutide-based diabetes and weight-loss drugs, are commercially available. However, the company is managing shipments of its Wegovy starter dose, which the FDA says is limited, “to responsibly initiate patients on treatment consistent with our commitment to patients and focus on continuity of care.”

Pharma in the States

TEXAS SUES OVER INSULIN PRICES — Texas Attorney General Ken Paxton sued insulin manufacturers and PBMs on Thursday, claiming they conspired to increase the drugs’ prices by up to 1,000 percent.

The state action is the latest example of governments of all levels scrutinizing the practices of the three major insulin manufacturers — Novo, Lilly and Sanofi — and the pharmacy middlemen that negotiate with them on behalf of insurers.

A Novo spokesperson called the allegations “meritless.” A spokesperson for Express Scripts, one of the PBMs being sued, pointed to the company’s previous statement on the FTC’s insulin lawsuit.

 

A message from The Council for Citizens Against Government Waste:

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Pharma Worldwide

GILEAD TO DONATE REMDESIVIR — Gilead will donate about 5,000 vials of its remdesivir antiviral to Rwanda for emergency use against the Marburg virus disease causing an ongoing outbreak in the country, the California-based company said Thursday.

The drug, which has not been tested in humans against Marburg, has received an emergency use authorization in Rwanda, Gilead said. Remdesivir has been approved as a Covid-19 treatment in some 50 countries and has broad-spectrum antiviral activity in vitro and in animal models against multiple viruses, including Marburg, Ebola and coronaviruses, the company said in a statement.

Why it matters: The Marburg virus, which belongs to the same virus family as Ebola, is one of the deadliest viruses known to humankind, killing in some cases more than 8 in 10 people who contract it.

Rwanda declared an outbreak of the virus a week ago. It has confirmed 36 cases; 11 people have died, most of them health care workers.

Some people in isolation and receiving supporting treatment have started to improve, with five testing negative Wednesday, Dr. Sabin Nsanzimana, Rwanda’s health minister, told reporters Thursday.

WHAT WE'RE READING

WuXi AppTec and WuXi Biologics are exploring sales of some manufacturing and production facilities, Reuters’ Rishabh Jaiswal reports.

The U.K. is proposing a phased rollout of Eli Lilly’s weight-loss treatment tirzepatide, EndPoints News’ Nicole DeFeudis reports.

 

A message from The Council for Citizens Against Government Waste:

Due to a lack of transparency and oversight, bad actors are taking advantage of the 340B Drug Pricing Program. Congress must enact reforms to the program with commonsense solutions to ensure patients receive affordable medications they deserve and prevent special interests from abusing the program. Clearly defining who is a 340B patient and limiting eligibility to only low-income patients is crucial to the future of the program. The health and well-being of millions of Americans depend on fixing the mess in 340B and the time for action is now. Learn more about the need for 340B reform.

 
 

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Lauren Gardner @Gardner_LM

 

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