With Megan R. Wilson

INSULIN DEBATE, TAKE TWO — Sens. Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.) are waging an awkward battle over their legislation to reduce insulin costs as Senate leaders weigh their cross-aisle plan as an alternative to one from Sens. Raphael Warnock (D-Ga.) and John Kennedy (R-La.), David and POLITICO’s Burgess Everett report.

Leaders of the Senate Diabetes Caucus and Warnock are pitching Senate Majority Leader Chuck Schumer, who has avoided taking a firm stance on which bipartisan bill he favors, as part of a larger drug pricing measure that could move forward as soon as this month.

“Our approach reflects our years of working on this issue, and it’s so much broader. It’s so much more comprehensive,” Collins told POLITICO in a joint interview with Shaheen. The New Hampshire senator quipped that “our proposal is better than theirs” before taking a more diplomatic tack: “It’s more comprehensive. That’s a better way to say it.”

The policies: The Warnock-Kennedy effort would offer people with private insurance the Inflation Reduction Act’s price cap for Medicare patients of a $35 copay for a 30-day supply of one of each form of insulin, such as vials or pens — a policy President Joe Biden advocated in his State of the Union Address this year. It also directs the Department of Health and Human Services to set up a program in which the uninsured would have access to the same $35 rate through “qualified entities,” a term that likely refers to federally qualified health centers.

In contrast, the Collins-Shaheen bill would limit monthly cost-sharing for at least one insulin type and dosage to $35 or 25 percent of the list price, whichever is lower. It would also require pharmacy benefit managers — the pharmaceutical middlemen that negotiate drug discounts with drugmakers and design prescription drug benefits for health plans — to pass through 100 percent of insulin rebates and discounts from manufacturers to insurance plans. It largely limits insurers from imposing prior authorization and medical management on insulin products and seeks to expedite new competition to further reduce costs.

The path forward: “It seems to me the short way home is to let all four of us come together with Sen. Schumer and work something out in one bill,” Kennedy said. “But having said that, the real issue is how to pay for it. If we can pay for it, I can sell it on my side.”

IT’S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Yesterday, the FDA conditionally approved the first-ever treatment for our feline friends with a form of anemia related to chronic kidney disease.

Send news, tips and happy cat pics to David Lim ([email protected] or @davidalim) or Katherine Ellen Foley ([email protected] or @katherineefoley).

TODAY ON OUR PULSE CHECK PODCAST, host Ben Leonard talks with Megan R. Wilson, who is tracking health care legislation on the Hill, including efforts to lower health care costs and increased access to cheaper generic drugs. Megan breaks down the proposals in the House and Senate that have bipartisan support.

BIOGEN REVEALS NEW ALS DRUG COST — Qalsody, the newly greenlit drug to treat a form of amyotrophic lateral sclerosis caused by a specific mutation, will cost patients roughly $200,000 annually. Biogen, Qalsody’s manufacturer, confirmed to Prescription Pulse on Monday that the drug’s wholesale acquisition cost per single-dose vial is $14,230. Patients receive three doses for their first six weeks of treatment, followed by another dose every month, totaling about 14 doses a year. Biogen said it would provide financial assistance to eligible patients.

This price tag is slightly higher than Relyvrio, an ALS treatment from Amylyx Pharmaceuticals approved in September, which costs $158,000 annually. According to the FDA, roughly 500 people live with this form of ALS.

FIRST RSV VAX ON THE HORIZON? The FDA is expected to decide by Wednesday on GSK’s respiratory syncytial virus vaccine candidate for adults 60 and older. If approved, it would be the first vaccine to offer protection against RSV, which can result in severe disease or death for the very young and older people.

In late-stage clinical trials, GSK’s candidate was more than 80 percent effective at preventing moderate cases of RSV and more than 90 percent effective at preventing severe disease compared with those who didn’t get vaccinated. Earlier this year, an independent panel of advisers endorsed the FDA’s approval of the shot.

Pfizer also has an RSV vaccine under consideration for adults over 60, but the FDA isn’t slated to decide on it until the end of this month. The FDA’s external advisory committee also endorsed the approval of Pfizer’s candidate, but some experts voiced concerns about its safety and duration.

MORE WEIGH IN ON ALZHEIMER’S DRUG COVERAGE — On Monday, 26 attorneys general across red and blue states and territories said they wrote to HHS Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure, requesting that CMS widen coverage of new Alzheimer’s drugs like Leqembi for Medicare beneficiaries.

The attorneys general are the latest group to voice their displeasure with CMS’ monoclonal antibody coverage, which restricts coverage of the drugs to patients enrolled in a clinical trial — even though no trials are enrolling.

Last week, bipartisan lawmakers grilled Brooks-LaSure on her agency’s decision to limit coverage.

TRUMP ADMIN COVID BOOK HITS SHELVES — When Covid-19 was declared a national emergency on March 13, 2020, former President Donald Trump, former Vice President Mike Pence and CEOs of pharmacy chains, diagnostic manufacturers and testing laboratories took to the Rose Garden to address the American public.

Drive-thru testing sites would allow people to be screened for the virus, Trump said. And a new website where people could input their symptoms, determine whether they needed a test and be directed to a drive-thru site would launch in days, Pence added.

The issue, according to a new book by Brett Giroir, Trump’s then-testing czar, Memoir of a Pandemic, was that the promises were “completely unachievable.”

“There was no way we were going to have where to go get tested and what’s open,” Giroir told Prescription Pulse Monday, reflecting on the pandemic’s early days.

Looking forward: The book also echoes themes from other pandemic tell-alls. Giroir makes the case that the CDC should be revamped as a less academic, more operational agency and that it should be given flexible funding not tied to a fiscal year so it can more quickly respond to emergencies.

SENATE HELP COMMITTEE TO MARK UP GENERIC DRUG AND PBM BILLS — The Senate HELP Committee considers today a slate of legislation that aims to promote competition for generic drugs and reins in pharmacy benefit managers, Megan reports. The measures are largely bipartisan and part of a growing number of congressional measures to help lower drug costs.

One bill, led by committee chair Bernie Sanders (I-Vt.) and ranking member Bill Cassidy (R-La.), takes swipes at PBMs, including prohibiting their ability to charge health plans more for a drug than they reimburse pharmacies for dispensing it, a practice known as spread-pricing.

PBMs push back: The Pharmaceutical Care Management Association maintains that it provides a net benefit to insurance plans and employers and works to lower the cost of medicine.

The PBM bill “would mandate a one-size-fits-all contracting arrangement between pharmacy benefit companies and clients, which would be a dramatic shift from the flexibility and range of choices employers seek in their contract negotiations with PBMs,” a PCMA spokesperson said in a statement. “Patients would directly feel the negative impact when it comes to their prescription drug benefits,” should the legislation become law.

The Pharmaceutical Care Management Association hired Lucia Lebens to lead its federal lobbying team as senior vice president of federal affairs and political strategy. Before that, she was the vice president of government relations and public policy at student loan servicer Navient.

The Supreme Court said Monday it is taking up a case that could effectively end the so-called Chevron deference, endangering the authority of executive branch agencies like the FDA, POLITICO’s Josh Gerstein and Alex Guillén report.

On Monday, the FDA published final guidance for industry on animal studies assessing the safety of potential gene therapies in nontargeted tissues.

Also on Monday, the FDA published final guidance for industry interest in developing novel nicotine replacement therapies to help smokers quit.