Democrats turn to selling new drug pricing deal

From: POLITICO Pulse - Wednesday Nov 03,2021 02:05 pm
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Quick Fix

Democrats clinched an agreement on prescription drug prices but still need to smooth divides in caucus — and among activists — over whether the proposal goes far enough.

— CDC has endorsed the first-ever Covid shot for young kids, after advisers downplayed some concerns that the vaccine should be narrowly focused.

— Yet another senator is calling on Covid-19 vaccine makers to make their shots available for more widespread manufacturing.

WELCOME TO WEDNESDAY PULSE where we are surprised bats swooped in for the bird-of-the-year title with their current pandemic branding. Send your favorite birds (bats count) to sowermohle@politico.com and acancryn@politico.com.

 

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From out-of-pocket costs, to deductibles, to hospital bills – the most vulnerable patients face challenges. 3 in 10 Americans who have insurance still face a financial barrier to care. We need to make the cost of medicine more predictable and affordable. Learn more.

 
Driving the Day

DEMS TURN TO SELLING NEW DRUG PRICING DEAL — The agreement House and Senate Democrats announced Tuesday a major step towards allowing the government to negotiate drug prices — something the industry has fought for years — but a curtailed version of the party’s original plan that is already garnering criticism from progressives.

The details: The proposal, set to be included in the reconcilaition package, would let the government negotiate the cost of 20 drugs per year by 2028 but carve out exceptions for small biotech companies. Plus, only drugs that have been on the market for several years and have passed their initial exclusivity periods — either 9 or 12 years on the market — would be eligible for negotiation. And to the dismay of many progressive lawmakers and outside advocates, the deal also would limit drug companies’ price hikes to the 2021 inflation rate, not the far lower 2016 rate they had supported, Alice Miranda Ollstein writes.

Yet the deal announced Tuesday lets Democrats move past one major sticking point in the nearly $2 trillion package they still hope to approve in the House this week. Sen. Kyrsten Sinema (D-Ariz.), a persistent critic of drug-pricing reforms, has come out in support of the latest version. Plus the proposed fines on drug price hikes past inflation apply to both Medicare and private plans, a win for supporters like Senate Finance Chair Ron Wyden (D-Ore.).

A party divided? Some Democrats worry the narrower policy will fail to deliver on the party’s campaign promises and years of pushing for broad government negotiation on pricey medicines.

Senate Budget Chair Bernie Sanders said the current version goes “nowhere near far enough” while Majority Whip Dick Durbin sought to explain the move: “I would prefer a much stronger version, but I don’t want to end up empty handed.”

House Speaker Nancy Pelosi said Tuesday that House committee leaders are drafting the new agreement’s text and hammering out details.

Industry lobby PhRMA, meanwhile, blasted the new version as a “essentially Speaker [Nancy] Pelosi’s disastrous H.R. 3 dressed up as a compromise,” referring to the broader negotiation bill still championed in the House. While the lobby warned the negotiation proposal could curb new drug development, it also applauded a popular measure included in the plan that would cap seniors’ out-of-pocket costs.

The generic drug lobby, Association for Accessible Medicines, also criticized the proposal. “Patient access to more affordable generic and biosimilar medicines would be threatened” with the direct drug negotiation approach, AAM President and CEO Dan Leonard said in a statement, adding that affordability would also be hurt by inflation-based rebates on generics and biosimilars included in the measure.

 

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CDC RECOMMENDS PFIZER SHOT FOR KIDS — The Centers for Disease Control and Prevention late Tuesday endorsed the first Covid-19 vaccine for kids aged 5 to 11, hours after an advisory panel unanimously recommended the shot , showing more confidence in broad vaccination than Food and Drug Administration advisers just days earlier.

The background: Some members of FDA’s vaccine advisory committee last week suggested they would have been more comfortable supporting emergency use authorization for Pfizer and BioNTech’s vaccine if the shot were recommended only for kids of color or those with certain underlying health conditions, given the higher risk for disease for those groups and the still-thin safety data, Lauren Gardner reports.

But the CDC advisers did not share those concerns. They argued that existing data, particularly for teens, laid out the known risks for side effects like myocarditis and multisystem inflammatory syndrome — and the benefits outweighed the risks.

"We need to acknowledge the unknowns, but I think we’ve done that today," said Matthew Daley, senior investigator at the Institute for Health Research at Kaiser Permanente Colorado and a member of the CDC panel.

CDC Director Rochelle Walensky within hours endorsed the shots' administration, and federal officials have said that 15 million children’s doses — one-third the amount of adult doses — were being shipped to distribution centers ahead of the vote.

FIRST IN PULSE: KING WANTS ROYALTY-FREE VAX RAMP UP — Sen. Angus King is pressuring Moderna and Pfizer to open their vaccines up for generic manufacturing, calling it a critical step to producing the doses needed to curb the pandemic worldwide.

In a letter to the companies, King highlighted Merck’s recent decision to license its new Covid-19 antiviral pill to the UN-backed Medicines Patent Pool, a move that will make the treatment available in more than 105 countries.

“We clearly need more of every aspect of the vaccination supply chain, but we critically need to increase the production of vaccines,” he wrote, urging Moderna and Pfizer to follow suit.

The senator also asked the companies to consider participating in the World Health Organization’s South African technology transfer hub and the Pan American Health Organization’s Latin American hubs — as well as commit to a royalty-free license to the MPP for any additional Covid-19 treatments they may develop.

CMS HIKES PENALTIES TIED TO PRICE TRANSPARENCY — The federal government will penalize hospitals as much as $5,500 a day for failing to make their prices accessible to the public, according to new CMS regulations finalized Tuesday.

The steeper fines starting Jan. 1 come after the agency said that it found “sub-optimal compliance” among providers subject to the transparency requirements. Smaller hospitals that refuse to follow the rules will face a minimum penalty of $300 a day, while larger hospitals with bed counts greater than 30 will now be charged $10 per bed per day.

Among the other decisions that CMS is rolling out:

The agency is maintaining a Trump-era 340B cut. The Biden administration will continue paying a sharply lower rate for drugs acquired through the 340B program that was first finalized during the Trump administration. The decision to keep the rate — which is the average sale price minus 22.5 percent for certain drugs — intact drew immediate criticism from some provider groups, with America’s Essential Hospitals warning it would deepen safety net hospitals’ financial challenges.

CMS will restore a list of “inpatient-only” services. The agency is reversing the Trump administration’s planned elimination of a list of services that Medicare only pays for when performed in inpatient settings. The decision was driven by patient safety concerns, CMS said, and will add back to the IPO list nearly all of the 298 services that were cut last year.

Pay cuts for specialist providers. The reimbursement reductions in areas like vascular surgery and radiation oncology will phase in over time to soften the blow. But it still left physician groups outraged, and prompted vows from some lawmakers to pass legislation reversing the cuts.

“Many of the specialists who will be affected by these misguided cuts provide treatment for diseases that disproportionately affect Black and Latino patients,” Rep. Bobby Rush said Tuesday.

 

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NIH LAUNCHES COVID AND PREGNANCY STUDY — The National Institutes of Health is funding a four-year follow-up study tracking people who got Covid-19 while pregnant — and their children — for any long-term effects.

The new project is part of NIH’s RECOVER Initiative designed to understand why some people end up with long-term Covid-19 side effects including fatigue, brain fog, sleep disorders, anxiety and depression while other people don’t. The pregnancy study, led by University of Utah School of Medicine’s Torri Metz, will explore where the severity of Covid-19 during volunteers’ pregnancy ultimately influenced the development of “Long Covid,” particularly compared to people who were not pregnant when infected.

 

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Names in the News

Cityblock Health CEO Iyah Romm is taking a six-month leave of absence from the health care startup. The company will form an office of the CEO in the interim led by board chair and former Biden White House Covid-19 official Andy Slavitt.

 

A message from PhRMA:

The most vulnerable patients face challenges.

3 in 10 Americans who have insurance still face a financial barrier to care.

We need to make the cost of medicine more predictable and affordable. That means covering more medicines from day one, making out-of-pocket costs more predictable, and sharing negotiated savings with patients at the pharmacy counter.

Learn more.

 
What We're Reading

Public health’s pandemic brain drain is leaving laboratories without the personnel needed to run tests for deadly disease, monitor drinking water and do other largely unseen-yet-crucial work, Kaiser Health News’ Anna Maria Barry-Jester reports..

Thousands of airmen who flew fighter jets in recent decades are at higher risk than other people of developing certain cancers, according to the largest study on military aviation and cancer, The Air Force Times’ Rachel S. Cohen reports.

A California judge sided with major drug manufacturers in an opioid case, ruling that there was “simply no evidence” the companies fueled the nation’s epidemic, The Associated Press’ Robert Jablon and Donald Thompson report.

 

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