STAT

STAT+: Pharmalittle: U.S. Senate committee passes PBM bills; Pfizer CEO predicts pharma will sue over Medicare price negotiations

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda will focus largely on Mrs. Pharmalot as she turns another page on the calendar and also on fostering a potential mascot — wish us luck. And of course, we hope to squeeze in another listening party.

The rotation will likely include this, this, this and this. And what about you? Once again, this is a wonderful time to enjoy the great outdoors — beaches, woods, and lakes are beckoning. Or you could putter about your castle — a little spring cleaning is a good thing. And if mom is around, remember to say hi. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The U.S. Senate health committee passed a package of bills aimed at speeding generic drug competition and reining in pharmacy benefit managers, but it failed to pass an ambitious reform despite strong bipartisan support, STAT explains. The committee passed, 18 to 3, a bill that would ban pharmacy benefit managers from using spread pricing. The bill would also require that pharmacy benefit managers disclose rebates, fees, and other payments they receive and pass them on to the insurers for whom they negotiate the concessions. Lawmakers did not vote on a bill that would ban pharmacy benefit managers from charging administrative fees based on a percentage of a drug’s list price.

Pfizer chief executive officer Albert Bourla indicated that pharmaceutical companies will likely take legal action against Medicare drug price negotiations, CNBC tells us. Bourla referred to a provision in the Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. Bourla called the plan “negotiation with a gun to your head.” The first negotiations start in September and new prices will go into effect in 2026. He said the most “certain way” to stop negotiations would be to call on Congress to introduce legislation that will revise the plan, but noted he is “not optimistic” about that happening.

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1 year 11 months ago

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STAT

STAT+: AbbVie sues a behind-the-scenes company for exploiting its patient assistance program

AbbVie has filed a lawsuit against a behind-the-scenes company that helps health plan sponsors take advantage of the assistance programs created by drug companies to provide specialty medicines to patients for free.

At issue is a maneuver called alternative funding, which a growing number of drugmakers contend exploits their charitable programs. Basically, a plan sponsor excludes certain expensive drugs from coverage and taps an outside vendor to help patients obtain the medicines for free from patient assistance programs run by drug makers or foundations.

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1 year 11 months ago

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STAT

STAT+: Wyden decries ‘astonishingly low’ tax rates for pharma companies as he probes business maneuvers

Thanks to changes in tax law six years ago, several of the largest pharmaceutical companies saw their tax rates fall substantially, but they also reported that most of their profits were shifted offshore in an effort to avoid paying U.S.

taxes, according to a memo by a U.S. Senate Committee.

Specifically, the average effective tax rate for seven of the biggest drugmakers fell by 40% — dropping to 11.6% in 2020, down from 19.6% in 2016. In 2017, a new law was passed that permanently lowered corporate tax rates from 35% to 21%. Meanwhile, many of the largest pharmaceutical companies reported that 75% of their profits came from overseas.

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1 year 11 months ago

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MedCity News

Acelyrin Plans IPO to Fund Pivotal Tests of Drug That Could Rival AbbVie’s Humira

Biotech IPOs continues to be almost non-existent, but Acelyrin wants to see if the public markets have an appetite for its lead drug candidate. The small protein drug could match up favorably against blockbuster biologics and it has reached pivotal testing in three inflammatory disorders.

2 years 1 day ago

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MedCity News

What Do Payers Need to Help Value-Based Contracting Deals for Novel Therapies Succeed? [Sponsored]

A panel discussion at the annual Abarca Forward conference in Puerto Rico last month sought to identify some of the innovative financial approaches that can be applied to managing the high price of novel therapies. Conversations also addressed what payers need for these financing models to be sustainable.

2 years 1 day ago

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STAT

STAT+: Pharmalittle: Genentech finds no evidence of fraud in paper by former top exec; FDA withdraws approval for premature-birth drug

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, once gain, rather modest. We plan to promenade with the official mascot and his stay-over playmate, catch up on our reading, and hold another listening party with Mrs.

Pharmalot — the rotation will include this, this and this. And what about you? Given the spate of tumultuous news these past few days, perhaps spending time by calming ocean waters or in the solitude of a woodsy area is in order. Or you could zone out and binge-watch something fanciful on the telly. Or perhaps this is an opportunity to plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Genentech said an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and currently president at Stanford University, did not find evidence of fraud or intentional wrongdoing, STAT reports. But the review also points to another previously undisclosed case of scientific misconduct by a post-doctoral researcher in Tessier-Lavigne’s lab. The findings come after the university newspaper reported former Genentech employees claimed an internal review uncovered falsified data and that the neuroscientist tried to keep that information quiet.

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2 years 1 week ago

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STAT

STAT+: Pharmalittle: FDA panel backs conditional approval for Biogen ALS drug; pharma fights tactic for lowering specialty med costs

Rise and shine, everyone, another busy day is on the way. This morning is getting off to a fabulous start, though, as a delightfully warm sun is enveloping the subdued Pharmalot campus, where the official mascot is happily snoozing and the sounds of spring can be heard from our window.

As always, we are quaffing some cups of stimulation — roasted coconut is our choice du jour — and assembling some tidbits for your pleasure. So, time to get cracking. Hope you have a smashing day, and do stay in touch. We always enjoy your tips and insights. …

A U.S. Food and Drug Administration advisory panel concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients, STAT reports. The panel voted 9-0 that the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 5-3 vote (with one abstention) the panel concluded the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval. The mixed votes suggest the FDA will likely grant accelerated approval, which would allow Biogen to market the drug while it collects additional data to confirm its benefit.

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2 years 3 weeks ago

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STAT

STAT+: Drugmakers push back on a clever tactic employers use to avoid paying for specialty medicines

In the face of rising drug prices, health plan sponsors have quietly used a clever, but questionable tactic over the past few years to deflect costs. And now, some pharmaceutical companies are pushing back.

The maneuver goes by different names — it’s sometimes called a specialty carve out, or alternative funding – but relies on exploiting charitable programs. It works like this: a health plan sponsor excludes certain expensive specialty medicines from coverage and taps an outside vendor to help patients obtain the drugs for free from patient assistance programs run by drugmakers or foundations.

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2 years 3 weeks ago

Pharma, Pharmalot, drug pricing, Insurance, Pharmaceuticals, STAT+

MedCity News

HHS Cites 27 Medicare-Covered Drugs Whose Prices Rose Faster Than Inflation

Companies who raised drug prices higher than the rate of inflation must rebate the difference to Medicare, according to a provision of the Inflation Reduction Act. The highest-profile product on the list might be AbbVie’s blockbuster immunology drug Humira.

2 years 1 month ago

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STAT

STAT+: Pharmalittle: Biden administration to fine drugmakers for price hikes on 27 meds; Dems push pharmacy chains over access to abortion pill

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember, there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a delightful cup of stimulation.

Our choice today is mocha marshmallow. No prescription is required, so no rebates must be paid or tracked. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. Postcards and telegrams are welcomed. …

The Biden administration will fine drugmakers that hiked prices faster than the inflation rate on 27 medicines administered in physician offices, STAT notes. Pfizer had the most drugs on the list of any manufacturer, with five. AbbVie’s blockbuster rheumatoid arthritis drug, Humira, is on the list. Gilead Sciences, Endo International, Leadiant Biosciences, and Kamada had two drugs each. The fines are some of the first major changes to the U.S. drug pricing landscape since the Inflation Reduction Act became law. But White House officials said they intend to delay actual invoices for the price hikes until 2025.

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2 years 1 month ago

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