What's fair? New ICER re­port shows pay­ers gen­er­al­ly en­sur­ing fair ac­cess to drugs

The non­prof­it In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view on Wednes­day re­leased a new re­port high­light­ing the ways in which pay­ers are gen­er­al­ly en­sur­ing fair ac­cess to pre­scrip­tion drugs, even when based on a set of cri­te­ria set by the non­prof­it.

While not­ing the lack of trans­paren­cy hin­dered the re­port’s re­sults, ICER said that the “great ma­jor­i­ty” of pay­er poli­cies in the for­mu­la­ries eval­u­at­ed are struc­tured in a way to sup­port many key el­e­ments of how ICER de­fines “fair ac­cess.”

The re­port, which ICER called “an ex­plorato­ry analy­sis in­tend­ed to chart a roadmap for fu­ture re­search,” dug in­to a list of 28 drugs con­sid­ered “fair­ly priced” by ICER and the cost-con­tain­ment org re­viewed how fair­ly dif­fer­ent pay­ers cov­ered the drugs. The list (see be­low) in­cludes three seem­ing­ly ex­pen­sive new drugs: No­var­tis’ $1.6 mil­lion Zol­gens­ma treat­ment for spinal mus­cu­lar at­ro­phy, and Kym­ri­ah, its $475,000 can­cer drug, and Kite’s $373,000 Yescar­ta.

Then ICER looked in­to da­ta from the largest for­mu­la­ries and cov­er­age poli­cies among 15 of the largest com­mer­cial pay­ers (by cov­ered lives) in the US, in­clud­ing CVS Health (Aet­na) and Ex­press Scripts. The avail­able cov­er­age poli­cies on these drugs were eval­u­at­ed to de­ter­mine whether they meet a set of “fair ac­cess” cri­te­ria, in­clud­ing pa­tient cost shar­ing, clin­i­cal el­i­gi­bil­i­ty cri­te­ria, re­stric­tions on pre­scriber qual­i­fi­ca­tions, and step ther­a­py (i.e. try­ing less ex­pen­sive op­tions be­fore “step­ping up” to drugs that cost more).

Over­all, the num­ber of drug-for­mu­la­ry poli­cies meet­ing ICER’s “fair ac­cess” cri­te­ria was very high, al­though in some cas­es the pol­i­cy wasn’t avail­able. There was al­so very high con­cor­dance across all 15 for­mu­la­ries and for the list of drugs on fair ac­cess cri­te­ria for clin­i­cal el­i­gi­bil­i­ty cri­te­ria, step ther­a­py, and pre­scriber re­stric­tions.

“Be­cause over­all con­cor­dance with the fair ac­cess cri­te­ria was so high, there is lit­tle vari­a­tion across drugs by which to ex­plore cor­re­la­tion with fea­tures of the drug, drug class, or con­di­tion,” the re­port said. ICER al­so re­vealed that cov­er­age poli­cies made by six pay­ers were changed fol­low­ing dis­cus­sion of the re­port’s draft re­sults.

But the find­ings for one drug, Genen­tech’s Hem­li­bra, “stands out,” ICER said, adding:

The sin­gle drug with no­tably low­er rates of con­cor­dance across cost shar­ing, clin­i­cal el­i­gi­bil­i­ty cri­te­ria, and step ther­a­py, is emi­cizum­ab for he­mo­phil­ia A. This is one of the most ex­pen­sive drugs among those in this as­sess­ment, and it is used chron­i­cal­ly, un­like the one-time CAR-T and gene ther­a­py treat­ments that round out the most ex­pen­sive drugs in this list. Emi­cizum­ab is al­so a drug for which there are al­ter­na­tive treat­ments, al­beit treat­ments that are more ex­pen­sive on an an­nu­al ba­sis. There­fore, it may not be sur­pris­ing that the uti­liza­tion man­age­ment of emi­cizum­ab is more re­stric­tive than for oth­er drugs in this as­sess­ment.

In its con­clu­sion, ICER again point­ed to the lim­i­ta­tions of the avail­able da­ta around drug pric­ing as a rea­son for the re­port’s lack of com­plete­ness.

“This as­sess­ment has been pre­sent­ed as much as a sign of the lim­i­ta­tions in the ev­i­dence avail­able to us – and to the pub­lic – as it has a re­port that can give im­por­tant in­sights in­to the cur­rent sta­tus of in­sur­ance cov­er­age for drugs in the US. As such, it is like­ly to ful­ly sat­is­fy no one,” the non­prof­it added. But it al­so made clear: “Pay­ers should be ac­cord­ed cred­it where cred­it is due: the ev­i­dence avail­able and the lim­i­ta­tions of our re­search ef­fort leave many ques­tions, but the great ma­jor­i­ty of pay­er poli­cies in the for­mu­la­ries eval­u­at­ed are struc­tured in a way to sup­port many key el­e­ments of fair ac­cess.”

Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

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Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

Pfiz­er, Bris­tol My­ers dom­i­nate top 10 pre­dic­tions for the best-sell­ing drugs of 2022

The annual exercise where analysts try and predict which drugs will become blockbusters and make the most money tends to highlight the biggest trends in biopharma R&D. 2022 is no exception.

The team at Evaluate Vantage published its predictions for the top 10 selling drugs for the year — expecting tens of billions of dollars in sales and highlighting an industry-wide focus on certain diseases and indications.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.