Opin­ion: Pric­ing in­fo with new drug ap­provals: Time for trans­paren­cy

For years Con­gress has raised con­cerns with the way some drug­mak­ers pay to de­lay gener­ic ver­sions of their brand­ed block­busters, as well as oth­er patent and ever­green­ing tech­niques to add to their sales of old­er prod­ucts.

These games and oth­er ob­fus­ca­tion tac­tics have long ex­tend­ed to drug pric­ing too. Find­ing in­for­ma­tion on the price of a new drug, or even bet­ter, what some­one will ac­tu­al­ly have to pay out of pock­et for that new drug (which is usu­al­ly not the same as the WAC or list price that’s an­nounced), can be ex­ceed­ing­ly dif­fi­cult to find or un­der­stand. Some­times com­pa­nies will an­nounce the list price for a new drug, but oth­er times that an­nounce­ment will come lat­er, or be buried in an SEC fil­ing, or on­ly dis­cov­er­able pub­licly in a gov­ern­ment data­base years lat­er.

Take, for ex­am­ple, the re­cent FDA ap­proval of Vi­a­tris’ new in­ter­change­able biosim­i­lar Sem­glee, which the­o­ret­i­cal­ly will serve as much-need­ed com­pe­ti­tion in an al­ways ex­pen­sive in­sulin mar­ket.

The price for this in­ter­change­able Sem­glee was sup­posed to come down to about $100, ac­cord­ing to an Ax­ios re­port, which, if true, would be al­most one-third the price of its ref­er­ence prod­uct, Sanofi’s block­buster Lan­tus.

How­ev­er, a Vi­a­tris spokesper­son told me, and again lat­er con­firmed, that the ac­tu­al price of the in­ter­change­able ver­sion of Sem­glee has not been re­leased yet, and won’t be re­leased un­til the launch date.

Bob Her­man, the au­thor of the Ax­ios re­port, passed along an email in which the same Vi­a­tris spokesper­son con­firmed, “That’s right re­gard­ing pric­ing.”

But the same spokesper­son ex­plained to me: “Ax­ios ref­er­enced cur­rent pric­ing in­for­ma­tion in their re­port­ing,” and the spokesper­son point­ed to a press re­lease from Au­gust 2020, not­ing Sem­glee’s WAC of about $150 per pack­age of five 3ml pens and $98.65 per 10ml vial, which it said is the low­est WAC for any long-act­ing in­sulin glargine on the mar­ket. The list price of Sem­glee pen is equiv­a­lent to the Lan­tus launch price in 2007, and the Sem­glee vial is list­ed at Lan­tus’s 2010 pric­ing.

But again, the spokesper­son did not say if this will or won’t be the price of the new in­ter­change­able Sem­glee, but said in­stead, “We are not shar­ing pric­ing in­for­ma­tion of the in­ter­change­able biosim­i­lar Sem­glee at this time. Fur­ther in­for­ma­tion will be pro­vid­ed at prod­uct launch.”

So why didn’t Vi­a­tris cor­rect the Ax­ios re­port, which was cit­ed wide­ly?

Vi­a­tris told End­points: “We did not feel the need to cor­rect the Ax­ios piece be­cause the re­porter had asked what the price was for the ex­ist­ing, cur­rent­ly mar­ket­ed Sem­glee prod­uct.”

The in­ter­change­able ver­sion of Sem­glee may end up be­ing more ex­pen­sive than that cur­rent­ly mar­ket­ed biosim­i­lar, which launched last year, so the $100 gener­ic in­sulin head­line of­fered good press for the firm.

Buried be­neath this one ex­am­ple are hun­dreds of oth­ers where the price of a new drug is on­ly lat­er, or some­times nev­er, men­tioned pub­licly. More sun­shine in­to these prices would be wel­come news for many con­sumers who con­tin­ue to find out how much their drugs cost when they get to the phar­ma­cy counter. This lack of trans­paren­cy sit­u­a­tion can be even worse in the case of physi­cian-ad­min­is­tered drugs.

As Con­gress at­tempts to ad­dress drug pric­ing, it would be wel­come news if there was a re­quire­ment that com­pa­nies dis­close the price of their new drugs along­side any new ap­provals.

As high launch prices, par­tic­u­lar­ly in on­col­o­gy, be­come the new nor­mal, it’s im­por­tant that the pub­lic un­der­stands ear­ly on, at the very least, what the list prices for those new drugs are.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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With few re­main­ing un­ap­proved drugs, re­searchers tell FDA its Un­ap­proved Drugs Ini­tia­tive is no longer ef­fec­tive

Back in May, the FDA decided to reverse a Trump-era decision to pull the agency’s controversial Unapproved Drugs Initiative, with the FDA citing “multiple legal and factual inaccuracies.”

But now a group of researchers from Harvard, funded by Arnold Ventures, raises new questions about why the UDI program might not be necessary in its current form.

Designed in 2006 as a way for the FDA to transition old drugs from unapproved to approved products, the agency sought to better ensure that unsafe products were removed from the market.

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