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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.