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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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