Sen. Bernie Sanders (Michael Brochstein/Sipa via AP Images)

‘A mess across the board’: Sen­ate com­mit­tee kicks off talks on drug pric­ing re­forms

The US is still the on­ly coun­try in the world that doesn’t ne­go­ti­ate phar­ma­ceu­ti­cal prices across the board, ex­perts told a Sen­ate com­mit­tee on Tues­day, but how ex­act­ly to fix that re­mains un­clear and few of the so­lu­tions dis­cussed will sur­prise any­one watch­ing the pric­ing de­bate play out over the last decade.

Set­ting the tone for the hear­ing, which fea­tured com­ments from a type 1 di­a­betes pa­tient, Elia Spates, who has seen her in­sulin costs triple over about a decade, Sen. Bernie Sanders (I-VT) honed in on the fact that Spates is not alone, and 1 out of 5 Amer­i­cans could not af­ford their pre­scrip­tion drugs last year.

“How crazy is that?” he asked rhetor­i­cal­ly.

Sanders re­cent­ly in­tro­duced three bills co-spon­sored by oth­er De­moc­rats to tack­le drug prices, of­fer­ing re­cy­cled ideas on peg­ging the price of drugs in the US to for­eign coun­tries’ prices (an idea al­so float­ed by for­mer Pres­i­dent Trump), al­low­ing HHS to ne­go­ti­ate drug prices un­der Medicare Part D (which has been de­bat­ed for more than a decade), and al­low­ing drug im­ports from Cana­da (which is al­ready on­go­ing).

Aaron Kessel­heim

Ex­perts at the hear­ing of­fered their own so­lu­tions for what should be done. Aaron Kessel­heim, pro­fes­sor of med­i­cine at Har­vard Med­ical School, ex­plained a more de­tailed ap­proach – call­ing for the US to eval­u­ate new drugs up­front based on a re­view of their clin­i­cal ben­e­fits and then al­low­ing the gov­ern­ment to ne­go­ti­ate prices based on their find­ings. He al­so called for the fed­er­al gov­ern­ment to crack down on price in­creas­es “well be­yond in­fla­tion,” and to en­sure that patents for new med­i­cines are le­git­i­mate.

“The phar­ma­ceu­ti­cal lob­by is large and well-fund­ed and will ar­gue that any re­duc­tion in rev­enues will harm in­no­va­tion. But most drugs ap­proved each year are not tru­ly in­no­v­a­tive and in a re­view of 2017 new ap­provals, on­ly a mi­nor­i­ty of those re­viewed by in­de­pen­dent ex­pert bod­ies of­fered more than min­i­mal clin­i­cal ad­van­tages over avail­able treat­ments,” he said in his writ­ten tes­ti­mo­ny.

But De­moc­rats hold a ra­zor-thin ma­jor­i­ty in the Sen­ate, mean­ing Re­pub­li­cans will need to be won over to get a stand­alone bill passed.

Alex Law­son, the ex­ec­u­tive di­rec­tor of So­cial Se­cu­ri­ty Works who’s been work­ing be­hind the scenes on drug pric­ing on Capi­tol Hill, told End­points News in a phone in­ter­view that he thinks ma­jor drug pric­ing re­forms will be tagged on­to an­oth­er in­fra­struc­ture bill, which has to hap­pen be­fore Sep­tem­ber, be­cause it would be im­pos­si­ble for the De­moc­rats to get 60 votes to pass a stand­alone bill.

Alex Law­son

“I think ne­go­ti­a­tion will be the heart of what it is – some form of ne­go­ti­a­tion,” he said. “In­dus­try thinks that they won’t have to deal with ex­tra­or­di­nar­i­ly high drug prices be­cause the vac­cines are turn­ing the cor­ner on this pan­dem­ic, and I think they’re sore­ly mis­tak­en.”

The idea of hav­ing the sav­ings from high drug prices pay for new in­fra­struc­ture is al­so at­trac­tive to De­moc­rats, he not­ed.

But some Re­pub­li­cans, hes­i­tant to harm a biotech ecosys­tem that is flour­ish­ing and has brought the US mul­ti­ple Covid-19 vac­cines in less than a year, fo­cused their com­ments Tues­day on ways to re­duce pa­tients’ out-of-pock­et ex­pens­es with­out hurt­ing drug­mak­ers’ bot­tom lines, as well as ways to in­crease trans­paren­cy and en­sure re­bates end up in pa­tients’ pock­ets.

Louisiana Re­pub­li­can Bill Cas­sidy al­so ex­pressed con­cerns about the fed­er­al gov­ern­ment set­ting drug prices uni­lat­er­al­ly, which could have a chill­ing ef­fect on VCs that fund the work that takes a com­pound from the bench to a tri­al, and are ex­pect­ing a re­turn on their in­vest­ments.

Re­pub­li­can Su­san Collins of Maine not­ed she hopes Con­gress can find com­mon ground on the is­sue of drug prices be­cause “when a doc­tor pre­scribes a need­ed med­ica­tion, an in­sur­mount­able is­sue should not be the cost.”

In­di­ana Re­pub­li­can Mike Braun, how­ev­er, went in the oth­er di­rec­tion and in­di­cat­ed a will­ing­ness to let the gov­ern­ment step in, call­ing the cur­rent drug pric­ing sys­tem “a mess across the board.” He al­so said of the phar­ma­ceu­ti­cal in­dus­try, “There is no oth­er sec­tor of our econ­o­my that has less trans­paren­cy, less com­pe­ti­tion and more bar­ri­ers to en­try and dis­en­gaged con­sumers. One al­ter­na­tive is to bring in gov­ern­ment.”

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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Re­gen­eron's Evkeeza shows promise in curb­ing high triglyc­erides, but will ge­net­ic dis­par­i­ties lim­it use?

When Regeneron scored an early approval for lipid lowering antibody Evkeeza back in February, the drugmaker cracked open a new pathway to lower abnormally high cholesterol levels. Now, Regeneron is chasing high triglycerides as well with some promising mid-stage data — but will genetic restrictions limit the drug’s use?

Regeneron’s Evkeeza (evinacumab) cut median triglyceride levels by more than 800 mg/dL (57%) in patients with a rare disorder causing abnormally high triglyceride levels compared with an overall increase of 50 mg/dL (1.8%) in participants on placebo, according to Phase II data presented Sunday at the virtual American College of Cardiology meeting.

Pascal Soriot, AstraZeneca CEO (AP Images)

As­traZeneca's Farx­i­ga missed big on Covid-19 study, but it's tak­ing SGLT2 safe­ty da­ta as a sil­ver lin­ing

AstraZeneca hasn’t seen many setbacks in recent months for SGLT2 inhibitor Farxiga, which broke ground in heart failure and kidney disease regardless of diabetes diagnosis. But the British drugmaker had to admit defeat in taking Farxiga into Covid-19. However, follow-up results add a bit of a silver lining to that trial’s safety data.

Of hospitalized Covid-19 patients dosed with AstraZeneca’s Farxiga, 11.2% experienced an organ failure or died after 30 days of therapy compared with 13.8% of those given placebo, according to follow-up data from the DARE-19 study revealed Sunday at the virtual American College of Cardiology meeting.