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.”

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.