US law­mak­ers now want to hear from the mid­dle­men PBMs to un­pack their role in drug pric­ing

The US Sen­ate Fi­nance Com­mit­tee is up­ping the ante on the is­sue of drug pric­ing with yet an­oth­er hear­ing — this time with phar­ma­cy ben­e­fit man­agers, the mid­dle­men that ne­go­ti­ate re­bates with drug­mak­ers in ex­change for for­mu­la­ry cov­er­age and the pur­port­ed vil­lains be­hind sky­rock­et­ing list prices (ac­cord­ing to big Phar­ma) in a hear­ing last month.

On Tues­day, Sen­a­tors Chuck Grass­ley and Ron Wyden in­vit­ed ex­ec­u­tives from five PBMs — Cigna, CVS, Hu­mana, Unit­ed­Health’s Op­tum­Rx and Prime Ther­a­peu­tics — to tes­ti­fy on April 3 in the third drug pric­ing hear­ing this year.

Chuck Grass­ley

The first hear­ing in Jan­u­ary fo­cused on in­sulin af­ford­abil­i­ty, while the sec­ond in Feb­ru­ary in­volved sev­en phar­ma­ceu­ti­cal ex­ec­u­tives, who square­ly placed the blame for sky­rock­et­ing list prices on the mid­dle­men, as­sert­ing that they are forced to hike the prices of pre­scrip­tion drugs in re­sponse to high­er re­bates that all-pow­er­ful PBMs ne­go­ti­ate.

Last week, large US PBM Ex­press Scripts $ES­RX shot back, sug­gest­ing the pow­er to low­er drug prices ul­ti­mate­ly lies with the man­u­fac­tur­ers. “We of­ten have asked drug com­pa­nies to sim­ply low­er their prices. In­stead, drug com­pa­nies have elect­ed to in­crease prices and in­crease re­bates. This is the op­tion drug mak­ers have cho­sen for them­selves and for the mar­ket­place,” the com­pa­ny said in a state­ment.

“The PBMs de­fense is of­ten fin­ger point­ing, blam­ing ex­or­bi­tant drug pric­ing on the man­u­fac­tur­ers and tak­ing no re­spon­si­bil­i­ty for the prob­lem. In fact, it is the PBMs who bear a great deal of the blame, and their prac­tices have led to se­vere in­fla­tion of the prices of both gener­ic and brand­ed med­ica­tions. This lim­its ac­cess to need­ed med­ica­tions for pa­tients.  It is our hope that the Com­mit­tee does not let them get away with pass­ing the buck,” said Robert Levin, pres­i­dent of the Al­liance for Trans­par­ent and Af­ford­able Pre­scrip­tions (AT­AP), in an emailed state­ment to End­points News.

The gen­er­al job de­scrip­tion for PBMs is to ad­min­is­ter drug ben­e­fits for em­ploy­ers and health plans and run big mail-or­der phar­ma­cies. But what goes on be­hind closed doors be­tween these firms and drug­mak­ers in terms of ne­go­ti­a­tions re­mains some­what of a mys­tery.

Ron Wyden

“Mid­dle­men in the health care in­dus­try owe pa­tients and tax­pay­ers an ex­pla­na­tion of their role. There’s far too much bu­reau­cra­cy and too lit­tle trans­paren­cy get­ting in the way of af­ford­able, qual­i­ty health care,” Grass­ley and Wyden said in a Tues­day state­ment.

All re­bates are passed through in Medicare and 95%+ on the com­mer­cial side with con­tin­ued ef­forts to move re­bate to sub­si­dize out of pock­et (OOP) costs for high­er uti­liz­ing se­niors at the point of sale, Leerink’s Ana Gupte not­ed. “(E)spe­cial­ly UNH which is now mov­ing their ef­forts from ful­ly in­sured em­ploy­ers in 2019 to self- in­sured com­menc­ing 2020. The large PBMs (CVS, CI (ES­RX), UNH) are al­ready im­ple­ment­ing al­ter­na­tive pay­ment mod­els that re­ly less on re­bates.”

Ear­li­er in the day, Unit­ed­Health said it was ex­pand­ing a change to how it han­dles re­bates from drug­mak­ers by re­quir­ing new em­ploy­er clients to pass the dis­counts on to peo­ple who take the med­ica­tions. The move will ap­ply to em­ploy­ers that ink new con­tracts af­ter Jan 1, 2020, the com­pa­ny said.

At the last hear­ing with phar­ma­ceu­ti­cal ex­ec­u­tives, drug­mak­ers ar­gued in fa­vor of cut­ting re­bates not just for Medicare but al­so on the com­mer­cial side to even the play­ing field for all drug man­u­fac­tur­ers, as suf­fi­cient in­cen­tive to low­er list prices.

“Al­though the phar­ma ex­ecs ex­pressed their pref­er­ence for a po­ten­tial re­bate re­struc­tur­ing to oc­cur in both gov­ern­ment and com­mer­cial sec­tors, we be­lieve any large-scale changes in com­mer­cial will be dif­fi­cult with a di­vid­ed Con­gress and the ex­pect­ed push back from large em­ploy­ers who al­ready pass along re­bates to re­duce costs for their em­ploy­ees,” Gupte said.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug developers are “inching ahead” in improving access to much-needed drugs around the world — an issue that has been underscored by the Covid-19 pandemic. But there’s still more work to do, Access to Medicine Foundation executive director Jayasree Iyer said.

Every two years, the Access to Medicines Index ranks the top 20 biotechs leading the push for better access to medicines in low- and middle-income countries. This year’s report, published Tuesday, looks at drug access in 106 countries.

Vir's CMO says he's sur­prised that a low dose of their he­pati­tis B drug ap­pears promis­ing in ear­ly slice of da­ta — shares soar

Initial topline data from a Phase I study of a new therapeutic for chronic hepatitis B virus was so promising that it surprised even the CMO of the company that produces it.

Vir Biotechnology on Tuesday announced that its VIR-3434 molecule reduced the level of virus surface antigens present in a blinded patient cohort after eight days of the trial with just a single 6 mg dose. Six of the eight patients in the cohort were given the molecule, and the other two a placebo—all six who received the molecule saw a mean antigen reduction of 1.3 log10 IU/mL, Vir said.

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Eli Lil­ly demon­strates that 2 an­ti­bod­ies beat 1 for guard­ing against se­vere Covid-19. But can that solve the first an­ti­body’s prob­lem amid slow up­take?

It seems safe to say that two antibodies are better than one.

Eli Lilly released the largest results yet on Tuesday for their Covid-19 neutralizing antibody cocktail, announcing that the combo reduced deaths and hospitalizations in coronavirus patients by 70%. Across 1,000 patients, there were 11 such events in the treatment group and 36 in the placebo group.

The breakdown for deaths alone was even starker: 10 in the placebo group and 0 in the treatment group. Lilly added that the drug hit secondary endpoints for reducing viral load and alleviating symptoms, although they did not disclose numbers.

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George Yancopoulos (L) and Len Schleifer (Regeneron)

Re­gen­eron touts pos­i­tive pre­lim­i­nary im­pact of its Covid an­ti­body cock­tail, pre­vent­ing symp­to­matic in­fec­tions in high-risk group

Regeneron flipped its cards on an interim analysis of the data being collected for its Covid-19 antibody cocktail used as a safeguard against exposure to the virus. And the results are distinctly positive.

The big biotech reported Tuesday morning that their casirivimab and imdevimab combo prevented any symptomatic infections from occurring in a group of 186 people exposed to the virus through a family connection, while the placebo arm saw 8 of 223 people experience symptomatic infection. Symptomatic combined with asymptomatic infections occurred in 23 people among the 223 placebo patients compared to 10 of the 186 subjects in the cocktail arm.

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News brief­ing: Nestlé whips up re­search col­lab­o­ra­tion with new­ly-un­veiled Flag­ship up­start; Mar­i­anne De Backer joins Kro­nos board

Flagship Pioneering tapped into a variety of trendy R&D themes when it officially debuted Senda Biosciences a few months ago, most prominently its focus on the microbiome, computational biology and cellular interactions. And while it’s all still in its infancy, the founders clearly elicited some high-profile attention from a major player which straddles the line between food and medicine.

Nestlé Health Science has partnered with Senda on one of its initial slate of R&D focuses, aligning itself with the biotech on metabolics, with a focus on some big targets, including obesity and glycemia.