Steven Pearson, ICER president (Jeff Rumans)

ICER calls out three drugs from BMS and Lil­ly in re­port on un­sup­port­ed price in­creas­es in Cal­i­for­nia

Drug pric­ing watch­dog ICER on Thurs­day re­leased its fi­nal re­port on drug price in­creas­es in Cal­i­for­nia that were un­sup­port­ed by new clin­i­cal ev­i­dence, point­ing to three out­liers — Bris­tol My­ers Squibb’s can­cer drugs Revlim­id and Spry­cel, and Eli Lil­ly’s mi­graine drug Em­gal­i­ty.

The re­port builds on a price trans­paren­cy law passed in Cal­i­for­nia in 2017, which re­quires man­u­fac­tur­ers to re­port year-over-year spend­ing in­creas­es to pre­scrip­tion drugs’ WAC prices, but does not in­clude net prices, which ICER took is­sue with.

The non­prof­it watch­dog said it win­nowed down lists of the most ex­pen­sive drugs in Cal­i­for­nia from 2020, seek­ing in­put as to whether its fig­ures on net prices, if avail­able, were cor­rect. While con­ver­sa­tions with man­u­fac­tur­ers on net prices can­celed out many of the top ones list­ed, ICER said in all three of these cas­es, the price in­creas­es were high and un­jus­ti­fied by new clin­i­cal ev­i­dence.

In the case of BMS’ Revlim­id (lenalido­mide), which be­gan fac­ing gener­ic com­pe­ti­tion this year, ICER said it was ranked 14th on Cal­i­for­nia’s 2020 list of spe­cial­ty drugs with the high­est year-over-year in­creas­es in to­tal spend­ing, with the WAC in­creas­ing by about 6% in 2020, al­though the net price in­crease was un­known.

BMS’ Spry­cel (dasa­tinib) sim­i­lar­ly saw a 6% WAC price spike in 2020, un­sup­port­ed by new da­ta, and ICER said its change in net price in 2020 amount­ed to about 10%.

More in­creas­es may have oc­curred in the in­ter­ven­ing years too as In­dia-based gener­ic man­u­fac­tur­er Apo­tex set­tled with BMS in 2013 and agreed to not launch its gener­ic ver­sion of Spry­cel un­til Sept. 2024.

In the case of Lil­ly’s Em­gal­i­ty (gal­canezum­ab), which the com­pa­ny says is pro­tect­ed from gener­ics with patents through 2033, the WAC in­creased by about 5%. The net price in­crease in the same pe­ri­od for Em­gal­i­ty re­mains un­known, ICER said, not­ing that SSR Health con­sid­ered its es­ti­mates of change in net price over the same 12-month pe­ri­od to be po­ten­tial­ly not re­li­able and the man­u­fac­tur­er did not pro­vide new in­fo.

All in all, ICER, which re­ceived fund­ing from the Cal­i­for­nia Health­Care Foun­da­tion to pro­duce this re­port, called on states to en­sure net price in­fo is in­clud­ed in any fu­ture drug price trans­paren­cy laws.

“States seek­ing to iden­ti­fy drugs for which in­creas­es in spend­ing may be in­ap­pro­pri­ate should in­cor­po­rate a re­quire­ment for re­port­ing of net price in­creas­es at the state lev­el across all pay­ers,” the re­port con­cludes.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European counties, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.

Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

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