New drug price law could help Part D en­rollees who can't fill can­cer treat­ments due to costs, White House says

The White House’s Coun­cil of Eco­nom­ic Ad­vi­sors said late last week that health cov­er­age can come in unique ways, such as with new­ly passed fed­er­al leg­is­la­tion, the In­fla­tion Re­duc­tion Act. And in cit­ing new da­ta, it re­veals some in­sights in­to can­cer pa­tients, a key em­pha­sis for the Biden Ad­min­is­tra­tion thanks to Pres­i­dent Biden’s re­vived Can­cer Moon­shot.

In a blog post pub­lished Fri­day, the White House high­light­ed re­duc­ing pre­scrip­tion drug costs for Medicare ben­e­fi­cia­ries as one of three ways it sees ac­cess to health­care in­creas­ing. The IRA specif­i­cal­ly caps out-of-pock­et costs for se­niors at $2,000 a year, in ad­di­tion to grant­i­ng Medicare the au­thor­i­ty to ne­go­ti­ate drug prices.

The CEA post sug­gests that of those 30% who can’t cur­rent­ly fill their pre­scrip­tions due to fi­nan­cial is­sues, some will be able to thanks to the $2,000 cap:

One re­cent study finds that up to 30 per­cent of Medicare ben­e­fi­cia­ries with­out sub­si­dies do not fill their an­ti­cancer drug pre­scrip­tions, like­ly due to cost con­straints (Fig­ure 5). With the new cap in place, ad­di­tion­al Medicare ben­e­fi­cia­ries who are cur­rent­ly fore­go­ing fill­ing their pre­scrip­tions may be able to fill their pre­scrip­tions.

Biden’s re­newed call for a Can­cer Moon­shot ear­li­er this month, tout­ing a goal of re­duc­ing the death rate by at least 50% with­in 25 years, comes as a le­gal chal­lenge to the new drug pric­ing law may al­so be in the works. In­dus­try and oth­ers may ar­gue that the drug pric­ing statu­to­ry scheme is “a puni­tive mea­sure sub­ject to the Ex­ces­sive Fines Clause,” ac­cord­ing to the Con­gres­sion­al Re­search Ser­vice.

Per Tom Bol­lyky, di­rec­tor of the glob­al health pro­gram at the Coun­cil on For­eign Re­la­tions (CFR):

Thomas Bol­lyky

Bol­lyky told End­points News lat­er in an email that while he had not close­ly re­viewed the analy­sis, the CEA analy­sis is still based on es­ti­mates and pro­ject­ed ben­e­fits. How­ev­er, it is im­por­tant from his view to ex­pand­ing the pol­i­cy dis­cus­sion from just eco­nom­ic im­pli­ca­tions and pos­si­ble fed­er­al sav­ings to pa­tient im­pact.

“It helps that this analy­sis is al­so con­nect­ed to broad­er con­text of ad­min­is­tra­tion pri­or­i­ties on can­cer. Re­cent­ly, the de­bate over IRA Medicare pric­ing re­forms has been most­ly had in terms of com­pet­ing pri­or­i­ties: re­duc­ing the eco­nom­ic drag of high drug costs to the sys­tem v. en­sur­ing fu­ture phar­ma­ceu­ti­cal in­no­va­tion.  Those is­sues are im­por­tant, but this blog post was a wel­come ef­fort to ex­pand the de­bate be­yond that,” he added.

Sta­cie Duset­z­i­na, as­so­ciate pro­fes­sor of health pol­i­cy at Van­der­bilt and au­thor of a pa­per the White House cites, told End­points via email that she agrees with the White House’s as­sess­ment.

An out-of-pock­et cap on Medicare Part D could mean that many more peo­ple are able to fill their can­cer treat­ments. We found that many Medicare ben­e­fi­cia­ries – 30% of those who do not have low-in­come sub­si­dies – were not fill­ing their can­cer treat­ments at all. In oth­er work we, and oth­er au­thors, have seen that hav­ing high­er out-of-pock­et costs al­so re­duces med­ica­tion ad­her­ence, even among peo­ple who start treat­ment.

To­day the re­tail price for many can­cer drugs ex­ceeds $15,000 per month, which can mean thou­sands of dol­lars of out-of-pock­et spend­ing for ben­e­fi­cia­ries. To give a con­crete ex­am­ple, we looked at this for the most com­mon­ly filled can­cer drugs in Medicare and every sin­gle one of them would cost a ben­e­fi­cia­ry over $3,000 out-of-pock­et for just the first pre­scrip­tion (first month of treat­ment). Most ben­e­fi­cia­ries would pay over $10,000 per year just for a sin­gle can­cer drug cov­ered un­der Part D, mak­ing it clear why peo­ple could strug­gle to af­ford to start or to stay on treat­ment to­day.

Sta­cie Duset­z­i­na

Ac­cord­ing to the study ab­stract, the re­searchers ex­am­ined just over 17,000 new pre­scrip­tions is­sued to Part D ben­e­fi­cia­ries from 2012-2018, in­clud­ing those who do and do not re­ceive a low-in­come sub­sidy. They found that ben­e­fi­cia­ries who re­ceived some type of sub­sidy were near­ly twice as like­ly to ob­tain the pre­scribed drug with­in 90 days as those with­out.

“Among ben­e­fi­cia­ries with­out sub­si­dies, we ob­served non­ini­ti­a­tion for 30 per­cent of pre­scrip­tions writ­ten for an­ti­cancer drugs, 22 per­cent for he­pati­tis C treat­ments, and more than 50 per­cent for dis­ease-mod­i­fy­ing ther­a­pies for ei­ther im­mune sys­tem dis­or­ders or hy­per­c­ho­les­terolemia,” the au­thors not­ed — adding that the study’s find­ings “sup­port cur­rent leg­isla­tive ef­forts to in­crease the ac­ces­si­bil­i­ty of high-price med­ica­tions by re­duc­ing out-of-pock­et ex­pens­es un­der Medicare Part D.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Mer­ck sues Johns Hop­kins for li­cens­ing Keytru­da patents in se­cret and in con­flict with re­search col­lab­o­ra­tion

Merck filed a lawsuit against Johns Hopkins University in Maryland federal court on Tuesday, arguing that the storied university obtained illegal patents as part of its research collaboration with the company and related to its blockbuster cancer drug Keytruda (pembrolizumab).

Merck alleges that the Baltimore-based university obtained and licensed Keytruda-related patents in secret while claiming that Keytruda was developed before and independent of a 2013 research collaboration between the two organizations. Hopkins also sought “hundreds of millions of dollars” tied to Keytruda sales because of the patents, Merck contends.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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