Bal­loon­ing 340B mar­ket reach­es al­most 15% of 2021 US phar­ma sales, IQVIA finds

The tale of a boom­ing fed­er­al drug dis­count pro­gram, which phar­ma com­pa­nies have sought to cur­tail, has of­ten been told but rarely with new num­bers.

Now, the drug pric­ing gu­rus at IQVIA say their lat­est da­ta shows that the pro­gram, known as 340B and once de­signed to give mas­sive dis­counts to on­ly a se­lect num­ber of out­pa­tient drugs for on­ly a se­lect few health care providers, has bal­looned to $93.6 bil­lion in sales in 2021, which is about 15% of the to­tal $668.3 bil­lion in phar­ma sales for the year.

What’s more, is that the 340B sales to­tal has near­ly dou­bled in just three years.

The da­ta ar­rive as at least 16 phar­ma com­pa­nies have now re­worked their 340B op­er­a­tions over the last sev­er­al years to work around a ris­ing num­ber of hos­pi­tals’ con­tract phar­ma­cies, even as law­suits have sought to con­strain the firms, some of which have tilt­ed to in­dus­try’s fa­vor.

Phar­ma com­pa­nies’ re­stric­tions on the pro­gram are work­ing, too, as IQVIA found that for 9 of these man­u­fac­tur­ers with re­stric­tions in place for some or all of 2021, re­tail and mail 340B sales fell 32% and 20%, re­spec­tive­ly. But for all oth­er phar­ma man­u­fac­tur­ers’ sales, re­tail and mail 340B sales grew 16% and 44%, re­spec­tive­ly.

An­oth­er sign the re­stric­tions are work­ing: 340B sales of di­a­betes drugs de­clined 7.4% year-on-year in 2021 ver­sus 22% growth seen in 2020.

Com­pli­cat­ing the mat­ter fur­ther is the fact that in­sulin jug­ger­naut Eli Lil­ly de­feat­ed in court the Biden ad­min­is­tra­tion’s Health Re­sources and Ser­vices Ad­min­is­tra­tion, the fed­er­al de­part­ment that runs the 340B pro­gram.

The judge, in that case, made clear that Con­gress may need to act in this sit­u­a­tion:

The de­mand for 340B drugs and the preva­lence of con­tract phar­ma­cies has ex­plod­ed in a way that Con­gress like­ly did not imag­ine ei­ther when the statute was first en­act­ed in 1992.

Still, HRSA con­tin­ues to go af­ter the phar­ma man­u­fac­tur­ers re­strict­ing 340B sales, as it re­ferred to Boehringer In­gel­heim’s con­tract phar­ma­cy changes for mon­e­tary penal­ties, ac­cord­ing to a re­cent let­ter to the com­pa­ny pres­i­dent.

HRSA said in a state­ment re­gard­ing the over­ar­ch­ing le­gal sit­u­a­tion:

We are pleased that two of three re­cent U.S. Dis­trict Court opin­ions in­volv­ing the 340B Pro­gram agree with HRSA that three phar­ma­ceu­ti­cal man­u­fac­tur­ers have un­law­ful­ly re­strict­ed ac­cess to 340B dis­count­ed drugs by cov­ered en­ti­ties that dis­pense med­ica­tions through con­tract phar­ma­cy arrange­ments – the core find­ing of HRSA’s May 17, 2021, Vi­o­la­tion Let­ters.  HRSA re­spect­ful­ly dis­agrees with the re­cent Dis­trict Court opin­ion find­ing that two oth­er man­u­fac­tur­ers had not vi­o­lat­ed the statute, and con­tin­ues to eval­u­ate its op­tions.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.