Kicking off 2022, hundreds of pharmaceuticals, including some blockbusters, saw their list prices rise by about 5% on average. But overall, net drug prices (cost after rebates) declined for the fourth year in a row, potentially complicating already stalled drug price reform efforts.
Among the drugs seeing new increases as of Jan. 1 are Gilead’s bevy of blockbuster HIV drugs.
Biktarvy, which pulled in more than $7 billion in worldwide sales in 2020, saw a 4.8% price increase in 2021, and now, another 5.6% increase in 2022, according to a new report from the nonprofit 46brooklyn Research.
Gilead offered the same 5.6% price hikes for its other HIV drugs: Descovy, which saw sales of more than $1.8 billion in 2020; Genvoya, which brought in more than $3 billion in 2020; and Odefsey, which had $1.7 billion in 2020 sales.
Pfizer, which is set to reap tens of billions, possibly even hundreds of billions, from its Covid-19 vaccine and pill this year and next year, also hiked the price of its blockbuster cancer drug Ibrance by 6.9% to start this year. Other Pfizer medicines, including several antibiotics and a form of chemo, saw their prices increase by 10% to start the year, according to GoodRx.
Meanwhile, Vertex increased the price of its blockbuster CF drug Trikafta by 4.9% in 2022. That might not seem like a big spike in the grand scheme of things, but the drug’s list price is currently set at $311,000 per year, so that’s a more than $15,000 per patient, per year increase.
ICER previously estimated that Vertex would need to lower the list price of Trikafta to between $67,900 and $85,500 per year in order to bring the cost in line with its benefits. Analyses of the hundreds of price increases across the spectrum have to be taken into context, and 46brooklyn says that at first look, the degree of price increases in 2022 appears to be ‘relatively greater than the 2021 behavior.’
And ever since the informal 9.9% price hike ceiling was enacted across pharma and biotech companies, change in net prices overall continues to decline in 2022, after three straight years of net price declines, according to Adam Fein, CEO of the Drug Channels Institute.
‘Obviously the devil’s in the details,’ Antonio Ciaccia of 46brooklyn told Endpoints News.
Some brand drugs that have lost exclusivity have much higher rebates than true brand drugs. Additionally, with launch prices being a greater emphasis point, it distorts the conversation around rebate vs list growth over time. And lastly, since PBMs, insurers, and these newer rebate GPOs aren’t obligated to pass through all those drugmaker concessions, even if net prices are going down, that would be purely from the view of the drugmaker, and the actual payer may be hearing that net prices are going down and wondering, ‘huh?’
The news of the price increases comes as Congress is still trying to forge a deal around a reconciliation bill that might include drug pricing provisions. Just before the holiday break, Sen. Joe Manchin (D-WV) halted progress on a deal that would’ve allowed Medicare to negotiate on drug prices. among other provisions.
Their Staying Power Lies in their Patient-Centricity
Decentralized clinical trials (DCTs) were traditionally utilized in an isolated fashion prior to the COVID-19 pandemic. To continue their research within the constraints of the pandemic, sponsors and clinical investigators pivoted to a decentralized model out of necessity. At the onset, regulatory agencies offered some guidance on the digital approaches that are acceptable to ensure DCT approaches are applied in a way that maintains patient safety, as well as data quality and integrity.
For anyone who’s been following how the US government has been allocating and shipping supplies of its Covid-19 treatments over the past year, the news has shifted so many times that it can be difficult to keep track of what’s still being shipped and where.
More change is coming this week too, as HHS has now decided to re-start shipments of both Eli Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products after a short pause because neither product works against the new variant Omicron. Lilly’s combo also was halted last June due to the presence of other variants.
All the big R&D trends are on display in this new, record-topping list of drug approvals for 2021. Plus one.
Add up everything OK’d from CDER and CBER, and you have 61 new drug approvals for last year, topping the 59 OKs that had tied a record in 2020. The dark days of the early 2000s are a distant memory now, with a host of hungry upstarts promising to make their own entries one day as Big Pharmas double down on innovation.
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Piramal CEO Peter DeYoung (Credit: Piramal Pharma Solutions via Youtube)
During a typically quiet holiday break in biotech, Piramal Pharma made some noise, and it’s starting off 2022 with yet another big announcement.
The CDMO will invest millions into creating a high-throughput screening facility that will enhance the already existing in vitro biology capabilities at its Ahmedabad, India drug discovery site. The new expansion is scheduled to go live in Q3 of this year, and couple its biology services with chemistry capabilities already in operation.
When the FDA lifted a clinical hold on Applied Therapeutics’ lead program in galactosemia last February, the New York biotech signaled that they were then on a smooth road toward an accelerated approval, with plans to file an NDA in the third quarter of 2021.
Regulators, though, apparently changed their mind.
Applied has decided to hold on submitting an NDA for AT-007 as a treatment for galactosemia, the company disclosed, following discussions with the FDA in which the agency indicated that ‘clinical outcomes data will likely be required for approval.’
Still recovering from a setback in its lead program, Ovid Therapeutics has turned to AstraZeneca for a suite of experimental epilepsy drugs.
Ovid is paying the Big Pharma partner $5 million in cash and $7.5 million in stock to access a library of early-stage small molecules targeting the KCC2 transporter, including lead candidate OV350. AstraZeneca stands to receive milestones adding up to more than $200 million and retains an option for a strategic collaboration.
Johan Kördel, Sound Bioventures founding partner
Novo Holdings starts the new year off with a bang — right into a biotech VC’s first fund.
The firm announced its undisclosed investment — a ‘cornerstone’ investment, according to Novo — this morning into Sound Bioventures Fund I, a fund appropriately managed by Sound Bioventures. The venture capital firm aims to invest one-third of its fund in Scandinavian biotechs, another third in US and UK biotechs, and the final third in other European biotechs outside Scandinavia and the UK.
Michel Vounatsos (Credit: World Economic Forum/Ciaran McCrickard)
As Biogen stares down an impending patent cliff for its spinal muscular atrophy blockbuster Spinraza, it’s betting $60 million that a new antisense oligonucleotide from Ionis will help keep the company’s lead in that space.
Building on a yearslong relationship with Ionis, Biogen plumped down $60 million just before the new year to secure commercial and development rights to BIIB115, a preclinical SMA drug looking to one-up Spinraza, the companies announced Tuesday. The latter raked in just over $2 billion last year (a slight decrease from the year before) but faces a patent expiration as early as 2023.
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Elizabeth Holmes leaves federal court after the verdict in San Jose, CA, Jan. 3, 2022 (Nic Coury/AP Images)
The Theranos saga has captivated the pharma world over the last two decades, from its founding to its sharp rise and even sharper decline. And late Monday, its founder and former CEO Elizabeth Holmes was found guilty on several counts related to misleading investors, with each carrying a maximum of up to 20 years in prison.
Jurors returned the verdict Monday evening, finding Holmes guilty on one count of conspiracy to commit wire fraud and three counts of wire fraud against specific investors, with several news outlets reporting on the result. Holmes was found not guilty on four counts related to defrauding patients and jurors deadlocked on three counts of misleading individual investors.
https://endpts.com/multiple-blockbusters-from-gilead-pfizer-vertex-see-list-price-hikes-to-start-2022/
