Akebia unveils IRA-driven price tag for kidney disease drug Vafseo, ends CSL collab

11 Jul 2024
www.fiercepharma.com
Akebia unveils IRA-driven price tag for kidney disease drug Vafseo, ends CSL collab
Preview
Source: FiercePharma
Despite a previous rejection, Akebia has priced Vafseo based on a potential expansion to nondialysis chronic kidney disease patients with anemia.
After a rocky road to approval and two amendments to the original pact, Akebia Therapeutics and CSL Vifor have terminated their collaboration around the oral chronic kidney disease (CKD) anemia drug Vafseo.
As Akebia regained full rights to sell Vafseo, the Massachusetts biotech disclosed Thursday that it has set Vafseo’s wholesale acquisition cost at $1,278 for a 30-day supply at the minimum starting dose in a 60-count bottle, or about $15,500 per year.
That price tag is notably higher than roughly $700 on average per 30-day supply for GSK’s rival drug Jesduvroq, according to the number provided by a GSK spokesperson. The exact dosing and price of Jesduvroq vary among patients with different hemoglobin levels.
Vafseo got its hard-fought FDA approval to treat CDK-related anemia in March but only among patients dependent on dialysis. But the current list price reflects “the potential value we believe is possible for a pre-dialysis CKD population, if approved,” Akebia’s chief commercial officer, Nicholas Grund, said during an investor call Thursday.
The Inflation Reduction Act, which restricts how fast a company may hike a drug’s price, also played into the pricing decision, Akebia CEO John Butler said on the call.
“[With] the IRA now, you really can’t change your price when you get a new indication,” Butler said. “You have one opportunity to price your drug, so we really have to think about that, that expanded label, as we thought about the strategic pricing and getting outside of dialysis.”
Akebia is planning to discuss with the FDA this year regarding a potential regulatory path forward in the nondialysis population, according to Grund.
Grund said Akebia has tested the pricing with stakeholders and believes it “will be compelling to physicians and dialysis providers.” But it’s still a bold move considering the uncertainties around a nondialysis indication.
The FDA had originally rejected Vafseo in a broader CKD population and then only approved it after Akebia refiled for the dialysis-dependent subgroup.
Vafseo belongs to an emerging class of drugs known as HFI-PHIs. Based on Nobel-wining science, these drugs once bore blockbuster sales expectations. However, the FDA raised safety concerns mainly around cardiovascular risks. So for Vafseo and GSK’s Jesduvroq, their U.S. indications were limited to the sicker dialysis population despite broader labels covering both dialysis and nondialysis patients in some countries outside the U.S.
What gives Akebia hopes is that the FDA recognizes that nondialysis patients need to be treated, as existing erythropoiesis-stimulating agents—which are given intravenously or under the skin—have only reached 75% of patients, Butler noted.
“The idea of a once-a-day oral product really just makes tremendous sense,” Butler said.
During Thursday’s call, Butler pointed to clinical data in U.S. patients with certain hemoglobin levels and patients with kidney functions close to dialysis, noting that they didn’t see increased cardiovascular risks.
Akebia’s previous deal with CSL Vifor allowed it to tap into a vast network of dialysis centers. The company now expects to have contracts in place with dialysis providers treating the vast majority of eligible Vafseo patients before January 2025, Butler said in a statement.
Ending the deal streamlines Vafseo’s launch activities and will “significantly simplify our operational approach to market access, which we believe will facilitate and accelerate the contracting process and all other aspects of a successful launch,” Butler said.
Akebia’s sales reps have been detailing Vafseo with physicians, who would then contract with CSL Vifor. Consolidating all activities under one company eliminates confusion, giving customers clarity on who they’re working with, Butler added.
In terms of headcount, Akebia doesn’t expect any changes because it already has a full commercial team.
“We need, if any, one, maybe zero, additional headcount for the change that the Vifor agreement brings about,” Brund said. “And so we’re very confident that the people we have in place have the relationships and the ability to do this effectively.”
Under the previous license agreement, CSL Vifor contributed $40 million, including partially funding the cost of manufacturing Vafseo. With the termination, CSL will receive quarterly tiered royalty payments ranging from 8% to 14% of Vafseo’s net sales starting from July 1, 2025, to cover the investments it had already made.
Separately, to give CSL a return on its investments, Akebia will pay CSL decreasing tiered royalty payments upon the first sale of Vafseo. Beginning on July 1, 2027, Akebia also has an option to adjust down the royalties with a one-time payment to CSL.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
[+3]
Indications
[+1]
Targets
-
Drugs
Chat with Hiro
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.