Akebia sets IRA-driven price for Vafseo, ends CSL partnership

Akebia Therapeutics, after experiencing a series of hurdles including two amendments to their initial agreement, has ended its partnership with CSL Vifor concerning the chronic kidney disease (CKD) anemia drug, Vafseo. This decision follows Vafseo’s recent FDA approval, which was limited to CKD patients on dialysis. Akebia has now fully regained the rights to market and sell the drug.

On Thursday, Akebia announced the wholesale acquisition cost of Vafseo. Priced at $1,278 for a 30-day supply at the minimum starting dose, the annual cost reaches approximately $15,500. This pricing is significantly higher compared to GSK’s competing drug, Jesduvroq, which averages around $700 for a similar duration. The pricing strategy reflects Akebia’s anticipation of expanding Vafseo’s market to include non-dialysis CKD patients if future approvals are granted.

Akebia’s Chief Commercial Officer, Nicholas Grund, highlighted that the current price indicates the potential value for a non-dialysis CKD population. John Butler, the CEO, elaborated that the Inflation Reduction Act (IRA) influenced their pricing decision. The IRA limits the frequency of price hikes for drugs, and Butler emphasized the necessity of setting a strategic price that would accommodate future indications.

Akebia plans to engage with the FDA this year to explore regulatory pathways for Vafseo’s use in non-dialysis CKD patients. Grund expressed confidence in the drug’s pricing, believing it would appeal to physicians and dialysis providers. However, achieving approval for non-dialysis use adds a layer of uncertainty to this strategy.

Initially, the FDA had rejected Vafseo for a broader CKD application, leading Akebia to refile exclusively for the dialysis-dependent subgroup. Vafseo, part of a new class of drugs known as HIF-PHIs (hypoxia-inducible factor prolyl hydroxylase inhibitors), initially had high sales expectations based on Nobel-winning science. Nevertheless, the FDA's concerns over cardiovascular risks limited the drug’s U.S. indications to dialysis patients. Some countries outside the U.S. have granted broader labels, encompassing both dialysis and non-dialysis patients for these drugs.

Despite the approval challenges, Akebia remains hopeful, noting the FDA’s acknowledgment of the unmet need among non-dialysis patients. Traditional erythropoiesis-stimulating agents, administered intravenously or subcutaneously, only reach 75% of CKD patients. A daily oral medication like Vafseo could, therefore, offer significant advantages.

During a recent investor call, Butler referenced clinical data indicating no increased cardiovascular risks among U.S. patients with specific hemoglobin levels and those nearing dialysis. This data supports the potential for broader application of the drug.

The termination of the partnership with CSL Vifor allows Akebia to streamline its operational approach, simplifying market access and accelerating the contracting process for Vafseo’s launch. Previously, Akebia’s sales representatives marketed Vafseo to physicians, who would then contract with CSL Vifor. Consolidating these activities under Akebia alone aims to reduce confusion and provide customers with a single point of contact.

In terms of staffing, Akebia does not anticipate significant changes, as the company already has a full commercial team in place. The previous agreement with CSL Vifor included a $40 million contribution from CSL, partially funding Vafseo’s manufacturing. Under the new terms, CSL will receive quarterly tiered royalty payments ranging from 8% to 14% of Vafseo’s net sales, starting from July 1, 2025, as compensation for their initial investment.

Furthermore, Akebia has agreed to pay CSL decreasing tiered royalties upon Vafseo’s first sale. Starting July 1, 2027, Akebia may also opt to reduce the royalties through a one-time payment to CSL, ensuring that CSL receives a return on its investments.