Drug manufacturer Takeda’s designated specialty pharmacy and distributor for its leukemia drug Iclusig is making 340B covered entities declare on a form whether they will opt in or opt out of 340B pricing on purchases, as a condition for obtaining Takeda’s drug.
The form says that, by selecting to obtain 340B pricing, the entity agrees to be billed “at the 340B acquisition cost for eligible purchased products,” and “shall comply with all applicable 340B requirements, including, but not limited to, submitting to manufacturer and government audits, completing required re-certifications, and protecting against diversion and duplicate discounts.”
By opting out of 340B pricing, the form says the entity agrees it will be billed “at standard pricing, regardless of whether a product is otherwise eligible for 340B pricing.”
The 340B statute bars disproportionate share hospitals, children’s hospitals, and freestanding cancer hospitals, upon enrolling in 340B, from using group purchasing organizations to obtain covered outpatient drugs. For these 340B hospitals, “standard pricing” would very likely be above GPO pricing, possibly wholesale acquisition cost.
“An authorized official of your organization must complete, sign, and date this Attestation,” the form says. “If you do not return a completed Attestation, you will be automatically classified as opting out of 340B pricing—even if you are a 340B Covered Entity that is registered” in the U.S. Health Resources and Services Administration’s 340B program database.
HRSA last week posted a notice from Takeda to covered entities, dated April 22, stating that specialty pharmacy AcariaHealth was “the network pharmacy for Iclusig.” Takeda said Foundation Care, an AcariaHealth unit that is both a specialty pharmacy and a drug wholesaler, would distribute Iclusig to health systems, hospitals, clinics, and government entities.
Takeda’s notice directs entities to visit a website to obtain Iclusig. “This website will provide forms and directions pertaining to product purchase,” the notice states. “After customer information is obtained and approval confirmation is received, 340B covered entities can begin to place their order.”
The website homepage links to Foundation Care’s 340B covered entity attestation form.
“Takeda takes its obligations under the 340B program seriously,” the notice says. “We seek to ensure that the ongoing distribution of Iclusig is compliant and transparent to HRSA, and that 340B covered entities are aware of the change related to the distribution of Iclusig, which will continue to provide access to therapy in a manner that is no more restrictive that it is for non-340B entities.”
Foundation Care’s 340B pricing opt-in/opt-out requirement for access to Inclusig appears to be unprecedented. The form offers no explanation why entities need to pick between getting 340B pricing or not, or why any would want to say no a lower price. It is unclear whether an entity’s choice applies just to Iclusig, or to all “340B pricing on eligible product purchases” from Takeda through Foundation Care. Nor is it clear whether the 340B pricing opt-in/op-out requirement is Foundation Care’s, Takeda’s, or belongs to both.
The requirement comes amid lawsuits involving six different drug manufacturers, the federal government, and hospitals, health centers, and HIV/AIDS clinics over whether manufacturers must offer 340B pricing when entities use contract pharmacies to dispense outpatient drugs. Starting last summer, the manufacturers either ceased 340B pricing on virtually all drugs shipped to contract pharmacies, or imposed conditions on such pricing. Their decisions followed public statements by HRSA questioning its ability to enforce 340B policies established in program guidance.
Health care attorneys who represent covered entities say Foundation Care’s 340B pricing opt-in/opt-out requirement could be an example of a drug manufacturer, its agent, or both testing the limits of HRSA’s power to enforce its 340B policies.
These attorneys believe the requirement—which they were made aware of late yesterday, and have not had a chance to evaluate in depth—likely violates the 340B statute, the 340B ceiling price and manufacturer civil monetary penalties final rule, and 340B guidance to pharmaceutical manufacturers.
HRSA said late this morning, “HRSA is aware of Takeda’s limited distribution plan and has posted it on our website. If covered entities are unable to obtain Takeda’s covered outpatient drugs at the 340B price, they should work with them in good faith to resolve any issues. If a covered entity is still unable to obtain the 340B price, they should reach out to HRSA directly.”
Takeda hase not yet responded to our request for comment.
