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Gilead Sciences will expand its data reporting requirements for 340B pricing on branded hepatitis C products to contract pharmacies wholly owned by covered entities.

Influential HIV/AIDS Group Asks Gilead to Exempt Ryan White Clinics from Company’s 340B Contract Pharmacy Restrictions

Ryan White Clinics for 340B Access (RWC-340B) has asked drug manufacturer Gilead to exempt all Ryan White clinics from the company’s conditions on 340B pricing on its branded hepatitis C treatments when covered entities use contract pharmacies.

RWC-340B made the request April 14 in a 13-page letter explaining its concerns about the company’s new policy. 

“RWC-340B has carefully reviewed and solicited legal advice on Gilead’s new contract pharmacy policy and has concluded that Gilead is prohibited from making access to 340B drugs contingent on” an entity’s provision of contract pharmacy claims data to Gilead’s contractor 340B ESP, RWC-340B said in the letter. It asked Gilead to “immediately reverse its position on contract pharmacy arrangements, at least for RWCs, and comply with its statutory and contractual obligation to offer 340B pricing on all covered outpatient drugs, including those dispensed through contract pharmacy arrangements with RWC- 340B members.”

Gilead announced the policy in March and it is scheduled to take effect on May 2. Hospital and grantee covered entities will have to provide claims level data for Gilead’s branded hepatitis C products to be able to continue to be eligible for bill to / ship to orders for multiple contract pharmacies. Entities that decline to provide their data and that do not have an in-house pharmacy can select a single contract pharmacy location. The policy does not apply to entities’ wholly owned contract pharmacies.

RWC-340B told Gilead that its policy undermines 340B’s function and purpose and undercuts Ryan White clinics’ commitment to provide care and support to patients living with HIV/AIDS who are coinfected with the hepatitis C virus. About one in five people living with HIV/AIDS is coinfected with HCV, the group noted.

“Many of our members do not operate their own in-house pharmacy and therefore rely on contract pharmacies to dispense self-administered HCV drugs to their safety-net patient population,” RWC-340B said. “Without contract pharmacies, our members will not be able to provide 340B discounted HCV drugs to their vulnerable patient population.”

RWC-340B said Gilead’s “request for data on claims submitted to Medicare Part D, TRICARE, and commercial insurers “falls outside the scope of the 340B program.” It said it has no “obligation to help Gilead or any other manufacturer protect itself from duplicate discounts involving non-Medicaid plans.” It also said Gilead “has not stated any basis for believing that it is subject to duplicate discounts on Medicaid claims submitted by covered entities or that covered entities are engaged in diversion.”

RWC-340B warned that Gilead contractor 340B ESP could let commercial payers and rebate claims processors use the 340B contract pharmacy claims data that covered entities submit to reduce retail drug reimbursement for those entities. It said 340B ESP’s terms ideally should “limit how manufacturers and other third parties use contract pharmacy data and would provide RWC-340B members with some protections from potential nefarious uses of their contract pharmacy data.”

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