Image of Harvoni pill bottle and pill
Gilead had added 45-day time limits for replenishment orders and claims submissions under its 340B contract pharmacy restrictions on Harvoni and its other branded hepatitis C medicines.

Gilead Adds 45-Day Lookback Clause to its 340B Contract Pharmacy Policy

Drug manufacturer Gilead on Wednesday added 45-day time limits for replenishment orders and claims submissions to its conditions on 340B pricing when covered entities use contract pharmacies.

Ten manufacturers require covered entities to provide claims data to industry contractor 340B ESP in exchange for being able to use more than one contract pharmacy to dispense the company’s drugs. Gilead is the seventh to incorporate a 45-day lookback clause in its policy. The others are Amgen, GlaxoSmithKline (GSK), Johnson & Johnson (J&J), Lilly, Pfizer, and Sanofi.

Gilead requires covered entities to provide claims data for its branded hepatitis C products to be able to continue to be eligible for bill to / ship to orders for the products 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. The policy took effect May 2.

Gilead on June 22 added two FAQs to its 340B contract pharmacy policy documents on 340B ESP’s website.

The first says:

What is Gilead’s policy regarding the timeframe for placing a replenishment order for Gilead’s branded hepatitis C products at 340B pricing for dispensing through my contract pharmacy?

  • Effective June 22, 2022, Gilead will process replenishment orders at 340B pricing for shipment to a covered entity’s contract pharmacy location(s) registered with 340B ESP for prescriptions dispensed to eligible 340B patients within forty-five (45) days of each data submission to 340B ESP.

The second says:

How can a covered entity register its contract pharmacy location(s) with 340B ESP if the contract pharmacy location(s) does not have data to submit as it has not dispensed Gilead branded hepatitis C products on behalf of the covered entity within the last 45 days?

  • Covered entities registering a contract pharmacy that does not have data to submit as the contract pharmacy has not dispensed Gilead branded hepatitis C products on behalf of the covered entity within the last 45 days may attest for their intent to submit applicable 340B claims in the Entity Profile tab in 340B ESP. After attesting, the covered entity is requested to submit the contract pharmacy 340B claims data within 45 days of applicable dispenses of Gilead branded hepatitis C products made on behalf of the covered entity.

A covered entity representative pointed out that under the two changes, it could take up to 90 days for a replenishment order to be shipped to an entity’s contract pharmacy.

Gilead says its policy “is tailored to minimize burdens on covered entities while mitigating duplicate discount and diversion concerns.”

Ryan White Clinics for 340B Access has asked Gilead to exempt all Ryan White clinics from the policy. RWC-340B says the conditions are illegal and undercut clinics’ ability to provide the hepatitis C drugs to their patients. The National Association of Community Health Centers told Gilead its policy is “unconscionable,” “appalling,” “wrongheaded,” and “the latest example of corporate greed from a pharmaceutical company.” It said Gilead should reverse the conditions on 340B pricing immediately. AIDS Healthcare Foundation launched a print and online media ad campaign lambasting the policy and protested outside Gilead’s California headquarters.