By letter dated March 15, 2022, Gilead announced that, effective May 2, 2022, it will implement a new “Contract Pharmacy Integrity Initiative” under which it will no longer honor  contract pharmacy arrangements with covered entities, including grantees, unless the covered entity submits 340B contract pharmacy claims through the 340B ESP platform or qualifies for an exception described below.  Gilead’s policy applies only to its brand name Hepatitis C products:  Epclusa® (sofosbuvir / velpatasvir), Harvoni® (ledipasvir / sofosbuvir), Sovaldi® (sofosbuvir) and Vosevi® (sofosbuvir/velpatasvir/voxilaprevir).  Gilead’s policy does not apply to authorized generics of Epclusa® and Harvoni® offered by its subsidiary, Asegua Therapeutics, nor does currently apply to its HIV drugs.

Gilead will make the following exemptions to its new restrictive contract pharmacy policy:

• No In-House Pharmacy:  Covered entities that do not have an in-house outpatient pharmacy capable of dispensing 340B priced drugs to their patients may designate a single contract pharmacy location to dispense 340B drugs on the covered entities’ behalf.  Contract pharmacy designations must be made through 340B ESP at www.340besp.com/designations.  Covered entities that request this exception are not required to register for an account with 340B ESP or submit claims data through the 340B ESP program.   If a covered entity has an in-house pharmacy, the covered entity must use that pharmacy and cannot designate a contract pharmacy instead.
• Wholly Owned Pharmacies:  Contract pharmacies that are wholly owned by a covered entity will continue to receive replenishment orders for 340B drugs.  The wholly owned pharmacy must be registered in OPAIS as a contract pharmacy of the covered entity.  Covered entities that qualify for this exemption must apply for a wholly owned contract pharmacy exemption at www.340Besp.com/wholly_owned_application.

Unlike other manufacturer policies, Gilead’s policy applies to all categories of 340B covered entities, including federal grantees and sub-grantees. The Powers 340B Team will be discussing Gilead’s restrictive contract pharmacy policy as well as possible responses from RWC-340B during today’s monthly member meeting.  We are interested to hear from RWC-340B members how this policy will impact their 340B program and we strongly encourage all RWC-340B members to join today’s member call at 4pm ET.

AbbVie Adds Imbruvica® to its 340B Contract Pharmacy Restrictions Policy

On March 1, 2021, AbbVie posted an update on the 340B ESP website announcing that it is adding cancer drug Imbruvica® to the list of drugs subject to AbbVie’s restrictive contract pharmacy policy, effective April 1, 2022.  Under AbbVie’s “340B program integrity initiative”, AbbVie will no longer honor contract pharmacy arrangements with hospitals unless the hospital submits 340B contract pharmacy claims through the 340B ESP platform. (AbbVie’s policy does not apply to federal grantees).  When AbbVie first announced its new policy on December 29, 2021, it was limited to only 24 products.  However, the announcement included an FAQ that noted that AbbVie intended to expand the initial list of drugs subject to the policy.