Gilead Sciences “Pharmacy Integrity Initiative” for Hepatitis C Drug Products
NASTAD is aware of a March 15, 2022 letter to 340B covered entities from Gilead Sciences regarding the company’s “Pharmacy Integrity Initiative” pertaining to its direct acting antiviral (DAA) products for hepatitis C. Central to this initiative is a requirement for 340B covered entities with contract pharmacies to register and provide claim level data (CLD) via 340B ESP, an online portal operated by the prescription drug information technology company Second Sight Solutions, contracted by several manufacturers.
This blog outlines the potential impact of this requirement on 340B covered entities providing viral hepatitis care that work with contract pharmacies.
Effective May 2, 2022, Gilead Sciences will begin requiring all 340B covered entities to register with 340B ESP and upload CLD for prescriptions of Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) dispensed from contract pharmacies. No other prescription drugs commercialized by Gilead Sciences, including its antiretroviral products for HIV treatment and prevention, are subject to its CLD reporting requirements at this time.
Covered entities that register and provide the requested CLD will be able to continue to use the contract pharmacies of their choice. Covered entities with on-site pharmacies that opt not to provide the requested CLD will no longer be eligible to place “ship to/bill to” replenishment orders for these DAAs dispensed through any of their 340B contract pharmacies. Covered entities without on-site pharmacies that opt not to provide the requested CLD will have the option to select a single contract pharmacy location for dispensing these products.
340B covered entities with contract pharmacies that exclusively serve uninsured patients – for example, ADAPs with direct purchase mechanisms for their full-pay medication programs, or sexually transmitted infection clinics – can register with 340B ESP and submit an attestation form indicating they do not serve clients with any form of insurance, such as Medicaid, Medicare Part D, or a commercial plan. Upon completing the attestation, the 340B covered entity will be notified if they will be exempt from having to submit CLD for Gilead’s DAA products.
While Gilead Sciences is not the first DAA manufacturer to require 340B covered entities with contract pharmacies to begin filing CLD with 340B ESP – Merck (manufacturer of Zepatier) and AbbVie (manufacturer of Mavyret) introduced their requirements in August 2021 and February 2022, respectively – Gilead Sciences is the first to extend this requirement to both hospitals and federal grantees, including Section 318 grantees and subgrantees, federally qualified health centers (FQHCs), and Ryan White HIV/AIDS Programs. The CLD requirements implemented by Merck and AbbVie are limited to safety-net hospitals with 340B contract pharmacies.
While NASTAD remains very concerned about CLD requirements and other restrictions being placed on prescription drugs eligible for the 340B Drug Pricing Program – and, by extension, our nation’s safety net providers – we recommend compliance with the demands to avoid access disruptions involving discounted medications and vital program savings generation. NASTAD, however, cannot advise on 340B covered entities’ legal obligations to adhere to the manufacturers’ requests or their legal requirements.
NASTAD also recommends that 340B covered entities consult with their contract pharmacies, pharmacy benefit manager(s), and/or contract pharmacy claims administrator(s) regarding the 340B ESP CLD requirements, including opportunities to streamline collection and submission of the data requested.
Finally, NASTAD continues to seek clarification from HRSA, manufacturers, and 340B subject-matter experts, and is working in coalition with its HIV, hepatitis, and 340B partners to ensure that health departments and other safety net programs continue to benefit fully from the cost containment and savings “to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.”