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Recent Manufacturer Restriction Updates

As of April 1st, 2024, 32 drug manufacturers have implemented various contract pharmacy restrictions for Covered Entities within the 340B Pricing Program. In this recent update, several drugs were added to the current restrictions for AbbVie, Astellas, and Teva manufacturers. Two new manufacturers were also included, with formal letters to covered entities by Genentech and Sumitomo. Below is a breakdown of the letters that were sent:


AbbVie

Effective May 1st, 2024, Venclexta will be added to the current list of applicable products under AbbVie’s program integrity initiative. Exception: Federal grantees, such as community health centers, federally qualified health centers, and Ryan White clinics, will be able to continue to place eligible bill-to/ship-to replenishment orders for their contract pharmacies.


Astellas

Effective May 1st, 2024, Myrbetriq (mirabegron) products will be added to their current list of applicable products under Astellas’ program integrity initiative. Exceptions: Federal grantees are excluded from the policy and will remain eligible for direct delivery of Myrbetriq products. This will also not impact those covered entities in Arkansas and Louisiana.


To continue getting pricing, covered entities impacted and without an in-house pharmacy capable of dispensing 340B products will need to choose one single contract pharmacy location and designate said pharmacy by April 19th within 340B ESP.


Teva

Effective April 8th, 2024, Teva updated their list of products to include Alvaiz in their contract pharmacy policy under the 340B Program Integrity Initiative. Exception: All federal grantee-covered entities are exempt from this policy.


Genentech

Effective May 1st, 2024, Genentech will limit 340B pricing on their portfolio of medicines that are adjudicated through a retail or specialty pharmacy except for Hemlibra and Evrysdi. They are encouraging voluntary submission of claims to support program transparency. A single contract pharmacy location registered in the HRSA database, designated by the 340B Covered Entity or child site, in cases where the covered entity does not have an in-house pharmacy capable of dispensing 340B purchased drugs to its patients. To maintain pricing, these designations must be made through the 340B ESP platform by April 22nd. Exception: There is no change for federal grantee-covered entities.


Sumitomo

Effective May 1st, 2024, Sumitomo will provide the 340B price for APTIOM, GEMTESA, MYFEMBREE, and ORGOVYX brands exclusively to locations registered as a 340B covered entity as described below:


  • APTIOM, GEMTESA, and MYFEMBREE

  • If a covered entity does not have an in-house pharmacy capable of dispensing these products purchased at the 340B price, it may designate a single pharmacy within 40 miles of the parent site location.

  • ORGOVYX

  • Any covered entity without an in-house pharmacy capable of dispensing specialty products may also designate one specialty pharmacy within Sumitomo’s limited distribution network.

  • Wholly owned exception: contract pharmacies registered in the HRSA OPAIS database that are wholly owned by a 340B hospital or have common ownership with a health system may remain eligible. You must apply through the 340B ESP platform for their wholly owned application. 

  • If a hospital-covered entity is granted an exemption, it may not also designate an independent contract pharmacy.


Exception: The policy does not apply to covered entities located in Louisiana or Arkansas, provided the covered entities in those states submit 340B claims data within 45 days of dispense for all their contract pharmacy relationships.

These changes must be made by April 19th to maintain 340B pricing.


As with all these changes, we recommend that each Covered Entity review its recent claims data to determine the best course of action before making any changes within the 340B ESP platform. 

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