| Date Issued | Manufacturer | Hyperlinks | Summary of Action Taken | Effective Date/Deadline | Exceptions for Certain Covered Entities | Consequences | Additional Information |
|---|---|---|---|---|---|---|---|
| 07-01-2020 | Eli Lilly | Limited Distribution Plan published on the HRSA website | See summary here. | Effective Date: July 1, 2020 | Covered entities that do not have an in-house pharmacy should contact 340B@lilly.com regarding an exception process. | N/A - Applies to all CEs | |
| 06-29-2020 | Merck Sharpe & Dohme Corp. | Letter to CEs | See summary here. | Registration deadline: August 14 | No exceptions. | Registration is "voluntary" & Merck will take “less collaborative, and substantially more burdensome” action if too few covered entities voluntarily provide the data. Merck may audit CE, but unclear if it will deny requests for 340B discounts. | Letter from Merck in response to letters from CEs |
| July | Sanofi | Letter to CEs | See summary here. | Registration deadline: October 1 | No exceptions. | Sanofi will not provide 340B discounts through contract pharmacies for its products. | |
| 08-17-2020 | Astra-Zeneca | Letter to covered entities | See summary here. | Effective date: October 1 | Astra-Zeneca will honor one contract pharmacy arrangement for those CEs that do not "maintain their own on-site dispensing pharmacy". These CEs should contact membership@AstraZeneca.com. | N/A - Applies to all CEs | In a letter to wholesalers, Astra-Zeneca stated that it will honor 340B pricing on all chargeback invoices prior to October 1, “but AstraZeneca asks for the removal of contract pharmacy eligibility prior to or by the end of business September 30, 2020.” |
| 08-17-2020 | Novartis Pharmaceuticals | Letter to CEs | See summary here. | Registration deadline: October 1 | No exceptions. | The letter states that CEs must “provide 340B claims data originating from [contract pharmacy] utilization in order to receive 340B reimbursements from Novartis.” This suggests that Novartis will not provide 340B discounts through contract pharmacies for its drug products. | |
| 10-30-2020 | Novartis Pharmaceuticals | Letter to covered entities | See summary here. | New policy effective Nov. 16, 2020 | If a hospital does not own its own pharmacy and will be left with no contract pharmacy, Novartis will "work with the affected institution to ensure it has appropriate access to a contract pharmacy." | NEW LESS-RESTRICTIVE APPROACH: Novartis states that it will not honor contract pharmacy agreements that are located outside of a 40-mile radius of the parent site. Novartis still encourages all covered entities to voluntarily upload their claims data to the 340B ESP platform, “in an effort to increase transparency, mitigate instances of duplicative discounts and maintain the integrity and sustainability of this vital [340B] program.” | |
| 08-27-2020 | N/A | 340B Pay Platform Website | Launching “340B Pay” platform which would transform 340B discount program into a "rebate program" by shifting a manufacturer’s responsibility from providing a 340B discount at the point of sale to paying a rebate after the drug is purchased, dispensed, and billed. | Launch date: September 8 | N/A | N/A | |
| 09-01-2020 | Eli Lilly (including subsidiaries and affiliates) | Limited Distribution Plan Notice for Eli Lilly and Company Products | See summary here. | Effective September 1, 2020 | Covered entities that do not have an in-house pharmacy should contact 340B@lilly.com regarding an exception process. "Special exception" made for Lilly insulin products so long as the following "conditions" are met: (1) 340B price at point of sale, (2) no mark-ups or dispensing fees, (3) no insurer or payer is billed for the drug (4) CE provides claims level data to demonstrate compliance. CEs must contact 340B@lilly.com to take advantage of insulins exception and provide supporting documentation. | N/A - Applies to all CEs. | In general, all Limited Distribution Plans are posted on the HRSA website. This LDP has not been posted. |
| 11-18-2020 | United Therapeutics Corporation | Letter to CEs | See summary here. | Phase 1: November 20, 2020 Phase 2: May 13, 2021 | CEs that do not have an on-site outpatient pharmacy may designate a signle contract pharmacy for which United Therapeutics will honor 340B prices. Permitted contract pharmacies limited to those chosen by United Therapeutics - https://www.utassist.com/hcp/ (select Our Services/Product Distribution). | On or after May 13, 2021, CEs that do not submit claims data will be denied 340B prices at contract pharmacies. | |
| 11-18-2020 | Novo Nordisk | Notice Regarding Limitation on Hospital Contract Pharmacy Distribution | See summary here. | Beginning January 1, 2021 | If a “hospital” covered entity does not have an in-house pharmacy capable of dispensing product to outpatients, that covered entity may designate one contract pharmacy location to which product purchased by that covered entity may be shipped. | N/A applies to all hospital covered entities. |