Sanofi was the second drug manufacturer yesterday to tighten its conditions on 340B pricing.

Sanofi Late Yesterday Tightened Restrictions on 340B Pricing

Drug manufacturer Sanofi late yesterday afternoon toughened its policy on 340B pricing involving the use of contract pharmacies. Its announcement came about two hours after Merck made a similar move.

Sanofi’s original policy applied to disproportionate share hospitals, rural referral centers, sole community hospitals, critical access hospitals, and health centers. Sanofi said the changes announced in a May 15 letter to covered entities affect the four hospital entity types only.

The letter said, effective June 1, the policy for these four hospital types will be:

  • Hospitals will continue to be able to purchase Sanofi products at a 340B price when shipped to an address registered on the 340B covered entity database as a parent or child site. They will no longer be able to place 340B replenishment orders for any contract pharmacies.
  • For any hospitals that do not have an in-house pharmacy, a single contract pharmacy location must be designated through the 340B ESP platform. No claims data is required for the designated single contract pharmacy location. If a hospital currently has a designation in place through industry vendor 340B ESP, it does not need to re-designate.
  • Contract pharmacies that are wholly owned by the hospital (or have common ownership with the hospital) will not be able to access 340B pricing unless the hospital does not have an in-house pharmacy, and the wholly owned pharmacy is designated as the single contract pharmacy through the 340B ESP platform.

Health centers “will have no change to the process that is in place today,” the letter said. For them, it said the process is:

  • All health center entities can purchase Sanofi products at the 340B price when shipped to an address registered on the 340B covered entity database as a parent or child site.
  • If a health center does not have an in-house pharmacy location registered on the covered entity database as a shipping address or child site of the covered entity, it may designate a single contract pharmacy for this purpose. A qualifying health center may choose a single contract pharmacy for itself and its child sites and Sanofi will provide 340B pricing in this circumstance, irrespective of whether the health center provides the data Sanofi requests. If the health center already has a designation in place, it does not need to take any action at this time.
  • In addition to the option for health centers that lack an in-house pharmacy to designate a single contact pharmacy at which to receive 340B pricing, health centers may also receive 340B pricing at an unlimited number of contract pharmacies by submitting claims data for 340B prescriptions of Sanofi products filled through those contract pharmacies.

An FAQ appended to the letter said, as before, if a health center chooses to provide claims data to 340B ESP in order to continuing using multiple contract pharmacies, it must do so within 45 days of the eligible claim’s date of dispense.

Sanofi’s said it conditions apply to these 28 drugs: Adlyxin, Admelog, Amaryl, Ambien, Apidra, Arava, Avalide, Avapro, Doxercalciferol, Dupixent, Enoxaparin Sodium, Flomax, Insulin Glargine, Ibesartan, Kevzara, Lantus, Leflunomide, Lovenox, Multaq, Plavix, Priftin, Primaquine, Renagel, Renvela, Sevelamer, Soliqua, Toujeo, and Zolpidem.

In late January, a federal appeals court ruled that the 340B statute does not require Sanofi, AstraZeneca, and Novo Nordisk to distribute drugs to an unlimited number of contract pharmacies. Nine companies, including Merck and Sanofi today, have stiffened their conditions on 340B pricing since that decision.

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