Effective 4/7/23: Makena Products No Longer Covered Under Pharmacy or Medical Benefit
Date: 04/11/23
On April 6, 2023, the U.S. Food and Drug Administration (FDA) announced the final decision to withdraw approval of Makena.
Pharmacy Benefit Update
Superior HealthPlan will follow the guidance from Texas Health and Human Services in removing the following Makena products and their clinical prior authorization from all formularies as of April 7, 2023.
NDC | Drug Name |
|---|---|
64011030103 | MAKENA 275 MG/1.1 ML AUTOINJCT |
00517176701 | HYDROXYPROGEST 250 MG/ML VIAL |
55150030901 | HYDROXYPROGEST 250 MG/ML VIAL |
64011030103 | MAKENA 275 MG/1.1 ML AUTOINJCT |
67457096701 | HYDROXYPROGEST 250 MG/ML VIAL |
69238179701 | HYDROXYPROGEST 250 MG/ML VIAL |
71225010401 | HYDROXYPROGEST 1,250 MG/5 ML |
71225010501 | HYDROXYPROGEST 250 MG/ML VIAL |
Medical Benefit/Clinician Administered Drug Update
Superior HealthPlan will follow the guidance from Texas Health and Human Services in removing Makena and its generics from the HHSC NDC-to-HCPCS Crosswalk and the fee schedule. HHSC has removed Makena and its generics (J1726) from the April Crosswalk and shows a termination date of April 6, 2023. Refer to the NDC-to-HCPCS relationships impacted by this update in the table below.
NDC | HCPCS | RELATION START DATE | RELATION END DATE | HCPCS DESCRIPTION | NDC LABEL NAME |
|---|---|---|---|---|---|
00517-1767-01 | J1726 | 6/29/2018 | 4/6/2023 | Makena, 10 mg | HYDROXYPROGEST 250 MG/ML VIAL |
00517-1791-01 | J1726 | 6/30/2018 | 4/6/2023 | Makena, 10 mg | HYDROXYPROGEST 250 MG/ML VIAL |
55150-0309-01 | J1726 | 5/21/2019 | 4/6/2023 | Makena, 10 mg | HYDROXYPROGEST 250 MG/ML VIAL |
55150-0310-01 | J1726 | 5/21/2019 | 4/6/2023 | Makena, 10 mg | HYDROXYPROGEST 1,250 MG/5 ML |
64011-0301-03 | J1726 | 1/1/2018 | 4/6/2023 | Makena, 10 mg | MAKENA 275 MG/1.1 ML AUTOINJECTOR |
67457-0967-01 | J1726 | 8/23/2019 | 4/6/2023 | Makena, 10 mg | HYDROXYPROGEST 250 MG/ML VIAL |
69238-1797-01 | J1726 | 3/19/2019 | 4/6/2023 | Makena, 10 mg | HYDROXYPROGEST 250 MG/ML VIAL |
71225-0104-01 | J1726 | 1/31/2019 | 4/6/2023 | Makena, 10 mg | HYDROXYPROGEST 1,250 MG/5 ML |
71225-0105-01 | J1726 | 3/25/2019 | 4/6/2023 | Makena, 10 mg | HYDROXYPROGEST 250 MG/ML VIAL |
For additional information, please reference FDA Commissioner and Chief Scientist Announce Decision to Withdraw Approval of Makena.