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Updates to the list of specialty drugs that will require precertification

November 22, 2021

​Effective January 1, 2022, the list of specialty drugs that are eligible for coverage under the medical benefit for Independence Administrators members and Independence Blue Cross commercial and Medicare Advantage HMO and PPO members will change.

The following drugs have been approved by the U.S. Food and Drug Administration (FDA) and will now require precertification:

  • Byooviz™ (ranibizumab-nuna) – Ophthalmic agents
  • Monjuvi® (tafasitamab-cxix) – Antineoplastic agents
  • Rethymic™ (allogeneic processed thymus tissue-agdc) – Miscellaneous therapeutic agents
  • Rylaze™ (asparaginase erwinia chrysanthemi [recombinant]-rywn) – Antineoplastic agents
  • Susvimo™ (ranibizumab injection, port delivery system) – Ophthalmic agents
  • Tivdak™ (tisotumab vedotin-tftv) – Antineoplastic agents

The following drugs are pending FDA approval and will require precertification as of the date they receive FDA approval:

  • balstilimab – Anti-PD-1/PD-L1 human monoclonal antibodies
  • cipaglucosidase alfa – Enzyme replacement agents
  • donislecel – Miscellaneous therapeutic agents
  • efbemalenograstim – Neutropenia
  • faricimab – Ophthalmic agents
  • olipudase alfa – Enzyme replacement agents
  • oportuzumab monatox – Antineoplastic agents
  • penpulimab – Anti-PD-1/PD-L1 human monoclonal antibodies
  • plinabulin – Neutropenia
  • SH-111 – Antineoplastic agents
  • sintilimab – Anti-PD-1/PD-L1 human monoclonal antibodies
  • ublituximab – Antineoplastic agents
  • vutrisiran – Miscellaneous therapeutic agents

The drug names listed above may change after the drug is approved by the FDA. All names were valid at the time of article publication.​

The following drugs were added to the precertification list during a prior update cycle. They have since been approved by the FDA, and the precertification list will be updated to reflect their new brand names:

  • amivantamab will be updated to Rybrevant™ – Antineoplastic agents
  • anifrolumab will be updated to Saphnelo™ – Immunological agents
  • avalglucosidase alfa will be updated to Nexviazyme® – Enzyme replacement agents

Removals

The following drugs will be removed from the precertification list:

  • Elzonris® (tagraxofusp-erzs) – Antineoplastic agents
  • Pepaxto® (melphalan flufenamide) – Antineoplastic agents
  • Trogarzo® (ibalizumab-uiyk) – Miscellaneous therapeutic agents

Learn more

Medical policies for FDA-approved drugs can be found on our Medical and Claim Payment Policy Portal. In the absence of a published medical policy, all precertification requests will be subject to review in accordance with the FDA-approved indications and Independence-recognized compendia.

These changes will be reflected in an updated precertification requirement list, which will be posted to the Independence Blue Cross and Independence Administrators websites.


This content was prepared for the Provider News Center and may not be reproduced in any way without the express written permission of Independence Blue Cross. Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association.
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