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​Updates to the list of specialty drugs that will require precertification

March 31, 2022

Effective July 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 recently been approved by the U.S. Food and Drug Administration (FDA) and will require precertification:

  • Carvykti™ (ciltacabtagene autoleucel) – Chimeric antigen receptor T-cell (CAR-T) therapy
  • infliximab (unbranded) – Immunological agents
  • Kimmtrak® (tebentafusp-tebn) – Antineoplastic agents
  • Opdualag™ (nivolumab and relatlimab-rmbw) – Antineoplastic agents
  • Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan)* – Antineoplastic agents
  • Releuko™ (filgrastim-ayow) – Neutropenia
  • Tezspire™ (tezepelumab-ekko) – Respiratory agents

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

  • Elivaldogene autotemcel – Gene replacement therapy
  • Eylea® (aflibercept) biosimilar – Ophthalmic agents
  • Relatimab – Antineoplastic agents
  • Skyrizi® IV (risankizumab-rzaa) – Immunological agents
  • Spesolimab – Immunological agents
  • Teclistamab – Antineoplastic agents
  • Tislelizumab – Anti-PD-1/PD-L1 human monoclonal antibodies
  • Toripalimab – Anti-PD-1/PD-L1 human monoclonal antibodies

The drug names listed above may change after the drug receives FDA approval. 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:

  • efgartigimod will be updated to Vyvgart™ – Miscellaneous therapeutic agents
  • faricimab will be updated to Vabysmo® – Ophthalmic agents
  • inclisiran will be updated to Leqvio® – Miscellaneous therapeutic agents
  • sutimlimab will be updated to Enjaymo™ – Miscellaneous therapeutic agents

Removals

The following drugs will be removed from the precertification list, since they are no longer available in the U.S. market:

  • Bebulin® – Hemophilia/Coagulation factor
  • Carimune® NF – Intravenous immunoglobulin (IVIG)

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.

 

*Precertification review will be provided by eviCore healthcare (eviCore), an independent company. ​


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