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​​​​​Upcoming changes to the list of specialty drugs that will require precertification

May 26, 2023

Effective July 1, 2023, the AmeriHealth companies are making changes to the list of specialty drugs that require precertification under the medical benefit.

Additions

The following drug has been approved by the FDA and will require precertification:

  • Lamzede® (velmanase alfa) – Enzyme Replacement Agents

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

  • bevacizumab-vikg – Ophthalmic Agents
  • delandistrogene moxeparvovec – Gene replacement/gene editing therapies
  • epcoritamab – Antineoplastic Agents
  • glofitamab – Antineoplastic Agents
  • high-dose aflibercept – Ophthalmic Agents
  • mirikizumb – Immunological Agents
  • nogapendekin alfa inbakicept – Antineoplastic Agents
  • pozelimab – Miscellaneous therapeutic agents
  • rozanolixizumab – Myasthenia Gravis Agents
  • trastuzumab duocarmazine – Antineoplastic Agents

Changes

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

  • etranacogene dezaparvovec will be updated to Hemgenix® – Gene replacement/gene editing therapies
  • instiladrin will be updated to Adstiladrin® – Antineoplastic agents
  • mirvetuximab soravtansine will be updated to ElahereTM – Antineoplastic agents
  • mosunetuzumab will be updated to LunsumioTM – Antineoplastic agents
  • teclistamab will be updated to TecvayliTM – Antineoplastic agents
  • teplizumab will be updated to TzieldTM – Miscellaneous therapeutic agents
  • toferson will be updated to QalsodyTM – Amyotrophic lateral sclerosis agent
  • tremelimumab will be updated to Imjudo® – Antineoplastic agents
  • ublituximab will be updated to Briumvi™ – Multiple sclerosis agents

The following medical benefit drugs will no longer require precertification approval effective July 1, 2023:

  • Ampligen®
  • Blenrep®
  • Cingal®
  • Exenatide sustained release
  • ITCA 650
  • RemuneTM
  • Replagal®

Lastly, a new category will be added for Myasthenia Gravis Agents.​​


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