​​​​​​​​​​​​​​​​​Effective January 1, 2024, AmeriHealth HMO, Inc. and its affiliates (collectively, AmeriHealth) is making changes to the list of specialty drugs that require precertification under the medical benefit.

Additions       

The following drugs haves been approved by the FDA and will require precertification:

• Vyvgart^® Hytrulo – Myasthenia Gravis Agents
• Talvey^™ – Antineoplastic Agents
• Elevidys – Gene replacement/gene editing therapies
• Uptravi IV – Pulmonary Arterial Hypertension
• Tyruko – Multiple Sclerosis Agents

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

• zolbetuximab – Antineoplastic Agents
• debamestrocel – Amyotrophic Lateral Sclerosis agents
• apadamtase alfa/cinaxadamtase alfa – Enzyme Replacement agents
• exagamglogene autotemcel – Gene replacement / gene editing Therapies
• fidanacogene elaparvovec – Gene replacement / gene editing Therapies
• lovotibeglogene autotemcel – Gene replacement / gene editing Therapies
• lifileucel – Tumor Infiltrating Lymphocyte (TIL) Therapy
• camrelizumab – Anti PD-1/PD-L1
• cosibelimab – Anti PD-1/PD-L1

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:

• Roctavian will be updated to Roctavian^®​ – Gene replacement/gene editing Therapies
• rozanolixizumab will be updated to Rystiggo^® – Myasthenia Gravis Agents

• pegunigalsidase alfa will be updated to Elfabrio^® – Enzyme Replacement Class

• retifanlimab will be updated to Zynyz^® – Anti PD-1/PD-L1 human monoclonal antibodies
• beremagene geperpavec will be updated Vyjuvek^® – Gene replacement/gene editing therapies
• etranacogene dezparvec will be updated to Hemgenix^® – Gene replacement/gene editing therapies

• donislecel will be updated to Lantidra^® – Miscellaneous Therapeutic Agents
• glofitamab will be updated to Columvi^® – Antineoplastic Agents
• epcoritamab will be updated to Epkinly^® – Antineoplastic Agents
• mirvetuximab soravtansine will be updated to Elahere^® – Antineoplastic Agents
• Stelara IV will be updated to Stelara^® – Immunological Agents
• aflibercept (high dose) will be updated to Eylea^® HD – Ophthalmic Agents
• tremelimumab will be updated to Imjudo^® – Antineoplastic Agents
• liblituximab will be updated to Briumvi^®​​ – Multiple Sclerosis Agents

The following medical benefit drugs will no longer require precertification approval effective January 1, 2024:

• Alimta^®​ (pemetrexed disodium)
• LumoxitiTM​ (moxetumomab pasudotox-tdfk)
• Makena^®​ (hydroxyprogesterone caproate)
• Qalsody​TM​  (tofersen)
• Radicava^®​ (edaravone)
• ​Sustol^®​ (granisetron)
• Tezspire^®​ (tezepelumab-ekko)
• Lantidra (donislecel)

A new category will be added for Tumor Infiltrating Lymphocyte (TIL) Therapy.

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 AmeriHealth-recognized compendia.

These changes will be reflected in an updated precertification requirement list, which will be posted to the AmeriHealth website.

Oncology biosimilar approval update

Through September 2023, the FDA has approved 43 biosimilars for existing biologic reference products, many for oncology and oncology-adjunct therapies. Each year, AmeriHealth evaluates industry trends, to find savings for members, without impacting care.

Avastin, Herceptin, Neulasta, Rituxan, and Neupogen each have multiple biosimilars, with varying costs. Effective January 1, 2024, the preferred products listed below will not require precertification approval for members.

New additions to the preferred products are indicated as “NEW." ​

 
*Bevacizumab will continue to be covered for ophthalmologic indications, without precertification approval, for all branded products (e.g., Avastin, Mvasi, Zirabev).
^†​Rituximab preferred products apply to all oncology and non-oncology indications.