Independence recently made several updates to the list of specialty drugs that require precertification, which are eligible for coverage under the medical benefit for Independence commercial and Medicare Advantage HMO and PPO members.

Additions for biosimilars

All biosimilars to originator products on the precertification list require precertification approval from Independence as soon as the biosimilar receives approval from the U.S. Food and Drug Administration (FDA). The following biosimilars were recently approved by the FDA and are now included on the precertification list:

• Herzuma^® (trastuzumab-pkrb) – Antineoplastic Agents
• Ontruzant^® (trastuzumab-dttb) – Antineoplastic Agents
• Truxima^™ (rituximab-abbs) – Antineoplastic Agents
• Udenyca^™ (pegfilgrastim-cbqv) – Colony-Stimulating Factors

Newly approved drugs from the FDA

The following drugs were added to the precertification list, as of January 1, 2019, using their clinical (non-brand) name. The precertification list is now updated to reflect the FDA-approved brand names for these drugs:

• Gamifant^® (emapalumab-lzsg) – Miscellaneous Therapeutic Agents
• Ultomiris^™ (ravulizumab-cwvz) – Miscellaneous Therapeutic Agents

Gene therapy

As of January 1, 2019, all drugs that are classified by Independence as gene therapy require precertification.

The following gene therapy drug is expected to receive FDA approval in the coming months for the treatment of spinal muscular atrophy: Zolgensma* (onasemnogene abeparvovec-xxxx).

Zolgensma will require precertification by Independence once it receives FDA approval.

For more information

Medical policies for these drugs are currently in development. In lieu of a published medical policy, requests for these drugs will be subject to precertification review using the FDA-approved guidelines.

These changes are reflected in an updated precertification requirement list, which has been posted to our website. 

*This brand name is subject to change, pending final FDA approval.