Policyholder Services

I read that Rituximab can be used in the treatment of intraocular lymphoma. Will OMIC cover this off-label treatment?

Rituximab (Rituxan) is approved by the FDA for intravenous use in the treatment of B-cell non-Hodgkins lymphoma. When treating intraocular lymphoma, this drug is injected intravitreally. Because of its non-approved route of administration, treatment of intraocular lymphoma, therefore, is considered an off-label use.

OMIC’s policy allows for the off-label use of FDA-approved drugs based on the insured’s sound clinical judgment. Informed consent, including discussion of the off-label nature of the treatment, should be carefully documented.

If an insured participates in clinical trials, coverage applies only if the trials are conducted under an American IRB-approved study.

For more information regarding the off-label use of approved drugs or devices and the use of unapproved drugs and devices, please read “When FDA Leaves Doctors to Their Own Devices,” lead article in OMIC’s Spring 2003 Digest.