Imaavy™
Drug - Imaavy™ (nipocalimab-aahu) [Janssen Biotech, Inc.]
January 2026
Therapeutic Area - Immunomodulators, Miscellaneous
Initial approval criteria
- Age ≥ 12 years; AND
- Diagnosis of generalized myasthenia gravis (gMG) with Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to IV disease; AND
- Positive serologic test for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies; AND
- Patient has had a thymectomy (note: applicable only to patients with AChR-positive disease and with thymomas OR non-thymomatous patients who are ≤ 50 years of age); AND
- Provider has assessed objective signs of neurological weakness and fatiguability on a baseline neurological examination (e.g., Quantitative Myasthenia Gravis [QMG] score); AND
- Patient has a baseline Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score of ≥ 3; AND
- Patient had an inadequate response to initial therapy based on their antibodies:
- AChR+ disease: minimum one-year trial of concurrent use with an oral corticosteroid plus another immunosuppressive therapy (e.g., azathioprine, cyclosporine, mycophenolate); OR
- MuSK+ disease: minimum one-year trial with immunosuppressive therapy (e.g., corticosteroids, azathioprine, mycophenolate) and rituximab; OR
- Patient required at least one acute or chronic treatment with plasmapheresis or plasma exchange or intravenous immunoglobulin (IVIG) in addition to immunosuppressant therapy; AND
- Patient had an inadequate response to initial therapy based on their antibodies:
- Patient does NOT have a history of serious hypersensitivity reaction to nipocalimab or any of the excipients in Imaavy; AND
- Patient does NOT have an active infection, including clinically important localized infections; AND
- Imaavy will NOT be used in combination with other immunomodulatory biologic therapies (e.g., rituximab, eculizumab, ravulizumab, rozanolixizumab-noli, pegcetacoplan, satralizumab, inebilizumab, efgartigimod); AND
- Patient will avoid or use caution with medications known to worsen or exacerbate symptoms of gMG (e.g., certain antibiotics, beta-blockers, botulinum toxins, hydroxychloroquine); AND
- Imaavy will NOT be administered with live-attenuated or live vaccines during treatment; AND
- Patient is up to date with all vaccinations in accordance with current vaccination guidelines prior to initiation of therapy.
- Initial approval is for 6 months
Renewal criteria
- Patient must continue to meet the above criteria; AND
- Patient must have an improvement of ≥ 1-point from baseline in the MG-ADL total score (note: can be substituted for an improvement of ≥ 1-point from baseline in the QMG total score, if available); AND
- Patient must demonstrate improvement in muscle strength testing with fatigue maneuvers as evidenced on neurologic examination when compared to baseline; AND
- Patient has NOT experienced any treatment-restricting adverse effects (e.g., serious infection, severe hypersensitivity reactions [e.g., anaphylaxis, angioedema], severe infusion-related reactions).
- Renewal approval is for 12 months
Quantity limits
- Initial dose: 30 mg/kg
- Maintenance dose: Tw15mg/kg every two weeks after the initial dose
- Patient’s weight (in kg) must be submitted at time of request
Billing for Imaavy
Imaavy must be billed as a professional claim.
Questions
Provider Call Center: (844) 575-7887