Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Rozanolixizumab-noli (Rystiggo) may be considered medically necessary when ALL of the following criteria are met:
- ONE of the following:
- The individual has a diagnosis of generalized Myasthenia Gravis (gMG) AND ALL of the following:
- ONE of the following: (lab test must be submitted)
- The individual has a positive serological test for anti-AChR antibodies AND ONE of the following:
- The individual has tried and had an inadequate response to Soliris (eculizumab), Ultomiris (ravulizumab), Vyvgart (efgartigimod), or Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc); or
- The individual has an intolerance or hypersensitivity to Soliris (eculizumab), Ultomiris (ravulizumab), Vyvgart (efgartigimod), or Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc); or
- The individual has an FDA labeled contraindication to Soliris (eculizumab), Ultomiris (ravulizumab), Vyvgart (efgartigimod), and Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc); or
- The individual has a positive serological test for anti-MuSK antibodies; and
- The individual has a Myasthenia Gravis Foundation of America (MGFA) clinical classification class of II-IVb; and
- BOTH of the following:
- The individual has a MG-Activities of Daily Living total score of greater than or equal to three (3); and
- At least three (3) points are from non-ocular symptoms; and
- ONE of the following:
- The prescriber has assessed the individual's current medications and discontinued any medications known to exacerbate myasthenia gravis (e.g., beta blockers, procainamide, quinidine, magnesium, anti-programmed death receptor-1 monoclonal antibodies, hydroxychloroquine, aminoglycosides); or
- The prescriber has provided clinical rationale indicating that discontinuation of the offending agent is not clinically appropriate; and
- ONE of the following:
- The individual has tried and had an inadequate response to at least ONE conventional agent used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide); or
- The individual has an intolerance or hypersensitivity to ONE conventional agent used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide); or
- The individual has an FDA labeled contraindication to ALL conventional agents used for the treatment of myasthenia gravis (i.e., corticosteroids, azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, methotrexate, cyclophosphamide); or
- The individual required chronic intravenous immunoglobulin (IVIG); or
- The individual required chronic plasmapheresis/plasma exchange; or
- The individual has another FDA approved indication for the requested agent; and
- If the individual has an FDA approved indication, then ONE of the following:
- The individual's age is within FDA labeling for the requested indication for the requested agent; or
- The prescriber has provided information in support of using the requested agent for the individual's age for the requested indication; and
- The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
- The individual will NOT be using the requested agent in combination with any of the following for the requested indication:
- Soliris (eculizumab)
- Ultomiris (ravulizumab-cwvz)
- Vyvgart (efgartigimod)
- Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc).
Initial Length of Approval: 3 months
Reauthorization Criteria
Continuation of therapy with rozanolixizumab-noli (Rystiggo) may be considered medically necessary when the following criteria are met:
- The individual has previously been approved for rozanolixizumab-noli (Rystiggo) through Blue Cross Blue Shield of North Dakota's precertification process; and
- The prescriber has provided information that the individual has had clinical benefit with the requested agent (e.g., improved MG-ADL total score, improved quantitative myasthenia gravis total score); and
- The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis; and
- The individual will NOT be using the requested agent in combination with any of the following for the requested indication:
- Soliris (eculizumab)
- Ultomiris (ravulizumab-cwvz)
- Vyvgart (efgartigimod)
- Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc).
The use of rozanolixizumab-noli (Rystiggo) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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