01Billing team: Prior authorization is required for these neonatal Fc receptor blockers.
02For Rystiggo (rozanolixizumab-noli), confirm the individual is 18 years of age or older, has a documented diagnosis of generalized Myasthenia Gravis with a positive anti-AChR or anti-MuSK antibody, has an MGFA clinical classification of class II-IV, and has an MG-ADL total score of at least 6.
03Confirm one of the following is documented: an inadequate response to corticosteroids and at least one immunosuppressive therapy, an FDA-labeled contraindication, intolerance or hypersensitivity to all conventional agents, or required chronic IVIG or plasmapheresis at least every 3 months over 12 months without symptom control.
04Confirm Rystiggo is not used in combination with a complement inhibitor such as eculizumab or ravulizumab, or with another neonatal Fc receptor blocker.
05Confirm the prescriber is a specialist or has consulted with one, that there is no FDA-labeled contraindication, and that the dosage is within program quantity limits.
06Initial approval is for 6 months.
07Renewal requires prior approval through the BCBSMS PA process, documented clinical response such as a 3-point or greater MG-ADL improvement from baseline, the same prescriber, combination and dosage requirements, and renewal approval is for 12 months.
08Vyvgart (efgartigimod alfa-fcab), Vyvgart Hytrulo and Imaavy are considered not medically necessary under this policy, so check the State Health Plan Medical Drug Formulary before billing them.
09Services related to delivery or administration of a medication that was not approved through the BCBSMS PA review process will be considered not medically necessary.
10Medication trials are determined from pharmacy claims over the preceding twelve months, and for new members the member or requesting provider must obtain and submit pharmacy records upon request, since medical records listing previously prescribed medications are not sufficient.