Rystiggo (rozanolixizumad-noli)

RYSTIGGO (rozanolixizumad-noli)

Office Administration – subcutaneous infusion

Diagnosis considered for coverage:

• Generalized Myasthenia Gravis (gMG): Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Coverage Criteria:

For diagnosis of generalized myasthenia gravis:

• Diagnosis of generalized myasthenia gravis; AND
• Patient is 18 years of age or older; AND
• Prescribed by or in consultation with a neurologist; AND
• One of the following:
  • Both of the following:
    • Patient is anti-acetylcholine receptor (AChR) antibody positive
    • One of the following:
      • Trial and failure, contraindication, or intolerance to two immunosuppressive therapies (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
      • Both of the following:
        • Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
        • Trial and failure, contraindication, or intolerance to one of the following:
          • Chronic plasmapheresis or plasma exchange (PE)
          • Intravenous immunoglobulin (IVIG), OR
  • Both of the following:
    • Patient is anti-muscle-specific tyrosine kinase (MuSK) antibody positive
    • One of the following:
      • Trial and failure, contraindication, or intolerance to two immunosuppressive therapies (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
      • Both of the following:
        • Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus)
        • Trial and failure, contraindication, or intolerance to one of the following:
          • Chronic plasmapheresis or plasma exchange (PE)
          • Intravenous immunoglobulin (IVIG)
          • Rituximab

Reauthorization Criteria:

For diagnosis of generalized myasthenia gravis:

• Documentation of positive clinical response to therapy

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Dosing:

• The recommended dosage (based on body weight) is administered as a subcutaneous infusion once weekly for 6 weeks.
• RYSTIGGO should only be prepared and infused by a healthcare provider.
• Administer using an infusion pump at a rate of 20 mL/hour.
• The safety of initiating subsequent cycles sooner than 63 days from the start of the prior treatment cycle has not been established. 
• Administer subsequent treatment cycles based on clinical evaluation.

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Approximately 80% to 90% of patients have anti-AChR antibodies, while ~8% of patients with gMG have anti-muscle-specific tyrosine kinase (MuSK) antibodies.
• RYSTIGGO offers the first treatment option for adults with gMG who are anti-MuSK antibody-positive. It was FDA-approved on June 27, 2023. 
• RYSTIGGO is a neonatal Fc receptor (FcRn) blocker that reduces circulating IgG, which is a different mechanism of action than previous drug therapies for gMG.
• Corticosteroids and immunosuppressives should be used in all patients with MG who have not met treatment goals after an adequate trial of pyridostigmine.
• Patients with refractory MG may be treated with immunosuppressive agents, as well as chronic IVIG or PLEX, cyclophosphamide, and rituximab (in anti-MuSK antibody positive MG).
   

Policy Updates:

• 03/01/2024 – New policy for Rystiggo approved by WHA P&T Committee. (P&T, 02/20/2024)

References:

1. Rystiggo Prescribing Information. UCB, Inc., Smyrna, GA. June 2023. 
2. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis. Neurology. 2016;87(4):419-25. 
3. Alhaidar MK, Abumurad S, Soliven B, Rezania K. Current Treatment of Myasthenia Gravis. J Clin Med. 2022 Mar 14;11(6):1597.