WHA

 

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. 
     

Last review date: March 1, 2024