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Rystiggo® (rozanolixizumab-noli)

Policy Number: PH-90714

Subcutaneous

 

Last Review Date: 2/01/2024

Date of Origin: 08/08/2023

Dates Reviewed: 08/2023, 12/2023, 2/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization 1

Initial coverage will be provided for 16 weeks. Coverage may be renewed every 6 months thereafter.

  1. Dosing Limits

A. Quantity Limit (max daily dose) [NDC Unit]:

  • Rystiggo 280 mg/2 mL single-dose vial: 3 vials per week for 6 doses per 63 days

B. Max Units (per dose and over time) [HCPCS Unit]:

  • 840 billable units (840 mg) weekly for 6 doses per 63 days
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND

Universal Criteria 1,3

Submission of medical records related to the medical necessity criteria is REQUIRED on all requests for authorizations. Records will be reviewed at the time of submission. Please provide documentation via direct upload through the PA web portal or by fax.

  • Will not be used in combination with other immunomodulatory biologic therapies (e.g., rituximab, eculizumab, ravulizumab, pegcetacoplan, satralizumab, inebilizumab, efgartigimod, zilucoplan, etc.); AND
  • Patient will avoid or use with caution medications known to worsen or exacerbate symptoms of myasthenia gravis (MG) (e.g., certain antibiotics, beta-blockers, botulinum toxins, hydroxychloroquine, etc.); AND
  • Will not be administered with live-attenuated or live vaccines during treatment; AND
  • Patient does not have an active infection, including clinically important localized infections; AND
  • Patient does not have a deficiency of immunoglobulin G (IgG) necessitating supplementation with IgG; AND

Generalized Myasthenia Gravis (gMG) Ф 1,3-6,8

  • Patient has Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to IV disease §; AND
  • Patient has a 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 or younger); AND
  • Physician has assessed objective signs of neurological weakness and fatiguability on a baseline neurological examination (e.g., including, but not limited to, the Quantitative Myasthenia Gravis (QMG) score, etc.); AND
  • Patient has a baseline MG-Activities of Daily Living (MG-ADL) total score of at least 3; AND
    • Patient had an inadequate response to initial therapy based on their antibodies:
  • AChR+ disease:

For PEEHIP Members Only

  • Patients must have tried and failed, had an inadequate response or intolerance to, or contraindication to Vyvgart IV prior to consideration of Rystiggo; AND
      •  
    • A minimum one-year trial of concurrent use with two (2) or more immunosuppressive therapies (e.g., corticosteroids plus an immunosuppressant such as azathioprine, cyclosporine, mycophenolate, etc.); OR
      • MuSK+ disease: a minimum one-year trial with immunosuppressive therapy (e.g., corticosteroids, azathioprine, or mycophenolate) and rituximab; OR
    • Patient required at least one acute or chronic treatment with plasmapheresis or plasma exchange (PE) or intravenous immunoglobulin (IVIG) in addition to immunosuppressant therapy

FDA Approved Indication(s); Compendia Recommended Indication(s); Ф Orphan Drug

§ Myasthenia Gravis Foundation of America (MGFA) Disease Clinical Classification: 5,6

  • Class I: Any ocular muscle weakness; may have weakness of eye closure. All other muscle strength is normal.
  • Class II: Mild weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.
    • IIa. Predominantly affecting limb, axial muscles, or both. May also have lesser involvement of oropharyngeal muscles.
    • IIb. Predominantly affecting oropharyngeal, respiratory muscles, or both. May also have lesser or equal involvement of limb, axial muscles, or both.
  • Class III: Moderate weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.
    • IIIa. Predominantly affecting limb, axial muscles, or both. May also have lesser involvement of oropharyngeal muscles.
    • IIIb. Predominantly affecting oropharyngeal, respiratory muscles, or both. May also have lesser or equal involvement of limb, axial muscles, or both.
  • Class IV: Severe weakness affecting muscles other than ocular muscles; may also have ocular muscle weakness of any severity.
    • IVa. Predominantly affecting limb, axial muscles, or both. May also have lesser involvement of oropharyngeal muscles.
    • IVb. Predominantly affecting oropharyngeal, respiratory muscles, or both. May also have lesser or equal involvement of limb, axial muscles, or both.
  • Class V: Defined as intubation, with or without mechanical ventilation, except when employed during routine postoperative management. The use of a feeding tube without intubation places the patient in class IVb.
  1. Renewal Criteria 1

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet universal and other indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: infection, severe hypersensitivity reactions (e.g., rash, angioedema, etc.), aseptic meningitis, etc.; AND
  • Patient has had an improvement (i.e., reduction) of at least 1-point from baseline in the Myasthenia Gravis-Specific Activities of Daily Living scale (MG-ADL) total score Δ; AND
  • Improvement in muscle strength testing with fatigue maneuvers as evidenced on neurologic examination when compared to baseline; AND
  • Patient requires continuous treatment, after an initial beneficial response, due to new or worsening disease activity (Note: a minimum of 63 days must have elapsed from the start of the previous treatment cycle)

(Δ May substitute an improvement of at least 1-point from baseline in the Quantitative Myasthenia Gravis (QMG) total score, if available)

  1. Dosage/Administration 1

Indication

Dose

Generalized Myasthenia Gravis (gMG)

Administer the recommended dose subcutaneously, via an infusion pump at a rate of up to 20 mL/hour, once weekly for 6 weeks.

  • <50 kg: 420 mg (3 mL)
  • 50 kg to <100 kg: 560 mg (4 mL)
  • ≥100 kg: 840 mg (6 mL)

Rystiggo is to be administered by a healthcare professional only.

Administer subsequent treatment cycles based on clinical evaluation. The safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle has not been established.

  1. Billing Code/Availability Information

HCPCS Code:

  • J9333 – Injection, rozanolixizumab-noli, 1 mg; 1 billable unit = 1 mg

NDC:

  • Rystiggo 280mg/2mL solution in a single-dose vial: 50474-0980-xx
  1. References
  1. Rystiggo [package insert]. Smyrna, GA; UCB, Inc., June 2023. Accessed January 2024.
  2. Sussman J, Farrugia ME, Maddison P, et al. Myasthenia gravis: Association of British Neurologists’ management guidelines. Pract Neurol 2015; 15: 199-206.
  3. Narayanaswami P, Sanders D, Wolfe G, Benatar M, et al. International consensus guidance for management of myasthenia gravis, 2020 update. Neurology® 2021;96:114-122. doi:10.1212/WNL.0000000000011124.
  4. Bril V, Drużdż A, Grosskreutz J, and MG0003 study team. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023 May;22(5):383-394. doi: 10.1016/S1474-4422(23)00077-7. PMID: 37059507. https://pubmed.ncbi.nlm.nih.gov/37059507
  5. Jayam-Trouth A, Dabi A, Solieman N, Kurukumbi M, Kalyanam J. Myasthenia gravis: a review. Autoimmune Dis. 2012;2012:874680. doi:10.1155/2012/874680
  6. Bril V, Druzdz A, Grosskreutz J, et al. Long-term Efficacy and Safety of Symptom-driven Cyclic Rozanolixizumab Treatment in Patients with Generalized Myasthenia Gravis: A Pooled Analysis of a Phase 3 Study and Two Open-label Extension Studies (P1-5.012). Neurology Apr 2023, 100 (17 Supplement 2) 3747; DOI: 10.1212/WNL.0000000000203497
  7. Guidon AC, Muppidi S, Nowak RJ,  et al. Telemedicine visits in myasthenia gravis: expert guidance and the Myasthenia Gravis Core Exam (MG-CE). Muscle Nerve 2021; 64:270-276
  8. Gronseth GS, Barohn R, Narayanaswami P. Practice advisory: Thymectomy for myasthenia gravis (practice parameter update): Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology. 2020;94(16):705. Epub 2020 Mar 25.
  9. Bril V, Benatar M, Andersen H, MG0002 Investigator Study Group, et al. Efficacy and Safety of Rozanolixizumab in Moderate to Severe Generalized Myasthenia Gravis A Phase 2 Randomized Control Trial. Neurology Feb 2021, 96 (6) e853-e865; DOI: 10.1212/WNL.0000000000011108.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

G70.0

Myasthenia gravis

G70.00

Myasthenia gravis without (acute) exacerbation

G70.01

Myasthenia gravis with (acute) exacerbation

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC

 

 

 

 

RYSTIGGO® (rozanolixizumab-noli) Prior Auth Criteria
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