Clinical Policy: Spesolimab-sbzo (Spevigo)

Reference Number: CP.PHAR.606
Effective Date: 03.01.23
Last Review Date: 05.26
Line of Business: Commercial, HIM/ICHRA, Medicaid

[Coding Implications](Coding Implications)
[Revision Log](Revision Log)

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.

Description

Spesolimab-sbzo (Spevigo®) is an interleukin-36 receptor antagonist.

FDA Approved Indication(s)

Spevigo is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.

Policy/Criteria

9. Dose does not exceed one of the following (a, b, or c):
   a. IV: 900 mg one time, followed by an optional second 900 mg dose 1 week later if flare symptoms persist;
   b. SC: 600 mg once, followed by maintenance dose of 300 mg every 4 weeks;
   c. Both of the following (i and ii):
   i. Initial dose (IV): 900 mg one time;
   ii. Maintenance dose (SC): 300 mg administered 4 weeks after the IV dose and every 4 weeks thereafter.

Approval duration:

• IV formulation – 1 month
• SC formulation:
  
  • Medicaid/HIM/ICHRA – 12 months
  • Commercial – 6 months or to the member’s renewal date, whichever is longer

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.

II. Continued Therapy

A. Generalized Pustular Psoriasis (must meet all):

Approval duration:

• IV formulation – Not applicable
• SC formulation:
  
  • Medicaid/HIM/ICHRA – 12 months
  • Commercial – 6 months or to the member’s renewal date, whichever is longer

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.

III. Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid, or evidence of coverage documents.

B. Combination use with biological disease-modifying antirheumatic drugs (bDMARDs) or potent immunosuppressants, including but not limited to any tumor necrosis factor (TNF) antagonists [e.g., Cimzia®, Enbrel®, Humira® and its biosimilars, Remicade® and its biosimilars, Simponi®], interleukin agents [e.g., Actemra® (IL-6RA) and its biosimilars, Aplast® (IL-1 blocker), Bimzelx™ (IL-17A and F antagonist), Cosentyx® (IL-17A inhibitor), Ilaris® (IL-1 blocker), Ilumya™ (IL-23 inhibitor), Kevzara® (IL-6RA), Kineret® (IL-1RA), Omvoh® (IL-23 antagonist), Siliq™ (IL-17RA), Skyrizi™ (IL-23 inhibitor), Spevigo® (IL-36 antagonist), Stelara® (IL-12/23 inhibitor) and its biosimilars, Taltz® (IL-17A inhibitor), Tremfya® (IL-23 inhibitor), Janus kinase inhibitors (JAKi) [e.g., Cibinqo®, Olumiant™, Rinvoq®, Xeljanz®/Xeljanz® XR], anti-CD20 monoclonal antibodies [Rituxan® and its biosimilars], selective co-stimulation modulators [Orencia®], integrin receptor antagonists [Entyvio®], tyrosine kinase inhibitors [Sotyktu™], and sphingosine 1-phosphate receptor modulator [Velsipity™] because of the additive

IV. Appendices/General Information

Appendix A: Abbreviation/Acronym Key

bDMARD: biological disease-modifying antirheumatic drug
DRESS: drug reaction with eosinophilia or systemic symptoms
FDA: Food and Drug Administration
GPP: generalized pustular psoriasis
GPPPGA: Generalized Pustular Psoriasis Physician Global Assessment
IV: intravenous
SC: subcutaneous

Appendix B: Therapeutic Alternatives

This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization.

Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic.
*Off-label

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s): severe or life-threatening hypersensitivity to spesolimab-sbzo or any of the excipients in Spevigo, drug reaction with eosinophilia or systemic symptoms (DRESS)
• Boxed warning(s): none reported

Appendix D: General Information

• Initiating or reinitiating SC Spevigo after treatment of a GPP flare with IV Spevigo: Four weeks after treatment of GPP flare with IV Spevigo, initiate or reinitiate SC Spevigo for treatment of GPP at dose of 300 mg administered every 4 weeks. A SC loading dose is not required following treatment of a GPP flare with IV Spevigo.
• Generalized Pustular Psoriasis Physician Global Assessment (GPPPGA) classification on intensity of GPP:
  ○ GPPPGA relied on the clinical assessment of the GPP patient’s skin presentation. The total score is calculated by taking the mean of the three sub-scores: 1) erythema; 2) pustules; and 3) scaling and crusting which were all assessed using a scale score 0 to 4 (0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe).
  ○ The final GPPPGA score:
  ■ 0 (clear defined as no visible pustules): if scores for all three sub-scores are 0
  ■ 1 (almost clear defined as low-density occasional small discrete pustules [noncoalescent]): if 0 < mean < 1.5
  ■ 2 (mild defined as moderate-density grouped discrete small pustules [noncoalescent]): if 1.5 ≤ mean < 2.5
  ■ 3 (moderate defined as high-density pustules with some coalescence): if 2.5 ≤ mean < 3.5
  ■ 4 (severe defined as very-high-density pustules with pustular lakes): if mean ≥ 3.5

V. Dosage and Administration

VI. Product Availability

• Single-dose vial for intravenous infusion: 450 mg/7.5 mL (60 mg/mL)

• Single-dose prefilled syringes: 150 mg/mL, 300 mg/2 mL (150 mg/mL)

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Reviews, Revisions, and Approvals

Important Reminder

This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable.

The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions, and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures.

This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time.

This clinical policy does not constitute medical advice, medical treatment, or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions.

Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan.

This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members, and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services.

Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

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