CurrentWashington State Health Care AuthorityPolicy 66.27.00.AL-1

Cytokine and CAM Antagonists: IL-36 Inhibitors

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Prior authorization and medical-necessity coverage for spesolimab-sbzo (Spevigo) for generalized pustular psoriasis under Washington Apple Health.

Policy Summary

PayerWashington State Health Care Authority

PolicyCytokine and CAM Antagonists: IL-36 Inhibitors

Policy CodePolicy 66.27.00.AL-1

Change TypeNew policy

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation for spesolimab-sbzo (Spevigo), including the applicable clinical criteria.

SourceLink

POLICY UPDATE CHANGES

A new policy for cytokine and CAM antagonist IL-36 inhibitors was created and approved by the DUR Board.

1IL-36 inhibitor covered

12+Minimum patient age

≥40 kgMinimum patient weight

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CurrentWashington State Health Care AuthorityPolicy 66.27.00.AL-1

Cytokine and CAM Antagonists: IL-36 Inhibitors

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Sign up for Washington State Health Care Authority Policy 66.27.00.AL-1 alerts

Get alerted when Policy 66.27.00.AL-1 changes without checking for updates manually.

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Prior authorization and medical-necessity coverage for spesolimab-sbzo (Spevigo) for generalized pustular psoriasis under Washington Apple Health.

Policy Summary

PayerWashington State Health Care Authority

PolicyCytokine and CAM Antagonists: IL-36 Inhibitors

Policy CodePolicy 66.27.00.AL-1

Change TypeNew policy

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation for spesolimab-sbzo (Spevigo), including the applicable clinical criteria.

SourceLink

POLICY UPDATE CHANGES

A new policy for cytokine and CAM antagonist IL-36 inhibitors was created and approved by the DUR Board.

1IL-36 inhibitor covered

12+Minimum patient age

≥40 kgMinimum patient weight

6 monthsInitial authorization

12 monthsReauthorization

J1747Covered HCPCS code

Coverage Criteria

Initial Therapy

Covered when all of the following documented criteria are met, including one of the two clinical pathways below:

ALL of the following

Patient is 12 years of age or older.
Patient's weight is at least 40 kg.
Prescribed by, or in consultation with, a dermatologist.
Diagnosis of generalized pustular psoriasis (GPP).
ONE of the following clinical pathways
- Acute GPP flare
  - Patient is experiencing an acute, moderate-to-severe intensity disease flare.
  - Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score is at least 3.
  - At least 5% body surface area (BSA) is covered with erythema and presence of pustules.
  - Fresh pustules are present.
  - Request is for the intravenous formulation.
- GPP without current flare
  - Patient is not currently experiencing a disease flare.
  - GPPGA total score is 0 or 1.
  - Patient has a history of 2 GPP flares of moderate-to-severe intensity with fresh pustulation within the past year.
  - Request is for the subcutaneous formulation.

Transition to Subcutaneous Therapy

For a patient who previously received intravenous spesolimab-sbzo for a GPP flare, subcutaneous therapy is covered when the following transition criterion is met:

ALL of the following

Patient has previously received a spesolimab-sbzo intravenous infusion for a GPP flare.
Subcutaneous spesolimab-sbzo will be initiated no earlier than four weeks after the most recent infusion.>= 4 weeks after most recent infusion

Reauthorization

Reauthorization requires documentation that all of the following criteria are met:

ALL of the following

Spesolimab-sbzo is not used in combination with another Cytokine and CAM medication.
Documentation demonstrates disease stability or a positive clinical response, such as improvement in body surface area (BSA) or GPPGA score.

Spesolimab-sbzo (Spevigo) must not be used in combination with another Cytokine and CAM medication.

Coding and Clinical Thresholds

Covered HCPCS CodeHCPCSCovered

J1747

Injection, spesolimab-sbzo, 1 mg

Patient age

Minimum age≥ 12 years

Applies toInitial therapy for generalized pustular psoriasis

Authorization period6 months when all criteria are met

Patient weight

Minimum weight≥ 40 kg

Applies toInitial therapy for generalized pustular psoriasis

Authorization period6 months when all criteria are met

Provider Actions and Authorization Risks

Prior Authorization

Prior Authorization Required for Spevigo

Prior authorization is required for spesolimab-sbzo (Spevigo). Approval requires documented medical necessity under the clinical policy; requests that do not meet all criteria may be reviewed case by case.

Applies to Spevigo for generalized pustular psoriasis (GPP).
Initial authorization is for 6 months when all criteria are met.

Step Therapy

Preferred-Drug Trial Required

For a non-preferred new-to-market agent, document an inadequate response or intolerance due to a severe adverse reaction or contraindication to preferred agents on the Apple Health Preferred Drug List (AHPDL).

At least two preferred agents must be tried when two or more preferred agents are available.
If only one preferred agent is available, document inadequate response to that one agent.

Background

Generalized pustular psoriasis (GPP) is a rare inflammatory skin condition characterized by recurrent, sometimes widespread pustules and systemic inflammation. Flares may occur multiple times per year or may be separated by years, and can be associated with withdrawal of systemic corticosteroids. Spesolimab-sbzo has been evaluated for acute moderate-to-severe GPP flares and for prevention of recurrent flares in patients 12 years or older who weigh at least 40 kg.

Definitions

Acute moderate-to-severe GPP flare

GPPGA thresholdTotal score of at least 3

Body surface areaAt least 5% covered with erythema and presence of pustules

Additional clinical findingPresence of fresh pustules

Treatment formulationIntravenous formulation

GPPGA

AbbreviationGPPGA

Full termGeneralized Pustular Psoriasis Physician Global Assessment

Initial Therapy Criteria

Initial GPP Therapy

Spesolimab-sbzo (Spevigo) may be approved when all general criteria and one clinical pathway are met.

General eligibility and clinical pathway

General criteria
- The patient is 12 years of age or older and weighs at least 40 kg.Age ≥ 12 years; weight ≥ 40 kg
- The patient has a diagnosis of generalized pustular psoriasis (GPP).
- The drug is prescribed by, or in consultation with, a dermatologist.
- Spesolimab-sbzo is not used in combination with another cytokine and CAM medication.

Continuation Criteria

Reauthorization

Reauthorization requires all of the following documented criteria.

Continuation criteria

Spesolimab-sbzo is not used in combination with another cytokine and CAM medication.
Documentation demonstrates disease stability or a positive clinical response, such as improvement in body surface area or GPPGA score.

Step Therapy

Step therapy requirement	Documentation required
Non-preferred agent	Document inadequate response or documented intolerance due to a severe adverse reaction or contraindication to at least two preferred agents.
Exception when only one preferred agent is available	Document inadequate response to the one preferred agent.

Quantity Limits and Dosing

Spevigo: acute GPP flare dosing

Dose900 mg

Route and administrationIntravenous infusion over 90 minutes

IndicationTreatment of a GPP flare

Additional doseIf flare symptoms persist, one additional 900 mg IV dose may be administered one week after the initial dose

Spevigo: subcutaneous loading and maintenance dosing

Loading dose600 mg subcutaneously

Follow-up dose300 mg subcutaneously 4 weeks later

Site of Care and Formulation

Billing Rule

Match the formulation to the clinical situation

Use the intravenous formulation for acute GPP flare treatment. Use the subcutaneous formulation when the patient is not currently experiencing a flare; after IV treatment for a flare, initiate subcutaneous therapy no earlier than four weeks after the most recent infusion.

Policy Summary

PayerWashington State Health Care Authority

PolicyCytokine and CAM Antagonists: IL-36 Inhibitors

Policy CodePolicy 66.27.00.AL-1

Change TypeNew policy

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation for spesolimab-sbzo (Spevigo), including the applicable clinical criteria.

SourceLink

On This Page

GPPGA score during acute flare

Minimum GPPGA score≥ 3

Clinical settingAcute, moderate-to-severe disease flare

Required formulationIntravenous formulation

Body surface area during acute flare

Minimum affected area≥ 5% of body surface area

Skin finding 1Erythema

Skin finding 2Presence of pustules

GPPGA score without current flare

Qualifying GPPGA score0 or 1

Clinical settingPatient is not currently experiencing a disease flare

Required formulationSubcutaneous formulation

Prior moderate-to-severe GPP flares

Number of prior flares2

SeverityModerate-to-severe intensity

Time periodWithin the past year

Required flare findingFresh pustulation

Verify current preferred status using the AHPDL.

Documentation Required

Initial Clinical Documentation

Submit initial clinical documentation confirming that the patient is at least 12 years old, weighs at least 40 kg, has GPP, and is prescribed Spevigo by or in consultation with a dermatologist.

Document patient age and weight.
Document the GPP diagnosis.
Identify the prescribing dermatologist or consulting dermatologist.
Document that Spevigo is not being used with another cytokine and CAM medication.
If the patient previously received IV Spevigo for a flare, document that subcutaneous treatment will begin no earlier than 4 weeks after the most recent infusion.

Documentation Required

Document an Acute GPP Flare

For treatment of an acute moderate-to-severe GPP flare, document all required clinical findings and request the intravenous formulation.

GPP Physician Global Assessment (GPPGA) total score of at least 3.
At least 5% body surface area (BSA) covered with erythema and presence of pustules.
Presence of fresh pustules.
Request must be for IV Spevigo.

Documentation Required

Document Flare-Prevention Need

When the patient is not currently experiencing a flare, submit documentation supporting flare prevention and request the subcutaneous formulation.

GPPGA total score of 0 or 1.
History of two moderate-to-severe GPP flares with fresh pustulation within the past year.
Request must be for subcutaneous Spevigo.

Documentation Required

Reauthorization Documentation

For reauthorization, document that the patient is not receiving Spevigo in combination with another cytokine and CAM medication and that treatment has maintained disease stability or produced a positive clinical response.

Examples of response include improvement in BSA or GPPGA score.
Reauthorization is for 12 months when all criteria are met.

Denial Risk

Initial Criteria Failure May Result in Denial

An initial request may be denied when required clinical criteria are not documented or are not met, including age, weight, prescriber specialty, diagnosis, formulation, or flare-status requirements.

The patient must be at least 12 years old and weigh at least 40 kg.
The diagnosis must be GPP and the prescriber must be a dermatologist or work in consultation with one.
The applicable acute-flare or flare-prevention criteria must be satisfied.
Required timing after a prior IV infusion must be documented for subcutaneous initiation.

Denial Risk

Avoid Concurrent Cytokine/CAM Therapy

Do not use Spevigo in combination with another cytokine and CAM medication. Concurrent therapy creates a denial risk for both initial authorization and reauthorization.

Document that no other cytokine and CAM medication is being used concurrently.

Denial Risk

No Documented Response: Reauthorization Risk

Reauthorization may be denied when the record does not demonstrate disease stability or a positive clinical response to Spevigo.

Submit objective follow-up findings, such as improvement in BSA or GPPGA score.
Document ongoing clinical benefit before requesting continued therapy.

Use in this policyTotal score used to assess GPP flare severity and treatment eligibility

ONE of the following clinical pathways

Acute flare pathway
- The patient is experiencing an acute, moderate-to-severe intensity GPP flare confirmed by a GPPGA total score of at least 3.GPPGA ≥ 3
- At least 5% of body surface area is covered with erythema and pustules.BSA ≥ 5% with erythema and pustules
- Fresh pustules are present.
- The request is for the intravenous formulation.
Non-flare prevention pathway
- The patient is not currently experiencing a GPP flare.
- The GPPGA total score is 0 or 1.GPPGA 0 or 1
- The patient has a history of 2 moderate-to-severe GPP flares with fresh pustulation within the past year.2 flares within the past year
- The request is for the subcutaneous formulation.

Maintenance dose300 mg subcutaneously every 4 weeks thereafter

IndicationTreatment of GPP when the patient is not experiencing a flare

Spevigo: maintenance dosing after IV administration

Timing after IV administrationFour weeks after IV Spevigo administration

Maintenance dose300 mg subcutaneously

FrequencyEvery 4 weeks