CurrentUnitedHealthcarePolicy 2025 P 2341-3

Spevigo® (spesolimab-sbzo) injection - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Defines UnitedHealthcare Commercial Plans prior authorization and medical necessity criteria for subcutaneous Spevigo for treatment and prevention of generalized pustular psoriasis (GPP) in patients ≥12 years and ≥40 kg, including initial authorization, reauthorization, combination-use exclusions, prescriber requirements, and duration of approval.

Policy Summary

PayerUnitedHealthcare

PolicySpevigo® (spesolimab-sbzo) injection - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 2341-3

Change TypeAdded / Revised / Updated

Effective DateJan 1, 2026

Next Review Date

Key ActionPrior authorization required for subcutaneous Spevigo; submit documentation supporting diagnosis, claims history or medical records, and prescriber attestation as specified; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

Program effective date set to 1/1/2026 and applies to subcutaneous formulations of Spevigo.

Revised diagnostic criteria per consensus guidelines.

Updated combination use language (exclusion of concomitant targeted immunomodulators).

Added coverage criteria for self- or caregiver-administered subcutaneous loading dose.

12+ / ≥40 kgCovered population age/weight

12 monthsAuth duration

≥3 / ≥2 / ≥5%

Flare criteria (GPPPGA / pustulation / BSA)

Covered w/ criteriaCoverage stance

Coverage Summary

Spevigo (spesolimab-sbzo) is indicated for generalized pustular psoriasis (GPP) and the policy applies to subcutaneous formulations for patients aged ≥12 years and weighing ≥40 kg under UnitedHealthcare Commercial plans; overall coverage stance is covered_with_criteria.

Quick facts & thresholds

Age & weight requirementPatients ≥ 12 years and weighing at least 40 kg

Authorization durationAuthorization will be issued for 12 months

Acceptable flare criteria - GPPPGA total>= 3 (moderate)

Acceptable flare criteria - GPPPGA pustulation subscore>= 2 (mild)

Acceptable flare criteria - Body surface area>= 5% BSA for erythema and pustules

Acceptable flare criteria - Clinical worseningNew appearance or worsening of pustules

Initial Therapy Criteria

Initial Authorization

Spevigo will be approved based on all of the following criteria:

ALL of the following

Diagnosis of generalized pustular psoriasis (GPP) based on both of the following
- Presence of primary, sterile, macroscopically visible pustules on erythematous base
- Pustulation is not restricted to the acral region or within psoriatic plaques
ALL of the following
- Used to prevent GPP flares

Continuation / Reauthorization Criteria

Reauthorization

Spevigo will be approved for reauthorization based on all of the following criteria:

Documentation of positive clinical response to therapy

Examples include preventing flares, reducing frequency of flares, prolonging time between flares, controlling signs and symptoms of GPP such as pustules, erythema, pain, itching

Reduction in the utilization of therapy used for GPP flares (e.g., intravenous Spevigo)

Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication

Examples include Enbrel (etanercept), Cimzia (certolizumab), Simponi (golimumab), Orencia (abatacept), adalimumab, Xeljanz (tofacitinib), Olumiant (baricitinib), Rinvoq (upadacitinib), ustekinumab, Skyrizi (risankizumab)

Prescribed by a dermatologist

Exclusions and Combination-use Restrictions

Spevigo must not be used in combination with another targeted immunomodulator for treatment of the same indication; informational examples include Enbrel, Cimzia, Simponi, Orencia, adalimumab, Xeljanz, Olumiant, Rinvoq, ustekinumab, Skyrizi, but these examples are informational and not an exhaustive list.

Applicable Codes

Diagnosis codes referencedICD-10

No codes listed

Combination immunomodulator examples (informational)mixed

Enbrel	etanercept (example targeted immunomodulator not permitted in combination)
Cimzia	certolizumab
Simponi	golimumab
Orencia	abatacept
adalimumab	adalimumab
Xeljanz	tofacitinib
Olumiant	baricitinib
Rinvoq	upadacitinib
ustekinumab	ustekinumab
Skyrizi	risankizumab

Provider Actions / Operational Requirements

Prior Authorization

Prior authorization required

Prior authorization required for subcutaneous Spevigo; initial and reauthorization approvals issued for 12 months; documentation must support criteria including diagnosis, claims history or medical records, and prescriber attestation as specified.

Initial and reauthorization approval duration: 12 months
Required documentation: diagnosis consistent with GPP criteria, claims history or medical records documenting therapy (date and duration), and prescriber attestation

Documentation Required

Document current therapy and samples

For patients documented as currently on Spevigo, submit claims history or medical records with date and duration of therapy; prescribers must document that patient did not use manufacturer samples or assistance programs to establish current use if claiming current user status.

Clinical Evidence & References

Key evidence includes the NEJM trial "Trial of Spesolimab-sbzo for Generalized Pustular Psoriasis" (2021) and the Spevigo package insert (Boehringer Ingelheim, May 2025). Initial and reauthorization criteria align with consensus diagnostic definitions and the clinical trial evidence as described in the background and references.

Background and Definitions

Spevigo is an IL-36 receptor antagonist indicated for treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients ≥12 years and weighing ≥40 kg; the policy applies to subcutaneous formulations. Initial and reauthorization criteria are aligned with consensus diagnostic definitions and clinical trial evidence.

GPPPGA: Generalized Pustular Psoriasis Physician Global Assessment

Revision History

5/2024material

P&T Approval: New prior authorization/medical necessity program established for subcutaneous Spevigo (program number 2025 P 2341-3).

5/2025material

P&T Approval / Annual review: Revised diagnostic criteria per consensus guidelines and updated combination-use language (exclusion of concomitant targeted immunomodulators).

10/2025material

P&T Approval: Added coverage criteria for self- or caregiver-administered subcutaneous loading dose; updated references.

Policy Summary

PayerUnitedHealthcare

PolicySpevigo® (spesolimab-sbzo) injection - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2025 P 2341-3

Change TypeAdded / Revised / Updated

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Patient is not currently experiencing a GPP flare

ONE of

Established on therapy under active UnitedHealthcare medical benefit: Patient has been established on therapy with Spevigo for GPP under an active UnitedHealthcare medical benefit prior authorization
Current user documented: Patient is currently on Spevigo therapy for GPP as documented by claims history or submission of medical records (Document date and duration of therapy) AND patient has not received a manufacturer supplied sample at no cost in the prescriber's office, or via manufacturer's patient assistance programs as a means to establish as a current user of Spevigo
New to Spevigo with prior flares: Patient has not previously been treated with Spevigo AND during the previous 12 months prior to initiating subcutaneous Spevigo the patient has had one or more moderate to severe GPP flares based on specified clinical criteria AND prescriber attests that the patient has experienced flares of a severity and/or frequency such that they would clinically benefit from prophylactic therapy with subcutaneous Spevigo

Patient is not receiving Spevigo in combination with another targeted immunomodulator for treatment of the same indication

Prescribed by a dermatologist

(If patient is new to Spevigo, the qualifying flare criteria for prior 12 months are one or more of: GPPPGA total score >= 3 (moderate); GPPPGA pustulation subscore >= 2 (mild); erythema and pustules cover >= 5% BSA; new appearance or worsening of pustules)GPPPGA total >= 3; pustulation subscore >= 2; >=5% BSA

Prescriber must attest clinical benefit from prophylactic therapy

Submit claims history or medical records documenting date and duration of Spevigo therapy
Prescriber must attest that patient did not receive manufacturer-supplied samples or assistance program products to establish current use

Denial Risk

Combination therapy exclusion

Claims may be denied if patient is receiving Spevigo in combination with another targeted immunomodulator for the same indication.

Risk of claim denial if combined with a targeted immunomodulator for the same indication (examples listed in policy)

Documentation Required

Prescriber specialty requirement

Prescriptions must be written by a dermatologist.

Prescriptions must be written by a dermatologist

Billing Rule

Automated approval possibility and supply limits

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; supply limits may apply.

Automated approvals may be based on claims history, ICD-10 diagnosis codes, and claim logic
Supply limits may apply

1/1/2026administrativeLatest

Effective Date: Program effective 1/1/2026; prior authorization criteria apply to subcutaneous formulations of Spevigo.