CurrentCignaPolicy IP0470

Collagenase (Santyl) ointment — Coverage Policy

Defines medical necessity, authorization, and reauthorization criteria for topical collagenase (Santyl) ointment for treatment of chronic dermal ulcers and severely burned areas for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCollagenase (Santyl) ointment — Coverage Policy

Policy CodePolicy IP0470

Change TypeNo material changes

Effective DateJan 1, 2023

Next Review DateJan 1, 2024

Key ActionObtain prior authorization and document that the patient is being treated for debridement of chronic dermal ulcers or severely burned areas; approvals may be for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

up to 12 monthsinitial approval duration

up to 12 monthsreauthorization approval duration

once dailytypical dosing frequency

250 units/gcollagenase concentration

Coverage and Medical Necessity Criteria

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inv-01: Medical Necessity Criteria - Initial

Covered when ALL of the following are met

Initial medical necessity for collagenase: Individual is being treated for debridement of chronic dermal ulcers and severely burned areas.

Dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence; adjust based on severity, alternative treatments, and prior response.

Initial Therapy

inv-10: Initial Therapy

Initial coverage criteria and usage guidance

Initial therapy: Used for debridement of chronic dermal ulcers and severely burned areas; apply once daily or more frequently if dressings become soiled. Dose and duration should be clinically appropriate and supported by evidence and prior response.

Manufacturer example: a 3 x 3 inch wound applied once daily for 30 days may require ~180 grams.

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for topical collagenase (Santyl) prior to initiation of therapy. When medical necessity criteria are met, initial authorization may be approved for up to 12 months. Reauthorization may be approved for up to 12 months when reauthorization criteria are met (documentation of beneficial response and continued fulfillment of initial criteria).

Initial approval duration: up to 12 months
Reauthorization approval duration: up to 12 months
Prior authorization required before therapy initiation

Step Therapy

No step therapy requirements apply to topical collagenase (Santyl) under this policy.

Documentation Required

Providers must document the diagnosis and clinical justification for debridement with topical collagenase. For initial requests, include documentation that the individual is being treated for debridement of chronic dermal ulcers or severely burned areas and that other standard wound care options were considered as appropriate. For reauthorization, provide documentation of a beneficial clinical response to therapy and continued need, along with any relevant wound assessments, treatment dates, and prior authorization reference.

Document the condition: treatment is for debridement of chronic dermal ulcers or severely burned areas
For initial requests, include clinical rationale and prior wound care measures
For reauthorization, document beneficial response and ongoing need, include wound assessments and treatment dates

Background and Indications

Collagenase (Santyl) ointment is a sterile enzymatic debriding ointment containing 250 collagenase units per gram in a white petrolatum base, indicated for debridement of chronic dermal ulcers and severely burned areas. It is typically applied once daily and may be applied more frequently if dressings become soiled; dose and duration should be clinically appropriate and supported by evidence and prior response.

Product Definition

Collagenase Santyl Ointment — Definition

Generic nameCollagenase (Santyl) ointment

DescriptionA sterile enzymatic debriding ointment containing 250 collagenase units per gram of white petrolatum USP.

IndicationsDebridement of chronic dermal ulcers and severely burned areas.

Typical application frequencyApply once daily or more frequently if dressings become soiled.

Manufacturer concentration250 collagenase units per gram