CurrentCignaPolicy N/A

Topical Collagenase (Santyl) Drug Quantity Management

Cigna drug quantity management policy governing maximum per-prescription quantities and coverage criteria for Santyl (collagenase santyl ointment 250 units/gram) for health benefit plans administered by Cigna companies; includes retail and home delivery quantity limits, approval criteria, exclusions, and review dates.

Policy Summary

PayerCigna

PolicyTopical Collagenase (Santyl) Drug Quantity Management

Policy CodePolicy N/A

Change TypeAnnual review — no criteria changes

Effective Date

Next Review Date

Key ActionIf requested quantity exceeds the Drug Quantity Management retail/home-delivery limits, document wound area (>25 cm2) or frequency of application to justify approval up to specified exception maximums; approvals are for 1 year.

POLICY UPDATE CHANGES

Annual Revision, Review Date = 10/02/2024; summary indicates No criteria changes.

Prior annual revision review date = 09/27/2023; No criteria changes.

180 gRetail max per Rx

540 gHome delivery max per Rx

540 g / 1,620 gException max (retail/home)

>25 cm2Wound area threshold

Coverage Summary

covered_with_criteria — Santyl product(s) is(are) covered as medically necessary when the following criteria is(are) met. Any other exception is considered not medically necessary. This policy governs retail and home delivery quantity limits for Santyl (collagenase santyl ointment 250 units/gram) for Cigna-administered health benefit plans and applies Drug Quantity Management per Rx.

Apply the Drug Quantity Management rule at point of service. Retail maximum per Rx = 180 grams and home delivery maximum per Rx = 540 grams. If the Drug Quantity Management rule is not met, coverage may be approved when the patient is treating wound area(s) > 25 cm2 or treating more frequently than once daily, with exception approval limits up to 540 grams per dispensing at retail or 1,620 grams per dispensing at home delivery.

Medically Necessary Criteria / Quantity Overrides

Santyl product(s) is(are) covered as medically necessary when the following criteria is(are) met. Any other exception is considered not medically necessary.

Exception for larger wounds or more frequent dosing: If patient is treating a wound area(s) greater than 25 cm2 OR treating more frequently than once daily, approve the requested quantity not to exceed 540 grams per dispensing at retail or 1,620 grams per dispensing at home delivery.>25 cm2; retail ≤ 540 g; home delivery ≤ 1,620 g
Approval duration: 1 year

ref(): "b0_1"

title": "Medically Necessary Criteria / Quantity Overrides"

ref":

Drug Quantity Management Rule (Default)

Drug Quantity Management Rule (default)

Apply Drug Quantity Management rule at point of service; if rule not met, coverage determined by criteria above.

Retail maximum quantity per Rx = 180 grams.180 grams
If rule met (i.e., request <= 180 g retail), coverage proceeds without exception per program intent.
Home delivery maximum quantity per Rx = 540 grams.540 grams
If rule met (i.e., request <= 540 g home delivery), coverage proceeds without exception per program intent.

ref": "b1_0"

title":

Surface thresholds

Wound area threshold> 25 cm2

Retail maximum per Rx180 grams

Home delivery maximum per Rx540 grams

Exception approval maximumsRetail up to 540 grams per dispensing; Home delivery up to 1,620 grams per dispensing

Provider Actions & Billing Rules

Prior Authorization

Quantity limit overrides require criteria

If requested quantity exceeds the Drug Quantity Management retail/home-delivery limits, provider must document that patient is treating wound area(s) > 25 cm2 or treating more frequently than once daily to justify approval up to specified exception maximums; approvals are for 1 year.

Documentation Required

Clinical documentation of wound size and frequency

Providers must document wound area in cm2 and frequency of application to support exception requests (e.g., wound >25 cm2 or application more than once daily).

Document wound area in cm2 and frequency of application

Billing Rule

Dispensing quantity limits

Do not dispense quantities exceeding retail maximum 180 g per Rx or home delivery maximum 540 g per Rx unless approved under exception criteria; exception approvals permit retail up to 540 g and home delivery up to 1,620 g per dispensing.

Retail up to 540 g; Home delivery up to 1,620 g (when exception approved)

Background & Clinical References

Santyl (collagenase santyl ointment 250 units/gram) is a sterile enzymatic debriding ointment indicated for debriding chronic dermal ulcers and severely burned areas. It is available in 30g and 90g tubes. According to the manufacturer dosing calculator, 128 g of ointment will cover one 25 cm2 wound for 30 days when applied once daily.

Manufacturer prescribing information: Collagenase Santyl ointment [prescribing information], Smith & Nephew, May 2019

Dosing calculator reference: Santyl Dosing Calculator (128 g covers one 25 cm2 wound for 30 days)