Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Cantharidin (e.g., Ycanth)

Description:

Cantharidin (e.g., Ycanth) is a topical solution indicated for the treatment of molluscum contagiosum in adults and pediatric individuals 2 years and older. It should only be administered by healthcare providers who have undergone training in the preparation and administration process. This drug-within-applicator product is the first FDA-approved formulation of cantharidin. Prior to FDA approval, compounded cantharidin product has been used topically to treat molluscum contagiosum lesions in provider’s offices.

The topical cantharidin solution is a vesicant produced by beetles in the order of Coleoptera (blister beetles or Spanish fly). When applied topically, cantharidin is absorbed by the lipid layers of epidermal cell membranes and causes activation or release of neutral serine proteases. These serine proteases cause acantholysis (loss of coherence between epidermal cells) and lysis of the infected skin.

Molluscum contagiosum (MC) is a viral infection that primarily affects children, immunocompromised individuals, and sexually active adults. It is caused by a poxvirus, and results in a skin disease characterized by lesions that may appear anywhere on the body. Direct person-to-person physical contact or contact through contaminated fomites spreads the disease. In immunocompetent individuals the disease is often self-limiting, but complications such as pain, itching, concomitant bacterial infection, underlying atopic dermatitis, genital lesions or infection in immunocompromised individuals may prompt the decision to initiate therapy. Choice of treatment is often based on patient-specific factors and treatment options include physical removal (cryotherapy, curettage, laser), topical therapy (cantharidin, retinoids, potassium hydroxide, podophyllotoxin, imiquimod, salicylic acid), and oral therapy (cimetidine).

Regulatory Status

Cantharidin (e.g., Ycanth) was approved by the U.S. Food and Drug Administration (FDA) on July 21, 2023, for the topical treatment of MC in adult and pediatric individuals 2 years of age and older. Ycanth is the first FDA-approved medication for this condition. Ycanth is a drug-device product that delivers the topical solution via a single-use applicator and must be administered by a healthcare provider.

Coding

See CPT/HCPCS Code section below.

Policy/
Coverage:

Prior Approval is required for cantharidin (e.g., Ycanth).

This policy does not address the use of the compounded cantharidin solution.

Effective Date May 15, 2024

Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria

Cantharidin (e.g., Ycanth) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when ALL the following criteria are met:

STANDARD REVIEW for up to 6 months:

1. Individual is 2 years of age or older (Ycanth, 2023); AND

2. Individual is diagnosed with molluscum contagiosum (Ycanth, 2023); AND

3. Cantharidin (e.g., Ycanth) is prescribed and administered by a dermatologist (including nurse practitioners and physician assistants working in a dermatology practice) (Hebert, 2023); AND

4. Lesions have not been treated with cantharidin in the past and use will be limited to maximum of 4 treatment cycles per infection (maximum of 8 applicators for approval duration) (Eichenfield, 2021); AND

5. Individual meets one of the following:

a. Individual is either immunocompromised, has a concomitant bacterial infection or concomitant atopic dermatitis (Herbert, 2023); OR

b. Infection is resulting in severe symptoms of pain or pruritus that are disturbing to normal activities of living (Herbert, 2023); OR

c. Infection is in area where lesions cannot be reasonably covered and there is a concern for contagion (Herbert, 2023); OR

d. Infection has not resolved one year after diagnosis, with or without conventional therapy (Herbert, 2023); AND

6. Must be dosed in accordance with the FDA label.

Dosage and Administration

Dosing per FDA Guidelines

The recommended dose of cantharidin (e.g., Ycanth) is maximum of two applicators per treatment session. Treatment sessions may be repeated every 3 weeks as needed for up to a maximum of 4 treatment sessions.

Cantharidin (e.g., Ycanth) is available as a single-use topical solution applicator.

Cantharidin (e.g., Ycanth) should be administered as a topical solution by a healthcare professional.

Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Cantharidin (e.g., Ycanth), for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For members with contracts without primary coverage criteria, cantharidin (e.g., Ycanth), for any indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Rationale:

The safety and efficacy of cantharidin were evaluated in two identical phase 3, randomized, double-blind trials (CAMP-1 and CAMP-2). Participants were 2 years of age and older and diagnosed with molluscum contagiosum (MC). Participants were randomized by household to receive one of the following via topical administration to all baseline and new lesions once every 21 days until clear or for a maximum of 4 applications (on Days 1, 21, 42, and 63): cantharidin or vehicle (placebo). The primary endpoint was the proportion of individuals achieving complete clearance of all treated MC lesions on Day 84. Secondary endpoints were the proportion of individuals achieving complete clearance of all treated MC lesions at Day 63, 42, and 21. Both trials met the primary endpoint of complete clearance of all treatable MC lesions. In the combined study population, complete clearance of all MC lesions at Day 84 occurred in 50% of individuals in the cantharidin group and in 15.6% of individuals in the vehicle group (P <0.0001).

CPT/HCPCS:

Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2025 American Medical Association.