Oscar Ycanth (cantharidin) (PG162) Form

Molluscum contagiosum (molluscum) is a widespread skin infection caused by the molluscum virus, a dermatotropic DNA poxvirus. This condition predominantly affects children and is common worldwide. The infection results in small, flesh-colored papules and papulovesicles, measuring 1-4 mm across, which usually have a distinct umbilicated or dimpled center. These papules are typically not accompanied by much inflammation; however, when an inflammatory response is observed, it often signals the start of disease resolution.

• Although molluscum lesions are generally painless, they might itch or become irritated. Scratching or picking at the bumps can lead to autoinoculation, scarring, or secondary bacterial infections.
• The primary mode of molluscum transmission is through direct person-to-person contact or by autoinoculation. Indirect transmission can occur through touching contaminated items like towels, clothes, or toys.¹

In immunocompetent individuals, molluscum contagiosum often resolves spontaneously within 6 to 12 months. Treatment may be warranted to decrease spread, relieve symptoms, or reduce duration.

Ycanth (cantharidin 0.7% topical solution) is indicated for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

• Ycanth is administered to patients only by health care providers. Providers apply a single application of Ycanth on the areas of patients’ skin with molluscum bumps every 3 weeks as needed.
• Ycanth is for topical use only. Ycanth is not for oral, mucosal, or ophthalmic use.

The safety and efficacy in pediatric patients below the age of 2 years have not been established.

• The safety and efficacy of drug use for longer than 12 weeks has not been established.

Definitions

"Central Umbilication" refers to a characteristic dimple or depression at the center of a lesion or papule.

"Immunocompetent" means having a functional immune system, not weakened by disease or medication.

"Immunosuppression" refers to a state where the immune system is suppressed, either by specific conditions like HIV, medications, or malignancies.

"Molluscum Contagiosum" is a viral skin infection caused by the molluscipox virus resulting in small, raised, typically painless bumps on the skin.

Medical Necessity Criteria for Initial Authorization

The Plan considers Ycanth (cantharidin) medically necessary when ALL of the following criteria are met:

1. The member is 2 years of age or older; AND
2. The member has a diagnosis of molluscum contagiosum; AND
3. IF the member is immunocompetent, documentation does NOT indicate that the member has uncomplicated, mild, non-genital molluscum contagiosum amenable to expectant observation; AND
4. The member is unable to use, or has tried and failed Podofilox 0.5% Topical Solution.

If the above prior authorization criteria are met, Ycanth (cantharidin) will be approved for 12-weeks, up to 4 applications, with repeat applications no more frequently than every 3 weeks.

Medical Necessity Criteria for Reauthorization

Reauthorization for up to 4 additional applications (up to 4 total) will be granted if the member has recent (within the last 6 weeks) clinical documentation demonstrating:

1. Partial response evidenced by reduction in number or size of lesions but with some remaining; AND
2. At least 3 weeks have passed since the last application; AND
3. Total duration of therapy has not exceeded 4 applications.

NOTE: In clinical trials, patients received up to 4 applications of Ycanth at intervals of approximately 21 days. Reauthorization requires evidence of continued benefit and allows retreatment within studied limits.

Experimental or Investigational / Not Medically Necessary

Ycanth (cantharidin) for any other indication or use is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. Non-covered indications include, but are not limited to, the following:

• Condylomata Acuminata, another term for genital warts, referring specifically to the raised, cauliflower-like appearance that these warts can have. They are caused by HPV and are not the same as molluscum contagiosum.
• Genital Warts, warts that appear on the genitalia and are caused by certain strains of HPV. They are not the same as molluscum contagiosum.
• Papilloma Viral Infection, benign tumors that arise from epithelial tissues and are caused by various types of the human papillomavirus (HPV).
• Sexually Transmitted Disease (STD), a broad category of diseases that are primarily transmitted through sexual contact. Both molluscum contagiosum and genital warts (caused by HPV) can be considered STDs, but the term STD includes many other diseases as well, such as chlamydia, gonorrhea, and HIV, to name a few.³
• Verruca (Warts), another term for warts. These are caused by HPV and are distinct from molluscum contagiosum.
• Verruca Vulgaris, i.e., common warts, typically seen on the hands and fingers. They are caused by the human papillomavirus (HPV) and are not the same as molluscum contagiosum.