SOLARAZE (diclofenac)
SELF ADMINISTRATION - TOPICAL
Diagnosis considered for coverage:
- Indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy
Coverage Criteria:
For diagnosis of actinic keratosis:
- Quantity requested does not exceed 100 grams per 30 day supply, AND
- Patient is 18 years of age or older, AND
- Patient has a diagnosis of actinic keratosis as confirmed by chart note documentation, AND
- Patient has failed or is not a good candidate for liquid nitrogen cryotherapy and surgical curettage, AND
- Patient has tried and failed topical imiquimod 5% or fluorouracil 5%
Coverage Duration:
- 3 months
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- Recommended dose: apply to lesion areas twice daily for 60 days to 90 days
- Lesions that do not respond to therapy should be carefully re-evaluated and management reconsidered
- Contraindications:
- Patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium
- In the setting of coronary artery bypass graft (CABG) surgery
- Black Box Warnings:
- Cardiovascular Thrombotic Events
- Additional warning for heart failure and edema
- Use with caution in patients with active gastrointestinal ulceration or bleeding and severe renal or hepatic impairments
- Solaraze® should not be applied to open skin wounds, infections, or exfoliative dermatitis
- Solaraze® should not be allowed to come in contact with the eyes
Policy Updates:
- 06/05/2017 – Criteria reviewed
- 10/12/2020 – Annual review. Format updated
- 06/15/2021 – Criteria updated. Format updated. Added quantity limit, chart note documentation, and trial and failure of imiquimod
References:
- Solaraze [package insert]. Melville (NY): PharmaDerm; 2016.
Last review date: June 15, 2021