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Topical Actinic Keratosis, Basal Cell Carcinoma, Genital Warts Agents Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-91037
The prior authorization with quantity limit program applies to Blue Partner, Commercial, GenPlus, SourceRx, and Health Insurance Marketplace formularies.
The quantity limit program applies to NetResults A series formulary.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
01-01-2025 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Aldara® (imiquimod) 5% cream* |
Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults Topical treatment of biopsy-confirmed primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured Treatment of external genital and perianal warts (condyloma acuminata) in patients 12 years or older |
*generic available |
6 |
Carac® (fluorouracil) 0.5% cream* |
Topical treatment of multiple actinic or solar keratoses of the face and anterior scalp
|
*generic available |
2 |
diclofenac 3% gel |
Topical treatment of actinic keratosis (AK)
|
|
1 |
Efudex® (fluorouracil) 5% cream* |
Topical treatment of multiple actinic or solar keratoses Treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites |
*generic available |
4 |
Fluoroplex® (fluorouracil) 1% cream |
Topical treatment of multiple actinic (solar) keratoses
|
|
3 |
KLISYRI® (tirbanibulin) 1% ointment |
Topical treatment of actinic keratosis on the face or scalp |
|
8 |
Tolak® (fluorouracil) 4% cream |
Topical treatment of actinic keratosis lesions of the face, ears, and/or scalp
|
|
5 |
Zyclara® (imiquimod) 3.75% cream* |
Topical treatment of clinically typical visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults Treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older |
*generic available |
7 |
Zyclara® (imiquimod) 2.5% cream |
Topical treatment of clinically typical visible or palpable actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults |
|
7 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Actinic Keratosis (AK) |
Actinic keratoses (AK or solar keratoses) are keratotic or scaling macules, papules, or plaques resulting from the intraepidermal proliferation of atypical keratinocytes in response to prolonged exposure to ultraviolet radiation.(9) Although most AKs do not progress to squamous cell carcinoma (SCC), AKs are a concern because the majority of cutaneous SCCs arise from pre-existing AKs and AKs that will progress to SCC cannot be distinguished from AKs that will spontaneously resolve or persist.(9,10) According to NCCN guidelines, topical first-line therapies for AK include 5-fluorouracil (5-FU), imiquimod, and tirbanibulin. Topical diclofenac is considered 2B (based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate) due to varying efficacy results across large randomized trials.(10) 5-FU and imiquimod are considered as first-line topical therapies, and diclofenac and tirbanibulin as second-line.(15) |
Superficial Basal Cell Carcinoma (BCC) |
Basal cell carcinoma (BCC) is a common skin cancer that arises from the basal layer of epidermis and its appendages. Although rarely metastatic, BCC can produce substantial local destruction along with disfigurement and may involve extensive areas of soft tissue, cartilage, and bone. First-line therapy is surgical excision, however for some patients with low-risk superficial BCC, where surgery is contraindicated or impractical, topical therapies such as 5-fluorouracil (5-FU) or imiquimod may be considered, even though the cure rate may be lower.(12) |
Genital Warts |
Condylomomata acuminata, also known as anogenital warts or external genital / perianal warts (EGW), are a manifestation of anogenital human papillomavirus (HPV) infection. The treatment of genital warts should be guided by the extent of disease (e.g., wart size, number, and anatomic site), patient preference, cost and availability of treatment, and the experience of the health care provider. Patient-applied therapies include imiquimod 3.75% and 5%, and podophyllotoxin. The majority of genital warts respond within 3 months of therapy.(14) |
REFERENCES
Number |
Reference |
1 |
Diclofenac 3% gel prescribing information. Glenmark Pharmaceuticals Inc. July 2023. |
2 |
Carac 0.5% cream prescribing information. Bausch Health US, LLC. May 2021. |
3 |
Fluoroplex prescribing information. Almirall, LLC. March 2022. |
4 |
Efudex prescribing information. Bausch Health Companies Inc. March 2024. |
5 |
Tolak prescribing information. Hill Dermaceuticals, Inc. August 2022. |
6 |
Aldara prescribing information. Valeant Pharmaceuticals International, Inc. October 2023. |
7 |
Zyclara prescribing information. Bausch Health US, LLC. January 2024. |
8 |
Klisyri prescribing information. Almirall, LLC. August 2021. |
9 |
Criscione VD, Weinstock MA, et al. Actinic keratoses: Natural history and risk of malignant transformation in the Veterans Affairs Topical Tretinoin Chemoprevention Trial. Cancer 2009; 115:2523. |
10 |
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Squamous Cell Skin Cancer. Version 1.2024. |
11 |
Reference no longer used. |
12 |
National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer. Version 3.2024. |
13 |
Refernce no longer used. |
14 |
Workowski KA, Bachmann LH, Chan PA, et al. Centers for Disease Control and Prevention (CDC) Treatment Guidelines on Sexually Transmitted Diseases. MMWR. 2021;70(4):1-187. |
15 |
Eisen DB, Asgari MM, Bennett DD, et al. Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol 2021; 85:e209. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
|
diclofenac sodium (actinic keratoses) gel |
3 % |
M ; N ; O ; Y |
Y |
|
|
Carac |
Fluorouracil Cream 0.5% |
0.5 % |
M ; N ; O ; Y |
M ; N |
|
|
|
Fluorouracil Cream 1% |
|
M ; N ; O ; Y |
|
|
|
Tolak |
Fluorouracil Cream 4% |
4 % |
M ; N ; O ; Y |
N |
|
|
Efudex |
Fluorouracil Cream 5% |
5 % |
M ; N ; O ; Y |
O ; Y |
|
|
Zyclara pump |
Imiquimod Cream 2.5% |
2.5 % |
M ; N ; O ; Y |
N |
|
|
Zyclara ; Zyclara pump |
Imiquimod Cream 3.75% |
3.75 % |
M ; N ; O ; Y |
O ; Y |
|
|
|
Imiquimod Cream 5% |
5 % |
M ; N ; O |
Y |
|
|
Klisyri |
tirbanibulin ointment |
1 % |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Quantity Limit |
|||||||||
|
diclofenac sodium (actinic keratoses) gel |
3 % |
300 |
Grams |
90 |
DAYS |
|
|
|
|
Fluorouracil Cream 1% |
|
60 |
Grams |
42 |
DAYS |
|
|
|
|
imiquimod cream |
5 % |
48 |
Packets |
112 |
DAYS |
|
|
|
Carac |
Fluorouracil Cream 0.5% |
0.5 % |
30 |
Grams |
28 |
DAYS |
|
|
|
Efudex |
Fluorouracil Cream 5% |
5 % |
240 |
Grams |
84 |
DAYS |
|
|
|
Klisyri |
tirbanibulin ointment |
1 % |
5 |
Packets |
90 |
DAYS |
|
|
|
Tolak |
Fluorouracil Cream 4% |
4 % |
40 |
Grams |
28 |
DAYS |
|
|
|
Zyclara ; Zyclara pump |
imiquimod cream |
3.75 % |
2 |
Bottles |
56 |
DAYS |
|
|
|
Zyclara ; Zyclara pump |
Imiquimod Cream 3.75% |
3.75 % |
56 |
Packets |
56 |
DAYS |
|
|
|
Zyclara pump |
Imiquimod Cream 2.5% |
2.5 % |
2 |
Bottles |
42 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
|
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
|
diclofenac sodium (actinic keratoses) gel |
3 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
|
Fluorouracil Cream 1% |
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
|
Imiquimod Cream 5% |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Carac |
Fluorouracil Cream 0.5% |
0.5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Efudex |
Fluorouracil Cream 5% |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Klisyri |
tirbanibulin ointment |
1 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Tolak |
Fluorouracil Cream 4% |
4 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Zyclara ; Zyclara pump |
Imiquimod Cream 3.75% |
3.75 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
Zyclara pump |
Imiquimod Cream 2.5% |
2.5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
|
diclofenac sodium (actinic keratoses) gel |
3 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
diclofenac sodium (actinic keratoses) gel |
3 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
Fluorouracil Cream 1% |
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
Fluorouracil Cream 1% |
|
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
imiquimod cream |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
|
Imiquimod Cream 5% |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Carac |
Fluorouracil Cream 0.5% |
0.5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Carac |
Fluorouracil Cream 0.5% |
0.5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Efudex |
Fluorouracil Cream 5% |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Efudex |
Fluorouracil Cream 5% |
5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Klisyri |
Tirbanibulin Ointment |
1 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Klisyri |
tirbanibulin ointment |
1 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Tolak |
Fluorouracil Cream 4% |
4 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Tolak |
Fluorouracil Cream 4% |
4 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zyclara ; Zyclara pump |
imiquimod cream |
3.75 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zyclara ; Zyclara pump |
Imiquimod Cream 3.75% |
3.75 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zyclara ; Zyclara pump |
Imiquimod Cream 3.75% |
3.75 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zyclara pump |
Imiquimod Cream 2.5% |
2.5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zyclara pump |
Imiquimod Cream 2.5% |
2.5 % |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
PA |
Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: Up to duration in the program quantity limit for the requested indication; or durations above program quantity limit with appropriate supportive information for up to 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL Standalone |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
QL with PA |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to duration in the program quantity limit for the requested indication; or durations above program quantity limit with appropriate supportive information for up to 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CSReg _ Topical_Actinic_Keratosis_Basal_Cell_Carcinoma_Genital_Warts_Agents_PAQL _ProgSum_ 01-01-2025 _ © Copyright Prime Therapeutics LLC. November 2024 All Rights Reserved