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Topical Actinic Keratosis, Basal Cell Carcinoma, Genital Warts Agents Prior Authorization with Quantity Limit and Quantity Limit Program Summary

Policy Number: PH-1037

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.

 

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

1/1/2023

FDA APPROVED 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 equivalent available

6

Carac®* 

(fluorouracil)

0.5% Cream 

Topical treatment of multiple actinic or solar keratoses of the face and anterior scalp

 

* –  generic equivalent 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 equivalent available

4

Fluoroplex® 

(fluorouracil)

1% cream 

Topical treatment of multiple actinic (solar) keratoses

 

3

Klisyri® 

(fluorouracil)

1% ointment

Topical treatment of actinic keratosis on the face or scalp

14

Tolak® 

(fluorouracil)

4% cream 

Topical treatment of actinic keratosis lesions of the face, ears, and/or scalp

 

5

Zyclara® 

(fluorouracil)

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

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 equivalent available

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) UpToDate indicates 5-FU and imiquimod as first-line topical therapies, and diclofenac and tirbanibulin as second-line.

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.(11) 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.(11,12)

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.(13,14) The majority of genital warts respond within 3 months of therapy.(14)

REFERENCES                                                                                                                                                                           

Number

Reference

1

Diclofenac 3% gel prescribing information. Glenmark Pharmaceuticals Inc. June 2016.

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. October 2021

5

Tolak prescribing information. Hill Dermaceuticals, Inc. March 2020

6

Aldara prescribing information. Valeant Pharmaceuticals International, Inc. June 2022

7

Zyclara prescribing information. Bausch Health US, LLC. June 2020.

8

Picato prescribing information. LEO Pharma Inc. February 2020. Reference no longer used. 

9

Berman B, et al. Treatment of Actinic Keratosis. UpToDate. Last updated June 2022. Literature review current through June 2022. Accessed July 2022.

10

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Squamous Cell Skin Cancer. Version 2.2022.

11

Aasi SZ, et al. Treatment and Prognosis of Basal Cell Carcinoma at Low Risk of Recurrence. UpToDate. Last updated March 2022. Literature review current through June 2022. Accessed July 2022.

12

National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer. Version 2.2022.

13

Rosen T, et al. Condylomata Acuminata (Anogenital Warts): Management of External Condylomata Acuminata in Men. UpToDate. Last updated April 2022. Literature review current through June 2022. Accessed July 2022.

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

Klisyri prescribing information. Almirall, LLC. December 2020.

 

POLICY AGENT SUMMARY PRIOR AUTHORIZATION

Agent Names

Strength

Targeted MSC

Available MSC

Preferred Status

Effective Date

CARAC*Fluorouracil Cream 0.5%

0.5 %

M ; N ; O ; Y

M

DICLOFENAC*diclofenac sodium (actinic keratoses) gel

3 %

M ; N ; O ; Y

O ; Y

FLUOROPLEX*Fluorouracil Cream 1%

1 %

M ; N ; O ; Y

N

FLUOROURACIL*Fluorouracil Cream 5%

5 %

M ; N ; O ; Y

O ; Y

IMIQUIMOD*Imiquimod Cream 5%

5 %

M ; N ; O

O ; Y

KLISYRI*tirbanibulin ointment

1 %

M ; N ; O ; Y

N

TOLAK*Fluorouracil Cream 4%

4 %

M ; N ; O ; Y

N

ZYCLARA PUMP*Imiquimod Cream 2.5%

2.5 %

M ; N ; O ; Y

N

ZYCLARA*Imiquimod Cream 3.75%

3.75 %

M ; N ; O ; Y

O ; Y

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Agent GPI

Agent Names

Strength

QL Amount

Dose Form

Days Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Effective Date

Quantity Limit

90773040003720

ALDARA*Imiquimod Cream 5%

5 %

48.0

PACKTS

112

Days

90372030003705

CARAC*Fluorouracil Cream 0.5%

0.5 %

30.0

GRAMS

28

Days

903740353040

DICLOFENAC*diclofenac sodium (actinic keratoses) gel

3 %

300.0

GRAMS

90

Days

90372030003730

EFUDEX*Fluorouracil Cream 5%

5 %

240.0

GRAMS

84

Days

90372030003710

FLUOROPLEX*Fluorouracil Cream 1%

1 %

60.0

GRAMS

42

Days

90374580004220

KLISYRI*Tirbanibulin Ointment 1%

1 %

5.0

PACKTS

90

Days

90372030003725

TOLAK*Fluorouracil Cream 4%

4 %

40.0

GRAMS

28

Days

90773040003710

ZYCLARA PUMP*Imiquimod Cream 2.5%

2.5 %

2.0

BOTTS

42

Days

90773040003715

ZYCLARA PUMP*Imiquimod Cream 3.75%

3.75 %

2.0

BOTTS

56

Days

90773040003715

ZYCLARA*Imiquimod Cream 3.75%

3.75 %

56.0

PACKTS

56

Days

Prior Authorization with Quantity Limit

90773040003720

ALDARA*Imiquimod Cream 5%

5 %

0.0

0

Actinic keratoses:

three boxes (36 packets) for up to 16 weeks

External genital and perianal warts (EGW) (condyloma acuminata):

12 packets per month for up to 16 weeks

Superficial basal cell carcinoma:

three boxes (36 packets) for up to 6 weeks

90372030003705

CARAC*Fluorouracil Cream 0.5%

0.5 %

0.0

0

Multiple actinic or solar keratoses:

one 30 gram tube per month for up to 4 weeks

903740353040

DICLOFENAC*diclofenac sodium (actinic keratoses) gel

3 %

0.0

0

Actinic keratoses:

one 100 gram tube per month for up to 90 days

90372030003730

EFUDEX*Fluorouracil Cream 5%

5 %

0.0

0

Multiple actinic or solar keratoses:

one 40 gram tube per month for up to 4 weeks

Superficial basal cell carcinomas:

two 40 gram tubes per month for up to 12 weeks

90372030003710

FLUOROPLEX*Fluorouracil Cream 1%

1 %

0.0

0

Multiple actinic or solar keratoses:

one 30 gram tube per month for up to 6 weeks

90374580004220

KLISYRI*Tirbanibulin Ointment 1%

1 %

0.0

0

Actinic keratoses (face or scalp):

5 packets for up to 90 days

90372030003725

TOLAK*Fluorouracil Cream 4%

4 %

0.0

0

Actinic keratoses:

one 40 gram tube per month for up to 4 weeks

90773040003710

ZYCLARA PUMP*Imiquimod Cream 2.5%

2.5 %

0.0

0

Actinic keratoses:

two 7.5 gm pump bottles for up to 6 weeks

90773040003715

ZYCLARA*Imiquimod Cream 3.75%

3.75 %

0.0

0

Actinic keratoses:

two boxes (56 packets) for up to 6 weeks

two 7.5 gm pump bottles for up to 6 weeks

External genital or perianal warts (EGW) (condyloma acuminata):

two boxes (56 packets) for up to 8 weeks

two 7.5 gm pump bottles for up to 8 weeks

CLIENT SUMMARY – PRIOR AUTHORIZATION

Agent Names

Strength

Client Formulary

CARAC*Fluorouracil Cream 0.5%

0.5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

DICLOFENAC*diclofenac sodium (actinic keratoses) gel

3 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

FLUOROPLEX*Fluorouracil Cream 1%

1 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

FLUOROURACIL*Fluorouracil Cream 5%

5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

IMIQUIMOD*Imiquimod 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 PUMP*Imiquimod Cream 2.5%

2.5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

ZYCLARA*Imiquimod Cream 3.75%

3.75 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Agent Names

Strength

Client Formulary

ALDARA*Imiquimod Cream 5%

5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

ALDARA*Imiquimod Cream 5%

5 %

NetResults A Series

CARAC*Fluorouracil Cream 0.5%

0.5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

CARAC*Fluorouracil Cream 0.5%

0.5 %

NetResults A Series

DICLOFENAC*diclofenac sodium (actinic keratoses) gel

3 %

NetResults A Series

DICLOFENAC*diclofenac sodium (actinic keratoses) gel

3 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

EFUDEX*Fluorouracil Cream 5%

5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

EFUDEX*Fluorouracil Cream 5%

5 %

NetResults A Series

FLUOROPLEX*Fluorouracil Cream 1%

1 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

FLUOROPLEX*Fluorouracil Cream 1%

1 %

NetResults A Series

KLISYRI*Tirbanibulin Ointment 1%

1 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

KLISYRI*Tirbanibulin Ointment 1%

1 %

NetResults A Series

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 PUMP*Imiquimod Cream 2.5%

2.5 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

ZYCLARA PUMP*Imiquimod Cream 2.5%

2.5 %

NetResults A Series

ZYCLARA PUMP*Imiquimod Cream 3.75%

3.75 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

ZYCLARA*Imiquimod Cream 3.75%

3.75 %

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; SourceRx

ZYCLARA*Imiquimod Cream 3.75%

3.75 %

NetResults A Series

PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Prior Authorization with Quantity Limit

Evaluation

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
  2. ONE of the following:
    1. BOTH of the following:
      1. The patient has a diagnosis of actinic (solar) keratoses AND
      2. The requested agent is diclofenac 3% gel, Carac (Fluorouracil) 0.5% cream, Efudex (Fluorouracil) 5% cream, Fluoroplex, Tolak, Aldara, Zyclara (Imiquimod) 3.75% cream, OR Zyclara 2.5% cream OR
    2. BOTH of the following:
      1. The patient has a diagnosis of actinic (solar) keratoses of the face and/or scalp: AND
      2. The requested agent is diclofenac 3% gel, Carac (Fluorouracil) 0.5% cream, Efudex (Fluorouracil) 5% cream, Fluoroplex, Tolak, Aldara, Zyclara (Imiquimod) 3.75% cream, Zyclara 2.5% cream, OR Klisyri OR
    3. BOTH of the following:
      1. The patient has a diagnosis of actinic (solar) keratoses of the trunk and/or extremities: AND
      2. The requested agent is diclofenac 3% gel, Efudex (Fluorouracil) 5% cream, Fluoroplex, OR
    4. BOTH of the following:
      1. The patient has a diagnosis of superficial basal cell carcinoma AND
      2. The requested agent is Aldara OR Efudex (Fluorouracil) 5% cream OR
    5. BOTH of the following:
      1. The patient has a diagnosis of external genital and/or perianal warts (EGW) / condyloma acuminata AND
      2. The requested agent is Aldara OR Zyclara (Imiquimod) 3.75% cream AND
  3. ONE of the following:
    1. For a diagnosis of actinic keratoses or superficial basal cell carcinoma, ONE of the following:
      1. The patient has tried and had an inadequate response to generic imiquimod 5% cream or generic fluorouracil solution OR
      2. The patient has an intolerance or hypersensitivity to therapy with generic imiquimod 5% cream or generic fluorouracil solution OR
      3. The patient has an FDA labeled contraindication to generic imiquimod 5% cream AND generic fluorouracil solution OR
    2. For a diagnosis of external genital warts, ONE of the following:
      1. The patient has tried and had an inadequate response to generic imiquimod 5% cream OR
      2. The patient has an intolerance of hypersensitivity to therapy with generic imiquimod 5% cream OR
      3. The patient has an FDA labeled contraindication to generic imiquimod 5% cream

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.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

QL Standalone

Quantities above the program quantity limit will be approved when ONE of the following is met:

  1. The prescriber has provided information in support of therapy with the requested quantity (dose) and/or duration of therapy for the requested agent

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:

  1. The requested quantity (dose) and/or duration does not exceed the program quantity limit for the requested indication OR
  2. The requested quantity (dose) and/or duration exceeds the program quantity limit AND the prescriber has provided information in support of therapy with the requested quantity (dose) and/or duration of therapy for the intended diagnosis

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

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.

 

 

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.

 

 

 

Commercial _ PS _ Topical Actinic Keratosis, Basal Cell Carcinoma, Genital Warts Agents Prior Authorization with Quantity Limit _ProgSum_ 1/1/2023