08/13/2020 1 Drug/Drug Class Topical Immunomodulators Clinical Criteria Information Included in this Document Elidel and Protopic 0.03% Protopic 0.1% Eucrisa Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical criteria rules Logic diagram: a visual depiction of the clinical criteria logic Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes) References: clinical publications and sources relevant to this clinical criteria
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08/13/2020 1
Drug/Drug Class
Topical Immunomodulators Clinical Criteria Information Included in this Document
Elidel and Protopic 0.03%
Protopic 0.1%
Eucrisa
Drugs requiring prior authorization: the list of drugs requiring prior authorization for this clinical criteria
Prior authorization criteria logic: a description of how the prior authorization request will be evaluated against the clinical criteria rules
Logic diagram: a visual depiction of the clinical criteria logic
Supporting tables: a collection of information associated with the steps within the criteria (diagnosis codes, procedure codes, and therapy codes)
References: clinical publications and sources relevant to this clinical criteria
Prior Authorization Topical Immunomodulators
Elidel and Protopic 0.03%
08/13/2020 2
Drugs Requiring Prior Authorization
The listed GCNS may not be an indication of TX Medicaid Formulary coverage. To learn the current formulary coverage, visit TxVendorDrug.com/formulary/formulary-search.
Label Name GCN
ELIDEL 1% CREAM 15348
PROTOPIC 0.03% OINTMENT 12289
TACROLIMUS 0.03% OINTMENT 12289
Clinical Edit Criteria Logic
1. Does the client have a diagnosis of localized skin graft versus host disease in the last 365 days?
Yes (Go to #2) No (Go to #3)
2. Has the client had a bone marrow transplant in the last 365 days?
Yes (Approve – 365 days) No (Go to #3)
3. Is the client less than or equal to 2 years of age?
Yes (Go to #4) No (Go to #5)
4. Does the client have a history of a topical steroid or nystatin / triamcinolone prescription in the last 730 days?
Yes (Go to #5) No (Deny)
5. Does the client have a diagnosis of Atopic Dermatitis (eczema) in the last 730 days?
Yes (Go to #6) No (Deny)
6. Does the client have a history of a topical steroid or nystatin / triamcinolone prescription in the last 730 days?
Yes (Go to #8) No (Go to #7)
7. Does the client have a history of a prior pimecrolimus (ELIDEL) / tacrolimus (PROTOPIC) prescription in the last 365 days?
Yes (Go to #8) No (Deny)
8. Does the client have a diagnosis of HIV or Immune System Disorder in the last 730 days?
Yes (Deny) No (Go to #9)
9. Does the client have a history of HIV drugs or immunosuppressants in the last 730 days?
Yes (Deny) No (Go to #10)
10. Does the client have a history of antineoplastic agents in the last 730 days?
Yes (Deny) No (Go to #11)
11. Does the client have a history of a skin absorption disorder or a skin malignancy in the last 730 days?
Yes (Deny) No (Go to #12)
Prior Authorization Topical Immunomodulators
Elidel and Protopic 0.03%
08/13/2020 3
12. Does the client have a history of a prior pimecrolimus (ELIDEL) / tacrolimus (PROTOPIC) prescription less than or equal to 180 days in the last 200 days?
Yes (Approve – 180 days) No (Deny)
Prior Authorization Topical Immunomodulators
Elidel and Protopic 0.03%
08/13/2020 4
Clinical Edit Criteria Logic
Step 3:Is the client less than or equal
to 2 years of age?
Step 4:Does the client have a history
of a topical steroid or nystatin/triamcinolone prescription in
the last 730 days?
Step 5:Does the client have a
diagnosis of Atopic Dermatitis (eczema) in the last 730
days?
Step 6:Does the client have a
history of a topical steroid or nystatin/triamcinolone prescription in the last
730 days?
Step 7:Does the client have a history
of a prior pimecrolimus (ELIDEL)/tacrolimus (PROTOPIC) prescription in the last
365 days?
Step 8:Does the client have a
diagnosis of HIV or Immune System Disorder in the last
730 days?
Step 9:Does the client have a history of HIV drugs or
immunosuppressants in the last 730 days?
Step 10:Does the client have a history of antineoplastic agents in the
last 730 days?
Step 12:Does the client have a
histroy of a prior pimecrolimus (ELIDEL)/tacrolimus (PROTOPIC) prescritpion less than or equal to
180 days in the last 200 days?
Yes
No
Yes
Yes
No
No
No No
Yes
Yes
DenyNo
DenyNo
Deny No
Deny Yes
Deny Yes
Deny
Yes
DenyNo
Approve for 180 days
Yes
Step 11:Does the client have a history of a skin absorption disorder or a
skin malignancy in the last 730 days?
No
Deny
Yes
Step 1:Does the client have
a diagnosis of localized skin graft versus host disease in
the last 365 days?
No
Step 2:Has the client had a bone marrow transplant in the
Step 12 (history of prior pimecrolimus/tacrolimus prescription ≤ 180 days)
Required quantity: 1
Look back timeframe: 200 Days
See the Topical Pimecrolimus/Tacrolimus Drugs table in Step 7.
Prior Authorization Topical Immunomodulators
Protopic 0.1%
08/13/2020 26
Drugs Requiring Prior Authorization
The listed GCNS may not be an indication of TX Medicaid Formulary coverage. To learn the current formulary coverage, visit TxVendorDrug.com/formulary/formulary-search.
Label Name GCN
PROTOPIC 0.1% OINTMENT 12302
TACROLIMUS 0.1% OINTMENT 12302
Clinical Edit Criteria Logic
1. Does the client have a diagnosis of localized skin graft versus host disease in the last 365 days?
Yes (Go to #2) No (Go to #3)
2. Has the client had a bone marrow transplant in the last 365 days?
Yes (Approve – 365 days) No (Go to #3)
3. Is the client < 16 years of age?
Yes (Deny) No (Go to #4)
4. Does the client have a diagnosis of Atopic Dermatitis (eczema) in the last 730 days?
Yes (Go to #5) No (Deny)
5. Does the client have a history of a topical steroid or nystatin / triamcinolone prescription in the last 730 days?
Yes (Go to #7) No (Go to #6)
6. Does the client have a history of a prior pimecrolimus (ELIDEL) / tacrolimus (PROTOPIC) prescription in the last 365 days?
Yes (Go to #7) No (Deny)
7. Has the client had a diagnosis of HIV or Immune System Disorder in the last 730 days?
Yes (Deny) No (Go to #8)
8. Does the client have a history of HIV drugs or immunosuppressants in the last 730 days?
Yes (Deny) No (Go to #9)
9. Does the client have a history of antineoplastic agents in the last 730 days?
Yes (Deny) No (Go to #10)
10. Does the client have a history of a skin absorption disorder or a skin malignancy in the last 730 days?
Yes (Deny) No (Go to #11)
11. Does the client have a history of a prior pimecrolimus (ELIDEL) / tacrolimus (PROTOPIC) prescription ≤ 180 days in the last 200 days?
Yes (Approve – 180 days) No (Deny)
Prior Authorization Topical Immunomodulators
Protopic 0.1%
08/13/2020 27
Clinical Edit Criteria Logic Diagram
Clinical Edit Criteria Supporting Tables
Step 2 – see Step 3 in Elidel and Protopic 0.03% section above
Step 3 – see Step 2 in Elidel and Protopic 0.03% section above
Step 4 – see Step 5 in Elidel and Protopic 0.03% section above
Step 5 – see Step 6 in Elidel and Protopic 0.03% section above
Step 6 – see Step 7 in Elidel and Protopic 0.03% section above
Step 7 – see Step 8 in Elidel and Protopic 0.03% section above
Step 8 – see Step 9 in Elidel and Protopic 0.03% section above
Step 9 – see Step 5 in Elidel and Protopic 0.03% section above
Step 3:Is the client < 16 years of age?
Step 4:Does the client have a
diagnosis of Atopic Dermatitis (eczema) in the last
730 days?
Step 5:Does the client have a
history of a topical steroid or nystatin/triamcinolone prescription in the last
730 days?
Step 6:Does the client have a
history of a prior pimecrolimus (ELIDEL)/tacrolimus (PROTOPIC)
prescription in the last 365 days?
Step 7:Has the client had a diagnosis of HIV or Immune System Disorder
in the last 730 days?
Step 8:Does the client have a history of HIV drugs or
immunosuppressants in the last 730 days?
Step 9:Does the client have a history of antineoplastic agents in the last
730 days?
Step 11:Does the client have a
history of a prior pimecrolimus (ELIDEL)/tacrolimus (PROTOPIC) prescription less than or equal
to 180 days in the last 200 days?
No
Yes
Yes
No
No No
No
DenyYes
DenyNo
DenyNo
Deny Yes
Deny Yes
Deny
Yes
DenyNo
Approve for 180 days
Yes
Yes
Step 10:Does the client have a history
of a skin absorption disorder or a skin malignancy in the last 730
days?
No
DenyYes
Step 1:Does the client have
a diagnosis of localized skin graft versus host disease in
the last 365 days?
Step 2:Has the client had a bone marrow transplant in the
Required diagnosis: 1 Look back timeframe: 365 Days
see Step 1 in Elidel and Protopic 0.03% section above
Step 2 (history of bone marrow transplant) Required code: 1
Look back timeframe: 365 Days see Step 2 in Elidel and Protopic 0.03% section above
Step 4 (diagnosis of atopic dermatitis)
Required diagnosis: 1
Look back timeframe: 730 Days
see Step 5 in Elidel and Protopic 0.03% section above
Step 5 (history of a topical steroid)
Required quantity: 1 Look back timeframe: 730 Days
see Step 4 in Elidel and Protopic 0.03% section above
Step 6 (history of a prior pimecrolimus/tacrolimus prescription)
Required quantity: 1
Look back timeframe: 365 Days see Step 7 in Elidel and Protopic 0.03% section above
Step 7 (diagnosis of HIV or immune system disorder)
Required quantity: 1
Look back timeframe: 730 Days
see Step 8 in Elidel and Protopic 0.03% section above
Step 8 (history of HIV drugs or immunosuppressants)
Required quantity: 1
Look back timeframe: 730 Days
see Step 9 in Elidel and Protopic 0.03% section above
Step 9 (history of antineoplastic agents)
Required diagnosis: 1
Look back timeframe: 730 Days
see Step 10 in Elidel and Protopic 0.03% section above
Step 10 (diagnosis of skin absorption disorder or skin malignancy)
Required diagnosis: 1
Look back timeframe: 730 days
see Step 11 in Elidel and Protopic 0.03% section above
Step 11 (history of a prior pimecrolimus/tacrolimus prescription)
Required quantity: 1
Look back timeframe: 200 Days see Step 7 in Elidel and Protopic 0.03% section above
Prior Authorization Topical Immunomodulators
Eucrisa
08/13/2020 29
Drugs Requiring Prior Authorization
The listed GCNS may not be an indication of TX Medicaid Formulary coverage. To learn the current formulary coverage, visit TxVendorDrug.com/formulary/formulary-search.
Label Name GCN
EUCRISA 2% OINTMENT 42792
Clinical Edit Criteria Logic
1. Does the client have a diagnosis of Atopic Dermatitis in the last 730 days?
Yes (Go to #2) No (Deny)
2. Is the client less than (<) 2 years of age?
Yes (Approve – 180 days) No (Go to #3)
3. Does the client have a claim for a topical steroid in the last 730 days?
Yes (Approve – 180 days) No (Deny)
Prior Authorization Topical Immunomodulators
Eucrisa
08/13/2020 30
Clinical Edit Criteria Logic Diagram
Step 1:Does the client have a diagnosis of Atopic Dermatitis in the last
730 days?
Step 2:Is the client less than (<) 2?
Step 3:Does the client have a claim for a
topical steroid in the last 730 days?
Yes
No
Yes
No
DenyNo
Approve for 180 days
Yes
Deny
Approve for 180 days
Prior Authorization Topical Immunomodulators
Eucrisa
08/13/2020 31
Clinical Edit Criteria Supporting Tables
Step 1 (diagnosis of atopic dermatitis)
Required diagnosis: 1
Look back timeframe: 730 Days
see Step 5 in Elidel and Protopic 0.03% section above
Step 3 (history of a topical steroid)
Required quantity: 1 Look back timeframe: 730 Days
see Step 4 in Elidel and Protopic 0.03% section above
Prior Authorization Topical Immunomodulators
08/13/2020 32
Clinical Criteria References
1. 2015 ICD-9-CM Diagnosis Codes. 2015. Available at www.icd9data.com. Accessed on
April 3, 2015.
2. 2015 ICD-10-CM Diagnosis Codes. 2015. Available at www.icd10data.com. Accessed
on April 3, 2015.
3. American Medical Association data files. 2015 ICD-9-CM Diagnosis Codes. Available at www.commerce.ama-assn.org.
4. American Medical Association data files. 2015 ICD-10-CM Diagnosis Codes. Available at
2017. Available at www.clinicalpharmacology.com. Accessed on April 13, 2017.
6. Micromedex [online database]. Available at www.micromedexsolutions.com. Accessed on April 13, 2017.
7. Elidel Prescribing Information. Bridgewater, NJ. Valeant Pharmaceuticals North America
LLC. August 2014.
8. Protopic Prescribing Information. Northbrook, IL. Astellas Pharma US, Inc. November
2016.
9. Eucrisa Prescribing Information. New York, NY. Pfizer Inc. April 2020.
10.Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of
atopic dermatitis. J Am Acad Dermatology. 2014 Jul;71(1):116-32.
11.Wahn U, Bos JD, Goodfield M, Caputo R, Papp K, Manjra A, et al. Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children.
Pediatrics 2002;110:e2.
12.Kapp A, Papp K, Bingham A, Folster-Holst R, Ortonne JP, Potter PC, et al. Long-termmanagement of atopic dermatitis in infants with topical pimecrolimus, a nonsteroid
13.Thaci D, Chambers C, Sidhu M, Dorsch B, Ehlken B, Fuchs S. Twice-weekly treatment with tacrolimus 0.03% ointment in children with atopic dermatitis: clinical efficacy and
14. Koo JY, Fleischer AB Jr, Abramovits W, Pariser DM, McCall CO, Horn TD, et al. Tacrolimus ointment is safe and effective in the treatment of atopic dermatitis: results
in 8000 patients. J Am Acad Dermatol 2005;53(Suppl):S195-205.
Added ICD-10 diagnosis codes Added additional medications in steps 7 and 8 Updated dates Added additional Clinical Edit Criteria References
12/04/16
Added Tacrolimus to the Drugs Requiring Prior Authorization Updated GCNs in Step 7 table Updated GCNs in Step 8 table
02/22/17
Added a skin absorption disorder or a skin malignancy question to both the Elidel/Protopic .03% section and the Protopic 1% section Updated both clinical edit logic diagrams Updated Step 8 table Added Step 9 table for skin absorption disorder or a skin malignancy diagnoses
05/31/2017
Updated Table 3 – removed ICD-9/10s for diaper rash/dermatitis
Added criteria for Eucrisa
Added GCN for Eucrisa to Drugs Requiring PA
Added criteria logic for Eucrisa
Added logic diagram for Eucrisa
Added supporting tables for Eucrisa
Updated references
07/01/2018
Added criteria for Elidel and Protopic 0.03%
Added criteria logic for Protopic 0.1%
Updated logic diagram for Elidel and Protopic 0.03%
Updated logic diagram for Protopic 0.1%
Added supporting tables for Elidel and Protopic 0.03%
Added supporting tables for Protopic 0.1%
5/10/2019
Updated to include formulary statement (The listed GCNS may not be an
indication of TX Medicaid Formulary coverage. To learn the current formulary coverage, visit TxVendorDrug.com/formulary/formulary-search.) on each ‘Drug
Requiring PA’ table
5/04/2020 Update criteria for Eucrisa
Update logic diagram for Eucrisa
8/13/2020 Updated age requirements for Eucrisa in logic and logic diagram