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Fax completed prior authorization request form to 800-854-7614 or submit Electronic Prior Authorization through
CoverMyMeds® or SureScripts.
All requested data must be provided. Incom
plete forms or forms without the chart notes will be returned
Pharmacy Coverage Guidelines are available at
www.mercycareaz.org/providers/completecare-forproviders/pharmacy
Cystic Fibrosis Medications
Pharmacy Prior Authorization Request Form
Do not copy for future use. Forms are updated frequently.
REQUIRED: Office notes, labs and medical testing relevant to request showing medical justification are required to support diagnosis
Member Information
Member Name (first & last):
Date of Birth:
Gender:
Female
Height:
Member ID:
City:
State:
Weight:
Prescribing Provider Information
Provider Name (first & last):
Specialty:
NPI#
DEA#
Office Address:
City:
State:
Zip Code:
Office Contact:
Office Phone
Office Fax:
Dispensing Pharmacy Information
Pharmacy Name:
Pharmacy Phone:
Pharmacy Fax:
Requested Medication Information
Preferred Agents:
Bethkis
Kitabis
Non-preferred Agents:
Cayston
Kalydeco
Pulmozyme
Orkambi
Symdeko
Tobramycin Nebulizer Sol
Tobi Podhaler
Trikafta
Are there any contraindications to formulary medications?
Yes
No
(if yes, specify):
New
request
Continuation
of therapy
Continuation of Therapy for Non-Cystic Fibrosis Bronchiectasis (Tobramycin
nebulizer solution OR Kitabis OR Tobi Podhaler OR Bethkis ONLY):
Response to therapy
Continuation of Therapy for Kalydeco OR Symdeko OR Orkambi OR Trikafta
ONLY):
Response with
improvement
and/or stable FEV
1
Pediatric
members ONLY:
Eye exam
ALT/AST
monitoring
D/C if ALT/AST >5
times ULN
ALT/AST >3 times ULN with bilirubin >2 times
ULN
Directions for Use:
Strength:
Dosage Form:
Quantity:
Day Supply:
Duration of Therapy/Use:
Medication request is NOT for an FDA approved, or compendia-
supported diagnosis (circle one): Yes No
Diagnosis:
ICD-10 Code:
What medication(s) have been tried and failed for this diagnosis? (please specify):
Turn-Around Time for Review
Standard (24 hours)
Urgent If waiting 24 hours for standard decision could seriously harm life, health, or ability to regain
maximum function, you can ask for an expedited decision.
Signature: _________________
Clinical Information
Pulmozyme
Does member have diagnosis of Cystic Fibrosis?
Yes
No
Is member at least 5 years of age?
Yes
No
Tobramycin Nebulizer Solution - Generic for Tobi
Are sputum cultures positive for P.aeruginosa?
Yes
No
Is FEV
1
between 25-80 predicted?
Yes
No
Is member colonized with Burkholderia cepacian?
Yes
No
Effective: 06/08/2020 C7023-A, C7027-A, C8504-A, C8697-A, C13276-A, C18014-A 12-2019 & 02-2020
Proprietary
_______________________________________________
click to sign
signature
click to edit
Proprietary
Effective: 06/08/2020 C7023-A, C7027-A, C8504-A, C8697-A, C13276-A, C18014-A 12-2019 & 02-2020 2 of 3
Bethkis
Kitabis
Is FEV
1
between 40-80% predicted?
Yes
No
Is FEV
1
between 25-75% predicted?
Yes
No
Are sputum cultures positive for P.aeruginosa?
Yes
No
Is member colonized with Burkholderia
cepacian?
Yes
No
Tobi Podhaler OR Tobramycin Nebulizer Solution - Generic for Tobi
Is FEV1 between 25-80%?
Yes
No
Is FEV1 between 25-75% predicted?
Yes
No
Did member have inadequate response OR intolerable side effect with Bethkis AND Kitabis?
Yes
No
Non-Cystic Fibrosis Bronchiectasis:
Tobramycin Nebulizer Solution
(generic for Tobi)
Kitabis
Bethkis
Tobi Podhaler
Did member have frequent acute exacerbations (THREE or more exacerbations OR TWO hospitalizations within ONE
year) OR progressive deterioration of lung function?
Yes
No
Do sputum cultures OR chart notes document presence of pseudomonas aeruginosa?
Yes
No
Was there trial with formulary alternatives
(ciprofloxacin, amoxicillin, amoxicillin-clavulanic,
doxycycline OR clarithromycin)?
Yes
No
Does member have contraindication to
formulary alternatives?
Yes
No
Was there inadequate response OR intolerable side effect with Bethkis AND Kitabis
Yes
No
N/A
Cayston
Is FEV
1
between 25-75% predicted?
Yes
No
Are sputum cultures positive for P.aeruginosa?
Yes
No
Is member colonized with Burkholderia cepacian?
Yes
No
Is member pregnant?
Yes
No
Was there inadequate response OR contraindication OR
intolerance with TWO different formulary tobramycin nebulizer
solution products?
Yes
No
Did sputum cultures show
resistance to tobramycin?
Yes
No
Kalydeco
Is there ONE gating mutation OR ONE residual function
mutation in CFTR gene that is responsive to Kalydeco?
Yes
No
Is member homozygous for F508del
mutation in CFTR gene?
Yes
No
For pediatric members ONLY: Was eye examination completed at baseline AND
will continue periodically throughout therapy?
Yes
No
N/A
Are ALTs and ASTs being monitored AND
LFTs being evaluated?
Yes
No
For members with moderated to
severe hepatic impairment ONLY:
Was dose reduced?
Yes
No
N/
A
For members taking moderate OR strong CYP3A inhibitor (fluconazole, erythromycin, ketoconazole,
itraconazole, posaconazole, voriconazole, telithromycin OR clarithromycin) was Kalydeco dose
REDUCED?
Yes
No
N/
A
Orkambi
Is member homozygous for F508del mutation in CFTR gene?
Yes
No
For pediatric members ONLY: Was eye examination completed at baseline AND
will continue periodically throughout therapy?
Yes
No
N/A
Are ALTs and ASTs being monitored AND
LFTs being evaluated?
Yes
No
For members with moderated to
severe hepatic impairment ONLY:
Has dose been reduced?
Yes
No
N/
A
If member is currently taking MODERATE OR STRONG CYP3A inhibitor (fluconazole, erythromycin,
ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin OR clarithromycin) was Orkambi
dose REDUCED?
Yes
No
N/
A
Symdeko
Lab results are present to support ONE of
the following:
Member IS HOMOzygous for
F508del mutation in CFTR gene
There is at least ONE mutation in CFTR
gene that is responsive to Symdeko
For members that are HOMOzygous for F508del mutation in CFTR gene, was there inadequate
response OR intolerable side effect with Orkambi?
Yes
No
N/A
For pediatric members ONLY: Was eye examination completed at baseline AND will continue
periodically throughout therapy?
Yes
No
N/A
Are ALTs / ASTs being monitored AND
LFTs being evaluated?
Yes
No
For members with moderated to
severe hepatic impairment ONLY:
Has dose been reduced?
Yes
No
N/A
For members taking moderate OR strong CYP3A inhibitor (fluconazole, erythromycin, ketoconazole,
itraconazole, posaconazole, voriconazole, telithromycin OR clarithromycin) was Symdeko dose
REDUCED?
Yes
No
N/A
Trikafta
Is there documentation of pretreatment FEV
1
?
Yes
No
Does member have at least ONE F508del
mutation in CFTR gene?
Yes
No
Is member HOMOZYGOUS for F508del
mutation in CFTR gene?
Yes
No
Was their inadequate response, or
intolerable side effect with Orkambi?
Yes
No
N/A
For members with moderated to severe hepatic impairment ONLY: Has dose been reduced?
Yes
No
N/A
For members taking moderate OR strong CYP3A inhibitor (fluconazole, erythromycin, ketoconazole,
itraconazole, posaconazole, voriconazole, telithromycin OR clarithromycin) was Trikafta dose
Yes
No
N/A
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___________________________________________________ __________________
REDUCED?
Additional information the prescribing provider feels is important to this review. Please specify below or submit medical records
Signature affirms that information given on this form is true and accurate and reflects office notes.
Prescribing Provider’s Signature: Date:
Please note: Incomplete forms or forms without the chart notes will be returned
Office notes, labs, and medical testing relevant to the request that show medical justification are required.
Standard turnaround time is 24 hours. You can call 800-624-3879 to check the status of a request.
Effec
tive: 06/08/2020
C7023-A,
C7027-A,
C8504-A,
C8697-A, C13276-A, C18014-A 12-2019
& 02-2020
Proprietary
click to sign
signature
click to edit