Proprietary
Effective: 06/08/2020 C7023-A, C7027-A, C8504-A, C8697-A, C13276-A, C18014-A 12-2019 & 02-2020 2 of 3
1
between 40-80% predicted?
1
between 25-75% predicted?
Are sputum cultures positive for P.aeruginosa?
Is member colonized with Burkholderia
cepacian?
Tobi Podhaler OR Tobramycin Nebulizer Solution - Generic for Tobi
Is FEV1 between 25-75% predicted?
Did member have inadequate response OR intolerable side effect with Bethkis AND Kitabis?
Non-Cystic Fibrosis Bronchiectasis:
Tobramycin Nebulizer Solution
(generic for Tobi)
Did member have frequent acute exacerbations (THREE or more exacerbations OR TWO hospitalizations within ONE
year) OR progressive deterioration of lung function?
Do sputum cultures OR chart notes document presence of pseudomonas aeruginosa?
Was there trial with formulary alternatives
(ciprofloxacin, amoxicillin, amoxicillin-clavulanic,
doxycycline OR clarithromycin)?
Does member have contraindication to
formulary alternatives?
Was there inadequate response OR intolerable side effect with Bethkis AND Kitabis
1
between 25-75% predicted?
Are sputum cultures positive for P.aeruginosa?
Is member colonized with Burkholderia cepacian?
Was there inadequate response OR contraindication OR
intolerance with TWO different formulary tobramycin nebulizer
solution products?
resistance to tobramycin?
Is there ONE gating mutation OR ONE residual function
mutation in CFTR gene that is responsive to Kalydeco?
Is member homozygous for F508del
mutation in CFTR gene?
For pediatric members ONLY: Was eye examination completed at baseline AND
will continue periodically throughout therapy?
Are ALTs and ASTs being monitored AND
LFTs being evaluated?
For members with moderated to
severe hepatic impairment ONLY:
A
For members taking moderate OR strong CYP3A inhibitor (fluconazole, erythromycin, ketoconazole,
itraconazole, posaconazole, voriconazole, telithromycin OR clarithromycin) was Kalydeco dose
A
Is member homozygous for F508del mutation in CFTR gene?
For pediatric members ONLY: Was eye examination completed at baseline AND
will continue periodically throughout therapy?
Are ALTs and ASTs being monitored AND
LFTs being evaluated?
For members with moderated to
severe hepatic impairment ONLY:
A
If member is currently taking MODERATE OR STRONG CYP3A inhibitor (fluconazole, erythromycin,
ketoconazole, itraconazole, posaconazole, voriconazole, telithromycin OR clarithromycin) was Orkambi
A
Lab results are present to support ONE of
the following:
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?
For pediatric members ONLY: Was eye examination completed at baseline AND will continue
periodically throughout therapy?
Are ALTs / ASTs being monitored AND
LFTs being evaluated?
For members with moderated to
severe hepatic impairment ONLY:
For members taking moderate OR strong CYP3A inhibitor (fluconazole, erythromycin, ketoconazole,
itraconazole, posaconazole, voriconazole, telithromycin OR clarithromycin) was Symdeko dose
Is there documentation of pretreatment FEV
1
Does member have at least ONE F508del
mutation in CFTR gene?
Is member HOMOZYGOUS for F508del
mutation in CFTR gene?
Was their inadequate response, or
intolerable side effect with Orkambi?
For members with moderated to severe hepatic impairment ONLY: Has dose been reduced?
For members taking moderate OR strong CYP3A inhibitor (fluconazole, erythromycin, ketoconazole,
itraconazole, posaconazole, voriconazole, telithromycin OR clarithromycin) was Trikafta dose