Symdeko® - NC Standard

Commercial Policy

Version Date: January 2025

Restricted Product(s):

Symdeko (tezacaftor/ivacaftor)

FDA Approved Use:

For the treatment of patients with cystic fibrosis (CF) age 6 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

Criteria for Approval of Restricted Product(s):

The patient is 6 years of age or older; AND
The patient has been diagnosed with cystic fibrosis; AND
One of the following (medical record documentation required):
1. The patient is homozygous for the F508del mutation; OR
2. The patient has at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene listed in the table below; AND
An FDA-cleared CF mutation test that is used to detect the presence of a mutation in CFTR gene has been used; AND
Please attach patient specific lab results and/or Cystic Fibrosis Foundation Patient Registry Report with confirmation of a mutation in the CFTR gene [medical record documentation required]; AND
Symdeko will not be used concurrently with other CFTR modulators (e.g., Alyftrek™, Kalydeco®, Orkambi®, Trikafta®); AND
The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., pulmonologist); AND
For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 1 year (365 days)

Mutation in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene

546insCTA
711+3A-->G
2789+5g-->A
3272-26A-->G
3849+10kbC-->T
A120T
A234D
A349V
A455E
A1006E
A1067T
D110E
D110H
D192G
D443Y
D443Y;G576A;R668C
D579G
D614G
D836Y
D924N
D979V
D1152H
D1270N
E56K
E60K
E92K
E116K
E193K
E403D
E588V
E822K
E831X
F191V
F311del
F311L
F508C
F508C;S1251N
F508del
F575Y
F1016S
F1052V
F1074L
F1099L
G126D
G178E
G178R
G194R
G194V
G314E
G551D
G551S
G576A
G576A;R668C
G622D
G970D
G1069R
G1244E
G1249R
G1349D
H939R
H1054D
H1375P
I148T
I175V
I336K
I601K
I618T
I807M
I980K
I1027T
I1139V
I1269N
I1366N
K1060T
L15P
L206W
L320V
L346P
L967S
L997F
L1324P
L1335P
L1480P
M152V
M265R
M9521
M952T
P5L
P67L
P205S
Q98R
Q237E
Q237H
Q359R
Q1291R
R31L
R74Q
R74W
R74W;D1270N
R74W;V201M
R74W;V201M;D1270N
R75Q
R117C
R117G
R117H
R117L
R117P
R170H
R258G
R334L
R334Q
R347H
R347L
R347P
R352Q
R352W
R553Q
R668C
R751L
R792G
R933G
R1066H
R1070Q
R1070W
R1162L
R1283M
R1283S
S549N
S549R
S589N
S737F
S912L
S945L
S977F
S1159F
S1159P
S589N
S737F
S912L
S945L
S977F
S1159F
S1159P
S1251N
S1255P
T3381
T1036N
T10531
V201M
V232D
V5621
V754M
V1153E
V1240G
V1293G
W1282R
Y109N
Y161S
Y1014C
Y1032C

Quantity Limitations:

Quantity limitations apply to brand and associated generic products.

Medication	Quantity per Day (Unless Specified)
Symdeko 50-75 mg tablets	2 tablets
Symdeko 100-150 mg tablets	2 tablets

Quantity Limit Exception Criteria:

The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 1 year (365 days)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

January 2025v2: Criteria update: Added Alyftrek to medications not to be used concurrently with requested medication.

January 2025: Criteria change: Added requirement that Symdeko will not be used concurrently with other CFTR. Added specialist requirement.

April 2022: Criteria change: Duration of approval added for 1 year. Quantity limits added.

December 2020: Criteria change: Updated CFTR genes eligible for approval

August 2019: Criteria update: Indication update to include pediatrics ages 6 years and up.

February 2018: Original utilization management criteria issued.

Blue Cross and Blue Shield of North Carolina does not discriminate on the basis of race, color, national origin, sex, age or disability in its health programs and activities. Learn more about our non-discrimination policy and no-cost services available to you.

Information in other languages: Español 中文 Tiếng Việt 한국어 Français العَرَبِيَّة Hmoob ру́сский Tagalog ગુજરાતી ភាសាខ្មែរ Deutsch हिन्दी ລາວ 日本語

© 2025 Blue Cross and Blue Shield of North Carolina. ®, SM Marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans. All other marks and names are property of their respective owners. Blue Cross and Blue Shield of North Carolina is an independent licensee of the Blue Cross and Blue Shield Association.