Alyftrek - NC Standard

Commercial Policy

Version Date: 01/01/2025

Restricted Product(s)

Alyftrek™ (vanzacaftor-tezacaftor-deutivacaftor)

FDA Approved Use

For the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene.
- If the patients genotype is unknown, an FDA-cleared CF mutation test should be able to confirm the presence at least one indicated mutation.

Criteria for Approval of Restricted Product(s)

The patient is 6 years of age or older; AND
The patient has a diagnosis of cystic fibrosis confirmed by ONE of the following:
1. An FDA-cleared CF mutation test that detected at least one F508del mutation in the CFTR gene; OR
2. The presence of at least one of the CFTR genes listed in the table below; 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
Alyftrek will not be used concurrently with other CFTR modulators (e.g., Kalydeco®^, Orkambi®, Symdeko®, 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
Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. [Medical records and references / evidence must be provided]; AND
For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Based on Clinical Data*

A455E
D1152H
F508del†
G1244E
G551D
G85E†
H1054D
I336K
L1077P†
L206W
M1101K†
R1066H
R352Q
R75Q
S1159F
S1251N
S549N
S549R
S945L
V562I
V754M
W1098C†
W1282R
Y563N†

Based on in vitro Data‡

1507_1515del9
2183A→G
3141del9
3195del6
3199del6
546insCTA
A1006E
A1067P
A1067T
A107G
A120T
A234D
A309D
A349V
A46D
A554E
A559T
A559V
A561E
A613T
A62P
A72D
C491R
D110E
D110H
D1270N
D1445N
D192G
D443Y
D443Y;G576A;R668C§
D513G
D565G
D579G
D614G
D836Y
D924N
D979V
D993Y
E116K
E116Q
E193K
E292K
E403D
E474K
E56K
E588V
E60K
E822K
E92K
F1016S
F1052V
F1074L
F1099L
F1107L
F191V
F200I
F311del
F311L
F508C
F508C;S1251N§
F575Y
F587I
G1047R
G1061R
G1069R
G1123R
G1247R
G1249R
G126D
G1349D
G149R
G178E
G178R
G194R
G194V
G27E
G27R
G314E
G424S
G463V
G480C
G480S
G551A
G551S
G576A
G576A;R668C§
G622D
G628R
G91R
G970D
G970S
H1085P
H1085R
H1375P
H139R
H199R
H199Y
H609R
H620P
H620Q
H939R
H939R;H949L
I1027T
I105N
I1139V
I1234Vdel6aa
I125T
I1269N
I1366N
I1398S
I148N
I148T
I175V
I331N
I502T
I506L
I506T
I556V
I601F
I618T
I807M
I980K
K1060T
K162E
K464E
L1011S
L102R
L1065P
L1324P
L1335P
L137P
L1480P
L15P
L165S
L320V
L333F
L333H
L346P
L441P
L453S
L619S
L967S
L997F
M1101R
M1137V
M150K
M152V
M265R
M952I
M952T
N1088D
N1303I
N1303K‡
N186K
N187K
N418S
P140S
P205S
P499A
P574H
P5L
P67L
P750L
P99L
Q1100P
Q1291R
Q1313K
Q237E
Q237H
Q359R
Q372H
Q452P
Q493R
Q552P
Q98R
R1048G
R1066C
R1066L
R1066M
R1070Q
R1070W
R1162L
R117C
R117C;G576A;R668C
R117G
R117H
R117L
R117P
R1283M
R1283S
R170H
R258G
R297Q
R31C
R31L
R334L
R334Q
R347H
R347L
R347P
R352W
R516G
R516S
R553Q
R555G
R560S
R560T
R668C
R709Q
R74Q
R74W
R74W;D1270N§
R74W;V201M;D1270N§
R74W;V201M§
R751L
R75L
R792G
R933G
S1045Y
S108F
S1118F
S1159P
S1235R
S1255P
S13F
S341P
S364P
S492F
S549I
S589N
S737F
S912L
S977F
T1036N
T1053I
T1086I
T1246I
T1299I
T338I
T351I
T604I
V1153E
V1240G
V1293G
V201M
V232D
V392G
V456A
V456F
V520F
V603F
W361R
Y1014C
Y1032C
Y109N
Y161D
Y161S
Y301C
Y569C
Y913C

Based on Extrapolation¶

1341G→A
1898+3A→G
2752-26A→G
2789+2insA
2789+5G→A
296+28A→G
3041-15T→G
3272-26A→G
3600G→A
3849+10kbC→T
3849+40A→G
3849+4A→G
3850-3T→G
4005+2T→C
5T;TG12
5T;TG13
621+3A→G
711+3A→G
E831X

Quantity Limitations

Quantity limitations apply to brand and associated generic products.

Medication	Quantity per Day (unless specified)
Alyftrek 4-20-50 mg tablet	3 tablets
Alyftrek 10-50-125 mg tablet	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: 365 days (1 year)

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 2025: 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.

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