Lunsumio is considered medically necessary when the following criteria are met:
Initial Approval Criteria
Follicular Lymphoma
A)
Diagnosis of relapsed or
refractory follicular lymphoma characterized as both of the following:
a.
Grade 1, 2 or 3a (low
grade or slow growing);
b.
Presence of at least one
bi-dimensionally measurable lesion (≥ 1.5 cm in its largest dimension for nodal
lesions, or ≥1.0 cm in its largest dimension for extranodal lesions;
B)
Prescribed by or in
consultation with an oncologist or a hematologist;
C)
Age ≥ 18 years;
D)
Member has received at
least two prior lines of systemic therapy including all of the following:
a.
One anti-CD20-directed
therapy (e.g., rituximab, Arzerra®, Gazyva®);
b.
One alkylating agent
(e.g., bendamustine, cyclophosphamide);
E)
Member does not have a
known current or past central nervous system (CNS) lymphoma, or a history of CNS
disease (e.g., stroke/transient ischemic attack with residual neurologic
deficits; epilepsy with seizures in the past 2 years; CNS vasculitis or
neurodegenerative disease);
F)
Dose does not exceed one
of the following:
a.
All of the following (i,
ii, and iii):
i.
Cycle 1:
1.
Day 1: 1 mg;
2.
Day 8: 2 mg;
3.
Day 15: 60 mg;
ii.
Cycle 2: Day 1: 60mg
iii.
Cycles 3+: Day 1: 30mg;
b.
Dose is supported by
practice guidelines or peer-reviewed literature for the relevant off-label use
(prescriber must submit supporting evidence). *Prescribed
regimen must be FDA-approved or recommended by NCCN
Approval duration: 9
months (8 treatment cycles of 21 days each)
Continued Therapy
Follicular Lymphoma
A)
Member meets one of the
following
a.
Received 8 initial
treatment cycles and needs further therapy due to incomplete or partial
response;
b.
Did not receive 8 initial
treatment cycles, and wishes to resume therapy;
B)
Member is responding
positively to therapy;
Approval duration: 12
months (see comments below)
·
For members who received
8 initial treatment cycles, 9 additional continued therapy cycles will be
approved for the total of 17 cycles between the initial and continued therapy.
·
For members who did not
receive 8 initial treatment cycles, but wish to resume therapy, approval will be
granted to complete the 8 initial treatment cycles after which re-authorization
for continued therapy will be required.