Effective: 03/03/2021 C4447-A 01-2021 Page 2 of 4
Proprietary
Does member have clinically isolated syndrome
suggestive of MS (experienced 1
st
clinical episode
AND MRI features consistent with MS)?
Is diagnosis of relapsing form of MS
(relapsing-remitting OR active
secondary progressive MS)?
ORAL AGENTS
Is diagnosis clinically isolated syndrome
suggestive of MS (experienced 1
st
clinical
episode AND MRI features consistent with
Is diagnosis relapsing form of MS
(relapsing-remitting OR active secondary
progressive MS)?
Is member FEMALE of reproductive potential?
Is FEMALE member pregnant?
Will FEMALE member be using effective contraception during treatment?
The following LABS have been completed within last SIX months:
☐
LFTs and bilirubin Tuberculin skin test ☐
☐
Is the diagnosis relapsing form of MS (for example, relapsing-remitting or active secondary progressive MS)?
Does member have clinically isolated syndrome suggestive of MS (for example, experienced 1
st
clinical episode and
MRI features consistent with MS)?
Was baseline (within 3 months) MRI scan obtained prior to starting TX course due to risk of PML?
Is there history of either varicella vaccine series OR zoster vaccine series if 50 years of age or older?
The following labs have been completed within past 6 months:
LFTs and bilirubin levels
Gilenya
Is diagnosis clinically isolated syndrome suggestive of MS
(experienced 1
st
clinical episode AND MRI features
Is diagnosis of relapsing form of
MS (relapsing-remitting OR active
secondary progressive MS)?
Labs have been completed within past 6 months:
CBC LFTs and bilirubin ECG Ophthalmic examination
Is there history of either varicella vaccine series OR zoster vaccine series if 50 years of age or older?
Documented history of ANY of the following:
MI - Unstable Angina – stroke – TIA - Decompensated HF requiring hospitalization OR
Class III/IV HF within past 6 months
HX of Mobitz type II (2
nd
OR 3
rd
degree AV block) OR sick sinus syndrome, unless there
Treatment with Class Ia OR Class III anti-arrhythmic drugs
Is diagnosis clinically isolated syndrome suggestive of MS
(experienced 1
st
clinical episode AND MRI features
Is diagnosis of relapsing form of
MS (relapsing-remitting OR active
secondary progressive MS)?
Was member tested for CYP2C9 variants to
determine CYP2C9 genotype?
Is member positive for CYP2C9*3/*3?
Labs have been completed within past 6 months:
☐ CBC
☐
☐
☐
LFTs and bilirubin ECG Ophthalmic exam
Is there history of either varicella vaccine series OR zoster vaccine series if 50 years of age or older?
Documented history of ANY of the following:
MI - Unstable Angina – Stroke – TIA - Decompensated HF requiring hospitalization OR
Class III/IV HF within past SIX months
History of Mobitz type II (2
nd
OR 3
rd
degree AV block) OR sick sinus syndrome, unless
member has pacemaker
Does member have clinically isolated syndrome
suggestive of MS
(experienced 1
st
clinical episode AND have MRI features
Is diagnosis of relapsing form of
MS (relapsing-remitting OR active
secondary progressive MS)?
Was baseline (within 3 months)
MRI scan obtained prior to starting
TX course due to risk of PML?
Is there infection with HIV AND active chronic infections
(Hepatitis OR TB) OR breastfeeding (during TX OR for
10 days after last dose)?
Is member a FEMALE of reproductive potential?
Is the FEMALE
member pregnant?