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Multiple Sclerosis Agents Step Therapy with Quantity Limit Program Summary

Policy Number: PH-91057

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies. 

POLICY REVIEW CYCLE

Effective Date

Date of Origin   

07-01-2024           

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Aubagio®

(teriflunomide)*

Tablet

Treatment of patients with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

*generic equivalent available

1

Avonex®

(interferon β-1a)

Injection for intramuscular use

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

2

Bafiertam®

(monomethyl fumarate)

Delayed-release capsule

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

3

Betaseron®

(interferon β-1b)

Injection for subcutaneous use

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

4

Copaxone®

(glatiramer acetate)*

Injection for subcutaneous use

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

*generic equivalent available

5

Extavia®

(interferon β-1b)

Injection for subcutaneous use

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

6

Gilenya®

(fingolimod)*

Capsule

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older

*generic equivalent available

7

Glatopa®

(glatiramer acetate)

Injection for subcutaneous use

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

8

Kesimpta®

(ofatumumab)

Injection for subcutaneous use

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

9

Mavenclad®

(cladribine)

Tablet

Treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease in adults

Because of its safety profile, use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternative drug indicated for the treatment of MS

Limitation of Use:
Mavenclad is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile

10

Mayzent®

(siponimod)

Tablet

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

11

Plegridy®

(peginterferon β-1a)

Injection for subcutaneous use or intramuscular use

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

12

Ponvory®

(ponesimod)

Tablet

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

27

Rebif®

(interferon β-1b)

Injection for subcutaneous use 

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

13

Tascenso®

(fingolimod)

Oral disintegrating tablet

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older

29

Tecfidera®

(dimethyl fumarate)*

Capsule

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

*generic equivalent available

14

Vumerity®

(diroximel fumarate)

Delayed-release capsule

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

15

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

CLINICAL RATIONALE

Multiple sclerosis

Multiple sclerosis (MS) is a disorder of the central nervous system (CNS) characterized by demyelization, inflammation, and degenerative changes. Most people with MS experience relapses and remissions of neurological symptoms, particularly early in the disease, and clinical events are usually associated with areas of CNS inflammation. Gradual worsening or progression, with or without subsequent acute attacks of inflammation or radiological activity, may take place early, but usually becomes more prominent over time. While traditionally viewed as a disease solely of CNS white matter, more advanced imaging techniques have demonstrated significant early and ongoing CNS gray matter damage as well.(16)

Those diagnosed with MS may have many fluctuating and disabling symptoms (including, but not limited to, fatigue, pain, bladder and bowel issues, sexual dysfunction, movement and coordination problems, visual disturbances, and cognition and emotional changes.(30) There are currently four major types of MS: clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS).(23)

Relapsing remitting multiple sclerosis (RRMS)

RRMS is characterized by clearly defined attacks (relapses) of new or increasing neurologic symptoms. These relapses are followed by periods of partial or complete recovery. There is no or minimal disease progression during the periods between disease relapses, though individual relapses may result in severe residual disability. The course of MS varies, however, about 85-90% of individuals with MS demonstrate a relapsing pattern at onset, which transitions over time in the majority of untreated patients to a pattern of progressive worsening with few or no relapses or MRI activity.(23)

Secondary progressive multiple sclerosis  (SPMS)

SPMS begins as RRMS, but over time the disease enters a stage of steady deterioration in function, unrelated to acute attacks. Most people with RRMS will transition to SPMS. In SPMS there is no progressive worsening of symptoms over time with no definite periods of remission.(23)

2017 McDonald Criteria for the diagnosis of Multiple Sclerosis:

Diagnostic criteria for multiple sclerosis combining clinical, imaging, and laboratory evidence have evolved over time. The increasing incorporation of paraclinical assessments, especially imaging, to supplement clinical findings has allowed earlier, more sensitive, and more specific diagnosis.(21,22)

The diagnosis of MS requires elimination of more likely diagnoses and demonstration of dissemination of lesions in the CNS in space and time.(21) 

Misdiagnosis of multiple sclerosis remains an issue in clinical practice, and several factors that potentially increase this risk have been identified. Multiple sclerosis has heterogeneous clinical and imaging manifestations, which differ between patients over time. There is no single pathognomonic clinical feature or diagnostic test; diagnosis of multiple sclerosis relies on the integration of clinical, imaging, and laboratory findings. MRI abnormalities associated with other diseases and non-specific MRI findings, which are common in the general population, can be mistaken for multiple sclerosis. The increasingly strong focus on timely diagnosis to alleviate uncertainty for patients and allow initiation of disease-modifying therapies might also increase the risk of misdiagnosis.(21)

With increasing availability and use of MRI, incidental T2 hyperintensities on brain imaging are common, the subset of individuals with MRI findings that are strongly suggestive of multiple sclerosis lesions but with no neurological manifestations or other clear-cut explanation are said to have radiologically isolated syndrome. There is no consensus on whether patients with radiologically isolated syndrome will develop MS. Some practitioners argue that these patients have a high likelihood of developing MS while others argue that up to two-thirds of these patients will not receive a diagnosis of MS in 5 years.  A consensus panel decided to require clinical manifestations to make the diagnosis of MS (2017 McDonald Criteria for the diagnosis of Multiple Sclerosis).(21)

The 2017 McDonald criteria to diagnose MS is shown in the chart below.(21,22)

Clinical Presentation

Additional Data needed to make MS diagnosis

In a person with a typical attack/CIS at onset

Greater than or equal to 2 attacks and objective clinical evidence of greater than or equal to 2 lesions
OR
Greater than or equal to 2 attacks and objective clinical evidence of 1 lesion with historical evidence of prior attack involving lesion in different location

None. Dissemination in space* and dissemination in time** have been met

Greater than or equal to 2 attacks and objective clinical evidence of 1 lesion

ONE of these criteria:
Additional clinical attack implicating different CNS site
OR
Greater than or equal to 1 symptomatic or asymptomatic MS-typical T2 lesions in greater than or equal to 2 areas of CNS: periventricular, juxtacortical/cortical, infratentorial, or spinal cord

1 attack and objective clinical evidence of greater than or equal to 2 lesions

ONE of these criteria:
Additional clinical attack
OR
Simultaneous presence of both enhancing and non-enhancing symptomatic or asymptomatic MS-typical MRI lesions
OR
New T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan)
OR
CSF specific (i.e., not in serum) oligoclonal bands

1 attack and objective clinical evidence of 1 lesion

ONE of these criteria:
Additional attack implicating different CNS site
OR
Greater than or equal to 1 MS-Typical symptomatic or asymptomatic T2 lesions in greater than or equal to 2 areas of CNS: periventricular, juxtacortical/cortical, infratentorial, or spinal cord

AND
ONE of these criteria:
Additional clinical attack
OR
Simultaneous presence of both enhancing and non-enhancing symptomatic or asymptomatic MS-typical MRI lesions
OR
New T2 enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan)
OR
CSF-specific (i.e., not in serum) oligoclonal bands

*Dissemination in space is defined as one or more T2-hyperintense lesions that are characteristic of multiple sclerosis in 2 or more of four areas of the CNS (periventricular, cortical or juxtacortical, and infratentorial brain regions, and the spinal cord) demonstrated by an additional clinical attack implicating a different CNS site or by MRI.(21)

**Dissemination in time is defined as simultaneous presence of gadolinium-enhancing and non-enhancing lesions at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI, with reference to a baseline scan, irrespective of the timing of the baseline MRI. The presence of CSF-specific oligoclonal bands does not demonstrate dissemination in time per se but can substitute for the requirement for demonstration of this measure.(21)

Treatment of MS

Both the Multiple Sclerosis Coalition and the American Academy of Neurology recommend initiating treatment with a DMA FDA approved for the patient’s phenotype as soon as possible following the diagnosis of multiple sclerosis. There are several DMAs with at least 10 mechanisms of action available to people with MS. The factors affecting choice of therapy at any point in the disease course are complex and most appropriately analyzed and addressed through a shared decision-making process between the individual and the treating clinician.(16,19)

The Multiple Sclerosis Coalition recommends that clinicians should consider prescribing a high efficacy medication such as alemtuzumab, cladribine, fingolimod, natalizumab or ocrelizumab for newly diagnosed individuals with highly active MS. Clinicians should also consider prescribing a high efficacy medication for individuals who have breakthrough activity on another DMA regardless of the number of previously used agents.(16) The American Academy of Neurology has recommended alemtuzumab, fingolimod, and natalizumab as options for patients with MS with highly active MS. There lacks a consensus for what constitutes as highly active MS, however.(19) The National Institute for Health and Care Excellence (NICE) defines rapidly evolving severe RRMS as two or more disabling relapses in 1 year, and one or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load compared with a previous MRI.(31)

Lack of response to DMAs is hard to define, as most patients with MS are not free of all disease activity. Relapses or new MRI detected lesions may develop after initiation of a DMA and before the treatment becomes effective for patients. When determining efficacy, sufficient time for the DMA therapy to take full effect and patient adherence are important considerations. Evidence of one or more relapses, 2 or more unequivocally new MRI-detected lesions, or increased disability on examination while being treated with a DMA for a 1 year period suggests a sub-optimal response, an alternative regimen (e.g., different mechanism of action) should be considered to optimize therapeutic benefit.(18) A National MS Society consensus statement recommends changing from one disease modifying therapy to another only for medically appropriate reasons (e.g., lack of efficacy, adverse effects, or if better treatments options become available).(16)

Existing MS therapies are partly effective in halting ongoing inflammatory tissue damage and clinical progression. MS pathogenesis is complex and probably heterogeneous among patient, suggesting that combination therapy strategies that target a range of disease mechanisms might be more effective than medications used as monotherapy. Although preliminary studies have provided favorable results, however, several subsequent large, randomized, controlled trials have had negative of conflicting results. There also may be more adverse reactions associated with combination therapies due to the additive effect.(24)

In 2020 a Canadian MS working group published recommendations on optimal therapy in relapsing forms of MS. This group notes that there are few studies that have directly compared injectable and oral DMTs. A recent network meta-analysis suggested that pegylated interferon-β-1a and dimethyl fumarate have superior efficacy to other base therapies, there are insufficient data to demonstrate that one base injectable or oral DMT is superior to another. As a result, the choice of initial treatment will need to be individualized according to disease activity, severity, and comorbidities.(25)

In addition to base therapies, the working group considers 5 DMTs to be of higher efficacy which although can be used as initial therapy, they are generally reserved for patients with a poor response or tolerability with a base therapy. Patients presenting with high disease activity or aggressive/rapidly evolving MS at onset could be considered to initiate therapy with one of these more effective therapies, but the most common treatment initiation is to start on a base therapy with the view of switching within 6-12 months. The 5 agents considered to be of higher efficacy are:(25)

  • Oral agents
    • Fingolimod
    • Cladribine
  • Monoclonal antibodies
    • Natalizumab
    • Ocrelizumab
    • Alemtuzumab

The MS working group discussed the criteria for switching therapies in RRMS and recommends a change in DMT is indicated for patients who meet any of the Major criteria below:(25)

 

Minor

Major

Relapse rate

  • One relapse in first 2 years of treatment
  • Greater than or equal to 2 relapses in first year of treatment

Severity

  • Mild
  • No functional impairment (school, work, daily activities, etc.)
  • No motor/cerebellar/brain stem /sphincter involvement
  • Moderate to severe
  • Functional impairment
  • Motor/cerebellar/brain stem/sphincter involvement

Recovery

  • Full recovery at 6 months
  • No functional impairment
  • EDSS change from baseline less than or equal to 1 point at 6 months unless baseline EDSS greater than 5.5
  • Incomplete recovery
  • Functional impairment
  • If EDSS at baseline was 0 then greater than a 1.5 point change from baseline
  • If EDSS greater than 0 but less than or equal to 5.5 at baseline then greater than 1 point change at 6 months
  • If EDSS greater than 5.5 any change would be a major concern

MRI

  • One new lesion
  • Greater than or equal to 3 new lesions during treatment excluding spinal cord lesions
  • Greater than 1 spinal cord lesion

The workgroup does note that on-treatment relapses should only be performed once the drug has achieved a full clinical effect (typically 2-6 months after drug initiation). Relapses that occur before the maximal efficacy of the drug has been reached should be given less weight, but major criteria should take precedence regardless of timing.(25)

For patients with SPMS the workgroup states that is generally advised to continue with the current DMT after onset of SPMS since many patients will have ongoing inflammatory disease and subclinical disease activity may worsen if treatment is withdrawn. A change in treatment may be warranted in patients with active SPMS who continue to have relapses or new MRI lesions, with the caveat that there is insufficient evidence to identify criteria for a suboptimal response in patients with SPMS.(25)

For patients with primary progressive MS clinicians should offer ocrelizumab to patients with active disease provided the benefits outweigh the risks. Caution is recommended when considering treatment for PPMS subgroups that are less likely to benefit from treatment, such as older patients, those with long-standing stable disease, and/or significant neurological deficits, since the limited benefits may not justify the risk associated with treatment. Rituximab may be considered as an alternative therapy for PPMS in regions that permit off-label use in MS due to cost or other considerations.(25)

The Institute for Clinical and Economic Review (ICER) evaluated a new IV treatment, ublituximab against current FDA and accepted use DMT for adults with RRMS. Only in the case of ublituximab vs placebo/no DMT is ublituximab superior rated. The ratings are noted below.(17)

Adults with RRMS

Treatment

Comparator

Evidence Rating

Ublituximab

Natalizumab

I: Insufficient

Ofatumumab

I: Insufficient

Ocrelizumab

I: Insufficient

Rituximab

I: Insufficient

Fumarate class (dimethyl, diroximel, monomethyl)

C++: comparable or better

Fingolimod

C++: comparable or better

Ozanimod

C++: comparable or better

Ponesimod

C++: comparable or better

Siponimod

I: Insufficient

Teriflunomide

B: Incremental

Placebo/no DMT

A: Superior

A: Superior - High certainty of a substantial (moderate-large) net health benefit
B: Incremental -  High certainty of a small net health benefit
C++: Comparable or better - Moderate certainty of a comparable, small, or substantial net health benefit, with which certainty of at least a comparable net health benefit
I: Insufficient - Any situation where the level of certainty in the evidence is low

ICER does note that payors should consider the following:(17)

  • Payors should remove barriers to access to rituximab for RMS patients who are appropriate candidates for this therapy. This includes coverage of biosimilar rituximab with little or no prior authorization given the lack of concern regarding use in appropriate patients and how inexpensive it is compared with other monoclonal antibodies of equal effectiveness
  • Payors should not unilaterally implement policies to switch RMS patients who are stable on their chosen DMT over to lower-cost biosimilar rituximab

Safety

  • Aubagio (teriflunomide) has a boxed warning with the following:(1)
    • Hepatotoxicity: clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Aubagio in the post marketing setting. Concomitant use of Aubagio with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of Aubagio and monitor ALT levels at least monthly for six months. If drug induced liver injury is suspected, discontinue Aubagio and start accelerated elimination procedure
    • Embryofetal toxicity: teratogenicity and embryolethality occurred in animals administered teriflunomide. Exclude pregnancy prior to initiating Aubagio therapy. Advise use of effective contraception in females of reproductive potential during treatment and during an accelerated drug elimination procedure. Stop Aubagio and use an accelerated drug elimination procedure if the patient becomes pregnant
  • Aubagio (teriflunomide) is contraindicated in:(1)
    • Severe hepatic impairment
    • Pregnant women and females of reproductive potential not using effective contraception. Aubagio may cause fetal harm
    • Hypersensitivity reaction to teriflunomide, leflunomide, or any of the inactive ingredients in Aubagio
    • Coadministration with leflunomide
  • Avonex (interferon β-1a) is contraindicated in:(2)
    • History of hypersensitivity to natural or recombinant interferon beta, albumin or any other component of the formulation
  • Bafiertam (monomethyl fumarate) is contraindicated in:(3)
    • Known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or any of the excipients of Bafiertam
    • Co-administration with dimethyl fumarate or diroximel fumarate
  • Betaseron (interferon β-1b) is contraindicated in:(4)
    • History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol
  • Copaxone (glatiramer) is contraindicated in:(5)
    • Known hypersensitivity to glatiramer acetate or mannitol
  • Extavia (interferon β-1b) is contraindicated in:(6)
    • History of hypersensitivity to natural or recombinant interferon beta, albumin (human), or mannitol
  • Gilenya (fingolimod) is contraindicated in:(7)
    • Recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure
    • History of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker
    • Baseline QTc interval greater than or equal to 500 msec
    • Treatment with Class Ia or Class III anti-arrhythmic drugs
    • Hypersensitivity to fingolimod or its excipients
  • Glatopa (glatiramer) is contraindicated in:(8)
    • Known hypersensitivity to glatiramer acetate or mannitol
  • Kesimpta (ofatumumab) is contraindicated in:(9)
    • Active HBV infection
  • Mavenclad (cladribine) contains a boxed warning with the following:(10)
    • Malignancies: Mavenclad may increase the risk of malignancy. Mavenclad is contraindicated in patients with current malignancy; evaluate the benefits and risks on an individual basis for patients with prior or increased risk of malignancy
    • Risk of teratogenicity: Mavenclad is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the risk of fetal harm
  • Mavenclad (cladribine) is contraindicated in:(10)
    • Patients with current malignancy
    • Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during Mavenclad dosing and for 6 months after the last dose in each treatment course
    • HIV infection
    • Active chronic infections (e.g., hepatitis or tuberculosis)
    • History of hypersensitivity to cladribine
    • Women intending to breastfeed on a Mavenclad treatment day and for 10 days after the last dose
  • Mayzent (siponimod) is contraindicated in:(11)
    • Patients with a CYP2C9 *3/*3 genotype
    • Patients who in the last 6 months have experienced: myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III/IV heart failure
    • Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker
  • Plegridy (peginterferon β-1a) is contraindicated in:(12)
    • History of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of Plegridy
  • Ponvory (ponesimod) is contraindicated in:(27)
    • Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure
    • Presence of Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless patient has a functioning pacemaker
  • Rebif (interferon β-1a) is contraindicated in:(13)
    • History of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation
  • Tascenso ODT (fingolimod) is contraindicated in:(29)
    • Recent myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure
    • History or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker
    • Baseline QTc interval greater than or equal to 500 msec
    • Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs 
    • Hypersensitivity reaction to fingolimod or any of the excipients in Tascenso ODT. Observed reactions include rash, urticaria, and angioedema
    • Concomitant use with other products containing fingolimod
  • Tecfidera (dimethyl fumarate) is contraindicated in:(14)
    • Known hypersensitivity to dimethyl fumarate or any of the excipients of Tecfidera
  • Vumerity (diroximel fumarate) is contraindicated in:(15)
    • Known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of Vumerity
    • Co-administration with dimethyl fumarate

REFERENCES

Number

Reference

1

Aubagio prescribing information. Genzyme Corporation. December 2022.

2

Avonex prescribing information. Biogen, Inc. July 2023.

3

Bafiertam prescribing information. Banner Life Sciences LLC. January 2023.

4

Betaseron prescribing information. Bayer HealthCare Pharmaceuticals, Inc. July 2023.

5

Copaxone prescribing information. Teva Neuroscience, Inc. February 2023.

6

Extavia prescribing information. Novartis Pharmaceuticals Corporation. July 2023.

7

Gilenya prescribing information. Novartis Pharmaceuticals Corporation. August 2023.

8

Glatopa prescribing information. Sandoz Inc. March 2023.

9

Kesimpta prescribing information. Novartis Pharmaceuticals Corporation. September 2022.

10

Mavenclad prescribing information. EMD Serono, Inc. September 2022.

11

Mayzent prescribing information. Novartis Pharmaceuticals Corporation. August 2023.

12

Plegridy prescribing information. Biogen, Inc. July 2023.

13

Rebif prescribing information. EMD Serono, Inc. July 2023.

14

Tecfidera prescribing information. Biogen, Inc. February 2023.

15

Vumerity prescribing information. Biogen Inc. February 2023.

16

Multiple Sclerosis Coalition. The Use of Disease Modifying Therapies in Multiple Sclerosis: Principals and Current Evidence. Updated June 2019. National Multiple Sclerosis Society. Available at: https://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/DMT_Consensus_MS_Coalition.pdf.

17

Institute for Clinical and Economic Review (ICER). Oral and Monoclonal Antibody Treatments for Relapsing Forms of Multiple Sclerosis: Effectiveness and Value. February 21, 2023.

18

Rae-Grant, Alexander, MD, et al. Practice Guideline Recommendations Summary: Disease-Modifying Therapies for Adults with Multiple Sclerosis. Neurology. 2018;90:777-788.

19

Corboy, John R, MD, et al. Comment on 2018 American Academy of Neurology Guidelines on Disease-Modifying Therapies in MS. Neurology. 2018;90:1106-1112.

20

Reference no longer used

21

Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis:2017 revisions of the McDonald criteria. Lancet Neurol 2018; 17:162-73.

22

National Multiple Sclerosis Society 2017 McDonald MS Diagnostic Criteria. Available at: https://www.nationalmssociety.org/For-Professionals/Clinical-Care/Diagnosing-MS/Diagnosing-Criteria.

23

MS international federation. Types of MS. Last updated 12th March 2022. Accessed at Types of MS | Multiple Sclerosis (msif.org)

24

Conway D, Cohen JA. Combination therapy in multiple sclerosis. Lancet Neurol 2010 Mar;9(3):299-308.

25

Freedman MS, Devonshire V, Duquette P, et al. Treatment Optimization in Multiple Sclerosis: Canadian MS Working Group Recommendations. The Can J Neurol Sci. 2020;47:437-455.

26

Reference no longer used

27

Ponvory prescribing information. Janssen Pharmaceuticals, Inc. April 2021.

28

Kitzler HH, Wahl H, Eisele JC, et al. Multi-component relaxation in clinically isolated syndrome; Lesion myelination may predict multiple sclerosis conversion. NeuroImage:Clinical 20 (2018)61-70.

29

Tascenso prescribing information. Handa Neuroscience, LLC. December 2022.

30

MS international federation. About MS - Symptoms. Accessed at  MS Symptoms | Multiple Sclerosis (msif.org).

31

National Institute for Health and Care Excellence. NICE Guidance - Conditions and diseases - Neurological conditions - Multiple sclerosis. Ofatumumab for treating relapsing multiple sclerosis. Technology appraisal guidance [TA699] Published:19 May 2021. Accessed at 3 Committee discussion | Ofatumumab for treating relapsing multiple sclerosis | Guidance | NICE.

POLICY AGENT SUMMARY STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Preferred Generic Agents

Aubagio

teriflunomide tab

14 MG ; 7 MG

Y

O ; Y

1. Preferred

Copaxone ; Glatopa

glatiramer acetate soln prefilled syringe

20 MG/ML ; 40 MG/ML

Y

O ; Y

1. Preferred

Gilenya

fingolimod hcl cap

0.25 MG ; 0.5 MG

Y

N ; O ; Y

1. Preferred

Tecfidera ; Tecfidera starter pack

dimethyl fumarate capsule delayed release  ; dimethyl fumarate capsule dr starter pack

120 & 240 MG ; 120 MG ; 240 MG

Y

O ; Y

1. Preferred

Preferred Brand Agents

Avonex ; Avonex pen ; Rebif ; Rebif rebidose ; Rebif rebidose titration ; Rebif titration pack

interferon beta-

22 MCG/0.5ML ; 30 MCG/0.5ML ; 44 MCG/0.5ML ; 6X8.8 & 6X22 MCG

M ; N ; O ; Y

N

1. Preferred

Betaseron

Interferon Beta- ; interferon beta-

0.3 MG

M ; N ; O ; Y

N

1. Preferred

Kesimpta

ofatumumab soln auto-injector

20 MG/0.4ML

M ; N ; O ; Y

N

1. Preferred

Mavenclad

cladribine tab therapy pack

10 MG

M ; N ; O ; Y

N

1. Preferred

Mayzent ; Mayzent starter pack

siponimod fumarate tab

0.25 MG ; 1 MG ; 2 MG

M ; N ; O ; Y

N

1. Preferred

Plegridy ; Plegridy starter pack

peginterferon beta-

125 MCG/0.5ML ; 63 & 94 MCG/0.5ML

M ; N ; O ; Y

N

1. Preferred

Aubagio

teriflunomide tab

14 MG ; 7 MG

M ; N ; O

O ; Y

2. Non-Preferred

Bafiertam

monomethyl fumarate capsule delayed release

95 MG

M ; N ; O ; Y

N

2. Non-Preferred

Copaxone

glatiramer acetate soln prefilled syringe

20 MG/ML ; 40 MG/ML

M ; N ; O

O ; Y

2. Non-Preferred

Extavia

Interferon Beta- ; interferon beta-

0.3 MG

M ; N ; O ; Y

N

2. Non-Preferred

Gilenya

fingolimod hcl cap

0.25 MG ; 0.5 MG

M ; N ; O

N ; O ; Y

2. Non-Preferred

Ponvory ; Ponvory 14-day starter pa

ponesimod tab  ; ponesimod tab starter pack

2-3-4-5-6-7-8-9 & 10 MG ; 20 MG

M ; N ; O ; Y

N

2. Non-Preferred

Tascenso odt

fingolimod lauryl sulfate tablet disintegrating

0.25 MG ; 0.5 MG

M ; N ; O ; Y

N

2. Non-Preferred

Tecfidera ; Tecfidera starter pack

dimethyl fumarate capsule delayed release  ; dimethyl fumarate capsule dr starter pack

120 & 240 MG ; 120 MG ; 240 MG

M ; N ; O

O ; Y

2. Non-Preferred

Vumerity

diroximel fumarate capsule delayed release

231 MG

M ; N ; O ; Y

N

2. Non-Preferred

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Aubagio

teriflunomide tab

14 MG ; 7 MG

30

Tablets

30

DAYS

Avonex

interferon beta-

30 MCG/0.5ML

4

Syringes

28

DAYS

Avonex pen

interferon beta-

30 MCG/0.5ML

4

Pens

28

DAYS

Bafiertam

monomethyl fumarate capsule delayed release

95 MG

120

Capsules

30

DAYS

Betaseron

Interferon Beta- ; interferon beta-

0.3 MG

14

Vials

28

DAYS

50419052401 ; 50419052435

Copaxone

glatiramer acetate soln prefilled syringe

20 MG/ML

30

Syringes

30

DAYS

68546031730

Copaxone ; Glatopa

glatiramer acetate soln prefilled syringe

20 MG/ML

30

Syringes

30

DAYS

00781323434 ; 00781323471

Copaxone ; Glatopa

glatiramer acetate soln prefilled syringe

40 MG/ML

12

Syringes

28

DAYS

00781325071 ; 00781325089 ; 63629881601

Copaxone ; Glatopa

Glatiramer Acetate Soln Prefilled Syringe 20 MG/ML

20 MG/ML

30

Syringes

30

DAYS

Copaxone ; Glatopa

Glatiramer Acetate Soln Prefilled Syringe 40 MG/ML

40 MG/ML

12

Syringes

28

DAYS

Copaxone ; Glatopa

Glatiramer Acetate Soln Prefilled Syringe 40 MG/ML

40 MG/ML

12

Syringes

28

DAYS

Extavia

Interferon Beta- ; interferon beta-

0.3 MG

15

Vials

30

DAYS

00078056912 ; 00078056961 ; 00078056999

Gilenya

fingolimod hcl cap

0.25 MG ; 0.5 MG

30

Capsules

30

DAYS

Kesimpta

ofatumumab soln auto-injector

20 MG/0.4ML

1

Pen

28

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (10 Tabs)

10 MG

20

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (4 Tabs)

10 MG

8

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (5 Tabs)

10 MG

10

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (6 Tabs)

10 MG

12

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (7 Tabs)

10 MG

14

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (8 Tabs)

10 MG

8

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (9 Tabs)

10 MG

9

Tablets

301

DAYS

Mayzent

Siponimod Fumarate Tab

1 MG

30

Tablets

30

DAYS

Mayzent

Siponimod Fumarate Tab 0.25 MG (Base Equiv)

0.25 MG

120

Tablets

30

DAYS

Mayzent

Siponimod Fumarate Tab 2 MG (Base Equiv)

2 MG

30

Tablets

30

DAYS

Mayzent starter pack

Siponimod Fumarate Tab

0.25 MG

1

Kit

180

DAYS

Mayzent starter pack

Siponimod Fumarate Tab 0.25 MG (12) Starter Pack

0.25 MG

12

Tablets

180

DAYS

Plegridy

Peginterferon Beta-

125 MCG/0.5ML

2

Syringes

28

DAYS

Plegridy

Peginterferon Beta-1a Soln Pen-injector 125 MCG/0.5ML

125 MCG/0.5ML

2

Pens

28

DAYS

Plegridy

Peginterferon Beta-1a Soln Prefilled Syringe 125 MCG/0.5ML

125 MCG/0.5ML

2

Syringes

28

DAYS

Plegridy starter pack

Peginterferon Beta-1a Soln Pen-inj 63 & 94 MCG/0.5ML Pack

63 & 94 MCG/0.5ML

1

Kit

180

DAYS

Plegridy starter pack

Peginterferon Beta-1a Soln Pref Syr 63 & 94 MCG/0.5ML Pack

63 & 94 MCG/0.5ML

1

Kit

180

DAYS

Ponvory

Ponesimod Tab

20 MG

30

Tablets

30

DAYS

Ponvory 14-day starter pa

Ponesimod Tab Starter Pack

2-3-4-5-6-7-8-9 & 10 MG

14

Tablets

180

DAYS

Rebif ; Rebif titration pack

interferon beta-

22 MCG/0.5ML ; 44 MCG/0.5ML ; 6X8.8 & 6X22 MCG

12

Syringes

28

DAYS

Rebif rebidose ; Rebif rebidose titration

interferon beta-

22 MCG/0.5ML ; 44 MCG/0.5ML ; 6X8.8 & 6X22 MCG

12

Syringes

28

DAYS

Rebif rebidose titration

Interferon Beta-1a Auto-inj 6X8.8 MCG/0.2ML & 6X22 MCG/0.5ML

6X8.8 & 6X22 MCG

1

Kit

180

DAYS

Rebif titration pack

Interferon Beta-1a Pref Syr 6X8.8 MCG/0.2ML & 6X22 MCG/0.5ML

6X8.8 & 6X22 MCG

1

Kit

180

DAYS

Tascenso odt

fingolimod lauryl sulfate tablet disintegrating

0.25 MG ; 0.5 MG

30

Tablets

30

DAYS

Tecfidera

dimethyl fumarate capsule delayed release

120 MG

14

Capsules

180

DAYS

64406000501

Tecfidera

dimethyl fumarate capsule delayed release

240 MG

60

Capsules

30

DAYS

64406000602

Tecfidera

Dimethyl Fumarate Capsule Delayed Release 120 MG

120 MG

14

Capsules

180

DAYS

Tecfidera

Dimethyl Fumarate Capsule Delayed Release 240 MG

240 MG

60

Capsules

30

DAYS

Tecfidera starter pack

dimethyl fumarate capsule dr starter pack

120 & 240 MG

60

Capsules

180

DAYS

Vumerity

diroximel fumarate capsule delayed release

231 MG

120

Capsules

30

DAYS

CLIENT SUMMARY – STEP THERAPY

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Aubagio

teriflunomide tab

14 MG ; 7 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Avonex ; Avonex pen ; Rebif ; Rebif rebidose ; Rebif rebidose titration ; Rebif titration pack

interferon beta-

22 MCG/0.5ML ; 30 MCG/0.5ML ; 44 MCG/0.5ML ; 6X8.8 & 6X22 MCG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Betaseron

Interferon Beta- ; interferon beta-

0.3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Copaxone ; Glatopa

glatiramer acetate soln prefilled syringe

20 MG/ML ; 40 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Gilenya

fingolimod hcl cap

0.25 MG ; 0.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kesimpta

ofatumumab soln auto-injector

20 MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mavenclad

cladribine tab therapy pack

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mayzent ; Mayzent starter pack

siponimod fumarate tab

0.25 MG ; 1 MG ; 2 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Plegridy ; Plegridy starter pack

peginterferon beta-

125 MCG/0.5ML ; 63 & 94 MCG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tecfidera ; Tecfidera starter pack

dimethyl fumarate capsule delayed release  ; dimethyl fumarate capsule dr starter pack

120 & 240 MG ; 120 MG ; 240 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Aubagio

teriflunomide tab

14 MG ; 7 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Bafiertam

monomethyl fumarate capsule delayed release

95 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Copaxone

glatiramer acetate soln prefilled syringe

20 MG/ML ; 40 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Extavia

Interferon Beta- ; interferon beta-

0.3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Gilenya

fingolimod hcl cap

0.25 MG ; 0.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ponvory ; Ponvory 14-day starter pa

ponesimod tab  ; ponesimod tab starter pack

2-3-4-5-6-7-8-9 & 10 MG ; 20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tascenso odt

fingolimod lauryl sulfate tablet disintegrating

0.25 MG ; 0.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tecfidera ; Tecfidera starter pack

dimethyl fumarate capsule delayed release  ; dimethyl fumarate capsule dr starter pack

120 & 240 MG ; 120 MG ; 240 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vumerity

diroximel fumarate capsule delayed release

231 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Aubagio

teriflunomide tab

14 MG ; 7 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Avonex

interferon beta-

30 MCG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Avonex pen

interferon beta-

30 MCG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Bafiertam

monomethyl fumarate capsule delayed release

95 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Betaseron

Interferon Beta- ; interferon beta-

0.3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Copaxone

glatiramer acetate soln prefilled syringe

20 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Copaxone ; Glatopa

glatiramer acetate soln prefilled syringe

20 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Copaxone ; Glatopa

glatiramer acetate soln prefilled syringe

40 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Copaxone ; Glatopa

Glatiramer Acetate Soln Prefilled Syringe 20 MG/ML

20 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Copaxone ; Glatopa

Glatiramer Acetate Soln Prefilled Syringe 40 MG/ML

40 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Copaxone ; Glatopa

Glatiramer Acetate Soln Prefilled Syringe 40 MG/ML

40 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Extavia

Interferon Beta- ; interferon beta-

0.3 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Gilenya

fingolimod hcl cap

0.25 MG ; 0.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Kesimpta

ofatumumab soln auto-injector

20 MG/0.4ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mavenclad

Cladribine Tab Therapy Pack 10 MG (10 Tabs)

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mavenclad

Cladribine Tab Therapy Pack 10 MG (4 Tabs)

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mavenclad

Cladribine Tab Therapy Pack 10 MG (5 Tabs)

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mavenclad

Cladribine Tab Therapy Pack 10 MG (6 Tabs)

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mavenclad

Cladribine Tab Therapy Pack 10 MG (7 Tabs)

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mavenclad

Cladribine Tab Therapy Pack 10 MG (8 Tabs)

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mavenclad

Cladribine Tab Therapy Pack 10 MG (9 Tabs)

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mayzent

Siponimod Fumarate Tab

1 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mayzent

Siponimod Fumarate Tab 0.25 MG (Base Equiv)

0.25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mayzent

Siponimod Fumarate Tab 2 MG (Base Equiv)

2 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mayzent starter pack

Siponimod Fumarate Tab

0.25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Mayzent starter pack

Siponimod Fumarate Tab 0.25 MG (12) Starter Pack

0.25 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Plegridy

Peginterferon Beta-

125 MCG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Plegridy

Peginterferon Beta-1a Soln Pen-injector 125 MCG/0.5ML

125 MCG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Plegridy

Peginterferon Beta-1a Soln Prefilled Syringe 125 MCG/0.5ML

125 MCG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Plegridy starter pack

Peginterferon Beta-1a Soln Pen-inj 63 & 94 MCG/0.5ML Pack

63 & 94 MCG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Plegridy starter pack

Peginterferon Beta-1a Soln Pref Syr 63 & 94 MCG/0.5ML Pack

63 & 94 MCG/0.5ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ponvory

Ponesimod Tab

20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Ponvory 14-day starter pa

Ponesimod Tab Starter Pack

2-3-4-5-6-7-8-9 & 10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Rebif ; Rebif titration pack

interferon beta-

22 MCG/0.5ML ; 44 MCG/0.5ML ; 6X8.8 & 6X22 MCG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Rebif rebidose ; Rebif rebidose titration

interferon beta-

22 MCG/0.5ML ; 44 MCG/0.5ML ; 6X8.8 & 6X22 MCG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Rebif rebidose titration

Interferon Beta-1a Auto-inj 6X8.8 MCG/0.2ML & 6X22 MCG/0.5ML

6X8.8 & 6X22 MCG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Rebif titration pack

Interferon Beta-1a Pref Syr 6X8.8 MCG/0.2ML & 6X22 MCG/0.5ML

6X8.8 & 6X22 MCG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tascenso odt

fingolimod lauryl sulfate tablet disintegrating

0.25 MG ; 0.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tecfidera

dimethyl fumarate capsule delayed release

120 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tecfidera

dimethyl fumarate capsule delayed release

240 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tecfidera

Dimethyl Fumarate Capsule Delayed Release 120 MG

120 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tecfidera

Dimethyl Fumarate Capsule Delayed Release 240 MG

240 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Tecfidera starter pack

dimethyl fumarate capsule dr starter pack

120 & 240 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Vumerity

diroximel fumarate capsule delayed release

231 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

STEP THERAPY CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

TARGET AGENT(S)

Preferred generic agent(s)

Preferred brand agent(s)

Nonpreferred agent(s)

dimethyl fumarate
fingolimod
glatiramer
Glatopa (glatiramer)
teriflunomide

Avonex (interferon b-1a)
Betaseron (interferon b-1b)
Kesimpta (ofatumumab)
Mavenclad (cladribine)
Mayzent (siponimod)
Plegridy (peginterferon b-1a)
Rebif (interferon b-1a)

Aubagio (teriflunomide)**
Bafiertam (monomethyl fumarate)
Copaxone (glatiramer)**
Extavia (interferon b-1b)
Gilenya (fingolimod)**
Ponvory (ponesimod)
Tascenso ODT (fingolimod)
Tecfidera (dimethyl fumarate)**
Vumerity (diroximel fumarate)

*These agents subject to duplicate therapy check only

**Generic available

Target Agent(s) will be approved when ALL of the following are met:

  1. ONE of following:
    1. The requested agent is eligible for continuation of therapy AND ONE of the following:
      1. The patient has been treated with the requested agent within the past 90 days OR
      2. The prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR

Agents Eligible for Continuation of Therapy

All target agents except the following are eligible for continuation of therapy:

Brand Aubagio
Brand Copaxone
Brand Gilenya
Brand Tecfidera

    1. The requested agent is a preferred generic agent OR
    2. The patient has highly active MS disease activity AND ALL of the following:
      1. The patient has greater than or equal to 2 relapses in the previous year AND
      2. ONE of the following:
        1. The patient has greater than or equal to 1 gadolinium enhancing lesion on MRI OR
        2. The patient has significant increase in T2 lesion load compared with a previous MRI OR
    3. The patient has been treated with at least 3 MS agents from different drug classes (see MS disease modifying agents drug class table) OR
    4. The requested agent is a preferred brand agent AND ONE of the following:
      1. The patient’s medication history includes use of ONE preferred generic agent OR
      2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, NOT to the route of administration) or hypersensitivity to ONE preferred generic agent OR
      3. The patient has an FDA labeled contraindication to ALL preferred generic agents OR
      4. There is support for using the requested agent over ALL preferred generic agents OR
    5. The requested agent is a nonpreferred agent AND BOTH of the following:
      1. ONE of the following:
        1. The patient’s medication history includes use of ONE preferred generic agent within the past 365 days OR
        2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, NOT to the route of administration) or hypersensitivity to ONE preferred generic agent OR
        3. The patient has an FDA labeled contraindication to ALL preferred generic agents AND
      2. ONE of the following:
        1. The patient’s medication history includes the use of ONE preferred brand agent or Zeposia (ozanimod) within the past 365 days OR
        2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, NOT to the route of administration) or hypersensitivity to ONE preferred brand agent or Zeposia OR
        3. The patient has an FDA labeled contraindication to ALL preferred brand agents AND Zeposia AND
  1. If the requested agent is a brand agent with a generic equivalent (listed below), ONE of the following:

Non-Preferred Agent

Generic Equivalent

Aubagio

teriflunomide

Copaxone

Glatopa/glatiramer

Gilenya

fingolimod

Tecfidera

dimethyl fumarate

    1. The patient’s medication history includes use of the generic equivalent OR
    2. The patient has an intolerance or hypersensitivity to the generic equivalent agent that is NOT expected to occur with the requested agent OR
    3. The patient has an FDA labeled contraindication to the generic equivalent agent that is NOT expected to occur with the requested agent AND
  1. The patient will NOT be taking an additional disease modifying agent (DMA) for the requested indication

Length of Approval:  12 months. NOTE: For agents requiring a starter dose for initial use, the starter dose can be approved for the FDA labeled starting dose and the maintenance dose can be approved for the remainder of 12 months.

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

QL with ST

Quantity Limit for Target Agent(s) will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
    1. BOTH of the following:
      1. The requested agent does not have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
    2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
    3. BOTH of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months NOTE: For agents requiring a starter dose for initial use, the starter dose can be approved for the FDA labeled starting dose and the maintenance dose can be approved for the remainder of 12 months 

 

CLASS AGENTS

Class

Class Drug Agents

Class Ia antiarrhythmics

Class Ia antiarrhythmics

 Pronestyl (procainamide)

Class Ia antiarrhythmics

 quinidine

Class Ia antiarrhythmics

NORPACE*Disopyramide Phosphate Cap

Class III antiarrhythmics

Class III antiarrhythmics

BETAPACE*Sotalol HCl Tab

Class III antiarrhythmics

Cordarone, Pacerone (amiodarone)

Class III antiarrhythmics

CORVERT*Ibutilide Fumarate Inj

Class III antiarrhythmics

MULTAQ*Dronedarone HCl Tab

Class III antiarrhythmics

TIKOSYN*Dofetilide Cap

MS Disease Modifying Agents drug class: CD20 monoclonal antibody

MS Disease Modifying Agents drug class: CD20 monoclonal antibody

BRIUMVI*ublituximab-xiiy soln for iv infusion

MS Disease Modifying Agents drug class: CD20 monoclonal antibody

KESIMPTA*Ofatumumab Soln Auto-Injector

MS Disease Modifying Agents drug class: CD20 monoclonal antibody

OCREVUS*Ocrelizumab Soln For IV Infusion

MS Disease Modifying Agents drug class: CD52 monoclonal antibody

MS Disease Modifying Agents drug class: CD52 monoclonal antibody

LEMTRADA*Alemtuzumab IV Inj

MS Disease Modifying Agents drug class: Fumarates

MS Disease Modifying Agents drug class: Fumarates

BAFIERTAM*Monomethyl Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug class: Fumarates

TECFIDERA*Dimethyl Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug class: Fumarates

VUMERITY*Diroximel Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug class: Glatiramer

MS Disease Modifying Agents drug class: Glatiramer

COPAXONE*Glatiramer Acetate Soln Prefilled Syringe

MS Disease Modifying Agents drug class: Glatiramer

GLATOPA*Glatiramer Acetate Soln Prefilled Syringe

MS Disease Modifying Agents drug class: IgG4k monoclonal antibody

MS Disease Modifying Agents drug class: IgG4k monoclonal antibody

TYSABRI*Natalizumab for IV Inj Conc

MS Disease Modifying Agents drug class: Interferons

MS Disease Modifying Agents drug class: Interferons

AVONEX*Interferon beta-1a injection

MS Disease Modifying Agents drug class: Interferons

BETASERON*Interferon beta-1b injection

MS Disease Modifying Agents drug class: Interferons

EXTAVIA*Interferon beta-1b injection

MS Disease Modifying Agents drug class: Interferons

PLEGRIDY*Peginterferon beta-1a injection

MS Disease Modifying Agents drug class: Interferons

REBIF*Interferon Beta-

MS Disease Modifying Agents drug class: Purine antimetabolite

MS Disease Modifying Agents drug class: Purine antimetabolite

MAVENCLAD*Cladribine Tab Therapy Pack

MS Disease Modifying Agents drug class: Pyrimidine synthesis inhibitor

MS Disease Modifying Agents drug class: Pyrimidine synthesis inhibitor

AUBAGIO*Teriflunomide Tab

MS Disease Modifying Agents drug class: Sphingosine 1-phosphate (SIP) receptor modulator

MS Disease Modifying Agents drug class: Sphingosine 1-phosphate (SIP) receptor modulator

GILENYA*Fingolimod HCl Cap

MS Disease Modifying Agents drug class: Sphingosine 1-phosphate (SIP) receptor modulator

MAYZENT*Siponimod Fumarate Tab

MS Disease Modifying Agents drug class: Sphingosine 1-phosphate (SIP) receptor modulator

PONVORY*Ponesimod Tab

MS Disease Modifying Agents Drug Class: Sphingosine 1-phosphate (SIP) receptor modulator

MS Disease Modifying Agents Drug Class: Sphingosine 1-phosphate (SIP) receptor modulator

TASCENSO*fingolimod lauryl sulfate tablet disintegrating

MS Disease Modifying Agents drug class: Sphingosine 1-phosphate (SIP) receptor modulator

MS Disease Modifying Agents drug class: Sphingosine 1-phosphate (SIP) receptor modulator

ZEPOSIA*Ozanimod capsule

CONTRAINDICATION AGENTS

Contraindicated as Concomitant Therapy

Examples of Contraindicated Concomitant Disease Modifying Agents (DMAs)
Aubagio (teriflunomide)*
Avonex (interferon β-1a)
Bafiertam (monomethyl fumarate)
Betaseron (interferon β-1b)
Briumvi (ublituximab-xiiy)
Copaxone (glatiramer)*
dimethyl fumarate
Extavia (interferon β-1b)
fingolimod
Gilenya (fingolimod)*
Glatopa (glatiramer)
glatiramer
Kesimpta (ofatumumab)
Lemtrada (alemtuzumab)
Mavenclad (cladribine)
Mayzent (siponimod)
Ocrevus (ocrelizumab)
Plegridy (peginterferon β-1a)
Ponvory (ponesimod)
Rebif (interferon β-1a)
Tascenso ODT (fingolimod)
Tecfidera (dimethyl fumarate)*
teriflunomide
Tysabri (natalizumab)
Vumerity (diroximel fumarate)
Zeposia (ozanimod)

* -generic available

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

ALBP _  Commercial _ CSReg _ Multiple_Sclerosis_Agents_STQL _ProgSum_ 07-01-2024  _ © Copyright Prime Therapeutics LLC. May 2024 All Rights Reserved