Asset Publisher

ph-1057

print Print Back Back

Multiple Sclerosis Agents Step Therapy with Quantity Limit Program Summary

Policy Number: PH-1057

 

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 

7/1/2023

FDA APPROVED 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 available

1

Avonex®

(interferon B-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 B-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 available

5

Extavia®

(interferon B-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 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

 

*Generic available

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 alternate 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 B-1a)

Injection for intramuscular use or 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

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 B-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 ODT™

(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 pediatric patients 10 years of age and older and weighing less than or equal to 40 kg

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 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)

Clinically isolated syndrome

CIS is a first episode of neurologic symptoms caused by inflammation and demyelination in the central nervous system. The episode, which by definition must last for at least 24 hours, is characteristic of multiple sclerosis but does not yet meet the criteria for a diagnosis of MS because people who experience a CIS may or may not go on to develop MS. When CIS is accompanied by lesions on a brain MRI that are similar to those seen in MS, the person has a high likelihood of a second episode of neurologic symptoms and diagnosis of relapsing-remitting MS. When CIS is not accompanied by MS-like lesions on brain MRI, the person has a much lower likelihood of developing MS.(23) 

 

When caused by an acute inflammatory demyelinating event, approximately 85% of all patients subsequently develop MS. The relationship between conventional brain MRI features and the short-term risk of CIS patients developing definite MS has been assessed by several studies and allows for the diagnosis of MS based on the 2017 McDonald criteria. However, in CIS patients with initial multifocal clinical symptom presentation the abnormal MRI did not stratify the risk for clinically definite disease conversion.(28)

 

CIS cohort studies spanning 7 through 20 years of follow-up investigated the long-term risk of MS development and found conversions rates of 65-80% for patients with an abnormal conventional MRI and 8-20% for those with an inconspicuous baseline MRI.(28)

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 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)

 

Safety (1-15,27,29)

  • Aubagio (teriflunomide) has a boxed warning with the following:
    • 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:
    • 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:
    • History of hypersensitivity to natural or recombinant interferon beta, albumin or any other component of the formulation
  • Bafiertam (monomethyl fumarate) is contraindicated in:
    • 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:
    • History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol
  • Copaxone (glatiramer) is contraindicated in:
    • Known hypersensitivity to glatiramer acetate or mannitol
  • Extavia (interferon β-1b) is contraindicated in:
    • History of hypersensitivity to natural or recombinant interferon beta, albumin or mannitol
  • Gilenya (fingolimod) is contraindicated in:
    • 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:
    • Known hypersensitivity to glatiramer acetate or mannitol
  • Kesimpta (ofatumumab) is contraindicated in:
    • Active HBV infection
  • Mavenclad (cladribine) contains a boxed warning with the following:
    • 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:
    • 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:
    • 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:
    • History of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of Plegridy
  • Ponvory (ponesimod) is contraindicated in:
    • 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:
    • History of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation
  • Tecfidera (dimethyl fumarate) is contraindicated in:
    • Known hypersensitivity to dimethyl fumarate or any of the excipients of Tecfidera
  • Tascenso ODT (fingolimod) is contraindicated in:
    • Patients who have in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA< decompensated heart failure requiring hospitalization or Class III/IV heart failure
    • Patients who have a history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker
    • Patients who have a baseline QTc interval greater than or equal to 500 msec
    • Patients who have cardiac arrhythmias requiring anti-arrhythmic treatment with Class Iz or Class III anti-arrhythmic drugs
    • Patients who have had a 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
  • Vumerity (diroximel fumarate) is contraindicated in:
    • 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. April 2022.

2

Avonex prescribing information. Biogen, Inc. November 2021.

3

Bafiertam prescribing information. Banner Life Sciences LLC. May 2021.

4

Betaseron prescribing information. Bayer HealthCare Pharmaceuticals, Inc. November 2021.

5

Copaxone prescribing information. Teva Neurosciences, Inc. April 2022.

6

Extavia prescribing information. Novartis Pharmaceuticals Corporation. November 2021.

7

Gilenya prescribing information. Novartis Pharmaceuticals Corporation. December 2019.

8

Glatopa prescribing information. Sandoz. April 2022.

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. June 2022.

12

Plegridy prescribing information. Biogen, Inc. March 2022.

13

Rebif prescribing information. EMD Serono, Inc. November 2021.

14

Tecfidera prescribing information.  Biogen, Inc. September 2022.

15

Vumerity prescribing information. Alkermes Inc. September 2022.

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). Disease-Modifying Therapies for Relapsing-Remitting and Primary-Progressive Multiple Sclerosis: Effectiveness and Value. March 6, 2017. Available at: https://icer-review.org/wp-content/uploads/2016/08/CTAF_MS_Final_Report_030617.pdf.

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

National Institute for Health and Care Excellence (NICE). Disease-Modifying Therapies For Multiple Sclerosis. 2018. Available at: https://www.nice.org.uk/guidance/ta127/chapter/2-The-technology. 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

Díaz C, Zarco LA, Rivera DM. Highly active multiple sclerosis: An update. Multiple sclerosis and Related Disorders 30 (2019) 215-224. 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 2021.

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

Agent Names

Strength

Targeted MSC

Available MSC

Final Age Limit

Preferred Status

Preferred Generic Agents

AUBAGIO*teriflunomide tab  ; TERIFLUNOMIDE*teriflunomide tab

14  ; 14 MG ; 7  ; 7 MG

Y

O ; Y

1. Preferred

FINGOLIMOD*fingolimod hcl cap  ; GILENYA*fingolimod hcl cap

0.25 MG ; 0.5 MG

Y

N ; O ; Y

1. Preferred

DIMETHYL*dimethyl fumarate capsule delayed release  ; DIMETHYL*dimethyl fumarate capsule dr starter pack  ; TECFIDERA*dimethyl fumarate capsule delayed release  ; TECFIDERA*dimethyl fumarate capsule dr starter pack

120  ; 120 & 240 MG ; 120 MG ; 240  ; 240 MG

Y

O ; Y

1. Preferred

Preferred Brand Agents

 (teriflunomide tab ) ; AUBAGIO (teriflunomide tab )

14  ; 14 MG ; 7  ; 7 MG

M ; N ; O

O ; Y

1. Preferred

AVONEX*interferon beta- ; REBIF*interferon beta-

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

M ; N ; O ; Y

N

1. Preferred

 (interferon beta-) ; BETASERON (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  ; 10 MG

M ; N ; O ; Y

N

1. Preferred

MAYZENT (siponimod fumarate tab ) ; MAYZENT STARTER PACK (siponimod fumarate tab )

0.25 MG ; 1 MG ; 2 MG

M ; N ; O ; Y

N

1. Preferred

PLEGRIDY (peginterferon beta-) ; PLEGRIDY STARTER PACK (peginterferon beta-)

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

M ; N ; O ; Y

N

1. Preferred

Non-Preferred Tecfidera

DIMETHYL*dimethyl fumarate capsule delayed release  ; DIMETHYL*dimethyl fumarate capsule dr starter pack  ; TECFIDERA*dimethyl fumarate capsule delayed release  ; TECFIDERA*dimethyl fumarate capsule dr starter pack

120  ; 120 & 240 MG ; 120 MG ; 240  ; 240 MG

M ; N ; O

O ; Y

2. Non-Preferred

Non-Preferred Gilenya

FINGOLIMOD*fingolimod hcl cap  ; GILENYA*fingolimod hcl cap

0.25 MG ; 0.5 MG

M ; N ; O

N ; O ; Y

2. Non-Preferred

Non-Preferred Agents Excluding Copaxone, Glatopa, Tecfidera

BAFIERTAM (monomethyl fumarate capsule delayed release )

95 MG

M ; N ; O ; Y

N

2. Non-Preferred

 (interferon beta-) ; EXTAVIA (interferon beta-)

0.3 MG

M ; N ; O ; Y

N

2. Non-Preferred

PONVORY*ponesimod tab  ; PONVORY*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*fingolimod lauryl sulfate tablet disintegrating

0.25 MG ; 0.5 MG

M ; N ; O ; Y

N

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  ; 14 MG ; 7  ; 7 MG

30

Tablets

30

DAYS

Avonex

Interferon Beta- ; interferon beta-

30  ; 30 MCG/0.5ML

4

Syringes

28

DAYS

Avonex pen

Interferon Beta- ; interferon beta-

30  ; 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

50419-0524-01 ; 50419-0524-35

Copaxone

glatiramer acetate soln prefilled syringe

20 MG/ML

30

Syringes

30

DAYS

68546-0317-30

Copaxone ; Glatopa

glatiramer acetate soln prefilled syringe

20 MG/ML

30

Syringes

30

DAYS

00781-3234-34 ; 00781-3234-71

Copaxone ; Glatopa

glatiramer acetate soln prefilled syringe

40 MG/ML

12

Syringes

28

DAYS

00781-3250-71 ; 00781-3250-89 ; 63629-8816-01

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

00078-0569-12 ; 00078-0569-61 ; 00078-0569-99

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  ; 10 MG

8

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (5 Tabs)

10  ; 10 MG

10

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (6 Tabs)

10  ; 10 MG

12

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (7 Tabs)

10  ; 10 MG

14

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (8 Tabs)

10  ; 10 MG

8

Tablets

301

DAYS

Mavenclad

Cladribine Tab Therapy Pack 10 MG (9 Tabs)

10  ; 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  ; 120 MG

14

Capsules

180

DAYS

Tecfidera

dimethyl fumarate capsule delayed release

240  ; 240 MG

60

Capsules

30

DAYS

Tecfidera

Dimethyl Fumarate Capsule Delayed Release 120 MG

120  ; 120 MG

14

Capsules

180

DAYS

Tecfidera

Dimethyl Fumarate Capsule Delayed Release 240 MG

240  ; 240 MG

60

Capsules

30

DAYS

Tecfidera starter pack

dimethyl fumarate capsule dr starter pack

120 & 240 MG

60

Capsules

180

DAYS

Tecfidera starter pack

Dimethyl Fumarate Capsule DR Starter Pack 120 MG & 240 MG

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  ; 14 MG ; 7  ; 7 MG

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

Aubagio

teriflunomide tab

14  ; 14 MG ; 7  ; 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- ; interferon beta-

22 MCG/0.5ML ; 30  ; 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

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  ; cladribine tab therapy pack

10  ; 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  ; 120 & 240 MG ; 120 MG ; 240  ; 240 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

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  ; 120 & 240 MG ; 120 MG ; 240  ; 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  ; 14 MG ; 7  ; 7 MG

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

Avonex

Interferon Beta- ; interferon beta-

30  ; 30 MCG/0.5ML

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

Avonex pen

Interferon Beta- ; interferon beta-

30  ; 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  ; 10 MG

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

Mavenclad

Cladribine Tab Therapy Pack 10 MG (5 Tabs)

10  ; 10 MG

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

Mavenclad

Cladribine Tab Therapy Pack 10 MG (6 Tabs)

10  ; 10 MG

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

Mavenclad

Cladribine Tab Therapy Pack 10 MG (7 Tabs)

10  ; 10 MG

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

Mavenclad

Cladribine Tab Therapy Pack 10 MG (8 Tabs)

10  ; 10 MG

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

Mavenclad

Cladribine Tab Therapy Pack 10 MG (9 Tabs)

10  ; 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  ; 120 MG

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

Tecfidera

dimethyl fumarate capsule delayed release

240  ; 240 MG

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

Tecfidera

Dimethyl Fumarate Capsule Delayed Release 120 MG

120  ; 120 MG

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

Tecfidera

Dimethyl Fumarate Capsule Delayed Release 240 MG

240  ; 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

Tecfidera starter pack

Dimethyl Fumarate Capsule DR Starter Pack 120 MG & 240 MG

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)
dimethyl fumarate*
fingolimod*
glatiramer*
teriflunomide*

 

Preferred brand agent(s)
Aubagio (teriflunomide)
Avonex (interferon b-1a)
Betaseron (interferon b-1b)
Kesimpta (ofatumumab)
Mavenclad (cladribine)
Mayzent (siponimod)
Plegridy (peginterferon b-1a)
Rebif (interferon b-1a)

 

Nonpreferred agent(s)
Bafiertam (monomethyl fumarate)
Copaxone (glatiramer)
Extavia (interferon b-1b)
Gilenya (fingolimod)
Glatopa (glatiramer)
Ponvory (ponesimod)
Tascenso ODT (fingolimod)
Tecfidera (dimethyl fumarate)
Vumerity (diroximel fumarate)

*These agents subject to duplicate therapy check only

Target Agent(s) will be approved when BOTH 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. Information has been provided that 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 Copaxone

Brand Gilenya

Glatopa

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. The prescriber has provided information in support of 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 Glatopa or a brand agent with a generic equivalent AND ONE of the following: (listed below)
    1. The patient’s medication history includes use of the corresponding generic equivalent OR
    2. The patient has an intolerance or hypersensitivity to the corresponding generic equivalent agent that is not expected to occur with the requested agent OR
    3. The patient has an FDA labeled contraindication to the corresponding generic equivalent agent that is not expected to occur with the requested agent AND

Non-Preferred products

Corresponding generic equivalent

Copaxone, Glatopa

glatiramer

Gilenya

fingolimod

Tecfidera

dimethyl fumarate

  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.

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

QL with ST

Quantity Limit for the 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) is greater than 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. Information has been provided to support 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. Information has been provided to 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) is greater than the maximum FDA labeled dose for the requested indication AND
      2. Information has been provided to support therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

CLASS AGENTS

Class

Class Drug Agents

Class Ia antiarrhythmics

Class Ia antiarrhythmics

NORPACE*Disopyramide Phosphate Cap

Class Ia antiarrhythmics

Pronestyl (procainamide)

Class Ia antiarrhythmics

quinidine

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 classes: CD 52 monoclonal antibody

MS Disease Modifying Agents drug classes: CD 52 monoclonal antibody

LEMTRADA*Alemtuzumab IV Inj

MS Disease Modifying Agents drug classes: CD20 monoclonal antibody

MS Disease Modifying Agents drug classes: CD20 monoclonal antibody

KESIMPTA*Ofatumumab Soln Auto-Injector

MS Disease Modifying Agents drug classes: CD20 monoclonal antibody

OCREVUS*Ocrelizumab Soln For IV Infusion

MS Disease Modifying Agents drug classes: Fumarates

MS Disease Modifying Agents drug classes: Fumarates

BAFIERTAM*Monomethyl Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug classes: Fumarates

TECFIDERA*Dimethyl Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug classes: Fumarates

VUMERITY*Diroximel Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug classes: Glatiramer

MS Disease Modifying Agents drug classes: Glatiramer

COPAXONE*Glatiramer Acetate Soln Prefilled Syringe

MS Disease Modifying Agents drug classes: Glatiramer

GLATOPA*Glatiramer Acetate Soln Prefilled Syringe

MS Disease Modifying Agents drug classes: IgG4k monoclonal antibody

MS Disease Modifying Agents drug classes: IgG4k monoclonal antibody

TYSABRI*Natalizumab for IV Inj Conc

MS Disease Modifying Agents drug classes: Interferons

MS Disease Modifying Agents drug classes: Interferons

AVONEX*Interferon beta-1a injection

MS Disease Modifying Agents drug classes: Interferons

BETASERON*Interferon beta-1b injection

MS Disease Modifying Agents drug classes: Interferons

EXTAVIA*Interferon beta-1b injection

MS Disease Modifying Agents drug classes: Interferons

PLEGRIDY*Peginterferon beta-1a injection

MS Disease Modifying Agents drug classes: Interferons

REBIF*Interferon Beta-

MS Disease Modifying Agents drug classes: Purine antimetabolite

MS Disease Modifying Agents drug classes: Purine antimetabolite

MAVENCLAD*Cladribine Tab Therapy Pack

MS Disease Modifying Agents drug classes: Pyrimidine synthesis inhibitor

MS Disease Modifying Agents drug classes: Pyrimidine synthesis inhibitor

AUBAGIO*Teriflunomide Tab

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

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

GILENYA*Fingolimod HCl Cap

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

MAYZENT*Siponimod Fumarate Tab

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

PONVORY*Ponesimod Tab

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

TASCENSO*fingolimod lauryl sulfate tablet disintegrating

MS Disease Modifying Agents drug classes: 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 (monoethyl fumarate)

Betaseron (interferon β-1b)

Briumvi (ublituximab-xiiy)

Copaxone (glatiramer)

Extavia (interferon β-1b)

Gilenya (fingolimod)

Glatopa (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)

Tysabri (natalizumab)

Vumerity (diroximel fumarate)

Zeposia (ozanimod)

 

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.

Commercial _ PS _ Multiple Sclerosis Agents Step Therapy with Quantity Limit _ProgSum_ 7/1/2023