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Zeposia (ozanimod) Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1147
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 |
12-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Zeposia® (ozanimod) Capsule |
|
|
1 |
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 demyelination, 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.(2) 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.(18) 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).(9) |
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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.(9) 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.(17) 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.(17) |
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Relapsing remitting multiple sclerosis |
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.(9) |
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Secondary progressive multiple sclerosis |
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.(9) |
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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.(7,8) The diagnosis of MS requires elimination of more likely diagnoses and demonstration of dissemination of lesions in the CNS in space and time.(7) 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.(7) 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).(7) The 2017 McDonald criteria to diagnose MS is shown in the chart below.(7,8)
* - 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.(8) ** - 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.(8) |
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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.(2,5) There is a subgroup of RRMS patients who have a more aggressive disease course marked by a rapid accumulation of physical and cognitive deficit, despite treatment with 1 or more DMTs. In the past, this disease phenotype was called aggressive MS; it is now called highly active MS. It is generally agreed that the severe nature of this phenotype requires different treatment decisions. There is no consensus on the definition of highly active MS or the treatment algorithm.(12) 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.(6) 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.(2) 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.(5) 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.(19) 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.(5) 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).(2) Existing MS therapies are partly effective in halting ongoing inflammatory tissue damage and clinical progression. MS pathogenesis is complex and probably heterogeneous among patients, 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.(10) 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 is 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.(11) 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:(11)
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:(11)
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.(11) 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.(11) 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.(11)
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.(3) Adults with RRMS
A: Superior - High certainty of a substantial (moderate-large) net health benefit ICER does note that payers should consider the following:(3) 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 Payers should not unilaterally implement policies to switch RMS patients who are stable on their chosen DMT over to lower-cost biosimilar rituximab |
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Ulcerative Colitis (UC) |
Ulcerative colitis (UC) is a chronic immune-mediated inflammatory condition affecting the large intestine associated with inflammation of the rectum, but that can extend to involve additional areas of the colon. The American College of Gastroenterology (ACG) recommends a treat-to-target approach and recommend therapeutic management should be guided by diagnosis (i.e., Montreal classification), assessment of disease activity (i.e., mild, moderate, and severe), and disease prognosis. The ACG treatment recommendations are further broken down into induction therapies and maintenance of remission. The 2019 ACG treatment guidelines recommend the following for therapeutic management of UC:(14) Induction of remission:
Maintenance of remission:
The American Gastroenterology Association (AGA) published recommendations for the management of mild to moderate UC:(15)
The American Gastroenterology Association (AGA) published recommendations for the management of moderate to severe UC:(16)
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Safety |
Zeposia (ozanimod) is contraindicated in:(1)
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REFERENCES
Number |
Reference |
1 |
Zeposia prescribing information. Celgene Corporation. August 2023. |
2 |
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. |
3 |
Institute for Clinical and Economic Review (ICER). Oral and monoclonal Antibody Treatments for Relapsing Forms of Multiple Sclerosis: Effectiveness and Value. February 21,2023. |
4 |
Rae-Grant, Alexander, MD, et al. Practice Guideline Recommendations Summary: Disease-Modifying Therapies for Adults with Multiple Sclerosis. Neurology. 2018;90:777-788. |
5 |
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. |
6 |
Reference no longer used |
7 |
Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis:2017 revisions of the McDonald criteria. Lancet Neurol 2018; 17:162-73. |
8 |
National Multiple Sclerosis Society 2017 McDonald MS Diagnostic Criteria. Available at: https://www.nationalmssociety.org/For-Professionals/Clinical-Care/Diagnosing-MS/Diagnosing-Criteria. |
9 |
MS international federation. Types of MS. Last updated 12th March 2022. Accessed at Types of MS | Multiple Sclerosis (msif.org) |
10 |
Conway D, Cohen JA. Combination therapy in multiple sclerosis. Lancet Neurol 2010 Mar;9(3):299-308. |
11 |
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. |
12 |
Reference no longer used |
13 |
Reference not used |
14 |
Rubin, D. T., MD, FACG, Ananthakrishnan, A. N., M.D., M.PH., Siegel, C. A., M.D., M.S., Sauer, B. G., M.D., M.Sc., FACG, & Long, M.D., M.PH., FACG. ACG Clinical Guideline: Ulcerative Colitis in Adults. The American Journal of Gastroenterology. 2019; 114:384-413. Retrieved March 8, 2019, from http://s3.gi.org/physicians/guidelines/UlcerativeColitis.pdf |
15 |
Ko, Cynthia W., Crockett, Seth, et al. AGA Clinical Practice Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis. Gastroenterology. 2019; 156(3):748-764. Retrieved March 8, 2019, from https://www.gastrojournal.org/article/S0016-5085(18)35407-6/pdf. |
16 |
Feuerstein, Joseph D. et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. Gastroenterology, Volume 0, Issue 0. |
17 |
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. |
18 |
MS international federation. About MS - Symptoms. Accessed at MS Symptoms | Multiple Sclerosis (msif.org) |
19 |
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 PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Zeposia ; Zeposia 7-day starter pac ; Zeposia starter kit |
ozanimod cap pack ; ozanimod hcl cap |
0.23MG & 0.46MG & 0.92MG ; 0.23MG &0.46MG 0.92MG(21) ; 0.92 MG ; 4 x 0.23MG & 3 x 0.46MG |
M ; N ; O ; Y |
N |
|
|
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 |
|
|||||||||
Zeposia |
ozanimod hcl cap |
0.92 MG |
30 |
Capsules |
30 |
DAYS |
|
|
|
Zeposia 7-day starter pac |
Ozanimod Cap Pack 4 x 0.23 MG & 3 x 0.46 MG |
4 x 0.23MG & 3 x 0.46MG |
7 |
Capsules |
180 |
DAYS |
|
|
|
Zeposia starter kit |
ozanimod cap pack |
0.23MG &0.46MG 0.92MG(21) |
28 |
Capsules |
180 |
DAYS |
|
|
|
Zeposia starter kit |
Ozanimod Cap Pack 4 x 0.23 MG & 3 x 0.46 MG & 30 x 0.92 MG |
0.23MG & 0.46MG & 0.92MG |
37 |
Capsules |
180 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Zeposia ; Zeposia 7-day starter pac ; Zeposia starter kit |
ozanimod cap pack ; ozanimod hcl cap |
0.23MG & 0.46MG & 0.92MG ; 0.23MG &0.46MG 0.92MG(21) ; 0.92 MG ; 4 x 0.23MG & 3 x 0.46MG |
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 |
Zeposia |
ozanimod hcl cap |
0.92 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zeposia 7-day starter pac |
Ozanimod Cap Pack 4 x 0.23 MG & 3 x 0.46 MG |
4 x 0.23MG & 3 x 0.46MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zeposia starter kit |
ozanimod cap pack |
0.23MG &0.46MG 0.92MG(21) |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Zeposia starter kit |
Ozanimod Cap Pack 4 x 0.23 MG & 3 x 0.46 MG & 30 x 0.92 MG |
0.23MG & 0.46MG & 0.92MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
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Zeposia PA with MS Step |
Immunomodulatory Agent Step Table
Note: A trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as ONE product Initial Evaluation Target Agent(s) will be approved when ONE of the following is met:
Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence Length of Approval: 12 months. NOTE: 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.
Renewal Evaluation Target Agent(s) will be approved when BOTH of the following are met:
Length of Approval: 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
Zeposia PA with MS Step |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months. NOTE: 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 |
NORPACE*Disopyramide Phosphate Cap |
Class Ia antiarrhythmics |
PROCAINAMIDE*Procainamide HCl Inj |
Class Ia antiarrhythmics |
QUINIDINE*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 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 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: CD52 monoclonal antibody |
|
MS Disease Modifying Agents drug classes: CD52 monoclonal antibody |
LEMTRADA*Alemtuzumab IV Inj |
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-1a injection |
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 |
MS Disease Modifying Agents Aubagio (teriflunomide) Avonex (interferon b-1a) Bafiertam (monomethyl fumarate) Betaseron (interferon b-1b) Briumvi (ublituximab-xiiy) Copaxone (glatiramer) dimethyl fumarate Extavia (interferon b-1b) fingolimod Gilenya (fingolimod) Glatopa (glatiramer) glatiramer Kesimpta (ofatumumab) Mavenclad (cladribine) Mayzent (siponimod) Plegridy (peginterferon b-1a) Ponvory (ponesimod) Rebif (interferon b-1a) Tascenso ODT (fingolimod) Tecfidera (dimethyl fumarate) Vumerity (diroximel fumarate) Zeposia (ozanimod)
Immunomodulatory Agents NOT to be used concomitantly Abrilada (adalimumab-afzb) Actemra (tocilizumab) Adalimumab Adbry (tralokinumab-ldrm) Amjevita (adalimumab-atto) Arcalyst (rilonacept) Avsola (infliximab-axxq) Benlysta (belimumab) Bimzelx (bimekizumab-bkzx) Cibinqo (abrocitinib) Cimzia (certolizumab) Cinqair (reslizumab) Cosentyx (secukinumab) Cyltezo (adalimumab-adbm) Dupixent (dupilumab) Enbrel (etanercept) Entyvio (vedolizumab) Fasenra (benralizumab) Hadlima (adalimumab-bwwd) Hulio (adalimumab-fkjp) Humira (adalimumab) Hyrimoz (adalimumab-adaz) Idacio (adalimumab-aacf) Ilaris (canakinumab) Ilumya (tildrakizumab-asmn) Inflectra (infliximab-dyyb) Infliximab Kevzara (sarilumab) Kineret (anakinra) Litfulo (ritlecitinib) Nucala (mepolizumab) Olumiant (baricitinib) Omvoh (mirikizumab-mrkz) Opzelura (ruxolitinib) Orencia (abatacept) Otezla (apremilast) Remicade (infliximab) Renflexis (infliximab-abda) Riabni (rituximab-arrx) Rinvoq (upadacitinib) Rituxan (rituximab) Rituxan Hycela (rituximab/hyaluronidase human) Ruxience (rituximab-pvvr) Siliq (brodalumab) Simponi (golimumab) Simponi ARIA (golimumab) Skyrizi (risankizumab-rzaa) Sotyktu (deucravacitinib) Stelara (ustekinumab) Taltz (ixekizumab) Tezspire (tezepelumab-ekko) Tremfya (guselkumab) Truxima (rituximab-abbs) Tysabri (natalizumab) Velsipity (etrasimod) Wezlana (ustekinumab-auub) Xeljanz (tofacitinib) Xeljanz XR (tofacitinib extended release) Xolair (omalizumab) Yuflyma (adalimumab-aaty) Yusimry (adalimumab-aqvh) Zeposia (ozanimod) Zymfentra (infliximab-dyyb) |
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 _ Zeposia_(ozanimod)_PAQL _ProgSum_ 12-01-2024