| Coverage Policy Manual | |
| Policy #: | 2023045 |
| Category: | Pharmacy |
| Initiated: | October 2023 |
| Last Review: | October 2024 |
|
|
|
|||||||||||
| Eculizumab (e.g., Soliris) and Biosimilars | |
|
|
|
| Description: |
Eculizumab, a recombinant humanized monoclonal IgG2/4 antibody selectively inhibits the terminal portion of the complement system by specifically binding to the terminal C5, which acts at a late stage in the complement cascade. Inhibition of the complement cascade at this point, preserves the normal, disease-preventing functions of proximal complement system while impeding the properties of C5 that promote inflammation and cell destruction. As a recombinant humanized monoclonal antibody that binds to complement protein C5, eculizumab effectively inhibits enzymatic cleavage and blocks formation of the terminal complement complex, preventing red cell lysis in paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated thrombotic microangiopathy in atypical hemolytic uremic syndrome (aHUS).
Regulatory Status
On March 16, 2007, Eculizumab (e.g., Soliris; Alexion Pharmaceuticals, Inc. Cheshire, CT), a humanized monoclonal antibody that binds to the human C5 complement protein, received accelerated approval by the U.S. Food and Drug Administration for the treatment of individuals with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Paroxysmal nocturnal hemoglobinuria (PNH) is a rare clonal hematopoietic stem disorder clinically characterized by chronic complement-mediated hemolysis, thrombosis, and bone marrow failure. Thrombosis, the major cause of death in PNH, is observed in approximately 40% of individuals. The symptoms associated with this disorder, including fatigue, pain, esophageal spasm, and erectile dysfunction, are often severe and disabling.
On September 23, 2011, the U.S. Food and Drug Administration (FDA) approved Eculizumab (e.g., Soliris) for the treatment of all pediatric and adult individuals with atypical hemolytic uremic syndrome (aHUS). Hemolytic-uremic syndrome (HUS) is characterized by hemolytic anemia, thrombocytopenia, and renal failure caused by platelet thrombi in the microcirculation of the kidney and other organs. Typical (acquired) HUS is triggered by infectious agents such as strains of E. coli (Stx-E. coli) that produce powerful Shiga-like exotoxins, whereas atypical HUS (aHUS) can be genetic, acquired, or idiopathic (of unknown cause). Onset of atypical HUS ranges from prenatal to adulthood. Individuals with genetic atypical HUS frequently experience relapse even after complete recovery following the presenting episode. Sixty percent of genetic aHUS progresses to end-stage renal disease (ESRD).
In October 2017, the FDA approved Eculizumab for the treatment of adult individuals with generalized Myasthenia Gravis (gMg) who are anti-acetylcholine receptor (AChR) antibody positive. MG is a common disorder of neuromuscular transmission characterized by a variable combination of weakness in ocular, bulbar, limb, and respiratory muscles. Autoantibodies to the acetylcholine receptor is present in 73% - 88% of individuals with gMG. In the REGAIN study (NCT01997229), Eculizumab produced meaningful improvements in ADL’s, muscle strength, functional ability, and quality of life in those individuals with AchR refractory gMG.
Eculizumab was also approved for neuromyelitis optic spectrum disorder (NMOSD) in adult individuals who are anti-aquapoin-4 (AQP4-IgG) antibody positive on June 27, 2019. NMOSD is a relapsing, autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord. At least two thirds of the cases are associated with AQP4-IgG and complement-mediated damage to the central nervous system.
On March 10, 2025, the U.S. Food and Drug Administration (FDA) approved Eculizumab (e.g., Soliris) for the treatment of pediatric individuals aged six years and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. This landmark approval makes Soliris the first and only treatment available for pediatric individuals living with this debilitating neuromuscular disease.
Complement inhibitors such as eculizumab have black box warnings for serious meningococcal infections. Life-threatening and fatal meningococcal infections have occurred in individuals treated with complement inhibitors and meningococcal infection may become rapidly life-threating or fatal if not recognized and treated early. Individuals should be immunized with meningococcal vaccines at least 2 weeks prior to initiation of therapy unless the risks of delaying therapy outweigh the risk of developing a meningococcal infection. The FDA has required the manufacturers to develop comprehensive risk management programs that include the enrollment of prescribers and dispensing pharmacies in Soliris Risk Evaluation and Mitigation Strategies (REMS) Program.
Coding
See CPT/HCPCS Code section below.
|
|
|
|
|
Policy/ Coverage: |
Effective April 01, 2018, prior approval is required for Eculizumab
(e.g., Soliris).
The use of these drugs requires documentation of direct physician (MD/DO) involvement in the ordering and evaluation as well as a signature in the medical records submitted for prior approval.
Effective January 1, 2026
Select products are preferred where there is an FDA approved indication for the biosimilar product and for all off-label uses of the reference product. According to the United States FDA “a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indications described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of these products have been established, just as they have been for the reference product.”
Preferred Products:
HCPCS Brand Name Generic Name
Q5152 Bkemv Eculizumab-aagh
Q5151 Epysqli Eculizumab-aagh
J1299 Soliris Eculizumab
Non-Preferred Products:
HCPCS Brand Name Generic Name
None
If the request is for a non-preferred product, one of the following criteria must be met for the non-preferred product to be covered:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Eculizumab (e.g., Soliris and biosimilars) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when
ALL the following criteria are met:
For FDA labeled indications, Eculizumab (e.g., Soliris and biosimilars) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.
Generalized Myasthenia Gravis (gMG)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Neuromyelitis Optica Spectrum Disorder (NMOSD)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Paroxysmal Nocturnal Hemoglobinuria (PNH)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Atypical Hemolytic Uremic Syndrome (aHUS)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
REINITIATION of eculizumab for aHUS:
Requests for reinitiation of eculizumab in aHUS may be approved if the following criteria are met (Fakhouri 2017):
Policy Guidelines
Complete or update meningococcal vaccination (for serogroups A, C, W, Y and B) at least 2 weeks prior to administration of the first dose of Eculizumab (e.g., Soliris), according to current Advisory Committee on Immunization Practices (ACIP) recommendations for individuals receiving a complement inhibitor. Revaccinate individuals in accordance with ACIP recommendations, considering the duration of therapy with Eculizumab (e.g., Soliris and biosimilars).
Myasthenia Gravis Foundation of America (MGFA) Clinical Classification:
Myasthenia Gravis Activities of Daily Living Scale (MG-ADL):
The MG-ADL scale assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. Each item is assessed on a 4-point scale; a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment. Score grade items are as follows (Wolfe, 1999):
Talking
Chewing
Swallowing
Breathing
Impairment of ability to brush teeth or comb hair
Impairment of ability to arise from a chair
Double vision
Eyelid droop
Dosage and Administration
Dosing per FDA Guidelines unless otherwise specified below.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
The recommended dosing for adults 18 years of age and older:
Atypical Hemolytic Uremic Syndrome (aHUS), Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD)- adults
The recommended dosing for adults 18 years of age and older:
Myasthenia Gravis (gMG) and Atypical Hemolytic Uremic Syndrome (aHUS)- pediatric individuals
For individuals less than 18 years of age, administer eculizumab, (e.g., Soliris) based upon body weight, according to the following schedule:
Body weight range Loading dose Maintenance dose
5kg to less than 10 kg 300mg weekly x 1 dose 300 mg at week 2; then every 3 weeks
10kg to less than 20 kg 600mg weekly x 1 dose 300 mg at week 2; then every 2 weeks
20kg to less than 30 kg 600mg weekly x 2 doses 600 mg at week 3; then every 2 weeks
30kg to less than 40 kg 600 mg weekly x 2 doses 900 mg at week 3; then every 2 weeks
Greater than or equal to 40 kg 900 mg weekly x 4 doses 1200 mg at week 5; then every 2 weeks
Eculizumab is available as a single dose vial that is 300 mg/30mL and should be administered by a healthcare professional.
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Eculizumab (e.g., Soliris and biosimilars) for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, eculizumab, for any other indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective April 23, 2025 to December 31, 2025
Select products are preferred where there is an FDA approved indication for the biosimilar product and for all off-label uses of the reference product. According to the United States FDA “a biosimilar is a biological product that has no clinically meaningful differences from the existing FDA-approved reference product. All biosimilar products meet the FDA’s rigorous standards for approval for the indications described in the product labeling. Once a biosimilar has been approved by the FDA, the safety and effectiveness of these products have been established, just as they have been for the reference product.”
Preferred Products:
HCPCS Brand Name Generic Name
J1299 Soliris Eculizumab
Non-Preferred Products:
HCPCS Brand Name Generic Name
Q5151 Epysqli Eculizumab-aagh
Q5152 Bkemv Eculizumab-aagh
If the request is for a non-preferred product, one of the following criteria must be met for the non-preferred product to be covered:
Effective April 23, 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Eculizumab (e.g., Soliris and biosimilars) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes when
ALL the following criteria are met:
For FDA labeled indications, Eculizumab (e.g., Soliris and biosimilars) must be dosed in accordance with the indication specific recommended dose per FDA label unless otherwise specified in the dosage and administration section.
Generalized Myasthenia Gravis (gMG)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Neuromyelitis Optica Spectrum Disorder (NMOSD)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Paroxysmal Nocturnal Hemoglobinuria (PNH)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
Atypical Hemolytic Uremic Syndrome (aHUS)
INITIAL APPROVAL STANDARD REVIEW for up to 12 months:
CONTINUED APPROVAL for up to 12 months:
REINITIATION of eculizumab for aHUS:
Requests for reinitiation of eculizumab in aHUS may be approved if the following criteria are met (Fakhouri 2017):
Policy Guidelines
Complete or update meningococcal vaccination (for serogroups A, C, W, Y and B) at least 2 weeks prior to administration of the first dose of Eculizumab (e.g., Soliris), according to current Advisory Committee on Immunization Practices (ACIP) recommendations for individuals receiving a complement inhibitor. Revaccinate individuals in accordance with ACIP recommendations, considering the duration of therapy with Eculizumab (e.g., Soliris and biosimilars).
Myasthenia Gravis Foundation of America (MGFA) Clinical Classification:
Myasthenia Gravis Activities of Daily Living Scale (MG-ADL):
The MG-ADL scale assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. Each item is assessed on a 4-point scale; a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. A total score ranges from 0 to 24, with the higher scores indicating more impairment. Score grade items are as follows (Wolfe, 1999):
Talking
Chewing
Swallowing
Breathing
Impairment of ability to brush teeth or comb hair
Impairment of ability to arise from a chair
Double vision
Eyelid droop
Dosage and Administration
Dosing per FDA Guidelines unless otherwise specified below.
Paroxysmal Nocturnal Hemoglobinuria (PNH)
The recommended dosing for adults 18 years of age and older:
Atypical Hemolytic Uremic Syndrome (aHUS), Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD)- adults
The recommended dosing for adults 18 years of age and older:
Myasthenia Gravis (gMG) and Atypical Hemolytic Uremic Syndrome (aHUS)- pediatric individuals
For individuals less than 18 years of age, administer eculizumab, (e.g., Soliris) based upon body weight, according to the following schedule:
Body weight range Loading dose
Maintenance dose
5kg to less than 10 kg 300mg weekly x 1 dose 300 mg at week 2; then every 3 weeks
10kg to less than 20 kg 600mg weekly x 1 dose 300 mg at week 2; then every 2 weeks
20kg to less than 30 kg 600mg weekly x 2 doses 600 mg at week 3; then every 2 weeks
30kg to less than 40 kg 600 mg weekly x 2 doses 900 mg at week 3; then every 2 weeks
Greater than or equal to 40 kg 900 mg weekly x 4 doses 1200 mg at week 5; then every 2 weeks
Eculizumab is available as a single dose vial that is 300 mg/30mL and should be administered by a healthcare professional.
Please refer to separate policy on Site of Care or Site of Service Review (policy #2018030) for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Eculizumab (e.g., Soliris and biosimilars) for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, eculizumab, for any other indication or circumstance not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Due to the detail of the policy statement, the document containing the coverage statements for dates prior to April 23, 2025 is not online. If you would like a hardcopy print, please email:
codespecificinquiry@arkbluecross.com
|
|
|
|
| Rationale: |
October 2022 Update
The Institute for Clinical and Economic Review (ICER) published a review for eculizumab and efgartigimod for the treatment of myasthenia gravis. It identified one Phase III trial each for eculizumab (REGAIN) and efgartigimod (ADAPT) but found insufficient data to compare these drugs to maintenance intravenous immunoglobulin IVIG and rituximab (RTX). In the Phase III REGAIN trial, patients with anti-AChR antibody positive, treatment-resistant gMG who received eculizumab had significantly better improvement in the myasthenia gravis activities of daily living (MG-ADL) and quantitative myasthenia gravis (QMG) scores than those on placebo at four weeks and eight weeks, and the improvements were sustained at 26 weeks. In addition, at week 26, the proportion of patients with minimal symptom expression (MG-ADL score of 0 or 1) was much greater in the eculizumab group (21.4% vs. 1.7%, p=0.0007) [Vissing J et al., 2020] In the open label extension through 130 weeks of follow up, the benefits were maintained, and may have increased compared with 26 weeks [Mantegazza R, et al., 2021] There were no excess adverse events (AEs) in the trials, although more patients in the eculizumab group stopped treatment due to AEs, and it carries a black box warning for meningococcal infections.
The Phase III ADAPT trial was conducted in gMG patients with or without anti-AChR-antibody; however, the primary outcome was in the subgroup of anti-AChR antibody positive patients. The proportion of patients with clinically meaningful improvement (≥2-point MG-ADL improvement sustained for
≥4 weeks) was much greater in the efgartigimod group compared to the placebo group. Anti-AChR antibody positive gMG patients who received efgartigimod did significantly better on MG-ADL and QMG than those who received placebo. However, the improvements were greater at four weeks than at eight weeks, reflecting the unusual dosing schedule in the trial.
Patients received their second treatment cycle only when they no longer had a clinically meaningful improvement on the MG-ADL. Thus, many patients were back near baseline at eight weeks. The anti-AChR antibody negative patients randomized to efgartigimod were only slightly more likely to respond based on the MG-ADL (68% vs. 63% in placebo group, p=NR). AEs did not appear to be more common with efgartigimod, but there are long-term concerns about infections with lowering of IgG levels.
One important area of uncertainty is that it is not clear if or when to stop either of the drugs in patients who are responding to them. For efgartigimod, the primary uncertainty is the appropriate dosing regimen. In the ADAPT trial, subsequent cycles were started once patients lost clinical benefits. It seems likely that in routine practice, patients and clinicians will not want to wait until the benefits have receded before starting another round of therapy. Also, despite their use in clinical practice, there is a lack of comparative efficacy data for both rituximab and IVIG used as maintenance therapy for gMG.
Taking into consideration the above information on the benefits and AEs of eculizumab, it was concluded that there is moderate certainty of a small or substantial net health benefit with high certainty of at least a small benefit for eculizumab added to conventional therapy (B+) in adults with gMG positive for anti-AChR antibodies “refractory” to conventional therapy. For efgartigimod, given the above information on short-term benefits, but uncertainties about dosing, long-term benefits, and long-term safety, it was concluded that that there is moderate certainty of a comparable, small, or substantial net health benefit of efgartigimod added to conventional therapy with high certainty of at least comparable net health benefit (C++) in adults with gMG positive for anti-AChR antibodies. While there is evidence for efgartigimod in adults with gMG negative for anti-AChR antibodies, it is sparse and of uncertain clinical and statistical significance. Thus, it was concluded that the evidence was insufficient (I) to distinguish the net health benefit of efgartigimod added to conventional therapy from conventional therapy alone in patients who test negative for anti-AChR antibodies. In addition, the evidence is insufficient (I) to distinguish the net health benefits of rituximab and IVIG from placebo, eculizumab, and efgartigimod.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.
September 2024 Update
Policy review completed with a literature search using the MEDLINE database through May 2024. Updated revised recommendations of the Neuromyelitis Optica Study Group (Journal of Neurology, 2024) set complement inhibitors such as eculizumab and ravulizumab on parity with CD19 antigen inhibitors such as inebilizumab and interleukin 6 antagonists such as satralizumab. Clinical criteria updated.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2024. No new literature was identified that would prompt a change in the coverage statement.
2025 Update
Criteria updated with lower age limit for myasthenia gravis indication based on the recent FDA approval.
|
|
|
|
| CPT/HCPCS: | |
|
|
|
| References: |
ACIP(2025) Advisory Committee on Immunization Practices (ACIP). Centers for Disease Control and Prevention www.cdc.gov/acip/index.html Alexion Pharmaceuticals.(2019) SOLIRIS® (eculizumab) injection, for intravenous use: Prescribing label. https://alexion.com/Documents/Soliris_USPI.pdf. Accessed June 30, 2019. Alhaidar MK, Abumurad S, Soliven B, Rezania K.(2022) Current Treatment of Myasthenia Gravis. J Clin Med. 2022 Mar 14;11(6):1597. doi: 10.3390/jcm11061597. PMID: 35329925; PMCID: PMC8950430. Andersen H, Mantegazza R, Wang JJ, et al.(2019) Eculizumab improves fatigue in refractory generalized myasthenia gravis [published correction appears in Qual Life Res. 2019 May 21:]. Qual Life Res. 2019;28(8):2247–2254. doi:10.1007/s11136-019-02148-2. Anderson H, Mantegazza R, Wang JJ, et al.(2019) Eculizumab improves fatigue in refractory generalized myasthenia gravis. Qual Life Res. 2019 Mar 23. doi: 10.1007/s11136-019-02148-2. Ardissino G, Testa S, Possenti I, et al.(2014) Discontinuation of eculizumab maintenance treatment for atypical hemolytic uremic syndrome: a report of 10 cases. Am J Kidney Dis. 2014; 64(4):633-637. Ariceta G, Besbas N, Johnson S, et al.(2009) Guideline for the investigation and initial therapy of diarrhea-negative hemolytic uremic syndrome. Pediatr Nephrol. 2009; 24(4):687-696. Bird, Shawn J.(2024) Chronic Immunotherapy for Myasthenia Gravis. UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed April 2, 2024. Subscription required. Bird, Shawn J.(2024) Overview of the treatment of myasthenia gravis. UpToDate, Connor RF (Ed), Wolters Kluwer. Accessed April 2, 2024. Subscription required. Bomback AS, Smith RJ, Barile GR, et al.(2012) Eculizumab for dense deposit disease and C3 glomerulonephritis. Clin J Am Soc Nephrol. 2012; 7(5):748-756. Brodsky RA, Young NS, Antonioli E, et al.(2010) Multicenter phase 3 study of the complement inhibitor eculizumab for the treatment of patients with paroxysmal nocturnal hemoglobinuria. Blood. 2008; 111(4):1840-1847. Brodsky RA.(2010) Stem cell transplantation for paroxysmal nocturnal hemoglobinuria. Haematologica. 2010; 95(6):855-856. Burwick RM, Feinberg BB.(2013) Eculizumab for the treatment of preeclampsia/HELLP syndrome. Placenta. 2013; 34(2):201-203. Canaud G, Kamar N, Anglicheau D, et al.(2013) Eculizumab improves posttransplant thrombotic microangiopathy due to antiphospholipid syndrome recurrence but fails to prevent chronic vascular changes. Am J Transplant. 2013; 13(8):2179-2185. Chapin J, Weksler B, Magro C, Laurence J.(2012) Eculizumab in the treatment of refractory idiopathic thrombotic thrombocytopenic purpura. Br J Haematol. 2012; 157(6):772-774. Howard JF Jr, Utsugisawa K. Benatar M, et al.(2017) Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Lancet Neurol. 2017; Dec;16(12):976-986. doi: 10.1016/S1474-4422(17)30369-1. Epub 2017 Oct 20. Jodele S, Dandoy CE, Lane A, et al.(2020) Complement blockade for TA-TMA: lessons learned from large pediatric cohort treated with eculizumab. Blood. 2020 Jan 13. pii: blood.2019004218. doi: 10.1182/blood.2019004218. [Epub ahead of print] Kulasekararaj AG, Hill A,Rottinghause, ST, et al.(2018) Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study. Blood. 2018 Dec 3. pii: blood-2018-09-876805. doi: 10.1182/blood-2018-09-876805. [Epub ahead of print] Lee,JW, Sicre deFontbrune F, Wong Lee Lee L, et al.(2018) Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naïve to complement inhibitors: the 301 study. Blood. 2018 Dec 3. Pii:blood-2018-09-876136. doi: 10.1182/blood-2018-09-876136. [Epub ahead of print] Mantegazza R, Wolfe GI, Muppidi S, et al.(2021) Post-intervention Status in Patients With Refractory Myasthenia Gravis Treated With Eculizumab During REGAIN and Its Open-Label Extension. Neurology. 2021;96:e610-e618. Mealy MA, Wingerchuk DM, Palace J, Greenberg BM, Levy M.(2014) Comparison of Relapse and Treatment Failure Rates Among Patients With Neuromyelitis Optica: Multicenter Study of Treatment Efficacy. JAMA Neurol. 2014;71(3):324–330. doi:10.1001/jamaneurol.2013.5699 Muppidi S, Utsugisawa K, Benatar M, et al.(2019) Long-term safety and efficacy of eculizumab in generalized myasthenia gravis. Muscle Nerve. 2019 Feb 14. doi: 10.1002/mus.26447. Pittock S.J. Berthele A, Fujihara, H.J., et al.(2019) Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder. N Engl J Med 2019 May 3. doi: 10.1056/NEJMoa1900866. [Epub ahead of print] Professional Resources on Myasthenia Gravis. Accessed May 4, 2022 at https://myasthenia.org/Professionals/Resources-for-Professionals Soliris (eculizumab) package insert. Boston, MA: Alexion Pharmaceuticals, Inc.; 2025 Feb. Soliris(2024) package insert Boston, MA: Alexion Pharmaceuticals; 2024. Tice JA, Touchette DR, Nikitin D, Campbell JD, Lien P-W, Moradi A, Rind DM, Pearson SD, Agboola F.(2021) Eculizumab and Efgartigimod for the Treatment of Myasthenia Gravis: Effectiveness and Value; Final Report. Institute for Clinical and Economic Review, September 10, 2021. Accessed October 10, 2022. https://icer.org/assessment/myasthenia-gravis/#timeline. Vissing J, Jacob S, Fujita KP, et al.(2020) Minimal symptom expression’ in patients with acetylcholine receptor antibody-positive refractory generalized myasthenia gravis treated with eculizumab. Journal of Neurology. 2020;267:1991-2001. |
|
|
|
| Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants. | |
| CPT Codes Copyright © 2025 American Medical Association. | |