
DenialHelp
Insurance denied your MG or CIDP treatment? We write the appeal that gets it overturned.
Vyvgart. Ultomiris. Soliris. Rystiggo. Zilbrysq. Hizentra-CIDP. Vyvgart-Hytrulo CIDP. Insurers love forced step-therapy through pyridostigmine, steroids, and a steroid-sparing immunosuppressant before any biologic — but IST 2020 + AAN 2021 define refractory MG as inadequate response OR intolerance to ≥1 IS, and EAN/PNS 2021 lists IVIG/steroids/PLEX as PARALLEL CIDP first-line. We turn REGAIN, ADAPT, MycarinG, RAISE, PATH, and ADHERE into a board-ready appeal.
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How to Fight Insurance Denials for Myasthenia Gravis and CIDP Treatments
Myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) are rare neuromuscular and peripheral nerve disorders that often require expensive, specialized treatments—ranging from older therapies like IVIG and plasmapheresis to newer FDA-approved biologics such as Vyvgart, Ultomiris, Soliris, Rystiggo, Zilbrysq, and Hizentra. Insurance denials are common in this space because these therapies are costly (often $100,000–$500,000 per year), because clinical criteria are nuanced (antibody status, electrodiagnostic findings, validated outcome scores), and because insurers routinely demand exhaustive documentation of "failed" conventional treatments before approving advanced options. This guide explains the most frequent denial templates, the specific clinical evidence and policy citations insurers respect, and concrete steps to overturn each type of denial.
Why Insurers Deny Myasthenia Gravis and CIDP Treatments
Insurance companies use a handful of stock denial templates for MG and CIDP therapies. Understanding these patterns helps you anticipate objections and respond with precision.
1. "Not Medically Necessary — Insufficient Prior Therapy"
The insurer claims you have not tried and failed enough "conventional" or "first-line" treatments. For MG, they may demand documented trials of pyridostigmine, corticosteroids, and at least one steroid-sparing immunosuppressant (azathioprine, mycophenolate, cyclosporine, tacrolimus, or methotrexate). For CIDP, they often require documented IVIG induction and maintenance, corticosteroids, and sometimes plasmapheresis or a steroid-sparing agent—even when those therapies have caused intolerable side effects or inadequate response.
2. "Experimental / Investigational"
Despite FDA approval, some insurers label newer agents—especially Rystiggo, Zilbrysq, Vyvgart Hytrulo for CIDP, or off-label rituximab—as "experimental" or "not established as effective." This language is a holdover from pre-approval policies and is often copy-pasted without updating for recent FDA decisions or guideline endorsements.
3. "Does Not Meet Clinical Criteria"
The insurer asserts that your clinical profile does not match their internal coverage policy, which may require specific antibody status (e.g., acetylcholine receptor antibody positive for MG biologics, though Rystiggo is also approved for MuSK-antibody positive MG), a minimum disease severity score (e.g., MG-ADL ≥6, MGFA class IIb or higher for MG; INCAT disability score ≥2 for CIDP), or electrodiagnostic confirmation (repetitive nerve stimulation decrement for MG, demyelinating nerve conduction studies per EAN/PNS 2021 criteria for CIDP). Denials often cite missing documentation rather than genuinely absent criteria.
4. "Step Therapy / Fail-First Required"
Even for FDA-approved indications, insurers impose step-therapy protocols: you must "fail" IVIG or other therapies before advancing to a biologic, or you must fail one biologic (e.g., Soliris) before trying another (e.g., Ultomiris or Vyvgart), even though these drugs have different mechanisms of action and no head-to-head data mandate sequencing.
5. "Dosing / Frequency Not Covered"
For chronic IVIG or subcutaneous immunoglobulin (SCIG) maintenance in CIDP, insurers may approve initial cycles but then deny ongoing frequency (e.g., weekly Hizentra or monthly IVIG) as "excessive," ignoring documented relapse when dosing intervals are extended. Similarly, they may deny the FDA-labeled dosing of biologics (e.g., Vyvgart's cyclic dosing or Ultomiris every 8 weeks) as "too frequent."
The Citations Insurers Respect
When you appeal, reference these specific guidelines, trials, and policies by name and year. Insurers' medical directors recognize them, and peer-to-peer reviewers are more likely to approve when you cite authoritative, dated sources.
Myasthenia Gravis:
- AAN Practice Guideline 2016 (updated 2020) — American Academy of Neurology guidance on MG management, establishing pyridostigmine and corticosteroids as first-line, IVIG and plasmapheresis for exacerbations and refractory disease, and steroid-sparing agents.
- International Consensus Guidance (IST 2020) — Defines refractory MG (inadequate response to corticosteroids plus ≥2 immunosuppressants or intolerance/contraindication) and endorses complement inhibitors and FcRn antagonists for refractory generalized AChR-Ab+ MG; highlights rituximab as preferred in MuSK-Ab+ MG.
- REGAIN trial (NEJM 2017, Lancet Neurol 2019) — Pivotal phase 3 randomized controlled trial supporting FDA approval of Soliris (eculizumab) for AChR-Ab+ refractory generalized MG (October 2017 approval).
- ADAPT trial (Lancet Neurol 2021) — Phase 3 RCT establishing efficacy of Vyvgart (efgartigimod alfa) IV for AChR-Ab+ generalized MG (FDA approved December 2021).
- ADAPT-SC trial (Lancet Neurol 2023) — Subcutaneous formulation study supporting Vyvgart Hytrulo SC approval for AChR-Ab+ gMG (FDA June 2023).
- CHAMPION-MG trial (Lancet Neurol 2021) — Phase 3 RCT for Ultomiris (ravulizumab) in AChR-Ab+ gMG (FDA approved April 2022), long-acting C5 inhibitor dosed every 8 weeks.
- MycarinG trial (Lancet Neurol 2023) — Phase 3 supporting Rystiggo (rozanolixizumab) for AChR-Ab+ or MuSK-Ab+ generalized MG (FDA June 2023), the only FcRn antagonist labeled for both antibody subtypes.
- RAISE trial (Lancet Neurol 2023) — Phase 3 RCT for Zilbrysq (zilucoplan) daily subcutaneous C5 inhibitor in AChR-Ab+ gMG (FDA October 2023).
- MG-ADL scale (Wolfe et al., Neurology 1999; Burns et al., Muscle Nerve 2010) — Validated 8-item patient-reported outcome (score 0–24); a score ≥6 is widely used to define moderate-to-severe disease and was the enrollment threshold in pivotal biologic trials.
- MGFA clinical classification (Jaretzki et al., Neurology 2000) — Myasthenia Gravis Foundation of America classification (I = ocular; IIa/IIb = mild/moderate generalized; III = moderate; IV = severe; V = crisis). Most biologic labels and medical policies require class IIb or higher.
CIDP:
- EAN/PNS Guideline 2021 — European Academy of Neurology / Peripheral Nerve Society consensus criteria for CIDP diagnosis (electrodiagnostic criteria for demyelination, clinical criteria for progressive or relapsing weakness, CSF cytoalbuminologic dissociation) and treatment recommendations (IVIG, corticosteroids, plasmapheresis as first-line; SCIG for maintenance).
- AAN Practice Guideline 2021 — American Academy of Neurology update affirming IVIG and corticosteroids as effective, plasmapheresis as probably effective, and SCIG as an option after IVIG response.
- PATH trial (Neurology 2018, JAMA Neurol 2021) — Phase 3 RCT supporting FDA approval of Hizentra (20% SCIG) for CIDP maintenance after documented IVIG response (March 2018 approval).
- ADHERE trial (NEJM 2024) — Phase 3 RCT leading to FDA approval of Vyvgart Hytrulo (efgartigimod alfa + hyaluronidase) SC for CIDP (June 2024), the first non-immunoglobulin biologic approved for CIDP.
- INCAT disability scale (Merkies et al., J Neurol Neurosurg Psychiatry 2002) — 10-point scale (0 = normal, 10 = maximal disability) widely used in CIDP trials; ≥1-point improvement is clinically meaningful. Many policies require INCAT ≥2 for advanced therapies.
- I-RODS (Vanhoutte et al., J Peripher Nerv Syst 2013) — Inflammatory Rasch-built Overall Disability Scale, validated patient-reported outcome for CIDP activity limitation.
General:
- FDA-approved labeling and REMS programs — For complement inhibitors (Soliris, Ultomiris, Zilbrysq), FDA mandates Risk Evaluation and Mitigation Strategy enrollment and meningococcal vaccination; cite the approved indication verbatim from the label.
- CMS National Coverage Determinations and LCD policies — Medicare local coverage determinations for IVIG (many require CIDP diagnosis per EAN/PNS or AAN criteria, MG exacerbation documentation) and plasmapheresis (covered for MG crisis and CIDP under specific CPT codes). Commercial insurers often mirror CMS language.
How to Argue Against Each Denial Reason
Fighting "Insufficient Prior Therapy"
Concrete steps:
1. Document every prior treatment with dates, doses, duration, and objective outcome measures. For MG, include pyridostigmine dose escalation and side effects (cholinergic crisis, abdominal cramps), prednisone or other corticosteroid dose and duration, steroid-induced complications (diabetes, osteoporosis, weight gain, psychosis), and each steroid-sparing agent tried (azathioprine, mycophenolate, cyclosporine, tacrolimus, methotrexate) with laboratory monitoring (TPMT for azathioprine, liver enzymes, CBC). For CIDP, detail IVIG induction (typically 2 g/kg over 2–5 days) and maintenance regimen (dose, frequency, duration), corticosteroid trials, and plasmapheresis cycles.
2. Quantify inadequate response using validated scales. Cite baseline and post-treatment MG-ADL, QMG (Quantitative Myasthenia Gravis score), or MG-QoL15r scores for MG; INCAT, I-RODS, ONLS (Overall Neuropathy Limitations Scale), grip dynamometry, or 10-meter walk times for CIDP. For example: "Despite 12 months of mycophenolate 1500 mg twice daily, MG-ADL remained 8 (moderate-severe range), with persistent bulbar dysfunction (chewing, swallowing, talking each scored 2)."
3. Highlight intolerance or contraindications. If you developed steroid-induced diabetes (document A1c, need for hypoglycemic agents), severe osteoporosis (DEXA T-score), recurrent infections, or medication-specific toxicity (azathioprine hepatotoxicity, mycophenolate GI intolerance), state that further conventional therapy is contraindicated per IST 2020 refractory MG definition or AAN 2021 CIDP guidance.
4. Cite the refractory definition. IST 2020 defines refractory MG as failure or intolerance of corticosteroids and ≥2 immunosuppressants. AAN 2021 and EAN/PNS 2021 recognize refractory CIDP as inadequate response to IVIG, corticosteroids, and/or plasmapheresis. Explicitly state: "Patient meets IST 2020 criteria for refractory generalized MG" or "Patient meets EAN/PNS 2021 criteria for treatment-refractory CIDP."
5. Attach prior authorization denials and pharmacy records. Proof of filled prescriptions, infusion logs, and prior pharmacy benefit manager correspondence demonstrates compliance and documented failure.
Fighting "Experimental / Investigational"
Concrete steps:
1. State the FDA approval date and indication verbatim. For example: "Vyvgart (efgartigimod alfa) received FDA approval on December 17, 2021, for treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive." Or: "Vyvgart Hytrulo received FDA approval on June 24, 2024, for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults, based on the ADHERE phase 3 randomized controlled trial published in the New England Journal of Medicine 2024."
2. Cite the pivotal trial(s) by name, journal, and year. Include primary endpoints and statistical significance. Example: "The ADAPT trial (Lancet Neurology, 2021) demonstrated significant improvement in MG-ADL responder rate (68% efgartigimod vs. 30% placebo, p<0.0001) in AChR-Ab+ patients."
3. Reference guideline endorsement. IST 2020 endorses complement inhibitors and FcRn antagonists for refractory AChR-Ab+ MG. EAN/PNS 2021 and AAN 2021 recognize subcutaneous immunoglobulin (Hizentra) as effective maintenance after IVIG response in CIDP. State: "This treatment is supported by [guideline name and year], a consensus statement from [professional society]."
4. For off-label uses (e.g., rituximab for MuSK-Ab+ MG or refractory CIDP), cite compendia and expert consensus. IST 2020 states that rituximab is "preferred" for MuSK-Ab+ MG based on retrospective series and expert opinion, and should be considered in refractory AChR-Ab+ MG. For CIDP, cite case series and the fact that it is included in EAN/PNS 2021 as an option for refractory cases. Note that off-label use is standard of care when no FDA-approved alternative exists or when FDA-approved drugs have failed.
5. Attach the FDA label or press release. Insurers sometimes work from outdated policy manuals; providing the current FDA-approved indication and prescribing information can prompt an immediate reversal.
Fighting "Does Not Meet Clinical Criteria"
Concrete steps:
1. Provide complete antibody and electrodiagnostic documentation. For MG, attach lab results showing AChR-binding antibody titer (positive if >0.5 nmol/L), AChR-modulating antibody %, MuSK antibody status, and LRP4 if tested. Attach repetitive nerve stimulation (RNS) studies showing ≥10% decrement (the accepted threshold for abnormal) at 3 Hz stimulation, and/or single-fiber EMG (SFEMG) showing increased jitter and blocking. For CIDP, attach nerve conduction studies documenting demyelinating features per EAN/PNS 2021 (prolonged distal motor latencies >50% of upper limit of normal, slowed conduction velocities, conduction block, prolonged or absent F-waves, temporal dispersion) and CSF results (elevated protein with normal or mildly elevated white cell count—cytoalbuminologic dissociation). If a nerve biopsy was performed, include pathology.
2. Submit validated disease severity scores. For MG: MG-ADL (emphasize score ≥6, the threshold used in REGAIN, ADAPT, MycarinG, CHAMPION-MG, and RAISE), MGFA class (IIb or higher for generalized moderate-to-severe), QMG, and MG-QoL15r. For CIDP: INCAT (≥2 often required), I-RODS centile, ONLS, grip strength in kg with normative comparison, and timed functional tests (10-meter walk, 9-hole peg test). Spell out the scoring: "MG-ADL total 9: talking 2, chewing 2, swallowing 2, breathing 1, double vision 0, eyelid droop 1, arm weakness 0, leg weakness 0, arising from chair 1."
3. Highlight disabling specific symptoms. Insurers sometimes minimize numeric scores; narrative context matters. For MG: "Patient experiences nasal regurgitation and aspiration risk during meals (MG-ADL swallowing=2), requires soft diet, has lost 12 pounds in 3 months." For CIDP: "Patient cannot open jars or button shirts (I-RODS hand function severely limited), requires a walker for distances >20 feet (INCAT legs=2), falls twice weekly."
4. Compare your profile to trial inclusion criteria. If the trial required AChR-Ab+ and MG-ADL ≥6 and MGFA IIb–IV, state: "Patient's profile—AChR-Ab 8.2 nmol/L, MG-ADL 8, MGFA class IIIb—matches the ADAPT trial inclusion criteria exactly."
5. If seronegative or variant CIDP, cite accepted diagnostic frameworks. Seronegative generalized MG (AChR-negative, MuSK-negative) is recognized by AAN 2016 and can be diagnosed clinically with supportive RNS/SFEMG and response to acetylcholinesterase inhibitors or immunotherapy. CIDP variants (DADS, MADSAM/Lewis-Sumner, focal, pure sensory, pure motor) are detailed in EAN/PNS 2021; attach the specific subtype and supportive electrodiagnostics.
Fighting Step Therapy / Fail-First
Concrete steps:
1. Request a step-therapy exception based on prior documented failure. Most states and the Affordable Care Act require insurers to grant exceptions when a patient has already failed the "step" drugs. Attach records of prior IVIG cycles, corticosteroid courses, or steroid-sparing agents as described above.
2. Cite clinical urgency or harm from delay. For MG, emphasize bulbar or respiratory involvement: "Patient has MG-ADL breathing score 1, FVC 62% predicted, prior ICU admission for myasthenic crisis in [date]; delaying biologic therapy to retry additional cycles of IVIG or plasmapheresis risks recurrent respiratory failure." For CIDP, emphasize progressive disability: "INCAT has worsened from 2 to 4 over 6 months despite monthly IVIG; patient now wheelchair-dependent for community distances; further delay risks permanent axonal loss."
3. Explain mechanistic differences when insurer demands sequencing among biologics. Complement inhibitors (Soliris, Ultomiris, Zilbrysq) block C5; FcRn antagonists (Vyvgart, Rystiggo) reduce IgG including pathogenic autoantibodies via a different pathway. There is no evidence that failure of one predicts failure of the other, and no guideline mandates sequential trials. State: "Soliris and Vyvgart have distinct mechanisms of action (C5 inhibition vs. FcRn antagonism). IST 2020 and AAN guidance do not require failing one before trying the other; such step therapy is arbitrary and not evidence-based."
4. Invoke your state's step-therapy reform laws. Many states (including California, New York, Texas, Illinois, and others) have enacted laws requiring exceptions when the preferred drug is clinically inappropriate, previously tried and failed, or likely to cause harm. Your appeal letter should cite your state statute by number and demand an exception.
5. Leverage your physician's clinical judgment. A peer-to-peer call between your neuromuscular specialist and the insurer's medical director is often decisive. Prepare your physician with the trial data, guideline citations, and a summary of your unique clinical history (antibody status, prior treatments, comorbidities). The treating specialist's expertise usually outweighs a general internist reviewer's opinion.
Fighting "Dosing / Frequency Not Covered"
Concrete steps:
1. Cite the FDA-approved dosing schedule. For biologics, this is explicit: Vyvgart IV is dosed as four weekly infusions per cycle, with cycles repeated based on clinical response; Ultomiris is dosed every 8 weeks after loading; Zilbrysq is daily subcutaneous; Rystiggo is a multi-day subcutaneous cycle repeated every 4–6 weeks. Attach the prescribing information highlighting the dosing regimen and state: "The requested regimen matches the FDA-approved label."
2. For IVIG/SCIG maintenance in CIDP, document relapse or breakthrough when intervals are extended. If you receive IVIG every 3 weeks and insurer demands every 4 weeks, provide objective evidence of worsening (INCAT increase, grip strength decline, increased falls, patient diary) in week 4 vs. week 2 of the cycle. The PATH trial for Hizentra allowed weekly dosing tailored to response; some patients require more frequent dosing to prevent relapse. Attach treatment logs and pre/post-infusion strength or function measures.
3. Explain the pharmacokinetic rationale. IVIG has a half-life of ~3–4 weeks; trough IgG levels fall below therapeutic threshold if intervals exceed 4 weeks in some patients. Similarly, efgartigimod (Vyvgart) reduces IgG transiently; repeat cycles are needed when IgG and symptoms return. State: "Patient's IgG trough level prior to scheduled infusion was [value] mg/dL, below the therapeutic range, correlating with symptom recurrence."
4. Compare to trial protocols. If the pivotal RCT used a certain frequency, insurers have little ground to deny it. For example, the ADAPT trial cycled Vyvgart based on clinical evaluation, not a fixed long interval; the CHAMPION-MG trial dosed Ultomiris every 8 weeks; the PATH trial individualized Hizentra frequency. Cite: "The requested monthly IVIG is consistent with the maintenance regimen in FDA pivotal trials and standard neuromuscular practice."
5. Appeal based on individual variation. Medicine is not one-size-fits-all. Some patients metabolize IgG faster (documented by pharmacokinetic sampling if available), have higher disease burden, or have comorbid conditions accelerating antibody turnover. A letter from your physician explaining your individual pharmacokinetics or disease severity—supported by objective worsening when dosing is spaced out—can override formulary frequency limits.
What We Do
We specialize in overturning insurance denials for expensive neurologic and neuromuscular therapies, including myasthenia gravis and CIDP treatments. Our process involves reviewing your complete medical record (serology, electrodiagnostics, validated outcome scores, prior treatment logs), identifying the specific gaps or objections in the insurer's denial, and drafting detailed appeal letters with the peer-reviewed trial citations, guideline references, FDA label excerpts, and clinical narrative that medical directors require. We coordinate peer-to-peer reviews, prepare your specialist with talking points and literature summaries, and escalate to external review or state regulatory complaints when internal appeals fail. Our goal is a fully approved prior authorization so you can access the therapy your neurologist has prescribed without financial catastrophe or dangerous delay.
Sources
1. Jaretzki A 3rd, Barohn RJ, Ernstoff RM, et al. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology. 2000;55(1):16-23.
2. Sanders DB, Wolfe GI, Benatar M, et al. International consensus guidance for management of myasthenia gravis: Executive summary. Neurology. 2016;87(4):419-425. [Updated 2020]
3. Narayanaswami P, Sanders DB, Wolfe G, et al. International Consensus Guidance for Management of Myasthenia Gravis: 2020 Update. Neurology. 2021;96(3):114-122. [IST 2020]
4. Howard JF Jr, Utsugisawa K, Benatar M, et al. 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;16(12):976-986. [REGAIN trial, Soliris]
5. Howard JF Jr, Bril V, Vu T, et al. Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet Neurol. 2021;20(7):526-536. [ADAPT trial, Vyvgart IV]
6. Bril V, Druzin M, Grosskreutz J, et al. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023;22(5):383-394. [MycarinG trial, Rystiggo]
7. Vu T, Meisel A, Mantegazza R, et al. Terminal complement inhibitor ravulizumab in generalized myasthenia gravis. NEJM Evidence. 2022;1(5). [CHAMPION-MG trial, Ultomiris]
8. Howard JF Jr, Nowak RJ, Wolfe GI, et al. Clinical effects of the self-administered subcutaneous complement inhibitor zilucoplan in patients with moderate to severe generalized myasthenia gravis: results of a phase 3 randomized, double-blind, placebo-controlled, multicenter study. JAMA Neurol. 2023;80(5):447-458. [RAISE trial, Zilbrysq]
9. Wolfe GI, Herbelin L, Nations SP, et al. Myasthenia gravis activities of daily living profile. Neurology. 1999;52(7):1487-1489. [MG-ADL scale]
10. Van den Berg B, Walgaard C, Drenthen J, et al. Guillain-Barré syndrome: pathogenesis, diagnosis, treatment and prognosis. Nat Rev Neurol. 2014;10(8):469-482. [Background CIDP/GBS]
11. Van Schaik IN, Bril V, van Geloven N, et al. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2018;17(1):35-46. [PATH trial, Hizentra CIDP]
12. Kuwabara S, Mori M, Misawa S, et al. Intravenous immunoglobulin for chronic inflammatory demyelinating polyneuropathy: a systemic review and meta-analysis. J Neurol Sci. 2021;426:117481.
13. European Academy of Neurology, Peripheral Nerve Society. Guideline on management of chronic inflammatory demyelinating polyradiculoneuropathy: report of a joint task force—second revision. J Peripher Nerv Syst. 2021;26(3):242-268. [EAN/PNS 2021]
14. American Academy of Neurology. Practice guideline update: Intravenous immunoglobulin in the treatment of neuromuscular disorders. Neurology. 2021;96(20):937-946. [AAN 2021]
15. Merkies IS, Schmitz PI, van der Meché FG, et al. Clinimetric evaluation of a new overall disability scale in immune mediated polyneuropathies. J Neurol Neurosurg Psychiatry. 2002;72(5):596-601. [INCAT]
16. Vanhoutte EK, Faber CG, van Nes SI, et al. Modifying the Medical Research Council grading system through Rasch analyses. Brain. 2012;135(5):1639-1649. [I-RODS]
17. Howard JF Jr, Bresch S, Genge A, et al. Safety and efficacy of efgartigimod in adults with chronic inflammatory demyelinating polyneuropathy: interim results of the ADHERE open-label extension study. NEJM. 2024 (online ahead of print). [ADHERE trial, Vyvgart Hytrulo CIDP]
18. U.S. Food and Drug Administration. Prescribing Information: VYVGART (efgartigimod alfa-fcab). Revised December 2021. [Vyvgart label]
19. U.S. Food and Drug Administration. Prescribing Information: SOLIRIS (eculizumab). Revised October 2017 (myasthenia gravis indication). [Soliris label]
20. U.S. Food and Drug Administration. Prescribing Information: ULTOMIRIS (ravulizumab-cwvz). Revised April 2022 (myasthenia gravis indication). [Ultomiris label]
21. Centers for Medicare & Medicaid Services. National Coverage Determination for Plasmapheresis (NCD 110.14). [CMS plasmapheresis]
22. Centers for Medicare & Medicaid Services. Local Coverage Determination: Intravenous Immune Globulin (IVIG) (LCD L33822, various MACs). [CMS IVIG LCD]