ModifiedColorado Rocky Mountain Health PlansPolicy 2026D0049AE

Complement C5 inhibitors

Drug policy for coverage criteria of complement C5 inhibitor products (Bkemv, Epysqli, PiaSky, Soliris, Ultomiris) across indications including aHUS, PNH, gMG, and NMOSD; impacts prescribers and prior authorization reviewers.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyCoverage criteria for Complement C5 inhibitors (Bkemv, Epijkstra, PiaSky, Soliris, Ultomiris)

Policy CodePolicy 2026D0049AE

Change TypeModified — material changes to continuation and initiation criteria

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization documenting diagnosis, specialist involvement, required prior therapy or preferred-product trial (e.g., ≥14-week trial of preferred eculizumab products before Soliris) and confirm REMS enrollment and meningococcal vaccination.

SourceLink

POLICY UPDATE CHANGES

Revised coverage criteria for aHUS continuation of therapy to require either being on Soliris meeting Preferred Product Criteria or being on Bkemv, Epysqli, or Ultomiris; removed prior requirement that patient was previously treated with the requested product.

Revised continuation criteria for PNH to require either being on Soliris meeting Preferred Product Criteria or being on Bkemv, Epysqli, PiaSky, or Ultomiris; removed prior requirement that patient was previously treated with the requested product.

Removed initial therapy criterion requiring history of ≥2 relapses in prior 12 months or ≥3 relapses in prior 24 months (with at least one in prior 12 months).

Added criterion prohibiting combination use of requested complement inhibitor with B-cell depletion therapy (e.g., inebilizumab) or immune globulin for the same indication.

Title changed from 'Complement Inhibitors' to a revised title; coverage rationale updated for multiple indications including aHUS, PNH, and generalized myasthenia gravis.

5products listed

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Coverage Criteria by Indication and Therapy Stage

aHUS Initial Therapy

Bkemv, Epysqli, Soliris, and Ultomiris are medically necessary for aHUS when ALL of the following are met

aHUS initial therapy criteria: {1} Documentation supporting diagnosis of aHUS by ruling out STEC-HUS and TTP (e.g., rule out ADAMTS13 deficiency); {2} Laboratory results, signs, and/or symptoms attributed to aHUS (e.g., thrombocytopenia, microangiopathic hemolysis, thrombotic microangiopathy, acute renal failure); {3} Patient is treatment naïve with the requested product; {4} Requested product is dosed according to US FDA labeled dosing for aHUS; {5} Prescribed by or in consultation with a hematologist or nephrologist; {6} Initial authorization ≤ 12 months

aHUS Continuation of Therapy

Continuation of therapy for aHUS when ALL of the following are met

aHUS continuation criteria: {1} Patient is on Soliris and meets Preferred Product Criteria OR patient is on Bkemv, Epysqli, or Ultomiris; {2} Documentation demonstrating positive clinical response from baseline (e.g., reduction of plasma exchanges, reduction of dialysis, increased platelet count, reduction of hemolysis); {3} Requested product dosed according to US FDA labeled dosing for aHUS; {4} Prescribed by or in consultation with a hematologist or nephrologist; {5} Reauthorization ≤ 12 months

PNH Initial Therapy

Bkemv, Epysqli, PiaSky, Soliris, and Ultomiris are medically necessary for PNH when ALL of the following are met

PNH initial therapy criteria: {1} Documentation supporting PNH diagnosis including flow cytometry confirming PNH clones and laboratory results/signs/symptoms attributed to PNH (e.g., abdominal pain, anemia, dyspnea, extreme fatigue, thrombosis, hemolysis/hemoglobinuria); {2} Requested product dosed per US FDA labeled dosing for PNH; {3} Patient is not receiving the requested product in combination with a different complement C5 inhibitor, a complement C3 inhibitor (e.g., Empaveli/pegcetacoplan), or a complement factor B inhibitor (e.g., Fabhalta/iptacopan); {4} For PiaSky (crovalimab) authorization only: history of trial and failure, contraindication, or intolerance to one of the listed alternatives (documented); {5} Prescribed by or in consultation with a hematologist or oncologist; {6} Initial authorization ≤ 12 months

PNH Continuation of Therapy

PNH continuation when ALL of the following are met

PNH continuation criteria: {1} Patient is on Soliris and meets Preferred Product Criteria OR patient is on Bkemv, Epysqli, PiaSky, or Ultomiris; {2} Documentation demonstrating positive clinical response from baseline (e.g., increased or stabilized hemoglobin, reduction in transfusions, improvement in hemolysis, decreased LDH); {3} Requested product dosed per US FDA labeled dosing for PNH; {4} Patient is not receiving the requested product in combination with a different complement C5 inhibitor, a complement C3 inhibitor, or a complement factor B inhibitor; {5} For PiaSky: patient is not receiving PiaSky in combination with a complement factor D inhibitor (e.g., Voydeya/danicopan); {6} Prescribed by or in consultation with a hematologist or oncologist; {7} Reauthorization ≤ 12 months

gMG Initial Therapy

Bkemv, Epysqli, Soliris, and Ultomiris are medically necessary for anti-AChR antibody positive generalized myasthenia gravis when ALL of the following are met

gMG initial therapy criteria: {1} Submission of medical records confirming: no prior failure of a complement C5 inhibitor; diagnosis of generalized myasthenia gravis (gMG); positive anti-AChR antibodies; MGFA class II–IV at initiation; MG-ADL ≥ 6 at initiation; {2} One of: history of failure of at least two immunosuppressive agents over ≥12 months OR failure of at least one immunosuppressive therapy plus ≥4 courses of plasmapheresis/IVIG over ≥12 months without symptom control; {3} Requested product initiated/titrated per US FDA labeled dosing for gMG; {4} Patient is not receiving concomitant disallowed therapies (e.g., B-cell depletion like inebilizumab/Uplizna, a different complement C5 inhibitor, complement C3 inhibitor Empaveli, complement factor B inhibitor Fabhalta, FcRn blockers, or immune globulin); {5} Prescribed by or in consultation with a neurologist; {6} Initial authorization ≤ 12 months

gMG Continuation of Therapy

gMG continuation when ALL of the following are met

gMG continuation criteria: {1} Patient is on Soliris and meets Preferred Product Criteria OR patient is on Bkemv, Epysqli, or Ultomiris; {2} Documentation demonstrating clinical benefit as detailed in continuation expectations (see MG-ADL improvement and reduction in signs/symptoms); {3} Requested product dosed according to US FDA labeled dosing for gMG; {4} Patient is not receiving concomitant disallowed therapies (e.g., B-cell depletion, another complement C5 inhibitor, FcRn blocker, or immune globulin); {5} Prescribed by or in consultation with a neurologist; {6} Reauthorization ≤ 12 months

gMG - Continuation Therapy

Continuation of therapy for generalized myasthenia gravis (gMG) is covered when ALL of the following are met:

gMG continuation: Submission of medical records demonstrating: (1) ≥2-point improvement in MG-ADL from baseline; and (2) reduction in signs/symptoms of myasthenia gravis; and (3) maintenance, reduction, or discontinuation of baseline IST prior to starting product (add-on, dose escalation, or additional rescue therapy from baseline while on requested product = treatment failure).

dosing_and_concomitant: Requested product dosed per US FDA labeled dosing for gMG; patient not receiving the requested product in combination with B-cell depletion therapy, a different complement C5 inhibitor, an FcRn blocker, or immune globulin for same indication.

prescriber_and_duration: Prescribed by or in consultation with a neurologist; reauthorization for no more than 12 months.

NMOSD - Initial Therapy

Bkemv, Epysqli, Soliris, and Ultomiris are medically necessary for NMOSD when ALL of the following are met:

diagnosis: Diagnosis of NMOSD by a neurologist with qualifying past medical history (optic neuritis, acute myelitis, area postrema syndrome, acute brainstem syndrome, symptomatic narcolepsy/diencephalic syndrome, or symptomatic cerebral syndrome with NMOSD-typical lesions), positive AQP4-IgG serology, and other diagnoses (e.g., MS) ruled out.

prior_therapy: Patient has not failed a previous course of a complement C5 inhibitor for NMOSD; history of failure/contraindication/intolerance to rituximab required (Medicare reviews note CMS reference); requested product initiated/titrated per US FDA NMOSD dosing.

concomitant_prohibited: Patient is not receiving the requested product in combination with anti-IL6 therapy, B-cell depletion therapy, or MS disease-modifying therapies for the same indication.

prescriber_and_duration:

NMOSD - Continuation Therapy

Continuation of therapy for NMOSD is covered when ALL of the following are met:

on_allowed_products: Patient is on Soliris and meets Preferred Product Criteria OR patient is on Bkemv, Epysqli, or Ultomiris.

clinical_response: Documentation of positive clinical response from baseline demonstrated by reduction in number/severity of relapses or signs/symptoms of NMOSD AND maintenance/reduction/discontinuation of baseline IST prior to starting product (add-on, dose escalation, or additional rescue therapy while on product = treatment failure).

dosing_and_concomitant: Requested product dosed per US FDA labeled dosing for NMOSD; patient not receiving product in combination with anti-IL6 therapy, B-cell depletion therapy, or MS DMTs for same indication.

prescriber_and_duration: Prescribed by or in consultation with a neurologist; reauthorization ≤ 12 months.

Continuation of Therapy

Continuation of therapy is covered when ALL of the following are met, including revised product/prior-therapy conditions:

Combination therapy exclusion: Patient is not receiving the requested product in combination with B-cell depletion therapy (e.g., inebilizumab) or an immune globulin (e.g., Hizentra, Privigen, Gammagard) for treatment of the same indication.

Added in 04/01/2026 revision

Prior product requirement for continuation (indication-specific): One of the following must be true: patient is on Soliris and meets the Preferred Product Criteria section, OR patient is on Bkemv, Epysqli, (for PNH also PiaSky), or Ultomiris.

Replaces prior 'previously treated with requested product' requirement

Initial Therapy

Initial therapy criteria revised:

Removed relapse-count requirement: Policy removed requirement that initiation be limited to patients with a history of ≥2 relapses in prior 12 months or ≥3 relapses in prior 24 months (with at least one in prior 12 months).

See Summary of Changes 04/01/2026

Bkemv, Epysqli, Soliris, and Ultomiris are unproven and not medically necessary for treatment of Shiga toxin E. coli–related hemolytic uremic syndrome (STEC‑HUS). The policy notes that available studies do not establish sufficient evidence of safety and effectiveness for eculizumab products in STEC‑HUS and that additional studies are warranted.

FDA product labeling for each listed complement C5 inhibitor explicitly includes a Limitation of Use stating the product is not indicated for STEC‑HUS; the policy reiterates this limitation and treats treatment of STEC‑HUS with these agents as not medically necessary.

The policy prohibits combination use of the requested complement C5 inhibitor with other immunomodulatory therapies for the same indication. Specifically, patients receiving anti‑IL6 therapy, B‑cell depletion therapy, MS disease‑modifying therapies, FcRn blockers, immune globulin, or a different complement inhibitor for the same condition are considered ineligible for concurrent coverage.

For continuation determinations the policy also requires documentation of clinical benefit from baseline (e.g., reduction in relapses or improvements in relevant clinical markers) and evidence that baseline immunosuppressive therapy was maintained, reduced, or discontinued prior to starting the C5 inhibitor. If a patient requires add‑on therapy, dose escalation of baseline immunosuppressive therapy, or additional rescue therapy while on the requested product, that will be considered treatment failure and will not meet continuation criteria.

Eculizumab (Soliris) and other listed complement C5 inhibitors (including biosimilars and related products) are not indicated for treatment of Shiga toxin E. coli–related hemolytic uremic syndrome (STEC‑HUS). The policy references FDA labeling and existing evidence gaps, concluding these agents are not medically necessary for STEC‑HUS.

The policy explicitly excludes concurrent use of complement inhibitors with B‑cell depletion therapy (for example, inebilizumab/Uplizna) or with immune globulin products (e.g., Hizentra, Privigen, Gammagard) for the same indication. Such combination therapy is listed as a criterion that will trigger denial for continuation or new authorization when present.

For continuation decisions the policy requires demonstration of clinical benefit from baseline (for example, ≥2‑point improvement in MG‑ADL for gMG or reduction in relapse frequency/severity for NMOSD) and documentation that baseline immunosuppressive therapy was maintained, reduced, or discontinued before initiating the complement inhibitor. The policy states that add‑on therapy, dose escalation of baseline immunosuppressive therapy, or additional rescue therapy while on the requested product will be considered treatment failure and therefore will not meet continuation criteria.

The policy has removed the prior initiation requirement tied to documented relapse counts. Specifically, the criterion that initiation be limited to patients with a history of ≥2 relapses in the previous 12 months or ≥3 relapses in the previous 24 months (with at least one in the prior 12 months) has been deleted.

Initial Therapy Criteria and Drug-Specific Regimens

Initial Therapy (drug-specific)

Initial therapy criteria vary by indication and require diagnosis-specific documentation, prescriber specialty, and FDA dosing; initial authorizations are for up to 12 months.

initial therapy summary: See indication-specific initial therapy sets for aHUS, PNH, gMG, and NMOSD capturing diagnostic confirmation, prior treatment requirements where applicable, dosing per US FDA label, specialist prescriber, and initial authorization ≤ 12 months.

Initial therapy (example: NMOSD)

Example — NMOSD initial therapy nodes and specifics

NMOSD_initial: Diagnosis by neurologist with qualifying history; positive AQP4-IgG serology; other diagnoses ruled out; no prior failure of a complement C5 inhibitor for NMOSD; history of failure/contraindication/intolerance to rituximab required; dosing per US FDA NMOSD label; prescribed by or in consultation with a neurologist; initial authorization ≤ 12 months.

Medicare reviews note CMS section reference

Continuation and Reauthorization Criteria

Continuation Therapy (general)

Continuation rules mirror initial therapy but require documented clinical response and prescriber specialty; reauthorizations are for up to 12 months.

continuation summary: Patient must be on an allowed product (Soliris meeting Preferred Product Criteria or Bkemv/Epysqli/PiaSky/Ultomiris as applicable), show documented clinical response from baseline, be dosed per US FDA labeling, be managed by appropriate specialist, and reauthorization is ≤ 12 months.

Continuation therapy nodes

Continuation criteria for C5 inhibitors vary by indication and require demonstration of clinical benefit and appropriate prescriber involvement.

gMG_continuation: See gMG continuation criteria: ≥2-point MG-ADL improvement, reduction in signs/symptoms, maintenance/reduction/discontinuation of baseline IST; dosing per FDA; no prohibited combinations; neurologist involvement; reauthorization ≤ 12 months.

Billing and Coding References

Procedure HCPCS/J-codes referencedHCPCS

J1299	Injection, eculizumab, 2 mg.
J1303	Injection, ravulizumab-cwvz, 10 mg.
J1307	Injection, crovalimab-akkz, 10 mg.
Q5151	Injection, eculizumab-aagh (epysqli), biosimilar, 2 mg.
Q5152	Injection, eculizumab-aeeb (bkemv), biosimilar, 2 mg.

Diagnosis ICD-10 codes referencedICD-10

D59.30	Hemolytic-uremic syndrome, unspecified.
D59.32	Hereditary hemolytic-uremic syndrome.
D59.39	Other hemolytic-uremic syndrome.
D59.5	Paroxysmal nocturnal hemoglobinuria [Marchiafava-Micheli].
G36.0	Neuromyelitis optica [Devic].
G70.00	Myasthenia gravis without (acute) exacerbation.
G70.01	Myasthenia gravis with (acute) exacerbation.

inv-20: MG-ADL initiation threshold — required MG-ADL >= 6

MG-ADL initiation thresholdMG-ADL total score ≥ 6 at initiation of therapy

Supporting requirementSubmission of medical records confirming MGFA class II–IV at initiation and positive anti‑AChR serology

Prescriber requirementPrescribed by, or in consultation with, a neurologist

inv-21: Preferred product trial duration — trial of preferred eculizumab products >= 14 weeks before Soliris

Preferred product trial durationDocumented trial of Bkemv and Epysqli for at least 14 weeks

Failure definitionTrial must result in minimal clinical response with residual disease activity to qualify for Soliris consideration

Prior Authorization, Documentation, REMS, and Denial Risks

Prior Authorization

Preferred product and Soliris exceptions — prior authorization preference for Bkemv and Epysqli; Soliris exception criteria

Bkemv (eculizumab-aeeb) and Epysqli (eculizumab-aagh) are the preferred eculizumab products. Coverage for Bkemv and Epysqli will be provided contingent on meeting the Diagnosis‑Specific Criteria. Coverage for Soliris (eculizumab) will be provided only when both the Preferred Product Criteria in this policy and the Diagnosis‑Specific Criteria are met. Members already receiving Soliris will be required to change to Bkemv or Epysqli to continue coverage unless they meet the Soliris exception criteria (see Preferred Product Criteria: documented trial failure or intolerance to preferred products and physician attestation of expected superior response or lack of expected cross‑reactive intolerance).

Preferred products: Bkemv (eculizumab-aeeb), Epysqli (eculizumab-aagh)
Soliris coverage requires meeting Preferred Product Criteria and Diagnosis‑Specific Criteria
Existing Soliris patients must transition to preferred product unless meeting Soliris exception criteria

Prior Authorization

Prior authorization required — documentation, specialist involvement, and PA expectations

Step Therapy Requirements

Step	Requirement	Notes
1
Trial of preferred eculizumab products (Bkemv and Epysqli) prior to Soliris
Trial should be at least 14 weeks with minimal clinical response to preferred products OR documented intolerance/contraindication/adverse event to both preferred products with physician attestation that Soliris would likely avoid the same issue

Step	Requirement	Notes
1
History of failure of, contraindication to, or intolerance to rituximab prior to coverage of a complement C5 inhibitor for NMOSD
Patient must not have failed a previous course of a complement C5 inhibitor for NMOSD; requirement applies in initial therapy prior to C5 inhibitor initiation and noted for Medicare reviews per CMS reference

Trial	Context	Key findings
PEGASUS
Enrolled adults with PNH and persistent anemia (hemoglobin <10.5 g/dL) despite at least 3 months of eculizumab
Pegcetacoplan was superior to eculizumab for mean hemoglobin change at week 16 (mean difference 3.84 g/dL) and higher transfusion-free rates (85% vs 15%)

Applicability	Policy statement	Implication
Medicare Advantage
Preferred therapy criteria are not applicable for Medicare Advantage members
For Medicare (Part B) determinations, CMS guidance and local coverage should be consulted; Preferred-product step requirements do not apply to Medicare Advantage membership per policy note

Administration Setting and Site-of-Care Notes

Note

Infusion center considerations: vaccination and prophylaxis noted; site‑of‑care not specified

Clinical trials and trial protocols note vaccination and antibiotic prophylaxis considerations; site‑of‑care limitations are not specified in this excerpt, so verify member benefits and institutional requirements for infusion center use.

PNH trials required meningococcal vaccination or prophylactic antibiotics until 2 weeks after vaccination. [chunk 33]
Site‑of‑care limitations are not defined in the policy excerpt; check member-specific benefits. [chunk 33]

Billing Rule

Administration routes: IV or SC per labeling and trials

Agents are administered intravenously or subcutaneously per product labeling and trial regimens; follow the product-specific route and dosing schedules described in FDA labeling and pivotal trials when scheduling administration in clinic or infusion center settings.

Preferred Products, Biosimilars, and Switching

Billing Rule

Soliris (eculizumab) and preferred eculizumab products

Soliris (eculizumab) is the reference eculizumab product; the policy designates Bkemv and Epysqli as the preferred eculizumab products and requires members on Soliris to change to Bkemv or Epysqli unless they meet the Soliris exception criteria.

Bkemv and Epysqli are listed as preferred eculizumab products; members on Soliris will be required to change to one of these unless they meet exception criteria. [chunk 4]

Billing Rule

Soliris preferred-product relationship and exception pathway

Soliris is the reference eculizumab product and an exception pathway is defined for remaining on Soliris if Preferred Product Criteria or documented intolerance/contraindication are met.

Coverage for Soliris contingent on meeting Preferred Product Criteria (≥14‑week trial of preferred products with minimal response and physician attestation) or documented intolerance/contraindication with physician attestation. [chunks 4–6]

Billing Rule

Background and Clinical Context

Complement C5 inhibitors (monoclonal antibodies such as eculizumab, ravulizumab, and crovalimab) bind complement protein C5 to inhibit terminal complement activation. These agents are indicated across multiple complement‑mediated disorders including atypical hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), and anti‑AChR antibody positive generalized myasthenia gravis (gMG), and some products are indicated for AQP4‑positive neuromyelitis optica spectrum disorder (NMOSD) depending on the product. FDA labeling for these products includes meningococcal vaccination guidance and REMS requirements because C5 inhibition increases the risk of invasive meningococcal infections; vaccination and monitoring recommendations are emphasized in the policy.

Key Definitions and Thresholds

inv-40: aHUS diagnostic exclusion — rule out STEC-HUS and TTP (ADAMTS13)

aHUS diagnostic exclusionMust rule out Shiga toxin E. coli–related HUS (STEC‑HUS)

TTP exclusionMust rule out thrombotic thrombocytopenic purpura (eg, ADAMTS13 deficiency)

Documentation impactFailure to document exclusion of STEC‑HUS and TTP may trigger denial of aHUS treatment requests

inv-41: gMG initiation thresholds — positive anti-AChR antibody, MGFA class II-IV, MG-ADL >= 6

Serology requirementPositive serologic test for anti‑AChR antibodies

Clinical classMGFA Clinical Classification of class II, III, or IV at initiation

Policy Revision History

2026-04-01policy_revisionLatest

Revised continuation criteria across indications (aHUS, PNH, gMG) to require that patients for continuation be on Soliris meeting Preferred Product Criteria or be on specified alternatives (Bkemv, Epysqli, PiaSky where listed, or Ultomiris) and removed the prior requirement that the patient was previously treated with the requested product.

2026-04-01policy_revision

Added prohibition in continuation criteria against receiving the requested complement inhibitor in combination with B-cell depletion therapy (e.g., inebilizumab) or immune globulin for the same indication.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyCoverage criteria for Complement C5 inhibitors (Bkemv, Epijkstra, PiaSky, Soliris, Ultomiris)

Policy CodePolicy 2026D0049AE

Change TypeModified — material changes to continuation and initiation criteria

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Confirm FDA indication, meningococcal vaccination, and REMS enrollment — vaccination timing and REMS enrollment requirements

Patients receiving complement inhibitors (Bkemv, Epysqli, PiaSky, Soliris, Ultomiris) are at increased risk for invasive Neisseria meningitidis infection. Vaccinate according to current ACIP recommendations and complete or update meningococcal vaccination at least 2 weeks before the first dose when possible. If urgent therapy is required, vaccinate as soon as possible and monitor closely for early signs of meningococcal infection.

Complete/update meningococcal vaccination ≥ 2 weeks prior to first dose when possible
Revaccinate per ACIP and consider duration of therapy
If unvaccinated and therapy urgent, vaccinate immediately and monitor closely

Step Therapy

Step requirement prior to C5 inhibitor in NMOSD — rituximab failure/intolerance/contraindication required

For NMOSD, initiation of any complement C5 inhibitor requires diagnosis confirmation by a neurologist with positive AQP4‑IgG and exclusion of alternate diagnoses. Additionally, a step requirement is in place: documentation of failure of, contraindication to, or intolerance of rituximab is required prior to use of a C5 inhibitor (for Medicare reviews, see CMS guidance). Continuation of therapy requires either the patient is on Soliris and meets Preferred Product Criteria or is on a preferred product (Bkemv, Epysqli, or Ultomiris) and documentation of clinical response (reduction in relapses/severity and ability to maintain/reduce/discontinue baseline IST).

NMOSD: positive AQP4‑IgG serology and neurologist diagnosis
Require prior failure/intolerance/contraindication to rituximab before C5 inhibitor (step therapy)
Continuation: patient on Soliris meeting Preferred Product Criteria OR on Bkemv/Epysqli/Ultomiris with documented clinical response

Note

Evidence comparing complement inhibitors — trial evidence (pegcetacoplan vs eculizumab; crovalimab vs eculizumab) may inform decisions

Comparative evidence among complement inhibitors may inform coverage decisions. Key trials include PEGASUS (pegcetacoplan vs eculizumab) demonstrating superior hemoglobin and transfusion outcomes with pegcetacoplan in PNH, and COMMODORE 2 (crovalimab vs eculizumab) showing noninferiority for hemolysis control. Such comparative data may be considered when assessing medical necessity and therapeutic selection.

PEGASUS: pegcetacoplan superior to eculizumab for hemoglobin increase and transfusion avoidance in select PNH patients
COMMODORE 2: crovalimab noninferior to eculizumab for hemolysis control