CareCost Prior authorization
Required
Check what the payer requires before you schedule Ultomiris.
29 payers, 527 rules, and a different question for each of Ultomiris’s four indications — diagnosis confirmation for PNH and aHUS, another product first for gMG and NMOSD.
29 payer policy sets hold a ravulizumab-cwvz policy · source-linked · reviewed August 2026
Aetna + PNH is shown as a live example until you choose a payer.
This payer requires an approval on file before Ultomiris is purchased or infused for this member.
Precertification of ravulizumab-cwvz (Ultomiris) is required of all Aetna participating providers and members in applicable plan designs
Covered under ICD-10 D59.5.
For the treatment of paroxysmal nocturnal hemoglobinuria (PNH), when all of the following criteria are met
What opens in CareCost
Aetna · Ultomiris · PNH
For every requirement: the exact payer criteria, the source citation, a check-off, and a save to the patient’s chart.
In CareCost: check off each requirement · save to the patient · print for the chart
Aetna · Ultomiris · PNH
You have already checked the policy, indication and covered dose. Open the remaining requirements and work them as a patient checklist.
CareCost tracks Ultomiris coverage requirements across 29 payer policy sets.
Aetna · Anthem / Elevance · UnitedHealthcare · Cigna · CareFirst BCBS · BCBS plans + more
Coverage clearance is only the first step.
CareCost carries the same patient through the entire workflow.
Finish this patient’s estimate →26 of 29 commercial payers with a ravulizumab-cwvz policy require prior authorization. The corpus splits into two different questions by indication: PNH and aHUS turn on a lab-confirmed diagnosis, while generalized myasthenia gravis and NMOSD turn on step therapy with another drug first. Reauthorization timing, quantity limits and site-of-care rules vary by plan on top of either path.
The 527 rules break out as 308 clinical prerequisites, 105 covered-indication rules, 26 prior-authorization rules, 21 contraindication exclusions, 20 quantity limits, 15 site-of-care rules, 12 dosing rules, 6 reauthorization rules, 4 combination rules (mostly a bar on stacking Ultomiris with a second complement inhibitor), 3 step-therapy-elsewhere rules, and a handful of continuation-of-therapy, billing-coding, not-covered and benefit-applicability notes.
26 require PA · 20 cap quantity or duration · 15 address site of care
26 of the 29 payers CareCost has read require an approval on file before ravulizumab-cwvz is covered. Aetna’s precertification rule reads: “Precertification of ravulizumab-cwvz (Ultomiris) is required of all Aetna participating providers and members in applicable plan designs.” The other 3 (HCSC, BCBS Kansas and BCBS South Carolina) carry no prior-authorization rule in this corpus, although BCBS South Carolina's site-of-care roster says the listed drugs require prior authorization.
These two indications ask for lab evidence of the diagnosis itself. Aetna: “at least 5% PNH cells, at least 51% of GPI-AP deficient poly-morphonuclear cells” for PNH and “ADAMTS 13 activity level above 5%” for aHUS, a threshold that rules out thrombotic thrombocytopenic purpura. BCBS Arkansas: “Equal to or more than 10% of PNH type III red cells.” Anthem: “Lactate dehydrogenase greater than 1.5 times the upper limit of normal” for PNH. Sixteen payers exclude the look-alike condition by name: BCBS Florida, “Ravulizumab is not indicated for the treatment of patients with Shiga toxin E.coli related hemolytic uremic syndrome (STEC-HUS).” Eight payers also bar stacking Ultomiris with a second complement inhibitor: Aetna “will not be used in combination with another complement inhibitor (e.g., Empaveli, Fabhalta, PiaSky, Soliris) for the treatment of PNH,” and BCBS Michigan asks for a trial of one first: “Trial and failure, contraindication, or intolerance to Empaveli.” BCBS Kansas adds a vaccination criterion: the patient must have “been immunized with a meningococcal vaccine at least 2 weeks prior to administration of the first dose of Ravulizumab.”
The two neurology indications run the opposite way: another drug tried and failed first. For gMG, most policies want pyridostigmine or an immunosuppressant tried first. Anthem: “Individual has had a trial and inadequate response or intolerance to an acetylcholinesterase inhibitor.” BCBS Kansas and BCBS South Carolina: “Trial and failure, contraindication, or intolerance to one immunosuppressive therapy (e.g., glucocorticoids, azathioprine, cyclosporine, mycophenolate mofetil, methotrexate, tacrolimus).” UnitedHealthcare: “History of failure of at least two immunosuppressive agents over the course of at least 12 months.” Wellmark: “Member has failed treatment over at least one year with at least two immunosuppressive therapies.” A few payers ask for a preferred FcRn blocker instead: Independence requires a documented contraindication or inadequate response to efgartigimod alfa-fcab (Vyvgart) IV, efgartigimod-alfa or rozanolixizumab-noli (Rystiggo); Blue Shield of California asks for “contraindication to one preferred product (e.g. Vyvgart, Vyvgart Hytrulo, or Epysqli).” For NMOSD, the preferred first drug is rituximab: UnitedHealthcare, “History of failure of, contraindication, or intolerance to rituximab therapy”; Centene, “Failure of rituximab (Ruxience™ and Truxima® are preferred) at up to maximally indicated doses, unless contraindicated.” BCBS Michigan instead asks for two other drugs first: “Adequate trial and failure of an adequate trial of, contraindication, or intolerance to Uplizna, and Enspryng.”
14 payers address where the infusion can happen (15 rules, since Blue Shield of California carries two). CareFirst covers “administration of Ultomiris in an outpatient hospital setting for up to 45 days when a member is new to therapy” before steering the patient elsewhere. Blue Shield of California names its “preferred site of service, including the home, a physician’s office, or an independent infusion center,” with a second rule addressing hospital-outpatient administration directly. Highmark (HMHS) will pay when Ultomiris is “administered in a physician’s office not affiliated with a hospital, specialized infusion centers not affiliated with a hospital or in the home.” Premera treats a mismatch as a denial: a request “administered in a site that does not meet the policy’s site-of-service criteria will be considered not medically necessary.” Regence groups the eculizumab products (Soliris, Bkemv, Epysqli and unbranded eculizumab-aagh) and Ultomiris IV under one site-of-care rule.
20 rules cap the amount, most as a pharmacy count rather than a milligram ceiling. Anthem: “Ultomiris 1100 mg/11 mL vial^ 3 vials per 56 days” and “Ultomiris 300mg/3 mL vial* 12 vials per 56 days.” BCBS Louisiana caps every indication the same way: “Dose does not exceed 3,600 mg every 8 weeks.” Capital BlueCross’s quantity limit (and BCBS Minnesota’s dosing rule) write the same ceiling in units: “300 units on Day 0 followed by 360 units on Day 14 and every 8 weeks thereafter” — the 3,000 mg loading dose, then the 3,600 mg top maintenance dose. BCBS South Carolina’s quantity limit is wrong: it lists a “900 mg weekly x 4 doses” schedule that is eculizumab’s dosing table, not Ultomiris’s — a payer-side error, not Ultomiris’s own regimen. Anthem’s same table also lists an on-body-injector product this label does not include; only the 300 mg and 1,100 mg vial lines apply to Ultomiris.
6 rules address renewal. BCBS Michigan: “Authorization Period: One year at a time.” Capital BlueCross: “Prior authorization validity may be renewed every 12 months thereafter.” HMSA approves the first course for only 3 months: “The drug will be initially approved for 3 months.” Regence ties renewal to a specific measurement by indication: for gMG, “A standard disease scoring tool must be included, such as the total myasthenia gravis activities of daily living (MG-ADL)”; for NMOSD, “There must be a reduction of clinical relapse OR provider attestation has been received that patient is continuing to have clinical benefit (stability or improvement).”
Not every payer covers Ultomiris’s whole label. PNH and aHUS each carry a rule at 28 of the 29 payers; generalized myasthenia gravis at 27; NMOSD, the narrowest, at 25. Horizon is one gap worth naming: its policy still authorizes gMG and NMOSD for “Eculizumab (Soliris) ONLY,” leaving Ultomiris covered there for PNH and aHUS alone. A payer that covers one indication does not automatically cover the rest — check the diagnosis on this patient’s claim against the payer’s own list before assuming the whole policy applies.
The family file lists no ravulizumab-cwvz biosimilar. When a policy names another complement inhibitor, it is an eculizumab product, a step target for a different indication, or a bar on combining two of them for the same patient.
| Product | Code | Maker | On this page |
|---|---|---|---|
| Ultomiris | J1303 | Alexion (AstraZeneca Rare Disease) | This page |
| Soliris | J1300 | Alexion (AstraZeneca Rare Disease) | Reference eculizumab; alternative, unpriced this quarter |
| Bkemv | Q5139 | Amgen | Eculizumab biosimilar, unpriced |
| Epysqli | Q5141 | Samsung Bioepis | Eculizumab biosimilar, unpriced |
| Piasky | J1307 | Genentech | Rival complement inhibitor, $551.51 per 10 mg, PNH only |
Soliris is the original eculizumab product from the same maker and has carried no ASP row since 2025 Q1 — unpriced this quarter, not free. Bkemv and Epysqli are eculizumab biosimilars, also unpriced. Piasky (crovalimab-akkz) is a separate complement inhibitor, not a ravulizumab-cwvz biosimilar, priced at $551.51 per 10 mg and labeled for PNH only.
A patient already on eculizumab does not restart Ultomiris’s loading schedule from zero. Under the label’s Table 2, a patient currently treated with eculizumab takes the Ultomiris loading dose at the time of the next scheduled eculizumab dose, then the first maintenance dose 2 weeks later. Regence groups both drugs under one site-of-care rule. Horizon has not caught up for the neurology indications: its policy still authorizes gMG and NMOSD for “Eculizumab (Soliris) ONLY,” so a patient switching to Ultomiris for either diagnosis may need to work from a different, older rule.
Each billable code on Ultomiris’s manifest carries its own dxKey in the Clearance corpus, so the payer count that applies changes with what’s on the claim.
| Indication | ICD-10 | dxKey | Payers with a rule for this indication |
|---|---|---|---|
| Paroxysmal nocturnal hemoglobinuria (1 month and older) | D59.5 | paroxysmal_nocturnal_hemoglobinuria | 28 of 29 |
| Atypical hemolytic uremic syndrome (1 month and older) | D59.39 | atypical_hemolytic_uremic_syndrome | 28 of 29 |
| Generalized myasthenia gravis, AChR antibody-positive (adult) | G70.00 | generalized_myasthenia_gravis | 27 of 29 |
| Neuromyelitis optica spectrum disorder, AQP4 antibody-positive (adult) | G36.0 | nmosd | 25 of 29 |
CareCost’s diagnosis picker above offers all four. NMOSD is the narrowest indication in this corpus, and it is also the one where the step-therapy target (rituximab, or Uplizna and Enspryng at some payers) is most likely to differ from the gMG target next to it.
Part B pays for Ultomiris at the ASP-based rate for J1303, the same buy-and-bill mechanism as any other infused specialty drug; nothing in this corpus documents a national coverage determination or a registry requirement specific to ravulizumab-cwvz. A Medicare Advantage plan administers that same benefit but can layer its own prior-authorization and site-of-care rules on top, including the ones quoted above. Check the plan’s own policy rather than assuming these rules carry over.
Ultomiris is billed with 96365 (therapeutic infusion, initial hour) alone, non-facility PFS $67.14. The 100 mg/mL formulation’s minimum infusion times are all under 90 minutes — 0.7 hours for the 3,300 mg maintenance dose at 60 to under 100 kg, 0.6 hours for the 2,700 mg loading dose at that band — so 96366 (each additional hour) applies only if the infusion actually runs past 90 minutes, and 96413 (chemotherapy administration) is the wrong code family for a complement inhibitor. The Medicare unit-of-service limit (MUE) for J1303 is 360 units, matching the 3,600 mg top maintenance dose.
Payer citation language above is drawn from CareCost’s own ravulizumab-cwvz policy corpus (29 payers, 527 rules). Check the specific payer’s language →
It depends on the payer and plan. 26 of the 29 ravulizumab-cwvz policies CareCost has read require prior authorization before Ultomiris is covered. The other 3 (HCSC, BCBS Kansas and BCBS South Carolina) carry no prior-authorization rule in this corpus, although BCBS South Carolina's site-of-care roster says the listed drugs require prior authorization. Check this patient’s payer →
A lab-confirmed diagnosis, not a step therapy. Aetna requires “at least 5% PNH cells, at least 51% of GPI-AP deficient poly-morphonuclear cells” for PNH and “ADAMTS 13 activity level above 5%” for aHUS, which rules out thrombotic thrombocytopenic purpura. BCBS Kansas also requires that the patient has “been immunized with a meningococcal vaccine at least 2 weeks prior to administration of the first dose of Ravulizumab.” Check this patient’s payer →
Yes, at most payers with a gMG or NMOSD policy. Anthem requires “a trial and inadequate response or intolerance to an acetylcholinesterase inhibitor” for gMG. UnitedHealthcare requires “History of failure of, contraindication, or intolerance to rituximab therapy” for NMOSD. Blue Shield of California asks for “contraindication to one preferred product (e.g. Vyvgart, Vyvgart Hytrulo, or Epysqli)” before gMG is approved. Check this patient’s payer →
It depends on the payer. CareFirst covers “administration of Ultomiris in an outpatient hospital setting for up to 45 days when a member is new to therapy” before steering elsewhere. Blue Shield of California names its “preferred site of service, including the home, a physician’s office, or an independent infusion center.” 14 payers in this corpus carry a site-of-care rule. Check this patient’s payer →
Yes. Anthem limits the 1,100 mg vial to “3 vials per 56 days” and the 300 mg vial to “12 vials per 56 days.” The Medicare unit-of-service limit (MUE) for J1303 is 360 units, matching the top 3,600 mg maintenance dose. Check this patient’s payer →
Data current: payer policies Aug 2026 · reviewed dates come from each payer
Payer medical and pharmacy policies · prior-authorization criteria · clinical coverage criteria. ICD-10 codes verified against the NLM Clinical Table Search Service. Medicare coverage and fee-schedule amounts from the CMS Medicare Coverage Database and the Medicare Physician Fee Schedule. Every CareCost requirement links back to its source policy.