This section lists the payer’s coverage criteria framework: each medication/indication entry specifies a Maximum Dosing Regimen (route, dose, frequency and any age/weight bands). Coverage is available when the requested dose, frequency, route and duration are at or below the listed maximum for the stated diagnosis and patient age/weight. Providers must document the diagnosis and any weight/age used to calculate mg/kg doses and should reference the effective date when applicable.

Requests that exceed the stated maximum dosing regimen for the product/diagnosis (for example higher mg/kg, more frequent dosing, or an unlisted route) are not supported by the quantity limits and may be denied or require prior authorization and additional justification. Specific examples include weight- and age-stratified limits for tocilizumab (CRS dosing capped at no more than 4 total doses, per-dose maxima as listed) and infliximab products (maximum maintenance doses up to 10 mg/kg depending on indication).

For denosumab products the policy distinguishes indications and schedules. Osenvelt (Denosumab-bmwo): for giant cell tumor of bone, hypercalcemia of malignancy and many palliative bone metastases regimens are Subcutaneous 120 mg on days 1, 8, and 15 of month 1, then 120 mg every 4 weeks; for osteopenia/osteoporosis in systemic mastocytosis the regimen is 60 mg every 6 months. Ospomyv (Denosumab-dssb) dosing for osteoporosis and some oncology-related prevention indications is listed as 60 mg every 6 months. Coverage requires adherence to the indication-specific schedule shown.

When dosing for an indication exceeds the listed maximum regimen the request falls outside the quantity limits. For example, the Cytokine Release Syndrome entry for tocilizumab limits dosing to weight bands with per-dose maxima (e.g., no more than 4 total doses, given at least 8 hours apart and with per-dose mg caps). Similarly, infliximab-type products include explicit upper induction and maintenance caps (up to 10 mg/kg in some scenarios). Exceeding these numeric limits may require prior authorization and will be subject to denial risk.

Ustekinumab products (IV and SC) have indication- and weight-based regimens. Otulfi (Ustekinumab-aauz) IV induction single doses are weight-tiered (<56 kg = 260 mg; 56–<86 kg = 390 mg; ≥86 kg = 520 mg). Otulfi SC maintenance for Crohn’s disease and other indications uses adult SC schedules (e.g., 90 mg every 8 weeks, with option for every 4 weeks for incomplete response) and distinct initial/maintenance schemes for plaque psoriasis and psoriatic arthritis by age/weight band. Coverage requires matching the route and weight/age band specified for the indication.

Exceeding the listed maximum dosing regimens may affect authorization and payment. Infliximab entries (Remicade, Renflexis, Inflectra) specify induction and maintenance ceilings (for example initial 5 mg/kg on weeks 0, 2, 6 with maximum induction or maintenance up to 10 mg/kg depending on indication and response). Requests proposing higher per-dose mg/kg, more frequent maintenance intervals than listed, or unlisted induction schedules are inconsistent with these quantity limits and may be denied or require documented justification and prior authorization review.

IV immune globulin (IVIG) products are included with many diagnosis-specific maximum regimens. Examples across products include CIDP induction and maintenance (initial 2 g/kg divided over 2–5 days then maintenance 1 g/kg every 3 weeks), solid-organ transplant allosensitization regimens (up to 3 g/kg divided over 2–5 days, max 1 g/kg/day), and Stevens–Johnson syndrome/TEN regimens (up to 3 g/kg per course). Use at doses or frequencies above the listed IVIG maxima is not supported without additional justification and may be considered not medically necessary.

Coverage of IVIG products requires that dosing and frequency match the product- and diagnosis-specific entries. Privigen, Panzyga, Gamunex-C, Gammagard/Gammaked/Gammaplex and other IVIG brands each list maximum regimens per diagnosis (for example, Privigen and Panzyga commonly use 2 g/kg per treatment divided over 2–5 days for many autoimmune indications, with maintenance schedules noted where applicable). Requests that exceed those brand-specific limits may be denied or require prior authorization with supporting documentation.

Provider requests that exceed maximum dosing regimens—either total course amounts, per-dose mg/kg caps, or frequency limits—are at risk for denial or will require prior authorization review. The document frames coverage as conditional on adherence to the listed maximums for each medication/diagnosis pair; deviations should be justified in the clinical record and submitted with any authorization request.

When submitting authorization requests for IVIG or other specialty agents, include documentation of diagnosis, patient weight/age (for weight-based dosing), planned dose and frequency, and the product name and effective date referenced. Many IVIG indications require explicit induction versus maintenance dosing (for example, CIDP initial 2 g/kg divided over 2–5 days, then maintenance 1 g/kg every 3 weeks), so supporting notes in the medical record should align with the table entry.

For denosumab products, oncology and bone indications have different schedules and total exposure implications. For example, Osenvelt lists a loading schedule of 120 mg on days 1, 8, 15 then 120 mg every 4 weeks for giant cell tumor of bone and oncologic uses; Prolia/Ospomyv-style regimens for osteoporosis use 60 mg every 6 months. These differences affect supply requests and authorizations; verify the indication to select the correct maximum regimen.

Otulfi (ustekinumab IV/SC) dosing is indication- and route-specific; IV dosing uses single weight-tiered amounts (<56 kg = 260 mg; 56–<86 kg = 390 mg; ≥86 kg = 520 mg), while SC maintenance for adults commonly uses 90 mg every 8 weeks (with option to increase to every 4 weeks for incomplete response). Requests must match the route and weight band shown for the diagnosis to be covered under these quantity limits.

The policy provides numerous examples where coverage requires both a listed diagnosis and adherence to the maximum dosing regimen. For biologics such as tocilizumab and abatacept (Orencia), dosing differs by indication and age/weight band (for example Orencia IV for acute GVHD prophylaxis uses 10 mg/kg in ≥6 years up to a maximum of 1000 mg on specific transplant days). Prior authorization submissions should mirror the exact diagnosis-specific regimen listed.

Infliximab products and biosimilars carry explicit induction and maintenance caps that vary by indication and age group. Inflectra and Remicade entries show initial induction doses (commonly 5 mg/kg on weeks 0, 2, 6) with maximum induction or maintenance allowances up to 10 mg/kg and, for incomplete response, intervals that may shorten (e.g., every 4 weeks). Coverage and quantity limits are tied to these numeric ceilings.

IVIG entries emphasize both total course amounts and per-day maxima where applicable (for example some transplant or SJS/TEN entries allow up to 3 g/kg divided over 2–5 days with a per-day cap of 1 g/kg). These numeric constraints should be applied when adjudicating supply requests to determine if the request is within the stated maximum dosing regimen.

Brand-specific IVIG examples illustrate similar patterns across products: Gamunex‑C entries list regimens such as 400 mg/kg dosing schedules for pediatric indications and courses up to 3 g/kg for severe dermatologic toxicities. When multiple regimen options appear for a single diagnosis (product variants or pediatric vs adult dosing), the provider should apply the product-specific line that matches the requested product and patient characteristics.

For rituximab products (Riabni, Rituxan) the table lists many oncology and autoimmune schedules with explicit per-dose and frequency constraints (e.g., common regimens of 375 mg/m² weekly or 1000 mg dosing patterns for certain autoimmune indications). Use beyond the documented frequency or dose (for example more frequent weekly dosing than allowed) may not be supported by these quantity limits and would need justification for prior authorization.

The document does not explicitly label separate "Not Medically Necessary" statements for most entries; however, it consistently indicates that dosing above the listed maximum regimens is not supported. Therefore, use at doses, frequencies, or for diagnoses not listed in the product entries may be considered outside the quantity limits and would require additional review.

IVIG overuse or requests exceeding per-course maximums (e.g., total grams per treatment or per-day caps) are specifically highlighted by multiple product entries. Examples across Privigen/Panzyga/Gamunex‑C/Gammagard show common maxima such as 2 g/kg per treatment for many autoimmune indications and up to 3 g/kg courses for severe conditions; exceeding these will likely require prior authorization and clinical justification.

Where weight- or age-based dosing applies, providers must document the patient’s measured weight and age used to determine the mg/kg or weight-band dose (for example to compute tocilizumab or ustekinumab doses). Failure to provide weight/age supporting evidence can impede authorization when the regimen is weight-tiered.

Numerical exceedances have explicit implications: orders above per-dose mg caps (e.g., tocilizumab per-dose maxima of 800 mg for CRS weight tiers or giant cell arteritis caps) or above maintenance ceilings (such as infliximab maintenance > 10 mg/kg) are inconsistent with these limits and may be denied unless appropriately justified with clinical documentation.

IVIG use beyond the listed frequencies (for example retreat intervals shorter than those specified or higher cumulative monthly exposure) is identified as potential overuse and may trigger payer review. Examples in the table make clear the usual maintenance intervals (e.g., CIDP maintenance 1 g/kg every 3 weeks) and typical retreat intervals for other diagnoses.

Some product entries include explicit effective dates (many show Effective 1/1/2026); when present, authorization requests should reference the effective date line for the product/diagnosis to ensure the applicable maximum dosing regimen is applied.

For IV or single-dose weight-tiered biologic administrations (such as IV ustekinumab/Imuldosa or Pyzchiva IV), the policy lists discrete weight bands with single-dose amounts (for example <56 kg = 260 mg; 56–<86 kg = 390 mg; ≥86 kg = 520 mg). These single-dose weight bands govern coverage for IV induction dosing and must be applied exactly when adjudicating requests.

Otulfi/ustekinumab entries include both IV single-dose weight bands and SC maintenance schedules; coverage requires selecting the regimen that corresponds to the route and indication: IV weight-banded single-dose induction or SC schedules such as 90 mg every 8 weeks for maintenance (with 4‑week option for incomplete response).

Dosing exceedance implications are consistent across agent classes: if the requested regimen would result in cumulative exposure, per-dose mg, or frequency greater than the table’s maximum, the request is outside the specified quantity limits and may require prior authorization review or be denied. Examples include denosumab schedules (120 mg loading plus q4w maintenance versus 60 mg q6 months), infliximab upper mg/kg caps, and IVIG per-course maxima.

When multiple products treat similar diagnoses (e.g., several IVIG brands), coverage is tied to the product-specific line and its maximum dosing regimen. Providers should ensure the requested brand and regimen correspond to a listed entry — otherwise the request may be treated as beyond the quantity limits for that product and require justification.

Osenvelt and Ospomyv entries illustrate that the same active ingredient may have different dosing schedules by indication (e.g., oncologic/palliative loading vs osteoporosis maintenance). Confirm the indication when matching the request to the correct maximum dosing regimen.

Where weight-band tables are used (ustekinumab/pyzchiva entries), the policy requires weight to determine the single IV dose; for SC maintenance dosing providers should document the chosen interval (e.g., every 8 weeks vs every 4 weeks for incomplete response).

IVIG dosing limits repeatedly show both per-course totals and per-day caps; adjudicators should apply both constraints (for example a 3 g/kg course divided over 2–5 days with a max of 1 g/kg/day). Requests that would exceed either the total course or the per-day cap are outside the listed maximum dosing regimens.

Throughout the document, exceeding the documented maximum dosing regimens (dose, frequency, route, or age/weight band) is explicitly identified as a basis for denial or requirement for prior authorization review. Providers should align supply and authorization requests to the product- and diagnosis-specific entries to avoid denials.

Background: This policy segment enumerates specialty medications relevant to immunology, rheumatology, neurology, oncology, transplant, and ophthalmology and establishes maximum dosing regimens by product and diagnosis (often weight‑ or age‑based). Many entries indicate an effective date (commonly Effective 1/1/2026), and coverage is conditioned on adherence to the listed regimen.