Medical specialty medication quantity limits (selected agents)
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Defines maximum dosing regimens and authorized indications (quantity limits) for specialty medications (examples: Actemra/tocilizumab, Adcetris/brentuximab vedotin, IVIG products, bevacizumab) effective 4/1/2026. Applies to Aetna medical specialty medication management for covered members/providers.
No material clinical or coverage changes in this revision.
Coverage Criteria — Maximum Dosing and Quantity Limits
inv-01: Initial and indication-specific dosing / quantity limits
Covered when ALL of the following are met for the specific agent/indication:
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inv-02: Alymsys / Bevacizumab dosing limits
Covered when drug is used for the specified diagnosis at or below the listed maximum dosing regimen
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inv-03: Asceniv (IVIG) dosing limits
Covered when IVIG is administered for the specified diagnosis at or below the listed maximum dosing regimen
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inv-04: Other listed specialty medications dosing limits
Covered when used for the specified diagnosis at or below the listed dosing regimen
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inv-05: Diagnosis-specific maximum dosing/regimen limits
Coverage is aligned to the listed diagnosis-specific maximum dosing regimens (examples below).
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inv-06: Diagnosis-specific maximum dosing regimens (excerpt)
Covered when dosing and indication match the diagnosis-specific maximum dosing regimens listed
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inv-07: Botox dosing limits
Botox (OnabotulinumtoxinA) quantity limits by indication:
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inv-08: Botulinum and spasticity dosing limits
Other botulinum products and indications (selected):
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inv-09: Biologics and specialty medication dosing limits
Selected biologics / specialty agents and their maximum dosing regimens:
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inv-10: Immunoglobulin and oncology dosing limits
Immunoglobulin and oncology agent dosing limits:
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inv-11: Enhertu dosing
Enhertu dosing limits across listed tumor types:
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inv-12: Medication-specific maximum dosing (partial entries)
Covered when dosing does not exceed the listed maximum dosing regimen for the specified diagnosis (entries shown are partial):
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inv-13: Diagnosis-specific maximum dosing regimens (Quantity limits)
Covered when dosing does not exceed the listed maximum dosing regimens for the specified diagnosis
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inv-14: Per-product, per-indication maximum IVIG dosing (examples)
Covered when dosing does not exceed the listed product- and indication-specific maximum regimens (route; dose; frequency) shown below.
inv-15: Product-specific maximum dosing regimens
Maximum dosing regimens for specified diagnoses and IVIG products (effective 4/1/2026):
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inv-16: Gammaplex maximum dosing regimens
Gammaplex IVIG maximum dosing regimens by diagnosis:
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inv-17: Gamunex-C maximum dosing regimens
Gamunex‑C IVIG maximum dosing regimens by diagnosis:
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inv-18: Diagnosis-specific maximum dosing limits (selected examples)
Dosing limits for Gammaplex/Gamunex‑C and other specialty drugs effective 4/1/2026. Covered when dosing does not exceed the listed maximum regimen per diagnosis.
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inv-19: Maximum dosing regimens by drug and indication (partial list)
Covered when administered at or below the listed maximum dosing regimens for the specified indications:
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inv-20: Indication-specific quantity limits (selected entries)
Coverage is limited to the listed diagnoses and maximum dosing regimens below.
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inv-21: Medication-specific maximum dosing regimens by diagnosis (partial)
Maximum dosing regimens specified for listed drugs when used for the named diagnoses (effective 4/1/2026).
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No explicit exclusions are listed in the coverage criteria excerpts. The document segment focuses on defining maximum dosing regimens and intervals by diagnosis and product (effective 4/1/2026) rather than enumerating conditions or populations that are categorically excluded from coverage. Refer to the listed indication-specific dosing lines (examples: tocilizumab entries for cytokine release syndrome, Actemra for giant cell arteritis, and multiple IVIG product lines) for the scope of the dose limits provided.
Administration or requests that would result in doses, dose frequencies, or re-treatment intervals that exceed the stated maximum regimens for each indication are not supported by the quantity limits shown. For example, intravitreal and IV agents have explicit per‑indication maximums (e.g., intravitreal Alymsys 1.25–1.5 mg every 4 weeks; Asceniv IVIG typically 2 g/kg divided over 2–5 days for many indications) and use beyond those listed dose/frequency limits is outside the dosing limits provided.
Any dosing request that exceeds the specified diagnosis‑specific maximum dosing regimens in this section (for example, higher mg/kg dosing, additional total doses beyond the stated course, or shorter re‑treatment intervals than the minimums listed) is not aligned with the listed quantity limits and may be subject to quantity‑limit enforcement or denial.
Coding and Dosing Highlights
| not provided | The chunks list diagnoses/indications and dosing but do not include explicit CPT/HCPCS/NDC or ICD-10 codes in these excerpts. |
Provider Actions — Prior Authorization, Documentation, and Denial Risk
Follow listed dosing/regimen limits
Follow the listed diagnosis-specific dosing and regimen limits in the Medical Specialty Medication Quantity Limits (effective 4/1/2026). Providers should adhere to the maximum dose, frequency, and minimum re-treatment intervals shown for each drug and indication. If the requested regimen exceeds the listed limits (dose, mg/kg, frequency, or earlier-than-allowed re-treatment), the request may be subject to denial or require prior authorization.
- The quantity limits define per-treatment maximum doses and minimum re-treatment intervals (examples: botulinum products — no re-treatment sooner than every 12 weeks; IVIG product-specific regimens and intervals).
- Prescribing and administration must follow the diagnosis-specific maximum dosing regimens (including age- and weight-based dosing where specified).
- Providers intending to use dosing, frequency, or re-treatment intervals that exceed these limits should request prior authorization that matches the diagnosis-specific dosing regimen being sought.
Prior authorization must match dosing limits
Prior authorization determinations, when applicable, should reflect the maximum diagnosis-specific dosing regimens and re-treatment intervals shown in the quantity limits effective 4/1/2026. Requests that propose greater doses, more frequent dosing, or earlier re-treatment than those listed should include a prior authorization request that documents the clinical rationale and matches the dosing being requested.
- Prior authorization must align with the product- and diagnosis-specific maximum dosing regimens and intervals.
- For specialty IVIG products, use the product-specific dosing/regimen when submitting prior authorization requests (see IVIG product entries with their per-diagnosis regimens).
Prior authorization not specified in excerpt
The excerpted quantity limits list maximum regimens and effective date but do not always state explicit prior authorization or denial processes within these chunks. Where PA or denial rules are not specified in this excerpt, providers must still follow the dosing limits and supply documentation when requesting exceptions.
- Not present in this excerpt: explicit prior authorization policy language or step therapy directions for many entries — the document provides quantity limits and effective date (4/1/2026) as the authoritative dosing constraints.
- No explicit denial triggers are listed in these chunks; however, requests inconsistent with the listed route, dose, frequency, or interval may be subject to denial under broader utilization management rules.
Required documentation for dosing
Document the diagnosis and the exact dosing regimen requested. For weight-based dosing, include the patient’s current weight and the mg/kg calculations supporting the requested dose. Provide indication-specific clinical rationale when requesting doses or intervals outside the listed maximums.
- Required documentation: diagnosis, intended dosing regimen (including weight and mg/kg math for weight-based dosing), frequency, and planned re-treatment interval.
- When requesting IVIG, indicate the specific product and the product-specific dosing schedule being used.
- Prescriptions or prior authorization requests should reference the applicable diagnosis entry and the exact regimen from the quantity limits table.
Use product-specific dosing when requesting IVIG
Use the product-specific dosing regimens listed for IVIG and other immune globulin products when requesting authorization or submitting claims. The table lists many IVIG products with diagnosis-specific maximum dosing regimens (for example, 2 g/kg per treatment divided over 2–5 days for multiple indications; maintenance schedules vary by product and diagnosis).
- When seeking authorization for IVIG, reference the named product (e.g., Gammagard, Gamunex-C, Flebogamma DIF, Octagam, etc.) and the diagnosis-specific dosing/regimen from the quantity limits.
- Provide dosing interval and maintenance plan consistent with the product-specific entry in the limits table.
Dosing limits (informational)
These dosing limits are informational and define the payer’s maximum allowed regimens effective 4/1/2026. They should be used for treatment planning and prior authorization requests but do not, in isolation, replace full PA or coverage policy language that may exist elsewhere.
- Dosing limits include effective date (4/1/2026) and per-diagnosis maximums; consult full policy or PA rules for procedural requirements.
- No step therapy requirements are specified in this excerpt.
Dose/Interval overage
Requests that exceed listed dose, frequency, or re-treatment intervals — for example higher mg/kg dosing, more frequent maintenance, or re-treatment sooner than the minimum interval (such as botulinum products before 12 weeks) — may be denied or require a detailed prior authorization and supporting clinical documentation.
- Examples of potential overage issues: dose exceeding the per-treatment maximum, more frequent dosing than allowed, or re-treatment earlier than the specified interval.
- When an overage is clinically justified, include robust documentation supporting the deviation in the PA request.
Step therapy not specified
There are no explicit step therapy requirements or step edits described in these chunks. If step therapy is relevant for a particular medication it is not specified within this excerpt, and providers should consult the complete policy or PA system for any step requirements.
- Step therapy not specified in this excerpt.
Provider action checklist
Summary action checklist for providers: follow the listed dosing/regimen limits; document diagnosis, weight, and mg/kg calculations when applicable; use product-specific IVIG dosing when applicable; and submit prior authorization requests that match the requested dosing if you intend to exceed limits or if PA is required by your payer system.
- Adhere to maximum doses, frequencies, and minimum re-treatment intervals shown in the quantity limits effective 4/1/2026.
- Include diagnosis, dosing details, patient weight for weight-based dosing, and clinical justification in PA requests.
- If no explicit PA is present in this excerpt, verify PA requirements in the payer’s authorization system; do not assume absence of PA from this dosing table alone.
Background — Scope and Purpose
This section provides payer‑specified maximum dosing regimens tied to specific diagnoses for specialty medications. Entries include per‑diagnosis routes, dose amounts (fixed or weight‑based), and dosing frequency or re‑treatment intervals for multiple specialty agents — examples include tocilizumab (Actemra) dosing by indication and weight bands, intravenous immune globulin products (Asceniv and others) with indication‑specific regimens (for example, 2 g/kg divided over 2–5 days for many conditions), and botulinum toxin and ophthalmic biologics with unit or per‑eye limits and minimum re‑treatment intervals.
Providers should note that these entries define the maximum authorized dosing regimens and quantity limits effective 4/1/2026. Prescribers requesting coverage should document the specific diagnosis, the intended dosing regimen (including patient weight when weight‑based dosing is specified), and the proposed schedule. If the intended dosing or frequency falls outside the listed maximums, providers should expect to pursue prior authorization consistent with payer processes and supply supporting documentation that justifies deviation from the listed limits.
Definitions and Key Terms
Revision History
Policy maximum dosing regimens and quantity limits became effective on 4/1/2026 for the listed specialty medications and indications.
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