CurrentUnitedHealthcarePolicy N/A

Maximum Dosage and Frequency (Medical Benefit Drug Policy)

Defines maximum per-administration dosages and dosing frequencies (and corresponding HCPCS unit limits) for selected physician‑administered medications; affects providers submitting medical benefit drug claims under UnitedHealthcare commercial plans, with state-specific exceptions noted.

Policy Summary

PayerUnitedHealthcare

PolicyMaximum Dosage and Frequency (Medical Benefit Drug Policy)

Policy CodePolicy N/A

Change TypeNo material changes indicated

Effective DateN/A

Next Review DateN/A

Key ActionDocument administered dose and frequency and ensure dosing is within the policy's maximums or submit justification/prior authorization for doses beyond those limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

140 kg / 2.71 m2Adult upper-level weight/BSA

~100+Drugs with listed maximums

800 mgExample max (Actemra)

15 mg/kgExample weight-based (Avastin)

04/01/2026Document effective date

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Coverage Criteria

Coverage within policy maximums

Covered when ALL of the following are met

Within maximums: Medication is given within the maximum dosage per administration and dosing frequency as defined by body surface area, patient weight, or a set maximal dosage independent of patient body size.see HCPCS/NDC maximums and Maximum Allowed Frequencies in this policy

Coverage supported when use is consistent with FDA labeling or published clinical evidence (e.g., RCTs, systematic reviews, national compendia).

Not medically necessary beyond maximums

Not covered / Not medically necessary when ANY of the following are true

Beyond maximums: Use of medications beyond the maximum dosages and/or frequency defined in this policy is unproven and considered not medically necessary.exceeds listed HCPCS maximums, NDC Maximum Allowed volumes/units, or 95th percentile adult-based limits (140 kg / 2.71 m2)

Continued use beyond labeled indications or published clinical evidence may result in denial.

General maximum-quantity rule

Apply these maximums when adjudicating claims for HCPCS- or NDC-billed specialty drugs

Apply listed maximum: The payer's allowed quantity for each drug is the maximum listed per HCPCS unit or per NDC presentation; adjudicators should limit claims to these amounts.per line item (HCPCS units or NDC volume/vials as listed)

See specific drug entries for unit conversions (e.g., mg per HCPCS unit; mL or vials per NDC).

Standard billing limits

Covered when dosing and billing do not exceed the listed maximum NDC quantities and frequencies derived from FDA labeling or UnitedHealthcare clinical evidence.

Maximums enforced: Provider billing must not exceed the product-specific Maximum Allowed NDC quantities or the Maximum Allowed Frequencies for the indicated diagnosis.see NDC Maximum Allowed and Maximum Allowed Frequencies sections

Exceeding these limits may require prior authorization or may be denied; absence of a specific NDC does not imply exemption from limits.

Maximum allowed frequencies (per-medication)

Covered when administered at or below the listed maximum frequency per medication and indication

Kanjinti (trastuzumab-anns): Administered once every week for oncology indications as listed.once every week

See Maximum Allowed Frequencies section for indication-specific details.

Keytruda (pembrolizumab): Administered once every 3 weeks for oncology indications as listed.once every 3 weeks

See Maximum Allowed Frequencies section for indication-specific details.

Leqvio (inclisiran): Initial dose, then at 3 months, then every 6 months thereafter for hyperlipidemia.initial, 3 months, then q6 months

Maximum Dosage Criteria

Covered when dosing is within the following limits

Maximum dose adherence: Medication use is within product-specific maximum dosages based on body weight or body surface area as defined by FDA prescribing information or supported literature; this policy establishes an upper bound using the 95th percentile adult weight (140 kg) and BSA (2.71 m2).≤ product-specific max OR ≤95th-percentile-based max (140 kg / 2.71 m2)

Use beyond these maxima is not supported by clinical evidence and increases risk of adverse events.

Dose-based coverage criteria

Covered when ALL of the following are met

Dose within supported limits: Medication use is within product-specific maximum dosages based on body weight or body surface area as defined in FDA prescribing information or supported literature.use ≤ product max (policy uses 95th percentile adult limits: 140 kg / 2.71 m2)

Providers should document administered dose and frequency and reference FDA labeling/compendia; dosing beyond these limits is considered not medically necessary.

This Medical Benefit Drug Policy does not apply to the states listed below. Providers in these states should consult the referenced state‑specific policy or guideline for maximum dosage and frequency rules: Arizona (no state policy/guideline noted), Kansas (no state policy/guideline noted), North Carolina (no state policy/guideline noted), Ohio (refer to Maximum Dosage and Frequency for Ohio Only), and Pennsylvania (refer to Maximum Dosage and Frequency for Pennsylvania Only).

When adjudicating claims billed with NDCs, note that the absence of a specific NDC from the NDC listing does not imply the product is exempt from the policy’s maximum allowed quantities. Allowed NDC quantities are calculated from the policy’s maximum dosage information and the NDC billing process; providers should assume maximums may apply even if an NDC is not explicitly listed.

Requests that exceed the policy’s listed maximum dosages, volumes, units, or frequencies are not supported by the evidence summarized in this policy. Use of medications beyond the stated maximums is therefore considered not medically necessary and may be denied unless clinical justification consistent with the policy’s exceptions is provided.

Listing of a procedure, HCPCS, CPT or NDC code in this policy is provided for reference only. Inclusion of a code does not imply that the service or product described by that code is a covered benefit; coverage and reimbursement depend on applicable federal, state and contractual requirements and other policies or guidelines.

Dosing that would exceed product‑specific maximum dosages when calculated based on patient body weight or body surface area is discouraged. This policy defines upper‑level adult thresholds using the 95th percentile values (weight = 140 kg, BSA = 2.71 m2) to set maximum allowable dosages; dosing beyond those limits is unsupported by the evidence and is not recommended.

Clinical evidence summarized in this policy does not support medication dosing based on body surface area or patient weight beyond the established maximums. Use above those established BSA/weight‑based caps is considered unproven and therefore not medically necessary.

Continued use of a medication at doses or for indications that exceed the FDA‑labeled indication or published clinical evidence is considered not medically necessary. Providers should document that ongoing therapy remains within labeled indications or supported literature when requesting authorization or submitting claims.

Use beyond the listed maximum frequency or quantity without prior authorization or adequate clinical justification may be considered not medically necessary and subject to payment adjustment or denial. Maximum allowed frequencies are based on FDA prescribing information where available; for non‑labeled indications UnitedHealthcare‑derived frequencies apply.

Dosing that exceeds product‑specific maximums when calculated by patient weight or body surface area is considered both unsupported by clinical evidence and not medically necessary. The policy’s upper limits are based on FDA labeling, compendia, and the 95th percentile adult anthropometrics (140 kg / 2.71 m2).

Use of medications beyond the established maximum dosages—whether defined per administration, per kilogram, or per square meter—is not supported by the clinical evidence presented. Such dosing increases risk without demonstrated incremental benefit and therefore is considered not supported for coverage.

Coding and Product Codes

Maximum Allowed HCPCS (sample group)HCPCSCovered

J3262	Actemra (tocilizumab) – 1 mg per HCPCS unit
Q5133	Tofidence (tocilizumab-bavi) – 1 mg per HCPCS unit
Q5135	Tyenne (tocilizumab-aazg) – 1 mg per HCPCS unit

Bevacizumab and biosimilars HCPCSHCPCSCovered

J9035	Avastin (bevacizumab) – 10 mg per HCPCS unit
Q5129	Vegzelma (bevacizumab-adcd) – 10 mg per HCPCS unit
Q5107	Mvasi (bevacizumab-awwb) – 10 mg per HCPCS unit
Q5118	Zirabev (bevacizumab-bvzr) – 10 mg per HCPCS unit
Q5126	Alymsys (bevacizumab-maly) – 10 mg per HCPCS unit

Mixed sample HCPCSHCPCSCovered

J3145	Aveed (testosterone undecanoate) – 1 mg per HCPCS unit
J0585	Botox (onabotulinumtoxinA) – 1 unit per HCPCS unit
J0717	Cimzia (certolizumab pegol) – 1 mg per HCPCS unit
J2786	Cinqair (reslizumab) – 1 mg per HCPCS unit
J0589	Daxxify (daxibotulinumtoxinA-lanm) – 1 unit per HCPCS unit
J1071	Depo-Testosterone (testosterone cypionate) – 1 mg per HCPCS unit
J0638	Ilaris (canakinumab) – 1 mg per HCPCS unit
J3245	Ilumya (tildrakizumab-asmn) – 1 mg per HCPCS unit
J1306	Leqvio (inclisiran) – 1 mg per HCPCS unit
J2506	Neulasta (pegfilgrastim) – 0.5 mg per HCPCS unit

1–10 of 11

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Additional HCPCS examplesHCPCSCovered

J2507	Krystexxa (pegloticase) – 1 mg per HCPCS unit
J9038	Niktimvo (axatilimab-csfr) – 0.1 mg per HCPCS unit
J2182	Nucala (mepolizumab) – 1 mg per HCPCS unit
J1745	Remicade (infliximab) – 10 mg per HCPCS unit
J0222	Onpattro (patisiran) – 0.1 mg per HCPCS unit

HCPCS entries (sample)HCPCS

J1307

Orencia (abatacept) HCPCS code

HCPCS entries (continued)HCPCS

J0222

Patisiran HCPCS code (Onpattro)

HCPCS entries (continued)HCPCS

J0897

Prolia (denosumab) HCPCS code

Rituximab groupHCPCS

Q5115	Truxima (rituximab-abbs) HCPCS code
J9311	Riabni (rituximab) HCPCS code

Eculizumab groupHCPCS

J1299	Soliris (eculizumab) HCPCS code
Q5152	Bkemv (eculizumab biosimilar) HCPCS code

Neurology/autoimmune agentsHCPCS

J3032	Vyepti (eptinezumab) HCPCS code
J9332	Vyvgart (efgartigimod alfa-fcab) HCPCS code
J9334	Vyvgart Hytrulo HCPCS code

Immunotherapy/oncology agentsHCPCS

J9023	Bavencio (avelumab) HCPCS code
J9173	Imfinzi (durvalumab) HCPCS code
J9271	Keytruda (pembrolizumab) HCPCS code
J9119	Libtayo (cemiplimab) HCPCS code
J9022	Tecentriq (atezolizumab) HCPCS code

NDC codes (sample set)NDC

50242-0135-01	Actemra NDC (example)
50242-0060-01	Avastin NDC (example)
00023-1145-01	Botox NDC (example)
50242-0920-01	Hemlibra NDC (example)

Selected NDCs and descriptions from chunk 36NDC

50242-0132-10	Herzuma 420 mg vial
63459-0305-47	Herzuma NDC variant
63459-0307-41	Herzuma NDC variant
55513-0132-01	Kanjinti 420 mg vial
55513-0141-01	Kanjinti 150 mg vial
55513-0132-01	Ogivri NDC (also listed)
55513-0141-01	Ogivri NDC (also listed)
67457-0847-44	Ogivri NDC variant
00002-7575-01	Omvoh 300 mg/15 mL vial
00006-5033-02	Omvoh / Ontruzant NDC variant

Selected NDCs from chunk 37NDC

00069-0305-01	Trazimera / Ilaris NDC listed
00069-0306-01	Trazimera / Ilaris NDC listed
00078-0734-61	Ilaris / Ilumya 150 mg/mL vial
47335-0177-95	Ilumya 100 mg/mL PFS
00078-1000-60	Leqvio 284 mg/1.5 mL PFS

NDC codes and product descriptions (chunks 38–55)NDC

10454-0710-10	Myobloc 2,500 Units/0.5 mL vial
10454-0711-10	Myobloc 5,000 Units/mL vial
10454-0712-10	Myobloc 10,000 Units/2 mL vial
55513-0190-01	Neulasta 6 mg/0.6 mL PFS
55513-0192-01	Neulasta on-body injector
50881-0034-12	Niktimvo 9 mg/0.18 mL vial
50881-0023-11	Niktimvo 22 mg/0.44 mL vial
50881-0012-10	Niktimvo 50 mg/1 mL vial
00069-0324-01	Nyvepria 6 mg/0.6 mL PFS
67457-0833-06	Fulphila 6 mg/0.6 mL PFS

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NDCs with specified maximums (partial list)NDC

50242-0227-55	Xolair autoinjector NDC
55513-0710-01	Prolia 60 mg/1 mL PFS
55513-0730-01	Xgeva 120 mg/1.7 mL vial
61314-0240-63	Jubbonti 60 mg/1 mL PFS
61314-0228-94	Wyost 120 mg/1.7 mL vials
72606-0037-01	Stoboclo 60 mg/1 mL PFS
72606-0038-01	Osenvelt 120 mg/1.7 mL vials
65219-0668-01	Conexxence 60 mg/1 mL PFS
65219-0670-01	Bomyntra 120 mg/1.7 mL vials
65219-0672-01	Bomyntra 120 mg/1.7 mL PFS

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Additional NDCs with specified maximums (partial list)NDC

64406-0109-01	Qalsody (tofersen) 100 mg/15 mL vial
70510-2171-01	Radicava 30 mg/100 mL bag
00006-3029-01	Keytruda 50 mg vial (example)
61755-0008-01	Libtayo 350 mg/7 mL vial
50242-0918-01	Tecentriq 1,200 mg/20 mL vial
00074-5015-01	Skyrizi 600 mg/10 mL vial
00259-1605-01	Xeomin 50 unit vial
00259-1610-01	Xeomin 100 unit vial
00259-1620-01	Xeomin 200 unit vial

Applicable HCPCS/CPT codes referencedHCPCS

C9399	Unclassified drugs or biologicals.
J0129	Injection, abatacept, 10 mg (Code may be used for Medicare when drug administered under the direct supervision of a physician, not for use when drug self-administered.
J0177	Injection, aflibercept HD, 1 mg.
J0178	Injection, aflibercept, 1 mg.
J0179	Injection, brolucizumab-dbll, 1 mg.
J0222	Injection, patisiran, 0.1 mg.
J0225	Injection, vutrisiran, 1 mg.
J0517	Injection, benralizumab, 1 mg.
J0585	Injection, onabotulinumtoxinA, 1 unit.
J0586	Injection, abobotulinumtoxinA, 5 units.

1–10 of 37

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Applicable HCPCS/Codes (partial list)HCPCS

C9399	Unclassified drugs or biologicals.
J0129	Injection, abatacept, 10 mg
J0177	Injection, aflibercept HD, 1 mg
J0178	Injection, aflibercept, 1 mg
J0179	Injection, brolucizumab-dbll, 1 mg
J0222	Injection, patisiran, 0.1 mg
J0225	Injection, vutrisiran, 1 mg

Applicable HCPCS/Codes (continued)HCPCS

J0717	Injection, certolizumab pegol, 1 mg
J0897	Injection, denosumab, 1 mg
J1299	Injection, eculizumab, 2 mg
J1301	Injection, edaravone, 1 mg
J1303	Injection, ravulizumab-cwvz, 10 mg
Q5098	Injection, ustekinumab-srlf (imuldosa), biosimilar, 1 mg

Applicable NDC/Product codes (sample)NDC

50242-0135-01	Actemra 20 mg/mL vial (NDC)
71336-1003-01	Amvuttra 25 mg/0.5 mL PFS (NDC)
00023-1145-01	Botox 100 units vial (NDC)
00006-3029-01	Keytruda 50 mg vial (NDC)
75987-0080-10	Krystexxa 8 mg/mL vial (NDC)
00069-0305-01	Trazimera 420 mg vial (NDC)

Applicable Product Codes (NDC/HCPCS style)mixed

43598-0330-11	Zoledronic Acid 4 mg/5 mL vial.
51991-0065-98	Zoledronic Acid 4 mg/5 mL vial.
54288-0100-01	Zoledronic Acid 4 mg/5 mL vial.
55111-0685-07	Zoledronic Acid 4 mg/5 mL vial.
55150-0266-05	Zoledronic Acid 4 mg/5 mL vial.

Adult weight/BSA percentile — Upper limit

Adult upper-limit weight (95th percentile)140 kg

Adult upper-limit body surface area (95th percentile)2.71 m^2

Source basis

Provider Actions and Billing Guidance

Billing Rule

Use of maximums in adjudication

The allowed quantities listed in this policy are applied during claims adjudication. When billing by NDC, adjudicators and providers should use the Maximum Allowed units/volume specified for the listed NDC(s); absence of an NDC from the list does not exempt the product from the policy limits. NDC- and HCPCS-based allowed quantities are calculated from the product-specific maximum dosage/frequency defined in this policy and the mechanics of NDC billing.

Apply the listed Maximum Allowed mL, units, or vials per NDC when adjudicating NDC claims.
If billed using HCPCS/CPT/J-codes, apply the product- and dose-specific maximums as indicated elsewhere in the policy.
Absence of a specific NDC in the list does not imply the product is not subject to maximum allowed quantities.

Prior Authorization

Quantity Limits and Per-Product Maximums

Actemra (tocilizumab)

Actemra (tocilizumab) HCPCS units per administration example800 (HCPCS units) — sample maximum per administration

NDC volume exampleActemra NDC maximum allowed = 40 mL (20 mg/mL vials) as listed

Reference chunksHCPCS maximums listed in chunk 10; NDC maximums in chunk 31

Avastin (bevacizumab)

Avastin (bevacizumab) HCPCS units240 (HCPCS units)

Dose basis15 mg/kg dosing; HCPCS units = 10 mg per unit

NDC allowed volume example

Site of Care Considerations

Note

Billing Rule

Verify site of care and physician supervision for code selection

Several codes note use 'when administered under the direct supervision of a physician' versus self-administered; site of care may affect code usage and billing — verify appropriate code and place-of-service when submitting claims.

Biosimilar and Reference Product Information

Note

Biosimilars and reference biologics listed for reference

Biosimilars and their reference biologics are listed with codes for reference; this section does not state a preference for biosimilars versus reference products in this excerpt.

Definitions

Background

Background: Most physician‑administered medications included in this policy have defined maximum dosages per administration and maximum dosing frequencies. Those limits are determined by product labeling, clinical compendia, and published evidence and may be expressed as a fixed maximum dose, a weight‑based (mg/kg) or body surface area (mg/m2) calculation, or an NDC/HCPCS packaging‑based quantity. This policy supports use up to those maximums and establishes an upper adult bound using the 95th percentile adult weight (140 kg) and BSA (2.71 m2); use beyond these proven maxima is unproven and considered not medically necessary.

Step Therapy

Step	Requirement	Notes
None specified	No step therapy requirements are provided in this excerpt.	The policy states maximum allowed frequencies are based on FDA prescribing information or clinical evidence; step therapy details are not included in the provided section.