sierra health and life dose limits Policy Update

Coverage Criteria

Coverage criteria for dosing

Coverage stance for dosing:

In-range dosing: Use within the policy's maximum dosage and dosing frequency based on patient weight/BSA or set maxima is considered proven when consistent with labeled indications or supporting published clinical evidence.

Supported doses covered

Exceeding maximums: Doses beyond the policy maximums that are not supported by package labeling or published clinical evidence are considered unproven.

Considered not medically necessary for continued use

Maximum Frequency Rules

Maximum allowed administration frequencies by medication and indication

Eculizumab products: Administered once weekly for 5 doses (induction), then every 2 weeks thereafter for indications such as aHUS, MG, NMOSD, and PNH.

Applies to Soliris, Bkemv, Epijkstra/Epysqli

Spevigo (spesolimab‑sbzo): IV: single 900 mg dose; may give an additional IV 900 mg one week after if flare persists. SC: loading dose 600 mg (four 150 mg injections), then 300 mg at 4 weeks and every 4 weeks thereafter; if IV given for a flare, SC may be initiated 4 weeks later at 300 mg without loading dose.

Indication: generalized pustular psoriasis

Ustekinumab products (Stelara and biosimilars): Psoriasis/psoriatic arthritis: administered subcutaneously initially and 4 weeks later, then every 12 weeks. For certain Crohn's/UC products: IV once, then SC 8 weeks after initial IV, then every 8 weeks thereafter.

Product- and indication-specific schedules

Vabysmo (faricimab): nAMD: 6 mg intravitreal every 4 weeks for the first 4 doses, then one of specified extension regimens; most patients require dosing every 8 weeks; maximum 12 doses per year per eye. DME and RVO: initial monthly dosing followed by extension regimens described by indication.<= 12 doses per eye per year

Intravitreal administration; extension based on response

Pegfilgrastim and related products: Administered once every 2 weeks for oncology indications where stated (product labeling referenced).

Examples: Stimufend, Ziextenzo, others

Vyvgart and Vyvgart Hytrulo: Vyvgart: once weekly for 4 weeks for MG, with subsequent cycles based on clinical evaluation. Vyvgart Hytrulo: once weekly for 4 weeks for MG and for CIDP as indicated.

Subsequent cycles per clinical response

Xeomin (incobotulinumtoxinA): Administered no more frequently than every 12 weeks.>= 12 weeks between administrations

Frequency cap to reduce risk of toxin-related adverse events

Additional stated frequency rules (examples): Other listed products have specific maximum frequencies (e.g., Tecentriq every 2 weeks; Vyepti once every 3 months; Xolair once every 2 or 4 weeks depending on indication/weight/IgE).

See product-specific entries for exact intervals

Dose maximums (general)

Covered only up to established maximum dosages

Dose-limiting criteria: Use of medications is supported up to maximum dosages based on body weight or BSA as defined by FDA labeling or clinical evidence; maximums were set using the 95th percentile adult weight (140 kg) and BSA (2.71 m2).<= product-specific maximum dose

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

Use of medications beyond the policy's maximum dosages and/or frequency that are not supported by package labeling or published clinical evidence is considered unproven. The policy explicitly states that doses above established maxima—whether defined by body surface area, patient weight, or fixed per‑administration limits—lack evidence of additional benefit and may increase risk of adverse events, and therefore are not supported for coverage.

Listing a procedure, diagnosis, or billing code in this policy is for reference only and does not imply the service is covered. Coverage and reimbursement determinations are made according to the member‑specific benefit plan and applicable laws; inclusion of a code is not a guarantee of payment.

The policy does not support dosing beyond established maxima that are based on body surface area (BSA) or patient weight. Maximum dosages derived from FDA labeling, national compendia, or the policy's use of the adult 95th percentile anthropometric values are the upper limits of supported dosing; clinical evidence does not validate higher BSA/weight‑based doses.

If there is any inconsistency between this policy and a member's specific benefit plan, the member‑specific benefit plan document governs. Providers must check the member plan and applicable federal/state mandates prior to relying on this policy for coverage or payment decisions.

Continued use of a medication or continued dosing at levels that exceed the labeled indication or other published clinical evidence is considered not medically necessary. The policy treats ongoing administration beyond supported indications or evidence as not meeting medical necessity standards.

Administration at doses exceeding the policy's caps—specifically those derived from product labeling or the policy's 95th‑percentile‑based limits—is not supported. The document states that doses above these maximums are associated with increased risk without added benefit and therefore are not supported for coverage.

Coding and Code Lists

Sample HCPCS entries (continued throughout document)HCPCS

J3262	tocilizumab (Actemra) — 1 mg per unit; maximum allowed 800 units (800 mg)
Q5133	tocilizumab-bavi (Tofidence) — 1 mg per unit; maximum allowed 800 units (800 mg)
Q5135	tocilizumab-aazg (Tyenne) — 1 mg per unit; maximum allowed 800 units (800 mg)
J9035	bevacizumab (Avastin) — 10 mg per unit; maximum allowed 240 units (15 mg/kg)

HCPCS codes and maximum allowed units (selected examples)HCPCS

J0585	onabotulinumtoxinA (Botox) — 1 unit per HCPCS; maximum allowed 600 units
J0717	certolizumab pegol (Cimzia) — 1 mg per unit; maximum allowed 400 units (400 mg)
J2786	reslizumab (Cinqair) — 1 mg per unit; maximum allowed 500 units (3 mg/kg)
J2506	pegfilgrastim (Neulasta) — 0.5 mg per unit; maximum allowed 12 units (6 mg)
J9355	trastuzumab (Herceptin) — 10 mg per unit; maximum allowed 126 units (8 mg/kg)
J2507	pegloticase (Krystexxa) — 1 mg per unit; maximum allowed 8 units (8 mg)
J1299	eculizumab (Soliris) — 2 mg per unit; maximum allowed 600 units (1200 mg)
J1747	spesolimab-sbzo (Spevigo) — 1 mg per unit; maximum allowed 900 units (900 mg)
J9311	rituximab and hyaluronidase (Rituxan Hycela) — 10 mg per unit; maximum allowed 160 units (1600 mg)

HCPCS maximums (partial list from chunk 18)HCPCS

J1304	Qalsody (tofersen) — 1 mg per unit; Maximum Allowed = 100 HCPCS units (100 mg)
J1301	Radicava (edaravone) — 1 mg per unit; Maximum Allowed = 60 HCPCS units (60 mg)
J9312	Rituxan (rituximab) — 10 mg per unit; Maximum Allowed = 150 HCPCS units (per administration 500 mg/m2)
Q5119	Ruxience (rituximab-pvvr) — 10 mg per unit; Maximum Allowed = 150 HCPCS units (per administration 500 mg/m2)
Q5115	Truxima (rituximab-abbs) — 10 mg per unit; Maximum Allowed = 150 HCPCS units (per administration 500 mg/m2)
Q5123	Riabni (rituximab-arrx) — 10 mg per unit; Maximum Allowed = 150 HCPCS units (per administration 500 mg/m2)

HCPCS maximums (chunks 19-24)HCPCS

J9311	Rituxan Hycela (rituximab and hyaluronidase) — 10 mg per unit; Maximum Allowed = 160 HCPCS units (1,600 mg)
J9333	Rystiggo (rozanolixizumab-noli) — 1 mg per unit; Maximum Allowed = 840 HCPCS units (840 mg)
J1602	Simponi Aria (golimumab) — 1 mg per unit; Maximum Allowed = 300 HCPCS units (per = 2 mg/kg)
Q5152	Bkemv (eculizumab-aeeb) — 2 mg per unit; Maximum Allowed = 600 HCPCS units (1200 mg)
Q5151	Epijkstra (eculizumab-aagh) — 2 mg per unit; Maximum Allowed = 600 HCPCS units (1200 mg)
J1299	Soliris (eculizumab) — 2 mg per unit; Maximum Allowed = 600 HCPCS units (1200 mg)
J1747	Spevigo (spesolimab-sbzo) — 1 mg per unit; Maximum Allowed = 900 HCPCS units (900 mg)
Q5098	Imuldosa (ustekinumab-srlf) — 1 mg per unit; Maximum Allowed = 520 HCPCS units (520 mg)
Q9999	Otulfi (ustekinumab-aauz) — 1 mg per unit; Maximum Allowed = 520 HCPCS units (520 mg)
Q9996	Pyzchiva (ustekinumab-ttwe) — 1 mg per unit; Maximum Allowed = 90 HCPCS units (90 mg)

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NDC maximum allowed quantities (selected entries from chunks 26-37)NDC

50242-0135-01	Actemra (tocilizumab) 20 mg/mL vial — Maximum Allowed = 40 mL
50242-0060-01	Avastin (bevacizumab) 100 mg/4 mL vial — Maximum Allowed = 12 mL
50242-0061-01	Avastin (bevacizumab) 400 mg/16 mL vial — Maximum Allowed = 96 mL
55513-0206-01	Mvasi (bevacizumab-awwb) 100 mg/4 mL vial — Maximum Allowed = 12 mL
00069-0315-01	Zirabev (bevacizumab-bvzr) 100 mg/4 mL vial — Maximum Allowed = 12 mL
00023-1145-01	Botox (onabotulinumtoxinA) 100 unit vial — Maximum Allowed = 6 vials
67979-0511-43	Aveed (testosterone undecanoate) 750 mg/3 mL vial — Maximum Allowed = 3 mL
50474-0700-62	Cimzia (certolizumab pegol) 2 x 200 mg kit — Maximum Allowed = 2 vials
59310-0610-31	Cinqair (reslizumab) 100 mg/10 mL vial — Maximum Allowed = 50 mL
72960-112-01	Daxxify (daxibotulinumtoxinA-lanm) 100 unit vial — Maximum Allowed = 3 vials

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Applicable HCPCS/J codes and descriptionsHCPCS

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
J0517	Injection, benralizumab, 1 mg
J0585	Injection, onabotulinumtoxinA, 1 unit
J0586	Injection, abobotulinumtoxinA, 5 units
J0587	Injection, rimabotulinumtoxinB, 100 units

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Applicable Q/Biosimilar HCPCS codesHCPCS

Q5098	Injection, ustekinumab-srlf (Imuldosa), biosimilar, 1 mg
Q5099	Injection, ustekinumab-stba (Steqeyma), biosimilar, 1 mg
Q5100	Injection, ustekinumab-kfce (Yesintek), biosimilar, 1 mg
Q5103	Injection, infliximab-dyyb (Inflectra), biosimilar, 10 mg
Q5104	Injection, infliximab-abda (Renflexis), biosimilar, 10 mg
Q5107	Injection, bevacizumab-awwb (Mvasi), biosimilar, 10 mg
Q5108	Injection, pegfilgrastim-jmdb (Fulphila), biosimilar, 0.5 mg
Q5111	Injection, pegfilgrastim-cbqv (Udenyca), biosimilar, 0.5 mg
Q5112	Injection, trastuzumab-dttb (Ontruzant), biosimilar, 10 mg
Q5113	Injection, trastuzumab-pkrb (Herzuma), biosimilar, 10 mg

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NDC/product identifiersNDC/mfg

50242-0135-01	Actemra 20 mg/mL vial
50242-0136-01	Actemra 200 mg/10 mL vial
50242-0137-01	Actemra 400 mg/20 mL vial
70121-1754-01	Alymsys 100 mg/4 mL vial
55513-0180-01	Bkemv 300 mg/30 mL vial
71336-1003-01	Amvuttra 25 mg/0.5 mL PFS

Applicable NDC/Product Codes (sample)NDC

67457-0833-06	Fasenra 10 mg/0.5 mL PFS / Fulphila 6 mg/0.6 mL PFS
00310-1745-01	Fasenra 10 mg/0.5 mL PFS
00409-6557-01	Entyvio 300 mg vial
00409-6562-01	Epijkstra 300 mg/30 mL vial
00409-6562-20	Epijkstra 300 mg/30 mL vial
76420-0650-01	(listed product identifier — description blank in source)
00591-4128-79	(listed product identifier — description blank in source)
00009-0085-10	(listed product identifier — description blank in source)

Applicable NDC/Product Codes (sample)NDC

70121-1627-01	Fylnetra 6 mg/0.6 mL PFS
50242-0922-01	Hemlibra 105 mg/0.7 L
50242-0923-01	Hemlibra 150 mg/mL
50242-0132-01	Herceptin 150 mg vial
00006-3029-01	Keytruda 50 mg vial
00006-3029-02	Keytruda 50 mg vial

Applicable NDC/Product Codes (continued)NDC

00069-0809-01	Inflectra 100 mg vial
00173-0881-01	Nucala 100 mg vials
15054-0500-01	Dysport 500 units vial
00078-0435-61	Reclast 5 mg/100 mL solution in vial
57894-0030-01	Remicade 100 mg vial
55513-0224-01	Riabni 100 mg/10 mL vial
51759-0505-32	Selarsdi 45 mg/0.5 mL PFS
25682-0001-01	Soliris 300 mg/30 mL vial
00597-0035-10	Spevigo 450 mg/7.5 mL vial
50242-0227-01	Xolair 300 mg/mL PFS

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Applicable HCPCS/CPT editsHCPCS

Q5152	HCPCS code for Bkemv (eculizumab-aeeb)
Q5151	HCPCS code for Epijkstra (eculizumab-aagh)
Q5098	HCPCS code for Imuldosa (ustekinumab-srlf)
Q5157	HCPCS code for Osenvelt/Stoboclo (denosumab-bmwo)
J1073	Added HCPCS/J-code for Testopel (testosterone pellet)
S0189	Removed HCPCS code (annual edit)

Applicable NDCs addedNDC

51407-0929-11	NDC for Imuldosa (ustekinumab-srlf)
51407-0930-11	NDC for Imuldosa (ustekinumab-srlf)
51407-0931-11	NDC for Imuldosa (ustekinumab-srlf)
51759-0208-13	NDC for Epijkstra (eculizumab-aagh)
55513-0180-01	NDC for Bkemv (eculizumab-aeeb)
69448-0017-63	NDC for Imuldosa
69448-0018-63	NDC for Imuldosa
69448-0019-26	NDC for Imuldosa
72606-0037-01	NDC for Stoboclo (denosumab-bmwo)
72606-0038-01	NDC for Osenvelt (denosumab-bmwo)

inv-23: Upper weight/BSA limit used to set maxima

Upper weight limit used140 kg (adult 95th percentile)

Upper BSA limit used2.71 m2 (adult 95th percentile)

Basis for limitsUpper limits derived from clinical evidence and 95th percentile adult anthropometrics (Fryar, 2021)

inv-24: NDC maximum allowed note

Provider Actions and Billing Guidance

Prior Authorization

Prior Authorization Required for Dose Limits

Prior authorization is required when requested doses exceed the maximum allowed per this policy. Dose-limit based prior authorization: requests for doses or quantities that exceed the policy’s listed maximums (by HCPCS unit, NDC billing quantity, or frequency) must include clinical justification and supporting documentation (weight or BSA, diagnosis, prior dosing history).

Applicable to HCPCS- and NDC-billed claims
Include patient weight (kg) and/or body surface area (m2) when dose is weight- or BSA-based
Document prior therapies and rationale for exceeding policy limits

Denial Risk

Denial Risk for Exceeding Policy Limits

Dose-limit based prior authorization reviews will assess whether the requested dosing exceeds the policy’s maximums and whether the request is clinically justified. Requests exceeding HCPCS unit maximums, NDC maximum quantities, or the maximum allowed frequency are subject to denial if supporting documentation does not demonstrate medical necessity.

Quantity Limits and Per-Product Maximums

inv-60: Multiple per-entry maximum HCPCS units as listed

Multiple HCPCS entriesPer-entry maximum HCPCS units are specified for each listed product (see individual entries) — follow product-specific limits

Examples includeActemra (J3262) 800 units; Avastin (J9035) 240 units; Rituxan Hycela (J9311) 160 units

Unit conventionsSome codes use 1 mg per unit, others 10 mg per unit, or units per HCPCS as shown

inv-61: Qalsody — quantity limit example

Qalsody HCPCS limitMaximum Allowed = 100 HCPCS units (1 mg per unit)

HCPCS codeJ1304

Initial Therapy Criteria

Initial Dosing / induction frequency when specified

Initial dosing/induction frequency when specified

Eculizumab induction: Administered once weekly for 5 doses (induction), then every 2 weeks thereafter.

Applicable to Soliris, Bkemv, Epijkstra/Epigslist products; indication-specific

Stelara induction (SC): Administered subcutaneously initially and 4 weeks later, then every 12 weeks thereafter.

Indication: psoriasis/psoriatic arthritis; some products use IV then SC schedule for IBD indications

Vabysmo (faricimab) nAMD induction: 6 mg intravitreal every 4 weeks for the first 4 doses before extension regimens are applied.first 4 doses at 4-week intervals

Step Therapy / Induction Guidance

Step therapy rule	Notes
No step therapy requirements specified in this portion of the policy.

Agent / class	Induction (initial) schedule	Maintenance / note
Byooviz (ranibizumab-nuna)
Three monthly doses (0.5 mg intravitreal once monthly).
Patients may be treated with 3 monthly doses followed by less frequent dosing or may receive one dose every 3 months after 4 monthly doses; maximum 12 doses/year per eye.

Agent	Initial dosing	Extension/maintenance regimens
Vabysmo (faricimab)
6 mg intravitreal every 4 weeks for the first 4 doses (initial monthly dosing).
After induction, one of specified extension regimens may be used (examples: Weeks 28 & 44; Weeks 24, 36 & 48; Weeks 20, 28, 36 & 44); most patients require dosing every 8 weeks; maximum 12 doses/year per eye.

Site of Care

Note

infusion center | office | hospital outpatient | home (as applicable)

These medications are administered in medical‑benefit settings; select the appropriate site of care when documenting or requesting authorization (infusion center, office, hospital outpatient, or home where applicable).

Identify the planned site of care on the request (e.g., infusion center vs. office).
Some products may have site‑specific billing or prior authorization considerations.

Documentation Required

office | infusion center — intravitreal agents administered via intravitreal injection

Intravitreal agents are administered via intravitreal injection in office or infusion center settings; document the treated eye(s) and route when requesting authorization or submitting claims.

Specify intravitreal route and which eye(s) are being treated.
Include regimen (e.g., induction vs maintenance) in documentation.

Background

This policy establishes upper dose limits for medical‑administered drugs using either product‑specific maxima or anthropometric thresholds based on the adult 95th percentile (140 kg weight; BSA 2.71 m2). These limits are applied to per‑administration dosing and, where specified, to maximum dosing frequency (for example, intravitreal agents commonly capped at 12 doses per eye per year).

Definitions

inv-53: Upper level limit — policy-created upper dose limit based on 95th percentile adult weight/BSA

Policy-created upper level limitAn upper dose limit is set using the 95th percentile adult weight (140 kg) and BSA (2.71 m2)

PurposeUsed to cap product-specific maximum dosages when applicable

ExceptionPer-entry allowed units/vials may exceed this limit for patients whose body weight or BSA exceed the 95th percentile

inv-54: Intravitreal injection frequency — induction monthly then maintenance

Intravitreal induction frequencyTypical induction: monthly dosing for initial doses (e.g., 3–4 monthly doses)

Maintenance frequencyFollowed by less frequent maintenance dosing (commonly every 8 weeks or as product labeling allows)

Biosimilar Notes

Billing Rule

Biosimilar HCPCS/Q codes are listed alongside reference products; substitution rules not stated

Biosimilar HCPCS/Q codes are listed alongside reference products in the policy; the document does not state substitution or preference rules—use the listed HCPCS/Q code that corresponds to the product administered.

Report the HCPCS/Q code that matches the exact product (reference or biosimilar) administered.
Do not assume interchangeability without payer or plan direction.

Revision History

01/01/2026material_revisionLatest

Revised list of applicable drug products and added denosumab-bmwo (Stoboclo & Osenvelt), eculizumab-aagh (Epijkstra/Epijkstra®), eculizumab-aeeb (Bkemv), and ustekinumab-srlf (Imuldosa); added HCPCS and NDC maximum allowed quantities and frequencies for these products; updated Testopel HCPCS codes (added J1073, removed S0189).

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Maximum Dosage and Frequency for Medical-Administered Drugs