CurrentCignaPolicy DQM005

Adalimumab Products Drug Quantity Management Policy - Per Days

Cigna Drug Quantity Management policy setting quantity limits (retail and home delivery) and availability for Humira and multiple adalimumab biosimilars/polished products; approvals provided per criteria with typical durations noted (1 year or one-time 30 days). This part (1 of 2) covers product list, FDA indications overview, FDA dosing summary, product forms/strength availability table, policy statement, and detailed per-product quantity limits for many strengths/forms/starter packs.

Policy Summary

PayerCigna

PolicyAdalimumab Products Drug Quantity Management Policy - Per Days

Policy CodePolicy DQM005

Change TypeNew policy

Effective DateAug 15, 2025

Next Review Date

Key ActionIf the Drug Quantity Management rule is not met at point of service, submit requests consistent with the policy criteria and provide documentation of diagnosis, age, weight, and prior dosing history to support prior authorization or quantity override requests.

POLICY UPDATE CHANGES

New policy created.

16+Adalimumab products listed

4 per 28 daysTypical retail limit (40 mg)

12 per 84 daysTypical home delivery limit (40 mg)

1 yearStandard approval duration

130 days

Induction lookback period

Coverage Summary

This policy is the Cigna Drug Quantity Management program for Humira and multiple adalimumab biosimilars (Policy Number DQM005), effective 08/15/2025, and is current. It sets per-day quantity limits for retail and home delivery and applies across the reference product and listed biosimilars of the same strength (pens, prefilled syringes, vials).

Typical approval durations are 1 year for standard approvals and one-time approvals are provided for 30 days. Quantity limits differ by channel (retail vs home delivery) — e.g., many 40 mg products have typical retail limits of 2–4 per 28 days and home delivery limits of 6–12 per 84 days depending on product/strength and the criteria applied.

Approvals are provided when the Drug Quantity Management rule is met at point of service; if the rule is not met, coverage is determined by the specific policy criteria and any requested override must meet the documented criteria (including documentation of prior dosing history, diagnosis, age, weight, and absence of adalimumab claims in the prior 130 days).

Policy Statement / Approvals

Approvals are provided when Drug Quantity Management rule is met; if not met, coverage determined by the Criteria below:

ALL of the following

Approvals are provided for 1 year in duration unless otherwise noted
'One-time' approvals are provided for 30 days in duration unless otherwise noted
All adalimumab products of the same strength (pens, prefilled syringes, vials) accumulate toward the total quantity limit

Exceptions to Quantity Limits (Medically Necessary Overrides)

Exceptions to quantity limits (medically necessary overrides)

Exceptions are covered as medically necessary when the following criteria are met. Any other exception is considered not medically necessary.

ALL of the following

Adalimumab 10 mg prefilled syringes: No overrides recommended.
Note: 20 mg, 40 mg, and 80 mg pens/syringes available if higher dose required.

Adalimumab 40 mg pens/syringes — Increased Dosing & Initiation Overrides

Adalimumab 40 mg pens/syringes - increased dosing and initiation overrides

Approve 4 syringes per 28 days (retail) or 12 syringes per 84 days (home delivery) if ALL are met:

ALL of the following

Adalimumab is being used to treat ulcerative colitis.
Patient is 5 to 17 years of age.
Patient weighs between 20 kg (44 lbs) and < 40 kg (88 lbs).

Approve when any of the following conditions apply

Patient has been receiving adalimumab 40 mg every other week for 12 weeks or longer and dose is increased to 40 mg once weekly or 80 mg once every other week: approve 4 pens/syringes per 28 days (retail) or 12 per 84 days (home delivery).

Adalimumab 80 mg pens — Induction / One-time Overrides

Adalimumab 80 mg pens - induction/one-time overrides

ANY of the following

One-time override for 3 additional pens (retail or home delivery) for ulcerative colitis initiation/additional induction dosing if no adalimumab claims in prior 130 days AND patient is ≥ 18 years.
At retail: previous 28-day amount + 3; at home delivery: previous 84-day amount + 3.
One-time override for 4 additional pens (retail) or 8 additional pens (home delivery) for ulcerative colitis initiation if no adalimumab claims in prior 130 days AND patient is 5 to 17 years AND weighs ≥ 40 kg (88 lbs).
At retail: previous 28-day amount + 4; at home delivery: previous 84-day amount + 8.
One-time override for 3 additional pens (retail) or 7 additional pens (home delivery) for hidradenitis suppurativa initiation if no adalimumab claims in prior 130 days AND patient meets ONE of: (i) ≥ 18 years OR (ii) 12–17 years and weighs ≥ 60 kg (132 lbs).
At retail: previous 28-day amount + 3; at home delivery: previous 84-day amount + 7.

Starter Pack Overrides (Various Starter Pack Types)

Starter pack overrides (various starter pack types)

ANY of the following

Starter Pack of 4 x 40 mg pens: one-time override for 4 additional pens if patient requires additional induction dosing and no adalimumab claims in past 130 days.
Approval quantity = number of 40 mg pens (Starter Pack) received in past 365 days + 4.
Starter Pack of 6 x 40 mg pens: one-time override for 6 additional pens if patient requires additional induction dosing and no adalimumab claims in past 130 days.
Approval quantity = number of 40 mg pens (Starter Pack) received in past 365 days + 6.
Starter Pack of 3 x 80 mg pens: one-time override for 3 additional pens if patient requires additional induction dosing and no adalimumab claims in past 130 days.
Approval quantity = number of 80 mg pens (Starter Pack) received in past 365 days + 3.

Provider Actions

Documentation Required

Quantity management enforcement at point of sale

If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the policy criteria. Providers must submit requests consistent with the criteria and include covered diagnosis/procedure codes as applicable; approvals are typically provided for 1 year (one-time approvals: 30 days) per the policy statement.

Billing Rule

Accumulation across products of same strength

All adalimumab products of the same strength (pens, prefilled syringes, vials) accumulate toward the total quantity limit — quantity limits apply across biosimilars and the reference product.

Applicable Codes & Policy Identifiers

Policy identifiersmixed

DQM005

Coverage Policy Number (Cigna) for Adalimumab quantity limits

Clinical Evidence & References

Primary references include the Humira prescribing information (Humira Feb 2024) and prescribing information for multiple biosimilars (various manufacturers, 2023–2025) as cited in the policy references.

The policy notes that adalimumab products are TNF inhibitors with multiple FDA-approved indications (ankylosing spondylitis, Crohn's disease, hidradenitis suppurativa, juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, uveitis) and explicitly states that biosimilar indications may differ from the reference product; dosing summaries and FDA-approved dosing tables are provided in the policy.

Definitions

SC — Subcutaneous: administered by subcutaneous injection.

QW — Once weekly: dosing frequency of once weekly.

MTX — Methotrexate: reference to concomitant methotrexate in some indications.

CD — Crohn's disease: an FDA-approved indication for adalimumab products.

UC — Ulcerative colitis: an FDA-approved indication; pediatric and adult dosing differs by weight/age.

HS — Hidradenitis suppurativa: an FDA-approved indication with specific weight/age dosing thresholds.

Revision History

2025-08-15policy_createdLatest

New policy created (New policy).

Policy Summary

PayerCigna

PolicyAdalimumab Products Drug Quantity Management Policy - Per Days

Policy CodePolicy DQM005

Change TypeNew policy

Effective DateAug 15, 2025

Next Review Date

On This Page

Patient has been receiving 40 mg once weekly or 80 mg once every other week dosing: approve 4 pens/syringes per 28 days (retail) or 12 per 84 days (home delivery).

Patient is initiating treatment or requires additional induction dosing (no adalimumab claims in past 130 days): approve a one-time override for 8 additional pens/syringes at retail or home delivery.

Hidradenitis suppurativa dosing

Adalimumab is being used to treat hidradenitis suppurativa.
Patient is ≥ 12 years of age.
Patient weighs ≥ 60 kg (132 lbs).
Approve 4 pens/syringes per 28 days (retail) or 12 per 84 days (home delivery).

Ulcerative colitis pediatric ≥40 kg

Adalimumab is being used to treat ulcerative colitis.
Patient is 5 to 17 years of age.
Patient weighs ≥ 40 kg (88 lbs).
Approve 4 pens/syringes per 28 days (retail) or 12 per 84 days (home delivery).

One-time override for 3 additional pens (retail or home delivery) for Crohn's disease initiation if no adalimumab claims in prior 130 days AND patient meets ONE of: (i) ≥ 18 years OR (ii) 6–17 years and weighs ≥ 40 kg (88 lbs).

At retail: previous 28-day amount + 3; at home delivery: previous 84-day amount + 3.

Starter Pack of 4 x 80 mg pens: one-time override for 4 additional pens if patient requires additional induction dosing and no adalimumab claims in past 130 days.

Approval quantity = number of 80 mg pens (Starter Pack) received in past 365 days + 4.

Starter Pack of 1 x 80 mg pen + 2 x 40 mg pens: one-time override for 3 additional pens if patient requires additional induction dosing and no adalimumab claims in past 130 days.

Approval quantity = number of 40 mg and 80 mg pens (Starter Pack) received in past 365 days + 3.

Starter Pack of 3 x 80 mg pens + 1 x 40 mg pen: one-time override for 4 additional pens if patient requires additional induction dosing and no adalimumab claims in past 130 days.

Approval quantity = number of 40 mg and 80 mg pens (Starter Pack) received in past 365 days + 4.

Starter Pack of 3 x 80 mg prefilled syringes: one-time override for 3 additional syringes if patient requires additional induction dosing and no adalimumab claims in past 130 days.

Approval quantity = number of 80 mg syringes (Starter Pack) received in past 365 days + 3.

Starter Pack of 1 x 80 mg prefilled syringe + 1 x 40 mg prefilled syringe: one-time override for 2 additional syringes if patient requires additional induction dosing and no adalimumab claims in past 130 days.

Approval quantity = number of 40 mg and 80 mg syringes (Starter Pack) received in past 365 days + 2.

Prior Authorization

Quantity overrides require review

Submit prior authorization or quantity override requests with documentation verifying the requested diagnosis, patient age and weight, and, when requesting initiation/induction overrides, evidence of absence of adalimumab claims in the prior 130 days (lookback used to determine one-time induction overrides and approval quantities).

Documentation Required

Document prior dosing history

For one-time induction overrides, document the number of adalimumab pens/syringes received in the past relevant lookback period (e.g., past 28 days for retail, 84 days for home delivery, or past 365 days for starter packs) as specified in the policy to calculate the approval quantity.