Subject: Specialty Quantity Limit Humira 2270-H P2021
Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for the most
common uses of the medication. The recommended dosing parameters
for all FDA-approved indications fall within the standard limits.
Coverage of an additional quantity may be reviewed on a case-by-case
basis upon request.
II. COVERED QUANTITIES
|
Medication
|
Standard Limit
|
FDA-recommended dosing
|
|
Humira (adalimumab) 10
mg/0.1 mL single-use
prefilled syringe
|
2 syringes per 28
days
|
RA/PsA/AS
- 40 mg every other week
- For RA, patients not taking concomitant methotrexate: may increase to 40 mg every week or 80 mg every other week if needed
PJIA/Pediatric uveitis (2 years and up)
- 10 kg to < 15 kg: 10 mg every other week
- 15 kg to < 30 kg: 20 mg every other week
- ≥ 30 kg: 40 mg every other week
Pediatric CD (6 years and up)
- 17 kg to < 40 kg: loading doses of 80 mg on day 1 and 40 mg two weeks later (day 15); maintenance dose starting at week 4 (day 29) of 20 mg every other week
- ≥ 40 kg: loading doses of 160 mg on day 1 (given in one day or split over two consecutive days) and 80 mg two weeks later (day 15); maintenance dose starting at week 4 (day 29) of 40 mg every other week
Pediatric UC (5 years and up)
- 20 kg to < 40 kg: loading doses of 80 mg on day 1, 40 mg 1 week later (day 8), and 40 mg one week later (day 15); maintenance dose starting at week 4 (day 29) of 40 mg every other week or 20 mg every week
- ≥ 40 kg: loading doses of 160 mg on day 1 (single dose or split over two consecutive days), 80 mg one week later (day 8), and 80 mg one week later (day 15); maintenance dose starting at week 4 (day 29) of 80 mg every other week or 40 mg every week
Adult CD and UC
- Loading doses: 160 mg on day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (day 15)
- Maintenance dose: two weeks later (day 29), 40 mg every other week
Plaque psoriasis/uveitis
- 80 mg, followed by 40 mg every other week starting one week after the initial dose of 80 mg
Adolescent hidradenitis suppurativa (12 years and up)
- 30 kg to < 60 kg: 80 mg on day 1, 40 mg on day 8 and subsequent doses 40 mg every other week
- ≥ 60 kg: Follow adult dosing
Adult hidradenitis suppurativa
- Loading doses: 160 mg on day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (day 15)
- Maintenance dose: begin 40 mg every week or 80 mg every other week two weeks later (day 29)
|
|
Humira (adalimumab) 20
mg/0.2 mL single-use
prefilled syringe
|
2 syringes per 28
days
|
|
Humira (adalimumab) 40
mg/0.4 mL single-use
prefilled syringe/pen
|
4 syringes/pens
per 28 days
|
|
Humira (adalimumab) 40
mg/0.8 mL single-use
prefilled syringe/pen
|
4 syringes/pens
per 28 days
|
|
Humira (adalimumab) 80
mg/0.8 mL single-use
prefilled pen
|
2 pens per 28
days
|
|
Humira (adalimumab) 80
mg/0.8 mL Pediatric Crohn’s
Disease Starter Pack
|
3 syringes per 28
days
|
|
Humira (adalimumab) 80
mg/0.8 mL and 40 mg/0.4
mL Pediatric Crohn’s Disease
Starter Pack
|
2 syringes per 28
days
|
|
Humira (adalimumab) 80
mg/0.8 mL Pediatric
Ulcerative Colitis Starter Pack
|
4 pens per 28
days
|
|
Humira (adalimumab) 40
mg/0.8 mL pen Crohn’s
Disease, Ulcerative Colitis, or
Hidradenitis Suppurativa
Starter Pack
|
6 pens per 28
days
|
|
Humira (adalimumab) 80
mg/0.8 mL pen Crohn’s
Disease, Ulcerative Colitis, or
Hidradenitis Suppurativa
Starter Pack
|
3 pens per 28
days
|
|
Humira (adalimumab) 40 mg/0.8 mL pen Psoriasis, Uveitis, or Adolescent Hidradenitis Suppurativa Starter Pack
|
4 pens per 28
days
|
|
Humira (adalimumab) 80
mg/0.8 mL and 40 mg/0.4
mL Psoriasis, Uveitis, or
Adolescent Hidradenitis
Suppurativa Starter Pack
|
3 pens per 28
days
|
Abbreviations: RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; PJIA = polyarticular juvenile idiopathic arthritis; CD = Crohn’s disease; UC = ulcerative colitis
Place of Service:
Outpatient
The above policy is based on the following references:
- Humira [package insert]. North Chicago, IL: AbbVie Inc.; February 2021.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
March 16, 2022
