Subject: Specialty Quantity Limit Remicade-Avsola-Inflectra-Renflexis 2274-H P2021
|
REMICADE
(infliximab)
|
|
AVSOLA
(infliximab-axxq)
|
|
INFLECTRA
(infliximab-dyyb)
|
|
RENFLEXIS
(infliximab-abda)
|
Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for the most
common uses of the medication. If member’s plan allows a quantity
limit exception review for the requested medication, coverage of an
additional quantity may be provided up to the exception limit with prior
authorization.
II. COVERED QUANTITIES
|
Medication
|
Standard
Limit
|
Exception Limit*
|
FDA-recommended
dosing
|
|
Remicade (infliximab)
injection 100 mg vial
|
5 vials per
42 days
|
Induction dose
(excluding high dose
pediatric CD and UC)
• Up to 100 kg: up
to 15 vials per 43
days
• Above 100 kg: up
to 30 vials per 43
days
Induction dose for
high dose pediatric
CD and UC:
• Up to 100 kg: up
to 30 vials per 43
days
• Above 100 kg: up
to 60 vials per 43
days
Adult CD following
loss of response/
high dose pediatric
CD and UC
maintenance/high
dose pediatric UC
transitioning into
adulthood
maintenance/RA with
incomplete response:
• Up to 100 kg: up
to 10 vials per 56
days
• Above 100 kg: up
to 20 vials per 56
days
Maintenance dose
(above 100 kg)
• CD/PsA/PsO/UC: up to 10 vials per 56 days
• RA: up to 6 vials
per 56 days
• AS: up to 10 vials
per 42 days
• Other indications: up to 10 vials per
42 days
|
Adult CD
• 5 mg/kg at 0, 2 and 6
weeks, then every 8
weeks (may increase
the dose up to 10
mg/kg for loss of
response)
UC/PsA/Pediatric
CD/Pediatric
UC/Plaque psoriasis
• 5 mg/kg at 0, 2 and 6
weeks, then every 8
weeks
RA
• 3 mg/kg at 0, 2 and 6
weeks, then every 8
weeks, in combination
with methotrexate
(may increase the
dose up to 10 mg/kg
or treat as often as
every 4 weeks)
AS
• 5 mg/kg at 0, 2 and 6
weeks, then every 6
weeks
|
|
Avsola
(infliximab-axxq)
injection 100 mg vial
|
|
Inflectra (infliximab- dyyb) injection 100
mg vial
|
|
Renflexis (infliximab
abda) injection 100
mg vial
|
Abbreviations: RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; CD = Crohn’s disease; UC = ulcerative colitis; PsO = plaque psoriasis
* Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.
Place of Service:
Outpatient
The above policy is based on the following references:
- Remicade [package insert]. Horsham, PA: Janssen Biotech, Inc.; May 2020.
- Avsola [package insert]. Thousand Oaks, CA: Amgen; December 2019.
- Inflectra [package insert]. New York, NY: Pfizer Inc; June 2021.
- Renflexis [package insert]. Whitehouse Station, NJ. Merck & Co., Inc; February 2021.
- Wallace C, Colletti R, et al. Understanding Real-World Biologic Maintenance Dosing Patterns Among Pediatric Ulcerative Colitis and Crohn’s Disease Patients. Gastroenterology. 2021; 160: S30.
- Turner D, Ruemmele F, et al. Management of Paediatric Ulcerative Colitis, Part 2: Acute Severe Coltiis – An Evidence-based Consensus Guideline From the European Crohn’s and Colitis Organization and the European Society of Paediatric Gastroenterology, Hepatology, and Nutrition. 2018; 67: 292-310.
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
