Infliximab biosimilar
products (Inflectra or Renflexis) are covered without prior authorization (PA)
but are subject to retrospective review to ensure compliance with the Medical
Policy Statement below. Remicade requires
prior authorization (PA). For new patient starts, a covered biosimilar product
(Inflectra or Renflexis) must be tried first before Remicade would be approved.
All Remicade renewal/continuation requests also require documentation of
trial of a covered biosimilar. If
trial of a covered biosimilar product is not considered to be suitable for the
member, then the provider needs to submit a clinical rationale with relevant
clinical literature.
1)
Rheumatoid Arthritis,
Psoriatic Arthritis
A)
Members age 18 and older
with active disease who has failed to respond to any of the non-steroidal
anti-inflammatory drugs (NSAIDS).
B)
The recommended dose is 3
mg/kg as an infusion at 2 and 6 weeks after the initial infusion, then every 8
weeks. For continued use beyond 30 weeks, there must be documentation of
demonstrable improvement.
C)
In cases of incomplete
response or relapse, consideration may be given to increasing the dose as high
as 10 mg/kg per dose, or increasing the dosing frequency to every 4 weeks.
2)
Crohn’s
Disease
A)
Continuation of therapy after the initial 6-month period should be based on
patient response to therapy. Indicated for the treatment of moderately to
severely active Crohn’s Disease or fistulizing Crohn’s Disease in patients age 6
years and older who have had an inadequate response to conventional therapy:
·
Corticosteroids
·
5-aminosalicylates,
and/or
·
Mercaptopurine
(Purinethol) with azathioprine (Imuran).
B)
The recommended dosing is
a loading schedule of 5 mg/kg doses given at weeks 0, 2, and 6. Therapy then
continues at 5 mg/kg every 8 weeks. Continuation of therapy after the initial 3
doses should be based on patient response to therapy.
C)
If there is no response
to therapy by week 14, no response is likely and the treatment should be
discontinued.
D)
For patients who respond
initially but relapse while on treatment, consideration may be given to
increasing the dose to 10 mg/kg every 8 weeks.
3)
Ankylosing Spondylitis
A)
Member is 18 years of age
or older;
B)
The initial dosing is a
loading regimen of 5 mg/kg per dose at weeks 0, 2, and 6;
C)
Maintenance dosing is 5
mg/kg per dose every 6 weeks;
D)
Continuation of therapy
after the initial 3 months should be based on patient’s response to therapy.
4)
Psoriasis
Member is 18 years of age
or older, has moderate to severe chronic plaque psoriasis, and meets the
following selection criteria:
A)
Plaque psoriasis has been
present for more than 1 year; AND
B)
Ten percent or more body
surface area is affected by plaque psoriasis;
AND
C)
Member has a history of
failure for at least a 3 month trial of, contraindication, or intolerance to ALL
of the following:
i.
Topical therapy with
corticosteroids, Vitamin D analogs (e.g. calcitriol, calcipotriene), calcineurin
inhibitor (e.g. tacrolimus, pimecrolimus), or salicylic acid combination
product; AND
ii.
Phototherapy of at least
3 months duration with narrow-band UVB (in the office or at home) used alone or
in combination with topical or systemic therapy (see BI029 for additional
information regarding UV light therapy). This
requirement may be waived in any of the following situations:
1.
History or presence of
melanoma or other skin cancer, lupus erythematosus, or xeroderma pigmentosum,
2.
Psoriasis involving areas
around the eye where eye protection may cause blockage of phototherapy to
affected area,
3.
Documented systemic
disease involving the joints (meeting specific criteria for psoriatic
arthritis), OR
4.
Very sever plaque
thickness or scaling (4 on a scale of 0 to 4);
AND
iii.
Systemic therapy of at
least 3 months duration with methotrexate or other non-biologic DMARD. This
requirement may be waived in any of the following situations:
1.
Member has chronic
hepatic disease,
2.
Member has acquired
immunodeficiency disease (AIDS),
3.
Member is pregnant or
breast-feeding, OR
4.
Member has anemia,
neutropenia, or thrombocytopenia; AND
iv.
History of inadequate
response to Humira.
5)
Ulcerative Colitis
Members 6 years of age or
older with moderate to severe active ulcerative colitis refractory to one or
more of the following standard therapies:
A)
Corticosteroids (e.g.,
Prednisone, Methylprednisolone);
B)
5-aminosalicylic acid
agents (e.g., Sulfasalazine, Mesalamine, Balsalazide);
C)
Immunosuppressant’s
(e.g., azathioprine, cyclosporine, 6-mercaptopurine).
6)
Posterior Uveitis
Associated With Behcet’s Syndrome
Members with refractory
posterior uveitis associated with Behcet’s syndrome that has had an inadequate response to conventional
therapy with systemic corticosteroids and/or immunosuppressive agents. Continued
use of Remicade after six months should only be considered in the case of
objectively documented improvement (improvement in visual acuity or reduction in
number of episodes).
Codes
Used In This BI:
J1745 – Infliximab Injection, 10 mg
Q5103 - Injection, infliximab-dyyb, biosimilar, (inflectra), 10 mg
Q5104 - Injection, infliximab-abda, biosimilar, (renflexis), 10 mg
Q5121 - Injection, infliximab-axxq, biosimilar, (Avsola), 10mg
84999 – Unlisted chemistry procedure (used for infliximab antibodies)