MEDICAL POLICY POLICY TITLE GOLIMUMAB (SIMPONI® ARIA™) POLICY NUMBER MP- 2.179 Page 1 [Note: Final page is signature page and is kept on file, but not issued with Policy.] Original Issue Date (Created): November 26, 2013 Most Recent Review Date (Revised): November 26, 2013 Effective Date: April 1, 2014 I. POLICY GOLIMUMAB (SIMPONI® ARIA™) REQUIRES 100% MEDICAL DIRECTOR REVIEW Note:. Golimumab is available in 2 forms. Golimumab (Simponi®) is available in single dose prefilled syringes and in prefilled SmartJect® autoinjector for self-administered subcutaneous administration. The SmartJect ® autoinjector has been awarded the "Ease-of-Use Commendation" by the Arthritis Foundation ® . Golimumab (Simponi® Aria™) is available in 50mg/4mL (12.5 mg/ml) single use vials. This policy only pertains to Golimumab (Simponi® Aria™) infusions covered under the Medical benefit. The efficacy and safety of switching between intravenous and subcutaneous formulations and routes of administration have not been established. Preauthorization Requirements for Golimumab (Simponi® Aria™) Requests for Golimumab (Simponi®Aria™) must be accompanied by a completed preauthorization form prior to treatment, at 6 months, and then every 12 months during treatment. Various index tools have been developed to assess the severity and monitor the efficacy of treatment for the following diseases, and any appropriate index form may be used providing improvement can be measured. Note: Patients must be tested for latent tuberculosis prior to receiving Golimumab (Simponi® Aria™). If positive, treatment for TB should be started prior to starting Simponi® Aria™. In addition, patients should be monitored for active TB during treatment, even if initial latent TB test is negative. Golimumab (Simponi® Aria™ ) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate. Pediatric Use: The safety and effectiveness of Golimumab (Simponi® Aria™) in pediatric patients less than 18 years of age have not been established.
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MEDICAL POLICY
POLICY TITLE GOLIMUMAB (SIMPONI® ARIA™)
POLICY NUMBER MP- 2.179
Page 1 [Note: Final page is signature page and is kept on file, but not issued with Policy.]
Original Issue Date (Created): November 26, 2013
Most Recent Review Date (Revised): November 26, 2013
Effective Date: April 1, 2014
I. POLICY
GOLIMUMAB (SIMPONI® ARIA™) REQUIRES 100% MEDICAL DIRECTOR REVIEW
Note:. Golimumab is available in 2 forms.
Golimumab (Simponi®) is available in single dose prefilled syringes and in prefilled SmartJect®
autoinjector for self-administered subcutaneous administration. The SmartJect® autoinjector has
been awarded the "Ease-of-Use Commendation" by the Arthritis Foundation®.
Golimumab (Simponi® Aria™) is available in 50mg/4mL (12.5 mg/ml) single use vials. This
policy only pertains to Golimumab (Simponi® Aria™) infusions covered under the Medical
benefit.
The efficacy and safety of switching between intravenous and subcutaneous formulations and
routes of administration have not been established.
Preauthorization Requirements for Golimumab (Simponi® Aria™)
Requests for Golimumab (Simponi®Aria™) must be accompanied by a completed
preauthorization form prior to treatment, at 6 months, and then every 12 months during
treatment. Various index tools have been developed to assess the severity and monitor the
efficacy of treatment for the following diseases, and any appropriate index form may be used
providing improvement can be measured.
Note: Patients must be tested for latent tuberculosis prior to receiving Golimumab (Simponi®
Aria™). If positive, treatment for TB should be started prior to starting Simponi® Aria™. In
addition, patients should be monitored for active TB during treatment, even if initial latent TB
test is negative.
Golimumab (Simponi® Aria™ ) is approved by the U.S. Food and Drug Administration (FDA)
for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA)
in combination with methotrexate.
Pediatric Use: The safety and effectiveness of Golimumab (Simponi® Aria™) in pediatric
patients less than 18 years of age have not been established.
MEDICAL POLICY
POLICY TITLE GOLIMUMAB (SIMPONI® ARIA™)
POLICY NUMBER MP- 2.179
Page 2 [Note: Final page is signature page and is kept on file, but not issued with Policy.]
Golimumab (Simponi® Aria™) may be considered medically necessary for the treatment of
moderately to severely active rheumatoid arthritis, in combination with methotrexate when the
following criteria are met:
Consulting rheumatologist recommends treatment with Golimumab (Simponi® Aria™ ) AND
The member has tried and failed therapy with a self- injectable biologic DMARD agent.
AND
The patient has had an inadequate response or inability to tolerate a trial of conventional
therapy (e.g. aminosalicylates, corticosteroids, and /or immunomodulators [e.g. 6-mercaptopurine, azathioprine, cyclosporine and methotrexate]); AND
Documentation that there is a medical contraindication to the administration of Golimumab
(Simponi®) prefilled syringes.
Other Indications
Other uses of Golimumab (Simponi® Aria™) are considered investigational. There is insufficient
evidence to support a conclusion concerning the health outcomes or benefits associated with this
procedure for the above indications.
Maintenance Therapy
Golimumab (Simponi® Aria™) maintenance therapy may be considered medically necessary
when therapy has demonstrated efficacy as evidenced by an improvement in disease activity * at 6
months and maintenance of at least that improvement at each 12 month re-evaluation and
documentation that there is a continued medical contraindication to the administration of
Golimumab (Simponi®) prefilled syringes
*As measured by a standardized disease activity tool (e.g. Clinical Disease Activity Index
[CDAI], Simplified Disease Activity Index [SDAI], Rheumatoid Arthritis Disease Activity Index
[RADAI], Disease Activity Score based on 28-joint evaluation [DAS28] score, Bath Ankylosing
Spondylitis Disease Activity Index(BASDI), Crohn’s Disease Activity Index [CDAI], Harvey
Bradshaw Index [HBI]).
Cross-references:
MP-2.129 Abatacept (Orencia®)
MP- 2.133 Infliximab (Remicade®)
MP- 2.138 Certolizumab (Cimzia®)
MP-2.148 Tocilizumab (Actemra®)
MP-2.103 Off-label Use of Prescription Drug and Medical Devices
MEDICAL POLICY
POLICY TITLE GOLIMUMAB (SIMPONI® ARIA™)
POLICY NUMBER MP- 2.179
Page 3 [Note: Final page is signature page and is kept on file, but not issued with Policy.]
II. PRODUCT VARIATIONS
[N] = No product variation, policy applies as stated
[Y] = Standard product coverage varies from application of this policy, see below
[N] Capital Cares 4 Kids [N] Indemnity
[N] PPO [N] SpecialCare
[N] HMO [N] POS
[Y] SeniorBlue HMO* [Y] FEP PPO* *
[Y] SeniorBlue PPO*
*Step therapy requiring a trial of self-administered biologic therapy or similar self-administered injectable
or oral medication does not apply.
** The FEP program dictates that all drugs, devices or biological products approved by the U.S. Food and
Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved drugs,
devices or biological products may be assessed on the basis of medical necessity.
III. BACKGROUND/DESCRIPTION
Disease-modifying anti-rheumatic drugs (DMARDs) act by altering the underlying disease rather
than treating symptoms. There are two types: DMARDs may be classified as nonbiologic and
biologic.
Nonbiologic DMARDs include hydroxychloroquine, leflunomide, methotrexate, minocycline,
and sulfasalazine. These agents reduce disease activity, slow the erosion of affected joints, and
may improve the patient’s quality of life. The nonbiologic DMARDs have evidence of efficacy
and well-characterized safety profiles. The selection of specific therapy depends on specific
patient factors, such as prognosis, disease activity, previous therapies, and comorbid disease.
Generally, methotrexate or leflunomide are reasonable first choices, but other agents may be
appropriate based on the specific situation. Two- and three-drug combinations may also be
appropriate for those patients who receive an inadequate response to monotherapy, depending on
disease severity and duration, and other prognostic factors.
Biologic DMARDs (may also be called anti-TNF drugs) include self-administered medications
such as etanercept (Enbrel®), adalimumab (Humira®), certolizumab pegol (Cimzia®),
golimumab (Simponi®) and anakinra (Kineret®), and the infused medications such as infliximab
(Remicade®), abatacept (Orencia®), and rituximab (Rituxan®).
Golimumab is a fully human anti-TNF-alfa (TNF-α) monoclonal antibody. Golimumab binds to
both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents
the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα (a
cytokine protein.). TNFα, a naturally occurring cytokine, is involved in normal inflammatory and
MEDICAL POLICY
POLICY TITLE GOLIMUMAB (SIMPONI® ARIA™)
POLICY NUMBER MP- 2.179
Page 4 [Note: Final page is signature page and is kept on file, but not issued with Policy.]
immune responses and plays an important role in the inflammatory responses associated with
rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.
Golimumab (Simponi® Aria™) (Janssen Biotech) was approved by the U.S. Food and Drug
Administration (FDA) July 18, 2013 for the treatment of adults with moderately to severely
active rheumatoid arthritis in combination with methotrexate. Simponi® Aria™ will be
administered by infusion. Simponi® Aria™ is the second formulation of Simponi to be approved
by the FDA. Injectable Simponi was approved by the FDA on April 24, 2009.
Dosage and Administration
The Simponi® Aria™ dosage regimen is 2 mg per kg given as an intravenous infusion over 30
minutes at weeks 0 and 4, then every 8 weeks thereafter.
Simponi® Aria™ should be given in combination with methotrexate. Other non-biologic
January 18, 2913. [Website] : www.uptodate.com . Accessed October 9, 2013. Simponi®Aria™ (Golimumab) for Infusion Received FDA Approval for Treatment of
Moderately to Severely Active Rheumatoid Arthritis. July 18, 2013. [Website]:
Page 12 [Note: Final page is signature page and is kept on file, but not issued with Policy.]
Covered when medically necessary:
HCPCS
Code Description
J1602 Injection, Golimumab, 1 MG, for intravenous use
ICD-9-CM
Diagnosis
Code*
Description
696.0 Psoriatic arthropathy
714-714.2 Rheumatoid arthritis and other inflammatory polyarthropathies
720.0 Ankylosing spondylitis
*If applicable, please see Medicare LCD or NCD for additional covered diagnoses. The following ICD-10 diagnosis codes will be effective October 1, 2014
ICD-10-CM
Diagnosis
Code*
Description
L40.54 –
L40.8 Arthropathic psoriasis and other psoriasis
M05.00 –
M08.09 Rheumatoid Arthritis with rheumatoid factor
M45.9 Ankylosing spondylitis of unspecified sites in spine
X. POLICY HISTORY
MP 2.179 CAC 11/26/13 New policy. Previously silent. Now MN with criteria.
Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage
Insurance Company®, Capital Advantage Assurance Company® and Keystone Health Plan® Central. Independent
licensees of the BlueCross BlueShield Association. Communications issued by Capital BlueCross in its capacity as
administrator of programs and provider relations for all companies