2.179 golimumab (simponi aria) - supercoder · 2020. 5. 22. · simponi® aria™ is the second...

MEDICAL POLICY

POLICY TITLE GOLIMUMAB (SIMPONI® ARIA™)

POLICY NUMBER MP- 2.179

[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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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

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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

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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

DMARDs, corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and/or analgesics

may be continued during treatment with Simponi® Aria™.

Warnings and Precautions

Prior to initiating Simponi® Aria™ and periodically during therapy, evaluate patients for active

tuberculosis and tested for latent infection. Prior to initiating Simponi® Aria™, patients should

be tested for hepatitis B viral infection.

Patients treated with Simponi® Aria™ are at increased risk for developing serious infections

involving various organ systems and sites that may lead to hospitalization or death.

Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic

organisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis,

histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported

with TNF-blockers. Patients have frequently presented with disseminated rather than localized

disease. The concomitant use of a TNF-blocker and abatacept or anakinra was associated with a

higher risk of serious infections; therefore, the concomitant use of Simponi®Aria™ and these

biologic products is not recommended

Treatment with Simponi® Aria™ should not be initiated in patients with an active infection,

including clinically important localized infections. Patients greater than 65 years of age, patients

with co-morbid conditions and/or patients taking concomitant immunosuppressants such as

corticosteroids or methotrexate may be at greater risk of infection. Consider the risks and

benefits of treatment prior to initiating Simponi® Aria™ in patients:

• with chronic or recurrent infection;

• who have been exposed to tuberculosis;

• with a history of an opportunistic infection;

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• who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as

histoplasmosis, coccidioidomycosis, or blastomycosis; or

• with underlying conditions that may predispose them to infection.

Malignancies, some fatal, have been reported among children, adolescents, and young adults

who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of

which Simponi® Aria™ is a member. Approximately half the cases were lymphomas, including

Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies,

including rare malignancies that are usually associated with immunosuppression, and

malignancies that are not usually observed in children and adolescents. The malignancies

occurred after a median of 30 months (range 1 to 84 months) after the first dose of TNF blocker

therapy. Most of the patients were receiving concomitant immunosuppressants.

Rheumatoid Arthritis (RA)

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects the lining of the joints

and results in significant chronic pain, loss of function and disability. The annual incidence of

RA is reported to be around 30 per 100,000 population. Potential risk factors for RA include:

cigarette smoking, occupational exposure to dust, fibers, silica and asbestos and electrical and

wood working occupations.

IV. RATIONALE

The efficacy and safety of Simponi® Aria™ were evaluated in one multicenter, randomized,

double-blind, controlled trial (Trial 1) in 592 patients ≥ 18 years of age with moderately to

severely active RA despite concurrent MTX therapy and had not previously been treated with a

biologic TNF-blocker. Patients were diagnosed according to the American College of

Rheumatology (ACR) criteria, at least 3 months prior to administration of study agent and were

required to have at least 6 swollen and 6 tender joints. Patients were randomized to receive either

Simponi® Aria™2 mg/kg (n=395) or placebo (n=197) over a 30 minute intravenous infusion at

Weeks 0, 4 and every 8 weeks thereafter in addition to their weekly maintenance MTX dose (15-

25 mg/kg). All patients receiving placebo + MTX received Simponi® Aria™+ MTX after Week

24, but the trial remained blinded until all patients had completed 52 weeks of treatment.

Efficacy data were collected and analyzed through Week 52. Patients were allowed to continue

stable doses of concomitant low dose corticosteroids (equivalent to ≤ 10 mg of prednisone a day)

and/or NSAIDs and patients may have received oral MTX during the trials. The use of other

DMARDs including cytotoxic agents or other biologics was prohibited.

The primary endpoint in Trial 1 was the percentage of patients achieving an ACR 20 response at

Week 14. In Trial 1, the majority of subjects were women (82%) and were Caucasian (81%) with

a median age of 52 years and a median weight of 70 kg. Median disease duration was 4.7 years,

MEDICAL POLICY




and 50% of the patients used at least one DMARD other than MTX in the past. At baseline, 81%

of patients received concomitant NSAIDs and 81% of patients received low dose corticosteroids

(equivalent to ≤ 10 mg of prednisone a day). The median baseline DAS28-CRP was 5.9 and the

median van der Heijde-Sharp score at baseline was 28.5.

Clinical Response

A greater percentage of patients treated with the combination of Simponi® Aria™+ MTX

achieved ACR 20 at Week 14 and ACR50 at Week 24 versus patients treated with the placebo +

MTX as shown in Table 2. The percent of patients achieving ACR 20 responses by visit for Trial

1 is shown in Figure 1.

Table 2: Trial 1 – Proportion of Patients with an ACR Response

Trial 1 Active RA, despite MTX

Placebo + MTX SIMPONI ARIA™ + MTX

95% CIa

Nb 197 395

ACR 20

Week 14 25% 59% 25.9, 41.4

Week 24 32% 63% 23.3, 39.4

ACR 50

Week 14 9% 30% 15.3, 27.2

Week 24 13% 35% 15.1, 28.4

ACR 70

Week 14 3% 12% 5.3, 13.4

Week 24 4% 18% 8.8, 18.1 aFor difference in proportions bN reflects randomized patients.

Figure 1: Trial 1 – Percent of Patients Achieving ACR 20 Response Over Time:

Randomized Patients

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The analysis is based on the intent-to-treat population. Last observation carried forward was

performed for missing data. Patients who discontinued treatment due to lack of efficacy

were counted as non-responders, as were patients who started prohibited medication or

failed to achieve at least a 10% improvement in joint counts at Week 16.

The improvement in all components of the ACR response criteria for the Simponi® Aria™

+ MTX group was greater compared to the placebo + MTX group in Trial 1 as shown in

Table 3

Table 3: Trial 1 – Components of ACR Response at Week 14

Trial 1

Active RA, despite MTX

Placebo + MTX Simponi® Aria™+ MTX

Na 197 395

Number of swollen joints (0-66)

Baseline 15 15

Week 14 11 6

Number of tender joints (0-68)

Baseline 26 26

Week 14 20 13

Patient’s assessment of pain (0-10)

Baseline 6.5 6.5

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Week 14 5.6 3.9

Patient’s global assessment of disease activity (0-10)

Baseline 6.5 6.5

Week 14 5.5 4.0

Physician’s global assessment of disease activity (0-10)

Baseline 6.3 6.2

Week 14 4.9 3.1

HAQ score (0-3)

Baseline 1.6 1.6

Week 14 1.4 1.1

CRP (mg/dL) (0-1)

Baseline 2.2 2.8

Week 14 1.8 0.9

Note: All values are means. aN reflects randomized patients; actual number of patients evaluable for each

endpoint may vary.

At Week 14, a greater proportion of patients treated with Simponi® Aria™+ MTX achieved a low level

of disease activity as measured by a DAS28-CRP less than 2.6 compared with the placebo + MTX group

(15% compared to 5%; 95% confidence interval for difference [6.3%,15.5%]).

Radiographic Response

In Trial 1, structural joint damage was assessed radiographically and expressed as a change in

van der Heijde-Modified Sharp Score (vdH-S) and its components, the erosion score and Joint

Space Narrowing (JSN) score, at Week 24 compared to baseline. The Simponi® Aria™+ MTX

treatment group inhibited the progression of structural damage compared with placebo + MTX,

as assessed by total vdH-S score as shown in Table 4.

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Table 4: Trial 1 – Radiographic Change from Baseline at Week 24

Placebo + MTX

(N=197)a

Simponi® Aria™+

MTX

(N=395)a,b

Mean Mean

Change Total vdH-S Score 1.1 0.03*

Change Erosion Score 0.5 -0.1

Change JSN Score 0.6 0.1 a N reflects randomized patients b p-value is displayed only for the major secondary endpoint

*p≤0.001

At Week 24, a greater proportion of patients in the Simponi® Aria™ + MTX group (71%) had

no progression of structural damage (change in the total vdH-S score ≤ 0), compared to 57% of

patients in the placebo + MTX group. At Week 52, the mean change from baseline in total vdH-

S score was 1.2 in patients originally randomized to placebo + MTX who crossed over to

Simponi® Aria™+ MTX at Week 16 or 24, and 0.1 in patients originally randomized to

Simponi® Aria™+ MTX who remained on active treatment.

Physical Function Response in Patients with RA

Physical function was assessed by the disability index of the Health Assessment Questionnaire

(HAQ-DI) At Week 14, the Simponi® Aria™+ MTX group showed greater mean improvement

in the HAQ-DI compared with placebo + MTX (0.5 compared to 0.2; 95% confidence interval

for difference [0.2, 0.4]).

V. DEFINITIONS

CLINICAL DISEASE ACTIVITY INDEX (CDAI) is a composite index for quantifying disease

activity in RA. It utilizes 4 clinical parameters namely, swollen and tender joints out of 28 (the

set designated for DAS28) and global assessment of the patient and assessor on a visual

analogue scale. No laboratory parameter is needed. The categories of disease activity are:

remission ≤ 2.8, low disease activity 2.9 to 10, moderate disease activity 10.1 to 22 and high

disease activity > 22.

DISEASE ACTIVITY SCORE (DAS) 28 is a measure of disease activity in RA. The score is

calculated by a complex mathematical formula, which includes the number of tender and

swollen joints (out of a total of 28), the erythrocyte sedimentation rate (ESR, a blood marker of

inflammation), and the patient’s ‘global assessment of global health' (indicated by marking a 10

MEDICAL POLICY




cm line between very good and very bad). High disease activity relates to DAS28 >5.1,

moderate to DAS28 of >3.2 to 5.1, low disease activity is regarded in the range of 2.6 to 3.2,

and remission <2.6.

OFF-LABEL refers to the use of a drug to treat a condition for which it has not been approved by

the U.S. Food and Drug Administration (FDA), especially when such may relieve unpleasant

symptoms or prove compassionate. Drug effects that have been observed but not specifically

proven (and for which no application has been made) may be exploited for unproven, or "off-

label" uses by licensed medical practitioners.

SIMPLIFIED DISEASE ACTIVITY INDEX (SDAI) is a composite index for quantifying disease

activity in RA. It includes the sum of the tender joint count, swollen joint count, patient global

assessment, physician global assessment, and C-reactive protein (CRP). The categories of

disease activity are: remission ≤ 3.3, low disease activity 3.3 to 11, moderate disease activity 11

to 26 and high disease activity > 26.

MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS are at greater risk of

developing joint damage and disability than patients with mildly active disease. These patients

typically meet the American College of Rheumatology (ACR)/European League Against

Rheumatism (EULAR) criteria for RA and exhibit a combination of the following:

At least five inflamed joints

Elevation in the erythrocyte sedimentation rate (ESR) and/or serum C-reactive

protein (CRP) concentration

Positive rheumatoid factor and/or anticyclic citrullinated peptide (CCP) antibodies

(present in most patients)

Evidence of inflammation on plain radiography of the hands, wrists, or feet, such as

osteopenia and/or periarticular swelling. In addition, minimal joint space narrowing

and small peripheral erosions may be observed.

VI. BENEFIT VARIATIONS

The existence of this medical policy does not mean that this service is a covered benefit under

the member's contract. Benefit determinations should be based in all cases on the applicable

contract language. Medical policies do not constitute a description of benefits. A member’s

individual or group customer benefits govern which services are covered, which are excluded,

and which are subject to benefit limits and which require preauthorization. Members and

providers should consult the member’s benefit information or contact Capital for benefit

information.

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VII. DISCLAIMER

Capital’s medical policies are developed to assist in administering a member’s benefits, do not constitute medical

advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of

members. Members should discuss any medical policy related to their coverage or condition with their provider

and consult their benefit information to determine if the service is covered. If there is a discrepancy between this

medical policy and a member’s benefit information, the benefit information will govern. Capital considers the

information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law.

VIII. REFERENCES

Arthritis Foundation Ease-of-Use [Website]: http://www.arthritis.org/resources/ease-of-use-

new/eou-search/?q=smartject&submit=.

Accessed October 9, 2013

BCBSA Specialty Pharmacy Combined Capacity (SPCC) Report #1. Biologic-Response

Modifiers in Rheumatic Diseases. April 2010.

Centers for Medicare and Medicaid Services (CMS) Medicare Benefit Policy Manual.

Publication 100-02. Chapter 15. Section 50.4.2. Unlabeled Use of Drug. Effective 06/05/08

[Website]: http://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/downloads/bp102c15.pdf. Accessed October 9, 2013.

Centers for Medicare and Medicaid Services (CMS) Medicare Benefit Policy Manual.

Publication 100-02. Chapter 15. Sections 50, 50.4.1, 50.4.3. Drugs and Biologicals.

Effective 06/08/12. [Website]: http://www.cms.gov/manuals/Downloads/bp102c15.pdf.

Accessed October 9, 2013.

Schur, P, Cohen, S. Initial treatment of moderately to severely active rheumatoid arthritis in

adults In: UpToDate Online Journal [serial online]. Waltham, MA: UpToDate; updated

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]:

http://www.janssenbiotech.com/sites/default/files/pdf/PressRelease07182013.pdf.

Accessed October 9, 2013.

IX. CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The

identification of a code in this section does not denote coverage as coverage is determined by the terms

of member benefit information. In addition, not all covered services are eligible for separate

reimbursement.

http://www.arthritis.org/resources/ease-of-use-new/eou-search/?q=smartject&submit

http://www.arthritis.org/resources/ease-of-use-new/eou-search/?q=smartject&submit

http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf

http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf

http://www.cms.gov/manuals/Downloads/bp102c15.pdf

http://www.uptodate.com/

http://www.janssenbiotech.com/sites/default/files/pdf/PressRelease07182013.pdf

MEDICAL 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

2.179 golimumab (simponi aria) - supercoder · 2020. 5. 22. · simponi® aria™ is the second...

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