On September 27, 2013, Cimzia received FDA approval for treatment of adult patients with active psoriatic arthritis.

On October 17, 2013, Cimzia received FDA approval for the treatment of adults with active ankylosing spondylitis.

On May 25, 2018, Cimzia received FDA approval for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy

On March 2019, Cimzia received FDA approval for the treatment of adults with active non-radiographic axial spondyloarthritis, with objective signs of inflammation. Nr-axSpa is a type of inflammatory arthritis that causes inflammation that causes inflammation in the spine and other symptoms. There is no visible damage seen on xrays, so it is referred to as non-radiographic. The safety and efficacy of Cimzia for the treatment of nr-axSpaA was demonstrated in a randomized clinical study of 317 adult patients with this condition with objective signs of inflammation. The primary efficacy measure of the trial was the improvement response on the Ankylosing Spondylitis Disease Activity Score. At Week 52, a greater proportion of nr-axSpA patients treated with Cimzia had ASDAS0MI response compared to patients treated with placebo. At both Week 12 and 52, ASAS40 responses were greater for patients treated with Cimzia compared to patients treated with placebo.

[INFORMATIONAL NOTE: On June 3, 2008, the FDA issued an Early Warning Communication About an Ongoing Safety Review involving the association of Tumor Necrosis Factor (TNF) blockers and the development of lymphomas and other cancers among children and young adults. Over a ten-year interval using the FDA’s Adverse Event Reporting System, reports have described cancer occurring in children using TNF blockers when they were 18 years of age or less to treat juvenile idiopathic arthritis, Crohn’s disease, and other diseases. Until the evaluation is complete and further long term studies have been conducted, caution should be advised in the use of TNF blockers in children and young adults.]

[INFORMATIONAL NOTE: The FDA-approved Cimzia (certolizumab pegol) package insert has the following BLACK BOX WARNINGS:

• RISK OF SERIOUS INFECTIONS
  • Patients treated with Cimzia are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
  • Cimzia should be discontinued if a patient develops a serious infection or sepsis.
  • Reported infections include:
    • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Cimzia use and during therapy. Treatment for latent infection should be initiated prior to Cimzia use.
    • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
    • Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.
  • The risks and benefits of treatment with Cimzia should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
  • Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Cimzia including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
• LYMPHOMAS and other MALIGNANCIES
  • Lymphoma and other malignancies, some fatal have been reported in children and adolescent patients treated with TNF blockers. Cimzia is not indicated for use in pediatric patients.]

The requirements of the Horizon BCBSNJ Certolizumab Pegol (Cimzia) Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).

1. Please refer to a separate policy on Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) under the Drug Section.

2. Prior to initiation of Certolizumab pegol (Cimzia), members must meet ALL of the following criteria:

• Member has been tested for latent tuberculosis (TB) AND if positive the patient has begun therapy for latent TB; AND
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g. rheumatologist, gastroenterologist, dermatologist) or has consulted with a specialist in the area of the patient’s diagnosis AND
• The requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
  · Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
  · Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
  · Member has acute mental status/cognitive changes or physical impairment due to another condition; or
  · Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
  · Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
  · Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver

[INFORMATIONAL NOTE: As per the FDA approved package insert, prior to initiating therapy, patients should be evaluated for Hepatitis B virus (HBV) risk, and if appropriate, HBV infection should be ruled out or treatment initiated.]

• moderately to severely active Crohn’s disease in members who meet ONE of the following:
  • Have tried and failed ONE oral immunosuppressive therapy for at least 3 months or has a contraindication to or are unable to tolerate ALL conventional therapy (i.e., 6-mercaptopurine, aminosalicylates, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], mesalamine, methotrexate, sulfasalazine) OR
  • Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of Crohn's disease
• moderately to severely active rheumatoid arthritis (RA) when ONE of the following criteria is met:.
  A. Member has tried and failed at least a 3 month trial of ONE conventional agent such as methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine or has an intolerance or contraindication to ALL of the following conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) OR
  B. Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of RA
  

[INFORMATIONAL NOTE: The ACR 2015 recommendations on use of biological DMARDs in RA patients are based on duration, severity and prior exposure to non-biologic DMARDs.
In order to assess if a patient is a candidate for biologic DMARD therapy, RA disease activity should be measured as per the tests below:




Table 2. Disease activity cutoffs for each American College of Rheumatology-recommended disease activity measure*
Disease activity measure	Scale	Remission	Low/Minimal	Moderate	High/severe
Patient-driven composite tools
PAS	0-10	0.00-0.25	0.26-3.70	3.71 to <8.0	8.00-10.00
PAS-II	0-10	0.00-0.25	0.26-3.70	3.71 to <8.0	8.00-10.00
RAPID-3	0-10	0-1.0	>1.0 to 2.0	>2.0 to 4.0	>4.0 to 10
Patient and provider composite tool
CDAI	0-76	≤2.8	>2.8 to 10.0	>10.0 to 22.0	>22.0
Patient, provider, and laboratory composite tools
DAS28 (ESR or CRP)	0-9.4	<2.6	≥2.6 to <3.2	≥3.2 to ≤5.1	>5.1
SDAI	0-86	≤3.3	>3.3 to ≤11.0	>11.0 to ≤26	>26
*PAS= Patient Activity Scale; RAPID-3= Routine Assessment of Patient Index Data with 3 measures; CDAI= Clinical Disease Activity Index; DAS28= Disease Activity Score with 28-joint counts; ESR= erythrocyte sedimentation rate; CRP= C-reactive protein; SDAI= Simplified Disease Activity Index


Algorithm 1 - Once RA disease severity has been measured, they can be stratified in different treatments algorithms depending on the duration of the disease:
• Patients with Early RA (disease duration <6 months)
  • Low disease activity or remission
    • DMARD monotherapy is recommended
    • DMARD monotherapy is recommended for those who are DMARD naïve
    • If there is continued disease activity with DMARD therapy, consider combination of traditional DMARDs and TNF inhibitor or non TNF biologics
• Patients with established RA (disease duration ≥6 months or meeting the 1987 ACR RA classification criteria)
  • 1987 ACR RA classification criteria:
    · Morning stiffness
    · Arthritis of 3 or more joint areas
    · Arthritis of hand joints
    · Symmetric arthritis
    · Rheumatoid nodules
    · Serum rheumatoid factor
    · Radiographic changes
  · Consider DMARD monotherapy for all patients of low, moderate, or high disease activity who are DMARD naïve
  · For patients who do not respond adequately on DMARD monotherapy, consider combination therapy of traditional DMARD, or TNF inhibitor with or without MTX, or non TNF biologic with or without MTX, or tafacitinib with or without MTX
  · If patients continue to have moderate or high disease activity, consider switching to a different agent within the drug class of TNF inhibitors, or non TNF biologics (with or without MTX) or tafacitinib with or without MTX]
  
• Active moderate to severe psoriatic arthritis (PsA) when ONE of the following criteria are met:
  • Member has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive) OR
  • Member has concomitant severe psoriasis (PS) (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences) OR
  • Member has tried and had an inadequate response to ONE conventional agent (i.e., cyclosporine, hydroxychloroquine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months or has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL of the following conventional agents (i.e., cyclosporine, leflunomide, methotrexate, sulfasalazine) OR
  • Member's medication history indicates use of another biologic immunomodulator agent or Otezla that is FDA labeled or supported by compendia for the treatment of PsA
[INFORMATIONAL NOTE: FDA approval of Cimzia for active PsA is based on data from the RAPID™-PsA study, (Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of certolizumab pegol in 409 patients with active and progressive adult onset PsA). Patients received a loading dose of Cimzia 400 mg at weeks 0, 2, and 4 or placebo, followed by either Cimzia 200 mg every other week, 400 mg every 4 weeks, or placebo every other week. Patients were evaluated for signs and symptoms of PsA using the ACR20 response at week 12 and for structural damage using the modified Total Sharp Score (mTSS) at week 24. ACR20 response was significantly higher at week 12 in patients who received Cimzia 200 mg every other week and Cimzia 400 mg every 4 weeks as compared with placebo (58.0% and 51.9% vs 24.3%, p<0.001). Differences in ACR50 and ACR70 responses in Cimiza combined groups vs placebo were apparent from week 4 and significant at week 24 (ACR50: 42.1% vs 12.5%, ACR70: 26.0% vs 4.4%, p<0.001). Patients treated with Cimzia 200 mg every other week demonstrated greater reduction in radiographic progression compared with placebo-treated patients at Week 24, as measured by change from baseline in total modified mTSS Score. Patients treated with Cimzia 400 mg every four weeks did not demonstrate greater inhibition of radiographic progression at Week 24, compared with placebo-treated patients. Treatment with Cimzia also resulted in improvement in skin manifestations in patients with PsA.]

• Active ankylosing spondylitis (AS) when the member meets ONE of the following:
  • Member has tried and had an inadequate response to two different non-steroidal anti-inflammatory drugs (NSAIDs) used in the treatment of AS for at least a 4-week total trial or member has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL NSAIDs used in the treatment of ankylosing spondylitis OR
  • Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of AS

[INFORMATIONAL NOTE: FDA approval of Cimzia for active ankylosing spondylitis was based on data from RAPIDaxSpA, a phase 3 multicenter, randomized, double-blind, placebo-controlled study (AS-1), designed to evaluate the safety and efficacy of certolizumab pegol after 24 weeks in 325 patients >18 years of age with adult-onset active axial spondyloarthritis for at least 3 months. The majority of patients in the study had active AS. Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >4, and spinal pain >4 on a 0-10 Numerical Rating Scale (NRS). Patients must have been intolerant to or had an inadequate response to at least one NSAID. Patients were treated with a loading dose of Cimzia 400mg at Weeks 0, 2, and 4 (for both treatment arms) or placebo followed by either 200mg of Cimizia every 2 weeks or 400mg of Cimzia every 4 weeks or placebo. Concomitant NSAIDs were received by 91% of the AS patients. Patients were evaluated for Assessment of SpondyloArthritis international Society 20 (ASAS20) response at Week 12. Secondary outcomes included change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Bath Ankylosing Spondylitis Metrology Index (BASMI) linear.

At Week 12, a greater proportion of AS patients treated with Cimzia 200mg every 2 weeks or 400mg every 4 weeks achieved ASAS20 response compared to AS patients treated with placebo (57%, 64%, and 37%, respectively; p≤0.004). At week 24, combined Cimzia arms showed significant ( p<0.001) differences in change from baseline versus placebo in BASFI (−2.28 vs −0.40), BASDAI (−3.05 vs −1.05), and BASMI (−0.52 vs −0.07). Improvements were observed as early as week 1. The most common infectious AEs were nasopharyngitis (8.8% Cimzia vs 6.5% placebo) and upper respiratory tract infection (4.0% Cimzia vs 2.8% placebo)]

• Member has tried and had an inadequate response to ONE conventional agent (i.e., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PS for at least 3-months or has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of PS; OR
• Member has severe active PS (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); OR
• Member has concomitant severe psoriatic arthritis (PsA) (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive; OR
• Member's medication history indicates use of another biologic immunomodulator agent or Otezla that is FDA labeled or supported by compendia for the treatment of PS
• Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) when ONE of the following are met:
  • Member has tried and had an inadequate response to two different NSAIDs used in the treatment of nr-axSpA for at least a 4-week total trial or member has an intolerance, FDA labeled contraindication, or hypersensitivity to ALL NSAIDs used in the treatment of nr-axSpA; OR
  • Member's medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported by compendia for the treatment of nr-axSpA

• As per the FDA labeled package insert: limited data from the ongoing pregnancy registry on use of Cimzia in pregnant women are not sufficient to inform a risk of major birth defects or other adverse pregnancy outcomes. Data has shown that the placental transfer of Cimzia was negligible in most infants at birth and low in other infants at birth. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. Minimal Cimzia concentrations were observed in breast milk. No serious adverse reactions were noted in the 17 infants in the study.
• BASDAI is a validated diagnostic test that is used to determine the effectiveness of drug therapy for the treatment of Ankylosing Spondylitis. The BASDAI includes the following questions with 0 = none and 10 = very severe
  • How would you describe the overall level of fatigue/tiredness you have experienced
  • How would you describe the overall level of AS neck, back or hip pain you have had
  • How would you describe the overall level of pain/swelling in joints other than neck, back, or hips you have had
  • How would you describe the overall level of discomfort you have had from any areas tender to touch or pressure
  • How would you describe the overall level of morning stiffness you have had from the time you wake up
• ASDAS assesses disease activity in patients with anklylosing spondylitis with back pain severity, duration of morning stiffness, patient global assessment of disease activity, and peripheral pain/swelling]

• Active Crohn’s disease: 400 mg (given as 2 subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every 4 weeks.
• Rheumatoid arthritis: 400 mg (given as 2 subcutaneous injections of 200 mg) initially, and at Weeks 2 and 4, followed by 200 mg every other week for an initial approval period of 3 months. For maintenance dosing, certolizumab pegol (Cimzia) 400 mg every 4 weeks can be considered.
• Active psoriatic arthritis: 400 mg (given as 2 subcutaneous injections of 200 mg) initially, at week 2 and 4, followed by 200 mg every other week. For maintenance dosing, 400 mg every 4 weeks can be considered.
• Active ankylosing spondylitis: 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks.
• Plaque Psoriasis: 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week.
  • Members with body weight ≤ 90 kg, dosing can be given as 400 mg (given as 2 subcutaneous injections of 200 mg each) initially at weeks 2 and 4, followed by 200 mg every other week
• Non-radiographic axial spondyloarthritis: 400 mg (given as 2 subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week or 400 mg every 4 weeks

• Member continues to meet initial review criteria; AND
• Absence of unacceptable toxicity from the drug (e.g.: malignancy, serious infections, sepsis); AND
• Member has shown clinical improvement in signs and symptoms compared to baseline with the requested agent (i.e. slowing of disease progression or decrease in symptom severity and/or frequency; AND
• The requested drug will be administered in an office/outpatient setting by a healthcare professional or home infusion by a home-health nurse and is there is documentation that member will not be self-administering. Documentation must be provided stating the member is unable to self-administer due to one of the following reasons:
  · Member has a history of anaphylaxis to prior therapy with a related pharmacologic or biologic agent despite standard premedication; or
  · Member is unable to successfully self-administer with proper technique due to a motor/dexterity condition; or
  · Member has acute mental status/cognitive changes or physical impairment due to another condition; or
  · Member has in the past demonstrated compliance issues and therefore needs medical supervision to adequately receive the drug; or
  · Member has clinically diagnosed needle phobia (supported by documentation including a psychiatric evaluation) and therefore cannot self-administer; or
  · Member’s age prohibits them to successfully administer the medication and their medications cannot adequately be managed by a caregiver
  

There is no National Coverage Determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for this service. Therefore, Medicare Advantage Products will follow the Horizon Policy.

**Note: Bullet 1 of the policy section referring to Site of Administration for Infusion and Injectable Prescription Medications (Policy #142) does not apply for Medicare Advantage Products.

Medicaid Coverage

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
________________________________________________________________________________________

Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

___________________________________________________________________________________________________________________________

Index:
Certolizumab Pegol (Cimzia)
Cimzia (Certolizumab Pegol)

References:

1. Cimzia (certolizumab pegol) package insert. UCB, Inc. Smyrna, Georgia. September 2019.

2. US Food and Drug Administration. Early Communication About an Ongoing Safety Review of Tumor Necrosis Factor (TNF) Blockers. 2008 June [cited 2008 Jun 5] [1 screen]. Available from: URL: http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm

3. New Drug: Cimzia (certolizumab pegol). Pharmacist’s Letter/Prescriber’s Letter 2008;24(6):240607.

4. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med Jul 19 2007;357(3):228-238.

5. Schreiber S, Khaliq-Kareemi M, Lawrence IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med Jul 19 2007;357(3):239-250.

6. Lichtenstein G, Schreiber S, Sandborn W, Hanauer S, Feagan B. Maintenance of response and remission rates after 18 months of treatment with certolizumab pegol in patients with active Crohn’s disease. Paper presented at: Digestive Disease Weekly; May 19-24, 2007; Washington, DC.

7. Sandborn W, Hanauer S, Rutgeers P, Colombel JF, Schreiber S. Re-induction and maintenance therapy with subcutaneous certolizumab pegol in patients with Crohn’s disease following treatment failure: PRECiSE 2 study. Paper presented at: Digestive Disease Weekly; May 19-24, 2007; Washington, DC.

8. Colombel J, Schreiber S, Hanauer S, Rutgeerts P, Sandborn W. Long-term tolerability of subcutaneous certolizumab pegol in active Crohn’s disease: Results from PRECiSE 3 and 4. Paper presented at: Digestive Disease Weekly; May 19-24, 2007; Washington, DC.

9. Keystone e, Mason D, Combe B. The anti-TNF certolizumab pegol in combination with methotrexate is significantly more effective than methotrexate alone in the treatment of patients with active rheumatoid arthritis: 1 year results from the RAPID 1 study. Paper presented at: American College of Rheumatology; November 7-11, 2007; Boston, MA.

10. Smolen J, Brzezicki J, Mason D, Kavanaugh A. Efficacy and safety of certolizumab pegol in combination with MTX in patients with active RA despite MTX therapy: Results from the RAPID 2 Study. Paper Presented at: European League Against Rheumatism; June 13-16, 2007; Barcelona, Spain.

11. Landewe RB, Strand V, Smolen J, Van der Heijde D. Liquid formulation certolizumab pegol with methotrexate decreases progression of structural joint damage in RA patients: The RAPID 2 Study. Paper presented at: American College of Rheumatology; November 7-11, 2007; Boston MA,

12. Schiff M, Keininger DL, Tahiri-Fitzgerald E. Certolizumab pegol added onto MTX improves physical function and reduces pain in patients with RA who have an incomplete response to MTX: Data from RAPID 2. Paper Presented at: European League Against Rheumatism; June 13-16, 2007; Barcelona, Spain.

13. Strand V, Keininger DL, Tahiri-Fitzgerald E. Certolizumab pegol therapy added to MTX produces clinically meaningful improvements in health-related QoL and relieves fatigue in patients with RA with an incomplete response to MTX: Results from RAPID 2 Study. Paper presented at: European League Against Rheumatism; June 13-16, 2007; Barcelona, Spain.

14. Fleischmann R, Mason D, Cohen S. Efficacy and safety of certolizumab pegol monotherapy in patients with rheumatoid arthritis failing previous DMARD therapy. Paper presented at: European League Against Rheumatism; June 13-16, 2007; Barcelona, Spain.

15. Strand V, Brown M, Purcaru O, Richard L. Certolizumab pegol monotherapy improves productivity in patients with active rheumatoid arthritis: Results from a Phase III, randomized, controlled trial. Paper Presented at: European League Against Rheumatism; June 13-16, 2007; Barcelona, Spain.

16. Fleischmann R, Keininger DL, Tahiri-Fitzgerald E, Mease P. Certolizumab pegol monotherapy 400 mg every 4 weeks improved physical function and reduces pain in patients with rheumatoid arthritis who have previously failed DMARD therapy. Paper presented at: European League Against Rheumatism; June 13-16, 2007; Barcelona, Spain.

17. Strand V, Keininger DL, Tahiri-Fitzgerald E, Fleischmann R. Certolizumab pegol monotherapy 400 mg every 4 weeks improved health-related quality of life and relieves fatigue in patients with rheumatoid arthritis who have previously failed DMARD therapy. Paper presented at: European League Against Rheumatism; June 13-16, 2007; Barcelona, Spain.

18. Strand V, Keininger DL, Tahiri-Fitzgerald E. Certolizumab pegol results in clinically meaningful improvements in physical function and health-related quality of life in patients with active rheumatoid arthritis despite treatment with methotrexate. Paper presented at: American College of Rheumatology; November 7-11, 2007; Boston, MA.

19. Keystone E, van der Heijde D, Mason D, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis. Arthritis & Rheumatism 2008;58(11):3319-3329.

20. Smolen J, Landewé RB, Mease P, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomized controlled trial. Ann Rheum Dis 2009:68:797-804.

21. Fleischmann R, Vencovsky J, van Vollenhoven RF, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis 2009;68:805-811.

22. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology. 2008 Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis. Arthritis & Rheumatism 2008 June;59(6):762-784.

23. ClinicalTrials.gov. Certolizumab pegol in subjects with adult onset active and progressive psoriatic arthritis. Available from: http://clinicaltrials.gov/ct2/show/NCT01087788?term=cimzia&rank=31

24. ClinicalTrials.gov. Certolizumab pegol in subjects with active axial spondyloarthritis. Available from: http://clinicaltrials.gov/ct2/show/NCT01087762?term=cimzia&rank=8

25. Gary R. Lichtenstein , MD , Stephen B. Hanauer , MD, William J. Sandborn , MD and The Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn’s Disease in Adults. Am J Gastroenterol advance online publication, 6 January 2009.

26. Altaha D, Neogi T, Silman A, et al. 2010 Rheumatoid Arthritis Classification Criteria. Arthritis and Rheumatism 2010;62(9):2569-2581.

27. MICROMEDEX® 2.0 (Healthcare Series). DRUGDEX® Evaluations. certolizumab. Available at: http://www.thomsonhc.com. Accessed March 04, 2015.

28. Singh JA, Furst DE, Bharat A, et al. 2012 Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2012 May;64(5):625-39.

29. Anderson J, Caplan L, Yazdany J, et al. Rheumatoid Arthritis Disease Activity Measures: American College of Rheumatology Recommendations for Use in Clinical Practice. Arthritis Care Res, 2012 May;64(5):640-47.

30. Mease PJ, Fleischmann R, Deodhar AA et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis 2013 Aug 28;0:1-8.

31. R Landewé, J Braun, A Deodhar, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-bling randomized placebo-controlled Phase 3 study. Ann Rheum Dis. 2013 Sep 6. doi: 10.1136/annrheumdis-2013-204231. [Epub ahead of print].

32. Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.

33. Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008 May;58(5):826-50.

34. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, Van Voorhees AS, Elmets CA, Leonardi CL, Beutner KR, Bhushan R, Menter A. Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologics. J Am Acad Dermatol 2008 May;58(5):851-64.

35. Clinical Pharmacology [database online]. Certolizumab pegol. Updated May 29, 2018. Accessed June 26, 2018.

36. Certolizumab pegol. In: McEvoy GK, editor. AHFS: Drug Information (2015). Bethesda, MD:

American Society of Health-System Pharmacists; 2015. Updated June 11, 2014. Accessed March 09, 2015. http://online.statref.com/Document.aspx?fxId=1&docId=1565

42. Garret S. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activitiy Index. J Rheumatol. 1994 Dec;21(12):2286-91.

43. Singh JA, Guyatt G, Ogdie A, et al. “2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis.” Arthritis &amp; Rheumatology, vol. 71, no. 1, 2018, pp. 5–32., doi:10.1002/art.40726.

44. Clinical Pharmacology. Cimzia. Available at https://www.clinicalkey.com/pharmacology/monograph/3473?sec=monindi&n=Cimzia. Accessed 05/30/2019

45. National Institute for Health and Care Excellence. NICE 2017. Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs. Published 24 May 2017. Technology Appraisal Guidance [TA445]. https://www.nice.org.uk/guidance/TA445/chapter/1-Recommendations. Accessed June 2019.

46. Ward MM, Guthri LC, Alba MI. Rheumatoid Arthritis Response Criteria And Patient-Reported Improvement in Arthritis Activity: Is an ACR20 Response Meaningful to Patients”. Arthritis Rheumatol. 2014 Sep; 66(9): 2339–2343. doi: 10.1002/art.38705

45. Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019 October; 71(10): 1599-1613.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS
J0717


* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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