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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 10/01/2010 Title: Cimzia (Certolizumabpegol)
Revision Date: 02/01/2019 Document: BI275:00
CPT Code(s): J0717
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Cimzia is used to treat severe Rheumatoid Arthritis, Crohn’s disease, ankylosing spondylitis, psoriasis, and psoriatic arthritis.

2)    Cimzia requires pre-authorization.

3)    Cimzia is a specialty drug and must be obtained through the contracted specialty pharmacy.


Medical Statement

For all covered conditions, Cimzia will be covered only when member does not have active infection and has been tested for tuberculosis.

1.    Crohn’s Disease          
Certolizumab Pegol (Cimzia®) is considered medically necessary for members 18 years of age or older with moderately-to-severely active Crohn`s disease as manifested by any of the following signs/symptoms:

a)    Diarrhea;

b)    Abdominal pain;

c)    Bleeding;

d)    Weight loss;

e)    Perianal disease;

f)     Internal fistulae;

g)    Intestinal obstruction;

h)   Megacolon;

i)     Extra-intestinal manifestations: arthritis or spondylitis; and

2.    Rheumatoid Arthritis

For adults 18 years of age or older with moderately to severely active rheumatoid arthritis (at least 6 swollen and tender joints, at least 45 minutes of morning stiffness, and elevated ESR or CRP unless patient on corticosteroids)

3.    Ankylosing Spondylitis

For adults 18 years of age or older with active ankylosing spondylitis   AND

4.    Psoriatic Arthritis

a)    For adults 18 years of age or older with active psoriatic arthritis AND

b)    At least 3 swollen and tender joints

5.    Psoriasis

a)    For adults 18 years of age or older with moderate-to-severe plaque psoriasis AND

b)   Plaque psoriasis has been present for more than 1 year AND

c)    Ten percent or more body surface area (BSA) is affected by plaque psoriasis AND

d)   Members has a history of failure of at least a 3-month trial of, contraindication, or intolerance to ALL of the following:

1.    Topical therapy with corticosteroids, Vitamin D analogs (e.g. calcitriol, calcipotriene), calcineurin inihibtor (e.g. tacrolimus, pimecrolimus), or salicylic acid combination product AND

2.    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 BI 029 for additional information regarding UV light therapy) This requirement may be waived in any of the following situations: a) history or presence of melanoma or other skin cancer, lupus erythematosus, or xeroderma pigmentosum, b) psoriasis involving areas around the eye where eye protection may cause blockage of phototherapy to affected area, c) documented systemic disease involving the joints (meeting specific criteria for psoriatic arthritis), or 4) very severe plaque thickness or scaling (4 on a scale of 0 to 4) AND

3.    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: a) member has chronic hepatic disease, b) member has acquired immunodeficiency syndrome (AIDS), c) member is pregnant or breast-feeding, or d) member has anemia, neutropenia, or thrombocytopenia

 

Codes Used In This BI:

J0718             Injection Certolizumab Pegol, 1mg (code deleted 1-1-14)

J0717             Injection Certolizumab Pegol, 1mg


Limits

Cimzia is considered experimental/Investigative for all other uses.

Because there are no studies supporting concomitant therapy with any two biologics, and because combinations have resulted in increases in serious infections, only one biologic will be covered at a time.


Background

Certolizumab pegol (Cimzia®) (UCB, Inc., Smyrna, GA) is the first PEGylated anti- tumor necrosis factor (TNF)-alpha monoclonal antibody that has a high affinity for human TNF-alpha and selectively targets TNF-alpha in inflamed tissue.  Excess TNF-alpha production has been implicated in a wide variety of diseases, including Crohn`s disease, rheumatoid arthritis and other autoimmune diseases.

In April 2008, the U.S. Food and Drug Administration (FDA) approved Certolizumab pegol for adults with moderately-to-severely active Crohn`s disease who have not responded to conventional therapies. The approval of Certolizumab pegol was based on safety and efficacy data from clinical trials in more than 1,500 patients with Crohn`s disease.

The PEGylated Antibody Fragment Evaluation in Crohn`s Disease: Safety and Efficacy (Precise) program enrolled more than 1,300 patients in 4 trials and evaluated the safety and efficacy of Certolizumab pegol. The Precise 1 and Precise 2 studies were 26-week trials that evaluated induction and short-term maintenance of remission. Outcome data from the Precise 3 and Precise 4 studies, designed to evaluate long-term maintenance of remission, have not yet been published.

The Precise 1 trial, a placebo-controlled phase IIII study, stratified patients (n = 662) according to baseline levels of C-reactive protein (CRP).  Patients were randomly assigned to receive either 400 mg of Certolizumab pegol or placebo subcutaneously at weeks 0, 2, and 4 and then every 4 weeks.  Primary endpoints were the induction of a response at week 6 and a response at both weeks 6 and 26.  Among patients with a baseline CRP level of at least 10 mg per liter, 37% of patients in the Certolizumab group had a response at week 6, as compared with 26% in the placebo group.  At both weeks 6 and 26, the corresponding values were 22% and 12%, respectively.  In the overall population, response rates at week 6 were 35% in the Certolizumab group and 27% in the placebo group; at both weeks 6 and 26, the response rates were 23% and 16%, respectively.  At weeks 6 and 26, the rates of remission in the two groups did not differ significantly.  Serious adverse events were reported in 10% of patients in the Certolizumab group and 7% of those in the placebo group; serious infections were reported in 2% and less than 1%, respectively.  In the Certolizumab group, antibodies to the drug developed in 8% of patients, and antinuclear antibodies developed in 2%. The authors concluded that in patients with moderate-to-severe Crohn`s disease, induction and maintenance therapy with Certolizumab pegol was associated with a modest improvement in response rates, as compared with placebo, but with no significant improvement in remission rates (Sandborn, et al., 2007).

The Precise 2 trial, a placebo-controlled study, evaluated the efficacy of Certolizumab pegol maintenance therapy in adults (n = 668) with moderate-to-severe Crohn`s disease.  Certolizumab pegol (400 mg) was administered subcutaneously at weeks 0, 2, and 4 as induction therapy.  Patients with a clinical response (defined as reduction of at least 100 from the baseline score on the Crohn`s Disease Activity Index [CDAI]) at week 6 were stratified according to their baseline CRP level and were randomly assigned to receive 400 mg of Certolizumab pegol or placebo every 4 weeks through week 24, with follow-up through week 26.  Among patients with a response to induction therapy at week 6 (n= 428 or 64%), the response was maintained through week 26 in 62% of patients with a baseline CRP level of at least 10 mg per liter (the primary endpoint) who were receiving Certolizumab pegol (versus 34% of those receiving placebo) and in 63% of patients in the intention-to-treat population who were receiving Certolizumab pegol (versus 36% receiving placebo).  Among patients with a response to induction therapy at week 6, remission (defined by a CDAI score of 150) at week 26 was achieved in 48% of patients in the Certolizumab group and 29% of those in the placebo group. The use of immunosuppressant’s, corticosteroids, and previous treatment with infliximab were not demonstrated to affect the response rate.  Serious infections, including one case of pulmonary tuberculosis, occurred in 3% of patients receiving Certolizumab pegol and in less than 1% of patients receiving placebo.  Antinuclear antibodies developed in 8% of the patients in the Certolizumab group; antibodies against Certolizumab pegol developed in 9% of all patients who entered the induction phase. The authors concluded that patients with moderate-to-severe Crohn`s disease who had a response to induction therapy with 400 mg of Certolizumab pegol were more likely to have a maintained response and a remission at 26 weeks with continued Certolizumab pegol treatment than with a switch to placebo.

Certolizumab pegol was approved by the FDA on April 24, 2009 for adults with moderately-to-severely active rheumatoid arthritis (RA).  It can be administered as combination therapy with methotrexate (MTX) or as monotherapy.  The recommended dose for patients with moderately-to-severely active RA is 400 mg initially and at weeks 2 and 4, followed by 200 mg every other week.  For maintenance dosing, 400 mg every 4 weeks can be considered.  It is self-administer by subcutaneous injection.  According to the prescribing information, Certolizumab pegol should not be used in combination with biological disease-modifying Antirehumatic drugs (DMARDs) or other TNF blocker therapies.

The FDA approval is based on data from 4 multi-center placebo-controlled phase III trials, involving more than 2,300 patients aged 18 years or older with moderately-to-severely active RA.  Patients who received Certolizumab pegol together with MTX, experienced a significant reduction in the signs and symptoms of RA at week 24 with some showing clinical responses within 1 to 2 weeks, compared with MTX alone.  Additionally, radiographic data showed Certolizumab pegol, together with MTX, inhibited progression of joint damage, with a significantly smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared with MTX alone (p < 0.001).

Keystone, et al. (2008) evaluated the safety and efficacy of 2 dosage regimens of Certolizumab pegol as adjunctive therapy to MTX in patients with active RA who had an inadequate response to MTX therapy alone.  In this 52-week, phase III, multi-center, randomized, double-blind, placebo-controlled, parallel-group trial, 982 patients were randomized 2:2:1 to receive treatment with 400 mg of Certolizumab pegol as an initial dosage and at weeks 2 and 4, with a subsequent dosage of 200 mg or 400 mg given every 2 weeks, plus MTX, or placebo plus MTX.  Co-primary endpoints were the response rate at week 24 according to the American College of Rheumatology 20% criteria for improvement (ACR20) and the mean change from baseline in the modified TSS at week 52.  At week 24, ACR20 response rates using non-responder imputation for the Certolizumab pegol 200-mg and 400-mg groups were 58.8% and 60.8%, respectively, as compared with 13.6% for the placebo group.  Differences in ACR20 response rates versus placebo were significant at week 1 and were sustained to week 52 (p < 0.001).  At week 52, mean radiographic progression from baseline was reduced in patients treated with 200 mg of Certolizumab pegol (0.4 Sharp units) or 400 mg (0.2 Sharp units) as compared with that in placebo-treated patients (2.8 Sharp units) (p < 0.001 by rank analysis).  Improvements in all ACR core set of disease activity measures, including physical function, were observed by week 1 with both Certolizumab pegol dosage regimens.  Most adverse events were mild or moderate.  The authors concluded that 200 mg or 400 mg of Certolizumab pegol plus MTX resulted in a rapid and sustained reduction in RA signs and symptoms, inhibited the progression of structural joint damage, and improved physical function as compared with placebo plus MTX treatment in RA patients with an incomplete response to MTX.


Reference

1)    American College of Rheumatology; Model Biologics Policy 2010.

2)    Singh AJ, Furst DA, Bharat A, et al.  2012 Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirehumatic Drugs and Biologic Agents in the Treatment of Rheumatoid Arthritis.  Arthritis Care & research. 2012; 64(5):625-639.

3)    U.S. Food and Drug Administration (FDA). FDA approves Cimzia to treat Crohn`s disease. FDA News. Rockville, MD; April 22, 2008. Available at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html. Accessed May 20, 2008.

4)    Choy EH, Hazleman B, Smith M, et al. Efficacy of a novel PEGylated humanized anti-TNF fragment (CDP870) in patients with rheumatoid arthritis: A phase II double-blinded, randomized, dose-escalating trial. Rheumatology (Oxford). 2002; 41(10):1133-1137.

5)    National Horizon Scanning Centre (NHSC). Certolizumab pegol for moderate to severe Crohn`s disease - horizon scanning review. Birmingham, UK: NHSC; 2004.

6)    National Horizon Scanning Centre (NHSC). Certolizumab pegol (Cimzia) for rheumatoid arthritis - horizon scanning review. Birmingham, UK: NHSC; 2005.

7)    Schreiber S, Rutgeerts P, Fedorak RN, et al; CDP870 Crohn`s Disease Study Group. A randomized, placebo-controlled trial of Certolizumab pegol (CDP870) for treatment of Crohn`s disease. Gastroenterology. 2005; 129(3):807-818.

8)    Sandborn WJ, Feagan BG, Stoinov S, et al; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn`s disease. N Engl J Med. 2007; 357(3):228-238.

9)    Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al; PRECISE 2 Study Investigators. Maintenance therapy with Certolizumab pegol for Crohn`s disease. N Engl J Med. 2007; 357(3):239-250.

10)   Behm BW, Bickston SJ. Tumor necrosis factor-alpha antibody for maintenance of remission in Crohn`s disease. Cochrane Database Syst Rev. 2008 ;( 1):CD006893.

11)   Rutgeerts P, Schreiber S, Feagan B, et al; CDP870 Crohn`s Disease Study Group. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn`s disease. Int J Colorectal Dis. 2008; 23(3):289-296.

12)   Keystone E, Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: Findings of a fifty-two-week phase III, multicenter, randomized double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008; 58(11):3319-3329.

13)   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(6):797-804.

14)   Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, et al. Efficacy and safety of Certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying Antirehumatic therapy: The FAST4WARD study. Ann Rheum Dis. 2009; 68(6):805-811.

15)   Cimzia Product Information. UCB, Inc. June 2018.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.