Last Review Date: 10/03/2023

Date of Origin:  11/28/2011

Dates Reviewed:  12/2011, 11/2012, 11/2013, 12/2013, 08/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 12/2017, 03/2018, 06/2018, 07/2018, 10/2018, 05/2019, 10/2019, 10/2020, 10/2022, 10/2023

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed, unless otherwise specified.

• Therapy for the Management of Immunotherapy-Related Toxicity may not be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Loading Dose

• Cimzia 200 mg single-dose vial lyophilized powder for reconstitution: 6 vials first 29 days
• Cimzia 200 mg single-dose prefilled syringe starter kit: 6 syringes first 29 days

• Maintenance Dosing

• Cimzia 200 mg single-dose vial lyophilized powder for reconstitution: 2 vials every 14 days
• Cimzia 200 mg single-dose prefilled syringes: 2 syringes every 14 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• Management of Immune-Checkpoint Inhibitor Related Toxicity
  • 400 billable units x 1 dose
• Plaque Psoriasis (PsO)
  • 400 billable units every other week
• All Other Indications
  • Loading Dose
    • 400 billable units on weeks 0, 2 and 4
  • Maintenance Dose
    • 400 billable units every 4 weeks

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND
• Patient has been evaluated and screened for the presence of hepatitis B virus (HBV) prior to initiating treatment; AND
• Physician has assessed baseline disease severity utilizing an objective measure/tool; AND

Universal Criteria ¹

• Patient has been evaluated and screened for the presence of latent TB (tuberculosis) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
• Patient does not have an active infection, including clinically important localized infections; AND
• Patient will not receive live vaccines during therapy; AND

• Patient is not on concurrent treatment with another TNF-inhibitor, IL-inhibitor, biologic response modifier or other non-biologic agent (e.g., apremilast, tofacitinib, baricitinib, upadacitinib, abrocitinib, deucravacitinib, etc.); AND

Rheumatoid Arthritis (RA) † ^1,30,33

• Documented moderate to severe active disease; AND
• Patient has had at least a 3-month trial and failed previous therapy with ONE oral disease modifying anti-rheumatic drug (DMARD) such as methotrexate, azathioprine, auranofin, hydroxychloroquine, penicillamine, sulfasalazine, leflunomide, etc.; AND
• Prescribed in combination with methotrexate unless contraindicated

Crohn’s Disease (CD) † ^1,8,20,34

• Documented moderate to severe active disease; AND
• Documented failure, contraindication, or ineffective response at maximum tolerated doses to a minimum 3-month trial of corticosteroids or immunomodulators (e.g. azathioprine, 6-mercaptopurine, or methotrexate)

Psoriatic Arthritis (PsA) † ^{1,26,31,35,45}

• Documented moderate to severe active disease; AND

• For patients with predominantly axial disease, a trial and failure of at least a 4-week trial of ONE non-steroidal anti-inflammatory agent (NSAID), unless use is contraindicated; OR
• For patients with peripheral arthritis, dactylitis, OR active enthesitis, a trial and failure of at least a 3-month trial of ONE oral disease-modifying anti-rheumatic drug (DMARD) such as methotrexate, azathioprine, sulfasalazine, hydroxychloroquine, etc.

Ankylosing Spondylitis (AS) † ^1,13,25,46

• Documented active disease; AND
• Patient had an adequate trial and failure of at least TWO non-steroidal anti-inflammatory drugs (NSAIDs) over 4 weeks (in total), unless use is contraindicated

Non-radiographic Axial Spondyloarthritis (nr-axSpA) † ^1,9,25,46

• Patient has objective signs of inflammation noted by an elevation of C-reactive protein (CRP) above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging (MRI); AND
• Patient is without definitive radiographic evidence of structural damage on sacroiliac joints; AND
• Documented active disease; AND
• Patient had an adequate trial and failure of at least TWO non-steroidal anti-inflammatory drug (NSAIDs), unless use is contraindicated

Plaque Psoriasis (PsO) † ^{1,27-29,32,36,37,44}

• Documented moderate to severe plaque psoriasis for at least 6 months with at least one of the following:

• Involvement of at least 3% of body surface area (BSA); OR
• Psoriasis Area and Severity Index (PASI) score of 10 or greater; OR
• Incapacitation or serious emotional consequences due to plaque location (e.g., hands, feet, head and neck, genitalia, etc.) or with intractable pruritis; AND

• Patient did not respond adequately (or is not a candidate) to a 4-week minimum trial of topical agents (i.e., anthralin, coal tar preparations, corticosteroids, emollients, immunosuppressives, keratolytics, tapinarof, roflumilast, retinoic acid derivatives, and/or vitamin D analogues); AND
• Patient did not respond adequately (or is not a candidate) to a 3-month minimum trial of at least ONE non-biologic systemic agent (i.e., immunosuppressives, retinoic acid derivatives, and/or methotrexate); AND
• Patient did not respond adequately (or is not a candidate*) to a 3-month minimum trial of phototherapy (i.e., psoralens with UVA light [PUVA] or UVB with coal tar or dithranol)

Note: Patients with body weight ≤ 90 kg should initiate therapy at the lower dosing regimen of 200 mg every other week plus loading doses.

Management of Immune Checkpoint Inhibitor-Related Toxicities ‡ ^47,48

• Patient has been receiving therapy with an immune checkpoint inhibitor (e.g., nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab, ipilimumab, tremelimumab, dostarlimab, etc.); AND
• Patient has moderate or severe immunotherapy-related inflammatory arthritis; AND
• Used as additional disease modifying antirheumatic drug (DMARD) therapy; AND
• Patient’s symptoms have not improved after holding immunotherapy AND one of the following:

• Patient has not responded to oral corticosteroids; OR
• Patient is unable to taper corticosteroids; OR
• Patient has not had response to conventional synthetic (cs) DMARDs (i.e., methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine)

† FDA Approved Indication(s); ‡ Compendium Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage can be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe hypersensitivity reactions, serious infection, heart failure, lupus-like syndrome, demyelinating disease, cytopenias, development of malignancies, hepatitis B reactivation, etc.; AND

Rheumatoid Arthritis ^1,17-19

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts, reduction of C-reactive protein, improvement of patient global assessment, and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Disease Activity Score-28 (DAS28) of 1.2 points or more or a ≥20% improvement on the American College of Rheumatology-20 (ACR20) criteria].

Crohn’s Disease ^1,19

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as endoscopic activity, number of liquid stools, presence and severity of abdominal pain, presence of abdominal mass, body weight compared to IBW, hematocrit, presence of extra intestinal complications, use of anti-diarrheal drugs, tapering of corticosteroids or discontinuation of corticosteroid therapy, and/or an improvement on a disease activity scoring tool [e.g. an improvement on the Crohn’s Disease Activity Index (CDAI) score or the Harvey-Bradshaw Index score]. 

Psoriatic Arthritis ^1,15,45

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as the number of tender and swollen joint counts and/or an improvement on a disease activity scoring tool [e.g. defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria].

Ankylosing Spondylitis ^1,13,42,46

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, morning stiffness, and/or an improvement on a disease activity scoring tool [e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS) or an improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)].

Non-radiographic Axial Spondyloarthritis ^1,39,46

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as total back pain, physical function, reduction of C-reactive protein, and/or an improvement on a disease activity scoring tool [e.g. ≥ 1.1 improvement on the Ankylosing Spondylitis Disease Activity Score (ASDAS), achievement of an ASDAS-Major Improvement (ASDAS-MI e.g. improvement of ≥ 2.0 is the ASDAS and/or reaching the lowest possible ASDAS),  improvement of ≥ 2 on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)), improvement of the Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) score from baseline, or an ASAS40 response (defined as a ≥40% improvement and an absolute improvement from baseline of ≥2 units in ≥3 of 4 domains without any worsening in the remaining domain)].

Plaque Psoriasis ^{1,22,32,36-38,44}

• Disease response as indicated by improvement in signs and symptoms compared to baseline such as redness, thickness, scaliness, and/or the amount of surface area involvement (a total BSA involvement ≤1%), and/or an improvement on a disease activity scoring tool [e.g. a 75% reduction in the PASI score from when treatment started (PASI 75) or a 50% reduction in the PASI score (PASI 50) and a four-point reduction in the DLQI from when treatment started]; AND
• Dose escalation (up to the maximum dose and frequency specified below) may occur upon clinical review on a case by case basis provided that the patient has:
  • Shown an initial response to therapy; AND
  • Received the three loading doses at the dose and interval specified below; AND
  • Received a minimum of one maintenance dose at the dose and interval specified below; AND
  • Responded to therapy (by treatment week 6) with subsequent loss of response

Management of Immunotherapy-Related Toxicity ^47,48

4. • May not be renewed
5. Dosage/Administration ¹

   Indication	Dose
   Rheumatoid Arthritis (RA)	Loading 400 mg, subcutaneously, at weeks 0, 2 and 4; then Maintenance 200 mg subcutaneously, every other week, thereafter (or 400 mg every 4 weeks)
   Crohn’s Disease (CD)	Loading 400 mg, subcutaneously, at weeks 0, 2 and 4; then Maintenance 400 mg, subcutaneously, every 4 weeks, thereafter
   Psoriatic Arthritis (PsA)	Loading 400 mg, subcutaneously, at weeks 0, 2 and 4; then Maintenance 200 mg, subcutaneously, every other week, thereafter (or 400 mg every 4 weeks)
   Plaque Psoriasis (PsO)	400 mg, subcutaneously, every other week Optional alternate dosing for patients with body weight  ≤ 90 kg Loading: 400 mg, subcutaneously, at weeks 0, 2 and 4 Maintenance: 200 mg, subcutaneously, every other week thereafter
   Ankylosing Spondylitis (AS)	Loading 400 mg, subcutaneously, at weeks 0, 2 and 4; then Maintenance 200 mg, subcutaneously, every other week, thereafter (or 400 mg every 4 weeks)
   Non-radiographic Axial Spondyloarthritis (nr-AxSpa)	Loading 400 mg, subcutaneously, at weeks 0, 2 and 4; then Maintenance 200 mg, subcutaneously, every other week, thereafter (or 400 mg every 4 weeks)
   Management of Immunotherapy-Related Toxicity	Up to 400 mg subcutaneously x 1 dose
   *Note:  400 mg doses are given as 2 subcutaneous injections of 200 mg each

6. Billing Code/Availability Information

HCPCS Code:

• J0717* – Injection, certolizumab pegol, 1 mg; 1 billable unit = 1mg

* Code may be used for medicare when drug is administered under the direct supervision of a physician; not to be used when drug is self-administered

NDC(s):

• Cimzia 200mg single-dose vials, lyophilized powder for reconstitution (carton of 2): 50474-0700-xx
• Cimzia 200 mg/mL single-dose prefilled syringes (carton of 2): 50474-0710-xx
• Cimzia 200 mg/mL single-dose prefilled syringe starter kit (carton of 6): 50474-0710-xx

7. References

1. Cimzia [package insert]. Smyrna, GA; UCB, Inc; December 2022; Accessed September 2023.
2. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab Pegol for the Treatment of Crohn’s Disease (PRECISE 1). NEJM 2007; 357:228-38.
3. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al; PRECISE 2 Study Investigators. Maintenance therapy with certolizumab pegol for Crohn’s disease. NEJM 2007 July 19; 357(3):239-50.
4. 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 Nov; 58(11):3319-29.
5. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov 6. Doi: 10.1002/acr.22783.
6. Gottlieb A, Korman NJ, Gordon KB, et al. 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.
7. Gossec L, Smolen JS, Ramiro S, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2015 Dec 7. Pii: annrheumdis-2015-208337. Doi: 10.1136/annrheumdis-2015-208337.
8. Terdiman JP, Gruss CB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute guideline on the use of thiopurines, methotrexate, and anti-TNF-α biologic drugs for the induction and maintenance of remission in inflammatory Crohn’s disease. Gastroenterology. 2013 Dec; 145(6):1459-63. Doi: 10.1053/j.gastro.2013.10.047.
9. Ward MM, Deodhar, A, Akl, EA, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2015 Sep 24. Doi: 10.1002/art.39298.
10. Lichtenstein GR, Hanauer SB, Sandborn WJ, Practice Parameters Committee of American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009; 104(2):465.
11. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017 Mar 6. Pii: annrheumdis-2016-210715.
12. Ramiro S, Smolen JS, Landewé R, et al. Pharmacological treatment of psoriatic arthritis: a systematic literature review for the 2015 update of the EULAR recommendations for the management of psoriatic arthritis.  Ann Rheum Dis 2016;75:490-498 doi:10.1136/annrheumdis-2015-208466​
13. Van Der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis.  Ann Rheum Dis doi:10.1136/annrheumdis-2016-210770
14. National Institute for Health and Care Excellence. NICE 2016. Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor. Published 26 Oct 2016. Technology Appraisal Guidance [TA415]. https://www.nice.org.uk/guidance/ta415/chapter/1-Recommendations. Accessed September 2023.
15. 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. Accessed September 2023.
16. National Institute for Health and Care Excellence. NICE 2018. Rheumatoid Arthritis in Adults: Management. Published 11 July 2018. Last updated 12 October 2020. NICE Guideline [NG100]. https://www.nice.org.uk/guidance/ng100. Accessed September 2023.
17. National Institute for Health and Care Excellence. NICE 2010. Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after failure of a TNF inhibitor. Published 25 August 2010. Technology appraisal guidance [TA195]. https://www.nice.org.uk/guidance/ta195. Accessed September 2023.
18. 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
19. National Institute for Health and Care Excellence. NICE 2019. Crohn’s Disease: Management. Published 03 May 2019. NICE Guideline [NG129]. https://www.nice.org.uk/guidance/ng129. Accessed September 2023.
20. Lichtenstein GR, Loftus EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol 2018; 113:481–517; doi: 10.1038/ajg.2018.27
21. National Institute for Health and Care Excellence. NICE 2008. Infliximab for the treatment of adults with psoriasis. Published 23 January 2008. Technology Appraisal Guidance [TA134]. https://www.nice.org.uk/guidance/ta134/resources/infliximab-for-the-treatment-of-adults-with-psoriasis-pdf-82598193811141.
22. Smith CH, Jabbar-Lopez ZK, Yiu ZK, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2017. Br J Dermatol. 2017 Sep;177(3):628-636. Doi: 10.1111/bjd.15665.
23. Felson DT, Smolen JS, Wells G, et al. American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical Trials, Arthritis and Rheumatism. 2011 Mar; 63(3): 573–586.
24. Singh J, Reston J, Gladman D, et al. American College of Rheumatology (ACR) and National Psoriasis Foundation (NPF) Psoriatic Arthritis Guideline. 2016 Nov; https://www.rheumatology.org/Portals/0/Files/ACR-NPF%20Psoriatic%20Arthritis%20Guideline%20Project%20Plan.pdf
25. Ward M, Deodhar A, Gensler LS, et al. 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Nonradiographic Axial Spondyloarthritis. Arthritis Rheumatol. 2019;71(10):1599-1613. Doi:10.1002/art.41042.
26. Singh JA, Guyatt G, Ogdie A, et al. 2018 American College of Rheumatology/National Psoriasis Foundation Guideline for the Treatment of Psoriatic Arthritis. Arthritis Rheumatol. 2019 Jan;71(1):5-32. Doi: 10.1002/art.40726.
27. Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol.  2019 Feb 13. Pii: S0190-9622(18)33001-9.  https://doi.org/10.1016/j.jaad.2018.11.057.
28. Richard EG. (2022). Psoralen plus ultraviolet A (PUVA) photochemotherapy. In Elmets CA, Corona R (Eds.), UptoDate. Last updated: Dec 01, 2022. Accessed on Sept 11, 2023. Available from https://www.uptodate.com/contents/psoralen-plus-ultraviolet-a-puva-photochemotherapy?search=Psoralen%20plus%20ultraviolet%20A%20(PUVA)%20photochemotherapy&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.
29. Hönigsman H. (2023). UVB therapy (broadband and narrowband). In Elmets CA, Corona R (Eds.), UptoDate. Last updated: Jan 18, 2023. Accessed on Sept 11, 2023. Available from https://www.uptodate.com/contents/uvb-therapy-broadband-and-narrowband?search=UVB%20therapy%20(broadband%20and%20narrowband).%20&source=search_result&selectedTitle=1~80&usage_type=default&display_rank=1.
30. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Rheumatol. 2021 Jul;73(7):1108-1123. Doi: 10.1002/art.41752.
31. Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):700-712. Doi: 10.1136/annrheumdis-2020-217159.
32. National Institute for Health and Care Excellence. NICE 2013. Psoriasis. Published 06 August 2013. Quality standard [QS40]. https://www.nice.org.uk/guidance/qs40. Accessed September 2023.
33. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Annals of the Rheumatic Diseases 2020;79:685-699.
34. Torres J, Bonovas S, Doherty G, et al. European Crohn’s and Colitis Organisation [ECCO] Guidelines on Therapeutics in Crohn’s Disease: Medical Treatment. Journal of Crohn’s and Colitis, 2020, 4–22 doi:10.1093/ecco-jcc/jjz180.
35. American Academy of Dermatology Work Group. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011 Jul;65(1):137-74.
36. Smith CH, Yiu ZZN, Bale T, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020 Oct;183(4):628-637. Doi: 10.1111/bjd.19039.
37. National Institute for Health and Care Excellence. NICE 2017. Psoriasis: assessment and management. Published 24 October 2012. Clinical guideline [CG153]. https://www.nice.org.uk/guidance/CG153. Accessed September 2023.
38. Armstrong AW, Siegel MP, Bagel J, et al.  From the Medical Board of the National Psoriasis Foundation: Treatment targets for plaque psoriasis.  J Am Acad Dermatol. 2017 Feb; 76(2):290-298.  Doi:  10.1016/j.jaad.2016.10.017.
39. Deodhar A, Blanco R, Dokoupilová E, et al. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. Doi: 10.1002/art.41477.
40. Gordon KB, Warren RB, Gottlieb AB, et al. Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). Br J Dermatol. 2021 Apr;184(4):652-662. Doi: 10.1111/bjd.19393.
41. Warren RB, Lebwohl M, Sofen H, et al. Three-year efficacy and safety of certolizumab pegol for the treatment of plaque psoriasis: results from the randomized phase 3 CIMPACT trial. J Eur Acad Dermatol Venereol. 2021 Dec;35(12):2398-2408. Doi: 10.1111/jdv.17486.
42. National Institute for Health and Care Excellence (NICE). Spondyloarthritis. Quality standard [QS170]. Published: 28 June 2018 https://www.nice.org.uk/guidance/qs170/chapter/Quality-statements. Accessed September 2023.
43. Elmets CA, Lim HW, Stoff B, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis with phototherapy. J Am Acad Dermatol. 2019 Sep;81(3):775-804. Doi: 10.1016/j.jaad.2019.04.042.
44. Elmets CA, Korman NL, Prater EF, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with topical therapy and alternative medicine modalities for psoriasis severity measures. J Am Acad Dermatol 2021 Feb; 84(2):432-470. Doi: 10.1016/j.jaad.2020.07.087
45. Tucker L, Allen A, Chandler D, et al. The 2022 British Society for Rheumatology guideline for the treatment of psoriatic arthritis with biologic and targeted synthetic DMARDs. Rheum 2022 Sept; 61(9): e255–e266. Doi: 10.1093/rheumatology/keac295
46. Ramiro S, Nikiphorou E, Sepriano A, et al. ASAS-EULAR recommendations for the management of axial spondyloarthritis: 2022 update. Ann Rheum Dis. 2023 Jan; 82(1):19–34. doi:10.1136/ard-2022-223296
47. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) certolizumab pegol. National Comprehensive Cancer Network, 2023. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed September 2023.
48. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Management of Immunotherapy-Related Toxicities. Version 2.2023. National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed September 2023.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A