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Asset Publisher
Cosentyx® (secukinumab)
Policy Number: PH-0229
Subcutaneous/Intravenous
Last Review Date: 08/01/2024
Date of Origin: 02/24/2015
Dates Reviewed: 02/2015, 01/2016, 01/2017, 01/2018, 08/2018, 08/2019, 03/2020, 07/2020, 07/2021, 08/2021, 01/2022, 08/2022, 06/2023, 08/2023, 11/2023, 12/2023, 08/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization
Initial coverage will be provided for 6 months and may be renewed annually thereafter.
- Dosing Limits
A. Quantity Limit (max daily dose) [NDC Unit]:
- Cosentyx 300 mg single-dose UnoReady Pen/prefilled syringe for subcutaneous injection:
- Loading: 1 pen/prefilled syringe at weeks 0, 1, 2, 3, 4
- Maintenance: 1 pen/prefilled syringe every 14 days
- Cosentyx 150 mg single-dose Sensoready Pen/prefilled syringe for subcutaneous injection:
-
- Loading: 2 pens/prefilled syringes/vials at weeks 0, 1, 2, 3, 4
- Maintenance: 2 pens/prefilled syringes/vials every 14 days
-
- Cosentyx 75 mg single-dose prefilled syringe for subcutaneous injection (for pediatric patients less than 50 kg):
- Loading: 1 prefilled syringe at weeks 0, 1, 2, 3, 4
- Maintenance: 1 prefilled syringe every 28 days
- Cosentyx 125 mg single-dose vial for intravenous infusion:
- Loading: 6 vials at week 0
- Maintenance: 3 vials every 28 days
B. Max Units (per dose and over time) [HCPCS Unit]:
Indication |
Max Units |
Enthesitis-Related Arthritis |
Loading:
Maintenance:
|
Plaque Psoriasis and Adult Psoriatic Arthritis with co-existent Plaque Psoriasis |
Loading:
Maintenance:
|
Psoriatic Arthritis and Ankylosing Spondylitis |
Subcutaneous Administration
Intravenous Administration
|
Non-Radiographic Axial Spondyloarthritis |
Subcutaneous Administration
Intravenous Administration
|
Hidradenitis Suppurativa |
Loading:
Maintenance:
|
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
|
- Patient is at least 18 years of age (unless otherwise specified); AND
- Physician has assessed baseline disease severity utilizing an objective measure/tool; AND
- Patient is up to date with all age-appropriate vaccinations, in accordance with current vaccination guidelines, prior to initiating therapy; AND
Universal Criteria 1
- Patient has been evaluated and screened for the presence of latent tuberculosis (TB) infection prior to initiating treatment and will receive ongoing monitoring for presence of TB during treatment; AND
- Will not be administered concurrently with live vaccines; AND
- Patient does not have an active infection, including clinically important localized infections; AND
- Patient is not on concurrent treatment with another biologic therapy (e.g. IL-inhibitor, TNF-inhibitor, integrin receptor antagonist, T cell costimulation modulator, etc.) or targeted synthetic therapy (e.g., apremilast, abrocitinib, tofacitinib, baricitinib, upadacitinib, deucravacitinib, ritlecitinib, ruxolitinib, etrasimod, ozanimod, etc.); AND
Plaque Psoriasis (PsO) † 1,13,26,27,32-34,43
- Patient is at least 6 years of age; AND
- 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, or genitalia, etc.) or with intractable pruritus; AND
- Patient meets ALL of the following ¥:
- 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, 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: For patients already established on biologic therapy, targeted synthetic therapy, or those with > 10% BSA involvement, trial and failure of topical agents, non-biologic systemic agents, and phototherapy is not required.
Adult Psoriatic Arthritis (PsA) † 1,12,28,35,44,45,51
- Documented moderate to severe active disease; AND
- For patients with predominantly axial disease OR enthesitis, a failure of at least a 4-week trial of ONE non-steroidal anti-inflammatory drug (NSAID), unless use is contraindicated; OR
- For patients with peripheral arthritis OR dactylitis, a failure of at least a 3-month trial of ONE conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) (e.g., methotrexate, azathioprine, sulfasalazine, leflunomide, or hydroxychloroquine, etc.); OR
- Patient is already established on biologic or targeted synthetic therapy for the treatment of PsA; AND
- May be used as a single agent or in combination with csDMARDs (e.g., methotrexate, etc.)
Note: Patients new to subcutaneous Cosentyx therapy must initiate treatment at the lower dosing regimen of the 150 mg dose before increasing to the 300 mg dose (unless they have co-existent plaque psoriasis)
Juvenile Psoriatic Arthritis (JPsA) † 1,36,37
- Patient is at least 2 years of age; AND
- Documented moderate to severe active polyarticular disease; AND
- May be used as a single agent or in combination with methotrexate; AND
- Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR a conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) (e.g., methotrexate, leflunomide, sulfasalazine, etc.); OR
- Patient is already established on biologic or targeted synthetic therapy for the treatment of JPsA
Ankylosing Spondylitis (AS) † 1,11,30,46
- Documented active disease; AND
- Patient had an adequate trial and failure of at least TWO (2) non-steroidal anti-inflammatory drugs (NSAIDs) over 4 weeks (in total), unless use is contraindicated; OR
- Patient is already established on biologic or targeted synthetic therapy for the treatment of AS
Note: Patients new to subcutaneous Cosentyx therapy must initiate treatment at the lower dosing regimen of the 150 mg dose before increasing to the 300 mg dose
Non-Radiographic Axial Spondyloarthritis (nr-axSpA) † 1,30,46
- 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 (2) non-steroidal anti-inflammatory drugs (NSAIDs) unless use is contraindicated; OR
- Patient is already established on biologic or targeted synthetic therapy for the treatment of nr-axSpA
Enthesitis-Related Arthritis (ERA) † 1,36,37
- Patient is 4 years of age to < 18 years of age; AND
- Documented moderate to severe active polyarticular disease; AND
- Patient has had at least a 1-month trial and failure (unless contraindicated or intolerant) of previous therapy with either oral non-steroidal anti-inflammatory drugs (NSAIDs) OR an oral conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) (e.g., methotrexate, leflunomide, sulfasalazine, etc.); OR
- Patient is already established on biologic or targeted synthetic therapy for the treatment of ERA
Hidradenitis Suppurativa (HS) † 1,48
- Patient has moderate to severe disease; AND
- Patient has a total of at least 5 inflammatory lesions (i.e. abscesses and/or inflammatory nodules); AND
- Patient’s inflammatory lesions affect at least 2 distinct anatomic areas
*Examples of contraindications to phototherapy (PUVA or UVB) include the following: 23,24,27 |
|
Note: Patients who do not have access to phototherapy will be reviewed on a case-by-case basis |
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- 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 exacerbations or new onset of inflammatory bowel disease, severe infections, hypersensitivity reactions (e.g. anaphylaxis, urticaria), etc.; AND
Plaque Psoriasis (PsO) 10,26,27,43,49,50
- 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. Psoriasis Area and Severity Index (PASI) score ≤ 3, physician’s global assessment (PGA) score ≤ 1, etc. ].
Adult Psoriatic Arthritis (PsA) 9,29,45,52
- 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, improvement on imaging (X-ray, ultrasound, or MRI), 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]; 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 improvement or response to therapy; AND
- Responded to therapy (by treatment week 8) with subsequent loss of response or continued active disease; AND
- Received loading doses and a minimum of one maintenance dose at the dose and interval specified below; OR
- Received a minimum of two maintenance doses at the dose and interval specified below
Juvenile Psoriatic Arthritis (JPsA) 1,38,39,52
- 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, improvement on imaging (X-ray, ultrasound, or MRI), and/or an improvement on a disease activity scoring tool [e.g. an improvement on a composite scoring index such as Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables].
Ankylosing Spondylitis (AS) 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)]; 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 improvement or response to therapy; AND
- Responded to therapy (by treatment week 8) with subsequent loss of response or continued active disease; AND
- Received loading doses and a minimum of one maintenance dose at the dose and interval specified below; OR
- Received a minimum of two maintenance doses at the dose and interval specified below
Non-Radiographic Axial Spondyloarthritis (nr-AxSpA) 31,46
- 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 in 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)].
Enthesitis-Related Arthritis (ERA) 1,38,39
- 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 Juvenile Arthritis Disease Activity Score (JADAS) or the American College of Rheumatology (ACR) Pediatric (ACR-Pedi 30) of at least 30% improvement from baseline in three of six variables].
Hidradenitis Suppurativa (HS) 1,48
- Disease response as indicated by a reduction in total abscess and inflammatory nodule count and/or reduction in skin pain, and/or an improvement on a disease activity scoring tool [e.g. a 50% or greater reduction in abscess and inflammatory nodule count with no increase in the number of abscesses or draining fistulas compared with baseline Hidradenitis Suppurativa Clinical Response (HiSCR)]; 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 improvement or response to therapy; AND
- Responded to therapy (by treatment week 8) with subsequent loss of response or continued active disease; AND
- Received loading doses and a minimum of one maintenance dose at the dose and interval specified below; OR
-
-
- Received a minimum of two maintenance doses at the dose and interval specified below
-
- Dosage/Administration 1
Indication |
Dose |
Plaque Psoriasis (PsO) |
Adults 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dose may be given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. Note: For some patients, a dosage of 150 mg may be acceptable.
Pediatric Patients ≥ 6 years of age
Note: Only the subcutaneously administered products may be used for this indication. |
Adult Psoriatic Arthritis (PsA) with co-existent Plaque Psoriasis (PsO) |
300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Each 300 mg dose may be given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg. Note:
|
Psoriatic Arthritis (PsA) |
Adults – Subcutaneous Administration With loading dose:
Without a loading dose:
Note: Cosentyx may be administered with or without a loading dose for ADULT patients for this indication. If the patient continues to have active psoriatic arthritis, increasing the SUBCUTANEOUS dose to 300 mg every 4 weeks may be considered (see criteria in section IV). Each 300 mg dose may be given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Adults – Intravenous Administration With loading dose:
Without a loading dose:
Note: Cosentyx may be administered with or without a loading dose for ADULT patients for this indication. Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults with PsA.
Pediatric Patients ≥ 2 years of age– Subcutaneous Administration
|
Ankylosing Spondylitis (AS) |
Subcutaneous Administration With loading dose:
Without a loading dose:
Note: Cosentyx may be administered with or without a loading dose for this indication. If the patient continues to have active ankylosing spondylitis, increasing the dose to 300 mg every 4 weeks may be considered (see criteria in section IV). Each 300 mg dose may be given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.
Intravenous Administration With loading dose:
Without a loading dose:
Note: Cosentyx may be administered with or without a loading dose for this indication. Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults with AS. |
Non-Radiographic Axial Spondyloarthritis (nr-axSpA) |
Subcutaneous Administration With loading dose:
Without a loading dose:
Note: Cosentyx may be administered with or without a loading dose for this indication.
Intravenous Administration With loading dose:
Without a loading dose:
Note: Cosentyx may be administered with or without a loading dose for this indication. Total doses exceeding 300 mg per infusion are not recommended for the 1.75 mg/kg maintenance dose in adults with nr-axSpA. |
Enthesitis-Related Arthritis (ERA) |
Note: Only the subcutaneously administered products may be used for this indication. |
Hidradenitis Suppurativa |
300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. Note:
|
NOTE:
|
- Billing Code/Availability Information
HCPCS Code(s):
- J3247 – Injection, secukinumab, intravenous, 1 mg; 1 billable unit = 1 mg (IV formulation ONLY)
- J3590 – Unclassified biologics (SQ formulation ONLY)
- C9399 – Unclassified drugs or biologicals (SQ formulation ONLY)
NDC(s):
- Cosentyx 300 mg/2 mL single-dose UnoReady® Pen (carton of 1) for subcutaneous injection: 00078-1070-xx
- Cosentyx 150 mg/mL single-dose Sensoready® Pen (carton of 1 or 2) for subcutaneous injection: 00078-0639-xx
- Cosentyx 300 mg/2 mL single-dose prefilled syringe (carton of 1) for subcutaneous injection: 00078-1070-xx
- Cosentyx 150 mg/mL single-dose prefilled syringe (carton of 1 or 2) for subcutaneous injection: 00078-0639-xx
- Cosentyx 75 mg/0.5 mL single-dose prefilled syringe for subcutaneous injection (for pediatric patients less than 50 kg; carton of 1): 00078-1056-xx
- Cosentyx 125 mg/5 mL solution in a single-dose vial for dilution prior to intravenous injection (carton of 1): 00078-1168-xx
- References
- Cosentyx [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corporation; November 2023. Accessed June 2024.
- Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis–results of two phase 3 trials. N Engl J Med. 2014 Jul 24;371(4):326-38. Doi: 10.1056/NEJMoa1314258. Epub 2014 Jul 9.
- Hsu S, Papp KA, Lebwohl MG, et al. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102.
- 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. Doi: 10.1016/j.jaad.2008.02.039.
- 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.
- 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.
- 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.
- 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.
- 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 June 2024.
- 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.
- Van Der Heijde D, Ramiro S, Landewé R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Annals of the Rheumatic Diseases Published Online First: 13 January 2017. Doi: 10.1136/annrheumdis-2016-210770.
- 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.
- 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 Apr; 80(4):1029-1072. https://doi.org/10.1016/j.jaad.2018.11.057.
- Blauvelt A, Prinz JC, Gottlieb AB, et al. Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol 2015; 172:484.
- Paul C, Lacour JP, Tedremets L, et al. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol 2015; 29:1082.
- McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 386:1137.
- Mease PJ, McInnes IB, Kirkham B, et al. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med 2015; 373:1329.
- Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890–897. Doi:10.1136/annrheumdis-2017-212687.
- Sieper J, Deodhar A, Marzo-Ortega H, et al. Secukinumab efficacy in anti-TNF-naive and anti-TNF-experienced subjects with active ankylosing spondylitis: results from the MEASURE 2 Study. Ann Rheum Dis 2017; 76:571.
- Baeten D, Sieper J, Braun J, et al. Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis. N Engl J Med 2015; 373:2534.
- Pavelka K, Kivitz A, Dokoupilova E, et al. Efficacy, safety, and tolerability of secukinumab in patients with active ankylosing spondylitis: a randomized, double-blind phase 3 study, MEASURE 3. Arthritis Res Ther 2017; 19:285.
- ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2016 Mar 16 - . Identifier NCT02696031, Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT); 2016 Mar 2. Available from: http://clinicaltrials.gov/ct/show/NCT00287391?order=1
- Richard EG. (2022). Psoralen plus ultraviolet A (PUVA) photochemotherapy. In Elmets CA, Corona R (Eds.), UptoDate. Last updated: Dec 01, 2022. Accessed on: July 2, 2024. 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.
- Elments, CA. (2024). UVB therapy (broadband and narrowband). In Callen J, Corona R (Eds.), UptoDate. Last updated: March 27,2024; Accessed on July 2, 2024. Available from https://www.uptodate.com/contents/uvb-therapy-broadband-and-narrowband?search=UVB%20therapy%20(broadband%20and%20narrowband&source=search_result&selectedTitle=1~80&usage_type=default&display_rank=1#H10844627.
- Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021 Apr;35(4):938-947. Doi: 10.1111/jdv.17002.
- Smith CH, Yiu ZZN, Bale T, et al; British Association of Dermatologists’ Clinical Standards Unit. 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.
- Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020 Jan;82(1):161-201. Doi: 10.1016/j.jaad.2019.08.049.
- 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.
- Mease PJ. Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S64-85. Doi: 10.1002/acr.20577.
- Ward MM, 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 Oct;71(10):1599-1613. Doi: 10.1002/art.41042.
- 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.
- 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 June 2024.
- 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 June 2024.
- 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.
- 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. Doi: 10.1016/j.jaad.2010.11.055.
- Ringold S, Angeles‐Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care & Research, Vol. 71, No. 6, June 2019, pp 717–734 DOI 10.1002/acr.23870.
- Ringold S, Weiss PF, Beukelman T, et al. 2013 update of the 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum. 2013 Oct;65(10):2499-512.
- Ringold S, Bittner R, Neggi T, et al. Performance of rheumatoid arthritis disease activity measures and juvenile arthritis disease activity scores in polyarticular-course juvenile idiopathic arthritis: Analysis of their ability to classify the American College of Rheumatology pediatric measures of response and the preliminary criteria for flare and inactive disease. Arthritis Care Res (Hoboken). 2010 Aug;62(8):1095-102.
- Consolaro A, Giancane G, Schiappapietra B, et al. Clinical outcome measures in juvenile idiopathic arthritis. Pediatric Rheumatology 18 April 2016 14:23.
- Ruperto N, Foeldvari I, Alexeeva E, et al. Efficacy and Safety of Secukinumab in Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Primary Results from a Randomised, Double-blind, Placebo-controlled, Treatment Withdrawal, Phase 3 Study (JUNIPERA). Annals of the Rheumatic Diseases 2021;80:201-202.
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Appendix 1 – Covered Diagnosis Codes
ICD-10 Codes |
ICD-10 Description |
L40.0 |
Psoriasis vulgaris |
L40.50 |
Arthropathic psoriasis, unspecified |
L40.51 |
Distal interphalangeal psoriatic arthropathy |
L40.52 |
Psoriatic arthritis mutilans |
L40.53 |
Psoriatic spondylitis |
L40.54 |
Psoriatic juvenile arthropathy |
L40.59 |
Other psoriatic arthropathy |
L73.2 |
Hidradenitis suppurativa |
M08.80 |
Other juvenile arthritis, unspecified site |
M08.811 |
Other juvenile arthritis, right shoulder |
M08.812 |
Other juvenile arthritis, left shoulder |
M08.819 |
Other juvenile arthritis, unspecified shoulder |
M08.821 |
Other juvenile arthritis, right elbow |
M08.822 |
Other juvenile arthritis, left elbow |
M08.829 |
Other juvenile arthritis, unspecified elbow |
M08.831 |
Other juvenile arthritis, right wrist |
M08.832 |
Other juvenile arthritis, left wrist |
M08.839 |
Other juvenile arthritis, unspecified wrist |
M08.841 |
Other juvenile arthritis, right hand |
M08.842 |
Other juvenile arthritis, left hand |
M08.849 |
Other juvenile arthritis, unspecified hand |
M08.851 |
Other juvenile arthritis, right hip |
M08.852 |
Other juvenile arthritis, left hip |
M08.859 |
Other juvenile arthritis, unspecified hip |
M08.861 |
Other juvenile arthritis, right knee |
M08.862 |
Other juvenile arthritis, left knee |
M08.869 |
Other juvenile arthritis, unspecified knee |
M08.871 |
Other juvenile arthritis, right ankle and foot |
M08.872 |
Other juvenile arthritis, left ankle and foot |
M08.879 |
Other juvenile arthritis, unspecified ankle and foot |
M08.88 |
Other juvenile arthritis, other specified site |
M08.89 |
Other juvenile arthritis, multiple sites |
M08.90 |
Juvenile arthritis, unspecified |
M08.9A |
Juvenile arthritis, unspecified, other specified site |
M08.911 |
Juvenile arthritis, unspecified, right shoulder |
M08.912 |
Juvenile arthritis, unspecified, left shoulder |
M08.919 |
Juvenile arthritis, unspecified, unspecified shoulder |
M08.921 |
Juvenile arthritis, unspecified, right elbow |
M08.922 |
Juvenile arthritis, unspecified, left elbow |
M08.929 |
Juvenile arthritis, unspecified, unspecified elbow |
M08.931 |
Juvenile arthritis, unspecified, right wrist |
M08.932 |
Juvenile arthritis, unspecified, left wrist |
M08.939 |
Juvenile arthritis, unspecified, unspecified wrist |
M08.941 |
Juvenile arthritis, unspecified, right hand |
M08.942 |
Juvenile arthritis, unspecified, left hand |
M08.949 |
Juvenile arthritis, unspecified, unspecified hand |
M08.951 |
Juvenile arthritis, unspecified, right hip |
M08.952 |
Juvenile arthritis, unspecified, left hip |
M08.959 |
Juvenile arthritis, unspecified, unspecified hip |
M08.961 |
Juvenile arthritis, unspecified, right knee |
M08.962 |
Juvenile arthritis, unspecified, left knee |
M08.969 |
Juvenile arthritis, unspecified, unspecified knee |
M08.971 |
Juvenile arthritis, unspecified, right ankle and foot |
M08.972 |
Juvenile arthritis, unspecified, left ankle and foot |
M08.979 |
Juvenile arthritis, unspecified, unspecified ankle and foot |
M08.98 |
Juvenile arthritis, unspecified, vertebrae |
M08.99 |
Juvenile arthritis, unspecified, multiple sites |
M45.0 |
Ankylosing spondylitis of multiple sites in spine |
M45.1 |
Ankylosing spondylitis of occipito-atlanto-axial region |
M45.2 |
Ankylosing spondylitis of cervical region |
M45.3 |
Ankylosing spondylitis of cervicothoracic region |
M45.4 |
Ankylosing spondylitis of thoracic region |
M45.5 |
Ankylosing spondylitis of thoracolumbar region |
M45.6 |
Ankylosing spondylitis of lumbar region |
M45.7 |
Ankylosing spondylitis of lumbosacral region |
M45.8 |
Ankylosing spondylitis of sacral and sacrococcygeal region |
M45.9 |
Ankylosing spondylitis of unspecified sites in spine |
M45.AB |
Non-radiographic axial spondyloarthritis of multiple sites in spine |
M45.A0 |
Non-radiographic axial spondyloarthritis of unspecified sites in spine |
M45.A1 |
Non-radiographic axial spondyloarthritis of occipito-atlanto-axial region |
M45.A2 |
Non-radiographic axial spondyloarthritis of cervical region |
M45.A3 |
Non-radiographic axial spondyloarthritis of cervicothoracic region |
M45.A4 |
Non-radiographic axial spondyloarthritis of thoracic region |
M45.A5 |
Non-radiographic axial spondyloarthritis of thoracolumbar region |
M45.A6 |
Non-radiographic axial spondyloarthritis of lumbar region |
M45.A7 |
Non-radiographic axial spondyloarthritis of lumbosacral region |
M45.A8 |
Non-radiographic axial spondyloarthritis of sacral and sacrococcygeal region |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |