Aetna considers secukinumab (Cosentyx) medically necessary for the following indications where the member has a documented negative TB test (which can include a tuberculosis skin test (PPD), an interferon-release assay (IGRA), or a chest x-ray)#N#Footnote 1 for screening testing for TB#N#* within 6 months of initiating therapy for persons who are naïve to biologic DMARDs or targeted synthetic DMARDs associated with an increased risk of TB, and repeated yearly for members with risk factors#N#Footnote 2 for Risk factors for TB include#N#** for TB that are continuing therapy with biologics:
In June 2020, Cosentyx (secukinumab) was U.S. FDA approved for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum (Novartis, 2020b). FDA approval was based on the efficacy and safety results from the PREVENT trial which showed a significant reduction in disease activity for patients treated with secukinumab versus placebo.
There are clinical trials regarding the use of secukinumab for the treatment of various diseases/conditions including alopecia areata, Alzheimer disease, atopic dermatitis, diabetes mellitus type-I, dry eye, hidradenitis suppurativa, ichthyoses, non-infectious uveitis, palmoplantar psoriasis, papulopustular rosacea, and rheumatoid arthritis.
Removed the following drug to the Non-Excluded CPT/HCPCS Codes - Table Format: C9399 and J3590, Zinbryta (daclizumab), effective 2/18/2021. This drug was taken of the market.
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.
CPT is provided “as is” without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon no upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.
You, your employees and agents are authorized to use CPT only as contained in the following authorized materials of CMS internally within your organization within the United States for the sole use by yourself, employees and agents. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.
Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license.
Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.
You, your employees and agents are authorized to use CPT only as contained in the following authorized materials of CMS internally within your organization within the United States for the sole use by yourself, employees and agents. Use is limited to use in Medicare, Medicaid or other programs administered by the Centers for Medicare and Medicaid Services (CMS). You agree to take all necessary steps to insure that your employees and agents abide by the terms of this agreement.
CPT is provided “as is” without warranty of any kind, either expressed or implied, including but not limited to, the implied warranties of merchantability and fitness for a particular purpose. AMA warrants that due to the nature of CPT, it does not manipulate or process dates, therefore there is no Year 2000 issue with CPT. AMA disclaims responsibility for any errors in CPT that may arise as a result of CPT being used in conjunction with any software and/or hardware system that is not Year 2000 compliant. No fee schedules, basic unit, relative values or related listings are included in CPT. The AMA does not directly or indirectly practice medicine or dispense medical services. The responsibility for the content of this file/product is with CMS and no endorsement by the AMA is intended or implied. The AMA disclaims responsibility for any consequences or liability attributable to or related to any use, non-use, or interpretation of information contained or not contained in this file/product. This Agreement will terminate upon no upon notice if you violate its terms. The AMA is a third party beneficiary to this Agreement.
Organizations who contract with CMS acknowledge that they may have a commercial CDT license with the ADA, and that use of CDT codes as permitted herein for the administration of CMS programs does not extend to any other programs or services the organization may administer and royalties dues for the use of the CDT codes are governed by their commercial license.
When a drug is included on a plan’s formulary but has a high copay or coinsurance, this type of letter can beused to appeal that they grant an exception for this patient and place the drug on a lower tier so that thepatient has a lower out-of-pocket expense. This letter should be sent by the patient.
COSENTYX may increase the risk of infections . In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects. Inplacebo-controlled clinical trials in patients with moderate to severe plaque psoriasis, higherrates of common infections such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%), and mucocutaneous infections with candida (1.2% versus0.3%) were observed with COSENTYX compared with placebo. A similar increase in risk ofinfection was seen in placebo-controlled trials in patients with psoriatic arthritis, ankylosingspondylitis and non-radiographic axial spondyloarthritis. The incidence of some types ofinfections appeared to be dose-dependent in clinical studies.