Ankylosing Spondylitis Efficacy | COSENTYX® (secukinumab)

J3247: Permanent J-code for the IV formulation of COSENTYX^®*

Effective July 1, 2024, for all sites of care

IV dosing calculator Provider and Co-pay Portal - IV IV Billing & Coding Guide

*If COSENTYX is administered on or after July 1, 2024, the permanent J-code replaces the miscellaneous J-code J3590.
It is the sole responsibility of the healthcare provider to select the proper codes and ensure the accuracy of all statements used in seeking coverage and reimbursement for an individual patient. Novartis cannot guarantee insurance coverage or reimbursement.

Reference: CMS, HCPCS Quarterly Update, April 2024.

Here with you to help address the hallmarks of disease that matter to patients with AS

Early diagnosis of inflammatory back pain with appropriate intervention can dramatically improve the signs and symptoms of ankylosing spondylitis.

More than 2X improvement vs placebo in ankylosing spondylitis (AS)

61% of patients in a mixed population achieved ASAS20 at Week 16 on COSENTYX^®(secukinumab) 150 mg (n=72) vs 28% on placebo (n=74) (NRI; P=0.0001) (MEASURE 2 primary end point)^1,9

Improvements in the hallmarks of disease that matter to patients at Year 5^7,8,10

Improvement in Mean Scores for AS with 150-mg Dose

In MEASURE 2, the above measures were prespecified exploratory end points in subgroups of biologic-naive patients taking COSENTYX 150 mg through Year 5. No clinical or statistical conclusions can be drawn.^7-9

Consider escalating to a 300 mg dose every 4 weeks for patients who continue to have active AS¹

Same price for the 150 mg and 300 mg dosages

Hear what matters to patients

Mean baseline morning stiffness score at Year 5: 6.8 (150 mg group). Mean change was -3.5. Morning stiffness was measured by BASDAI questions 5 (mean duration) and 6 (severity), measured on a 0 to 10 numeric response scale.^7,9
Mean baseline FACIT-Fatigue score at Year 5: 22.6 (150 mg group). Mean change was 10.6. Fatigue was measured by FACIT-Fatigue, a 13-item questionnaire that assesses self-reported fatigue and its impact on daily activities and function.^7,9
Mean baseline spinal pain score at Year 5: 66.9 (150 mg group). Mean change was -36.8. Spinal pain was measured using a 100-mm VAS as a component of ASAS.^7,9
Mean baseline nocturnal back pain score at Year 5: 66.8 (150 mg group). Mean change was -38.9. Nocturnal pain was measured using a 100-mm VAS as a component of ASAS.^8,9

Please see MEASURE 2 (pivotal trial) primary end point and study design details

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
COSENTYX^® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX^® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe PsO, higher rates 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% versus 0.3%) were observed in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.

In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections, and some fatal infections have been reported in patients receiving IL-17 inhibitors including COSENTYX. Cases of Hepatitis B virus reactivation have been reported.

Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.

If signs of Hepatitis B virus reactivation occur, consult a hepatitis specialist. COSENTYX is not recommended for use in patients with active viral hepatitis.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.

Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.

Eczematous Eruptions

In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.

Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.

Hypersensitivity Reactions

Serious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in COSENTYX treated subjects in clinical trials and in the post-marketing setting. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of COSENTYX and initiate appropriate therapy.

The removable caps of the COSENTYX Sensoready^® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Immunizations

Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Please see Full Prescribing Information, including Medication Guide.

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J3247: Permanent J-code for the IV formulation of COSENTYX®*

Here with you to help address the hallmarks of disease that matter to patients with AS

More than 2X improvement vs placebo in ankylosing spondylitis (AS)

Improvements in the hallmarks of disease that matter to patients at Year 57,8,10

Consider escalating to a 300 mg dose every 4 weeks for patients who continue to have active AS1

Hear what matters to patients

See the inflammation results in AS, an active disease correlateg,j

A robust safety profilem

Help patients get started quickly and successfully

Please see MEASURE 2 (pivotal trial) primary end point and study design details

Definitions and references

J3247: Permanent J-code for the IV formulation of COSENTYX^®*

Improvements in the hallmarks of disease that matter to patients at Year 5^7,8,10

Consider escalating to a 300 mg dose every 4 weeks for patients who continue to have active AS¹

See the inflammation results in AS, an active disease correlate^g,j

A robust safety profile^m