What is the risk of taking COSENTYX during pregnancy?

Limited human data are available on the use of COSENTYX during pregnancy. The available data from an embryo-fetal development study in monkeys showed no adverse developmental effects in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the maximum recommended human dose. However, the background risk of major birth defects and miscarriage in the indicated population is unknown.

Is COSENTYX safe to use while breastfeeding?

It is not known whether secukinumab is excreted in human milk or absorbed systemically after ingestion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for COSENTYX and any potential adverse effects on the breastfed child from COSENTYX or from the underlying maternal condition.

Can COSENTYX be used in pediatric patients?

The safety and effectiveness of COSENTYX have been established in pediatric subjects aged 6 years and older with moderate to severe plaque psoriasis, as well as in patients weighing 15 kg or more with juvenile psoriatic arthritis (JPsA) aged 2 years and older and enthesitis-related arthritis (ERA) aged 4 years and older. However, the safety and effectiveness of COSENTYX in pediatric patients below the age of 6 years or with body weight less than 15 kg have not been established.

Is there any information on the use of COSENTYX in geriatric patients?

Although no differences in safety or efficacy were observed between older and younger subjects in clinical trials, the number of subjects aged 65 years and older was not sufficient to determine whether they responded differently from younger subjects. Of the 3430 plaque psoriasis subjects exposed to COSENTYX in clinical trials, a total of 230 were 65 years or older, and 32 subjects were 75 years or older.

What is the maximum recommended human dose of COSENTYX?

The maximum recommended human dose (MRHD) of COSENTYX is not specified in the information provided. However, in an embryo-fetal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration of secukinumab during organogenesis at doses up to 30 times the MRHD.

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Cosentyx

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0.5 ML secukinumab 150 MG/ML Prefilled Syringe [Cosentyx]1 ML secukinumab 150 MG/ML Auto-Injector [Cosentyx]

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Dosage & administration

* Prior to COSENTYX initiation, complete all age appropriate vaccinations, evaluate patients for tuberculosis (TB) . See Full Prescribing Information for instructions on preparation and administration of COSENTYX.
* Plaque Psoriasis:
* Adults: Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 followed by 300 mg every 4 weeks. For some patients, a dose of 150 mg may be acceptable.
* Pediatric Patients 6 Years and Older: Recommended dosage based on body weight and administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter :

Body Weight at Time of Dosing	Recommended Dose
Less than 50 kg	75 mg
Greater than or equal to 50 kg	150 mg

* Psoriatic Arthritis:

Adults: Recommended dosages are:

* For PsA patients with coexistent moderate to severe plaque psoriasis, use the dosage and administration for plaque psoriasis.
* For other PsA patients, administer with or without a loading dosage.
* With a loading dosage: 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter
* Without a loading dosage: 150 mg every 4 weeks
* If a patient continues to have active PsA, consider a dosage of 300 mg every 4 weeks.

Pediatric Patients 2 years and older: Recommended dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.

* For patients weighing ≥ 15 kg and < 50 kg the dose is 75 mg.
* For patients weighing ≥ 50 kg the dose is 150 mg.

* Ankylosing Spondylitis: Administer with or without a loading dosage.
The recommended dosages are:
* With a loading dosage: 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
* Without a loading dosage: 150 mg every 4 weeks.
* If a patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg every 4 weeks.

* Non-Radiographic Axial Spondyloarthritis: Administer with or without a loading dosage. The recommended dosage is:
* With a loading dosage: 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
* Without a loading dosage: 150 mg every 4 weeks.

* Enthesitis-Related Arthritis: Recommended dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter.
* For patients weighing ≥ 15 kg and < 50 kg the dose is 75 mg.
* For patients weighing ≥ 50 kg the dose is 150 mg.

drug label

Cosentyx prescribing information

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samples

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prior authorization

Cosentyx prior authorization resources

Most recent Cosentyx prior authorization forms

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Verified: Sep 10, 2023Kaiser Permanente - Mid Atlantic Cosentyx Prior Authorization Form Mid-Atlantic States

Verified: Sep 28, 2023Paramount - Cosentyx Prior Authorization Form

Verified: Sep 28, 2023Optum Rx - Cosentyx Prior Authorization Form

Verified: Sep 28, 2023Caremark - Cosentyx Prior Authorization Form

Verified: Sep 22, 2023Independence Health - Value Formulary Immune Modulating Therapy Prior Authorization Form

Verified: Sep 22, 2023Independence Health - Select Formulary Immune Modulating Therapy Prior Authorization Form

PDFCoverage Authorization Request: Plaque Psoriasis

PDFCoverage Authorization Appeals: Plaque Psoriasis

PDFLetter of Medical Necessity: Plaque Psoriasis

PDFFormulary Exception Request Letter: Plaque Psoriasis

PDFTiering Exception Request Letter: Plaque Psoriasis

PDFCoverage Authorization Request: Psoriatic Arthritis

PDFCoverage Authorization Appeals: Psoriatic Arthritis

PDFLetter of Medical Necessity: Psoriatic Arthritis

PDFFormulary Exception Request Letter: Psoriatic Arthritis

PDFTiering Exception Request Letter: Psoriatic Arthritis

PDFDosage Appeals Letter: Psoriatic Arthritis

PDFCoverage Authorization Request: Ankylosing Spondylitis

PDFCoverage Authorization Appeals: Ankylosing Spondylitis

PDFLetter of Medical Necessity: Ankylosing Spondylitis

PDFFormulary Exception Request Letter: Ankylosing Spondylitis

PDFTiering Exception Request Letter: Ankylosing Spondylitis

PDFDosage Appeals Letter: Ankylosing Spondylitis

PDFCoverage Authorization Request: nr-axSpA

PDFCoverage Authorization Appeals: nr-axSpA

PDFLetter of Medical Necessity: nr-axSpA

PDFFormulary Exception Request Letter: nr-axSpA

PDFTiering Exception Request Letter: nr-axSpA

PDFDosage Appeals Letter: nr-axSpA

PDFCoverage Authorization Request: JPsa & ERA

PDFCoverage Authorization Appeals: JPsa & ERA

PDFLetter of Medical Necessity: JPsa & ERA

PDFFormulary Exception Request Letter: JPsa & ERA

PDFTiering Exception Request Letter: JPsa & ERA

PDFDosage Appeals Letter: JPsa & ERA

PDFCoverage Authorization Request: PsA with PsO

PDFCoverage Authorization Appeals: PsA with PsO

PDFLetter of Medical Necessity : PsA with PsO

PDFFormulary Exception Request Letter: PsA with PsO

PDFTiering Exception Request Letter: PsA with PsO

PDFMedical Exception Request Letter

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Benefits investigation

PDFConsentyx Connect Start Form

PDFCosentyx Connect Start Form - Spanish

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Reimbursement help (FRM)

PDFReceive Assistance from an FRM Regarding Reimbursement Information

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financial assistance

Cosentyx financial assistance options

Co-pay savings program

commercial only

PDFConsentyx Connect Start Form

PDFCosentyx Connect Start Form - Spanish

Enroll in Patient Savings Program

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Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

commercial only

PDFConsentyx Connect Start Form

PDFCosentyx Connect Start Form - Spanish

OTHEREnroll in Bridge Program

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

under insured

no insurance

goverment insurance

65+

PDFConsentyx Connect Start Form

PDFCosentyx Connect Start Form - Spanish

PDFCosentyx Patient Assistance Program Income Requirements

PDFNovartis Patient Assistance Foundation Application - English

PDFNovartis Patient Assitance Foundation Application - Spanish

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Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.