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GLOSSARY OF COMMONLY USED TERMS

Annual out-of-pocket maximum for prescription

The annual out-of-pocket maximum is the most a patient has to pay for prescription medications in a plan year. After a patient spends this amount on deductibles, co-payments, and co-insurance, their insurance plan pays 100% of the costs of prescription medications.

Appeal

An appeal is a formal request to a patient's health plan to reconsider their decision to deny coverage.

Buy and bill

Buy and bill is a process in which providers directly acquire prescription drugs that are administered in the office or infusion center. After the drug is administered to the patient, the provider then bills the patient's health plan for both the drug and its administration.

Co-insurance

Co-insurance is the percentage of healthcare costs the patient pays after meeting their deductible, but before reaching their out-of-pocket maximum. For example, an insurer might pay 75% and the patient would pay 25%.

Co-pay accumulator program

The co-pay accumulator program is an approach taken by some health plans that does not count the cost of a prescription drug toward a patient's annual deductible if a co-pay card or co-pay reimbursement is used.

Co-payment

A co-payment is a cost-sharing arrangement in which an insured person pays a specified charge when they receive a covered service, such as office visits, prescription medications, and other healthcare services.

Deductible

A deductible is the dollar amount patients are responsible for paying before their insurer starts contributing to the cost of their treatment.

Exception

An exception is a coverage request made to a patient's health plan to remove a plan restriction placed on a treatment.

Explanation of benefits (EOB)

An explanation of benefits is a statement from the health plan sent to members to track the use of medications and/or healthcare services and their associated costs and payments.

Formulary

A formulary is a list of prescription medications covered under a health plan's pharmacy benefit. Medications administered by a healthcare provider are typically covered under a health plan's medical benefit.

Group purchasing organizations (GPOs)

A GPO is a company that works with manufacturers and distributors to negotiate the pricing of prescription drugs, healthcare supplies, and medical equipment for providers.

Health plan

A health plan is an organization or program that provides financial coverage for healthcare services or medications.

HIPAA

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge.

In-network providers

In-network providers are healthcare professionals with whom a patient's plan has contracted to provide healthcare services.

Intravenous (IV)

Intravenous means occurring within or entering by way of a vein.

Medical benefit

The medical benefit is coverage from a health plan for healthcare services, including office and hospital visits, surgery, lab tests, preventative care, and medications administered by healthcare professionals (HCPs), such as IV infusions. Most health plans cover HCP-administered products under a medical benefit rather than a pharmacy benefit.

National Drug Code (NDC)

NDC is a universal product identifier with a unique set of numbers used for human drugs in the United States.

Out-of-network providers

Out-of-network providers are healthcare providers who do not contract with a patient's health insurance or plan. Out-of-network co-insurance and co-payments are usually more expensive than those in-network.

Pharmacy benefit

The pharmacy benefit is coverage from a health plan for prescription medications that are typically self-administered.

Pharmacy benefit manager (PBM)

A pharmacy benefit manager is a third-party organization hired to manage pharmacy benefits.

Predetermination

Predetermination is a process used by health plans to review and inform patients of their coverage and share of costs for a service before it is performed.

Preferred drug

A preferred drug is a medication designated as a valuable, cost-effective treatment option. In a multiple-tiered plan, preferred drugs are assigned to a lower tier than nonpreferred drugs.

Premedication

Premedication is medicine given prior to an operation or treatment.

Premium

The premium is the amount people pay for health insurance every month. In addition to premiums, people pay other costs for their healthcare, including a deductible, co-payments, and co-insurance.

Prescription deductible

The prescription deductible is the amount a patient pays for drugs before their health plan starts to pay a portion of the costs.

Prior authorization (PA)

Prior authorization, also called preauthorization, is an administrative tool used by health plans to determine if they will cover a prescribed procedure, service, or medication based on the patient's medical necessity.

Private insurance

Private, or commercial, insurance is any type of health insurance policy not offered or provided by the government. Providers are generally for profit and offer group and individual plans. The majority of Americans receive their insurance through an employer that covers all or part of the premium.

Reconstitution

Reconstitution is the process of making a powder or dry medicine into a liquid by adding a diluting agent.

Step therapy

Step therapy is a health plan policy that requires a patient to try and fail treatment with 1 or more plan-preferred drugs before the plan will cover a different drug for their health condition.

Subcutaneous (SC)

Subcutaneous means located or administered underneath the skin.

Tiers

Tiers are used by most health plans to categorize prescription drug coverage with scaled co-payments. Tiers are commonly based on brand or generic medications, preferred or nonpreferred medications, and traditional or specialty medications.

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INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

WARNINGS AND PRECAUTIONS

Infections

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INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).

COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

COSENTYX is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX 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.