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Health Care Professionals

Insurance Support – Glossary

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The following are frequently used terms about insurance for ENBREL:

Appeal
Request made to a health insurance company to reconsider a decision, such as a claim denial or denied prior authorization request. Most appeals must be submitted in writing within a specified period.

Assignment of benefits (AOB)
Instruction provided from an insured to a health plan, advising that payment for an item provided or service rendered should be sent directly to the provider of that item or service. In this scenario, the provider is responsible for billing the health plan for the item or service.

Benefit cap Top

Total dollar amount that a health insurance company will reimburse for covered drugs and/or medical services during a specified period, such as 1 year or a lifetime.

Claim
Form submitted to a health insurance company (by a health care provider or patient) to request payment for items or services.

Coding Top

Coding provides universal definition and recognition of diagnoses, procedures, products, and levels of care.

Co-insurance
Cost-sharing arrangement between an insured and health insurance company in which the insured will be required to pay a percentage of the cost for the health care services received (eg, 20% of the cost of ENBREL).

Co-payment Top

Cost-sharing arrangement between an insured and health insurance company in which the insured will be required to pay a specified dollar amount for a particular item or service (eg, $20 for a 1-month supply of ENBREL).

Current procedural terminology (CPT)
A system of terminology and coding developed by the American Medical Association (AMA) that is used for describing, coding, and reporting medical services and procedures.

Deductible Top

Cost-sharing arrangement between an insured and health insurance company in which the insured will be required to pay a fixed dollar amount of covered expenses each year before the health insurance company will reimburse for covered health care expenses. Generally, an insured must meet a deductible each calendar year.

Explanation of benefits (EOB)
Statement sent by health insurance companies to health care beneficiaries that details the charges for the services received, the amount the health insurance company will pay for those services, and the amount the beneficiary will be responsible for paying.

Formulary Top

Approved list of prescription medications covered by a health insurance company. Depending on the individual plan, an insured patient may have a "closed formulary," which would require that the insured patient use only those medications included on that health plan's formulary or they may have an "open formulary," which may allow access to all medications at a higher cost.

HCFA common procedure coding system (HCPCS)
Name given to CPT codes (Level I), alphanumeric codes (Level II), and local codes (Level III) used by health insurance companies and health care providers for billing purposes. Within the industry, most refer to Level II national codes as HCPCS codes.

International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) Top

Coding system maintained by the National Center for Health Statistics and the Centers for Medicare and Medicaid Services (CMS). This coding system differentiates diagnostic conditions and is used by hospitals, governments, health insurance plans, and health care providers.

Letter of medical necessity
Documentation intended to justify that the service rendered or item provided is reasonable and appropriate for the diagnosis or treatment of a medical condition or illness.

Medicaid Top

Federal and state health insurance program for individuals who meet established eligibility criteria (programs vary from state to state).

Medicare
Federal health insurance program for the elderly (age 65 and older), certain disabled individuals, and those with end-stage renal disease. Medicare is administered by the Centers for Medicare and Medicaid Services (CMS), formerly the Health Care Financing Administration (HCFA).

Medigap / MedSup Top

Health plans offered by private health insurance companies to individuals with Medicare. Plans cover costs not typically covered by Medicare (designed to "fill the gaps" of Medicare coverage). Costs covered may include co-insurance amounts, deductibles, and prescription drugs costs.

National Drug Code (NDC)
Numerical coding system for drug identification. NDC numbers are assigned by the Food and Drug Administration (FDA) and are typically used to bill health insurance companies for the drugs provided to health care beneficiaries. The NDC number for ENBREL is 58406-425-34.

Out-of-pocket maximum Top

Total dollar amount an insured will be required to pay for covered medical services during a specified period, such as 1 year. The out-of-pocket maximum may also be called the stop-loss limit or catastrophic expense limit.

Preexisting condition
Medical condition for which an insured received medical care prior to the health insurance coverage becoming effective. Depending upon the plan's policy language, the health insurance company may deny or limit the amount of care for which it will reimburse related to the preexisting condition.

Prior authorization Top

Review of need for health care items or services before services are rendered or products are provided. This refers to a decision made by the health insurance company or plan to cover or not cover the charges before the services are provided.

Private insurance
Insurance is a method for managing medical risk by spreading the risk over a group of individuals through pooled premiums that cover the costs of unanticipated illnesses or injuries. Private insurance is insurance that is not an entitlement or federal or state-funded program. Typically, this insurance is offered through an employer group, individual purchase, union group, or association group (AARP, Small Business Association).

Recertification Top

The process of renewing a prior authorization obtained through a health insurance company for a specific product or service. This process is often an abbreviated version of the prior authorization process. See prior authorization for more information.

Usual, customary, and reasonable charge
Prevailing charge for an item or service in a particular geographic area.

Verification of benefits
The process of determining a patient's specific insurance benefits for a product or service. This includes determining if the health insurance company covers the product or service and the patient's cost associated with obtaining the product or service.

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IMPORTANT SAFETY INFORMATION

RISK OF SERIOUS INFECTIONS

Patients treated with ENBREL are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of their underlying disease. ENBREL should not be initiated in the presence of sepsis, active infections or allergy to ENBREL or its components. ENBREL should be discontinued if a patient develops a serious infection or sepsis. Reported infections include: 1) Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before ENBREL use and periodically during therapy. Treatment for latent infection should be initiated prior to ENBREL use. 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness, and 3) Bacterial, viral and other infections due to opportunistic pathogens, such as listeriosis.

The risks and benefits of treatment with ENBREL should be carefully considered prior to initiating therapy in patients 1) with chronic or recurrent infection, 2) who have been exposed to tuberculosis, 3) who have resided or traveled in areas of endemic tuberculosis or endemic mycoses or 4) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ENBREL, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis prior to initiating therapy.

Neurologic Events
TNF inhibitors, including ENBREL, have been associated with rare cases of new onset or exacerbation of CNS demyelinating disorders (some presenting with mental status changes and some associated with permanent disability). Transverse myelitis, optic neuritis, multiple sclerosis, and cases of new onset or exacerbation of seizure disorders have been observed in association with ENBREL therapy. A causal relationship to ENBREL therapy remains unclear. Exercise caution when considering ENBREL for patients with these disorders.

Hematologic Events
Rare cases of pancytopenia, including aplastic anemia, some fatal, have been reported. A causal relationship to ENBREL therapy remains unclear. Exercise caution in patients who have a previous history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Consider discontinuing ENBREL if significant hematologic abnormalities are confirmed.

Malignancies
In clinical trials of all TNF inhibitors, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. The role of TNF inhibitors in the development of malignancies is unknown.

Hepatitis B Reactivation
TNF inhibitors, including ENBREL, have been associated with reactivation of hepatitis B virus (HBV) in chronic carriers of this virus. The majority of these reports occurred in patients on concomitant immunosuppressive agents, which may also contribute to HBV reactivation. Prescribers should exercise caution in prescribing TNF blockers for patients identified as carriers of HBV.

Moderate to Severe Alcoholic Hepatitis
Based on a study of patients treated for alcoholic hepatitis, physicians should use caution when using ENBREL in patients with moderate to severe alcoholic hepatitis.

Adverse Events
The most commonly reported adverse events in RA clinical trials were injection site reaction, infection, and headache. In clinical trials of all other adult indications, adverse events were similar to those reported in RA clinical trials.

In a JIA study, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adult RA patients in placebo-controlled trials. The types of infections reported in JIA patients were generally mild and consistent with those commonly seen in outpatient pediatric populations.

Please see accompanying Prescribing Information and Medication Guide.

INDICATIONS
Moderate to Severe Rheumatoid Arthritis (RA)
ENBREL is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis. ENBREL can be initiated in combination with methotrexate (MTX) or used alone.

  • In medical studies, ENBREL was shown to be effective in about 2 out of 3 adults with RA who used it, and has been shown to begin working in as few as 2 weeks, with most patients receiving benefit within 3 months. In an RA medical study, 55% of patients had no progression of joint damage.

Moderate to Severe Polyarticular Juvenile Idiopathic Arthritis (JIA)
ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.

  • In a medical study, ENBREL was shown to be effective in about 3 out of 4 children with JIA who used it. For these JIA patients, ENBREL has been shown to begin working in approximately 2 to 4 weeks.

Psoriatic Arthritis
ENBREL is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone.

  • In a medical study, ENBREL was shown to be effective in about 50% of psoriatic arthritis patients who used it. Clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.

Ankylosing Spondylitis (AS)
ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

  • In a medical study, ENBREL was shown to be effective in about 3 out of 5 adults with AS who used it. Clinical responses were seen at 2 weeks in 46% of patients, with 59% of patients receiving benefit within 8 weeks.

Moderate to Severe Plaque Psoriasis
ENBREL is indicated for the treatment of adult patients (18 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

  • In medical studies, nearly half of patients saw a significant improvement in their plaque psoriasis within 3 months of using ENBREL. Overall, 3 out of 4 patients saw improvement. ENBREL can work fast; many patients saw improvement within 2 months. ENBREL has been shown to be effective through 12 months of therapy.
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