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BELIMUMAB (Benlysta®)

The indication for the use of belimumab is the diagnosis of systemic lupus erythematosus in adult patients who receive standard therapy, have active status and are positive to autoantibodies.

The decision to treat a patient with belimumab must be based on the following criteria:

1. Patient is 5 years of age or older (See Dosing Pediatric Statement). For patients age 18 years and older, patient must have tried and failed, or have a documented contraindication to, subcutaneous Benlysta before the intravenous infusion will be authorized.

2. Treatment for the condition with standard therapy for at least 30 days.

(a) Standard therapy: antimalarial drugs, glucocorticoids and not biological, alone or in combination immunosuppressive.

3. Condition should be classified as active, a value ≥ 6 according to the criterion of evaluation clinical Safety of Estrogens in Lupus Erythematosus National assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) or other comparable criteria validated.

4. Positive laboratory results for autoantibodies on two separate occasions.

a) Title of antinuclear antibody (ANA) ≥ 1:80

b) Anti-double DNA Helix ≥ 30 IU/mL

5. Severe active lupus in the central nervous system absence 60 days prior to treatment with belimumab

a) Active lupus in the central nervous system determined by convulsions, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or vasculitis in central nervous system.

6. Absence of nephritis active severe as determined by blood and urine analysis.

a) Serum creatinine > 2.5 mg/dL

b) Proteinuria > 6 g/24 hr

7. Triple-S considered to pay the treatment with belimumab under the following conditions, identified by their corresponding ICD-10 codes:

(to) Lupus erythematosus

b) Unclassified autoimmune disease

This treatment in hospital administration, requires pre-authorization . The application must include the following documentation:

1. Number of the insured contract.

2. ICD-10 diagnostic code.

3. Documentation of medical necessity.

4. Weight of the patient. The dose is based on mg/Kg.

5. Initial dose 10 mg/kg every 2 weeks by 3 doses.

6. Maintenance 10 mg/kg every 4 weeks.

7. Amount of milligrams to take.

If a patient with any of the diagnoses approved for payment by this policy, it is admitted to the hospital, and as part of the treatment requires the use of belimumab, Triple-S will cover treatment then that the above requirements are met.

The admission of the patient to the hospital with the single and only purpose of administering belimumab requires individual pre-authorization for the admission and treatment.

Triple-S pays only the daily dose of the drug in hospital and ambulatory level after meet the pre-authorization process.

Triple-S does not consider for payment of Belimumab use under the following circumstances:

There is documentation of:

(a)To previous anaphylactic reactions.

(b) Active severe central nervous system lupus

(c) Severe systemic reactions to IgG, (nephritis lupus pneumonia, osteonecrosis, cholelithiasis, related to infusion reaction).

(d) Active severe lupus nephritis

(e) Use of other biological products or cyclophosphamide IV to treat lupus

There is no pre-authorization for treatment.

* Alert special Glaxo Smith Kline Inc. May 2012

Reaction of hypersensitivity serious including fatalities have been observed up to 4 hours then the infusion of belimumab. This reaction may be more severe in patients with other allergies. They occur most frequently during the first 2 doses.
Serious infections can occur in patients with chronic infections that can include death.
Medication increases the risk of malignancy.
Psychiatric events including: depression, insomnia, and suicides have been reported.

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