SOLIRIS (eculizumab): The first treatment specifically approved for PNH

For US Healthcare Professionals

Coding for Flow Cytometry

Coding for diagnostic pathology/laboratory billing of flow cytometry

Coding for Flow Cytometry

Flow cytometery of erythrocytes using anti-CD59 or of granulocytes using anti-CD55 or anti-CD59 provides the most accurate technique for the diagnosis of PNH. Flow cytometry is more sensitive, specific, and quantitative for PNH than other complement sensitivity measures, including the Ham, sucrose lysis, and complement lysis sensitivity tests.

Payors vary greatly on their specific medical policy for flow cytometry. It is important that laboratories clarify coding and billing requirements with the patient's respective health insurance plan. However, due to the rare nature of PNH, many payors may not have a formal PNH diagnostic code. Consequently, medical policies for flow cytometry should include one or more of the diagnosis codes listed in the table in order to reflect that a patient may be undergoing a diagnosis with flow cytometry for PNH clone determination.

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IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTION

SOLIRIS® increases the risk of meningococcal infections.

Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS; revaccinate according to current medication guidelines for vaccine use.

Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary.

The effect of withdrawal of anticoagulant therapy during SOLIRIS treatment has not been established. Therefore, treatment with SOLIRIS should not alter anticoagulant management.

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING INCLUDING WARNINGS, PRECAUTIONS, AND ADVERSE REACTIONS.

The most frequent adverse events observed in clinical studies were headache, nasopharyngitis, back pain, nausea, fatigue, and cough.

Please see important safety information (including boxed warning) as well as the complete prescribing information.