Prior Auth Protocol

FDA Approved Indications:

The prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia.

Health Net Approved Indications and Usage Guidelines:

AND

Patient is receiving a chemotherapy regimen likely to cause severe thrombocytopenia

OR

Patient with a history of chemotherapy induced thrombocytopenia from the previous cycle of therapy that is to receive another cycle of the same regimen

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
Neumega is not indicated following myeloablative chemotherapy.

General Information:

The safety and effectiveness of Neumega have not been established in pediatric patients.
Efficacy was demonstrated in patients who had experienced severe thrombocytopenia following the previous chemotherapy cycle.
Neumega is known to cause serious fluid retention that can result in peripheral edema, dyspneaon exertion, pulmonary edema, capillary leak syndrome, atrial arrhythmias, and exacerbation of pre-existing pleural effusions.
Fluid retention is reversible within several days following discontinuation of Neumega.
In clinical trials, cardiac events including atrial arrhythmias (atrial fibrillation or atrial flutter) occurred in 15% (23/157) of patients treated with Neumega at doses of 50 mcg/kg.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
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* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Neumega	50 mcg/kg SC once daily in the abdomen thigh, or hip (or upper arm if not self-injecting). Start 6 to 24 hours after the completion of chemotherapy. Monitor platelet counts periodically to assess the optimal duration of therapy. Continue dosing until the post-nadir platelet count is >50,000cells/mcL. In controlled clinical studies, doses were administered in courses of 10 to 21 days; dosing beyond 21 days per treatment course is not recommended.	21 days

Product Availability:

Vial: 5 mg powder for injection plus diluent

References:

Neumega [Prescribing Information]. Philadelphia, PA: Wyeth Pharmaceuticals; October 2012.
Neumega. In DrugPoints^R system [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed June 18, 2015.
Neumega. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed June 18, 2015.