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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
DESCRIPTIONPromacta (eltrombopag) is an orally bioavailable, small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production.
Promacta will be approved when the following are met:
i. The patient has a history of trial and failure of; or a documented intolerance, FDA labeled contraindication, or hypersensitivity to ONE of the following treatments: corticosteroids, immunoglobulins (IVIg or anti-D) OR
i. The patient’s platelet count is <75 x109/L AND the intent is to increase platelet counts sufficiently to initiate interferon therapy OR
a. The quantity requested is less than or equal to the program quantity limit OR
Length of Approval: 8 weeks Promacta for ITP. 12 weeks for Promacta for hepatitis C associated thrombocytopenia.
POLICY EXCEPTIONSPromacta prior authorization is not required for Federal Employee Program (FEP) and State Health Plan members.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
01/01/2014: New policy added.
11/12/2014: Policy statement criteria regarding hepatitis C associated thrombocytopenia updated to change the platelet count from "<100 x109/L" to "<75 x109/L." Added criteria for Promacta for severe aplastic anemia to the policy statement.
08/14/2015: Code Reference section updated for ICD-10.
05/31/2016: Policy number L.5.01.463 added. Investigative definition updated in Policy Guidelines.
06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
SOURCE(S)Promacta® Prescribing Information
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.