IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Nplate is indicated for the treatment of thrombocytopenia in:
a. Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
b. Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
2. Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HSARS]).
B. Compendial Uses
1. Myelodysplastic syndromes, for lower risk disease in patients with severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents, immunosuppressive therapy, or clinical trial
2. Chemotherapy-induced thrombocytopenia (CIT)
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
A. Immune thrombocytopenia: pretreatment and current platelet counts
B. Chemotherapy-induced thrombocytopenia (CIT): pretreatment and current platelet counts
III. EXCLUSIONS
Coverage will not be provided for members with the following exclusion: concomitant use of Nplate with other thrombopoietin receptor agonists (e.g., Promacta, Doptelet, Mulpleta) or with spleen tyrosine kinase inhibitors (e.g., Tavalisse)
IV. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a hematologist or oncologist.
V. CRITERIA FOR INITIAL APPROVAL
A. Immune thrombocytopenia (ITP)
Authorization of 6 months may be granted for treatment of ITP when both of the following criteria are met:
1. Inadequate response or intolerance to prior therapy with corticosteroids, immunoglobulins, or splenectomy.
2. Untransfused platelet count at any point prior to the initiation of the requested medication is less than 30x109/L OR 30x109/L to 50x109/L with symptomatic bleeding (e.g., significant mucous membrane bleeding, gastrointestinal bleeding or trauma) or risk factors for bleeding (see Section VII).
B. Hematopoietic syndrome of acute radiation syndrome (HSARS)
Authorization of 1 month may be granted for treatment of hematopoietic syndrome of acute radiation syndrome (acute exposure to myelosuppressive doses of radiation).
C. Myelodysplastic Syndromes
Authorization of 12 months may be granted for treatment of myelodysplastic syndromes when both of the following criteria are met:
1. Member has lower risk disease defined as Revised International Prognostic Scoring System (IPSS-R) (Very Low, Low, Intermediate), International Prognostic Scoring System (IPSS) (Low/Intermediate-1), WHO classification-based Prognostic Scoring System (WPSS) (Very Low, Low, Intermediate).
2. Member has severe or refractory thrombocytopenia following disease progression or no response to hypomethylating agents (such as azacitidine and decitabine), immunosuppressive therapy, or clinical trial.
D. Chemotherapy-induced thrombocytopenia
Authorization of 6 months may be granted for treatment of chemotherapy-induced thrombocytopenia (CIT) when any of the following criteria are met:
1. The platelet count is less than 100x109/L for at least 3-4 weeks following the last chemotherapy administration, or
2. Chemotherapy administration has been delayed related to thrombocytopenia
VI. CONTINUATION OF THERAPY
A. Immune thrombocytopenia (ITP)
1. Authorization of 3 months may be granted to members with current platelet count less than 50x109/L for whom the platelet count is not sufficient to prevent clinically important bleeding and who have not received a maximal Nplate dose for at least 4 weeks.
2. Authorization of 12 months may be granted to members with current platelet count less than 50x109/L for whom the current platelet count is sufficient to prevent clinically important bleeding.
3. Authorization of 12 months may be granted to members with current platelet count of 50x109/L to 200x109/L.
4. Authorization of 12 months may be granted to members with current platelet count greater than 200x109/L to less than or equal to 400x109/L for whom Nplate dosing will be adjusted to achieve a platelet count sufficient to avoid clinically important bleeding.
B. Hematopoietic syndrome of acute radiation syndrome (HSARS)
All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.
C. Myelodysplastic Syndromes
Authorization of 12 months may be granted for continued treatment of myelodysplastic syndromes in members who experience benefit from therapy (e.g., increased platelet counts, decreased bleeding events, reduced need for platelet transfusions).
D. Chemotherapy-induced thrombocytopenia
Authorization of 6 months may be granted for continued treatment of chemotherapy-induced thrombocytopenia (CIT) in members who experience benefit from therapy (e.g., increased platelet counts, decreased bleeding events, reduced need for platelet transfusions) to maintain a target platelet count goal of 100x109/L – 200x109/L.
VII. APPENDIX
Examples of risk factors for bleeding (not all inclusive)
· Undergoing a medical or dental procedure where blood loss is anticipated
· Comorbidity (e.g., peptic ulcer disease, hypertension)
· Mandated anticoagulation therapy
· Profession (e.g., construction worker) or lifestyle (e.g., plays contact sports) that predisposes member to trauma
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Nplate [package insert]. Thousand Oaks, CA: Amgen Inc.; February 2022.
2. The NCCN Drugs & Biologics Compendium® © 2020 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed June 15, 2021.
3. The NCCN Clinical Practice Guidelines in Oncology® Myelodysplastic Syndrome (Version 2.2020). © 2021 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed June 15, 2021.
4. Nuenert C, Terrel DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv 2019;3(23):3829–3866.
5. Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv 2019;3(22): 3780–3817.
6. Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113(11):2386-2393.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 1/1/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.