Print

Date Printed: August 23, 2017: 01:31 PM

Private Property of Blue Cross and Blue Shield of Florida.
This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J0000-88

Original Effective Date: 03/15/09

Reviewed: 06/08/16

Revised: 07/15/16

Subject: Romiplostim Injection (Nplate™)

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Related Guidelines Other References Updates  
           

DESCRIPTION:

Romiplostim (Nplate™) is an injectable thrombopoietin (TPO) mimetic that increases platelet production by binding and activating the TPO receptor, similar to endogenous TPO. In August 2008, the US Food and Drug Administration (FDA) approved romiplostim for treatment of thrombocytopenia in persons with chronic immune thrombocytopenia purpura (ITP) whose disease was refractory to corticosteroids, immunoglobulins, or splenectomy.

ITP is an autoimmune disorder characterized by a destruction of otherwise normal platelets and frequently occurs without a known or identifiable cause; it is considered a diagnosis of exclusion as there are no diagnostic tests to confirm ITP. In 1996, the American Society of Hematology (ASH) published a guideline outlining the diagnosis and management of ITP. This guideline was updated in 2011 due to advances in the definition and treatment of ITP. Treatment of newly diagnosed ITP is recommended when the platelet count is less than 30,000; this recommendation is considered standard of care by most clinicians and current evidence does not stipulate the minimal threshold of platelet count or a specific age threshold that an “average” person with ITP should be treated. Initial treatment options for ITP include:

• longer courses of corticosteroids (e.g., prednisone 1-2 mg/kg for 21 days) over shorter courses of corticosteroids (e.g., dexamethasone 40 mg for 4 days) or intravenous immune globulin (IVIG) as first line treatment

• IVIG in combination with corticosteroids when a more rapid response in platelet count is required

• Either IVIG or anti-D (in appropriate persons) as first line treatment if corticosteroids are contraindicated

Persons who are unresponsive to or relapse after initial corticosteroid therapy are considered to have chronic ITP. In this setting, the following treatment options are recommended:

• Splenectomy

• Thrombopoietin receptor agonists (e.g., eltrombopag [Promacta] or romiplostim [Nplate]) in persons at risk of bleeding who relapse after splenectomy or who have a contraindication to splenectomy and who have failed at least one other therapy

• Rituximab (Rituxan) may be considered for persons at risk of bleeding who have failed one line of therapy such as corticosteroids, IVIG or splenectomy

The development of TPO receptor agonists expanded the treatment armamentarium for persons with chronic ITP and these agents have been characterized as the most important advance in the management of ITP since the role of IVIG was discovered. Despite their contribution and therapeutic impact, several unanswered questions remain. Current ASH guidelines do not define the appropriate sequencing of second-line therapies and their use prior to splenectomy is unclear. Lastly, the durability of response associated with TPO receptor agonists is disquieting as they rarely produce off-treatment sustained remission. At this time, splenectomy remains the only treatment that provides sustained remission off-treatment at one year and beyond in a high proportion of persons with ITP.

POSITION STATEMENT:

I. Initiation of romiplostim (Nplate™) meets the definition of medical necessity when used to treat thrombocytopenia associated with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and ALL of the following criteria are met:

A. The member has demonstrated an insufficient response to EITHER of the following:

1. Adequate trial of corticosteroids (e.g., prednisone 1-2 mg/kg for 2-4 weeks)

2. Immunoglobulin therapy (e.g., intravenous immune globulin [IVIG])

B. The member has relapsed following splenectomy or has a contraindication to splenectomy

C. The member has tried/failed or has a contraindication to eltrombopag (Promacta)

D. The member’s platelet count is less than 30,000

E. Romiplostim is not used concurrently with another thrombopoietin receptor agonist (e.g., eltrombopag)

F. The dosage does not exceed 10 mcg/kg in 7 days and will be achieved using the fewest number of vials per dose.

Approval Duration: 8 weeks

II. Continuation of romiplostim meets the definition of medical necessity when used for the treatment of thrombocytopenia associated with chronic ITP when ALL of the following criteria are met:

A. The member has been previously approved by Florida Blue or another healthplan in the past 2 years for romiplostim for the treatment of chronic ITP, OR the member previously met all indication-specific criteria

B. The member has a beneficial response to therapy evidenced by a platelet count between 50,000 and 400,000

C. Romiplostim is not used concurrently with another thrombopoietin receptor agonist (e.g., eltrombopag)

D. The dose does not exceed 10 mcg/kg in 7 days and will be achieved using the fewest number of vials per dose.

Approval duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

FDA-approved: romiplostim is indicated for treatment of thrombocytopenia in persons with chronic immune thrombocytopenia (ITP) with an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Therapy should only be used in persons with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding; it should not be used in an attempt to normalize platelet counts. Romiplostim is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome or any cause of thrombocytopenia other than chronic ITP.

Initial dose: 1 mcg/kg subcutaneously once weekly. The dose should be based on actual body weight.

Dose adjustments: dose adjustments are based on platelet counts. During romiplostim therapy, assess complete blood cell counts (CBCs), including platelet count and peripheral blood smears, weekly until a stable platelet count (50,000 or higher for at least 4 weeks without dose adjustment) has been achieved. Obtain CBCs, including platelet counts and peripheral blood smears, monthly thereafter.

The weekly dose of romiplostim is adjusted in increments of 1 mcg/kg until a platelet count of at least 50,000 as necessary to reduce the risk for bleeding; do not exceed a maximum weekly dose of 10 mcg/kg.

The manufacturer recommends the following dose adjustments based on platelet count:

• If the platelet count is less than 50,000, increase the dose by 1 mcg/kg.

• If platelet count is more than 200,000 for 2 consecutive weeks, reduce the dose by 1 mcg/kg.

• If platelet count is more than 400,000 do not administer. Continue to assess the platelet count weekly. After the platelet count has fallen to less than 200,000, resume romiplostim at a dose reduced by 1 mcg/kg.

Discontinuation: Discontinue romiplostim if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of romiplostim therapy at the maximum weekly dose of 10 mcg/kg. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation of romiplostim.

Maximum dose: 10 mcg/kg weekly.

Drug Availability: romiplostim is supplied as 250- or 500 mcg single-use vials.

PRECAUTIONS:

Malignancy: in persons with myelodysplastic syndrome, romiplostim increases blast cell counts and increases the risk of progression to acute myelogenous leukemia.

Coagulopathy: thrombotic/thromboembolic complications may results from increases in platelet counts with romiplostim use. Portal vein thrombosis has been reported in persons with chronic liver disease receiving romiplostim; as such, romiplostim should be used with caution in persons with concomitant ITP and chronic liver disease.

Laboratory monitoring: obtain CBCs, including platelet counts, weekly during the dose-adjustment phase of therapy and then monthly following establishment of a stable dose. Obtain CBCs, including platelet counts, weekly for at least 2 weeks following discontinuation.

Neutralizing antibodies: if severe thrombocytopenia develops during romiplostim treatment, assess for formation of neutralizing antibodies.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

J2796

Injection, romiplostim, 10 micrograms

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

D69.3

Immune thrombocytopenic purpura

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products: No National Coverage Determination (NCD) was found at the time of the last guideline revised date. The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Romiplostim (Nplate), (L33748) located at fcso.com.

Medicare Part D: Florida Blue has delegated to Prime Therapeutics authority to make coverage determinations for the Medicare Part D services referenced in this guideline.

DEFINITIONS:

Thrombocytopenic Purpura: any of various types associated with a decrease in the number of platelets in the blood; there are two general types: in the primary or idiopathic type, the cause is unknown. The secondary or symptomatic type may be associated with exposure to drugs or other chemical agents or with any of numerous different diseases. The most prominent symptoms are bruising and petechiae. In the acute form there may be bleeding from body orifices.

RELATED GUIDELINES:

Eltrombopag (Promacta®) Tablets, 09-J1000-13
Immune Globulin Therapy, 09-J0000-06

Lenalidomide (Revlimid®), 09-J0000-80

Oprelvekin; Interleukin 11 (Neumega®), 09-J0000-63

Rituximab (Rituxan), 09-J0000-59

OTHER:

None applicable.

REFERENCES:

  1. Arnold DM. Positioning new treatment in the management of immune thrombocytopenia. Pediatr Blood Cancer 2013;60 Suppl 1:S19-22.
  2. Burzynski J. New options after first-line therapy for chronic immune thrombocytopenic purpura. Am J Health Syst Pharm 2009; 66 (2 Suppl 2): s11-21.
  3. Clinical Pharmacology. [database online]. Tampa, FL: Gold Standard, Inc.; 2016. URL. www.Clinicalpharamcology-ip.com Accessed 5/16/16
  4. George JN, Mathias SD, Go RS, Guo M, Henry DH, Lyons R, Redner RL, Rice L, Schipperus MR. Improved quality of life for romiplostim-treated patients with chronic immune thrombocytopenic purpura: results from two randomized, placebo-controlled trials. Br J Haematol. 2009 Feb 1; 144(3): 09-415. Epub 2008 Nov 11.
  5. Micromedex ® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 5/16/16.
  6. Neunert C, Lim W, Crowther M, et al. The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia. Blood 2011;117(16):4190-4207.
  7. Nplate (romiplostim) [package insert]. Amgen, Inc. Thousand Oaks (CA): April 2016.
  8. Romiplostim. In McEvoy GK, editor. AHFS drug information 2016 [monograph on the internet]. Bethesda (MD): American Society of Health-System Pharmacists; 2016 [cited 2016 May 16].

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 06/08/16.

GUIDELINE UPDATE INFORMATION:

03/15/09

New Medical Coverage Guideline.

04/15/09

Revision to guideline; consisting of adding coverage criteria of participation in Nplate™ program and platelet count and listing of non covered indications.

01/01/10

Annual HCPCS coding update: added HCPCS code J2796.

07/15/10

Review and revision to guideline; consisting of adding criteria of 18 years old or older, updated precautions section and updated references.

01/15/11

Revision to guideline; consisting of adding ICD-10 codes.

07/15/11

Review and revision to guideline; consisting of adding maximum dose to coverage criteria and update references.

07/15/12

Review and revision to guideline; consisting of updating position statement, precautions, program exceptions and references.

07/15/13

Review and revision to guideline; consisting of revising position statement to include recommendations from current American Society of Hematology guidelines for treatment of ITP, reformatting and revising description, dosage/administration, program exceptions and precautions section; updating references.

07/15/14

Review and revision to guideline; consisting of revising position statement and updating references.

07/15/15

Review and revision to guideline; consisting of updating precautions and references.

10/01/15

Revision consisting of update to Program Exceptions section.

10/15/15

Revision to guideline; consisting of updated position statement.

11/01/15

Revision: ICD-9 Codes deleted.

07/15/16

Review and revision to guideline; consisting of updating position statement, description, and references.

Date Printed: August 23, 2017: 01:31 PM