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09-J1000-13

Original Effective Date: 11/15/09

Reviewed: 06/08/16

Revised: 07/15/16

Subject: Eltrombopag (Promacta®) Tablets

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:

Eltrombopag (Promacta®) is an oral small molecule thrombopoietin (TPO) mimetic that increases platelet production by binding and activating the TPO receptor, similar to endogenous TPO. In November 2008, the US Food and Drug Administration (FDA) granted the accelerated approval for eltrombopag for treatment of thrombocytopenia in persons with chronic immune thrombocytopenia purpura (ITP) whose disease was refractory to corticosteroids, immunoglobulins, or splenectomy; full approval was granted in March 2011. In November 2012, the FDA approved eltrombopag for the treatment of thrombocytopenia in persons with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. In August 2014, the FDA approved the use of eltrombopag for patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

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 antagonists (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 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 before splenectomy is unclear. Lastly, the durability of response associated with TPO receptor antagonists 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:

Comparative Effectiveness

The Food and Drug Administration has deemed the drug(s) or biological product(s) in this coverage policy to be appropriate for self-administration or administration by a caregiver (i.e., not a healthcare professional). Therefore, coverage (i.e., administration) in a provider-administered setting such as an outpatient hospital, ambulatory surgical suite, physician office, or emergency facility is not considered medically necessary.

I. Initiation of eltrombopag (Promacta®) meets the definition of medical necessity when used to treat thrombocytopenia associated with ANY of the following conditions:

A. Chronic immune (idiopathic) thrombocytopenic purpura (ITP) and ALL of the following are met:

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

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

b. Immunoglobulins therapy (e.g., intravenous immune globulin [IVIG])

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

3. The member does not have chronic liver disease

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

5. Eltrombopag is not used concurrently with another thrombopoietin receptor agonist (e.g., romiplostim [Nplate™])

6. The dosage does not exceed 75 mg daily and will be achieved using the fewest number of tablets per day.

B. Chronic hepatitis C virus (HCV) infection and ALL of the following are met:

1. The member’s platelet count is less than 75,000

2. The intent of eltrombopag therapy is one of the following:

a. To allow the member to initiate interferon-based therapy

b. To allow the member to maintain interferon based therapy

3. The member is 18 years of age or older.

4. Eltrombopag is not used concurrently with another thrombopoietin receptor agonist (e.g., romiplostim [Nplate™])

5. The dosage does not exceed 100 mg daily and will be achieved using the fewest number of tablets per day.

C. Severe aplastic anemia (SAA) and ALL of the following are met:

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

2. The member has demonstrated an insufficient response to immunosuppressive therapy(e.g.,anti-thymocyte globulin, cyclosporine)

3. The member is 18 years of age or older

4. Eltrombopag is not used concurrently with another thrombopoietin receptor agonist (e.g., romiplostim [Nplate™])

5. The dosage does not exceed 150 mg daily and will be achieved using the fewest number of tablets per day.

Approval duration: 8 weeks (ITP, HCV), 16 weeks (SAA)

II. Continuation of therapy eltrombopag (Promacta®) meets the definition of medical necessity when used for treatment of adult members (i.e., 18 years of age or older) with thrombocytopenia associated with one of the following conditions and ALL of the condition-specific criteria are met:

A. Chronic ITP

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

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

3. Eltrombopag is not used concurrently with another thrombopoietin receptor agonist (e.g., romiplostim [Nplate™])

4. The dose does not exceed 75 mg daily and will be achieved using the fewest number of tablets per day.

B. Chronic HCV infection

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

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

3. The member is receiving concomitant interferon-based therapy

4. Eltrombopag is not used concurrently with another thrombopoietin receptor agonist (e.g., romiplostim [Nplate™])

5. The dose does not exceed 100 mg daily and will be achieved using the fewest number of tablets per day.

C. Severe aplastic anemia

1. The member has been previously approved by Florida Blue or another healthplan in the past 2 years for eltrombopag for the treatment of severe aplastic anemia, OR the member has previously met all indication-specific criteria

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

3. Eltrombopag is not used concurrently with another thrombopoietin receptor agonist (e.g., romiplostim [Nplate™])

4. The dose does not exceed 150 mg daily and will be achieved using the fewest number of tablets per day.

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: eltrombopag is indicated for the treatment of thrombocytopenia in in adult and pediatric patients 1 year and older with chronic immune thrombocytopenia (ITP) with an insufficient response to corticosteroids, immunoglobulins, or splenectomy. It is also indicated for thrombocytopenia in patients with chronic hepatitis C virus (HCV) to allow the initiation and maintenance of interferon-based therapy and for patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Dose adjustments are based upon the platelet count response. Do not use eltrombopag in an attempt to normalize platelet counts.

Eltrombopag should be administered on an empty stomach (1 hour before or 2 hours after a meal). Allow at least a 4-hour interval between eltrombopag and other medications (e.g., antacids), calcium-rich foods (e.g., dairy products and calcium fortified juices), or supplements containing polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc.

ITP

• Initial dose: 50 mg once daily for most adult patients and pediatric patents 6 years of age and older and 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed in persons of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A, B, C).

- East Asian ancestry, initiate eltrombopag at a reduced dose of 25 mg once daily.

- Mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate eltrombopag at a reduced dose of 25 mg once daily.

- East Asian ancestry with hepatic impairment (Child-Pugh Class A, B, C), initiate eltrombopag at a reduced dose of 12.5 mg once daily.

• Use the lowest dose of eltrombopag to achieve and maintain a platelet count ≥50,000 as necessary to reduce the risk for bleeding.

• Do not exceed a dose of 75 mg daily.

• Monitor clinical hematology and liver tests regularly throughout therapy with eltrombopag and modify the dosage regimen of eltrombopag based on platelet counts as outlined in Table 1. During therapy with eltrombopag, assess CBCs with differentials, including platelet count, weekly until a stable platelet count has been achieved. Obtain CBCs with differentials, including platelet counts, monthly thereafter.

Table 1

Dose Adjustments of Eltrombopag in Adults with ITP

Platelet Count Result

Dose Adjustment or Response

<50,000 following at least 2 weeks of eltrombopag

Increase daily dose by 25 mg to a maximum of 75 mg/day

For persons taking 12.5 mg once daily; increase the dose to 25 mg daily before increasing the dose amount by 25 mg.

≥200,000 to ≤400,000 at any time

Decrease the daily dose by 25 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.

For persons taking 25 mg once daily, decrease the dose to 12.5 mg daily.

>400,000

Stop eltrombopag; increase the frequency of platelet monitoring to twice weekly.

Once the platelet count is <150 x 109/L, reinitiate therapy at a daily dose reduced by 25 mg.

For persons taking 25 mg once daily, reinitiate therapy at a daily dose of 12.5 mg.

>400,000 after 2 weeks of therapy at lowest dose of eltrombopag

Discontinue eltrombopag

• In ITP patients with hepatic impairment, after initiating eltrombopag or after any subsequent dosing increase, wait 3 weeks before increasing the dose.

• Discontinue eltrombopag if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy with eltrombopag at the maximum daily dose of 75 mg. Excessive platelet count responses, as outlined in Table 1, or important liver test abnormalities also necessitate discontinuation of eltrombopag.

HCV

Use the lowest dose of eltrombopag to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin. Dose adjustments are based upon the platelet count response. Do not use eltrombopag to normalize platelet counts.

• Initial Dose: Initiate eltrombopag at a dose of 25 mg once daily.

• Monitoring and Dose Adjustment: Adjust the dose of eltrombopag in 25 mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Monitor platelet counts every week prior to starting antiviral therapy.

• During antiviral therapy, adjust the dose of eltrombopag to avoid dose reductions of peginterferon. Monitor CBCs with differentials (including platelet counts) weekly during antiviral therapy until a stable platelet count is achieved. Monitor platelet counts monthly thereafter. Do not exceed a dose of 100 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with eltrombopag.

For specific dosage instructions for peginterferon or ribavirin, refer to their respective prescribing information.

Table 2

Dose Adjustments of Eltrombopag in Adults with Chronic HCV

Platelet Count Result

Dose Adjustment or Response

<50,000 following at least 2 weeks of eltrombopag

Increase daily dose by 25 mg to a maximum of 100 mg/day

≥200,000 to ≤400,000 at any time

Decrease the daily dose by 25 mg.

Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.

>400,000

Stop eltrombopag; increase the frequency of platelet monitoring to twice weekly.

Once the platelet count is <150 x 109/L, reinitiate therapy at a daily dose reduced by 25 mg.

For persons taking 25 mg once daily, reinitiate therapy at a daily dose of 12.5 mg.

>400,000 after 2 weeks of therapy at lowest dose of eltrombopag

Discontinue eltrombopag

• Discontinuation: The prescribing information for pegylated interferon and ribavirin include recommendations for antiviral treatment discontinuation for treatment futility. Refer to pegylated interferon and ribavirin prescribing information for discontinuation recommendations for antiviral treatment futility.

• Eltrombopag should be discontinued when antiviral therapy is discontinued. Excessive platelet count responses or important liver test abnormalities also necessitate discontinuation of eltrombopag.

SAA

Use the lowest dose of eltrombopag to achieve and maintain a platelet count necessary to maintain a hematologic response. Dose adjustments are based upon the platelet count response. Hematologic response requires dose titration.

• Initial dose: 50 mg once daily, except in persons of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean) or who have mild to severe hepatic impairment (Child-Pugh Class A, B, C).

- East Asian ancestry, initiate eltrombopag at a reduced dose of 25 mg once daily.

- Mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate eltrombopag at a reduced dose of 25 mg once daily.

• After initiating eltrombopag, adjust the dose every 2 weeks as necessary to achieve and maintain a platelet count ≥50,000.

• Do not exceed a dose of 150 mg daily.

• Monitor clinical hematology and liver tests regularly throughout therapy with eltrombopag and modify the dosage regimen of eltrombopag based on platelet counts as outlined in Table 3. During therapy with eltrombopag, assess CBCs with differential, including platelet count, weekly until a stable platelet count has been achieved. Obtain CBCs with differentials, including platelet counts, monthly thereafter.

Table 3

Dose Adjustments of Eltrombopag in Adults with SAA

Platelet Count Result

Dose Adjustment or Response

<50,000 following at least 2 weeks of eltrombopag

Increase daily dose by 50 mg to a maximum of 150 mg/day

For persons taking 25 mg once daily; increase the dose to 50 mg daily before increasing the dose amount by 50 mg.

≥200,000 to ≤400,000 at any time

Decrease the daily dose by 50 mg. Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.

>400,000

Stop eltrombopag for 1 week.

Once the platelet count is <150 x 109/L, reinitiate therapy at a daily dose reduced by 50 mg.

>400,000 after 2 weeks of therapy at lowest dose of eltrombopag

Discontinue eltrombopag

• For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks: the dose of eltrombopag may be reduced by 50%. If counts remain stable after 8 weeks at the reduced dose, then discontinue eltrombopag and monitor blood counts. If platelet counts drop to less than 30,000, hemoglobin to less than 9 g/dL, or ANC to less than 0.5 x 109/L, eltrombopag may be reinitiated at the previous effective dose.

• Discontinue eltrombopag if no hematologic response has occurred after 16 weeks of therapy. If new cytogenetic abnormalities are observed, consider discontinuation of eltrombopag. Excessive platelet count responses, as outlined in Table 3, or important liver test abnormalities also necessitate discontinuation of eltrombopag.

Drug Availability: Eltrombopag is supplied as a tablet in the following strengths, 12.5-, 25-, 50-, 75-, and 100 mg and is also available as a 25 mg packet for oral suspension.

PRECAUTIONS:

Boxed Warning:

Eltrombopag may cause hepatotoxicity. When used in combination with interferon and ribavirin in persons with chronic HCV infection, eltrombopag may increase the risk of hepatic decompensation.

• Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of eltrombopag, every 2 weeks during the dose adjustment phase, and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.

• Evaluate abnormal serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline levels.

• Discontinue eltrombopag if ALT levels increase to ≥3X upper limit of normal (ULN) in persons with normal liver function or ≥3X baseline in persons with pre-treatment elevations in transaminases and are:

- progressively increasing, or

- persistent for ≥4 weeks, or

- accompanied by increased direct bilirubin, or

- accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation

Warnings/Precautions:

Hepatotoxicity: monitor liver function before and during therapy.

Hepatic decompensation: hepatic decompensation can occur in persons with chronic hepatitis C infection. Monitor persons with low albumin levels or with a MELD score of 10 or greater at baseline.

Thrombotic/thromboembolic complications: portal vein thrombosis has been reported in persons with chronic liver disease receiving eltrombopag. Monitor platelet counts regularly.

Cataracts: monitor patients regularly for signs and symptoms of cataracts developing or worsening.

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding

J8499

Prescription drug, oral, non-chemotherapeutic, Not Otherwise Specified

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

B18.2

Chronic Viral Hepatitis C

D69.3

Immune thrombocytopenic purpura

D61.09

Other constitutional aplastic anemia

D61.1

Drug-induced aplastic anemia

D61.2

Aplastic anemia due to other external agents

D61.3

Idiopathic aplastic anemia

D61.89

Other specified aplastic anemias and other bone marrow failure syndromes

D61.9

Aplastic anemia, unspecified

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) and/or Local Coverage Determination (LCD) were found at the time of the last guideline revised date.

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:

Hepatitis C Drug Therapy, 09-J0000-53
Immune Globulin Therapy, 09-J0000-06

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

Rituximab (Rituxan®), 09-J0000-59

Romiplostim Injection (Nplate™), 09-J0000-88

OTHER:

None applicable.

REFERENCES:

  1. 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.
  2. Cheng G. Eltrombopag, a thrombopoietin-receptor agonist in the treatment of adult chronic immune thrombocytopenia: a review of the efficacy and safety profile. Ther Adv Hematol 2012:3(3):155-64.
  3. Clinical Pharmacology. [database online]. Tampa, FL: Gold Standard, Inc.; 2016. URL. www.Clinicalpharamcology-ip.com Accessed 5/16/16.
  4. Corman SL, Mohammad RA. Eltrombopag: A Novel Oral Thrombopoietin Receptor Agonist. Ann Pharmacother. 2010 May 11.
  5. Danish F, Yasmin S. The role of eltrombopag in the management of hepatitis C virus-related thrombocytopenia. Hepat Med 2013;15(50:17-30).
  6. Eltrombopag. 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].
  7. 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. 2011; 144(3): 09-415. Epub 2008 Nov 11.
  8. McHutchison JG, Dusheiko G, Shiffman ML, et al. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med 2007;357:2227-36.
  9. Micromedex ® Healthcare Series [Internet Database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed 5/16/16.
  10. Promacta (eltrombopag) [package insert]. Novartis Pharmaceuticals. East Hanover, NJ: August 2015
  11. Olnes M.J., Scheinberg P. Calvo K.R., et al. Eltrombopag and improved hematopoiesis in refractory aplastic anemia. N Engl J Med. 2012; 367:11-19.
  12. Desmond R, Townsley DM, Dumitriu B et al. Eltrombopag restores trilineage hematopoiesis in refractory severe aplastic anemia that can be sustained on discontinuation of drug. Blood. 2014; 123: 1818-25.

COMMITTEE APPROVAL:

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

GUIDELINE UPDATE INFORMATION:

11/15/09

New Medical Coverage Guideline.

07/15/10

Review and revision to guideline; consisting of adding criteria of absence of chronic liver disease, updated precautions and references.

01/15/11

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

07/15/11

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

03/15/12

Revision to guideline; consisting of removing requirement for REMS enrollment.

07/15/12

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

02/15/13

Update to include new indication thrombocytopenia in HCV therapy, updated to include continuation of therapy for ITP and thrombocytopenia in HCV therapy

07/15/13

Review and revision to guideline; consisting of revising/reformatting position statement; revising/ reformatting description, dosage/administration, program exceptions and precautions section; updating references.

07/15/14

Review and revision to guideline; consisting of revising and reformatting the position statement. Updated dosage/administration section and references.

7/15/15

Review and revision to guidelines; consisting of revising and reformatting the position statement, description, dosage/administration, precautions and references section.

10/15/15

Revision to guideline; consisting of position statement

11/01/15

Revision: ICD-9 Codes deleted.

07/15/16

Review and revision to guidelines; consisting of updating the position statement, description, dosing, coding and references section.

Date Printed: August 23, 2017: 06:09 AM