Prior Auth Protocol

FDA Approved Indications:

Promacta

For the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Promacta should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.
For the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Safety and efficacy have not been established in combination with direct acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. Promacta should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.
For the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Nplate

For the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Nplate is not indicated in the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than chronic ITP. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts.

Health Net Approved Indications and Usage Guidelines:

Chronic Immune (idiopathic) Thrombocytopenic Purpura (ITP) - Promacta and Nplate Requests

Patients with immune (idiopathic) thrombocytopenia purpura whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. Promacta/Nplate should not be used in an attempt to normalize platelet counts.

Chronic Hepatitis C (CHC) - Promacta Requests Only

Diagnosis of thrombocytopenia in patients with chronic hepatitis C to allow initiation and maintenance of interferon-based therapy with ribavirin.

Severe Aplastic Anemia - Promacta Requests Only

Diagnosis of severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

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.

General Information:

Promacta should not be used to normalize platelet counts. In patients with chronic hepatitis C, Promacta should be used only in patients whose degree of thrombocytopenia prevents the initiation of interferon therapy or limits the ability to maintain optimal interferon-based therapy.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
cyclosporine	Dosage varies for treatment of aplastic anemia	This section intentionally left blank
methylprednisolone	Dosage varies for treatment of aplastic anemia	This section intentionally left blank

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Promacta (eltrombopaq)

ITP
50 mg PO QD for most adult and pediatric patients 6 years and older;
reduce initial dose in patients of East Asian ancestry or patients
with hepatic insufficiency. Do not exceed a daily dose of 75 mg.

25 mg PO QD for pediatric patients aged 1 to 5 years; reduce initial dose in patients of East Asian ancestry or patients with hepatic insufficiency. Do not exceed a daily dose of 75 mg.

NATL: One month initially
Then length of benefit provided patient maintains a platelet count between 50 x 10⁹/L and 200 x 10⁹/L

HNCA/HNMC: Length of benefit

Promacta (eltrombopaq)

Chronic Hepatitis C-associated thrombocytopenia

25 mg PO QD

Adjust to achieve a target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg.

Platelet Count Result	Dose Adjustment or Response
<50 x 10⁹/L following at least 2 weeks of Promacta	Increase daily dose by 25 mg (maximum of 100 mg/day)
≥200 x 10⁹/L to ≤400 x 10⁹/L at any time	Decrease the daily dose by 25 mg
>400 x 10⁹/L	Stop Promacta; increase the frequency of platelet monitoring to twice weekly Once the platelet count is <150 x 109/L, reinitiate Promacta at a daily dose reduced by 25 mg. For patients taking the 25 mg PO QD, reinitiate Promacta at a daily dose of 12.5 mg.
>400 x 10⁹/L after 2 weeks of therapy at lowest dose of Promacta	Discontinue Promacta

Coincide with duration of peg-interferon/ribavirin authorization to maintain target platelet count.

Nplate (romiplostim)

ITP
Initial dose of 1 mcg/kg (actual body weight) once weekly as a SC injection.
Do not exceed the maximum weekly dose of 10 mcg/kg.

NATL: One month initially.
Then 6 months or to member's renewal period, whichever is sooner, provided the patient maintains a platelet count between 50 x 10⁹/L and 200 x 10⁹/L

HNCA/HNMC: 6 months or to members renewal period, whichever is longer.

Promacta (eltrombopaq)

Aplastic Anemia
50 mg PO QD for most patients; reduce initial dose for patients of East Asian ancestry or patients with hepatic insufficiency.
Do not exceed a daily dose of 150 mg.

NATL: Four months initially. then length of benefit provided patient maintains a platelet count between 50 x 10⁹/L and 200 x 10⁹/L

HNCA/HNMC: Length of benefit

Product Availability:

Promacta tablet: 12.5 mg, 25 mg, 50 mg, 75 mg and 100 mg

Nplate: 250 mcg, 500 mcg single-use vials

References:

Promacta [Prescribing information] Research Triangle Park, NC: GlaskoSmithKline; September 2015.
Nplate [Prescribing information] Thousand Oaks, CA: Amgen; April 2016.
Bussel JB, Cheng G, Saleh MN, et al. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med 2007;357(22):2237-2247.
Promacta. In DrugPoints^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 7, 2016.
Nplate. In DrugPoints^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 7, 2016.
Promacta. American Hospital Formulary Service Drug Information. Available at:http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 7, 2016.
Nplate. American Hospital Formulary Service Drug Information. Available at:http://www.medicinescomplete.com/mc/ahfs/current/. Accessed July 7, 2016.
GlaxoSmithKline. Date on File. Study TPL103922/ENABLE 1 and TPL108390/ENABLE 2. (RMT4083). 2011.
AASLD/IDSA/IASUSA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed July 7, 2016.