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Asset Publisher
Thrombopoietin Receptor Agonists and Tavalisse Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1075
Nplate is listed for information purpose only and is not targeted in the program.
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
|
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Alvaiz™ |
Limitations of Use:
|
|
16 |
Doptelet® |
|
|
1 |
Mulpleta® |
|
|
2 |
Nplate® |
Limitations of Use:
|
|
3 |
Promacta® |
Limitations of Use:
|
|
4 |
Tavalisse® |
|
|
5 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
ITP |
Immune (idiopathic) thrombocytopenia (ITP) is an acquired autoimmune disorder characterized by a low platelet count resulting from platelet destruction and impaired platelet production. ITP can be an isolated primary condition, or it may be secondary to other conditions. The goal of all treatment strategies for ITP is to achieve a platelet count that is associated with adequate hemostasis, rather than a normal platelet count. Bleeding events are often unpredictable and patients with ITP, even in the setting of severe thrombocytopenia, may not exhibit bleeding beyond bruising and petechiae. However, more serious mucosal bleeding may occur, including menorrhagia, epistaxis, gastrointestinal hemorrhage, hematuria, or, rarely, intra-cranial hemorrhage. The decision as to whether a patient can be observed or requires further intervention is highly complex and varies based on comorbidities, medications, and age, which all impact the risk of bleeding. In addition, management approaches may vary based on disease duration, access to care, quality-of-life implications, and patient and provider preferences, among other factors. An International Working Group consensus panel defines ITP as newly diagnosed (diagnosis to 3 months), persistent (3-12 months from diagnosis), or chronic (lasting for more than 12 months).(6)
|
HCV associated thrombocytopenia |
A number of studies have suggested an association between hepatitis C virus (HCV) infection and immune thrombocytopenia (ITP) and/or autoimmune hemolytic anemia, either as a consequence of interferon therapy or in the setting of chronic infection without therapy. One of the largest studies included 120,691 United States veterans with chronic HCV who were matched with 454,905 controls. HCV was associated with ITP in both treated and untreated patients (hazard ratio 1.8).(11) |
Aplastic anemia |
Aplastic anemia (AA) is a diagnosis of exclusion. There is no single test that can be used to consistently diagnose AA from the multiple of other causes of bone marrow failure and the diagnostic evaluation must assess for and exclude these alterative etiologies. At initial presentation many patients exhibit fatigue, weakness, pallor, and headaches due to anemia. Often patients have petechiae of the skin and mucous membranes, epistaxis, and/or gum bleeding related to severe thrombocytopenia. Fever and infections can also be seen in these patients as a result of low white blood cell counts and neutropenia. AA patients identified earlier in the course of the disease by abnormalities found on routine laboratory testing may not have any physical manifestations of their disease.(15) |
Thrombocytopenia in liver disease |
Patients with acute and chronic liver disease frequently acquire unique changes in hemodynamic and hemostatic pathways that may result in life-threatening bleeding and thrombosis. Additionally, activation of hemostatic pathways may play a role in disease progression through prechymal extinction, or organ atrophy, recruitment of inflammatory cells and activation of stellate cells.(12) |
Hematopoietic syndrome of ARS |
Acute radiation syndrome (ARS) (sometimes known as radiation toxicity or radiation sickness) is an acute illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a very short period of time (usually a matter of minutes). The major cause of this syndrome is depletion of immature parenchymal stem cells in specific tissues. The three classic ARS syndromes are hematopoietic syndrome, gastrointestinal (GI) syndrome, and cardiovascular (CV)/central nervous system (CNS) syndrome. Of the 3, the hematopoietic syndrome is the only one that may be reversed through medical intervention preventing death. The survival rate of patient with bone marrow syndrome decreases with increasing dose. The primary cause of death is the destruction of the bone marrow resulting in infection and hemorrhage.(14) The required conditions for ARS are:(14)
|
Efficacy |
Doptelet(1) Doptelet (avatrombopag) is a thrombopoietin receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in an increased production of platelets. The efficacy of Doptelet for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure was established in 2 identically-designed multicenter, randomized, double-blind, placebo-controlled trials (ADAPT-1 and ADAPT-2). In each study, patients were assigned to the low baseline platelet count cohort (less than 40 X 10^9/L) or high baseline platelet count cohort (greater than or equal to 40 to less than 50 X 10^9/L) based on their platelet count at baseline. In the ADAPT-1 trial 149 patients were treated with Doptelet and 82 patients were treated with placebo both once daily for 5 days. In the ADAPT-2 trial, 128 patients were treated with Doptelet and 76 patients were treated with placebo. Across both baseline platelet count cohorts and the Doptelet and placebo treatment groups, patients underwent a broad spectrum of types of scheduled procedures that ranged from low to high bleeding risk. The major efficacy outcome in both trials was the proportion of patients who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following an elective procedure. Additional secondary efficacy outcomes were the proportion of patients who achieved platelet counts of greater than or equal to 50 X 10^9/L on the day of procedure and the change in platelet count from baseline to procedure day. Responders were defined as patients who did not require a platelet transfusion or any rescue procedure (whole blood transfusion, packed red blood cell transfusion, platelet transfusion, fresh frozen plasma or cryoprecipitate administration, Vitamin K, desmopressin, recombinant activated factor VII, aminocaproic acid, tranexamic acid, or surgical or interventional radiology performed to achieve hemostasis and control blood loss) for bleeding after randomization and up to 7 days following a scheduled procedure. In both baseline platelet count cohorts, patients in the Doptelet treatment groups had a greater proportion of responders than the corresponding placebo treatment groups that was both clinically meaningful and statistically significant. The percentage of responders in the low baseline platelet count cohort and treatment group that responded in the ADAPT-1 trial was 66% in the Doptelet group and 23% in the placebo group (p-value less than 0.0001). In the Adapt-2 trial the percentage of responders was 69% in the Doptelet group and 35% in the placebo group (p-value 0.0006). The percentage of responders in the high baseline platelet count cohort in ADAPT-1 trial was 88% in the Doptelet group and 38% in the placebo group (p-value less than 0.0001). In the ADAPT-2 trial the percentage of responders was 88% in the Doptelet group and 33% in the placebo group (p-value less than 0.0001). Both trials also demonstrated a higher proportion of patients who achieved the target platelet count of greater than or equal to 50 X 10^9/L on the day of the procedure (a secondary efficacy endpoint) and a greater mean change in platelet counts from baseline to the day of the procedure (a secondary efficacy endpoint). The efficacy of Doptelet in adult patients with chronic immune thrombocytopenia was evaluated in a phase 3, multicenter, randomized, double-blind, placebo-controlled trial (NCT01438840). Patients had received one or more chronic immune thrombocytopenia therapies and had an average platelet count (of less than 30 X 10^9/L). The major efficacy outcome was the cumulative number of weeks in which the platelet count was greater than or equal to 50 X 10^9/L during the 6-month treatment period in the absence of rescue therapy. Doptelet-treated patients had a longer duration of platelet counts greater than or equal to 50 x10^9/L in the absence of rescue therapy than those who received placebo (median 12.4 [0, 25] vs 0 [0, 2] weeks, respectively, p less than 0.0001. In addition, a larger proportion of patients in the Doptelet treatment group had platelet counts greater than or equal to 50 X 10^9/L at Day 8 compared to placebo (21/32; 66% vs 0/17; 0.0%, respectively; p less than 0.0001). Mulpleta(2) Mulpleta (lusutrombopag) is an orally bioavailable TPO receptor agonist that interacts with the transmembrane domain of human TPO receptors expressed on megakaryocytes to induce the proliferation and differentiation of megakaryocytic progenitor cells from hematopoietic stem cells and megakaryocyte maturation. The efficacy of Mulpleta for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure was evaluated in 2 randomized, double-blind, placebo-controlled trial (L-PLUS 1 and L-PLUS 2). Patients with chronic liver disease who were undergoing an invasive procedure and had a platelet count less than 50 X 10^9/L were eligible to participate. Patients were randomized to receive 3 mg of Mulpleta or placebo once daily for up to 7 days. In L-PLUS 1 the major efficacy outcome was the proportion of patients who require no platelet transfusion prior to the primary invasive procedure. In L-PLUS 2 the major efficacy outcome was the proportion of patients who required no platelet transfusion prior to the primary invasive procedure and no rescue therapy for bleeding (i.e., platelet preparations, other blood preparations, including red blood cells and plasma, volume expanders) from randomization through 7 days after the primary invasive procedure. In both the L-PLUS 1 and L-PLUS 2 trials, responders were defined as patients who had a platelet count of greater than or equal to 50 X 10^9/L with an increase of greater than or equal to 20 X 10^9/L from baseline. In the L-PLUS 1 trial the percentage of patients not requiring platelet transfusion prior to invasive procedure was 78% in the Mulpleta arm and 13% in the placebo arm (95% CI, p-value less than 0.0001). The percentage of patients that responded during the study was 76% in the Mulpleta arm and 6% in the placebo arm (95%CI, p-value less than 0.0001). In the L-Plus 2 trial the percentage of patients not requiring platelet transfusion prior to invasive procedure or rescue therapy for bleeding from randomization through 7 days after invasive procedure was 65% in the Mulpleta arm and 29% in the placebo arm (95% CI, p-value less than 0.0001). The percentage of patients that responded during the study was 65% in the Mulpleta arm and 13% in the placebo arm (95%CI, p-value less than 0.0001). Nplate(3) Nplate (romiplostim) is a thrombopoietin receptor agonist that increases platelet production through binding and activation of the thrombopoietin (TPO) receptor, similar in mechanism to endogenous TPO. The safety and efficacy of Nplate were assessed in two double-blind, placebo-controlled clinical studies, in an open-label single-arm study, and in an open-label extension study. Efficacy in all studies was defined as maintaining a target platelet count greater than or equal to 50 X 10^9/L. The safety and efficacy of Nplate in pediatric patients 1 year and older with ITP for at least 6 months were assessed in two double-blind, placebo controlled clinical trials. The efficacy in both studies was defined as maintaining a target platelet count of greater than or equal to 50 X 10^9/L. Efficacy studies of Nplate could not be conducted in humans with acute radiation syndrome for ethical and feasibility reasons. Approval for this indication was based on efficacy studies conducted in animals, Nplate’s effect on platelet count in healthy human volunteers, and on data supporting Nplate’s effect on thrombocytopenia in patients with ITP and insufficient response to corticosteroids, immunoglobulins, or splenectomy. Promacta(4) Promacta (eltrombopag) interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production. Safety and efficacy of Promacta in adult patients with persistent or chronic ITP were evaluated in three randomized, double-blind, placebo-controlled trials and in an open-label extension trial. Safety and efficacy of Promacta in pediatric patients 1 year and older with persistent or chronic ITP were evaluated in two double-blind, placebo-controlled trials. All of these trials showed clinically significant efficacy of Promacta vs placebo. Safety and efficacy of Promacta was evaluated in 2 randomized, double-blind, placebo-controlled trials for eltrombopag in treating thrombocytopenia in patients with chronic hepatitis C. One trial used peginterferon alfa-2a (Pegasys); the other used peginterferon alfa-2b (Pegintron), both were in combination with ribavirin. Approximately 30% of patients had been previously treated with interferon and ribavirin. Patients had to have platelet counts of less than 75 x10^9/L. The trials consisted of 2 phases: a pre-antiviral treatment phase and an antiviral treatment phase. Patients were allowed to be randomized for the antiviral treatment phase if they reached the platelet count threshold of greater than or equal to 90 X 10^9/L (trial 1) and greater than or equal to 100 x 10^9/L (trial 2). The maximum allowed time on open label eltrombopag was 9 weeks. The primary efficacy endpoint for both studies was sustained virologic response (SVR) defined as the percentage of patients with undetectable HCV-RNA at 24 weeks after completion of antiviral treatment. The median time to achieve the target platelet count in study 1 was approximately 2 weeks with 95% of patients initiating antiviral therapy. The safety of Promacta as first-line treatment of severe aplastic anemia was established based on a single-arm trial of 153 patients with severe aplastic anemia who had not received prior definitive immunosuppressive therapy. In this trial, Promacta was administered in combination with horse antithymocyte globulin (h-ATG) and cyclosporine. The efficacy of Promacta in combination with h-ATG and cyclosporine was established on the basis of complete hematological response at 6 months. A complete response was defined as hematological parameters meeting all 3 of the following values on 2 consecutive serial blood count measurements at least one week apart: absolute neutrophil count (ANC) greater than 1,000/microliter, platelet count greater than 100 X 10^9/L, and hemoglobin greater than 10 g/dL. A partial response was defined as blood counts no longer meeting the standard criteria for severe pancytopenia in severe aplastic anemia equivalent to 2 of the following values on 2 consecutive serial blood count measurements at least one week apart: ANC greater than 500/microliter, platelet count greater than 20 X 10^9/L, or reticulocyte count greater than 60,000/microliter. Overall response rate is defined as the number of partial responses plus complete responses. The overall response rate at month 6 was 79% (95% CI). The median duration of overall response was 70 months (95% CI). The median duration of complete response was 46 months (95% CI). Promacta was studied in a single-arm, single-center, open-label trial in 43 patients with severe aplastic anemia who had an insufficient response to at least one prior immunosuppressive therapy and who had a platelet count of less than or equal to 30 X 10^9/L. The efficacy was evaluated by the hematologic response assessed after 12 weeks of treatment. Hematologic response was defined as meeting 1 or more of the following criteria: 1) platelet count increases to 20 X 10^9/L above baseline, or stable platelet counts with transfusion independence for a minimum of 8 weeks; 2) hemoglobin increase by greater than 1.5 g/dL, or a reduction in greater than or equal to 4 units of red blood cell transfusions for 8 consecutive weeks; 3) ANC increase of 100% or an ANC increase greater than 0.5 X 10^9/L. Promacta was discontinued after 16 weeks if no hematologic response was observed. The response rate was 40% (95% CI) and the median of duration of response was not reached due to few events. Alvaiz(16) Alvaiz (eltrombopag) interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production. Safety and efficacy of Alvaiz has been established based on adequate and well-controlled studies of eltrombopag olamine in adult and pediatric patients 6 years and older with persistent or chronic ITP, adult patients with chronic hepatitis C-associated thrombocytopenia, and adult patients with refractory severe aplastic anemia. These studies are listed under Promacta. Tavalisse(5) Tavalisse (fostamatinib) is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase. Tavalisse was studied in two placebo-controlled efficacy and safety studies (FIT-1 and FIT-2), and an open-label extension study (FIT-3). A total of 150 patients with persistent or chronic immune thrombocytopenia, who had an insufficient response to previous treatment (which included corticosteroids, immunoglobulins, splenectomy, and/or a thrombopoietin receptor agonists) were enrolled in two identical, double-blind, placebo-controlled studies that were conducted in different countries. For each study, patients were randomized to receive Tavalisse or placebo for 24 weeks. Patients who did not respond to treatment after 12 weeks, as well as patients who completed the 24-week double blind study, were eligible to enroll in the open-label extension study. The efficacy of Tavalisse was based on stable platelet response (at least 50 X 10^9/L on at least 4 of the 6 visits between weeks 14 to 24). The percent of patients who had a stable platelet response was 16-18% in the Tavalisse arms and 0-4% in the placebo arms. The FIT-3 extension study enrolled 123 patients who completed 24 weeks of treatment in the FIT-1 and FIT-2 studies, or who did not respond to treatment any time after 12 weeks in these studies. Patients who were designated as responders in the FIT-1 and FIT-2 studies (defined as platelet count of at least 50 X 10^9/L) at the time of rollover continued in the extension study at their current trial dose and regimen. Patients who entered the extension study as non-responders (defined as platelet count less than 50 X 10^9/L) received Tavalisse 100 mg twice daily regardless of their dose and regimen in the prior study. Stable response in this study was prospectively defined as no 2 visits, at least 4 weeks apart, with a platelet count less than 50 X 10^9/L, without an intervening visit with a platelet count of at least 50 X 10^9/L (unrelated to rescue therapy), within a period of 12 weeks following initial achievement of the target platelet count. Among the patients who achieved stable response in FIT-1, FIT-2, and FIT-3 trials, 18 patients maintained the platelet count of at least 50 X 10^9/L for 12 months or longer. |
Safety |
All targeted agents have no FDA labeled contraindications of use.(1-5,16) |
REFERENCES
Number |
Reference |
1 |
Doptelet prescribing information. AkaRx, Inc. July 2021. |
2 |
Mulpleta prescribing information. Shionogi Inc. April 2020. |
3 |
Nplate prescribing information. Amgen. February 2022. |
4 |
Promacta prescribing information. Novartis. March 2023. |
5 |
Tavalisse prescribing information. Rigel Pharmaceuticals, Inc. November 2020. |
6 |
Neunert, C., Terrell, D. R., Arnold, D. M., Buchanan, G., Cines, D. B., Cooper, N., Cuker, A., Despotovic, J. M., George, J. N., Grace, R. F., Kühne, T., Kuter, D. J., Lim, W., McCrae, K. R., Pruitt, B., Shimanek, H., & Vesely, S. K. (2019). American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Advances, 3(23), 3829–3866. https://doi.org/10.1182/bloodadvances.2019000966 |
7 |
Reference no longer used |
8 |
Olnes, M. J., Scheinberg, P., Calvo, K. R., Desmond, R., Tang, Y., Dumitriu, B., Parikh, A. R., Soto, S., Biancotto, A., Feng, X., Lozier, J., Wu, C. O., Young, N. S., & Dunbar, C. E. (2012). Eltrombopag and improved hematopoiesis in refractory aplastic anemia. New England Journal of Medicine, 367(1), 11–19. https://doi.org/10.1056/nejmoa1200931 |
9 |
Reference no longer used |
10 |
Killick, S. B., Bown, N., Cavenagh, J., Dokal, I., Foukaneli, T., Hill, A., Hillmen, P., Ireland, R., Kulasekararaj, A., Mufti, G., Snowden, J. A., Samarasinghe, S., Wood, A., & Marsh, J. C. (2015). Guidelines for the diagnosis and management of adult aplastic anaemia. British Journal of Haematology, 172(2), 187–207. https://doi.org/10.1111/bjh.13853 |
11 |
Chiao, E. Y., Engels, E. A., Kramer, J. R., Pietz, K., Henderson, L., Giordano, T. P., & Landgren, O. (2009). Risk of Immune Thrombocytopenic Purpura and Autoimmune Hemolytic Anemia Among 120 908 US Veterans with Hepatitis C Virus Infection. Archives of Internal Medicine, 169(4), 357–363. https://doi.org/10.1001/archinternmed.2008.576 |
12 |
Intagliata, N. M., Argo, C. K., Stine, J. G., Lisman, T., Caldwell, S. H., & Violi, F. (2018). Concepts and controversies in haemostasis and thrombosis associated with liver disease: Proceedings of the 7th international coagulation in liver disease conference. Thrombosis and Haemostasis, 118(08), 1491–1506. https://doi.org/10.1055/s-0038-1666861 |
13 |
Reference no longer used |
14 |
Centers for Disease Control and Prevention. (2018, April 4). Acute Radiation Syndrome: A Fact Sheet for Clinicians. Centers for Disease Control and Prevention. https://www.cdc.gov/nceh/radiation/emergencies/arsphysicianfactsheet.htm |
15 |
DeZern, A. E., & Churpek, J. E. (2021). Approach to the diagnosis of aplastic anemia. Blood Advances, 5(12), 2660–2671. https://doi.org/10.1182/bloodadvances.2021004345 |
16 |
Alvaiz prescribing information. Teva Pharmaceuticals, Inc. February 2024. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Doptelet |
avatrombopag maleate tab |
20 MG |
M ; N ; O ; Y |
N |
|
|
Alvaiz |
eltrombopag choline tab |
18 MG ; 36 MG ; 54 MG ; 9 MG |
M ; N ; O ; Y |
N |
|
|
Promacta |
eltrombopag olamine powder pack for susp |
12.5 MG ; 25 MG |
M ; N ; O ; Y |
N |
|
|
Promacta |
eltrombopag olamine tab |
12.5 MG ; 25 MG ; 50 MG ; 75 MG |
M ; N ; O ; Y |
N |
|
|
Tavalisse |
fostamatinib disodium tab |
100 MG ; 150 MG |
M ; N ; O ; Y |
N |
|
|
Mulpleta |
lusutrombopag tab |
3 MG |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Alvaiz |
eltrombopag choline tab |
9 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Alvaiz |
eltrombopag choline tab |
18 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Alvaiz |
eltrombopag choline tab |
36 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Alvaiz |
eltrombopag choline tab |
54 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Doptelet |
Avatrombopag Maleate Tab 20 MG (Base Equiv) |
20 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Mulpleta |
Lusutrombopag Tab 3 MG |
3 MG |
7 |
Tablets |
7 |
DAYS |
|
|
|
Promacta |
Eltrombopag Olamine Powder Pack for Susp 12.5 MG (Base Eq) |
12.5 MG |
30 |
Packets |
30 |
DAYS |
|
|
|
Promacta |
Eltrombopag Olamine Powder Pack for Susp 25 MG (Base Equiv) |
25 MG |
30 |
Packets |
30 |
DAYS |
|
|
|
Promacta |
Eltrombopag Olamine Tab 12.5 MG (Base Equiv) |
12.5 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Promacta |
Eltrombopag Olamine Tab 25 MG (Base Equiv) |
25 MG |
30 |
Tablets |
30 |
DAYS |
|
|
|
Promacta |
Eltrombopag Olamine Tab 50 MG (Base Equiv) |
50 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Promacta |
Eltrombopag Olamine Tab 75 MG (Base Equiv) |
75 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
Tavalisse |
fostamatinib disodium tab |
100 MG ; 150 MG |
60 |
Tablets |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Alvaiz |
eltrombopag choline tab |
18 MG ; 36 MG ; 54 MG ; 9 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Doptelet |
avatrombopag maleate tab |
20 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Mulpleta |
lusutrombopag tab |
3 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Promacta |
eltrombopag olamine powder pack for susp |
12.5 MG ; 25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Promacta |
eltrombopag olamine tab |
12.5 MG ; 25 MG ; 50 MG ; 75 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Tavalisse |
fostamatinib disodium tab |
100 MG ; 150 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Alvaiz |
eltrombopag choline tab |
18 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Alvaiz |
eltrombopag choline tab |
9 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Alvaiz |
eltrombopag choline tab |
36 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Alvaiz |
eltrombopag choline tab |
54 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Doptelet |
Avatrombopag Maleate Tab 20 MG (Base Equiv) |
20 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Mulpleta |
Lusutrombopag Tab 3 MG |
3 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Promacta |
Eltrombopag Olamine Powder Pack for Susp 12.5 MG (Base Eq) |
12.5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Promacta |
Eltrombopag Olamine Powder Pack for Susp 25 MG (Base Equiv) |
25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Promacta |
Eltrombopag Olamine Tab 12.5 MG (Base Equiv) |
12.5 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Promacta |
Eltrombopag Olamine Tab 25 MG (Base Equiv) |
25 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Promacta |
Eltrombopag Olamine Tab 50 MG (Base Equiv) |
50 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Promacta |
Eltrombopag Olamine Tab 75 MG (Base Equiv) |
75 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Tavalisse |
fostamatinib disodium tab |
100 MG ; 150 MG |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
PA |
Initial Evaluation Target Agent(s) will be approved when the ALL of the following are met:
Compendia Allowed: AHFS, DrugDex 1 or 2a level of evidence, or NCCN 1 or 2a recommended use Lengths of Approval: NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.
Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Lengths of Approval: thrombocytopenia in hepatitis C - 6 months; all other indications - 12 months NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:
Initial Lengths of Approval: |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CSReg _ Thrombopoietin_Receptor_Agonists_and_Tavalisse_PAQL _ProgSum_ 10-01-2024 _
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