Coverage of TSP's (Nplate and Promacta)

[chantell.reagan]

In August 2008, the FDA had approved Nplate (romiplostim), the first thrombopoiesis-stimulating protein indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. An oral product, Promacta, was subsequently approved in November 2008 for the same indication. In the next quarter plans/PBMs might be reviewing this therapeutic area for the first time. The following are several points for considerations:

•What's the impact on my membership? Small patient population is affected by ITP - about 60,000 US adults or 1 to 13 per 100,000 individuals. Approximately 11-35% of them are refractory to first-and second-line treatment. Although Nplate and Promacta are indicated for adults, chronic disease can affect 15-20% of children with ITP.

•When is treatment with a thrombopoiesis-stimulating protein appropriate? Evidence suggests that generally ITP patients with platelet counts < 30,000/mcL are at an increased risk of bleeding and treatment
should be initiated. Failure of oral corticosteroids, IVIG, and/or splenectomy would be considered when platelet counts are below 30,000/mcL despite treatment. In fact, pivotal trials for Nplate and Promacta enrolled
adult patients with platelet counts < 30,000/mcL who had completed at least one treatment with corticosteroids, immunoglobulins, rituximab, cytotoxic therapies, danazol, azathioprine, and/or splenectomy. Where will Nplate and Promacta fit in the sequence of these treatments might be open to interpretation. Some experts believe that due to limited experience, the use of these products should be reserved only to experienced hematologists, after corticosteroids, rituximab and splenectomy have failed.

•How long should treatment with a thrombopoiesis-stimulating protein continue? In clinical trials, Promacta was given for up to 6 weeks, while the Nplate therapy was given for 24 weeks. In the Promacta trial, platelet levels dropped after treatment was discontinued. In clinical trials, the drugs were stopped if platelets were > 200,000 to 400,000/mcL. Additionally, the prescribing information states these drugs should be withheld when platelet counts exceed 400,000/mcL or if there’s no response within 4 weeks of treatment at the maximum dose. It appears that indefinite maintenance treatment may be required as long as platelet levels are below 200-400,000/mcL.

•What are the differences between the thrombopoiesis-stimulating proteins? No direct comparative trials were done. However, clinical trials show that similar endpoints were achieved with either agent in
comparison to placebo. A recent editorial in Lancet implies that both agents might be equivalent. More concrete clinical differences are related to the dosing and administration. Nplate is available as a weight-based SQ injection (to be provided by a healthcare professional, not to be self-injected), given once weekly, whereas Promacta is an oral agent given once daily. The AWP for Nplate is $1,328.13 for 250 mcg and $2,656.25 for 500 mcg single-use vials, which is approximately $5,312 for a monthly treatment at an average weekly dose of 2-3 mcg/kg and an average patient weight of 80 kg (as reported in clinical studies). The AWP for Promacta is not yet available in the public domain.

How are you handling the review of these products? With respect to coverage criteria, what is your opinion on the place in therapy for Nplate and Promacta?

Sources:

Nplate prescribing information

Promacta prescribing information

Bussel JB, Cheng G, Saleh MN, et al., Eltrombopag for the Treatment of Chronic Idiopathic Thrombocytopenic Purpura. NEJM. Nov 2007

Kuter DH et al. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet 2008;371(9610):395-403.Pubmed abstract

Nurden AT, Nurden P. Increasing the platelet count in chronic ITP. Lancet. 2008 Feb 2;371(9610):362-4. (no abstract available)

Blanchette V. Childhood immune thrombocytopenic purpura: diagnosis and management. Pediatr Clin North Am. Apr 2008; 55(2): 393-420. Pubmed abstract

Psaila B. Immune thrombocytopenic purpura. Hematol Oncol Clin North Am. Aug 2007; 21(4): 743-59. Pubmed abstract

Cines D.B., Bussel J.B.: How I treat idiopathic thrombocytopenic purpura (ITP). Blood 106. (7): 2244-51 (2005).

British Committee for Standards in Haematology General Haematology Task Force. Guidelines for the investigation and management of idiopathic thrombocytopenic purpura in adults, children and in pregnancy. Br J Haematol 120. (4): 574-596.2003.

George J.N., Woolf S.H., Raskob G.E., et al: Idiopathic thrombocytopenic purpura: a practice guideline developed by explicit methods for the American society of hematology. Blood 88. (1): 3-40.

Medscape Nplate monograph

Medscape article 12/08

Related link

[chantell.reagan]

The AWP for Promacta recently became available in the public domain. The monthly AWP ranges from $2062.50 (50mg/day) to $6187.50 (max daily dose of 75mg/day). This compares to Nplate at $5,312/month (avg weekly dose of 2-3 mcg/kg and an average patient weight of 80 kg (as reported in clinical studies).

Source:
Medscape Promacta monograph

[chantell.reagan]

It has been approximately 9 months since the FDA approval of the first agent (Nplate) to treat idiopathic thrombocytopenic purpura (ITP). We analyzed 7 local and national plans for their coverage determinations of both thrombopoietic agents, Nplate and Promacta. All plans follow prescribing guidelines for failure of previous treatments and 6/7 plans require patients to be at risk for spontaneous bleeding; however, there is no consistency in the definition of specific risk criteria.

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Sources:

Nplate prescribing information

Promacta prescribing information

BlueCross BlueShield of Alabama. Promacta policy

BlueCross BlueShield of Alabama (Preferred Care Services). Nplate policy

Blue Cross and Blue Shield of Florida. Medical coverage guidelines

BlueCross BlueShield of Tennessee. Eltrombopag (Promacta) policy

BlueCross BlueShield of Tennessee. Romiplostim (Nplate) medical policy

Excellus: Clinical Review Prior Authorization (CRPA)

The Regence Group. Nplate policy

Aetna. Clinical Policy Bulletin: Nplate

Cigna. Nplate Coverage Position

Cigna. Promacta Coverage Position