Subject: Doptelet 3081-A SGM P2021
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and
compendial uses are considered a covered benefit provided that all the
approval criteria are met and the member has no exclusions to the
prescribed therapy.
A. FDA-Approved Indications
1. Treatment of Thrombocytopenia in Patients with Chronic Liver
Disease (CLD)
Doptelet is indicated for the treatment of thrombocytopenia in
adult patients with chronic liver disease who are scheduled to
undergo a procedure.
2. Treatment of Thrombocytopenia in Patients with Chronic Immune
Thrombocytopenia (ITP)
Doptelet is indicated for the treatment of thrombocytopenia in
adult patients with chronic immune thrombocytopenia who have
had an insufficient response to a previous treatment.
All other indications are considered experimental/investigational and
not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior
authorization review:
A. Thrombocytopenia in chronic liver disease: pretreatment platelet
count
B. Immune thrombocytopenia: pretreatment and current platelet
counts
III. EXCLUSIONS
Coverage will not be provided for members with the following exclusion:
concomitant use of Doptelet with other thrombopoietin receptor agonists
(e.g., Mulpleta, Promacta, Nplate) or with spleen tyrosine kinase
inhibitors (e.g., Tavalisse)
IV. CRITERIA FOR INITIAL APPROVAL
A. Thrombocytopenia in chronic liver disease
Authorization of 30 days may be granted for treatment of
thrombocytopenia in members with chronic liver disease when both
of the following criteria are met:
1. Member has an untransfused platelet count of less than 50x109/L
taken within 14 days of the request.
2. Member is scheduled to undergo a procedure.
B. Chronic immune thrombocytopenia (ITP)
Authorization of 6 months may be granted for treatment of chronic
ITP when both of the following criteria are met:
1. Inadequate response or intolerance to prior therapy (for example,
corticosteroids or immunoglobulins).
2. Untransfused platelet count at any point prior to the initiation of
the requested medication is less than 30x109/L OR 30x109/L to
50x109/L with symptomatic bleeding (e.g., significant mucous
membrane bleeding, gastrointestinal bleeding or trauma) or risk
factors for bleeding (see Section VI).
V. CONTINUATION OF THERAPY
A. Thrombocytopenia in chronic liver disease
Continuation of therapy, defined as use beyond the initial approval for
same procedure, is not approvable. All members (including new
members) requesting authorization due to newly scheduled procedure
must meet all initial authorization criteria.
B. Chronic ITP
1. Authorization of 3 months may be granted to members with
current platelet count less than 50x109/L for whom the platelet
count is not sufficient to prevent clinically important bleeding and
who have not received a maximal Doptelet dose for at least 4
weeks.
2. Authorization of 12 months may be granted to members with
current platelet count less than 50x109/L for whom the current
platelet count is sufficient to prevent clinically important bleeding.
3. Authorization of 12 months may be granted to members with
current platelet count of 50x109/L to 200x109/L.
4. Authorization of 12 months may be granted to members with
current platelet count greater than 200x109/L to less than or equal
to 400x109/L for whom Doptelet dosing will be adjusted to achieve
a platelet count sufficient to avoid clinically important bleeding.
VI. APPENDIX
Examples of risk factors for bleeding (not all inclusive)
• Undergoing a medical or dental procedure where blood loss is
anticipated
• Comorbidity (e.g., peptic ulcer disease, hypertension)
• Mandated anticoagulation therapy
• Profession (e.g., construction worker) or lifestyle (e.g., plays contact
sports) that predisposes patient to trauma
Place of Service:
Outpatient
The above policy is based on the following references:
- Doptelet [package insert]. Durham, NC: AkaRx, Inc.; October 2020.
- Jurczak W, Chojnowski K, et al. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018;183(3):479-490.
- Nuenert C, Terrel DR, Arnold DM, et al. American Society of Hematology 2019 guidelines for immune thrombocytopenia. Blood Adv2019;3(23):3829–3866.
- Provan D, Arnold DM, Bussel JB, et al. Updated international consensus report on the investigation and management of primary immune thrombocytopenia. Blood Adv2019;3(22): 3780–3817.
- Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009;113(11):2386-2393.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
December 30, 2021
