Subject: Doptelet 3081-A SGM P2022
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.
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. PRESCRIBER SPECIALTIES
A. For diagnosis of chronic immune thrombocytopenia, this
medication must be prescribed by or in consultation with a
hematologist.
B. For diagnosis of thrombocytopenia in patients with chronic
liver disease, this medication must be prescribed by or in
consultation with a hematologist, hepatologist or
gastroenterologist.
V. 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 VII).
VI. 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.
VII. 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.; July 2021.
- 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.
January 31, 2023
