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L.5.01.405
Anzemet (dolasetron) tablets
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
Dolasetron and its active metabolite are selective serotonin 5-HT3 receptor antagonists. The 5HT3 receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema. Dolasetron, in turn, prevents afferent vagal stimulation from the gut to the chemoreceptor trigger zone (CTZ) in the brain. The CTZ is identified as the part of the brain primarily associated with nausea and vomiting.
Dolasetron mesylate (Anzemet) is indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years and older.
Prior authorization is required.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Initial Evaluation
Anzemet (dolasetron) tablets may be considered medically necessary when ALL of the following criteria are met:
The individual is 2 years of age or older;
The individual is receiving emetogenic chemotherapy or radiation therapy;
The individual is intolerant to or has failed (see definition of Medication Failure in Policy Guidelines section) therapy with ondansetron within the last 180 days.
The individual does not have any contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.
Length of Approval: Authorizations will correspond to chemotherapy regimen and up to the program limit.
State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary. BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
Medication Failure
Medication failure is defined as disease progression at generally accepted doses as appropriate for the disease state being treated. Dosages below the recommended dose for the specific condition being treated and/or experience of common side effects of medication will not be considered medication failure or lack of response for the purpose of this review.
BCBSMS determines patient medication trial and adherence by a review of pharmacy claims data over the preceding twelve months. Additional information may be requested on a case-by-case basis to allow for proper review. If member is new to BCBSMS and pharmacy records are needed to confirm medication trials and adherence, it is the responsibility of the member and/or requesting provider to obtain said records and to submit them to BCBSMS upon request. Medical records from the provider that list previously prescribed medications will not be sufficient to show medication trials or adherence.
01/01/2014: New policy added.
07/02/2015: Code Reference section updated for ICD-10.
05/26/2016: Policy number L.5.01.405 added. Policy Guidelines updated to add medically necessary and investigative definitions.
08/09/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
08/15/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.
09/14/2017: Policy statement updated to make correction: "Cesamet" should be "Anzemet/Kytril injection."
07/01/2018: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Added drug names to the top of the policy. Medically necessary criteria updated to state: The patient is intolerant to or failed therapy (continued symptoms despite use) with ondansetron within the last 180 days. Sources updated.
10/01/2019: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Anzemet/Kytril Injection" to "Anzemet tablet (dolasetron) Kytril Injection (granisetron)." Policy section updated to add that prior authorization is required and that the use of samples by a Member will not be considered current or stable therapy for purposes of Medical Policy review. Policy statement and Policy Exceptions updated to add generic drug names. For length of approval, added that authorizations will correspond to chemotherapy regimen and up to the program limit. Sources updated.
02/18/2021: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Policy title changed from "Anzemet tablet (dolasetron) Kytril Injection (granisetron)" to "Anzemet (dolasetron)." Policy updated to remove Kytril (granisetron). Policy section updated to change "patient" to "member" and to add criteria that the member is 2 years of age or older. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders." Added information regarding BCBSMS request for medical records and defined medication failure. Sources updated.
02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.
06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding indications for Dolasetron mesylate (Anzemet). Policy statement revised to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Policy statements updated to change "member" to "individual." Medically necessary criteria updated regarding contraindications to therapy and dose requirements. Sources updated.
Anzemet prescribing information. Validus Pharmaceuticals, LLC. December 2023. Last accessed March 2025.
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