CurrentMass General Brigham Health PlanPolicy N/A

Krintafel (tafenoquine) — prevention of P. vivax relapse

This policy governs prior authorization for the pharmacy benefit coverage of Krintafel (tafenoquine) to prevent relapse of Plasmodium vivax malaria in eligible members aged 16 and older.

Policy Summary

PayerMass General Brigham Health Plan

PolicyKrintafel (tafenoquine) — prevention of P. vivax relapse

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFeb 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and document member age, diagnosis of P. vivax malaria, proof of appropriate antimalarial therapy, and G6PD test showing >70% activity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥16minimum eligible member age

>70%required G6PD activity

2 tabsmaximum approval per request

PAprogram type

Coverage Criteria

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Eligibility criteria: Member is >= 16 years of age>=16 years

Diagnosis and treatment context: Member has a diagnosis of Plasmodium vivax malaria and is receiving appropriate antimalarial therapy for acute P. vivax infection

Krintafel is not indicated for treatment of acute P. vivax malaria; tafenoquine is used to prevent relapse

G6PD testing: Member has been tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency and has > 70% of G6PD normal activity prior to initiating therapy>70% normal activity

Document G6PD result in the medical record prior to therapy

Quantity limitation: Authorization approved for a maximum of 2 tablets (300 mg total) per request<=2 tablets (300 mg)

Coding and Clinical Thresholds

inv-03: G6PD activity — > 70% of G6PD normal activity

G6PD activity threshold> 70% of G6PD normal activity prior to initiating therapy

Test requiredMember must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency

Purpose of thresholdEnsure sufficient G6PD enzyme activity to reduce risk of hemolytic events with tafenoquine

DocumentationG6PD test result showing >70% normal activity must be included with authorization request

Prior Authorization & Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for Krintafel (tafenoquine) under the pharmacy benefit; approvals are limited to a maximum of 2 tablets (300 mg) per request and only when coverage criteria are met.

Step Therapy

Step therapy

No step therapy requirement specified for Krintafel under this policy.

Documentation Required

Required documentation

Documentation must demonstrate the member's age, a diagnosis of Plasmodium vivax malaria, that the patient is receiving appropriate antimalarial therapy for acute P. vivax infection, and a G6PD test result showing >70% of normal activity prior to initiating Krintafel.

Denial Risk

Reasons for potential denial

Requests may be denied if required documentation is missing, including evidence that the member is ≥16 years old, has a diagnosis of P. vivax malaria and is receiving appropriate antimalarial therapy, or lacks a G6PD test showing >70% normal activity, or if the request exceeds the 2-tablet (300 mg) limit.

Background

Tafenoquine is an 8‑aminoquinoline antimalarial with activity against pre‑erythrocytic (liver) forms—including dormant hypnozoites—as well as erythrocytic (asexual) stages and gametocytes of Plasmodium species, including P. vivax. By targeting liver hypnozoites, tafenoquine prevents development of the erythrocytic forms that are responsible for relapses of P. vivax malaria. It is not indicated for treatment of acute P. vivax infection.

Limitations & Definitions

inv-09: Limitation of use — Not indicated for the treatment of acute P. vivax malaria.

Limitation of useNot indicated for the treatment of acute P. vivax malaria

Intended useUsed to prevent relapse by targeting liver hypnozoites rather than treating acute blood-stage infection

Clinical implicationMember must be receiving appropriate antimalarial therapy for acute P. vivax infection in addition to tafenoquine for relapse prevention