CurrentCignaPolicy IP0119

Sickle Cell Disease - Oxbryta (voxelotor)

Defines Cigna coverage stance for voxelotor (Oxbryta) for treatment of sickle cell disease for members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicySickle Cell Disease - Oxbryta (voxelotor)

Policy CodePolicy IP0119

Change TypeProduct withdrawal; coverage clarified to not approved

Effective Date

Next Review Date

Key ActionDo not submit prior authorization requests for Oxbryta; coverage will not be approved following Pfizer's voluntary withdrawal.

SourceLink

POLICY UPDATE CHANGES

Pfizer is voluntarily withdrawing Oxbryta from the market; coverage will not be approved.

Added criteria for 'patient is currently receiving Oxbryta'.

Removed 'Will not be used concurrently with crizanlizumab (Adakveo®)'.

1explicit covered/decision stance changed to 'not approved' due to withdrawal

≥4yFDA approved age indication (prior to withdrawal)

2references for Pfizer withdrawal and communications

Coverage Criteria — Oxbryta (voxelotor)

Not Covered (Product Withdrawal)

Conditions Not Covered / Coverage stance

Primary stance: Voxelotor (Oxbryta) is considered experimental, investigational, or unproven and coverage will not be approved following Pfizer's voluntary withdrawal of all lots for sickle cell disease.

Withdrawal applies to all indications; all active clinical trials and expanded access programs have been discontinued per the manufacturer.

Voxelotor (Oxbryta) is considered experimental, investigational, or unproven for the treatment of sickle cell disease and coverage will not be approved.

Coverage of Oxbryta will not be approved because there are insufficient data establishing safety, efficacy, and improved health outcomes for any condition, including sickle cell disease; additionally, on September 25, 2024, Pfizer announced it is voluntarily withdrawing all lots of Oxbryta for the treatment of sickle cell disease.

Coding

Productmixed

Oxbryta (voxelotor) — product name listed; no billing codes provided in document

Policy Summary

PayerCigna

PolicySickle Cell Disease - Oxbryta (voxelotor)

Policy CodePolicy IP0119

Change TypeProduct withdrawal; coverage clarified to not approved

Effective Date

Next Review Date

Key ActionDo not submit prior authorization requests for Oxbryta; coverage will not be approved following Pfizer's voluntary withdrawal.

SourceLink

On This Page

Provider Actions and Authorization

Prior Authorization

Prior authorization not approvable due to withdrawal

Oxbryta (voxelotor) prior authorization requests will not be approved following the manufacturer's voluntary withdrawal of all lots for the treatment of sickle cell disease.

Step Therapy

Step therapy / concurrent use update

The prior concurrent-use exclusion language (for example, 'Will not be used concurrently with crizanlizumab (Adakveo®)') was removed in the Annual Revision dated 8/1/2024.

Documentation Required

Documentation and review expectations

When making coverage determinations, review the applicable benefit plan document, any applicable laws/regulations, relevant collateral source materials (including Coverage Policies), and the specific facts of the individual case; medical directors retain discretion.

Denial Risk

Denial trigger: product withdrawal

Coverage will not be approved because Pfizer voluntarily withdrew all lots of Oxbryta for sickle cell disease and discontinued active trials and expanded access programs worldwide.

Pfizer announced voluntary withdrawal of all lots of Oxbryta for sickle cell disease (Sept 25, 2024).
All active clinical trials and expanded access programs worldwide are being discontinued; manufacturer concluded benefits no longer outweigh risks.

Definitions

Oxbryta (voxelotor) — key facts

IndicationTreatment of sickle cell disease in patients ≥ 4 years of age (approved under accelerated approval based on hemoglobin increase).

Mechanism of actionOral hemoglobin S (sickle hemoglobin) polymerization inhibitor.

Regulatory status prior to withdrawalApproved under FDA accelerated approval contingent on confirmatory trials; indication applied to patients aged ≥ 4 years.

Manufacturer action (most actionable)Pfizer voluntarily withdrew all lots of Oxbryta for sickle cell disease on September 25, 2024; all active clinical trials and expanded access programs were discontinued.

Safety/monitoring notePfizer advised physicians to monitor patients for adverse events after discontinuation and to ensure appropriate follow-up; complications from abrupt interruption cannot be excluded.

OpenPayer

Sickle Cell Disease - Oxbryta (voxelotor)

Coverage Criteria — Oxbryta (voxelotor)

Coding

Provider Actions and Authorization

Background

Definitions