CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1505

Drug Policy: Piasky (crovalimab-akkz)

Defines accepted indications, inclusion and exclusion criteria, and approval authority for Piasky (crovalimab-akkz) medication requests for Neighborhood Health Plan members; applies to utilization management and prescribers submitting authorization requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDrug Policy: Piasky (crovalimab-akkz)

Policy CodePolicy UM ONC_1505

Change TypeRoutine review — no material coverage changes

Effective DateAug 30, 2024

Next Review Date

Key ActionSubmit prior authorization; continuation may be exempt if no disease progression, prior use within 1 year without >30-day lapse, and no additional medications are added.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

13minimum age

≥40 kgminimum weight

1500single dose max (mg)

3pages

08/14/24committee approval

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Coverage Criteria

inv-01: Initial coverage for PNH

Covered when ALL of the following are met:

PNH initial coverage: Member has a diagnosis of paroxysmal nocturnal hemoglobinuria (PNH); patient is 13 years of age or older; body weight is at least 40 kg; requested use is consistent with FDA labeling or is supported by CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature meeting CMS requirements.

References: Policy Section II.B and Purpose section for evidence sources.

inv-02: Continuation therapy — Continuation therapy exemption criteria

Continuation therapy exemption criteria:

Continuation request exemption: Member has not experienced disease progression on the requested medication; the medication was used within the last year without a lapse of more than 30 days of active authorization; no additional medications are being added to the continuation request.

If all conditions are met, continuation may be exempt from new authorization per policy Section II.A.

Requests for Piasky (crovalimab-akkz) will be excluded when there is evidence of disease progression while taking Piasky. Concurrent administration with other complement inhibitors for PNH — specifically eculizumab or ravulizumab — is not permitted and will trigger denial. Additionally, dosing that exceeds a single dose limit of 1500 mg is an exclusion. Finally, investigational or off‑label uses that are not supported by sufficient evidence (as defined by the policy’s criteria for acceptable clinical evidence and CMS‑recognized compendia or peer‑reviewed literature) will be denied.

Initial Therapy

inv-11: Initial therapy — Initial authorization considerations

Initial authorization considerations:

Initial authorization for PNH: Patient has paroxysmal nocturnal hemoglobinuria (PNH); patient is 13 years of age or older; body weight is at least 40 kg; requested use aligns with FDA-approved labeling or is supported by CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements.

See Purpose (supporting documentation) and Section II.B for population criteria.

Continuation Therapy

inv-12: Continuation therapy exemption — Continuation requests may be exempt from reauthorization when criteria are met

Continuation requests may be exempt from reauthorization when ALL of the following are met:

Continuation exemption nodes: No disease progression on the medication; medication was used within the last year without a lapse of more than 30 days of active authorization; no additional medications are being added to the request.

Per policy Section II.A.

Provider Actions & Requirements

Denial Risk

Exclusion criteria that trigger denial

Requests will be denied for any of the following exclusion criteria: disease progression while taking Piasky (crovalimab-akkz); concurrent use with other therapies used to treat PNH (for example, eculizumab or ravulizumab); dosing that exceeds the single dose limit of 1500 mg; and investigational or off-label uses that lack sufficient supporting evidence as defined by CMS-recognized compendia or acceptable peer-reviewed literature (see criteria for adequacy of evidence in policy).

Disease progression on Piasky
Concurrent use with other PNH therapies (eculizumab, ravulizumab)
Single dose > 1500 mg
Investigational/off-label indications lacking sufficient evidence (per policy evidence standards)

Documentation Required

Supporting documentation required

Requests must be supported by documentation consistent with accepted sources. Use must be supported by one of the following: FDA-approved product labeling, CMS-recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15. Documentation should include clinical notes, prior treatment history, laboratory or diagnostic results as applicable, and citations or copies of supporting literature when the indication is off-label.

Acceptable sources: FDA labeling; CMS-recognized compendia; NCCN or ASCO guidelines; peer-reviewed literature meeting CMS requirements
Include clinical notes, prior treatment history, and relevant labs/diagnostics
Supply supporting literature or citations for off-label uses

Denial Risk

Concurrent therapy restriction

Piasky should not be used concurrently with other PNH complement inhibitors. Concurrent therapy with agents such as eculizumab or ravulizumab is an exclusion and will result in denial of the request.

Concurrent use with eculizumab
Concurrent use with ravulizumab

Background

Piasky (crovalimab-akkz) is indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in adolescents and adults who meet the policy’s age and weight criteria. The policy requires patient selection consistent with FDA labeling and recognized clinical evidence sources; specifically, the therapy is intended for patients who meet the documented indication for PNH and the policy’s minimum eligibility thresholds.