CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1505

Piasky (crovalimab-akkz) — Drug Policy (PNH)

Defines authorization, inclusion and exclusion criteria, and management rules for Piasky (crovalimab-akkz) for Neighborhood Health Plan of Rhode Island members; applies to UM medication requests processed by Evolent for cancer indications, specifically PNH.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyPiasky (crovalimab-akkz) — Drug Policy (PNH)

Policy CodePolicy UM ONC_1505

Change TypeNo material changes

Effective DateAug 30, 2024

Next Review Date

Key ActionSubmit prior authorization to Evolent with supporting FDA labeling or CMS-recognized compendia and documentation showing no disease progression and no >30‑day lapse for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

13min age (PNH)

40 kgmin weight

1500 mgsingle-dose max

08/14/2024last review

Coverage Criteria for Piasky (crovalimab-akkz)

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PNH: Initial / Continuation coverage

Covered when ALL of the following are met for PNH:

PNH indication and population

Age and weight: Member is >= 13 years of age AND body weight >= 40 kg

Therapy intent: Request is for Piasky (crovalimab-akkz) for treatment of PNH

Continuation Therapy Exemption

Continuation requests exempt from policy when ALL are met:

Continuation exemptions: No disease progression on the requested medication

Continuation exemptions: Requested medication was used within the last year without a lapse >30 days of active authorization

Continuation exemptions: No additional medications are being added to the continuation request

Use of Piasky for off‑label or investigational indications that are not supported by sufficient evidence is considered not medically necessary. The policy requires that supporting evidence be generally accepted by the medical community or supported by CMS‑recognized compendia or acceptable peer‑reviewed literature. Relevant considerations for sufficiency include whether the patient and disease characteristics are represented in the evidence, whether the regimen studied matches the proposed use, whether reported outcomes are clinically meaningful (for example, ASCO‑recommended thresholds such as hazard ratio < 0.80 or survival benefits of at least 3 months for OS/PFS), whether the study design is appropriate, whether non‑randomized clinical trials may provide supportive evidence when subject numbers are sufficient, and that case reports or abstracts without full peer‑reviewed publications are generally inadequate.

Continuation Therapy Criteria

Continuation Therapy

Continuation requests are permitted if the following all apply:

Continuation criteria: Member has not experienced disease progression on Piasky

Continuation criteria: Medication was used within the last year without a lapse >30 days of active authorization

Continuation criteria: No additional medications are being added to the continuation request

Provider Actions and Requirements

Prior Authorization

Prior Authorization and Continuation Rules

Prior authorization required. Evolent (Utilization Management) must process all medication requests for Piasky (crovalimab-akkz); medications not authorized by Evolent may be deemed not approvable and not reimbursable. Continuation requests are allowed only when the 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 an active authorization, and no additional medications are being added to the continuation request.

All initial and continuation requests require review by Evolent UM.
Continuation requests exempt from reauthorization only if: no disease progression; prior use within last year with ≤30-day lapse; no additional medications added.

Step Therapy

Concurrent Therapy Restriction

Concurrent use of Piasky (crovalimab-akkz) with other therapies for paroxysmal nocturnal hemoglobinuria (PNH) is an exclusion and will trigger denial or step-conflict. Specifically, concurrent administration with eculizumab or ravulizumab is not allowed.

Concurrent use with eculizumab (Soliris) — exclusion.
Concurrent use with ravulizumab (Ultomiris) — exclusion.

Documentation Required

Supporting Documentation Required

Supporting documentation must be provided to justify use. Acceptable sources include the FDA approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards. Refer to the FDA label/pack insert for dosing and other product details.

FDA product labeling / package insert.
CMS‑recognized compendia.
NCCN or ASCO clinical guidelines.
Peer‑reviewed literature consistent with CMS Chapter 15 (full articles; meeting abstracts without full article are insufficient).

Denial Risk

Denial Triggers / Exclusion Criteria

Denial will be issued when exclusion criteria are met. Triggers include documented disease progression while on Piasky, dosing that exceeds the single dose limit of 1500 mg, investigational/off‑label uses lacking sufficient evidence (see evidence requirements), or concurrent excluded therapies. Insufficient evidence includes reliance on case reports or meeting abstracts without full peer‑reviewed publication, or evidence that does not adequately represent the patient population, regimen, or clinically meaningful outcomes.

Disease progression on Piasky — denial trigger.
Dose > 1500 mg single dose — denial trigger.
Concurrent excluded therapies (e.g., eculizumab, ravulizumab) — denial trigger.
Investigational or off‑label uses without sufficient evidence (case reports, abstracts alone, or evidence not representative) — denial trigger.

Step Therapy / Medication Sequence

Step	Requirement / Restriction	Notes
1	Mutual exclusivity: Piasky (crovalimab-akkz) must not be used concurrently with other complement inhibitors for PNH (e.g., eculizumab, ravulizumab).	This is a concurrent therapy restriction rather than a step-wise trial requirement; requests showing combined use with other PNH therapies will be excluded.
	Dosing constraint: single dose must not exceed 1500 mg.	Requests with dosing above the single-dose limit are listed in exclusion criteria and may be denied.
	Investigational/off‑label use without sufficient evidence is excluded.	Sufficient evidence is defined by standards (FDA labeling, CMS‑recognized compendia or acceptable peer‑reviewed literature); case reports/abstracts alone are generally insufficient.

Quantity and Dosing Limits

Piasky (crovalimab-akkz) — Quantity / Single-dose limit

Single-dose maximum1500 mg per single dose

Quantity-limit unitLimit expressed per single dose (mg)

Per-course reportingPolicy specifies single-dose limit; authorization evaluated against this maximum for each administered dose

Exclusion if exceededRequests exceeding the 1500 mg single-dose limit will be excluded

Definitions and Evidence Standards

Sufficient evidence (meets CMS standards)

Acceptable regulatory sourceFDA approved product labeling (prescribing information)

CompendiaCMS‑recognized compendia (e.g., Micromedex, Clinical Pharmacology, NCCN Drugs & Biologics)

Professional guidelinesNational Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines

Peer‑reviewed literature standardsPeer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 criteria (adequate representation of patient/therapy characteristics, clinically meaningful outcomes per ASCO standards, appropriate study design)

Evidence NOT sufficient aloneCase reports or meeting abstracts without a full peer‑reviewed article are generally insufficient

Background

Piasky (crovalimab-akkz) is indicated for treatment of paroxysmal nocturnal hemoglobinuria (PNH). For the purposes of authorization, clinical context and evidence standards referenced in this policy point reviewers to FDA labeling and to published clinical evidence; the policy’s exclusion and sufficiency criteria (see below) reflect the trial‑ and literature‑based expectations used to determine acceptable use in PNH.