CurrentCignaPolicy N/A

Niktimvo (axatilimab) prior authorization for graft-versus-host disease

Authorization form and coverage requirements for Niktimvo (axatilimab) for graft-versus-host disease, intended for prescribers submitting prior authorization requests to Cigna. Affects providers requesting coverage through Cigna Pharmacy Services and its specialty pharmacy.

Policy Summary

PayerCigna

PolicyNiktimvo (axatilimab) prior authorization for graft-versus-host disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form (or online via CoverMyMeds) with required documentation and await the standard 5-business-day response.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

2min systemic therapies

40 kgmin patient weight

Accredopreferred specialty pharmacy

Coverage Criteria for Niktimvo (axatilimab)

Policy Summary

PayerCigna

PolicyNiktimvo (axatilimab) prior authorization for graft-versus-host disease

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization form (or online via CoverMyMeds) with required documentation and await the standard 5-business-day response.

SourceLink

On This Page

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Initial therapy requirements: 1) Indication: Graft-Versus-Host Disease (GVHD), including chronic GVHD (cGVHD). 2) Patient is a new start (initial therapy) for Niktimvo. 3) Patient weighs at least 40 kg. 4) Patient's disease is considered chronic (may answer yes if patient has cGVHD). 5) Patient has tried at least two systemic medications for chronic GVHD (examples listed on the form).

Examples of systemic therapies are listed on the form (e.g., ruxolitinib, belumosudil, ibrutinib, imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, aldesleukin, corticosteroids, cyclosporine, tacrolimus, sirolimus, etanercept products, mycophenolate mofetil).

Continuation Therapy

Covered when ALL of the following are met for patients currently receiving Niktimvo

Continuation therapy requirements: 1) Patient is currently receiving Niktimvo. 2) Prescriber attests that the patient has demonstrated a beneficial clinical response (examples: reduction in corticosteroid dose, disease stabilization, and/or symptomatic improvement).

If prescriber indicates no beneficial response, supporting documentation must be provided for continued use.

Coverage for Niktimvo as an initial therapy is dependent on meeting all form criteria; if required conditions are not met (for example, patient weight <40 kg or lack of documentation showing trials of at least two prior systemic therapies for cGVHD), the request may be considered not covered or denied. Similarly, continuation requests require the prescriber to attest to a beneficial clinical response; absence of that support triggers requests for additional documentation and may lead to non‑coverage.

Initial Therapy Specific Criteria

Initial Therapy

Initial use criteria for Niktimvo

Initial use: 1) New start (initial therapy) for graft-versus-host disease (including cGVHD). 2) Patient weight >= 40 kg. 3) Disease considered chronic (cGVHD acceptable). 4) Documented trial of at least two systemic medications for cGVHD (see form for examples).>= 40 kg

Form lists examples of acceptable prior systemic therapies; select 'new start' if patient has been taking samples.

Continuation (Ongoing) Therapy Criteria

Continuation Therapy

Continuation (current use) requirement

Beneficial response: Prescriber must attest that the patient has demonstrated a beneficial clinical response to Niktimvo (examples include reduced corticosteroid dose, disease stabilization, or symptomatic improvement).

If 'No' is selected, prescriber should provide supporting documentation for continued therapy; include dates of use and how medication was obtained (samples, out-of-pocket, etc.).

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required before dispensing Niktimvo. Submit the completed prior authorization form (or submit online via CoverMyMeds) and await the standard 5-business-day response. For urgent requests, call Cigna to request escalation.

Submit via CoverMyMeds or SureScripts in EHR
Standard response time: 5 business days
For urgent requests call to expedite

Step Therapy

Step Therapy Requirement for Initial Use

For patients starting Niktimvo for chronic graft‑versus‑host disease (cGVHD), step therapy requires that the patient has tried at least two systemic therapies for cGVHD prior to approval. Examples of acceptable prior systemic therapies include ruxolitinib, belumosudil, ibrutinib, imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, interleukin‑2, methylprednisolone, cyclosporine, tacrolimus, sirolimus, etanercept products, and mycophenolate mofetil.

Initial use for cGVHD requires trial of ≥2 systemic medications (see examples)

Documentation Required

Required Documentation

Completed prior authorization documentation must be provided, including prescriber and patient identifiers, medication selection (product and strength), dose (mg or mg/kg), frequency, quantity, duration of therapy, J‑code (if applicable), and facility/dispensing information. Include whether this is a new start or continuation and, if continuation, dates of prior use and evidence of benefit.

Include Cigna ID, DOB, prescriber NPI/DEA/TIN, and contact information
Specify product (Niktimvo strength), dose (mg or mg/kg), quantity, frequency, duration, and J‑code
Provide facility/dispensing provider name, address, tax ID, and whether medication is long‑term

Denial Risk

Incomplete Documentation May Trigger Denial

Incomplete or missing clinical information may result in denial or delay. For initial therapy include indication (confirm cGVHD if applicable), patient weight (must document ≥40 kg for initial dosing when required), prior therapies tried, and clinical rationale. For patients already on therapy, document clinical benefit (for example, corticosteroid dose reduction, disease stabilization, or symptomatic improvement) or provide justification for continued use.

Missing indication, weight for initiation, or prior therapy history may trigger denial
If currently receiving drug, provide evidence of beneficial clinical response

Step	Requirement
1	Patient must have tried at least two systemic medications for chronic graft-versus-host disease (cGVHD). Examples listed on the form include Jakafi (ruxolitinib), Rezurock (belumosudil), Imbruvica (ibrutinib), imatinib, hydroxychloroquine, methotrexate, rituximab, pentostatin, interleukin-2 (eg, Proleukin), methylprednisolone, cyclosporine, tacrolimus, sirolimus, an etanercept product, and mycophenolate mofetil.

Site of Care and Dispensing

Note

Site of care / dispensing — Accredo, hospital outpatient, office stock, retail, or home infusion

Specify where the medication will be obtained; permitted routes include Accredo specialty pharmacy (Cigna's nationally preferred specialty pharmacy), hospital outpatient, prescriber's office stock (medical claim), retail pharmacy, or home infusion vendor.

Accredo contact options provided for ordering (e-prescribe, fax, verbal).

Definitions

inv-12: cGVHD — Chronic graft-versus-host disease definition note (chronicity qualifies for form question)

Definition noteChronic graft‑versus‑host disease (cGVHD) qualifies as 'chronic' for the form's chronicity question; form states: 'You may answer "yes" if they state the patient has cGVHD.'

Where usedApplied to the initial therapy question: 'Is the patient's disease considered to be chronic?'

Response optionsForm provides a yes/no checkbox for chronicity

ImplicationA 'yes' (including cGVHD) is part of meeting initial therapy coverage criteria

OpenPayer