CurrentAetnaPolicy N/A

Pepaxto (melphalan flufenamide) — Precertification Request Form / Coverage Criteria

Form and requirements for Aetna precertification of Pepaxto (melphalan flufenamide) for patients with multiple myeloma; used by providers to request initiation or continuation of therapy and document required clinical criteria (including prior lines of therapy and refractoriness).

Policy Summary

PayerAetna

PolicyPepaxto (melphalan flufenamide) precertification request / coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain precertification by submitting the completed Pepaxto form via Aetna phone or fax (distinct contact for Medicare Advantage Part B) and provide required documentation of prior lines of therapy and refractoriness.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1page

4+required fields for initiation

phone/faxcontact options

Start/Continuationrequest types

Coverage Criteria for Pepaxto (melphalan flufenamide)

inv-01: Initiation Therapy Criteria

Covered when ALL of the following are met for initiation requests:

Initiation criteria for Pepaxto: Patient has a diagnosis of multiple myeloma; requested medication will be used in combination with dexamethasone (checkbox); patient has received at least four prior lines of therapy; disease is refractory to at least one proteasome inhibitor (e.g., Velcade/bortezomib); disease is refractory to at least one immunomodulatory agent (e.g., Revlimid/lenalidomide); disease is refractory to at least one anti-CD38 monoclonal antibody (e.g., Darzalex/daratumumab)

Form lists these as required clinical documentation for initiation.

inv-02: Continuation Therapy Criteria

Criteria for continuation requests:

Continuation criteria: Documentation that the patient has not experienced disease progression or unacceptable toxicity while on the current regimen (checkbox to indicate presence of progression or unacceptable toxicity)

Required clinical documentation for continuation requests.

Policy Summary

PayerAetna

PolicyPepaxto (melphalan flufenamide) precertification request / coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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The form does not list separate, named exclusions. Instead, coverage determinations are driven by completion of the required clinical fields for initiation and continuation requests. For initiation, the request must document a diagnosis of multiple myeloma, whether Pepaxto will be used in combination with dexamethasone, that the patient has received at least four prior lines of therapy, and that disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti‑CD38 monoclonal antibody. For continuation, the form requires documentation about absence of disease progression or unacceptable toxicity while on the current regimen. Missing or negative answers to these required fields (for example, fewer than four prior lines of therapy or lack of refractoriness to the listed drug classes) are the operative reasons an authorization may not be approved.

Regimen	Indication / Notes	Coverage
Pepaxto (melphalan flufenamide) +/− dexamethasone
Use for treatment of multiple myeloma when initiation criteria are met; form asks whether the medication will be used in combination with dexamethasone (checkbox)
Covered with criteria

What Providers Must Do

Prior Authorization

Precertification required

Precertification is required for Pepaxto. Providers must submit the completed medication precertification request form using Aetna contact phone/fax numbers (Medicare Advantage Part B has a separate contact). Ensure the form indicates whether this is a start of treatment or a continuation and include dates.

Start of treatment vs Continuation of therapy must be indicated and dated
Use the Aetna precertification phone/fax numbers; Medicare Advantage Part B has distinct contact numbers

Documentation Required

Required documentation — complete all fields

For all precertification requests, complete every required field on the form: patient, insurance, prescriber, dispensing provider/administration, product, diagnosis, and clinical information. Illegible or incomplete forms may delay review.

Provide patient identifiers (name, DOB, contact, weight/height, allergies)
Include prescriber identifiers (NPI, license, DEA, specialty, contact)
Specify dispensing/provider site and administration details (place of administration, CPT administration codes if applicable)
Record primary and any secondary ICD-10 diagnosis codes
Signature and date required on the acknowledgement

Step Therapy

Step therapy / prior lines and refractoriness

The form requires confirmation that for initiation requests the patient has received at least four prior lines of therapy and that disease is refractory to specified drug classes (proteasome inhibitor, immunomodulatory agent, and anti‑CD38 monoclonal antibody). For continuation requests, indicate whether the patient has experienced progression or unacceptable toxicity on the current regimen.

Initiation: confirm ≥4 prior lines of therapy
Initiation: confirm refractory status to at least one proteasome inhibitor (e.g., bortezomib/Velcade)
Initiation: confirm refractory status to at least one immunomodulatory agent (e.g., lenalidomide/Revlimid)
Initiation: confirm refractory status to at least one anti‑CD38 monoclonal antibody (e.g., daratumumab/Darzalex)
Continuation: document disease progression or unacceptable toxicity while on current regimen

Denial Risk

Fraud / Incomplete information risk

Providing materially false information or concealing material facts on the request may constitute insurance fraud and can lead to criminal and civil penalties; the plan may request additional information or clarification to evaluate the request. Ensure the signer and date are completed.

Signature and date required on the acknowledgement
Do not provide materially false or concealed information — fraudulent acts carry criminal/civil penalties
Be prepared to supply additional documentation if requested by the plan

Definitions

Refractory to therapy (definition and form items)

DefinitionDisease refractory to therapy: disease that does not respond to (or progresses despite) treatment with an agent or drug class.

Examples of agent/classes listed on formProteasome inhibitor (e.g., Velcade/bortezomib); Immunomodulatory agent (e.g., Revlimid/lenalidomide); Anti-CD38 monoclonal antibody (e.g., Darzalex/daratumumab).

How refractoriness is documented on the formCheckboxes asking whether disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody must be completed for initiation requests.

Relevance to initiation criteriaRefractoriness to the listed agent/classes is a required clinical element for initiation of Pepaxto per the form.

Relation to continuation requestsContinuation requests require documentation of disease progression or unacceptable toxicity while on current regimen; refractoriness items apply primarily to initiation.

Primary ICD Code	Primary diagnosis ICD code for multiple myeloma or other specified diagnosis
Secondary ICD Code	Secondary diagnosis ICD code if applicable
Other ICD Code	Additional ICD codes if applicable

OpenPayer

Pepaxto (melphalan flufenamide) — Precertification Request Form / Coverage Criteria

Coverage Criteria for Pepaxto (melphalan flufenamide)

Allowed Regimens and Combinations

Coding: Administration and Diagnosis Codes

What Providers Must Do

Line of Therapy Definitions and Requirements

Definitions

Background