CurrentAetnaPolicy N/A

Adzynma (recombinant ADAMTS13) precertification for cTTP

Precertification form and required clinical documentation for Aetna coverage of Adzynma (ADAMTS13, recombinant-krhn) for treatment or prophylaxis of congenital thrombotic thrombocytopenic purpura (cTTP); directed to prescribers and dispensing providers requesting authorization. Affects Aetna members (including Medicare Advantage Part B) and their providers.

Policy Summary

PayerAetna

PolicyAdzynma (recombinant ADAMTS13) precertification for cTTP

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain precertification and submit required clinical documentation including genetic confirmation of cTTP (biallelic ADAMTS13 mutations) and ADAMTS13 activity at diagnosis.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

genetic requireddiagnosis confirmation

<10% or ≥10%activity options

benefit requiredcontinuation

Coverage Criteria for Adzynma (rADAMTS13)

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Initial and continuation therapy criteria

Coverage considered when the following grouped criteria are met:

Diagnosis of congenital thrombotic thrombocytopenic purpura (cTTP) confirmed by genetic testing showing biallelic ADAMTS13 mutations for initiation requestsgenetic confirmation required for initiation

Form asks to indicate prophylactic vs on-demand use and ADAMTS13 activity at diagnosis

Baseline laboratory: Document ADAMTS13 activity at time of diagnosis (options: <10%, ≥10%, Unknown)ADAMTS13 activity reported

Used for clinical assessment

Continuation of therapy: For continuation requests, documentation that the patient is receiving benefit from therapy (e.g., reduction/maintenance of TTP events, increase in platelet count, decrease in LDH)evidence of clinical benefit required for continuation

Form includes a yes/no field

Setting justification: If infusion in outpatient hospital setting, provide justification such as prior severe or refractory infusion reaction, laboratory-confirmed anti-rADAMTS13 antibodies, severe venous access issues, significant behavioral/physical/cognitive impairment without caregiver, or medical instability (cardiopulmonary/respiratory/renal) limiting ability to tolerate infusion in alternate settingsspecified condition(s) documented

Multiple checkboxes provided on form

No explicit clinical exclusions are listed on the precertification form beyond the requirement that all sections be completed. The form requires documentation of diagnosis and baseline laboratory information and asks providers to indicate whether the request is for prophylactic versus on‑demand use and to report the patient’s ADAMTS13 activity at diagnosis (options: Less than 10%, 10% or greater, or Unknown), and it requires genetic confirmation of cTTP for initiation requests (biallelic ADAMTS13 mutations). Absence of the requested genetic confirmation or completed clinical fields may therefore preclude approval.

The form includes an acknowledgement that knowingly submitting materially false or misleading information is a fraudulent insurance act subject to criminal and civil penalties. The plan also states it may request additional information or clarification as needed to evaluate requests; failure to provide requested documentation or clarify information can result in denial.

Precertification, Documentation, and Provider Responsibilities

Prior Authorization

Precertification Required

Prior authorization is required for Adzynma (ADAMTS13, recombinant-krhn). Submit a complete precertification request form with all required clinical documentation; incomplete or illegible requests may be returned for clarification or denied if required information is not provided.

Aetna Precertification Notification phone: 1-866-752-7021 (TTY: 711); Fax: 1-888-267-3277
Indicate whether request is: Start of treatment (include start date) or Continuation of therapy (include date of last treatment)
Complete patient, prescriber, dispensing provider, product/dose, and primary ICD code sections on the form

Documentation Required

Setting and Safety Justification

Document the clinical justification for the chosen infusion setting and any safety concerns that require the outpatient hospital setting or heightened monitoring. Provide prior adverse event history, antibody status, venous access or behavioral/medical instability details as applicable.

Indicate if infusion will occur in an outpatient hospital setting and justify why alternate settings are not suitable
Document any prior infusion adverse events and response to conventional interventions (acetaminophen, steroids, diphenhydramine, fluids, other pre-medications)
Report laboratory-confirmed anti-rADAMTS13 antibodies if present
Document severe venous access issues requiring special interventions available only in the outpatient hospital setting
Describe significant behavioral, physical, or cognitive impairment and caregiver availability if safety is a concern
Describe any medical instability (respiratory, cardiovascular, renal, or other) that may limit tolerance of infusion volume/load and necessitate hospital-level personnel/equipment

Documentation Required

Required Documentation

Complete every required section of the precertification form. Ensure all fields are legible and include supporting clinical information for initiation or continuation requests.

Patient information: full name, contact, DOB, weight, height, allergies
Prescriber information: name, credentials, specialty, NPI, state license, contact information
Product information: Adzynma, dose, frequency
Diagnosis information: primary ICD code and any additional applicable ICD codes
Clinical information: for initiation—genetic confirmation of cTTP (biallelic ADAMTS13 mutations) and ADAMTS13 activity at diagnosis; indicate prophylactic vs on-demand use
For continuation—document clinical benefit (reduction/maintenance of TTP events, platelet count increase, LDH decrease)
Include signature and date on the Acknowledgement section

Denial Risk

Incomplete Information Risk

Failure to provide complete, legible, and requested documentation may result in requests for additional information or denial of coverage.

The plan may request clarification or additional records to evaluate the request
If required documentation is not provided in a timely manner, the precertification request may be denied

Background on Adzynma and Clinical Context

Adzynma is recombinant ADAMTS13 intended for use in patients with congenital thrombotic thrombocytopenic purpura (cTTP). The precertification form distinguishes intended use as either prophylactic treatment or on‑demand treatment of cTTP and requires diagnostic confirmation for initiation: specifically, genetic testing demonstrating biallelic ADAMTS13 mutations. The form also requests baseline information including the patient’s ADAMTS13 activity at diagnosis to guide clinical assessment and documents safety considerations for infusion setting and prior infusion‑related adverse events.

OpenPayer

Adzynma (recombinant ADAMTS13) precertification for cTTP

Coverage Criteria for Adzynma (rADAMTS13)

Diagnosis and Administration Codes

Precertification, Documentation, and Provider Responsibilities

Background on Adzynma and Clinical Context

Key Definitions