CurrentAetnaPolicy N/A

Adzynma (ADAMTS13, recombinant-krhn) Medication Precertification Request

This document is Aetna's precertification/medication authorization request form for Adzynma (ADAMTS13, recombinant-krhn). It collects patient, insurer, prescriber, dispensing/provider, product, diagnosis, and required clinical information to support prior authorization for initiation or continuation of therapy, including clinical criteria specific to congenital TTP and safety/administration setting considerations.

Policy Summary

PayerAetna

PolicyAdzynma (ADAMTS13, recombinant-krhn) Medication Precertification Request

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must complete and submit this Aetna precertification form (all fields legible and completed) to Aetna Precertification Notification via phone 1-866-752-7021 or fax 1-888-267-3277 for Adzynma prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes for this policy/form.

1Precertification Form

cTTP-specificDiagnosis Focus

RequiredClinical Documentation

Document overview

This is Aetna's precertification/medication authorization request form for Adzynma (ADAMTS13, recombinant-krhn). It is used to request prior authorization for initiation or continuation of therapy and collects patient, insurer, prescriber, dispensing/provider/administration, product, and diagnosis information.

The form requires patient demographics and clinical identifiers (name, DOB, contact, weight/height, allergies), insurance details (member and group numbers, other coverage/Medicare/Medicaid), prescriber information (name, credentials, contact, NPI, specialty), and dispensing/provider or administration site details including place of administration and administration code(s) (CPT).

The form captures required clinical information for all requests including whether the infusion is in an outpatient hospital setting; prior infusion adverse events and response to conventional interventions; laboratory-confirmed anti-rADAMTS13 antibodies; severe venous access issues; behavioral/cognitive/caregiver concerns; and medical instability (cardiopulmonary, respiratory, renal, other).

For congenital TTP (cTTP)–specific requests the form asks whether the patient has a diagnosis of cTTP, whether the medication will be used for prophylactic or on-demand treatment, confirmation of diagnosis by genetic testing with biallelic ADAMTS13 mutations for initiation, and the patient's ADAMTS13 activity at diagnosis (Less than 10% | 10% or greater | Unknown). For continuation requests it asks whether the patient is receiving benefit from therapy (examples given: reduction/maintenance of TTP events, platelet count increase, LDH decrease).

Diagnosis-specific questions (cTTP)

Complete where applicable

ONE of

Does the patient have a diagnosis of congenital thrombotic thrombocytopenic purpura (cTTP)?
Yes/No
Please indicate the clinical setting for which the requested medication will be used: Prophylactic treatment of cTTP or On demand treatment of cTTP
Checkbox selection

For initiation requests

Has the diagnosis of cTTP been confirmed by genetic testing with biallelic mutations in the ADAMTS13 gene?
Yes/No
- Less than 10%
- 10% or greater
- Unknown

For continuation requests

Is the patient receiving benefit from therapy (e.g., reduction or maintenance of number of TTP events, increase in platelet count, decrease in LDH level)?
Yes/No

Thresholds

ADAMTS13 activity at diagnosisLess than 10% | 10% or greater | Unknown

Actions required of ordering providers

Prior Authorization

Submit precertification request

Providers must complete and submit the Aetna precertification form (all fields legible and completed) to Aetna Precertification Notification for Adzynma prior authorization. Submit via phone or fax to the numbers below.

Phone: 1-866-752-7021
Fax: 1-888-267-3277

Documentation Required

Provide required clinical documentation

Include documentation addressing the infusion setting; any prior infusion adverse events and the patient's response to interventions; presence of anti-rADAMTS13 antibodies; venous access concerns; behavioral, cognitive, or caregiver status; and medical stability (cardiopulmonary, respiratory, renal, or other). For congenital TTP (cTTP), provide confirmatory genetic testing showing biallelic ADAMTS13 mutations and the ADAMTS13 activity level at diagnosis for initiation requests, or evidence the patient is receiving benefit from therapy for continuation requests.

Documentation Required

Signature and attestation

The request must be signed and dated by the person completing the form. The form warns that knowingly providing false or misleading information is a fraudulent insurance act and that the plan may request additional information or clarification to evaluate the request.

Form background and definitions

This two-page form is used to request prior authorization for Adzynma infusions and captures the clinical and administrative data necessary for review.

It includes general safety and setting questions relevant to infusion administration (e.g., outpatient hospital setting, prior infusion adverse events and response to conventional interventions, anti-rADAMTS13 antibody status, venous access issues, behavioral/caregiver concerns, and medical instability) as well as cTTP-specific items such as diagnosis of congenital TTP (cTTP), genetic confirmation of biallelic ADAMTS13 mutations for initiation, and selection of ADAMTS13 activity at diagnosis (Less than 10% | 10% or greater | Unknown), plus assessment of benefit for continuation requests.

Term	Definition
{"text":"cTTP","status":""},{"text":"Congenital thrombotic thrombocytopenic purpura","status":"covered"}
{"text":"ADAMTS13 activity","status":""},{"text":"Laboratory measure of ADAMTS13 enzyme activity used to support cTTP diagnosis","status":"covered"}