CurrentCignaPolicy N/A

Aveed (testosterone undecanoate) prior authorization

This document is a Cigna prior authorization request form for Aveed (testosterone undecanoate) injection, governing requests for coverage and administration site for members receiving testosterone therapy; it applies to providers submitting PA for this medication.

Policy Summary

PayerCigna

PolicyAveed (testosterone undecanoate) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with required clinical information, dosing schedule, and pre-treatment serum testosterone measurements (as applicable) by fax or via covermymeds.com.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

750 mgsingle IM dose

initial +4wk +10wkdosing schedule

(855) 840-1678fax

Coverage Criteria and Medical Necessity

Information required for medical necessity evaluation

Coverage considerations captured on the form (provider must document ALL applicable items):

Diagnosis and symptom documentation: Patient has hypogonadism (primary or secondary) with persistent signs and symptoms of androgen deficiency prior to initiation of any testosterone therapy

Form requires confirmation of symptomatic hypogonadism

Laboratory confirmation if currently receiving therapy: If the patient is currently receiving testosterone therapy, there must be at least ONE pre-treatment serum testosterone (total or bioavailable) level with a low result as defined by the lab reference1 low pre-treatment level

checkbox on form

Laboratory confirmation if not currently receiving therapy:

Policy Summary

PayerCigna

PolicyAveed (testosterone undecanoate) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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If the patient is not currently receiving testosterone therapy, there must be TWO pre-treatment serum testosterone measurements taken in the early morning on two separate days and BOTH be low per lab reference

2 low early-morning measurements on separate days

Dosing conforms to Aveed regimen: Requested dosing is 750 mg IM initial, 750 mg at 4 weeks, then 750 mg every 10 weeks or less per dose

form asks to confirm dose regimen

The Aveed prior authorization form explicitly asks whether the medication is being used to enhance athletic performance. Use of testosterone for athletic performance enhancement is inappropriate; providers must indicate on the form if the request is for this purpose. A positive response for performance enhancement will render the request ineligible for coverage under the clinical indication of hypogonadism.

Requests that do not document symptomatic hypogonadism or that lack the required pre-treatment serum testosterone measurements may be incomplete and at risk for denial. The form requires documentation of pre-treatment signs and symptoms of androgen deficiency and: if the patient is currently receiving testosterone, at least one pre-treatment low serum testosterone; if not currently receiving testosterone, two early-morning serum testosterone measurements on separate days that are both low.

Dosing and Coding Notes

Aveed dosing schedule

Initial dose750 mg IM (intramuscular)

Second dose750 mg IM at 4 weeks after initial injection

Maintenance dosing750 mg IM every 10 weeks thereafter

What Providers Must Submit

Prior Authorization

Prior Authorization Required

Prior authorization is required for Aveed (testosterone undecanoate). Submit requests via fax to (855) 840-1678 or online at www.covermymeds.com/main/prior-authorization-forms/cigna/ (or via SureScripts in your EHR). For urgent requests, call (800) 882-4462. Include all required documentation listed below to avoid delays or denial.

Submission methods: Fax (855-840-1678), CoverMyMeds online form, or SureScripts in EHR
If urgent, call (800) 882-4462 to expedite
Standard review turnaround: 5 business days

Documentation Required

Laboratory Documentation Required

Attach all relevant laboratory results with dates and reference ranges. For patients currently receiving testosterone therapy, include at least one pre-treatment serum testosterone (total or bioavailable) level that was low per the laboratory reference range. For patients not currently receiving therapy, include two separate early-morning serum testosterone (total or bioavailable) measurements taken on two different days, and documentation that both were low per the laboratory reference values.

Lab tests: serum total or bioavailable testosterone
Timing: early-morning draws required for the two pre-treatment measurements when not currently on therapy
Documentation: include numeric results, dates, and laboratory reference ranges

Documentation Required

Required Clinical and Administrative Information

Provide complete patient and prescriber identifiers and administrative details on the PA form. Required fields include patient name, Cigna ID, date of birth, patient address and phone; prescriber name, specialty, DEA/NPI/TIN, office contact, phone and fax, and office address. Specify the medication requested (Aveed 750 mg/3 mL), dose, frequency, duration, and expected target dose/titration plan. Include clinical justification for the requested dose/quantity (prior medication trials, rationale, and pertinent history).

Patient identifiers: name, Cigna ID, DOB, address, phone
Prescriber identifiers: name, specialty, DEA/NPI/TIN, office contact, phone, fax, address
Medication details: drug name, strength, dose, frequency, duration, titration/target dose
Clinical justification: prior treatments tried, rationale for dose/quantity

Documentation Required

Site-of-Care Documentation

Document the planned site of administration and justification for that site. Indicate whether the drug will be given in the patient's home, physician's office, hospital outpatient, or other location. If a higher-intensity site is requested, provide medical necessity rationale and note whether the patient is a candidate for redirection to a less intensive setting (with assistance from Specialty Care Options Case Manager) where appropriate.

Site options: Home, Physician's Office, Hospital Outpatient, Other (specify)
Note: infusion should occur in the least intensive medically appropriate setting per some Cigna plans
If requesting hospital or higher-intensity site, include medical necessity rationale and redirection assessment

Step Therapy

Step/Therapeutic History

Document current and prior testosterone therapies and the therapeutic history supporting the request. Indicate whether the patient is currently receiving testosterone therapy. If currently receiving, state current treatment plan, target dose and titration, and provide at least one pre-treatment low serum testosterone result. If not currently receiving, document prior therapies attempted, reasons for discontinuation or failure, and provide two pre-treatment early-morning low testosterone measurements on separate days. For Aveed specifically, confirm requested dosing schedule (750 mg IM, an initial dose, a 4-week follow-up dose, then every 10 weeks) or justify any deviation.

State whether patient is currently on testosterone therapy and describe current regimen
If currently on therapy: provide at least one pre-treatment low testosterone result and current titration/target dose plan
If not currently on therapy: provide two separate early-morning low testosterone measurements and prior treatment trials with reasons for failure or intolerance
Confirm/justify Aveed dosing schedule: 750 mg IM, then 750 mg at 4 weeks, then every 10 weeks (or provide rationale for alternate dosing)

Initial Therapy — Coverage Conditions

Initial Therapy

Initial therapy documentation expectations captured on form:

Diagnosis: Document hypogonadism diagnosis and pre-treatment symptoms

checkboxes on form

Laboratory confirmation: If not currently receiving testosterone, provide two early-morning serum testosterone measurements on separate days that are both low2 low early-morning measurements

form requirement

Dosing plan: Provide requested dosing (750 mg initial, 750 mg at 4 weeks, then every 10 weeks) or rationale for alternative dosing and titration plan

form requests clinical support for dose/quantity

Continuation Therapy — Renewal/Refill Conditions

Continuation Therapy

Continuation requests must document prior therapy and pre-treatment lab evidence per form rules.

If currently receiving testosterone: Provide at least one pre-treatment serum testosterone measurement with low result and document current therapy details

checkbox on form

Step Therapy and Prior Trials

Prior agent / trial (name & dates)	Dose / duration / outcome	Clinical rationale for current request (including why alternative was ineffective or not appropriate)
Per form: list prior testosterone formulations or other relevant agents tried (e.g., topical gels, injectable esters, oral agents) with dates
Per form: document dose, duration, and clinical outcome for each prior therapy (e.g., inadequate symptomatic response, adverse effects, intolerance)
Per form: provide clinical support for requested Aveed dose/quantity including past medications tried and pertinent patient history to justify nonstandard dosing

Site of Care and Administration Setting

Note

Specify acquisition and administration site; justify least-intensive setting

Indicate where the medication will be obtained and administered and confirm that administration will occur in the least intensive medically appropriate setting; answer whether the patient is a candidate for redirection to an alternate setting and provide medical necessity rationale if not.

Select obtaining site (e.g., CVS Caremark, hospital outpatient, retail pharmacy, home health, physician office stock).
Select administration site (patient's home, physician's office, hospital outpatient) and document if candidate for redirection to alternate setting.

Background

Aveed (testosterone undecanoate) is a long-acting injectable testosterone formulation used to treat male hypogonadism. The prior authorization form collects clinical confirmation of primary or secondary hypogonadism, pre-treatment symptoms of androgen deficiency, documentation of prior or current testosterone therapy, and confirmation that the requested dosing follows the Aveed regimen (initial 750 mg IM, then 750 mg at 4 weeks, then 750 mg every 10 weeks) or provides clinical justification for an alternative dosing plan.

Definitions

Male (biological definition)

DefinitionIndividuals with the biological traits of a male, regardless of the individual's gender identity or gender expression.

Use in formQuestion asks patient gender and provides this biological definition to guide responses.

Note on gender reassignmentFor patients who have undergone gender reassignment, the form instructs to answer 'no' to the hypogonadism question.

Hypogonadism

Clinical definitionTesticular hypofunction/low testosterone with symptoms of androgen deficiency.

Common symptomsDepressed mood; decreased energy; progressive decrease in muscle mass; osteoporosis; loss of libido.

Pre-treatment timeframeSigns/symptoms and serum testosterone levels refer to the period prior to initiation of any testosterone therapy.