Subject: Aveed opt-out 2432-A SGM P2021

Drug

AVEED  (testosterone undecanoate injection)

Policy:

I.     INDICATION 

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications
Aveed is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
1.   Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome,
      orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone
      concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.
2.   Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or
      pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins
      in the normal or low range.

Aveed should only be used in patients who require testosterone replacement therapy and in whom the benefits of the product outweigh the serious risks of pulmonary oil microembolism and anaphylaxis.

Limitations of use:
     •   Safety and efficacy of Aveed in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.
     •   Safety and efficacy of Aveed in males less than 18 years old have not been established. 

All other indications are considered experimental/investigational and not medically necessary. 

II.   REQUIRED DOCUMENTATION

The following information is necessary to initiate the prior authorization review: For primary hypogonadism or hypogonadotropic hypogonadism, pretreatment morning serum total testosterone concentrations  

III.  EXCLUSIONS

Coverage will not be provided for members with any of the following exclusions: Use for age-related hypogonadism or late-onset hypogonadism

IV.   CRITERIA FOR INITIAL APPROVAL

Primary hypogonadism or hypogonadotropic hypogonadism
Authorization of 12 months may be granted for treatment of primary hypogonadism or hypogonadotropic hypogonadism when all of the following criteria are met:
1.   Member is a biological male or a person that self identifies as male.
2.   Member is at least 18 years of age.
3.   Member has at least two confirmed low morning serum total testosterone concentrations based on the reference laboratory range or current practice guidelines.

V.   CONTINUATION OF THERAPY 

Primary hypogonadism or hypogonadotropic hypogonadism
For members requesting authorization for continuation of therapy with primary hypogonadism or hypogonadotropic hypogonadism who are not currently receiving Aveed therapy through samples or a manufacturer’s patient assistance program, authorization of 12 months may be granted if the member meets criteria IV.1 and IV.2 above. All other members (including new members) must meet all initial authorization criteria.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Aveed [package insert]. Malvern, PA: Endo Pharmaceuticals Solutions Inc.; June 2020.  
2. Bhasin S, Brito JP, Cunninghan GR, et al. Testosterone Therapy in Men with Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 28, 2022