II-159-009

Medical Policy:

II-159-009

Topic:

Subcutaneous Hormone Pellets

Section:

Medicine

Effective Date:

May 31, 2021

Issued Date:

May 31, 2021

Last Revision Date:

March 2021

Annual Review:

March 2021

This policy version was replaced on February 28, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Hormone therapy can be delivered by several routes of administration: oral, transdermal, vaginal, injection, or subcutaneous implantation of pellets. When implanted in pellet form, the pellet is placed in the lower abdomen or buttocks. The procedure is performed in the physician’s office with the use of a local anesthetic and a small incision for insertion. Release of the drug continues over a 3-6 month time period.

The testosterone pellet, Testopel®, has received approval from the U.S. Food and Drug Administration (FDA) as replacement therapy for the following conditions associated with a deficiency or absence of endogenous testosterone:

Primary hypogonadism (congenital or acquired) - testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testes syndrome, or orchiectomy;
Hypogonadotrophic hypogonadism, also known as secondary hypogonadism (congenital or acquired) - gonadotropic LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma or radiation.

The prescribing information also states, if the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sex characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty.

Androgens may be used to stimulate puberty in carefully selected males with clearly delayed puberty. These patients usually have a familial pattern of delayed puberty that is not secondary to a pathological disorder; puberty is expected to occur spontaneously at a relatively late date. Brief treatment with conservative doses may occasionally be justified in these patients if they do not respond to psychological support. The potential adverse effect on bone maturation should be discussed with the patient and parents prior to androgen administration. An x-ray of the hand and wrist to determine bone age should be taken every 6 months to assess the effect of treatment on epiphyseal centers.

In 2015, the FDA issued a drug safety communication stating that prescription testosterone products are approved only for males with low testosterone levels caused by certain medical conditions and confirmed by laboratory tests. They cautioned that the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging. The FDA also concluded that there is a possible increased risk of heart attacks and strokes associated with testosterone use.

Implantation of pellets containing estrogen or estrogen combined with testosterone has also been proposed as treatment for symptoms associated with a decrease in naturally occurring hormones, such as female menopause. To date, no formulations of either of these types of pellets have received FDA approval. In addition, the use of these pellets has been shown to produce unpredictable and fluctuating serum concentrations of estrogens.

NOTE: This policy does not address the use of implanted progesterone products.

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

I. Subcutaneous Administration of Testosterone

Use of Testopel® subcutaneous testosterone pellets may be considered MEDICALLY NECESSARY AND APPROPRIATE for testosterone replacement therapy in males who meet ALL the following criteria:
- Diagnosis of ONE of the following:
  - Primary hypogonadism (congenital or acquired); OR
  - Secondary hypogonadism (congenital or acquired); OR
  - Delayed puberty;
- AND
- Laboratory testing confirms serum testosterone levels below the normal range as defined by the laboratory performing the test (e.g., total testosterone <300 ng/dL or free testosterone <9 ng/dL) when measured on at least two separate mornings; AND
- Oral, topical, and/or intramuscular testosterone replacement therapy have been tried and found to be ineffective or not tolerated; AND
- Prescribed by or in consultation with an endocrinologist or specialist knowledgeable in hormone therapy; AND
- For commercial health plan members only, step therapy supplement criteria may apply for select conditions (see policy II-242: Step Therapy Supplement).
Use of Testopel® subcutaneous testosterone pellets may be considered MEDICALLY NECESSARY AND APPROPRIATE for testosterone therapy in individuals undergoing masculinizing gender reassignment who meet ALL of the following criteria:
- Age 16 years or older; AND
- Diagnosis of gender dysphoria/incongruence or gender identity disorder confirmed by a mental health professional; AND
- Capacity to make a fully informed decision and to give consent to treatment; AND
- If significant medical or mental health concerns are present, they must be reasonably well-controlled; AND
- Oral, topical, and/or intramuscular testosterone replacement therapy have been tried and found to be ineffective or not tolerated; AND
- Prescribed by or in consultation with an endocrinologist or specialist knowledgeable in gender care and hormone therapy; AND
- For commercial health plan members only, step therapy supplement criteria may apply for select conditions (see policy II-242: Step Therapy Supplement).
Use of Testopel® subcutaneous testosterone pellets is considered NOT MEDICALLY NECESSARY for the treatment of male infertility, due to adverse effects on sperm production and fertility.
Use of Testopel® subcutaneous testosterone pellets is considered EXPERIMENTAL/INVESTIGATIVE for all other indications including, but not limited to treatment of symptoms associated with female menopause or reduced libido, due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
The subcutaneous administration of formulations of testosterone other than Testopel® is considered EXPERIMENTAL/INVESTIGATIVE for all indications due to lack of FDA approval of any other products.

II. Subcutaneous Administration of Estrogen or Estrogen Combined with Testosterone

Subcutaneous hormone pellets containing estrogen alone OR estrogen combined with testosterone (including bioidentical hormone formulations) are considered EXPERIMENTAL/INVESTIGATIVE for all indications, including but not limited to treatment of symptoms associated with female menopause, because there are no FDA-approved formulations of these products.

11980 J3490 S0189

Denial Statements

No additional statements.

Links

Blue Cross and Blue Shield of Minnesota medical policies apply generally to all Blue Cross and Blue Plus plans and products. Benefit plans vary in coverage and some plans may not provide coverage for certain services addressed in the medical policies. When determining coverage, reference the member’s specific benefit plan, including exclusions and limitations.

Medicaid products may provide different coverage for certain services, which may be addressed in different policies. For Minnesota Health Care Program (MHCP) policies, please consult the MHCP Provider Manual website.

Medicare products may provide different coverage for certain services, which may be addressed in different policies. For Medicare National Coverage Determinations (NCD), Local Coverage Determinations (LCD), and/or Local Coverage Articles, please consult CMS, National Government Services, or CGS websites.

Note that services with specific coverage criteria may be reviewed retrospectively to determine if criteria are being met. Retrospective denial of claims may result if criteria are not met.

Blue Cross and Blue Shield of Minnesota reserves the right to revise, update and/or add to its medical policies at any time without notice. Codes listed on this policy are included for informational purposes only and are subject to change without notice. Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement.

These guidelines are the proprietary information of Blue Cross and Blue Shield of Minnesota. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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