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Testopel (testosterone pellets)

Policy Number: PH-0282

 

(Subcutaneous implant)

Document Number: IC-0282

Last Review Date: 08/02/2018

Date of Origin: 07/26/2016

Dates Reviewed: 07/2016, 10/2016, 01/2017, 01/2018, 08/2018

  1. Length of Authorization

6 months (delayed puberty only); 12 months (all other indications)

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:
  • Testopel 75 mg implantable pellet: 6 pellets per 90 day supply
  1. Max Units (per dose and over time) [Medical Benefit]:
  • 6 billable units (450mg) every 90 days 
  1. Initial Approval Criteria

Testopel will be approved when ALL of the following are met:

  1. ONE of the following:
    1. ALL of the following:
      1. The patient has ONE of the following:
        1. The patient is an adolescent with delayed puberty

OR

        1. The patient has primary or secondary (hypogonadotropic) hypogonadism

AND

      1. If the patient is an adolescent with delayed puberty ONE of the following:
        1. The patient is male

               OR

        1. The prescriber has provided documentation that the requested agent is medically appropriate for the patient’s gender

AND

      1. ONE of the following:
        1. The patient is not currently receiving testosterone replacement therapy and meets BOTH of the following:
          1. The patient has a sign/symptom of hypogonadism

AND

          1. The patient has ONE of the following pretreatment levels:
            1. Total serum testosterone level that is below the testing laboratory’s lower limit of the normal range or is less than 300 ng/dL

               OR

            1. Free serum testosterone level that is below the testing laboratory’s lower limit of the normal range

OR

        1. The patient is currently receiving testosterone replacement therapy AND has ONE of the following current levels:
          1. Total serum testosterone level that is within OR below the testing laboratory’s lower limit of the normal range OR is less than 300 ng/dL

OR

          1. Free serum testosterone level is within OR below the testing laboratory’s normal range

OR

  1. The patient has a diagnosis of gender identity disorder (GID) and ALL of the following:
      1. The patient is an adult (18 years of age or older)

AND

      1. The patient has received evaluation from TWO qualified mental health professionals who have independently assessed the patient and ALL of the following:
        1. At least one of the evaluating professionals must have a doctoral degree (PhD, MD, Ed.B, D.Sc, D.S.W. or Psy.D) and be capable of adequately evaluating co-morbid psychiatric conditions

AND

        1. One evaluation should be from a person who has only had an evaluative role with the patient

AND

        1. The evaluations document that the patient has demonstrated a knowledge and understanding of the expected outcomes of cross-sex hormone treatment, as well as the medical and social risks and benefits

AND

      1. ONE of the following:
        1. The patient does not suffer from psychiatric comorbidity that interferes with the diagnostic work-up or treatment

OR

        1. If the patient has significant medical or mental health issues present, they must be reasonably well controlled and noted in the medical documentation submitted

AND

      1. For patients new to therapy, the patient has completed at least 12 continuous months of living in a congruent gender role with his/her gender identity (real life experience) prior to cross-sex hormone treatment (this should be noted in medical documentation submitted including start/end dates)

AND

  1. The patient does NOT have any FDA labeled contraindication(s) to therapy with the requested agent

AND

  1. ONE of the following:
    1. The patient will be receiving only one androgen or anabolic agent

OR

    1. The prescriber has submitted documentation in support of therapy with more than one agent

AND

  1. ONE of the following:
    1. The quantity requested is within the set quantity limit

OR

    1. The quantity (dose) requested is within FDA approved labeling and the prescribed dose cannot be achieved using a lesser quantity of a higher strength

OR

    1. The quantity (dose) requested is greater than the maximum dose recommended in FDA labeling and the prescriber has submitted documentation in support of therapy with a higher dose for the intended diagnosis which has been reviewed and approved

Compounded testosterone products containing ingredients that are not FDA approved, including but not limited to bulk powders/chemicals/products and compound kits, do not meet medical criteria for coverage and are considered investigational. These compounded products are not included in this policy and are not covered.

  1. Dosage/Administration

Indication

Dose

Replacement therapy in androgen-deficient males

150 mg to 450 mg implanted subcutaneously by a healthcare provider every 3 to 6 months

Delayed Puberty

Dosages in delayed puberty generally are in the lower range of that listed above and, for a limited duration, for example 4 to 6 months.

Note:

  • Each pellet contains 75 mg of testosterone
  • Adequate effect of the pellets ordinarily continues for three to four months, sometimes as long as six months.
    • It has been found that approximately one-third of the material is absorbed in the first month, one-fourth in the second month and one-sixth in the third month.
  • The number of pellets to be implanted depends upon the minimal daily requirements of testosterone propionate determined by a gradual reduction of the amount administered parenterally.
    • The usual dosage is as follows: implant two 75 mg pellets for each 25 mg testosterone propionate required weekly. (Thus when a patient requires injections of 75 mg per week, it is usually necessary to implant 450 mg (6 pellets). With injections of 50 mg per week, implantation of 300 mg (4 pellets) may suffice for approximately three months.)
  1. Billing Code/Availability Information

HCPCS Code:

  • S0189 – testosterone pellet, 75mg injection: 1 billable unit = 75mg
  • J3490 – Unclassified drugs

NDC:

  • Testopel 75mg -- 66887-0004-xx
  1. References
  1. Testopel [package insert]. Malvern, PA; Auxilium Pharmaceuticals, Inc.; October 2016. Accessed June 2018.
  2. Bhasin S, Cunningham GR, Hayes FJ et al. Testosterone therapy in adult men with androgen deficiency syndromes: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2006; 91: 1995–2010.
  3. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab May 2018; vol 103; 5: 1715-1744.
  4. First Coast Service Options, Inc. Local Coverage Determination (LCD): Testosterone pellets (Testopel®) (L33412). Centers for Medicare & Medicaid Services, Inc. Updated on 7/01/2014 with effective date 10/01/2015. Accessed June 2018.
  5. Noridian Healthcare Solutions, LLC. Local Coverage Article: Testopel Coverage (A55056). Centers for Medicare & Medicaid Services, Inc. Updated on 05/12/2016 with effective date 07/12/2016. Accessed June 2018.
  6. Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD): Treatment of Males with Low Testosterone (L36538). Centers for Medicare & Medicaid Services, Inc. Updated on 10/01/2017 with effective date 10/01/2017. Accessed June 2017.
  7. Noridian Healthcare Solutions, LLC. Local Coverage Article: Testopel Coverage (A55057). Centers for Medicare & Medicaid Services, Inc. Updated on 05/12/2016 with effective date 07/12/2016. Accessed June 2018.
  8. Noridian Healthcare Solutions, LLC. Local Coverage Determination (LCD): Treatment of Males with Low Testosterone (L36569). Centers for Medicare & Medicaid Services, Inc. Updated on 10/01/2017 with effective date 10/01/2017. Accessed June 2018.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

E23.0

Hypopituitarism

E29.1

Testicular hypofunction

E30.0

Delayed puberty

E89.3

Postprocedural hypopituitarism

E89.5

Postprocedural testicular hypofunction

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD) and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto Government Benefit Administrators, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC