Appeal type: Formulary Exception
Decision: Upheld

Diagnosis: Gender dysphoria.

Treatment: Formulary Exception for Testosterone Gel.

The insurer denied coverage for the Formulary Exception for Testosterone Gel.

The denial is upheld. 

This is a transgender male patient who presented for a 6-month follow-up visit for diagnosis of transsexualism.  Testosterone was started and he reported that things are going well but he had a difficult experience with intramuscular (IM) injections and would like to switch route of administration.  Options were discussed with the patient and he preferred Androgel. 

The insurer has denied a formulary exception request for Testosterone Gel.  In their Final Adverse Determination letter they state the plan criteria covers this drug when the patient has tried and had an inadequate treatment response or intolerance to the required number of formulary alternatives, or has had a documented clinical reason such as expected adverse reaction or contraindication that prevents the patient from trying the formulary alternatives, if complete and valid documentation is provided.  The patient's use of this drug does not meet the requirement.  This is based on the information provided.  Formulary alternatives are: testosterone gel (generic Androgel 1.62%), testosterone solution, Androderm. Requirement: Trial and failure of all the formulary alternatives, but not more than three.   

This patient has a diagnosis of gender dysphoria and has transitioned from a female to male individual.

The goal of treatment in female-to-male (FTM) transsexual individuals is to stop menses and induce virilization, including a male pattern of sexual hair, male physical contours, and clitoral enlargement.  The principal hormonal treatment is a testosterone preparation.

There are many available testosterone preparations and routes of administration, including injectables, gels, and buccal tablets. 

Clinical studies have demonstrated the efficacy of several different androgen preparations to induce masculinization in FTM transsexual persons.

Regimens to change secondary sex characteristics follow the general principle of hormone replacement treatment of male hypogonadism.  Either parenteral or transdermal preparations can be used to achieve testosterone values in the normal male range (320-1000 nanograms per deciliter (ng/dl)).

Similar to androgen therapy in hypogonadal men, testosterone treatment in the FTM individual results in increased muscle mass and decreased fat mass, increased facial hair and acne, male pattern baldness, and increased libido.  Specific to the FTM transsexual person, testosterone will result in clitoromegaly, temporary or permanent decreased fertility, deepening of the voice, and, usually, cessation of menses.

The patient is requesting coverage for Androgel.

There are 3 formulary alternatives available to this patient: testosterone gel (generic Androgel 1.62%), testosterone solution and Androderm.  All 3 preparations have the same efficacy, safety, ease of application and side effects as the requested product.

There is no indication for the requested product Androgel. The formulary drug(s) are not likely to cause the patient an adverse reaction. The formulary drug(s) have not been ineffective based on the patient's clinical history. The requested drug will not be more effective than the formulary drug.

The carrier's denial of Request for Formulary Exception for Testosterone Gel is upheld.