Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Central Precocious Puberty
Treatment: Fensolvi
The insurer denied Fensolvi.
The denial is overturned.

The patient is an adolescent female followed by her pediatric endocrinologist for short stature in the setting of small for gestational age. She is on growth hormone therapy. Recently, there was concern that her bone age may be advancing too rapidly. Recent physical exam also showed Tanner stage IV breasts and pubic hair development. Earlier last year, the patient's luteinizing hormone was 0.72 while Estradiol was elevated at 64. 
Three months ago, head magnetic resonance imaging did not show any pituitary abnormality. The patient's endocrinologist would like to initiate pubertal suppression using Fensolvi. 

Coverage was denied by the health plan as not medically necessary. The denial letter stated that her "current Plan-approved criteria does not allow coverage of the requested medication for central precocious puberty [CPP] in female patients unless the first signs of puberty appear at less than 8 years of age."

An appeal letter from the patient's endocrinologist pointed out that patient had noticeable features of puberty (breast and pubic hair) already present, presumably started before eight years old. Further, her recent bone age was read as closest to the 11.5 year old standard at chronological age of nine years and eight months, decreasing her predicted adult height from 63.7 to 61.5 inches.

The requested Fensolvi is medically necessary.

Pubertal suppression is considered medically necessary if criteria for CPP have been met, and the patient is at risk of developing early menarche and/or short stature as a consequence. The main goal of treatment in children with CPP is preservation of height potential. It is very difficult to accurately predict height outcome for any individual child. The degree of height gained depends on multiple factors, including chronological age, pubertal stage, skeletal maturation, and tempo of pubertal development. A subset of children with CPP has a slowly progressive form of early puberty that does not benefit from intervention in terms of adult height. [5] Therefore, a period of observation of six months has been recommended unless puberty is quite advanced (Tanner stage III breast development in girls) at initial presentation. [1]

This patient clearly has rapidly progressive CPP, with Tanner stage IV breast development and rapidly advancing bone age, as well as significantly elevated estradiol levels for age and is therefore at risk of not achieving her genetic height potential. A recent study on 48 girls with CPP treated with leuprolide depot showed that predicted adult height improved in most girls who initiated treatment after chronological age of seven years. The other concern often used as a rationale for treatment is negative psychosocial consequences of precocious puberty, particularly in girls. There have been studies that suggested increased stress and anxiety in girls with CPP. [3, 4]

Although the patient does not meet her policy's coverage guidelines for Fensolvi treatment, this is medically necessary in this situation and supported by the literature.