Humatrope denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient’s parent has requested authorization and coverage for Humatrope 12 mg cartridge. Findings: The physician reviewer found that cccording to both the American Association of Clinical Endocrinologists and the Pediatric Endocrine Society, sustained postnatal growth failure in children who have been SGA is considered an indication for growth hormone treatment. SGA causes a pathophysiologic process in utero that adversely affects fetal growth. Treatment with growth hormone in children with SGA usually stimulates substantial catch-up growth during the first two years of treatment, followed by a slower but constant increase in growth. GH treatment regimens prescribed for children with SGA have a reassuring safety profile.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Humatrope 12 mg cartridge for treatment of the enrollee’s medical condition.Findings: Two physician reviewers found that Williams syndrome is a genetic disorder resulting from microdeletion of chromosome 7q11.23. Common characteristics include dysmorphic facial features, global cognitive impairment, supravalvular aortic stenosis, and renal/urinary tract abnormalities. Endocrine abnormalities include short stature, precocious puberty, hypothyroidism, and hypercalcemia. This patient has been diagnosed with idiopathic short stature, with anticipated adult height significantly below mid-parental height predictions. Prior to a trial of growth hormone therapy, his height velocity was 4 cm, and increased to 9.27 cm with growth hormone administration.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for Humatrope growth hormone. The Health Plan denied the request and reported that the requested medication is not medically necessary for the treatment of this patient. At issue in this case is whether the requested Humatrope growth hormone is medically necessary for treatment of the patient’s medical condition. Tritos and Klibanski reported that GH therapy has beneficial effects on stature growth in several conditions characterized by GH insensitivity, including chronic renal failure, Turner syndrome, Prader-Willi syndrome, postnatal growth delay in patients with intrauterine growth retardation who do not demonstrate catch-up growth, idiopathic short stature, short stature homeobox-containing (SHOX) gene mutations, and Noonan syndrome.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Humatrope 6 mg. The Health Plan has denied this request indicating that the requested medication is not medically necessary for treatment of the enrollee, who has a history of panhypopituitarism, growth hormone deficiency and adrenal insufficiency.Findings: The records support that this patient has growth hormone deficiency. While the benefits of growth hormone therapy replacement in adults with growth hormone deficiency is well documented, the medical literature and guideline recommendations do not differentiate between the different brands of medications for treatment of growth hormone deficiency. The American Association of Clinical Endocrinologists indicates in their guidelines the following: “In the United States, recombinant GH [growth hormone] is approved by the FDA [U.S.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Humatrope, then check the rights and deadlines that apply to your plan.