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202101-134528

2021

Healthfirst Inc.

Medicaid

Skin Disorders

Pharmacy/ Prescription Drugs

Medical necessity

Upheld

Case Summary

Diagnosis: Skin Disorders.
Treatment: Pharmacy/Prescription Drugs.
The insurer denied Colesevelam Hydrochloride 3.75 GM Pak for medical necessity.
The denial was upheld.

This patient is a female. She has a past medical history of biliary atresia status post-surgical repair (Kasai procedure), upper gastrointestinal (GI) bleed (UGIB) secondary to esophageal varices, status/post (s/p) endoscopic variceal ligation (EVL) times (x) 3. She is suffering from pruritus and portal hypertension.
At issue is the medical necessity of Colesevelam Hydrochloride 3.75 GM Pak.
The health plan's determination of medical necessity is upheld in whole.

No, the requested health service/treatment of Colesevelam Hydrochloride 3.75 GM Pak is not medically necessary for this patient.
When treating pediatric patients with pruritus, the use of Colesevelam Hydrochloride 3.75 GM Pak is not well established nor supported by adequate scientific evidence. According to Kuiper, Edith MM, et al: "This trial shows that colesevelam significantly lowers serum bile acid levels in cholestatic individuals with pruritus but is not more effective than a placebo in alleviating pruritus." The available literature does not allow a well-supported conclusion regarding the safety and efficacy of Colesevelam Hydrochloride in treating pediatric cholestatic pruritus. Therefore, the requested health service is not consistent with the generally accepted practices and is not proven to be medically beneficial.
Therefore, the medical necessity cannot be established for Colesevelam Hydrochloride 3.75 GM Pak for this patient.

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