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Medicaid Coverage Increases for Pheburane for Urea Cycle Disorders

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Current treatments urea cycle disorders, which causes ammonia to build up in the blood, have a bitter taste and smell. Pheburane was developed with a special coating that masks the taste of sodium phenylbutyrate. It has a list price of $4,375 per bottle.

Six state Medicaid programs — Texas, Oklahoma, North Dakota, Utah, New Hampshire and New Mexico — have included Pheburane (sodium phenylbutyrate) on their preferred drug lists, and California has included the drug on its Contract Drug List with no prior authorization. In addition, Pheburane is covered with preferred status at several PBMs — including Express Scripts.

Pheburane was launched in September 2022 to treat urea cycle disorders (UCDs), a genetic condition that causes ammonia to build up in the blood. It is indicated for the long-term management of adults and children with urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.

Pheburane is an oral pellet formulation of sodium phenylbutyrate (NaPB) that was developed with a special coating that masks the taste of sodium phenylbutyrate. The bitter taste and smell of sodium phenylbutyrate, has well as the many pills of some brands, has impacted adherence to medication.

Pheburane was developed by Lucane Pharma and licensed to Medunik USA. The wholesale acquisition cost of Pheburane is $4,375 for a bottle, which is 174 grams. Company officials said this is about one-third the price of Ravicti and half of the price of Olpruva, are other available phenylbutyrate products used to treat UCD.

In addition, Medunik offers a patient program called UNIK Support Program, which offers specialized services including a copay savings program, patient care liaison services, mail order pharmacy and other support services. Pheburane is provided through Accredo, Evernorth’s specialty pharmacy

Tanya Carro

Tanya Carro

“The competitive price of Pheburane combined with increasing coverage from public and private payers is a testimony of Medunik USA’s commitment to the UCD community and its stakeholders,” Tanya Carro, executive vice president of Medunik USA, said in a press release.

Urea cycle disorders are genetic conditions that causes ammonia to build up in the blood. This can lead to brain damage and neurocognitive impairments. They can be fatal if left untreated. UCDs affect one in 35,000 people in the United States; it is estimated that about 2,000 people in the United States require treatment.

Related: FDA Approves New Therapy for Urea Cycle Disorders

In January 2023, the FDA approved Olpruva, which was developed by Acer Therapeutics and Relief Therapeutics also to treat urea cycle disorders. Olpruva is formulation of sodium phenylbutyrate packaged as a premeasured, single dose packet.

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