DUVYZAT (givinostat)

DUVYZAT (givinostat)

Self-Administration-oral suspension

Diagnosis considered for coverage:

• Duchenne muscular dystrophy (DMD): Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.

Coverage Criteria:

For diagnosis of Duchenne muscular dystrophy (DMD):

• Diagnosis of Diagnosis of Duchenne muscular dystrophy (DMD), AND

• One of the following:

  • Patient has a confirmed mutation of the dystrophin gene

  • Muscle biopsy confirmed an absence of the dystrophin protein, AND

• Patient is 6 years of age or older, AND

• Patient is ambulatory without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.) prior to initiating Duvyzat, AND

• Requested drug will be used concomitantly with a corticosteroid regimen (e.g., prednisone/prednisolone, Emflaza [deflazacort], Agamree), AND

• Prescribed by or in consultation with a pediatric neurologist with expertise in treating DMD

Reauthorization Criteria:

For diagnosis of Duchenne muscular dystrophy (DMD):

• Patient has experienced a benefit from therapy (e.g., improvement in preservation of muscle strength), AND

• Patient is maintaining ambulatory status without needing an assistive device (e.g., without side-by-side assist, cane, walker, wheelchair, etc.), AND

• Patient continues to receive concomitant corticosteroid regimen (e.g., prednisone/prednisolone, Emflaza [deflazacort], Agamree)

Coverage Duration: 

• Initial: 6 months

• Reauthorization: 12 months

Dosing: 

For diagnosis of Duchenne muscular dystrophy (DMD):

• 10 to <20 kg: Oral: 22.2 mg twice daily

• 20 to <40 kg: Oral: 31 mg twice daily

• 40 to <60 kg: Oral: 44.3 mg twice daily

• ≥60 kg: Oral: 53.2 mg twice daily

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Obtain and evaluate baseline platelet counts and triglycerides prior to initiation of Duvyzat.                             Do not initiate Duvyzat in patients with a platelet count less than 150 x 10^9/L.

• Dosage modifications may be needed for decreased platelet counts, diarrhea, increased triglycerides, or QTc prolongation.

Policy Updates:

• 10/01/2024 – New policy approved by WHA P&T Committee. (P&T, 11/20/2024)  

References:

1. Duvyzat Prescribing Information. ITF Therapeutics, LLC. Concord, MA. March 2024. 

2. Birnkrant DJ, Bushby K, Bann CM, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. The Lancet Neurology. 2018;17(3):251-267. 

3. Gloss D, Moxley RT 3rd, Ashwal S, Oskoui M. Practice guideline update summary: Corticosteroid treatment of Duchenne muscular dystrophy: Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2016;86(5):465-72.