VESICARE LS (solifenacin succinate suspension)

VESICARE LS (solifenacin succinate suspension)

Self-Administration - Oral

Indications for Prior Authorization:

• Indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older

Coverage Criteria:

For diagnosis of neurogenic detrusor overactivity:

• Dose is appropriate for the patient’s weight OR dose does not exceed 10 mL (10 mg) once daily, AND
• Patient is 2 years of age or older, AND
• Medical records document a diagnosis of neurogenic detrusor overactivity (NDO), AND
• Patient has tried and failed (a minimum 30-day supply), contraindication (e.g., safety concerns, not indicated for patient's age/weight), or intolerance to generic oxybutynin syrup or tablets

Reauthorization Criteria:

For diagnosis of neurogenic detrusor overactivity:

• Dose is appropriate for the patient’s weight OR dose does not exceed 10 mL (10 mg) once daily, AND
• Medical records document a positive response to therapy

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

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:

• The recommended doses are weight-based and are administered once daily
• Do not exceed the recommended Vesicare LS oral suspension starting dose in patients with severe renal impairment (CL < 30 mL/min/1.73 m2)
• Do not exceed the recommended Vesicare LS oral suspension starting dose in patients with moderate hepatic impairment (Child-Pugh B). Do not use Vesicare LS in patients with severe hepatic impairment (Child-Pugh C)
• Do not exceed the recommended Vesicare LS oral suspension starting dose when Vesicare LS is administered with strong CYP3A4 inhibitors such as ketoconazole
• Contraindications
  • With gastric retention
  • With uncontrolled narrow-angle glaucoma and
  • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in Vesicare LS oral suspension. Reported adverse reactions have included anaphylaxis and angioedema
• Warnings: angioedema and anaphylactic reactions, urinary retention, gastrointestinal disorders, CNS effects, controlled narrow-angle glaucoma, and QT prolongation in patients at high risk of QT prolongation

Policy Updates:

• 11/16/2021 – New policy approved by P&T

References:

• Vesicare LS Prescribing Information. Astellas Pharma US, Inc. Northbrook, IL. June 2020.