Vyalev

Foslevodopa + Foscarbidopa

• Brand(s): Vyalev
• Dosage Form/Strength: 240 mg/mL/12 mg/mL Solution for Infusion
• Effective date: September 5, 2024

For the treatment of advanced levodopa-responsive Parkinson's disease (PD) in patients who meet all of the following criteria:

1. 18 years of age and older;
   AND
2. Has not been able to achieve satisfactory control of severe, debilitating motor fluctuations and hyper-/dyskinesia despite optimized treatment with available combinations of PD treatments¹ including all the following:
   o Maximally tolerated doses of levodopa in combination with carbidopa (Note: the patient must have demonstrated an initial clinical response to an adequate trial of maximally tolerated doses of levodopa to be eligible for Vyalev); AND
   o A catechol-O-methyltransferase (COMT) inhibitor, if not contraindicated²; AND
   o A dopamine agonist, if not contraindicated²; AND
   o A monoamine oxidase-B (MAO-B) inhibitor, if not contraindicated²; AND
   o Amantadine, if not contraindicated²;
   AND
3. Has severe disability associated with at least 25% of the waking day in the off state and/or ongoing, bothersome levodopa-induced dyskinesias, despite having tried frequent dosing of levodopa (at least five doses per day)³;
   AND
4. Patient or caregiver must demonstrate correct understanding and use of the Vyalev delivery system;
   AND
5. Prescribed by neurologists who are movement disorder subspecialists, or who have expertise in managing advanced PD.

Notes:

1. Clinical details pertaining to the severity of the patient’s disability while in the off-state as well as a complete history of all previous and current medications (e.g., name, start date and duration of therapy, doses used, side effects, and response) must be included.
2. If a contraindication is deemed to be applicable to the patient, the requesting physician must state the contraindication and provide the rationale why it is considered a contraindication for the patient.
3. Patients on levodopa/carbidopa intestinal gel may be considered for a switch to Vyalev on a case-by-case basis.

Exclusion criteria:

Patients meeting one or more of the following clinical circumstances will NOT be considered.

• Patient with severe psychosis.
• Patient with severe dementia.
• Combination therapy with levodopa/carbidopa intestinal gel.

Renewal Criteria:

Renewal of reimbursement will be considered in patients who continue to benefit from treatment, including a significant reduction in the time spent in the off state and an improvement in the severity of the disability in the off state.

At the time of renewal, please confirm the average daily dose.

Recommended dose:

Administer dose as a continuous subcutaneous infusion over 24 hours with doses calculated based on levodopa equivalents. Refer to the Vyalev product monograph for dosing guidelines.

Duration of Approval of Initials and Renewals: 1 Year

EAP Drug Request Form:

Standard Form for EAP Drug Requests