What is Vyalev?
Vyalev (foscarbidopa-foslevodopa) is a prescription medication approved by the FDA for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD) [1.6.1, 1.6.5]. It is a combination of prodrugs that convert into carbidopa and levodopa within the body [1.7.4]. Levodopa is a precursor to dopamine, the neurotransmitter that is depleted in Parkinson's disease. Carbidopa helps prevent the breakdown of levodopa before it reaches the brain, allowing more of it to be effective [1.7.4, 1.7.5].
Unlike traditional oral medications that can lead to peaks and valleys in drug levels, Vyalev is administered as a continuous, 24-hour subcutaneous infusion via a portable pump called the Vyafuser™ [1.6.4, 1.6.5]. This method of delivery aims to provide a more stable and consistent level of levodopa in the plasma, which can lead to an increase in "on" time (periods of good symptom control) and a decrease in "off" time (periods when symptoms return) [1.6.3, 1.7.3]. The FDA approval was based on a Phase 3 trial that showed patients treated with Vyalev had a significant improvement in "on" time without troublesome dyskinesia compared to those on oral carbidopa/levodopa [1.6.5].
Administration and Dosage
Vyalev is administered subcutaneously, typically in the abdominal area, using the Vyafuser pump [1.7.1]. Patients and their caregivers are trained on how to use the device, including how to prepare the medication and rotate the infusion site every three days to reduce the risk of skin reactions [1.8.2]. Dosing is personalized and programmed into the pump by a healthcare provider based on the individual's needs [1.5.1]. Patients should always have a backup supply of oral carbidopa/levodopa in case the infusion is interrupted for an hour or more [1.8.5].
Breaking Down the Cost of Vyalev
The question 'How much does Vyalev cost?' has a complex answer, with prices varying significantly based on several factors. The Wholesale Acquisition Cost (WAC), which is the price before any discounts or rebates, has been reported to be around $119,000 annually per patient, according to its manufacturer, AbbVie [1.2.3]. Another estimate from Canada's Drug and Health Technology Agency (CADTH) places the average annual cost at $62,023, assuming a daily use of one vial [1.2.1, 1.3.2]. A price guide from Drugs.com lists a supply of 70 milliliters (seven 10 mL vials) at approximately $2,247.35 [1.2.2].
The final out-of-pocket cost for a patient depends on:
- Insurance Coverage: Commercial insurance plans, Medicare, and Medicaid all have different policies for covering Vyalev. Coverage is often determined on a case-by-case basis, especially as the drug is relatively new [1.5.1, 1.6.2].
- Dosage: The prescribed dosage can vary, with a maximum of up to three vials per day, which would significantly increase the annual cost up to $186,069 based on some estimates [1.2.4].
- Deductibles and Copays: The specifics of a patient's insurance plan, including their annual deductible and copayment or coinsurance requirements, will directly impact their costs.
- Pharmacy: The price can vary between different specialty pharmacies that are equipped to handle and ship Vyalev [1.5.1].
Patient Assistance and Support Programs
To help mitigate the high cost, AbbVie offers a patient support program called VYALEV Complete. This program provides a range of services at no cost to eligible patients, including [1.5.1, 1.5.2]:
- Nurse Ambassadors: Patients are assigned a dedicated Nurse Ambassador to provide one-on-one guidance, training on the pump system, and support [1.5.3].
- Insurance Navigation: The program helps patients understand their insurance coverage and navigate prior authorizations and appeals [1.5.1].
- Financial Assistance: For commercially insured patients experiencing insurance delays or denials, VYALEV Complete may provide the medication at no charge for up to 24 months, subject to eligibility criteria. This offer is not available to patients covered by government programs like Medicare or Medicaid [1.5.4].
Comparison of Parkinson's Treatment Costs
It is useful to compare Vyalev's cost to other treatments for advanced Parkinson's disease. While a direct comparison is complex due to varying mechanisms and administration, looking at the annual costs of alternatives provides context.
| Treatment | Form | Average Annual Cost (Approx.) | Notes |
|---|---|---|---|
| Vyalev (foslevodopa-foscarbidopa) | Subcutaneous Infusion | $62,023 - $119,000 [1.2.1, 1.2.3] | Continuous 24-hour pump delivery. |
| Duodopa (LCIG) | Intestinal Gel | $62,023 [1.2.4] | Requires a surgically placed tube. |
| Generic Oral Levodopa-Carbidopa | Oral Tablet | $162 - $5,307 [1.2.4, 1.3.5] | Costs vary widely based on formulation (IR/CR) and dosage. |
| Apomorphine (Movapo) | Subcutaneous Injection | $8,317 - $11,089 [1.2.4] | Used as a rescue therapy for "off" episodes, not continuous. |
| Deep Brain Stimulation (DBS) | Surgical Implant | N/A (High upfront cost) | Involves a surgical procedure with ongoing device management costs. |
Potential Side Effects
The most common side effects associated with Vyalev are related to the infusion site, including redness, pain, swelling, nodules, and infection [1.7.1, 1.8.3, 1.8.4]. Other frequent adverse reactions include hallucinations and dyskinesia (involuntary movements) [1.8.1]. Serious side effects can occur, such as falling asleep during daily activities, impulse control issues (like compulsive gambling or shopping), psychosis, and cardiovascular events [1.8.5]. Patients should discuss their full medical history with their doctor before starting treatment [1.8.1].
Conclusion
Vyalev represents a significant advancement in the management of motor fluctuations for people with advanced Parkinson's disease, offering a non-surgical, continuous delivery system [1.6.3, 1.7.3]. However, this innovation comes at a substantial price. While the list price is high, the final cost to the patient can be lower after accounting for insurance, and manufacturer support programs like VYALEV Complete are crucial resources for navigating access and affordability [1.5.4]. Patients and their care partners should work closely with their healthcare providers and the support program to fully understand the potential costs and benefits of this therapy.
For more information directly from the manufacturer, you can visit the official VYALEV™ website.
