Common Questions about New Vyalev Treatment for Parkinson’s

A new Parkinson's medication - the second in 2024 - was approved in the U.S. in October. The drug, Vyalev, is an under-the-skin continuous infusion of levodopa and carbidopa. Unlike pills that you take throughout the day, Vyalev uses a pump device that you wear at all times, and only disconnect when you shower, bathe or swim.

Vyalev is a liquid reformulation of levodopa, the gold standard for Parkinson's symptom relief. The difference is that the medication is delivered continuously through the day and night. This, ideally, helps smooth out "off" times, especially during the night and early morning, when symptoms return because medication levels in fluctuate.

Here, we answer your questions about this new treatment.

Who is a candidate for Vyalev?

The medication aims to give more time throughout the day when symptoms are controlled ("on" time) and lessen ups and downs in symptoms (motor fluctuations) or extra movement (dyskinesia). If you experience a lot of time with symptoms ("off" time) or have motor fluctuations and/or dyskinesia despite taking medication frequently or if you generally don't have optimal symptom control on your current medication regimen, Vyalev may be an option.

How do you start Vyalev?

Your doctor prescribes the medication through a specialty pharmacy, which sends you the medication, pump and supplies. A nurse ambassador teaches you how to use the pump and administer medication. Your doctor calculates how much medication to give through the pump based on how much medication you're currently taking. You may need two to three or more visits with your doctor in the days and weeks following initiation to find the best dosage and rate of administration.

What does the Vyalev pump look like?

The pump device is about the size of two stacked cell phones. It weighs less than a pound. You carry it in a waist belt, vest or similar case. The medication runs 24 hours a day, even when you are sleeping, but you temporarily disconnect it for showering, bathing or swimming.

How does the Vyalev system connect to the body?

A small needle is inserted just under the skin. The needle is removed, but a small tube (cannula) remains to infuse medication. You change the needle and tube each day, inserting in different skin areas to lessen the chance of nodules, or bumps.

The medication comes in prefilled, single-use syringes that you load in the pump. Medication must be refrigerated but can be left unrefrigerated (as for travel) for a one-time period of up to 28 days.

What are the side effects?

The main side effects are related to skin infusion areas. These locations could develop infection, redness, swelling, warmth or nodules. To lessen risks, make sure your hands and skin are clean and dry when starting or stopping medication and regularly switch infusion sites.

When will Vyalev become available?

After FDA approval, all medications go through a process to determine insurance coverage. Because of the device component with this drug, the process is longer and, for people on Medicare, could take 10 to 12 months. For people on other types of insurance, the medication may be available in the coming months.

Regardless of your insurance, if you are interested, speak with your doctor. They can tell you more about the medication and help determine if your insurance covers the treatment now or keep you posted on when they do.

Just as with other medications and treatments, your out-of-pocket and other costs will vary depending on your insurer and plan.

Note that this medication has also been approved in several other countries outside the U.S., and regulatory and coverage processes vary country by country.

• Rachel Dolhun, MD, DipABLM

  Principal Medical Advisor