In what clinical situations do you switch to Vyalev in patients with Parkinson's disease?

Vyalev (foscarbidopa/foslevodopa) administered by subcutaneous infusion with an external battery-operated pump, was recently FDA-approved. Conceptually, it offers the prospect of continuous levodopa administration which should improve dyskinesia and motor fluctuations. Skin reactions can be problematic in some patients. Setting up and operating the pump and tubing can also be difficult for some patients.

In general, Vyalev is a reasonable option if a patient has troublesome motor fluctuations or dyskinesia despite other interventions (e.g., partitioning oral carbidopa/levodopa dosing, other extended-release carbidopa/levodopa formulations, and amantadine). Patients with poor skin integrity or significant cognitive deficits would be at higher risk for unsuccessful therapy.

Note that Vyalev is a specialty drug so access is limited. It is also currently covered by Medicare Part B, not D.

Agree with the above, which provides general rationale for considering the SQ levodopa. This medication was only just approved a few months ago and few people are on it at this point. In real-world practice, most patients who meet criteria for foslevodopa would also be candidates for deep brain stimulation - or focused ultrasound. Seeing as the latter is far more tried and true most will end up getting one of those. Individuals who are not good DBS candidates, or those who are just against having a neurosurgical treatment, may be better candidates for SQ levodopa.

I have one patient who I am considering for this last reason.

Of course, as Dr. Fang mentions, some patients with cognitive impairment may not be good candidates for the SQ pump as well - and would be equally poor candidates for DBS.

It will take a few years of early adopter data and post-approval research to really know how good this treatment will be. Approval by medicare part D will help speed this along.

Vyalev provides another option for individualized treatment of PD. In general, Vyalev is for patients with symptom fluctuations including prolonged off-time while taking oral medications. In addition to the considerations mentioned by others, Vyalev may prove useful for patients with dysphagia or GI issues that would impact the absorption of oral levodopa (gastroparesis, SIBO, etc). I imagine it will be a bridge to DBS for many patients. I think it will help non-motor fluctuations during the day and may improve sleep quality if used overnight. Looking forward to phase 4 studies and real-life experience, as mentioned it is new on the market.