New Levodopa Pump Approved

[pdpatient]

The new Levodopa pump has been approved by the FDA. Expected to be available through Medicare by summer 2025. Here is the link and followed by a Google Gemini created summary.

news.abbvie.com/2024-10-17-...

Summary & Explanation

The U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa) for adults with advanced Parkinson's disease. This is the first and only 24-hour continuous subcutaneous infusion levodopa-based therapy for treating motor fluctuations in this population.

Mechanism of Action: VYALEV™ delivers a continuous supply of levodopa, a crucial neurotransmitter for managing Parkinson's symptoms, throughout the day and night via subcutaneous infusion. This continuous delivery is designed to address the motor fluctuations experienced by patients with advanced Parkinson's disease, where oral medications become less effective.

Clinical Trial Results: Phase 3 clinical trials demonstrated that patients using VYALEV™ 0experienced a superior improvement in "on" time without troublesome dyskinesia compared to those using oral immediate-release carbidopa/levodopa. "On" time refers to periods when motor symptoms are well-controlled, while "off" time represents the return of symptoms. The improvement in "on" time was observed as early as the first week of treatment and persisted throughout the 12-week study period. A 52-week open-label study further evaluated the long-term safety and efficacy of VYALEV™.

Dosage and Administration: VYALEV™ offers personalized dosing to meet individual patient needs, adjusting for morning, daytime, and nighttime requirements. The medication is administered via continuous subcutaneous infusion.

Side Effects:The most common side effects were infusion site reactions, hallucinations, and dyskinesia (involuntary movements). Most reactions were non-serious and mild to moderate in severity. Serious side effects, including falling asleep unexpectedly during daily activities, hallucinations, unusual urges (such as gambling or compulsive shopping), and infusion site infections, were also reported and require immediate medical attention. Patients should inform their healthcare provider about all medications they are taking, as interactions with other drugs can occur.

Availability: The timing of patient access to VYALEV™ depends on individual insurance plans. Coverage for Medicare patients is anticipated in the second half of 2025.

[cjCardio53]

I just filled the forms from neuro Thurs,. and next step is for company to call me...Hoorray!!!

[pdpatient in reply to cjCardio53]

Nice! Who's your insurance carrier?

[cjCardio53 in reply to pdpatient]

I have medicare/network health

[pdpatient in reply to cjCardio53]

So, maybe I misunderstood you. Are you saying that you are expecting to be approved for the pump now? My understanding is that it won't be available to Medicare until the summer.

What forms did you fill, of it may ask?

[cjCardio53 in reply to pdpatient]

My neuro and I filled out the "Enrollment and Prescription" form Thurs. Fri my NP sent to the company and said the next step the company will be contacting me.

[Nikosmom]

Thanks so much for posting this information. I have been eagerly awaiting a progress report on the pump.

I was a little disappointed about the side effects. We ‘ll see. At least we are heading in the right direction.

[caitilin in reply to Nikosmom]

“Side Effects:” related to the “pump”

The mention of the two most common side effects, ie “hallucinations and dyskinesia”, instantly deflated my enthusiasm about the “pump”.

I think these “side effects” are also some of the same as those reported by folks who are on too high a level of levodopa.

I wonder how easily the pump will maintain an individual’s dosage effectively.

[Myfatcat]

I am a veteran. Do I get a shot at this setup? Anyone?

[pdpatient in reply to Myfatcat]

Are you eligible for VA medical care? If yes, I believe if I am not mistaken, you automatically also qualify for Medicare. That would make you eligible for the pump rollout next summer. Call Medicare to confirm this.