ABBV-951 (foslevodopa/foscarbidopa) — Abbvie’s continuous infusion formulation of levodopa/carbidopa that’s administered under the skin — will now be accessible at low or no cost to people in England with advanced Parkinson’s disease whose severe motor fluctuations are no longer controlled by standard treatments.
That’s according to the final recommendation by the National Institute for Health and Care Excellence (NICE), which states that ABBV-951 should be covered by the country’s national health service (NHS) for certain Parkinson’s patients. Specifically, it cites those with the neurodegenerative disease who “are not able to receive apomorphine or undergo deep brain stimulation, or when these treatments no longer control symptoms.”
The therapy’s listing on the NHS means ABBV-951, sold under the brand name Produodopa, will be available for free or with a small copay to eligible patients in the country. In England, NICE is responsible for drafting recommendations about which therapies will be listed and who will be eligible for them.
The committee analyzes a treatment’s potential benefits along with its cost, which is determined in negotiations between the NHS and the therapy’s developer. Terms of the commercial agreement between NHS England and Abbvie are confidential and the agreed price was not disclosed.
ABB-953 still under review in US for Parkinson’s
The NICE recommendation follows the therapy’s approval in the U.K. in October 2022. Similar regulatory decisions followed in Japan, Germany, and Spain. Meanwhile, a decision on ABBV-951’s approval is pending in the U.S.
Produodopa “represents an important new treatment for people with advanced Parkinson’s, providing an easy-to-use option that can help them manage their symptoms more reliably and effectively,” Helen Knight, director of medicines evaluation at NICE, said in a press release.
About 900 adults with advanced Parkinson’s in England are estimated to benefit from this treatment.
“This is the first time NICE has approved a treatment for Parkinson’s and comes after NICE was able to work with the company to address the issues that had initially prevented a positive recommendation,” Knight said.
“We are determined to get the best care to patients fast and ensure value for the taxpayer,” she added.
Parkinson’s is caused by the progressive death of nerve cells in the brain that produce dopamine, a chemical messenger involved in movement control.
Oral levodopa, a precursor of dopamine, is a mainstay of Parkinson’s treatment. The therapy is commonly combined with carbidopa to prevent levodopa from being converted into dopamine before it reaches the brain. This ensures all the levodopa reaches its target organ without the need to increase dosage.
However, the benefits of this type of treatment may wear off before it’s time for the next dose — resulting in so-called off episodes. As the disease progresses, such off episodes become more frequent, causing fluctuations in motor symptoms. Patients on levodopa also may develop dyskinesia, or uncontrolled and involuntary movements, over time.
Additional therapies used to help patients control symptoms during off periods include apomorphine — sold under the brand name Apokyn, among others — that mimic dopamine’s activity in the brain. Apokyn is given subcutaneously, or under the skin, with a pen device, or as a continuous infusion during the day.
Other non-oral therapies include AbbVie’s Duopa, a formulation of levodopa and carbidopa infused directly into the intestines, and deep brain stimulation, known as DBS. That’s a surgical procedure that involves placing a device inside the brain to deliver electrical impulses to stimulate specific brain areas. DBS has been used to treat motor symptoms in people with more advanced Parkinson’s and those with a poor response to other therapies.
Therapy shown in trials to reduce Parkinson’s off episodes
ABBV-951 is a soluble, subcutaneous formulation of foslevodopa and foscarbidopa, two prodrug versions of levodopa and carbidopa. Prodrugs are inactive molecules that are metabolized into the active medicine once they are inside the body.
The therapy is administered continuously for 24 hours a day, given directly under the skin through a specialized pump — a method that’s minimally invasive and typically convenient for patients. The prodrugs can be absorbed into the bloodstream, which allows more consistent amounts of levodopa to reach the brain and provides a faster decline in off times.
Key evidence of ABBV-951’s clinical efficacy came from an AbbVie-sponsored Phase 3 clinical trial (NCT04380142). It tested ABBV-951 and an oral placebo — given to 74 participants — against a continuous infusion of a placebo and oral immediate-release levodopa/carbidopa, given to 67 patients.
All participants had advanced Parkinson’s and motor fluctuations that were inadequately controlled by their treatment regimens. Treatment lasted for 12 weeks, or about three months.
The results showed that those treated with ABBV-951 had significantly greater on time without troublesome dyskinesia compared with those receiving oral levodopa/carbidopa (mean of 2.72 vs. 0.97 hours). Off time also was markedly and consistently reduced with ABBV-951.
Patients on the experimental therapy also were nearly four times less likely to report being on an off state when they woke up each day relative to those given oral levodopa/carbidopa (17% vs. 63%).
I was surprised at how effective [Produodopa] was at controlling my symptoms. Having the pump working 24 hours a day is a key benefit and it gave me back a degree of control in the management of my symptoms.
“I’m delighted that NICE have approved foslevodopa-foscarbidopa (Produodopa) as I’ve seen the benefit of the therapy,” Phil Hockey, who has lived with Parkinson’s for six years, said in a separate press release from Parkinson’s UK.
“I was surprised at how effective it was at controlling my symptoms. Having the pump working 24 hours a day is a key benefit and it gave me back a degree of control in the management of my symptoms. It even meant a return to my favorite sport, cycling!” Hockey added.
In the release, Parkinson’s UK noted that it will be working to assure that the therapy is available widely across the country. The hope, according to the advocacy organization, is that similar submissions and recommendations will occur in Scotland, Wales, and Northern Ireland, so that patients across the U.K. can benefit from the therapy.
AbbVie also has launched additional trials to assess the safety and efficacy of longer treatment with ABBV-951. One such trial (NCT03781167) has already been completed, while another (NCT04750226) is still ongoing at sites in the U.S. and Australia and expected to end in 2025.
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October 31, 2023 at 12:25AM
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ABBV-951 now available at low/no cost in England to some patients - Parkinson's News Today
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