Implementing Levodopa‐Carbidopa Intestinal Gel for Parkinson Disease: Insights from US Practitioners

Abstract

Background Levodopa‐carbidopa intestinal gel (LCIG, designated in the United States as carbidopa‐levodopa enteral suspension, CLES) was approved in the United States in 2015 for the treatment of refractory motor fluctuations in individuals with Parkinson disease (PD). Many neurologists in the United States have not had personal experience with implementation and management of the unique delivery system for this treatment. Methods and Findings This educational review was developed to provide practitioners with an understanding of LCIG use from the clinician's point of view. Practical recommendations for the use of LCIG from the early planning stages through long‐term patient management were compiled from the published literature, regulatory guidance, and clinical experience. Among the topics reviewed were: assembling a multidisciplinary treatment team, identifying treatment candidates, patient/care partner education, procedural considerations, post‐procedural care, LCIG initiation and titration, troubleshooting issues, and ongoing monitoring. For most of these steps, a considerable amount of individualization is possible, which allows clinicians to tailor protocols based on the needs of their teams, the healthcare system, and the patient and care partner. Although clinical practices are heterogeneous, themes of early planning, ongoing education, and a team‐based approach to management are universal. Conclusions By using established protocols and insights gleaned from experienced practitioners, clinicians who are unfamiliar with LCIG can more feasibly incorporate this treatment option into their armamentarium for treating PD motor fluctuations.

Reply to: DUOPA® is an Excellent Alternative Treatment but with Some Caveats

“…A full issue of the Journal of the American Medical Association was recently devoted to the important topic of industry influence on biomedical publishing . Financial relationships are sources of bias that warrant special attention, and we adhered closely to MDCP's disclosure policies to ensure transparency in this regard . Dr. Lamichhane's letter highlights the success of these efforts.…”

“…1 Financial relationships are sources of bias that warrant special attention, and we adhered closely to MDCP's disclosure policies to ensure transparency in this regard. 2 Dr. Lamichhane's letter 3 highlights the success of these efforts.…”

“…With respect to specific reimbursement challenges: (1) although there is no CPT code for drug titration, there is significant counseling and education that occurs concurrently with drug titration that could support time-based billing; (2) in Medicare Part A inpatient environments, medications are not reimbursed separately from other care costs, but rather must be covered by the fixed daily rate for the diagnosis-related group (DRG). When drug costs exceed the DRG reimbursement, as is currently the case for CLES, justification of this expenditure must be made on a caseby-case basis.…”

Response from the Editors RE: DUOPA® is an Excellent Alternative Treatment but with Some Caveats

“…Lamichhane has raised concerns about the possible conflicts of interest (COI) in the paper of Michelle Burack et al However, having perused the paper we believe that all COI listed by Dr. Burack were clearly disclosed in the appropriate section of the paper, and the authors followed the journal instructions, which are based on recommendations of COPE and followed by other biomedical journals. “Editors should have policies that require all authors to declare any relevant financial and non‐financial conflicts of interest and publish at least those that might influence a reader's perception of a paper, alongside the paper.…”

“…To achieve the maximum effect within the research community, editors adhere to universal standards and good practices. Reaction and response to published research by other researchers is an important part of scholarly debate and is encouraged; therefore, we very much appreciate the letter sent by Dronacharya Lamichhane, 2 and the subsequent response from Michelle Burack et al 3 Lamichhane has raised concerns about the possible conflicts of interest (COI) in the paper of Michelle Burack et al 4 However, having perused the paper we believe that all COI listed by Dr. Burack were clearly disclosed in the appropriate section of the paper, and the authors followed the journal instructions, which are based on recommendations of COPE and followed by other biomedical journals. "Editors should have policies that require all authors to declare any relevant financial and non-financial conflicts of interest and publish at least those that might influence a reader's perception of a paper, alongside the paper.…”