Objective: To estimate the budget impact of introducing apomorphine sublingual film (APL-130277; APL) as an on-demand treatment for patients with Parkinson’s disease (PD) and “OFF” episodes from a US payer perspective.

Background: Oral carbidopa/levodopa is considered the “gold standard” of PD therapy; however, motor complications, including “OFF” episodes, may occur over time. On-demand treatments can be taken to treat “OFF” episodes when they occur. APL is currently being investigated as an on-demand treatment for patients with PD and “OFF” episodes.

Method: Models from a US commercial and Medicare perspective were developed to assess the budget impact of APL in a hypothetical health plan over a 1-year time horizon. The models considered the effect of APL entry on the utilization of other FDA-approved on-demand treatments for patients with PD and “OFF” episodes, as well as the number of patients not currently receiving on-demand treatment. Eligible patients were estimated based on US census data, literature, and market research. The number of “OFF” hours was simulated on a patient level based on outcome distributions from clinical trials. Associated pharmacy costs were estimated based on wholesale acquisition cost and assumed a price range for APL comparable to that of the leading competitor. Medical costs were calculated based on literature and data from Adelphi Real World’s Disease Specific Programmes™. Budget impact was estimated overall and per member per month (PMPM). One-way sensitivity analyses were conducted.

Results: Using hypothetical plan sizes of 1 million covered lives, the models estimated that 213 and 4,140 patients in a commercial and Medicare population, respectively, were eligible for on-demand treatment of PD-related “OFF” episodes. The majority of APL uptake was assumed to originate from eligible patients not currently using an on-demand treatment for “OFF” episodes. Introducing APL was estimated to increase the PMPM budget by $0.002 in a commercial population and $0.041 in a Medicare population. For reference, Medicare fee-for service allowed costs are in excess of $1,000 PMPM; mean drug spending by Part D plans exceeds $200 PMPM.

Conclusion: Over a 1-year time horizon, introducing APL for the on-demand treatment of “OFF” episodes in patients with PD has a low budget impact to a US health plan relative to prevailing PMPM plan costs.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/budget-impact-of-apomorphine-sublingual-film-for-on-demand-treatment-of-patients-with-parkinsons-disease-and-off-episodes/