Comparative Effectiveness of Carbidopa/Levodopa Enteral Suspension and Deep Brain Stimulation on Pill Burden Reduction in Medicare Fee-for-Service Patients with Advanced Parkinson's Disease.

INTRODUCTION: Complex polypharmacy regimens to manage persistent motor fluctuations result in significant pill burden for patients with advanced Parkinson's disease (APD). This study evaluated the effectiveness of carbidopa/levodopa enteral suspension (CLES) and deep brain stimulation (DBS) on reducing pill burden in APD patients. METHODS: We utilized 100% Medicare fee-for-service claims from 2014 to 2018 linked to CLES Patient Support Program (PSP) data. CLES initiators (CLES-I) were propensity matched 1:1 with patients enrolled in PSP who did not initiate treatment (CLES-NI) (N = 188) or undergo DBS, and 1:3 with patients who received DBS (N = 204, N = 612). Average daily pill burden and levodopa equivalent daily dosage (LEDD) were measured at baseline, 0-6 months and 7-12 months follow-up. RESULTS: CLES-I and CLES-NI had higher pill burden than DBS patients at baseline. However, at 6 months post-treatment, CLES-I had significantly fewer pills/day than CLES-NI (4.7 versus 11.4, p < 0.05) and DBS (4.8 versus 7.4, p < 0.05). A significant reduction in pill burden was observed at 0-6 months (46.3%) and 7-12 months (68.3%) follow-up for CLES-I (p < 0.001) versus increased burden for CLES-NI (+10.5%, p < 0.05 and +8.2%, p > 0.05) and insignificant reductions for DBS (-3.9% and -6.1%, p > 0.05). Mean adjusted pill burden showed 57.3% fewer pills at 0-6 months and 74.1% at 7-12 months among CLES-I compared with CLES-NI, and 49.6% and 70.1% reduction compared with DBS. CLES-I showed a decrease in LEDD at 7-12 months compared with baseline (935 to 237 mg) and to CLES-NI (237 mg versus 1112 mg) and DBS patients (236 mg versus 594 mg). CONCLUSION: CLES led to a significant reduction in pill burden and oral LEDD compared with CLES-NI and DBS patients. Pill burden reduction could be considered a treatment goal for patients with APD challenged by complex polypharmacy regimens that interfere with activities of daily living and quality of life.

Management of uncontrollable motor movements in patients with advanced Parkinson's disease rely on oral levodopa-based treatments. Non-motor symptoms such as depression and anxiety are managed with additional oral medications. Over time, higher and more frequent dosing of oral medications is required, resulting in complex medication regimens that impact quality of life and adherence.A real-world study of 10,752 Parkinson's disease patients between 2014 and 2018 evaluated the effectiveness of two device-aided therapies to reduce pill burden, carbidopa/levodopa enteral suspension and deep brain stimulation. Carbidopa/levodopa suspension treatment involves continuous delivery of levodopa to the intestines through a surgical port attached to a portable pump. Brain stimulation involves surgery to attach metal wires to the brain to send electrical pulses via an implanted stimulator.As Parkinson's disease predominately affects the elderly, we compared Medicare patients on carbidopa/levodopa suspension to a matched control group receiving no suspension and to those receiving brain stimulation. Average pill burden/day was measured prior to receiving a device-aided treatment (baseline) and at 0­6 months and 7­12 months post-treatment (follow-up).The top graph shows that by 6-months post-treatment, patients on carbidopa/levodopa suspension required fewer pills than those without suspension (4.7 versus 11.4), with further pill reduction at 12 months (3.5 versus 11.1). The bottom graph shows that by 6 months, patients on carbidopa/levodopa suspension required fewer pills than patients treated with brain stimulation (4.8 versus 7.4), with further reduction at 12 months (3.6 versus 7.0). The reduction in oral pill burden suggests that the carbidopa/levodopa suspension may present an opportunity to simplify treatment regimens.

The Increased Clinical and Economic Burden of Hyperkalemia in Medicare Patients Admitted to Long-Term Care Settings.

INTRODUCTION: Older patients are at increased risk for hyperkalemia (HK). This study describes the prevalence, recurrence, and clinical and economic burden of HK in Medicare patients admitted to a long-term care (LTC) setting. METHODS: Retrospective cohort study using 100% Medicare Fee-for-Service (FFS) claims identified patients aged ≥ 65 years with index admission between 2017 and 2019 to a LTC setting (skilled nursing, home health, inpatient rehabilitation, or long-term acute care). Beneficiaries were required to have 12 months continuous medical and pharmacy coverage prior to index LTC admission and ≥ 30 days after LTC discharge (follow-up). Patient characteristics, healthcare resource utilization, and costs were assessed. HK was defined as ICD-10 diagnosis code E87.5 in any claim position or Medicare Part D fill for oral potassium binder. RESULTS: Of 4,562,231 patients with a LTC stay, the prevalence of HK was 14.7% over the full study period (pre-index, index stay, and follow-up). Excluding those with HK only during the follow-up period resulted in 4,081,103 patients. Of these, 290,567 (7.1%) had HK and 3,790,536 (92.9%) did not have HK during or within 14 days prior to index LTC stay. The HK recurrence rate during index stay and follow-up was 48.3%. Unmatched HK versus non-HK patients were more often male (43.0% vs. 35.4%), Black (13.5% vs. 8.0%), dual eligible for Medicaid (34.2% vs. 25.0%), with higher mean Charlson Comorbidity Index scores (6.2 vs. 3.9) (all p < 0.0001). After propensity matching, HK patients were 2.2 times more likely to be hospitalized, with higher mortality (30.8% vs. 21.5%) and higher total healthcare costs during both index stay (US$26,520 vs. $18,021; p < 0.0011) and follow-up ($57,948 vs. $41,744 (p < 0.0011) versus matched non-HK patients. CONCLUSION: Prevalence and recurrence of HK was high among LTC patients, and HK was associated with significantly greater clinical and economic burden during and post-LTC.

Hyperkalemia is a serious medical condition commonly occurring in nursing home residents. It is characterized by abnormally high blood levels of potassium that if untreated can be life-threatening. High levels of potassium can be the result of kidney disease and inability to remove potassium from the bloodstream; eating foods high in potassium; and/or taking medications that interfere with the kidney's ability to remove potassium from the bloodstream. Older patients who have chronic kidney disease, heart failure, diabetes, and high blood pressure are at particularly high risk for hyperkalemia. Management is difficult as it requires reducing intake of foods high in potassium, adjusting medications that cause hyperkalemia, and potentially treating with oral potassium binders to reduce potassium blood levels. This study focused on the clinical outcomes, healthcare services use, and costs incurred by Medicare beneficiaries 65 years and older admitted to long-term care, where the occurrence of hyperkalemia is often high yet unrecognized. Patients with a diagnosis of hyperkalemia immediately before and during admission to long-term care or after discharge had an increased rate of death compared with patients without a hyperkalemia diagnosis. Hyperkalemia patients also had more hospitalizations and visits to the Emergency Department and outpatient facilities, resulting in higher total medical costs. Total costs for hyperkalemia patients were highest for those with chronic kidney disease, heart failure, and diabetes.