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Economics of Acromegaly Treatment in Brazil: A Budget Impact Analysis of Pituitary Surgery Compared with Long-Term Octreotide LAR.

ABSTRACT: BACKGROUND:Acromegaly is a rare, chronic and debilitating disease whose treatment places a high burden on health systems. In the reality of the Brazilian public health network, many patients are kept on drug treatment because of barriers to access to surgery. OBJECTIVE:The aim of this study was to estimate the costs and budget impact of routine transsphenoidal endoscopic surgery in relation to those of long-term drug treatment with octreotide long-acting release (LAR) from a cohort of patients followed at the referral medical centre for acromegaly treatment in the Federal District, Brazil. METHODS:Based on micro-costing data collected using mixed methods from a local perspective of the public health system, we performed a budget impact analysis (BIA) on a 3-year time horizon. Uncertainty was handled with deterministic (tornado and scenario) and probabilistic (Monte Carlo simulations) sensitivity analyses. RESULTS:Compared with the continued use of octreotide LAR at a dose of 30 mg every 28 days, the incremental budget impact of conducting two surgeries per month, considering a cure rate of 55%, could bring savings of approximately US$879,362.18 (95% CI 860,176.29-898,548.08) over 3 years. Depending on the key variable values, the savings amplitude ranged from US$431,836.39 to US$1,519,132.04. CONCLUSIONS:Improving access to surgery could result in significant cost reductions in acromegaly treatment. The present study stands out for being the first to estimate the costs of transsphenoidal surgery in the context of the public health system in Brazil.

SUBMITTER: Porto LB

PROVIDER: S-EPMC6533371 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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Economics of Acromegaly Treatment in Brazil: A Budget Impact Analysis of Pituitary Surgery Compared with Long-Term Octreotide LAR.

Porto Lara Benigno LB Zimmermann Ivan Ricardo IR Naves Luciana Ansaneli LA

PharmacoEconomics - open 20190601 2

<h4>Background</h4>Acromegaly is a rare, chronic and debilitating disease whose treatment places a high burden on health systems. In the reality of the Brazilian public health network, many patients are kept on drug treatment because of barriers to access to surgery.<h4>Objective</h4>The aim of this study was to estimate the costs and budget impact of routine transsphenoidal endoscopic surgery in relation to those of long-term drug treatment with octreotide long-acting release (LAR) from a cohor ...[more]

PMID: 30390240

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Project description:ContextBiochemical control reduces morbidity and increases life expectancy in patients with acromegaly. With current medical therapies, including the gold standard octreotide long-acting-release (LAR), many patients do not achieve biochemical control.ObjectiveOur objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly.Design and settingWe conducted a prospective, randomized, double-blind study at 84 sites in 27 countries.PatientsA total of 358 patients with medically naive acromegaly (GH >5 μg/L or GH nadir ≥1 μg/L after an oral glucose tolerance test (OGTT) and IGF-1 above the upper limit of normal) were enrolled. Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging.InterventionsPatients received pasireotide LAR 40 mg/28 days (n = 176) or octreotide LAR 20 mg/28 days (n = 182) for 12 months. At months 3 and 7, titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted, but not mandatory, if GH ≥2.5μg/L and/or IGF-1 was above the upper limit of normal.Main outcome measureThe main outcome measure was the proportion of patients in each treatment arm with biochemical control (GH <2.5 μg/L and normal IGF-1) at month 12.ResultsBiochemical control was achieved by significantly more pasireotide LAR patients than octreotide LAR patients (31.3% vs 19.2%; P = .007; 35.8% vs 20.9% when including patients with IGF-1 below the lower normal limit). In pasireotide LAR and octreotide LAR patients, respectively, 38.6% and 23.6% (P = .002) achieved normal IGF-1, and 48.3% and 51.6% achieved GH <2.5 μg/L. 31.0% of pasireotide LAR and 22.2% of octreotide LAR patients who did not achieve biochemical control did not receive the recommended dose increase. Hyperglycemia-related adverse events were more common with pasireotide LAR (57.3% vs 21.7%).ConclusionsPasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly.

Project description:Abstract Background Oral octreotide capsules (OOC) are a treatment option for patients with acromegaly in the United States. The MPOWERED trial (NCT02685709) showed that OOC were noninferior to injectable somatostatin receptor ligands (iSRLs; octreotide or lanreotide) in maintenance of biochemical control in patients previously responding to both treatments, as well as demonstrated improvements in patient-reported outcomes among patients receiving OOC. Objective Report long-term safety and efficacy outcomes with OOC from the open-label extension (OLE) of MPOWERED. Methods Patients were eligible for and could voluntarily enroll into the OLE if they had completed the 15-month core treatment phase of MPOWERED (6-month Run-in phase plus 9-month randomized controlled treatment [RCT] phase or, for OOC nonresponders during/at end of Run-in at participating sites, combination sub-study evaluating OOC in combination with cabergoline) and were adequately biochemically controlled per investigator assessment. Maintenance of response (definition: IGF-I <1.3×ULN; single timepoint) was assessed in each year of the OLE in patients responding at the start of that year. Additional analyses were performed on patients switching to OOC in the OLE from iSRLs in the core study. Results Sixty patients elected to enroll in the OLE (35 who received OOC and 19 who received iSRLs in the RCT phase, 6 from the combination sub-study). Median and maximal OOC exposure durations in the OLE were 2.2 and 3.5 years, respectively. A total of 94%, 90%, and 93% of patients receiving OOC monotherapy maintained biochemical response at the end of years 1, 2, and 3 of the OLE, respectively (using last observation carried forward imputation). Of patients switching from iSRLs to OOC during the OLE, 79% reported very good (47%) or excellent (32%) symptom control at the end of the OLE, compared with 47% (42% very good, 5% excellent) at the end of the RCT phase while receiving iSRLs. Patients switching from iSRLs also experienced significant improvements in the treatment convenience and treatment satisfaction domains (both P<0.05) of the Acromegaly Treatment Satisfaction Questionnaire. Median OOC compliance rate during the OLE was 99%. OOC safety during the OLE was consistent with that observed during the core study, with no new safety signals observed with long-term exposure. Conclusions The OLE of MPOWERED demonstrated a high percentage (≥90%) of patients maintaining biochemical response while receiving OOC monotherapy with a favorable long-term safety profile of OOC. Those who switched from iSRLs to OOC demonstrated improvements in symptom control, treatment convenience, and treatment satisfaction. Presentation: Sunday, June 12, 2022 1:12 p.m. - 1:17 p.m., Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.

Dataset Information

Economics of Acromegaly Treatment in Brazil: A Budget Impact Analysis of Pituitary Surgery Compared with Long-Term Octreotide LAR.

Publications

Economics of Acromegaly Treatment in Brazil: A Budget Impact Analysis of Pituitary Surgery Compared with Long-Term Octreotide LAR.

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