Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European countries

Rotar, Alexandru; Preda, Alin; Löblová, Olga; Benković, Vanesa; Zawodnik, S.; Gulàcsi, László; Niewada, Maciej; Boncz, I; Petrova, Guenka; Dimitrova, Maria; Klazinga, Niek

doi:10.1016/j.healthpol.2018.01.006

Cited by 24 publications

(21 citation statements)

References 8 publications

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“…Numerous countries have begun prioritizing cost-effectiveness when assessing new medical technologies to more effectively allocate limited health resources given the rising public sector costs associated with an aging population, increased prevalence of patients with chronic diseases, and the introduction of costly new drugs [1,2,3]. It is often difficult to determine reimbursement prices for newly developed drugs when the cost-effectiveness of these drugs in clinical practice remain unclear [4,5].…”

Section: Introductionmentioning

confidence: 99%

“…Many countries have begun to employ risk-sharing agreements as a new approach to improve patient access to new drugs. Under these agreements, pharmaceutical companies and insurance payers mutually agree to share the financial burdens or uncertainties regarding clinical outcomes [3,13,14,15]. Countries such as Australia, Great Britain, and Canada have separate organizations or expedited assessment pathways for costly anticancer drugs during the technology assessment and reimbursement decision-making processes [16,17,18,19].…”

Section: Introductionmentioning

confidence: 99%

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Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System

Yoo

Kim

Lee

et al. 2019

IJERPH

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This study reviews and evaluates the national drug formulary system used to improve patient access to new drugs by making reimbursement decisions for new drugs as part of the South Korean national health insurance system. The national health insurance utilizes three methods for improving patient access to costly drugs: risk-sharing agreements, designation of essential drugs, and a waiver of cost-effectiveness analysis. Patients want reimbursement for new drugs to be processed quickly to improve their access to these drugs, whereas payers are careful about listing them given the associated financial burden and the uncertainty in cost-effectiveness. However, pharmaceutical companies are advocating for drug prices above certain thresholds to maintain global pricing strategies, cover the costs of drug development, and fund future investments into research and development. The South Korean government is expected to develop policies that will improve patient access to drugs with unmet needs for broadening health insurance coverage. Simultaneously, the designing of post-listing management methods is warranted for effectively managing the financial resources of the national health insurance system.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System

Yoo

Kim

Lee

et al. 2019

IJERPH

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“…A lack of transparency also serves as another issue [2,5,37,42]. In most cases, the detailed condition of agreements and the results from evaluating patients' health outcome remain con dential.…”

Section: Discussionmentioning

confidence: 99%

How can we improve patients’ access to new drugs under uncertainties?: South Korea’s experience with risk sharing arrangements

Lee

Bae

et al. 2020

Preprint

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Background: New drugs including cancer drugs and orphan drugs are becoming increasingly more expensive. Risk sharing arrangements (RSAs) could manage the risk based on both financial impact and the health outcome of new drugs if reimbursed. To improve patients’ access to new drugs under uncertainties, many developed countries have adopted RSAs. In this study, we aimed to understand the effects of RSAs in South Korea on patients’ access.Methods: We reviewed current status of RSA drugs in South Korea. The number of appraisals and time gap between market approval and reimbursement per RSA drug were considered to quantify improvement of patients’ access as they showed how rapidly decisions on reimbursement of RSA drugs were derived. Then, we applied a comparative analysis to determine whether the RSA drugs in South Korea were reimbursed in the UK, Italy, and Australia. Most data for this study were obtained from websites of the governmental department/agencies responsible for appraisal of drug reimbursement in each country. And literatures related to RSAs were investigated as well.Results: The eligibility for Korean RSAs had two key components - drugs for cancer and rare diseases and not having other alternative treatments. As of the first half of 2019, there were 39 RSA drugs reimbursed in South Korea, the majority of which were financial-based schemes. Refund and expenditure cap were the representative types (89.7%). After introduction of RSAs, the time gap and number of appraisals were decreased. Based on the indications of RSA drugs, the level of drug coverage in South Korea was found lower than Italy, similar to the UK, and higher than Australia.Conclusions: RSAs in South Korea significantly enhanced patients’ access to new drugs and led to the alleviation of patients’ out-of-pocket expenses. The drug coverage of South Korea had a level comparable to that of other countries. This study provides implications for countries that have a dual mission of containing pharmaceutical expenditure and improving access to new drugs.

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“…Croatian patients had more elective hospitalization for CRT implantation (85%), although almost half of the patients (46%) were hospitalized due to HF during the past year before the implantation. This is probably due to organizational arrangements concerning hospitals' budget limitations and reimbursement issues and a need to screen the population with the CRT indication [ 10 , 12 , 16 , 17 ]. Also, patients in Croatia received more CRT-pacemaker (CRT-P) devices compared with other European countries (58 vs. 30%) despite a significant proportion having an indication for a CRT-defibrillator according to the current guidelines [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

Croatian National Data and Comparison with European Practice: Data from the Cardiac Resynchronization Therapy Survey II Multicenter Registry

Brusich

Zeljković

Pavlović

et al. 2018

Cardiology Research and Practice

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Aims The Cardiac Resynchronization Therapy (CRT) Survey II was conducted between October 2015 and December 2016 and included data from 11088 CRT implantations from 42 countries. The survey's aim was to report on current European CRT practice. The aim of this study was to compare the Croatian national CRT practice with the European data. Methods Five centres from Croatia recruited consecutive patients, in a 15-month period, who underwent CRT implantation, primary or an upgrade. Data were collected prospectively by using online database. Results A total of 115 patients were included in Croatia, which is 33.2% of all CRT implants in Croatia during the study period (total n=346). Median age of the study population was 67 (61–73) years, and 21.2% were women. Primary heart failure (HF) aetiology was nonischemic in 61.1% of patients, and HF with wide QRS was the most common indication for the implantation (73.5%). 80% of patients had complete left bundle branch block, and over two-third had QRS ≥150 ms. Device-related adverse events were recorded in 4.3% of patients. When compared with European countries, Croatian patients were significantly younger (67 vs. 70 years, p=0.012), had similar rate of comorbidities with the exception of higher prevalence of hypertension. Croatian patients significantly more often received CRT-pacemaker when compared with European population (58.3 vs. 29.9%, OR 3.27, 95%CI 2.25–4.74, p < 0.001). Conclusion Our data indicate strict selection of patients among HF population and adherence to guidelines with exception of higher proportion of CRT-pacemaker implantation. This is likely to be influenced by healthcare organization and reimbursement issues in Croatia.

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Rationalizing the introduction and use of pharmaceutical products: The role of managed entry agreements in Central and Eastern European countries

Cited by 24 publications

References 8 publications

Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System

Improving Patient Access to New Drugs in South Korea: Evaluation of the National Drug Formulary System

How can we improve patients’ access to new drugs under uncertainties?: South Korea’s experience with risk sharing arrangements

Croatian National Data and Comparison with European Practice: Data from the Cardiac Resynchronization Therapy Survey II Multicenter Registry

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