Sharing knowledge for policy action in low- and middle-income countries: A literature review of managed entry agreements

Castro, Héctor; Malpica-Llanos, Tanya; Musila, Ruth N.; Konduri, Niranjan; Amaris, Ana Maria; Sullivan, J.M.; Gilmartin, Colin

doi:10.1177/2399202619834246

“…Nevertheless, cancer drugs account for most of the RSA drugs in these countries. This is because they are lifesaving and very expensive [5,41]. There seems to be more focus on financial-based schemes in all four countries.…”

Section: Discussionmentioning

confidence: 99%

“…The development and management of RSAs result in administrational and bureaucratic burden. Further, transaction time and the costs for executing RSAs to all stakeholders are burdensome with performance-based schemes being more difficult than financial-based schemes [2,5,41]. To adopt performance-based schemes, payers should be prepared to measure appropriate health outcomes.…”

Section: Discussionmentioning

confidence: 99%

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

Lee

¹

,

Bae

²

,

Bae

³

et al. 2021

BMC Health Serv Res

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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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“…The development and management of RSAs result in administrational and bureaucratic burden. Further, transaction time and the costs for executing RSAs to all stakeholders are burdensome with performance-based schemes being more di cult than nancial-based schemes [2,5,41]. To adopt performance-based schemes, payers should be prepared to measure appropriate health outcomes.…”

Section: Discussionmentioning

confidence: 99%

How Can We Improve Patients’ Access to New Drugs Under Uncertainties? : South Korea’s Experience with Risk Sharing Arrangements

Lee

¹

,

Bae

²

,

Bae

³

et al. 2020

Preprint

View full text Add to dashboard Cite

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.

show abstract

“…Nevertheless, cancer drugs account for most of the RSA drugs in these countries. This is because they are lifesaving and very expensive [5,41]. There seems to be more focus on nancial-based schemes in all four countries.…”

Section: Discussionmentioning

confidence: 99%

“…The development and management of RSAs result in administrational and bureaucratic burden. Further, transaction time and the costs for executing RSAs to all stakeholders are burdensome with performance-based schemes being more di cult than nancial-based schemes [2,5,41]. To adopt performance-based schemes, payers should be prepared to measure appropriate health outcomes.…”

Section: Discussionmentioning

confidence: 99%

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

Lee

¹

,

Bae

²

,

Bae

³

et al. 2020

Preprint

0

View full text Add to dashboard Cite

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.

show abstract

Sharing knowledge for policy action in low- and middle-income countries: A literature review of managed entry agreements

Cited by 7 publications

References 17 publications

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

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

How Can We Improve Patients’ Access to New Drugs Under Uncertainties? : South Korea’s Experience with Risk Sharing Arrangements

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

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