Performance-based managed entry agreements for new medicines in OECD countries and EU member states

Wenzl, Martin; Chapman, Suzannah

doi:10.1787/6e5e4c0f-en

Cited by 44 publications

(64 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Such agreements are now common. Two thirds of OECD countries have introduced managed entry agreements to address the large uncertainty associated with early market access, most commonly for cancer drugs (Wenzl and Chapman, 2019). Despite their widespread use, the value of these arrangements to patients and health care systems is unclear.…”

mentioning

confidence: 99%

Unintended Consequences of Coverage Laws Targeting Cancer Drugs

Salcher‐Konrad¹,

Naci²

2020

J. Law. Med. Ethics

View full text Add to dashboard Cite

Why do cancer drugs get such an easy ride?" (Light and Lexchin, 2015). This question was originally asked about regulatory standards for approval, but it may be just as pertinent to cancer drugs' coverage in insurance plans. In a case study in Massachusetts, Leopold and colleagues identified several state laws targeting the coverage of cancer drugs in health insurance programs. Such "onco-exceptionalism" in coverage policy poses challenges for payers confronted with high-cost drugs with limited evidence on clinical benefits (Leopold et al., 2020). Leopold et al.'s nuanced analysis reveals how payers navigate the complex terrain between regulatory and payment policy.

show abstract

mentioning

confidence: 99%

Unintended Consequences of Coverage Laws Targeting Cancer Drugs

Salcher‐Konrad¹,

Naci²

2020

J. Law. Med. Ethics

View full text Add to dashboard Cite

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%

“…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%

“…Over two-thirds of the Organization for Economic Co-operation and Development and European Union countries have been utilizing or had utilized RSAs by 2019 [5]. Goals, schemes, and implementations for risk sharing differ according to the background of each country.…”

mentioning

confidence: 99%

See 2 more Smart Citations

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

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

Ein transparentes Modell für einen fairen Preis für innovative Arzneimittel in Europa

Hendrickx

Kanga-Tona²

2021

Arzneimittel-Kompass 2021

View full text Add to dashboard Cite

Zusammenfassung Zusammenfassung Das empfindliche Gleichgewicht zwischen Bezahlbarkeit von Arzneimitteln, Nutzen für Gesundheitssysteme und Patient:innen sowie Einnahmen für die Pharmafirmen hat sich zugunsten letzterer eingependelt. Die europäischen Gesundheitssysteme tun sich schwer damit, Patient:innen zeitnahen Zugang zu neuartigen Arzneimitteln zu ermöglichen, weil deren hohe Preise nicht gerechtfertigt sind. Wie aber verschafft man den Patient:innen Zugang und setzt dabei gleichzeitig Anreize für die Pharmaindustrie, in neue Arzneimittel zu investieren, die die Patient:innen auch wirklich brauchen? In ihrem Modell für eine faire Preisfestsetzung in Europa plädiert die Association Internationale de la Mutualité (AIM) für eine aktivere Rolle der Preisfestsetzungs- und Erstattungsbehörden in Europa bei der Definition und Festsetzung „fairer“ Preise für innovative Arzneimittel. Alternativ zum bisherigen Value-based Pricing schlägt die AIM einen einfachen, aber effektiven Algorithmus vor, der auf die zugrunde liegenden Kosten und den therapeutischen Nutzen abstellt. Wenn man den Gewinn auf ein vernünftiges Maß beschränken und gleichzeitig relevante Innovationen honorieren würde, dann könnte man die Arzneimittelpreise senken und den Patient:innen einen besseren Zugang zu diesen Medikamenten verschaffen. Mit ihrem Modell für eine faire Preisfestsetzung in Europa leistet die AIM einen Beitrag zu einer zentralen Debatte, die die Gesundheitssysteme weltweit in den kommenden Jahren beschäftigen wird.

show abstract

Performance-based managed entry agreements for new medicines in OECD countries and EU member states

Abstract: This document, as well as any data and map included herein, are without prejudice to the status of or sovereignty over any territory, to the delimitation of international frontiers and boundaries and to the name of any territory, city or area.

Cited by 44 publications

References 20 publications

Unintended Consequences of Coverage Laws Targeting Cancer Drugs

Unintended Consequences of Coverage Laws Targeting Cancer Drugs

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

Ein transparentes Modell für einen fairen Preis für innovative Arzneimittel in Europa

Contact Info

Product

Resources

About