Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany

Lauenroth, Victoria Desirée; Kesselheim, Aaron S.; Sarpatwari, Ameet; Stern, Ariel Dora

doi:10.1377/hlthaff.2019.01122

Cited by 38 publications

(49 citation statements)

References 25 publications

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“…52 In developed countries like Germany, price negotiations led to a 24.5% decrease in negotiated prices relative to launch prices. 53 Consistent with these previous findings, price reduction together with enlistment on the health insurance reimbursement scheme was important for promoting utilization of anticancer medicines. 23,54,55 Another implication was that price negotiation could help controlling pharmaceutical spending.…”

Section: Discussionsupporting

confidence: 83%

Trends of Negotiated Targeted Anticancer Medicines Use in China: An Interrupted Time Series Analysis

Huang

Ung

Wushouer

et al. 2021

Int J Health Policy Manag

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Background: In order to relieve the financial burden of the patients in China, the Ministry of Health (MoH) conducted the first national price negotiation and successfully negotiated three expensive medicines including 2 targeted anticancer medicines (TAMs), icotinib and gefitinib. However, little evidence was available to demonstrate the impact of the national negotiation on TAMs use. The purpose of the study is to evaluate the implementation of the national price negotiation policy in China on TAMs use. Methods: We used interrupted time series (ITS) design to examine the changes in the daily cost, the monthly hospital purchasing volume and spending of icotinib and gefitinib with pharmaceutical procurement data from 594 tertiary hospitals in 29 provinces of mainland China between January 2015 and July 2017. The period between May and July 2016 was applied to assess the impact of policy. Results: The daily cost of icotinib and gefitinib decreased by 50.08% (P < .001) and 53.89% (P < .001) 12 months after the national negotiation, respectively. In terms of volume, the negotiation was associated with increases in the trend of the monthly hospital purchasing volume of icotinib and gefitinib by 4.87 thousand defined daily doses (DDDs) (P < .001) and 6.89 thousand DDDs (P < .001). However, the monthly hospital purchasing spending of icotinib and gefitinib decreased rapidly by US$0.51 million (P < .010) and US$0.82 million (P < .050) following policy implementation, respectively. Conclusion:The first national negotiation had successfully cut off the price of two negotiated TAMs and promoted TAMs use in China. In the future, government should conduct further price negotiations and include more medicines with clinical benefits into reimbursement schemes to alleviate patients' financial burden and promote their access to essential treatment.

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Section: Discussionsupporting

confidence: 83%

Trends of Negotiated Targeted Anticancer Medicines Use in China: An Interrupted Time Series Analysis

Huang

Ung

Wushouer

et al. 2021

Int J Health Policy Manag

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“…However, Molto et al (2020) found that 40% of new oncology medicines recently received a breakthrough therapy designation, and were more likely than non-breakthrough therapies to provide a meaningful clinical benefit [10]. In addition, Lauenroth et al (2020) found that the reforms in Germany led to reimbursed prices for new oncology medicines falling following evaluation; subsequently, more in line with the clinical benefit seen [11].…”

Section: Introductionmentioning

confidence: 99%

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications

Godman

Hill

Simoens

et al. 2021

Expert Review of Pharmacoeconomics & Outcomes Research

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Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems. Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines. Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments.

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“…Nonetheless, years after its introduction, the AMNOG has improved the ratio of negotiated prices and the clinical bene t of evaluated compounds. (11,12) Recently, the G-BA formulated the requirement of an "application-accompanying data collection", whose legal basis was established in Germany in the so-called Law for More Safety in the Supply of Medicines. (13,14) This is intended to help close the existing evidence gap in the approval of ODs and ATMPs, since their e cacy and safety is proven in the context of the centralized approval for the European Economic Area.…”

Section: Introductionmentioning

confidence: 99%

Spinal Muscular Atrophy: The High Costs of Innovative Therapies for Rare Diseases

Brennenstuhl

Green

Störzinger

et al. 2021

Preprint

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Background: Despite numbers of prescriptions filled remaining constant, expenditures for drugs are rising. Among others, this is caused by high prices for orphan drugs and advanced therapy medicinal products (ATMPs). Despite attempts by policymakers to intervene, the increasing use of these therapies poses numerous challenges on the health care system.Results: Using data from the University Hospital Heidelberg, we found that the division of pediatric neurology is experiencing a strong increase in drug costs, caused by two pharmaceuticals for the treatment of spinal muscular atrophy (SMA), Nusinersen and Onasemnogene Abeparvovec. To put this finding in a broader context, we conducted a survey of 41 German SMA treatment centers revealing a general lack of human and infrastructure resources for therapy and follow-up care, which demonstrates insufficient reimbursement of treatment. To improve structural conditions, we propose that disease-independent registries for medication surveillance that comply with the rules of the European Union are needed as well as the development of a fair funding model.Conclusion: Innovative forms of therapy require a critical discussion and concise regulation of treatment application and follow-up reimbursement as well as international industry-independent registry work. Based on the previously described model of “evidence-based dynamic pricing” by the Techniker Krankenkasse, we propose a revised model which offers an internationally scalable solution to meet these challenges.

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Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany

Cited by 38 publications

References 25 publications

Trends of Negotiated Targeted Anticancer Medicines Use in China: An Interrupted Time Series Analysis

Trends of Negotiated Targeted Anticancer Medicines Use in China: An Interrupted Time Series Analysis

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications

Spinal Muscular Atrophy: The High Costs of Innovative Therapies for Rare Diseases

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