Pharmaceutical Policy Reform — Balancing Affordability with Incentives for Innovation

Conti, Rena M.; Rosenthal, Meredith B.

doi:10.1056/nejmp1515068

Cited by 28 publications

(19 citation statements)

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“…To the best of the authors' knowledge, this is the first study in which the correlation between incremental cost and incremental OS has been successfully evaluated in a series of different countries. Given that the value-based approach [Young, 2015] is widely recognized to be the most 'modern' solution in this field, it is interesting to note that Scandinavian countries [Vogler et al 2015] and, to a lesser extent, Japan [Takayama and Narukawa, 2015] and Italy [Martone et al 2014a] routinely employ the value-based approach for pricing new anticancer agents, whereas the US does not [Conti and Rosenthal, 2016]. Our results are perfectly in line with these different strategies adopted by these four countries.…”

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confidence: 80%

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Pricing of innovative drugs: correlation between incremental cost and survival gain in four countries

Mengato

Messori

2016

Ther Adv Med Oncol

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In pharmacoeconomics, ICER (incremental costeffectiveness ratio) is a recognized parameter that quantifies the cost-effectiveness for the comparison between an innovative drug and the standard of care [McCabe et al. 2008]. An extensive literature has been published on how ICERs should be interpreted and how their values ultimately translate into pricing decisions (e.g. value-based pricing). Given that ICER algebraically is the ratio of incremental cost and incremental benefit (i.e. survival gain), we designed a study to assess the correlation between these two parameters in different developed countries. A strong correlation would indicate that drug prices are strictly related to the benefit, while a poor correlation would indicate that prices are unrelated to benefits. To our knowledge, while hundreds of papers have been focused on theoretical and practical implications of ICERs, only a few studies have assessed the above mentioned correlation, and no study at all has performed an international comparison. The present analysis was restricted to anticancer agents and was aimed at carrying out this specific international comparison.We first performed a literature search in PubMed (www.pubmed.org) and Google Scholar (www. scholar.google.it) covering the period from 1 January 2010 to the present time (the last query was on 17 February 2016). The keywords employed to select eligible papers were the following: survival AND gain AND cost AND (oncology OR 'anticancer drug'). The time interval from 1 January 2010 to present time was selected also to obtain the overall survival (OS) data of those drugs for which this information was unavailable from included studies. Eligible papers were included in our analyses if they met the following criteria for each innovative drug: reporting of clinical indication, standard of care, incremental OS and incremental cost. Papers were included even though the latter two parameters were not directly presented, but enough information was given to recalculate them. To include as many papers as possible, our search was extended to all citations reported in the references of included articles. We separately examined whether the inclusion criteria were met by individual studies. Differences in this assessment were resolved by consensus. Standard correlation analyses were carried out to generate our results.Our first extraction of eligible papers from PubMed selected a total of 258 citations. After inspection of the abstract or the full text of these articles, a total of eight studies [Martone et al. 2014a[Martone et al. , 2014bSchnipper et al. 2015;Ebara et al. 2013;Shiroiwa et al. 2011;Tsuchiya et al. 2011;Mouri et al. 2013;Österlund et al. 2014] were found to satisfy the inclusion criteria; these articles referred to the following four countries: Italy, US, Japan and Scandinavia. Figure 1 (panels a through d) illustrates the results of our analyses. The values of correlation coefficient showed a substantial association between incremental cost and incremental OS for Scandinavia (r = 0.767...

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supporting

confidence: 80%

“…Our results are perfectly in line with these different strategies adopted by these four countries. In particular, in the US a lively debate is ongoing on how drugs should be priced, mainly because the results obtained thus far based on the current approach are largely thought to be unsatisfactory [Conti and Rosenthal, 2016].…”

mentioning

confidence: 99%

Pricing of innovative drugs: correlation between incremental cost and survival gain in four countries

Mengato

Messori

2016

Ther Adv Med Oncol

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“…In the USA, the high price of prescription drugs was a topic for policy proposals from presidential candidates [2], and the need to balance affordability with incentives for innovation was recently discussed in the New England Journal of Medicine [3]. In Europe, most countries define yearly, and sometime mid-term, growth targets in drug spending.…”

Section: Introductionmentioning

confidence: 99%

Approaches to manage ‘affordability’ of high budget impact medicines in key EU countries

Flume

Bardou

Capri

et al. 2018

Journal of Market Access & Health Policy

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Background: The launch of hepatitis C (HCV) drugs such as sofosbuvir or ledipasvir has fostered the question of affordability of novel high budget impact therapies even in countries with high domestic product. European countries have developed a variety of mechanisms to improve affordability of such therapies, including ‘affordability thresholds’, price volume agreements or caps on individual product sales, and special budgets for innovative drugs. While some of these mechanisms may help limit budget impact, there are still significant progresses to be made in the definition and implementation of approaches to ensure affordability, especially in health systems where the growth potential in drug spending and/or in the patient contribution to health insurance are limited. Objectives: In this article, we will review how seven countries in western Europe are approaching the question of affordability of novel therapies and are developing approaches to continue to reward new sciences while limiting budget impact. We will also discuss the question of affordability of cost-effective but hugely expensive therapies and the implications for payers and for the pharmaceutical industry. Results: There is clearly not one solution that is used consistently across countries but rather a number of ‘tools’ that are combined differently in each country. This illustrates the difficulty of managing affordability within different legal frameworks and within different health care system architectures.

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“…Thus, perhaps it is inevitable that these tensions would bubble over into U.S. presidential candidate policy proposals and state and federal lawmakers’ preoccupations focused on understanding and potentially reforming branded prescription drug “prices.” Congressional investigations regarding how several pharmaceutical companies set prices are underway, while increased transparency on how companies set prices is the subject of proposals that are pending in seven state legislatures (Conti & Rosenthal, ). As in previous periods of health reform debate, lawmakers and other stakeholders have recently identified a slate of possible reforms to address high prescription drug prices.…”

Section: Introductionmentioning

confidence: 99%

Pharmaceutical Policy Reform — Balancing Affordability with Incentives for Innovation

Cited by 28 publications

References 1 publication

Pricing of innovative drugs: correlation between incremental cost and survival gain in four countries

Pricing of innovative drugs: correlation between incremental cost and survival gain in four countries

Approaches to manage ‘affordability’ of high budget impact medicines in key EU countries

The Advantages of Awarding the Federal Government Negotiating Power Over the Prices of Prescription Drugs

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