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V1.0 researched and written by Elise Erickson, edited by Suerie Moon, last updated June 2018



The literature surrounding health technology assessment (HTA) is rich*. One challenge is that there is no set terminology or clear borders when referring to the issue of how to assess the value of a medicine, and its relationship to price. "HTA" is used in some of the literature, whereas others use "pharmacoeconomics" or "cost-effectiveness analysis," and others "value-based pricing." Adding to this challenge, it is a highly technical topic, which means that a significant amount of the literature may be less accessible to non-specialists.




Medicine/drug/pharmaceutical and health technology assessment, cost-effective analysis, pharmacoeconomics, value-based pricing.


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In general, the literature notes the increasing use of HTA in health decision-making as countries continue to spend more on health care, and usually promotes the use of HTA, while also recognizing and critiquing its limitations. Towse and Barnsley (2013) provide an approachable, general overview of the topic, and Henshall and Schuller (2013) provide an overview of the different ways to assess the value of a medicine (see in particular ‘Table 1.Summary of Core and Wider Elements of Value, and Approaches to Measurement and Valuation’). Sorensen, Drummond and Kanavos’ (2008) report "Ensuring Value for Money in Health Care: The Role of HTA in the EU" also provides a useful overview of the surrounding debate.

The WHO’s Guideline on Country Pharmaceutical Pricing Policies (2015), for instance, recommends using HTA as a tool for reimbursement decision-making, and for price setting and negotiation, but recognizes that HTA requires advanced technical capacity and notes the need for accompanying legislative/administrative frameworks, and transparency throughout the process. For a detailed list of studies carried out concerning HTA, see Annex J of the WHO Guidelines on Country Pharmaceutical Pricing Policies. Similarly, a report by Sorensen, Drummond, and Kanavos  (2008), which focuses on HTA in Europe, argues that HTA plays an important role in evidence-based decision making, but notes several weak points including the disparate roles of different HTA bodies, the need for more stakeholder involvement in the HTA process (i.e. greater involvement of patients and industry), and lack of transparency in the HTA process (2008).

Much of the discussion focuses on how best to calculate value (i.e. which factors should and should not be included), how to operationalize value-based pricing (VBP), and how to use it in health decision-making (World Health Organization (WHO) 2015Sussex, Towse, and Devlin 2013). Most studies look at HTA as an independent tool, rather than comparing it to other pricing tools. One study, however, compares HTA with reference pricing and found that HTA is superior (in that it is more nuanced), but it also noted the high cost of carrying out HTAs (Drummond et al. 2010).


Most of the studies focus on high income countries (Drummond et al. 2010). There are country-specific papers for the UK (NICE), Canada, Australia, Sweden, US, and Germany, among others; and some papers that compare processes across countries (Henry, Hill, and Harris 2005). There exist a handful of studies analyzing HTA agencies in particular, including in Europe, the UK, Australia, and many in Canada. While some studies introduce and describe the various agencies (e.g. Canada (Lefebvre, Lafeuille, and Tiggelaar 2017; Menon and Stafinski 2009; Paris and Belloni 2014), and Australia (Hailey 2009)), others examine more specific aspects of the agencies. In Canada, the Common Drug Review (CDR) was introduced in 2003 in place of the 18 separate review processes that previously existed (“CADTH Common Drug Review (CDR),” n.d.).


When examining the extent to which the listing decisions align with HTA body recommendations, Allen et al. (2016) found “moderate to substantial agreement” between the provincial listing decisions and the CDR. Comparing the quantity drug listings before and after the establishment of Canada’s CDR, Gamble et al. (2011), find that fewer drugs were listed after the agency’s creation, and that the time-to-listing fell in certain smaller Canadian provinces. A study commissioned by the Canadian Agency for Drugs and Technologies in Health examined how patient perspectives were assimilated into Common Drug Review (CDR) assessment reports and recommendations, finding that patient views were used to situate assessments and to interpret the evidence (Berglas et al. 2016). The study also stresses the importance of taking both the recovery process and health sustainability into account when assessing a drug. McCormick, Berescu, and Tadros (2018) examined recommendations for orphan drugs in Canada specifically, finding that positive recommendations have increased over time, usually conditional on a drop in price. In the UK context, a study by Dakin et al. (2015) suggests that NICE decision-making and thresholds for rejection had not changed significantly over time. When examining the extent to which NICE guidance is implemented, Sheldon et al. (2004) find that implementation varied depending on several factors including strong professional support, a clear evidence base, and no increase in cost. Looking at Sweden, a study of the Pharmaceutical Benefits Board (LFN)’s priority-setting procedure suggests that an accountable and reasonable procedure can bring about priority-setting that is “generally perceived as fair and legitimate by the major stakeholders and may increase social learning in terms of accepting the necessity of priority setting in health care” (Jansson 2007).


There are significantly fewer analyses of HTA in LMICs. A study of middle-income countries use of HTA found that their use of HTA is increasing, but developing at an uneven speed (Oortwijn, Mathijssen, and Banta 2010). Sivalal (2009) describe how Malaysia’s HTA agency has increased in terms of both size and resources since its creation in 1995, but note major challenges with regards to sustainability, including: a sufficient level of trained staff and appropriate awareness around the function and value of the agency. Previously, Sivalal (1998) describe an HTA training course in Malaysia shortly after its agency was created. The authors suggest this could be a useful resource for others designing HTA training courses in developing countries. Teerawattananon et al. (2009) describe the various factors that contributed to the development of HTA in Thailand, including studies on the poor distribution of health technologies, followed by an economic recession and the implementation of a universal health coverage plan.


Other studies compare HTA agencies across countries. For instance, a study comparing the value-added assessments (those that go beyond the HTA economic or clinical benefit assessment) between European countries found a number of similarities and differences with regards to the practices of value-assessment, and argued for greater transparency in the value-assessment criteria to enhance resource allocation and therefore societal welfare (Angelis, Lange, and Kanavos 2018). In fact, concerns over transparency in these processes was a reoccurring theme in the literature (Hailey 2009).  Clement et al. (2009) compare how effectiveness and cost-effectiveness are used in Canada’s CDR, the UK’s NICE, and Australia’s PBAC. They conclude that the listing decisions varied between the agencies—which is unsurprising considering that the agencies have different mandates and processes. In fact, the authors suggest that the differences in decisions are mostly driven by differences in processes and risk attitudes, rather than the interpretation of clinical or economic evidence. McMahon, Morgan, and Mitton (2006) highlighted various considerations for Canada’s CDR (just after CDR was created) based on lessons learned from the UK’s NICE.


  • More studies analyzing use or feasibility of HTA in low- or middle-income countries

  • Analyses of HTA as an input to medicines pricing and incentive for innovation​


  • Abbott, Frederick. 2016. “Excessive Pharmaceutical Prices and Competition Law: Doctrinal Development to Protect Public Health.” UC Irvine Law Review 6 (3): 281."
    Abstract: Public health budgets and individual patients around the world struggle with high prices for pharmaceutical products. Difficulties are not limited to low income countries. Prices for newly introduced therapies to treat hepatitis C, cancer, joint disease and other medical conditions have entered the stratosphere. In the United States, state pharmaceutical acquisition budgets are at the breaking point -- or have passed it -- and treatment is effectively rationed. Competition/antitrust law has rarely been used to address “excessive pricing” of pharmaceutical products. This is a worldwide phenomenon. In the United States, the federal courts have refused to apply excessive pricing as an antitrust doctrine, either with respect to pharmaceutical products or more generally. Courts in some other countries have been more receptive to considering the doctrine, but application in specific cases has been sporadic, including with respect to pharmaceuticals. This remains a paradox of sorts. Competition law experts acknowledge that one of the principal objectives of competition policy is to protect consumers against the charging of excessive prices. The currently preferred alternative is to address the “structural problems” that allow the charging of excessive prices. That is, “fixing the market” so that the underlying defect by which excessive prices are enabled is remedied. There is a fundamental problem with the “fixing the market” approach when addressing products protected by legislatively authorized market exclusivity mechanisms such as patents and regulatory marketing exclusivity. That is, mechanical aspects of the market are not broken in the conventional antitrust sense. Rather, the market has been designed without adequate control mechanisms or “limiters” that act to constrain exploitive behavior. Political institutions, such as legislatures, that might step in are constrained by political economy (e.g., lobbying), and do not respond as they should. Competition law and policy should develop robust doctrine to address excessive pricing in markets lacking adequate control mechanisms. This article will focus specifically on the pharmaceutical sector because of its unique structure and social importance. This focus is not intended to exclude the possibility that development of excessive pricing doctrine would be useful in other contexts. This article is divided into two parts. The first addresses competition policy and why it is appropriate to develop the doctrine of excessive pricing to address distortions in the pharmaceutical sector. The second addresses the technical aspect of how courts or administrative authorities may determine when prices are excessive, and potential remedies. The policy prescription of this article is twofold: first, the United States should incorporate excessive pricing doctrine in its antitrust arsenal, and; second, other countries should maintain the status quo with respect to multilateral competition rules that allow them flexibility to develop and refine doctrine, including excessive pricing doctrine, that is best suited to their circumstances and interests. Link:
  • Heller, Peter S. “The Prospects of Creating ‘Fiscal Space’ for the Health Sector.” Health Policy and Planning 21, no. 2 (March 1, 2006): 75–79."
    Abstract: Not Available Link:
  • Lexchin, Joel. 2015. “Drug Pricing in Canada.” In Pharmaceutical Prices in the 21st Century, 25–41. Adis, Cham."
    Abstract: Not available Link:
  • Love, James. 2012. “Affidavit: Natco Pharma Limited versus Bayer Corporation.”"
    Abstract: Not available Link:
  • Ottersen, Trygve, Riku Elovainio, David B. Evans, David McCoy, Di Mcintyre, Filip Meheus, Suerie Moon, Gorik Ooms, and John-Arne Røttingen. 2017. “Towards a Coherent Global Framework for Health Financing: Recommendations and Recent Developments.” Health Economics, Policy, and Law 12 (2): 285–96."
    Abstract: The articles in this special issue have demonstrated how unprecedented transitions have come with both challenges and opportunities for health financing. Against the background of these challenges and opportunities, the Working Group on Health Financing at the Chatham House Centre on Global Health Security laid out, in 2014, a set of policy responses encapsulated in 20 recommendations for how to make progress towards a coherent global framework for health financing. These recommendations pertain to domestic financing of national health systems, global public goods for health, external financing for national health systems and the cross-cutting issues of accountability and agreement on a new global framework. Since the Working Group concluded its work, multiple events have reinforced the group’s recommendations. Among these are the agreement on the Addis Ababa Action Agenda, the adoption of the Sustainable Development Goals, the outbreak of Ebola in West Africa and the release of the Panama Papers. These events also represent new stepping stones towards a new global framework. Link:
  • Wirtz, Veronika J., Hans V. Hogerzeil, Andrew L. Gray, Maryam Bigdeli, Cornelis P. de Joncheere, Margaret A. Ewen, Martha Gyansa-Lutterodt, et al. 2017. “Essential Medicines for Universal Health Coverage.” The Lancet 389 (10067): 403–76."
    Abstract: Not available Link:
  • World Health Organization. n.d. “Essential Medicines.” WHO.
    Abstract: Not available Link:
  • Xu, Ke, David B Evans, Kei Kawabata, Riadh Zeramdini, Jan Klavus, and Christopher J L Murray. 2003. “Household Catastrophic Health Expenditure: A Multicountry Analysis.” The Lancet 362."
    Abstract: Not available Link:

* For the purposes of this review, we have established three categories to describe the state of the literature: thin, considerable, and rich. 

 -   Thin: There are relatively few papers and/or there are not many recent papers and/or there are clear gaps

-   Considerable: There are several papers and/or there are a handful of recent papers and/or there are some clear gaps

-   Rich: There is a wealth of papers on the topic and/or papers continue to be published that address this issue area and/or there are less obvious gaps


Scope: While many of these issues can touch a variety of sectors, this review focuses on medicines. The term medicines is used to cover the category of health technologies, including drugs, biologics (including vaccines), and diagnostic devices.

Disclaimer: The research syntheses aim to provide a concise, comprehensive overview of the current state of research on a specific topic. They seek to cover the main studies in the academic and grey literature, but are not systematic reviews capturing all published studies on a topic. As with any research synthesis, they also reflect the judgments of the researchers. The length and detail vary by topic. Each synthesis will undergo open peer review, and be updated periodically based on feedback received on important missing studies and/or new research. Selected topics focus on national and international-level policies, while recognizing that other determinants of access operate at sub-national level. Work is ongoing on additional topics. We welcome suggestions on the current syntheses and/or on new topics to cover.

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