Abstract
Background:
The purpose of this study was to compare centralized reimbursement/coverage decision-making processes for health technologies in 23 European countries, according to: mandate, authority, structure, and policy options; mechanisms for identifying, selecting, and evaluating technologies; clinical and economic evidence expectations; committee composition, procedures, and factors considered; available conditional reimbursement options for promising new technologies; and the manufacturers’ roles in the process.
Methods:
A comprehensive review of publicly available information from peer-reviewed literature (using a variety of bibliographic databases) and gray literature (eg, working papers, committee reports, presentations, and government documents) was conducted. Policy experts in each of the 23 countries were also contacted. All information collected was reviewed by two independent researchers.
Results:
Most European countries have established centralized reimbursement systems for making decisions on health technologies. However, the scope of technologies considered, as well as processes for identifying, selecting, and reviewing them varies. All systems include an assessment of clinical evidence, compiled in accordance with their own guidelines or internationally recognized published ones. In addition, most systems require an economic evaluation. The quality of such information is typically assessed by content and methodological experts. Committees responsible for formulating recommendations or decisions are multidisciplinary. While criteria used by committees appear transparent, how they are operationalized during deliberations remains unclear. Increasingly, reimbursement systems are expressing interest in and/or implementing reimbursement policy options that extend beyond the traditional “yes,” “no,” or “yes with restrictions” options. Such options typically require greater involvement of manufacturers which, to date, has been limited.
Conclusion:
Centralized reimbursement systems have become an important policy tool in many European countries. Nevertheless, there remains a lack of transparency around critical elements, such as how multiple factors or criteria are weighed during committee deliberations.
Keywords: reimbursement, centralized review, health technologies, Europe
Introduction
The past decade has seen unprecedented growth in the number of new, often high-cost, health technologies and consumer demand for access to them. It has also seen increased public awareness and scrutiny of decisions about which technologies to include in the basket of publicly insured services.1–3 To improve the legitimacy of such decisions and optimize health outcomes through the effective use of increasingly strained health care resources, many payers, particularly those in Europe, have established centralized systems for determining the reimbursement status of new health technologies.4,5 In this invited review, we compare these systems across selected countries in Northern, Southern, Western, Eastern, and Central Europe, examining:
Their mandate, authority, organizational structure, and policy options
Mechanisms for identifying, selecting, and evaluating technologies
Clinical and economic evidence expectations
Review committee composition, procedures, and key factors considered during deliberations
Use of conditional reimbursement options for enabling access to promising new technologies around which considerable uncertainty related to clinical and/or economic value exists
The role of manufacturers in steps comprising the reimbursement review process.
Methods
This review is based upon findings from a comprehensive search for publicly available information on centralized reimbursement systems in selected European countries. Peer-reviewed literature published in English over the past decade (ending in January 2011) was located using a structured search strategy that combined relevant controlled vocabulary terms, ie, MeSH and EMTREE (eg, “technology, medical,” “reimbursement mechanisms,” “decision-making,” “technology assessment,” “health policy”) and free text terms (eg, “pharmaceuticals,” “medical devices,” “coverage,” “funding,” “centralized review,” “health technology assessment,” and “reimbursement,” the full search strategy being available from the authors). Such terms were identified through an analysis of words used to index references familiar to the authors. The strategy was applied to several health-related electronic bibliographic databases, including PubMed, MEDLINE, EMBASE, HealthSTAR, CINAHL, EconLit, PASCAL, SCOPUS, International Pharmaceutical Abstracts, Web of Science, and the UK Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects, National Health Service Economic Evaluation Database, and Health Technology Assessment). For comprehensiveness, reference lists of retrieved papers and the most recent issues of health policy-related journals were hand-searched.
A search for gray (unpublished) literature (eg, working papers, conference abstracts, reports, presentations, government documents) was also performed using the Google® search engine and terms from the main search strategy. In addition, the following dedicated gray literature databases were scanned: the New York Academy of Medicine’s Gray Literature database, Knowledge Utilization database, Systematic Reviews for Management and Policy Making, and National Health Service Evidence in Health and Social Care. Separate searches for information on centralized reimbursement processes within health care systems of the top 30 European countries ranked according to gross domestic product per capita by the World Bank were also conducted. This number was considered sufficient to capture the full spectrum of such processes. For each country, the websites of relevant ministries (eg, health, social affairs, economics), translated into English with Google Translate®, were scanned for documents describing legislation and other policies and processes for making reimbursement decisions on new health technologies, including pharmaceuticals, medical devices, diagnostic tests, and procedures.
Documents retrieved from the various searches were reviewed independently by two of the authors. Published papers unrelated to the introduction of individual health technologies (eg, those on macrolevel priority setting) were excluded. Because the purpose of this review was to examine current actual processes, papers proposing specific decision-making tools or discussing one component of decision-making were also excluded. Information on process-related characteristics of the centralized reimbursement systems, including perceived strengths and weaknesses, was extracted using a standardized, pretested data abstraction form. To ensure it reflected the current policy environment, the following individuals were consulted: corresponding authors of published papers, contacts listed on organizations’ websites, and European policy experts with whom the authors were already acquainted.
Extracted information was tabulated to facilitate the identification of patterns or trends across country-specific reimbursement processes, and subsequently analyzed qualitatively using content analysis and constant comparison techniques.
Results
Of the 30 European countries initially identified for the review, information on centralized reimbursement processes could only be found for 23. Therefore, the review included the following 23 countries: Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Norway, Poland, Portugal, Scotland, Slovakia, Spain, Sweden, Switzerland, the Netherlands, the United Kingdom, and Wales.
Mandate of centralized reimbursement systems
The majority (18/23) of countries have established centralized reimbursement processes to support coverage decision-making for either pharmaceuticals or pharmaceuticals and devices needed for their delivery. In general, eligible pharmaceuticals comprise those requiring a prescription. Two-thirds of such processes review both inpatient and outpatient pharmaceuticals (12/18), while one-third (6/18) considers those administered in outpatient settings only (Table 1). The remaining five countries have invested in centralized reimbursement systems that span medical devices, procedures, and pharmaceuticals (Table 1). Despite differences in the scope of technologies included, such processes share a similar mandate to determine the reimbursement status of new technologies. In most of the countries, this amounts to a decision on whether to add the technology to a “positive list” (ie, list of insured services). However, a small proportion of the countries also maintain a “negative list” (ie, a list of nonreimbursable services), broadening the mandate of their centralized reimbursement systems to include decisions resulting in active exclusion of some technologies from the benefit plan (Table 1). In legislation governing most systems (13/23), decisions are authoritative (ie, must be implemented), rather than advisory (ie, recommendations). Given that the price of a technology can significantly influence assessments of value for money and affordability, many of the countries have also incorporated pricing into the mandates of such systems (discussed in detail later). Finally, all consider at least three funding decision options, ie, provide, do not provide, and provide with restrictions or conditions (ie, restrict use to specific providers or patients meeting certain criteria, Table 1). In addition, approximately one-third have introduced a fourth option, ie, provide while additional evidence is collected. The latter comprises a provisional funding arrangement in which the technology is reimbursed in the interim while information needed to reduce uncertainties in existing evidence is collected to support a definitive decision.
Table 1.
Centralized reimbursement system and mandate
| Country | Centralized reimbursement review/decision-making body (role) | Technology scope | Decision problem |
Decision “scope” |
Available decision options |
||||
|---|---|---|---|---|---|---|---|---|---|
| Reimbursement | Linkage to pricing | Provide | Do not provide | Provide with restrictions | Provide while additional evidence is collected | ||||
| Austria |
|
Yes56,59 | Yes21,56,59 | Yes56 | Yes56 | Yes56 | Not specified | ||
| Belgium |
|
Yes21 | Yes21 | Yes21 | Yes21 | Yes21 | Yes21 | ||
| Czech Republic |
|
|
Yes67 | Yes67 | Yes65 | Yes65 | Yes65 | Not specified | |
| Denmark |
|
Yes68 | No68 | Yes38,69 | Yes38,69 | Yes38,69 | Not specified | ||
| Estonia |
|
|
Yes72 | Yes72 | Yes72 | Yes72 | Yes72 | No67 | |
| Finland |
|
Yes76 | Yes76 | Yes77 | Yes73 | Yes73 | No74 | ||
| France |
|
Yes16,20,22,78 | Yes16,20,22,78 | Yes20 | Yes20 | Yes20 | Yes16,20 | ||
| Germany |
Note: Must not exclude technologies for which there is no alternative18,81 |
Yes19 | Yes82,84 | Yes19 | Yes19 | Yes19 | Yes19 | ||
| Greece |
|
|
Yes85 | Yes87 | N/A | N/A | N/A | N/A | |
| Hungary |
|
Yes88 | Not specified | Yes90 | Yes90 | Yes90 | Not specified | ||
| Ireland |
|
Yes91 | No91 | Yes91 | Yes91 | Yes91 | No93 | ||
| Italy |
|
|
Yes96,97 | Yes96,97 | Yes96 | Yes96 | Yes96 | Yes96 | |
| Norway |
|
|
Yes98 | Yes98 | Yes98 | Yes98 | Yes98 | Not specified | |
| Poland |
|
|
|
Yes100 | Yes100 | Yes100 | Yes100 | Yes100 | Not specified |
| Portugal |
|
|
Yes103 | Yes99 | Yes99 | Yes99 | Yes99 | No99 | |
| Scotland |
|
|
|
Yes104 | No104 | Yes104 | Yes104 | Yes99 | No99 |
| Slovakia |
|
Yes106 | Yes106 | Yes102 | Yes102 | Yes102 | Not specified | ||
| Spain |
|
Yes21 | Yes21 | Yes21 | Yes21 | Yes21 | No21 | ||
| Sweden |
|
Yes111 | Yes112 | Yes109 | Yes109 | Yes109 | Yes109 | ||
| Switzerland |
|
|
Yes113,114 | Yes113,114 | Yes113,114 | Yes113,114 | Yes113,114 | Not specified | |
| The Netherlands |
|
|
Yes117,118 | No31 | Yes31 | Yes31 | Yes119 | Yes119 | |
| United Kingdom |
|
|
Yes7 | No7 | Yes7 | Yes7 | Yes7 | Yes7 | |
| Wales |
|
|
|
Yes120 | No120 | Yes120 | Yes120 | Yes120 | Yes120 |
Assessment of health technologies in centralized reimbursement systems
Approaches to the identification of technologies for review by centralized reimbursement systems vary across countries (Table 2). Broadly, there are three strategies: technologies may be submitted by manufacturers seeking coverage for newly licensed pharmaceuticals (13/23); they may be referred by potential payers (eg, government, sickness funds) or users (eg, hospitals, providers, patients), as well as manufacturers (8/23); or they may be identified by payers or users only (2/23). Systems limited to consideration of reimbursement applications from manufacturers alone typically review submissions in order of receipt, unless a technology is eligible for “fast tracking,” which moves it to the front of the queue. In countries with such mechanisms (eg, the Netherlands), eligibility criteria include technologies (mainly pharmaceuticals) used to treat rare or life-threatening conditions for which no alternatives beyond best supportive care exist. Some countries (eg, Scotland and Norway) have more closely linked centralized regulatory and reimbursement processes in order to reduce overall inefficiencies in technology policy. Specifically, pharmaceuticals are automatically sent to the centralized reimbursement system for review upon market approval. In systems that accept referrals from multiple stakeholders, technology selection and/or prioritization criteria have been established. For example, Germany’s Federal Joint Committee, which determines which technologies to review, takes into account clinical relevance, cost implications, and potential “risks” related to the technology and its introduction into the health care system.6 In the UK, the topic selection panel of the National Institute of Health and Clinical Excellence, whose members include health care providers and patient representatives, formulate recommendations following consideration of: the burden of disease for which the technology targets; anticipated clinical impact (ie, whether the technology represents a significant medical advance that could yield substantial health benefits); potential impact on National Health Service costs and resources; alignment of the technology with broader government priority areas; concerns over appropriateness of use in practice; and potential for national guidance to add value.7 Recommendations are forwarded to the Department of Health, which makes the final decision.
Table 2.
Comparison of processes for identifying, selecting, and assessing technologies
| Country | Centralized reimbursement review/decision-making body (role) |
Technologies to be considered for review |
Health technology assessment |
||
|---|---|---|---|---|---|
| Technology identification | Technology selection | Synthesis and analysis of evidence (assessment report) | Evaluation of evidence provided (evaluation report) | ||
| Austria | Referred by:
|
|
|
||
| Belgium |
|
Referred by:
|
|
|
|
| Czech Republic |
|
Referred by:
|
|
|
|
| Denmark | Referred by:
|
|
|
||
| Estonia | Referred by:
|
|
|
|
|
| Finland | Referred by:
|
|
|
||
| France |
Depends on type of appraisal16,20 Single technology appraisal Referred by:
Typically classes of pharmaceuticals or categories of devices Referred by:
|
Single technology appraisals
|
Single technology appraisals
|
Single technology appraisals
|
|
| Germany | Referred by:
|
|
|||
| Greece |
|
Referred by:
|
|
|
|
| Hungary | Referred by:
|
|
|
|
|
| Ireland | Referred by:
Referred by:
|
|
|
||
| Italy | Referred by:
|
|
|
||
| Norway | Referred by:
|
|
|
||
| Poland |
|
Referred by:
|
|
|
|
| Portugal | Referred by:
|
|
|
|
|
| Scotland |
|
Referred by: |
|
|
|
| Slovakia | Referred by:
|
|
|
|
|
| Spain | Referred by:
|
|
|
||
| Sweden | Referred by: |
|
|||
| Switzerland | Referred by: |
|
|
|
|
| The Netherlands |
|
Referred by:
|
|
|
|
| United Kingdom |
|
Referred by:
|
Selection criteria:
Technology selection panel composition:
|
Single technology appraisals
|
Single technology appraisals
|
| Wales |
|
Referred by: |
|
|
|
Across centralized reimbursement systems, technology identification and selection is followed by some form of health technology assessment (Table 2). This involves collection and synthesis of evidence (clinical and, in most cases, economic), the findings of which are presented in an assessment report, and critical appraisal of the relevance, quality, and generalizability of that evidence. The results of the latter are summarized in an evaluation report. Responsibility for the preparation of these reports varies. In systems where a manufacturer’s submission initiates the reimbursement review process, the assessment report is part of the submission (Table 2). Therefore, its preparation rests with the manufacturer. Most systems have developed a standard template/structure for the report and submission guidelines to which manufacturers must adhere. These guidelines largely include content/information requirements and internationally accepted methods for synthesizing and analyzing evidence. In two of the countries, responsibility for the assessment depends upon the type of review (“appraisal”). Both France and the UK have created “single technology appraisal” and “multiple technology appraisal” processes. “Single technology appraisals” compare the candidate technology with a limited number of alternatives for a specific, well-defined indication (eg, disease stage). Their scope most closely resembles processes based upon manufacturers’ submissions. “Multiple technology appraisals” consider either several indications for a candidate technology or several technologies (along with the candidate technology) for a condition at one or more points in its course, taking a disease management approach. The assessment report for a single technology appraisal is prepared by the manufacturer. For a multiple technology appraisal, the report is drafted either internally with support from external content and methodological experts (France) or by an independent academic group (the UK). Finally, in some countries, technical staff of a dedicated health technology assessment body or the centralized reimbursement system itself undertake the assessment report, regardless of the scope (eg, Germany).
With one exception (the UK), responsibility for preparing the evaluation report that accompanies each assessment also lies with technical staff and, if necessary, external experts. The National Institute of Health and Clinical Excellence commissions independent academic groups to evaluate assessments submitted by manufacturers as part of its single technology appraisal process.
Clinical and economic evidence expectations of centralized reimbursement systems
Centralized reimbursement systems have issued their own guidelines or endorsed internationally recognized published ones specifying clinical and economic evidence requirements for assessment reports (Tables 3 and 4). These guidelines state topics to be addressed and the types of information accepted for addressing them. In most cases (16/23), specified clinically-related topics are similar and include: burden of illness and/or characteristics of the target patient population; therapeutic claim of the candidate technology; safety; efficacy; and effectiveness (preferably comparative effectiveness) across relevant patient subgroups (Table 3). Additionally, several require information on current management or the place of the candidate technology within existing treatment pathways (eg, France and the UK), and its proposed frequency and duration of use (eg, Austria). Across systems and where reported, there is a shared preference for information on health outcomes that represent final clinical endpoints related to mortality, morbidity, and quality of life. Less frequently, information on adverse events/complications is also required. This may be explained by the fact that a prerequisite for reimbursement review is typically regulatory approval. Therefore, systems may view reconsideration of adverse events, which relate to the safety of a technology, unnecessary. In systems proposing or stipulating the use of quality-adjusted life-years (7/23), change in health-related quality of life is to be measured in patients and then valued in the public or general population (eg, the UK). Surrogate outcomes are discouraged or not accepted unless well validated (eg, Germany). Lastly, some systems elicit the views of patients and or carers in identifying topic specific outcomes and their relative importance (eg, Germany).
Table 3.
Comparison of clinical evidence requirements
| Country | Centralized reimbursement review/decision-making body (role) |
Clinical evidence requirements |
|||
|---|---|---|---|---|---|
| Topic | Preferred clinical outcomes | Type | Source | ||
| Austria |
|
|
Preference for:
|
||
| Belgium |
|
Preference for: | |||
| Czech Republic |
|
|
|
|
|
| Denmark |
|
|
Preference for:
|
|
|
| Estonia |
|
Preference for:
|
|
||
| Finland |
|
|
Preference for:
|
|
|
| France |
|
|
Preference for:
|
|
|
| Germany |
|
Preference for:
Evidence from other available direct comparative experimental and observational studies, as well as systematic reviews and meta-analyses complying with internationally recognized guidelines, should also be included8
|
|
||
| Greece |
|
|
|
|
|
| Hungary |
|
|
|
Preference for:
|
|
| Ireland |
|
Preference for:
|
|
||
| Italy |
|
|
Preference for: |
|
|
| Norway |
|
Preference for: | |||
| Poland |
|
|
Preference for:
|
|
|
| Portugal |
|
|
|
Preference for: |
|
| Scotland |
|
|
|
|
|
| Slovakia |
|
|
Preference for:
|
|
|
| Spain |
|
|
Preference for:
|
|
|
| Sweden |
|
|
Preference for:
|
||
| Switzerland |
|
|
|
|
|
| The Netherlands |
|
|
Preference for: |
|
|
| United Kingdom |
|
|
Preference for:
|
||
| Wales |
|
|
|
|
|
Table 4.
Comparison of economic evidence requirements
| Country | Centralized reimbursement review/decision-making body (role) |
Economic analysis |
Budget impact analysis |
Other economic information | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Required | Economic analysis types accepted | Perspective/costs included | Comparator | Sensitivity analysis | Systematic review of economic analysis studies | Required | Costs included | |||
| Austria | Yes for:
|
|
|
Yes – type not specified21 | Yes | No information found | N/A |
|
||
| Belgium | Yes for:
Not required for orphan pharmaceuticals62 |
Probabilistic17 | Yes17 | Yes11 | ||||||
| Czech Republic |
|
Yes66 |
|
No information found | Method not specified | No information found | Yes138 | No information found | No information found | |
| Denmark | No, but often included to justify high price68,71,160 |
If included, methods should comply with Danish Guidelines for the Socio-economic Analysis of Medicines68 |
|
|
Method not specified, but key parameters associated with uncertainty should be explored38 | No information found | Yes38 | No information found |
|
|
| Estonia | Yes84,139 |
|
|
Method not specified | No information found | No information found | No information found | No information found | ||
| Finland | Yes for: Pharmaceuticals considered for reimbursement in one of the special refund categories74,76 |
|
Method not specified | Yes76 | Yes161 | No information found |
|
|||
| France | Yes for:
|
Following 3 comparators required:
|
Method not specified | Yes for pharmaceuticals22 | Yes20 | No information found | ||||
| Germany | Yes for: | Any one of:
Efficiency frontier analysis12 |
|
One-way and multi-way (performed as probabilistic)24 | Yes84 | Yes, except when no alternative exists18 | No information found | No information found | ||
| Greece | Yes for:
|
No information found | No information found | No information found | No information found | No information found | Yes85 | No information found |
|
|
| Hungary | Yes84 | Preference for:
|
|
|
Yes, but type not specified163 | No information found | Yes84 |
|
No information found | |
| Ireland | Yes146 | Preference for:
Any one of the following may be acceptable if rationale is provided: |
|
Probabilistic and deterministic125 | No information found | Yes | No information found | |||
| Italy | Yes for: | Preference for: |
|
Methods not specified, but should involve multi-way analysis148 | No information found | Yes148 | No information found |
|
||
| Norway | Yes for:
|
Preference for:
|
|
|
Probabilistic preferred150 | No information found | Yes149 Aggregate added expense to health service for first 5 years149 |
No information found | ||
| Poland | Yes for:
|
|
|
|
Methods not specified | No information found | Yes84 | No information found | No information found | |
| Portugal | Yes44,160 | Any one of :
|
|
Methods not specified | No information found | No101 | N/A | No information found | ||
| Scotland |
|
Yes168 | Any one of : |
|
|
Probabilistic168 | No information found | Yes30 | No information found |
|
| Slovakia | Yes105,106 |
Methods should comply with national economic guidelines170 |
|
Probabilistic106,152 | Yes152 | Yes Estimated over first 5 years84 |
No information found | No information found | ||
| Spain | No21 | Preference for:
Any one of the following may be acceptable if rationale is provided:
|
|
|
Multi-way10 | No information found | Yes, comparing “corresponding products”10 | No information found | No information found | |
| Sweden | Yes, if requested21 | Any one of: |
|
Not specified | No information found |
|
||||
| Switzerland | No, but should be included if available115,172 | No information found | No information found | No information found | No information found | No information found | Yes115,172 | No information found | ||
| The Netherlands |
|
Yes for pharmaceuticals with added therapeutic value (Annex 1B), except for orphan pharmaceuticals with small budget impact or absence of active alternative154 | One-way, multi-way, and probabilistic35 | No information found | Yes154 | No information found |
|
|||
| United Kingdom |
|
Yes7 | Probabilistic157 | Yes13,157 | Yes13,157 | No information found | ||||
| Wales |
|
Yes174 | Any one of: |
|
|
Probabilistic28 | Yes28 | Yes28,174 | No information found | |
In general, centralized reimbursement systems state a preference for head-to-head randomized controlled trials comparing the candidate technology with standard care, no active treatment/best supportive care, or placebo (if no alternatives exist, Table 3). However, increased interest in evidence of “comparative effectiveness” over “comparative efficacy” among most reimbursement systems has led to requests for inclusion of head-to-head randomized controlled trials conducted in “naturalistic settings” (ie, pragmatic trials, in the UK) and other direct comparative studies (observational and experimental in design), the collective findings of which may offer a more accurate prediction of the behavior of the technology in general clinical practice (eg, France, Germany, and Sweden). Also, there appears to be emerging recognition of the need for flexibility in evidence expectations under certain circumstances. Recently, Germany’s Institute for Quality and Efficiency in Health Care, which conducts health technology assessments and makes reimbursement recommendations on selected health technologies to the Federal Joint Committee, issued methodological guidelines suggesting that when no active alternative treatment exists, well designed case series would be deemed adequate.8
While across systems, the preferred source of such clinical evidence is published, peer-reviewed studies, many encourage, and in several cases require if available, inclusion of unpublished or ongoing studies (eg, Austria, Belgium, Norway, Poland, Slovakia, Sweden, the Netherlands, and the UK), commercial in-confidence data (eg, Austria, France, Sweden, and the UK) and/or current national and international clinical practice guidelines (eg, France) in assessment reports. In recent years, some systems have incorporated submissions from patient and/or carer organizations into their processes (eg, Scotland, Sweden, and the UK). Such submissions are increasingly viewed as an important source of information regarding the relative value of outcome measures employed in clinical studies and the meaningfulness or significance of findings to patients and carers. Finally, while systems tend not to explicitly exclude sources of information, Belgium’s Drug Reimbursement Committee states that abstracts are not accepted.9
Most centralized reimbursement systems (20/23) have made mandatory the inclusion of a formal economic evaluation/analysis for either some (ie, those for which alternative(s) exist(s), eg, Germany, or those offering “added therapeutic value,” eg, Austria and Belgium, or all candidate technologies to inform deliberations around “value for money” and/or “efficiency.” In the latter case, the type of evaluation is rarely stipulated, because options available depend, in part, on the magnitude of the incremental benefit of the technology over its comparators. However, a rationale must be presented, and methods adopted must comply with economic guidelines developed or endorsed by the centralized reimbursement system (Table 4). For technologies that appear to offer “added therapeutic value” (ie, are more effective), some systems indicate a preference for certain types of evaluations, such as cost-utility analysis by Ireland’s Health Service Executive.10 Others state explicitly which types will not be accepted, such as cost-benefit analysis by Belgium’s Drug Reimbursement Committee.11 In addition to a formal economic evaluation, the Institute for Quality and Efficiency in Health Care in Germany requires an efficiency frontier analysis, which assesses the relative value of different technologies within a given therapeutic area.12 Regarding the perspective to be taken for the economic evaluation, the proportion of systems adopting a “payer,” “societal,” or both “payer” and “societal” perspective is similar. Among systems considering a payer’s perspective only, costs to be captured are often restricted to those directly related to care associated with the use of the candidate technology throughout the course of a disease or condition (ie, direct costs to the health care system). One exception is the National Institute of Health and Clinical Excellence, which specifies inclusion of direct and indirect costs to the National Health Service and Personal Social Services.13 In systems requiring a societal perspective, costs specified comprise direct costs to not only the health care system, but also services beyond health care and indirect (lost productivity) costs. However, they must be reported separately (eg, Finland, Portugal, and the Netherlands). In Sweden, The Dental and Pharmaceutical Benefits Board has taken a wider view on indirect costs, requesting that time lost by patients and carers be considered, along with lost productivity.14,15 Thus, its methods broadly resemble those of “holistic” economic analysis, a technique initially developed for economic evaluations of public programs, the costs and benefits of which are often complex. Nevertheless, considerable debate over the valuation of items such as “time lost” within academic and policy communities remains. This may be why other systems employing a societal perspective have assumed a narrower position on eligible indirect costs. With respect to the choice of comparator for the economic evaluation, almost all systems specify use of one of the following: “standard care,” “the most commonly used alternative,” or “alternative most likely to be replaced.” France also requires separate analyses with two additional comparators, ie, the most recently reimbursed alternative and the least expensive alternative.16 In Belgium, if the candidate technology represents an “addon” treatment, the comparator must constitute current treatment without the candidate technology.17 Further, the use of “offlabel” treatments as the comparator is not permitted.11 All systems rely upon sensitivity analyses to assess the stability of estimates generated through the economic evaluation, but few stipulate the type. Among those that do, probabilistic sensitivity analysis is the most commonly prescribed (eg, Belgium, Germany, Scotland, Slovakia, the UK, and Wales).
In recent years, affordability has become an increasingly important consideration for centralized reimbursement systems, with almost all of those included in this review (where information could be found) requiring a budget impact analysis (Table 4). However, some waive this analysis in certain circumstances, eg, when no alternative treatment exists (Belgium).17 Although information describing the specific costs to be included appears scarce, based on that available, they mirror those for the economic evaluation of the same technology. Specifically, if the economic evaluation is limited to direct costs, so must the budget impact analysis, eg, Hungary and Ireland.
Reimbursement decisions: review committee composition, procedures, and key factors
In most of the centralized reimbursement systems, the assessment and evaluation reports are sent to and scrutinized by a review committee (sometimes referred to as an appraisal committee). While the composition of this committee varies across systems, it is usually multidisciplinary, with members representing payers, administrators, health care providers, and academia (eg, health economists, Table 5). Approximately one-third have also appointed patient representatives to their respective committees (eg, Sweden, Switzerland, and the UK), although not always as voting members (Germany),18,19 and one-fifth include manufacturers (Belgium, Switzerland, the UK, and Wales). In most systems, the authority of the review committee is advisory (ie, makes recommendations). Aside from lists of factors/criteria considered (Table 6), publicly available procedural information on committee deliberations is often limited to conditions under which presentations/testimonials from external experts (including patients) are sought or accepted and whether an incremental cost-effectiveness ratio threshold is employed. Among the exceptions is France. There, review committees (the Commission d’Evaluation des Medicaments (CEM), followed by the Transparency Commission) adhere to a two stage process. First, the CEM assigns a “medical benefit” or “SMR” level/score to the candidate technology (a new pharmaceutical). The score is based on a five-point scale, with “I” representing “major medical benefit” and “V” representing “insufficient to justify reimbursement.”16,20–23 Upon approval of the score by the Minister, the CEM then compares the technology with already reimbursed alternatives in order to formulate an opinion on the “improvement in medical benefit” or “ASMR” level. Six possible levels exist, ranging from I (major innovation) to VI (negative opinion regarding inclusion on the benefit list). Therefore, “innovativeness” is viewed as the size of the incremental clinical benefit achieved by the candidate technology. The opinion of the CEM is forwarded to the Transparency Commission, who makes a formal recommendation on the ASMR classification. This classification is, in turn, used to negotiate price and reimbursement rate. In Germany, the “innovativeness” of a technology is also based on whether it offers “added therapeutic value.” Moreover, it plays an important role in determining the content of subsequent committee deliberations, because “cost-benefit” analyses are only taken into account when a technology has been deemed innovative.18–24 The review committee of the Italian Medicines Agency, ie, the Technical Scientific Committee, explicitly weighs both the availability of existing treatments and the extent of clinical benefit in its assessment of a new pharmaceutical’s innovativeness. The two attributes are scored separately and then combined to determine whether it represents an “important,” “moderate,” or “modest” innovation.25 This rating, along with the category of clinical value to which the pharmaceutical has been assigned, is sent to a second review committee, ie, the Pricing and Reimbursement Committee, which negotiates price and reimbursement status with the manufacturer.26,27
Table 5.
Comparison of decision-making processes
| Country | Centralized reimbursement review/decision-making body (role) | Committee composition | Steps in review/decision-making process | Use of cost-effectiveness threshold | Timelines for review/decision | Appeals mechanisms |
|---|---|---|---|---|---|---|
| Austria | 20 voting members:
|
|
No21 | 180 days (includes pricing and reimbursement decision)58 |
|
|
| Belgium | 31 members (23 voting including chair):
Nonvoting:
|
|
No62 | 150 days (includes pricing and reimbursement)21 |
|
|
| Czech Republic | No information found |
|
No138 | 75 days (includes pricing and reimbursement decision) |
|
|
| Denmark | Maximum of 7 members: Must include:
|
|
No68 | 90 days after receipt of “adequate application”38 | ||
| Estonia | No information found | No information found | No information found | No information found | No information found | |
| Finland | 7 members of Pharmaceuticals Pricing Board:
7 members of Expert Group: |
|
No181 | 180 days (includes pricing and reimbursement decision)181 |
|
|
| France | Transparency Committee within French National Authority for Health: 20 voting members (includes chair):
7 Specialist subcommittees of clinical experts |
Single technology appraisals
Multiple technology appraisals
|
No20 |
|
|
|
| Germany | 13 members including representatives from: |
|
No18 | No information found |
|
|
| Greece | 7 members including representatives from:
|
|
No information found | 90 days (includes pricing and reimbursement decision)186 | No information found | |
| Hungary | Technology Appraisal Committee: includes members delegated by stakeholder groups102 |
|
No information found | No information found | Decision may be appealed to Appeals Committee Includes representatives from:
|
|
| Ireland | No information found |
|
No fixed threshold, but €45,000/QALY used as a guide91,125,165 | 90 days (for reimbursement decision)93 | Decision may be appealed to designated expert committee91 | |
| Italy | Technical Scientific Committee: Includes 17 members:
|
|
No126 | 180 days (includes pricing and reimbursement decision)188 | No information found | |
| Norway | No information found | Process depends on anticipated budget impact of pharmaceutical: If <5 million Krone/year:
|
No34 | 180 days (includes pricing and reimbursement decision)34 | No information found | |
| Poland | Consultative Council: 12 voting members including representatives from:
Drug Management Team: Includes representatives of:
|
|
No information found | 180 days (includes pricing and reimbursement decision)100 | None127 | |
| Portugal |
|
No information found |
|
No information found | 90 days (includes pricing and reimbursement decision)36 |
|
| Scotland |
|
No information found |
|
No fixed threshold, but range of £20,000–£30,000/QALY used as a guide30 | No information found |
|
| Slovakia | Reimbursement Committee: Includes 11 members representing:
|
|
No fixed threshold, but range of €20,000–€26,500/QALY used as a guide105 | No information found |
|
|
| Spain | Inter-Ministerial Pricing Commission: Includes representatives from:
|
|
No132 | 180 days (includes pricing and reimbursement decision)132 | No information found | |
| Sweden | Expert Board: Includes 11 members and a chair: |
|
No fixed threshold, but €45,000/QALY used as a guide35 | 180 days (includes pricing and reimbursement decision)192 | ||
| Switzerland | Federal Drug Commission: Includes 25 voting members representing: |
|
No information found | No information found |
|
|
| The Netherlands |
|
Committee of the Dutch Healthcare Insurance Board: Includes:
Includes:
|
For outpatient pharmaceuticals:
For high-cost inpatient pharmaceuticals:
|
No fixed threshold, but €20,000/QALY used as a guide 31 |
|
|
| United Kingdom |
|
Includes:
|
Single technology appraisal
Multiple technology appraisal Same as single technology appraisal process except: 1) Formal scoping process to develop review protocol is required; 2) Independent academic group conducts assessment (rather than the manufacturer); 3) Independent academic group attends Technology Appraisals Committee meetings13 |
No fixed threshold, but range of £20,000–£30,000/QALY used as a guide37,196,197 | Single technology appraisal approximately 39 weeks29 |
|
| Wales |
|
Includes:
|
|
No fixed threshold, £20,000/QALY used as a guide28 | No information found |
|
Table 6.
Comparison of key factors considered during committee deliberations
| Country | Centralized reimbursement review/decision-making body (role) |
Clinical need |
Clinical benefit/value* |
Cost-benefit ratio (cost-effectiveness; efficiency; “value for money”)† | Impact on health resources/affordability (budget impact) | Innovativeness | Other | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Disease burden (severity and number of patients) | Availability of alternatives | Place of technology in care pathway/strategy | Safety (risk–benefit ratio; harm–benefit ratio) | Efficacy/effectiveness | Side effects | Acceptability (tolerance, convenience) | ||||||
| Austria | Yes55 | Yes58 | Not specified | Not specified | Yes55 | Not specified | Not specified | Yes (“pharmacoeconomic evidence”)58 | Yes55 | Yes50 |
|
|
| Belgium | Yes11,17 | Yes21 | Not specified | Yes9 | Yes (across patient subgroups)9 | Yes9 | Yes11,17 | Yes11,17 | Yes11,17 | Yes35 | ||
| Czech Republic | Yes84 | Yes84 | Not specified | Yes84 | Yes84 | Not specified | Yes66 | Yes84 | Yes84 | Not specified | ||
| Denmark | Not specified | Not specified | Not specified | Yes21,68 | Yes (across patient subgroups)21,68 | Yes21,68 | Not specified | Yes21,68 | Not specified | Not specified | ||
| Estonia | Yes84 | Yes84 | Not specified | Not specified | Yes84 | Not specified | Not specified | Yes84 | Yes84 | Not specified | ||
| Finland | Yes181 | Yes181 | Not specified | Not specified | Yes (across patient subgroups)181 | Not specified | Not specified | Yes181 | Yes181 | Not specified | ||
| France | Yes35 | Yes35 | Yes35 | Yes80 | Yes35 | Yes80 | Yes80 | Not specified | Yes80 | Yes35 | ||
| Germany | Yes19 | Yes19 | Not specified | Yes19 | Yes19 | Not specified | Not specified | Yes‡19 | Yes113 | Yes19 | ||
| Greece |
|
Yes186 | Yes186 | Not specified | Yes186 | Yes186 | Not specified | Not specified | Yes (“pharmacoeconomic effectiveness”)186 | Not specified | Not specified | |
| Hungary |
|
Yes186 | Yes84 | Not specified | Not specified | Yes84 | Not specified | Not specified | Yes186 | Yes84 | Not specified |
|
| Ireland | Yes125,165 | Yes125,165 | Not specified | Not specified | Yes125,165 | Not specified | Not specified | Yes125,165 | Yes125,165 | Yes125,165 | ||
| Italy | Yes27 | Yes27 | Not specified | Yes96 | Yes (across patient subgroups)27 | Not specified | Yes27 | Yes27 | Yes27 | Yes20 | ||
| Norway | Yes34 | Not specified | Not specified | Yes149 | Yes (across patient subgroups)34 | Not specified | Not specified | Yes34 | Yes34 | Not specified | ||
| Poland |
|
Yes84 | Not specified | Not specified | Yes84 | Yes84 | Not specified | Not specified | Yes84 | Yes84 | Not specified | |
| Portugal | Yes36 | Yes36 | Not specified | Yes36 | Yes36 | Not specified | Not specified | Yes36 | Not specified | Not specified | ||
| Scotland |
|
Yes104 | Yes30 | Not specified | Yes104 | Yes104 | Not specified | Not specified | Yes104 | Yes104 | Yes30 | |
| Slovakia | Yes106 | Yes84 | Not specified | Yes106 | Yes106 | Yes106 | Yes106 | Yes84,105 | Yes84,106 | Not specified |
|
|
| Spain | Yes132 | Yes132 | Not specified | Yes10 | Yes (across patient subgroups)132 | Not specified | Not specified | Not specified | Yes132 | Yes108 | ||
| Sweden | Yes21 | Yes109 | Not specified | Yes21 | Yes (across patient subgroups)15,21 | Not specified | Not specified | Yes21 | No21 | Not specified | ||
| Switzerland | Not specified | Not specified | Not specified | Not specified | Yes108 | Not specified | Not specified | Yes (“value for money”)109 | Not specified | Yes108 |
|
|
| The Netherlands |
|
Yes35 | Yes21 | Not specified | Yes35 | Yes35,117 | Yes35 | Yes35 | Yes35,117 | Yes¥21,201 | Yes35 | |
| United Kingdom |
|
Yes202 | Yes202 | Yes202 | Yes202 | Yes (across patient subgroups)202 | Not specified | Not specified | Yes202 | Not specified | Yes35,197 | |
| Wales |
|
Yes28 | Not specified | Not specified | Not specified | Yes (across patient subgroups)28 | Not specified | Not specified | Yes28 | Yes174 | Yes28 | |
Notes:
In a well-defined population;
price proportionate to effect;
cost efficiency takes into account costs of treatment per patient, as well as costs of compensatory allowance due to lost income and costs of restoring patients’ capacity to work;
efficiency of resource use within a single therapeutic area relative to existing interventions;
not a formal criterion.
Regardless of the reimbursement system, one of the main goals of the review committee is to determine the “therapeutic value” of a candidate technology. Broadly, its assessment combines consideration of clinical benefit with that of clinical need, taking into account key factors related to each dimension. For clinical need, they comprise, at a minimum, burden of illness (prevalence of severity) of the target condition and availability of alternatives. For clinical benefit, they include at least safety (risk–benefit ratio) and efficacy/effectiveness, on the basis of which an overall estimate of the ratio of the benefits to harms of a candidate technology is estimated (Table 6). While a further goal shared by most review committees is to formulate an opinion on whether the candidate technology represents “value for money” or an efficient use of resources, their approach to accomplishing this differs. Approximately one-third are guided by, but not compelled to adhere to, a predefined incremental cost-effectiveness threshold or threshold range.28,29 Typically, if the incremental cost-effectiveness for a candidate technology lies below the threshold, it is deemed cost-effective or good value for money. If it lies above the threshold, additional factors are taken into account when judging acceptability (eg, uncertainties in estimates of outcomes, the severity of condition, and wider societal benefits).30,31 Across systems whose committees do not refer to an incremental cost-effectiveness threshold, approaches to operationalizing “value or money” appear vague, with information largely limited to statements such as “reasonableness of cost relative to therapeutic value” (Table 6).32 Similarly, although all but one of the systems (Sweden21) list “affordability” or “impact of the candidate technology on health system resources” among factors/criteria considered by their respective review committees, no information describing processes for deciding whether or not a technology is affordable could be found.
Equity or ethical implications comprise decision-making factors/criteria (explicitly or implicitly) in one-third of systems. For example, Sweden’s Dental and Pharmaceutical Benefits Board stipulates two principles that decisions must reflect, ie, the “need and solidarity principle” (patients in the greatest need or “worse off ” must be given priority) and the “human value principle” (sociodemographic characteristics of patient populations cannot influence decisions).21,33 Along with “solidarity,” the Norwegian Medicines Agency explicitly takes into account “equity,” as do review committees in Hungary and Poland.26,34–36 However, the way in which this is accomplished during deliberations is not clear. Committees using an incremental cost-effectiveness threshold to guide decisions implicitly incorporate equity by virtue of the assumptions underpinning the incremental cost-effectiveness calculation (ie, each quality-adjusted life-year [QALY] carries the same weight, regardless of the characteristics of the patients receiving it (eg, age, gender, social status, income). Consideration of additional, often competing ethical principles by these committees is operationalized through “exception” conditions under which the normal “efficiency” expectations do not need to be met (eg, “last chance” therapies, orphan technologies, life-extending, end-of-life treatments).37 Under such conditions, not all QALYs are deemed equal. Rather, a form of “solidarity” premium is applied, where, for example, QALYs gained in the later stages of disease are given greater weight. While there is little disagreement over the importance of instituting “exception” conditions as a means of ensuring that reimbursement decisions embody the broader values of the population, considerable debate around definitions/qualifiers (eg, what constitutes “last chance”? or by what period of time must a technology lengthen survival in order to be regarded as “life-extending”?) remains. Finally, the following factors are simply listed as criteria/factors by a small proportion of committees: alignment with government priorities; feasibility; and/or risk of off-label use of the technology (Table 6).
In general, systems aim to complete single technology reviews within 180 days of submission/identification of candidate technology, the time period prescribed by the European Union Transparency Directive. Based on tracking data, the actual time required appears to depend primarily on whether the assessment report accompanies a reimbursement application (eg, Belgium) or is undertaken (internally or externally) by the system once a technology is identified for review (eg, the UK, Table 5). In the latter case, review times can be 90 days or less (eg, Denmark and France).20,38
The majority of systems have established mechanisms for appealing recommendations or decisions. Briefly, there are two main types of disputes, ie, those related to process and those amounting to disagreements over the interpretation of the evidence. In approximately one-third of systems, acceptable grounds for appeals are those of the first type only (“failed to act in accordance with processes”39). For the most part, appeals are heard by an expert panel appointed by the respective health care organization or “payer” (eg, Ministry of Health, Table 5). Alternatively, they must be filed in an administrative court (eg, Germany and Sweden).
Conditional reimbursement enabling access to new technologies
Increasingly, reimbursement systems are expressing interest in and/or implementing reimbursement policy options that extend beyond the traditional “yes,” “no,” or “yes with restrictions” options. Such policy options take the form of provisional reimbursement arrangements, in which funding for a technology is provided in the interim while evidence needed to make a definitive decision is collected.40 Collectively referred to as “Access with Evidence Development” (AED) schemes, they have emerged in response to calls for mechanisms that balance access to new technologies with the need to ensure their safe, effective, and efficient introduction and use in the health care system. In recent years, these calls have heightened, as tension between payers and manufacturers, patients, and providers has intensified. Many new high-cost technologies are supported by limited, albeit promising, evidence. Therefore, reimbursement decisions are made under conditions of considerable uncertainty, with significant risks and consequences of “getting it wrong” (wasted scarce resources and poor health outcomes). AED schemes attempt to reduce such risks through “managed entry” of new technologies into everyday clinical practice. There are three main types, ie, coverage linked to an outcomes guarantee, coverage as part of a study, and automatic reassessment (Table 7). Often referred to as “risk-sharing” schemes, “patient access schemes,” and “payment by results,” the first type consists of contractual arrangements between payers and manufacturers, where payment is tied to the achievement of an outcome, be it financial or health-related.41,42 Such schemes have been employed in approximately one-third of the systems in this review (Table 7). They include financially-based price-volume agreements, where manufacturers must “pay back” the cost of sales exceeding those forecasted (eg, Belgium, France, Germany, Hungary, Portugal),41,43,44 and expenditure caps, in which manufacturers cover the cost of “treatment” in patients for whom costs over a fixed time period exceed a prespecified amount (eg, Italy, the UK).41,45 Health-related risk sharing arrangements, also called “no cure no pay” schemes, have been implemented by a smaller proportion of systems (Belgium, Denmark, Italy, the UK).41,45–47 Under such schemes, continued reimbursement of a technology (usually a pharmaceutical for a rare disorder or cancer) requires evidence of a predefined treatment effect. The second type, “coverage as part of a study,” involves provision of interim funding by payers in order to conduct studies designed to collect specific information needed to fill key evidence gaps. Typically, such evidence gaps relate to the effectiveness and/or cost implications of the technology in “real world” settings. Funding may be partial (costs of the technology and/or health care associated with its use) or full (all health care and research costs). This type of scheme constitutes a policy option in approximately one quarter of the reimbursement systems, the majority of which have mandates that span pharmaceutical and nonpharmaceutical technologies (eg, France, Germany, the UK, Table 7). Eligible technologies vary across systems, but often include those defined as “innovative” (eg, granted an “innovation pass” in the UK) and those anticipated to significantly impact health care organization budgets (eg, the Netherlands).25,48 The third type of AED scheme, “automatic reassessment,” comprises a programmed review of a reimbursement decision following a fixed period on the “benefit list” or when additional evidence is available.49–51 It has become a part of the policy framework in half of the reimbursement systems included in this review, with most requiring reassessments of all technologies within their decision-making scope (Table 7). Despite the appeal of AED schemes, evidence of their effectiveness is both limited and mixed. Recent reviews have highlighted the challenges involved in both their design and implementation.52,53 Such challenges primarily stem from the need to reach consensus among stakeholders on the terms of the scheme. Often, considerable time and resources have been required to resolve disagreements over elements such as the value proposition, outcomes to be measured and for what period, how the scheme should be funded, and to whom its oversight should be handed. Further, negotiations have, in some cases, resulted in complex arrangements that failed to generate the evidence needed to support a policy decision and/or created a significant administrative burden on payers and providers involved in its implementation. In an effort to address these issues, guidelines for conducting AED schemes, derived from international experiences to date, were recently published.53,54 Moreover, some systems have proposed alternative approaches to dealing with decision uncertainties. For example, earlier this year, National Institute of Health and Clinical Excellence announced a new form of value-based reimbursement termed “flexible pricing.”45–48 Under this approach, manufacturers adjust the price of a technology (pharmaceutical) in response to additional evidence of actual benefit to patients as it emerges. The National Institute of Health and Clinical Excellence subsequently assess this evidence, along with the proposed price, and determines whether the technology represents “value for money.” If a negative opinion is reached, the National Institute of Health and Clinical Excellence may veto the proposed price. Given the potential benefits of such an approach (eg, reduced administrative burden and system resource requirements) it has already sparked interest among the National Institute of Health and Clinical Excellence’s counterparts across Europe.
Table 7.
Comparison of conditional reimbursement policy options for managing decision uncertainties
| Country | Centralized reimbursement review/decision-making body (role) |
Policy options for addressing decision-making uncertainties |
||||
|---|---|---|---|---|---|---|
| Reassessment | Value-based pricing/reimbursement | Reimbursement as part of a formal study | Risk-sharing schemes/payment by results | Other | ||
| Austria |
|
No56 | No information found | No information found | No information found | |
| Belgium |
|
No information found | No information found | Financially or clinically based:
|
|
|
| Czech Republic |
|
|
Manufacturer may request a surcharge of up to 30% over the basic reimbursement level if evidence suggests pharmaceutical demonstrates “superior” therapeutic benefits66 | No information found | No information found | No information found |
| Denmark |
|
No information found | No information found | Clinically based:
|
No information found | |
| Estonia | No information found | No information found | No information found | Financially based:
|
No information found | |
| Finland | No information found | No information found | No information found | No information found | ||
| France | For pharmaceuticals
|
No information found |
|
For pharmaceuticals Financially based:
|
For pharmaceuticals for serious or rare diseases | |
| Germany | For medical devices and procedures
|
For pharmaceuticals Financially based:
|
|
|||
| Greece |
|
No information found | No information found | No information found | No information found | No information found |
| Hungary | No information found | No information found | No information found | Financially based:
|
No information found | |
| Ireland | No information found | No information found | No information found | No information found | No information found | |
| Italy | No automatic/routine reassessment, with the exception of pharmaceuticals reimbursed under condition that additional studies would be conducted25 | No information found | For pharmaceuticals classified as “potentially innovative”
|
Clinically based:
|
|
|
| Norway |
|
No information found | No information found | No information found |
|
|
| Poland | No information found | No information found | No information found | No information found | No information found | |
| Portugal | No information found | No information found | No information found | Financially based:
|
No information found | |
| Scotland |
|
|
No information found | No information found | No information found | No information found |
| Slovakia | No information found | No information found | No information found | No information found | No information found | |
| Spain | No information found | No information found | No information found | No information found | No information found | |
| Sweden |
|
No information found | No information found | |||
| Switzerland | No information found | No information found | No information found | No information found | ||
| The Netherlands |
|
No information found | New inpatient pharmaceuticals with projected costs >5% of hospital budget
|
No information found | No information found | |
| United Kingdom |
|
|
|
For pharmaceuticals “Patient access schemes”42 Financially based:
Clinically based:
|
|
|
| Wales |
|
|
No information found | No information found | No information found | No information found |
Role of manufacturers in steps comprising the reimbursement review process
Few reimbursement systems have established roles for manufacturers beyond referral of a technology for review and the opportunity to comment on draft reports and/or preliminary recommendations (Table 8). Where “multiple technology appraisal” processes exist and assessment reports are commissioned or undertaken by the reimbursement system, manufacturers may participate in defining the scope or protocol of the assessment (France, Germany, the UK) or submit information to the group preparing such reports (Germany, Ireland, Spain, the UK). Among systems that prepare the evaluation report only, about half invite manufacturers to contribute information (Scotland, Italy, Sweden, the UK, Wales). Involvement of manufacturers otherwise appears limited to single examples, eg, able to participate in consultations during the assessment (France) or attend review committee meetings (Wales).
Table 8.
Comparison of the role of manufacturers in centralized reimbursement processes
| Country | Centralized reimbursement review/decision-making body (role) | Refer technology topics for reimbursement consideration | Participate in defining scope and/or protocol of assessment | Comment on draft protocol | Participate in consultations during assessment | Submit information to group preparing assessment report | Submit information to group preparing evaluation report | Present views during committee meetings | Nominate clinical and/or patient experts to make oral presentation to committee | Attend committee meeting | Comment on report and/or draft recommendations | Appeal recommendations or decisions |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Austria | Yes | N/A | N/A | N/A | N/A | No | No | No | No | No | Yes | |
| Belgium | Yes | N/A | N/A | N/A | N/A | No | No | No | No | Yes | Yes | |
| Czech Republic | Yes | N/A | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | Yes | |
| Denmark | Yes | N/A | N/A | N/A | N/A | No | No | No | No | Yes, if recommendation is negative | Yes | |
| Estonia | Yes | N/A | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | No information found | |
| Finland | Yes | N/A | N/A | N/A | N/A | No | No | No | No | Yes, if recommendation is negative | Yes | |
| France | Yes | Yes (multiple technology appraisals) N/A (single technology appraisals) |
No | Yes (multiple technology appraisals) N/A (single technology appraisals) |
No (multiple technology appraisals) N/A (single technology appraisals) |
No | No | No | No | Yes | Yes | |
| Germany | No | Yes | Yes | No | Yes | No | No | No | No | Yes | Yes (decisions only) | |
| Greece |
|
Yes | N/A | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | No information found |
| Hungary |
|
Yes | N/A | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | Yes |
| Ireland | Yes | N/A | N/A | N/A | Yes | No | No | No | No | Yes | Yes | |
| Italy | Yes | N/A | N/A | N/A | No | Yes | No | No | No | Yes | No | |
| Norway | Yes | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | No information found | Yes | |
| Poland | Yes | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | No information found | No information found | |
| Portugal | Yes | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | No information found | Yes | |
| Scotland |
|
Yes | N/A | N/A | N/A | No | Yes | No | No | No | Yes | Yes |
| Slovakia | Yes | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | No information found | No | |
| Spain | No | No | No | Yes | Yes | No | No | No | No | No | No | |
| Sweden | Yes | N/A | N/A | N/A | N/A | Yes | Yes | No | No | Yes | Yes | |
| Switzerland | Yes | N/A | N/A | N/A | N/A | No information found | No information found | No information found | No information found | No information found | Yes | |
| The Netherlands |
|
Yes | N/A | N/A | N/A | N/A | No | No | No | No | No | Yes |
| United Kingdom |
|
Yes | Yes (multiple technology appraisals) N/A (single technology appraisals) |
No (multiple technology appraisals) N/A (single technology appraisals) |
No (multiple technology appraisals) N/A (single technology appraisals) |
Yes (multiple technology appraisals) N/A (single technology appraisals) |
Yes (single technology appraisals) N/A (single technology appraisals) |
No | Yes | No | Yes | Yes |
| Wales |
|
Yes | N/A | N/A | N/A | N/A | Yes | No | No | Yes | Yes | Yes |
Conclusion
Centralized reimbursement systems have become an important policy tool in many European countries. Their introduction has, inarguably, brought greater consistency to processes and an improved sense of legitimacy to decisions. Nevertheless, there remains a lack of transparency around critical elements, such as how multiple factors or criteria are weighed during committee deliberations. Further, empirical studies evaluating the extent to which centralized reimbursement systems with advisory as opposed to decision-making authority are able to reduce inequities in access to new technologies within jurisdictions appear sparse.
Given the rapid pace with which new technologies that appear promising are now entering the market and the need to work alongside broader government industrial policies for encouraging innovation in an economic climate that demands prudent use of strained health care resources, the adoption of AED schemes by reimbursement systems seems inevitable. However, until more information on the outcomes of initiatives such as flexible pricing in the UK becomes available, their implementation should be approached with caution.
Footnotes
Disclosure
The authors report no conflicts of interest in this work.
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