Reimbursement Applications Research Articles

PHP44 Public Financing of Medicines in Portugal (2007-2011): Accessibility to Medicinal Products with New Molecules or New Therapeutic Indications

Accessibility (time to financing decision) to new medicines is a major concern in Europe. Recently the European Commission has proposed to streamline and reduce the duration of national decisions on pricing and reimbursement of new medicines. The objective of this study was to evaluate the accessibility to medicinal products with new molecules or new therapeutic indications (NMNTI) in Portugal, since 2007 and characterize the determinants of the assessment process by the Portuguese Ministry of Health. Data on 119 NMNTI reimbursement applications to the PMH between January 2007 and June 2011 was kindly provided by submitting pharmaceutical companies. Time to financing decision was assessed using the Turnbull non-parametric estimator and variability in time to financing decision was explored using accelerated failure time regression models with Gaussian mixture distributions, both allowing for interval, left and right censoring. The likelihood of public financing and its determinants was evaluated through the estimation of logistic regression models. Median time from submission to decision 331 days (95%CI: 292-398) was excessive relative to those in the Law for the decision: 70 days (hospital) and 110 days (ambulatory). In hospital medicines no decision was taken in less than 70 days. Only 10% of the decisions from ambulatory drugs were taken within the timelines in the law. Of particular concern was median decision times for orphan medicines (718 days), oncology drugs (743 days) and new therapeutic indications of medicines already reimbursed (890 days). From a vast number of variables studied, only in cardiovascular medicines the likelihood of non-public financing was significant lower (p=0.026). Accessibility to new medicines or medicines with new therapeutic indications in Portugal is compromised by an excessively long assessment process by the Portuguese Ministry of Health. Of particular concern is accessibility to orphan and oncology drugs.

Assessing Personalized Medicines in Australia

Background. Since the mapping of the human genome in 2003, the development of biomarker targeted therapy and clinical adoption of “personalized medicine” has accelerated. Models for insurance subsidy of biomarker/test/drug packages (“codependent technologies” or technologies that work better together) are not well developed. Our aim was to create a framework to assess the safety, effectiveness, and cost-effectiveness of these technologies for a national coverage or reimbursement decision. Methods. We extracted information from assessments of recent Australian reimbursement applications that concerned genetic tests and treatments to identify items and evidence gaps considered important to the decision-making process. Relevant international regulatory and reimbursement guidance documents were also reviewed. Items addressing causality theory were included to help explain the relationship between biomarker and treatment. The framework was reviewed by policy makers and technical experts, prior to a public consultation process. Results. The framework consists of 5 components—context, clinical benefit, evidence translation, cost-effectiveness, and financial impact—and a checklist of 79 items. To determine whether the biomarker test, the drug, both, or neither should be subsidized, we considered it crucial to identify whether the biomarker is a treatment effect modifier or a prognostic factor. To aid in this determination, the framework explicitly allows the linkage of different types of evidence to examine whether targeting the biomarker varies the likely clinical benefit of the drug, and if so, to what extent. Conclusions. The first national framework to assess personalized medicine for coverage or reimbursement decisions has been developed and introduced and may be a suitable model for other health systems.

Assessment of Pharmacoeconomic Evaluations Submitted for Reimbursement in Korea

Objective To assess the quality of pharmacoeconomic evaluations (PEs) submitted with new drug applications for reimbursement and to investigate the role of PEs for coverage decisions in Korea. Methods Forty-seven PEs that were submitted by pharmaceutical companies for coverage decisions between June 2005 and December 2009 were included in this study. To assess their appropriateness with regard to the PE guidelines, we used the Health Insurance Review and Assessment services (HIRA) checklist consisting of 20 items based on the PE guidelines. We also evaluated the results for coverage decisions, as “recommended,” “recommended with restricted use,” or “not recommended,” based on the incremental cost-effectiveness ratio and the range of uncertainty. Results On average, 14 of the 20 items on the HIRA checklist were fulfilled (70.9%, range 35.0%–100%). The compliance rate for the following items was above 70%: presentation of perspectives and evaluation methods, a sufficient time horizon, and appropriateness of comparators and health outcomes. The compliance rate for the following items was below 70%: omission of objectives for the study, inappropriate target population, unclear selection process for effectiveness and cost, inappropriate cost estimation, insufficient justification of generalizability, and description of study limitations. The range of incremental cost-effectiveness ratios per quality-adjusted life-years of PEs from a societal perspective varied from dominant to 59K USD (n = 13): it consisted of dominant to 28K USD for “recommended” submissions (n = 6), 8K to 20K USD for “recommended with restricted use” submissions (n = 4), and 13K to 59K for “not recommended” ones (n = 3). Conclusions Our study showed that most PEs in this study have reached an adequate level for coverage decisions. Overall barriers associated with a lack of relevant evidence could account for the low compliance rate with specific items in the PE guidelines. PEs with good quality submitted for coverage decisions have played an important role for selecting cost-effective drugs.

Critical Assessment of Belgian Reimbursement Dossiers of Orphan Drugs

Orphan medicinal products are designed to diagnose or treat rare diseases that are serious, life threatening or chronically debilitating and that affect 50 or fewer people in every 100 000 in the EU. In Belgium, the Drug Reimbursement Committee (DRC) evaluates reimbursement requests for orphan drugs based on multiple criteria: the therapeutic value, price and proposed reimbursement tariff; the importance of the drug in clinical practice; and the budget impact of the drug. This study aimed to assess reimbursement dossiers of orphan drugs in Belgium and to compare them with the clinical evidence submitted to the European Medicines Agency (EMA). A qualitative analysis examined all reimbursement dossiers of orphan drugs that were submitted in Belgium between January 2002 and June 2008. The following information was extracted from each dossier: description of the orphan drug; indication; reimbursement status; therapeutic value and needs; budget impact; and number of registered indications. For selected orphan drugs, an in-depth analysis extracted and compared information about the clinical trials, their primary endpoints and results from EMA documents (i.e. the marketing authorization application file, European public assessment report and summary of product characteristics) and the Belgian reimbursement dossiers. Reimbursement was awarded to the majority of orphan drugs. In addition to the official criteria, other negotiable factors, such as price adjustments, employment incentives, patient population restrictions and funding of diagnostic tests by the company, seemed to play a role in the reimbursement decision. Despite the low number of patients, randomized controlled trials were conducted for many orphan drugs. Budget-impact analyses were simplistic and did not consider the impact across multiple indications. Some differences were also observed between the clinical evidence submitted to the EMA and that submitted to the Belgian DRC. In addition to the official criteria, other negotiable factors, such as price adjustments and employment incentives, may play a role in Belgian reimbursement decisions of orphan drugs. Some differences have also been noted between the clinical evidence reported in EMA documents and the evidence included in Belgian reimbursement dossiers of orphan drugs. There appears to be a need for further standardization of Belgian reimbursement applications and for European cooperation in sharing clinical evidence of orphan drugs.

Budget impact analysis in economic evaluation: a proposal for a clearer definition

Budget impact analysis (BIA) is a relatively recent method for economic evaluation (EE) in the field of health care. It assesses the financial consequences of the introduction of a new technology in a specific setting in the short-to-medium term [1]. BIA is supposed to be complementary to more established types of EEs, providing additional information for decisions on the reimbursement of new technology [1]. Several countries (e.g. Australia, Canada, Belgium, Croatia, Hungary, and Poland) require manufacturers to make a BIA at present, often alongside a cost-effectiveness analysis (CEA), to support applications for national or regional reimbursement [2]. Two main reasons are often mentioned for healthcare systems' increasing interest [3, 4] in this technique. First, they have to deal with continuous development of technology on one hand, and budget constraints on the other. While CEA broadly including costutility analysis (CUA) [5] may help assigning priority to interventions, BIA is perceived as useful in assessing their sustainability, a major concern for budget holders with scarce financial resources. A second reason for interest in BIA seems to be the lack

A Comparative Analysis of the Impact of a Positive List System on New Chemical Entity Drugs and Incrementally Modified Drugs in South Korea

Background Medical costs in South Korea have risen, in part due to increased demand and consumption of pharmaceutical products by an aging population and also because of the introduction of newer, more expensive drugs. In an effort to stabilize the financing of health insurance and alleviate the financial burden on individuals, the government implemented a policy changing the national health insurance drug-listing system from a negative list system to a positive list system (PLS). Objectives The goal of this study was to compare differences in drug-listing rates for new chemical entities (NCEs) and incrementally modified drugs (IMDs) after South Korea introduced the PLS in December 2006. Parameters significantly affecting NCE and IMD listings were also identified. Methods New drug-listing data for 2007 and 2008 were obtained from the databases of the Health Insurance Review Agency and the Ministry of Health and Welfare. Descriptive analyses on the reimbursement rate and logistic regression analysis were conducted. Statistical significance was tested for all results, and P < 0.05 was considered statistically significant. Results A total of 150 reimbursement applications (79 for NCEs, 71 for IMDs) were examined for this study. The overall drug-listing rate was lower than before the introduction of the PLS. Drug reimbursement rates for NCEs (50.6%) were lower than those for IMDs (74.6%) ( P = 0.0025). However, the price negotiation rate was 85.0% for NCEs compared with 73.6% for IMDs ( P = 0.1847). The time required for both reimbursement and drug pricing was significantly longer for NCE than for IMD listings ( P < 0.05). Cost-effectiveness and budget impact were 2 significant variables affecting the listing of NCEs. However, no significant variable was identified for IMDs. Conclusions The PLS challenges the drug-listing system by decreasing the drug-listing rate and lengthening the period for reimbursement determinations. These effects were more pronounced for NCE listings than for IMD listings.

A comparative study of reimbursement application patterns between Iceland and Sweden

Objective The objective of this paper was to examine access to new reimbursed prescription drugs in two European countries, Sweden and Iceland, both of which are small in terms of economic importance. We performed the analysis through a comparison of the number of accepted and rejected reimbursement applications. We also investigated the price level of reimbursed drugs in the two countries. Methods We performed a retrospective, comparative study of actual reimbursement decisions in Iceland and Sweden. For all reimbursement decisions in 2009 we investigated and compared the date of decision, the type of decision and, for accepted applications, prices. Key findings Iceland made 18 reimbursement decisions, Sweden made 30. In addition, Sweden received 11 applications that were withdrawn at a late stage in the application process. Two applications were rejected in Iceland; nine applications were rejected in Sweden. Out of the 16 drugs reimbursed in Iceland, there was no decision in Sweden for one of the drugs by June 2010; all others were reimbursed. Out of the 20 drugs reimbursed in Sweden, there was no decision in Iceland for 11 of the drugs by June 2010. There was no decision in Iceland for most of the drugs that were rejected for reimbursement in Sweden. The median price was 5% higher in Iceland than in Sweden. Conclusions For the year 2009, Sweden received far more applications than Iceland, and also made decisions on more applications. However, the number of reimbursed new medicines was only slightly higher in Sweden. Most of the medicines reimbursed in Iceland in 2009 already existed in Sweden or, if not, were accepted in 2009. The prices of reimbursed medicines were higher in Iceland than in Sweden. Although further evidence is needed, this paper indicates that pharmaceutical companies apply for reimbursement of prescription drugs in Sweden before applying in Iceland.

Extrabudgetary ('NUB') payments: A gateway for introducing new medical devices into the German inpatient reimbursement system?

Abstract Most new medical devices in Germany are first introduced in the inpatient sector. The key hurdles to marketing them are thus to ensure their inclusion in the German Diagnosis-Related Group (G-DRG) system and to bridge the financial gap in the interim. In 2005, a system of extrabudgetary payments was introduced to bridge this gap and to expedite the inclusion of new technologies in the G-DRG system. The present study aims (1) to describe prototypical regulatory pathways for including new medical devices and other technologies in the G-DRG system and (2) to analyse real-world data on applications for extrabudgetary reimbursement to determine the pathways these technologies followed between 2005 and 2009. The findings show that the technologies did indeed follow the prototypical pathways and that patients' access to them has been improved by the system of extrabudgetary payments. Some technologies, however, have still not been fully included in the G-DRG system, even after four years. Moreover, impr...

Analysis of 4-year Dutch reimbursement application data of biological therapies for psoriatic arthritis

To get the approval for reimbursement of biological therapies for PsA, patients need to fulfil specific criteria in many countries. The aim of this study was to evaluate the 4-year Dutch reimbursement application data, including the diagnostic, disease activity and response criteria that were applied for treatment of PsA with biologics. All initial and follow-up applications for approval of treatment with biologics were included for investigation. Data were analysed descriptively with regard to application characteristics, patient characteristics and response to therapy. In the period studied, 3723 application forms of 1991 patients were received. This concerned 2118 initial treatment applications and 1605 follow-up applications. Of all initial treatment applications, 2003 (94.6%) were approved. The major part of all applications concerned requests for etanercept (59.1%), followed by adalimumab (38.2%). Patients were suffering from polyarthritis in most cases (63.1%). MTX was used by nearly all patients, but only 55.8% had used the required dosage of 25 mg/week. Approximately 79.4% of all patients met the response criteria after 3 months of treatment. The mean number of affected joints declined from 7.7 at first application to 1.4 at follow-up. The initial visual analogue scale (VAS) score indicated by patients decreased from 71.2 to 24.1 at follow-up. The VAS score indicated by physicians decreased from 66.0 to 18.4. Biologics are expensive, but highly effective in the treatment of PsA. Careful compilation of treatment and reimbursement criteria is important for patients as well as for physicians and health insurance companies.

Does the company's economic performance affect access to occupational health services?

BackgroundIn Finland like in many other countries, employers are legally obliged to organize occupational health services (OHS) for their employees. Because employers bear the costs of OHS it could be that in spite of the legal requirement OHS expenditure is more determined by economic performance of the company than by law. Therefore, we explored whether economic performance was associated with the companies' expenditure on occupational health services.MethodsWe used a prospective design to predict expenditure on OHS in 2001 by a company's economic performance in 1999. Data were provided by Statistics Finland and expressed by key indicators for profitability, solidity and liquidity and by the Social Insurance Institution as employers' reimbursement applications for OHS costs. The data could be linked at the company level. Regression analysis was used to study associations adjusted for various confounders.ResultsNineteen percent of the companies (N = 6 155) did not apply for reimbursement of OHS costs in 2001. The profitability of the company represented by operating margin in 1999 and adjusted for type of industry was not significantly related to the company's probability to apply for reimbursement of the costs in 2001 (OR = 1.00, 95%CI: 0.99 to 1.01). Profitability measured as operating profit in 1999 and adjusted for type of industry was not significantly related to costs for curative medical services (Beta -0.001, 95%CI: -0.00 to 0.11) nor to OHS cost of prevention in 2001 (Beta -0.001, 95%CI: -0.00 to 0.00).ConclusionWe did not find a relation between the company's economic performance and expenditure on OHS in Finland. We suppose that this is due to legislation obliging employers to provide OHS and the reimbursement system both being strong incentives for employers.

Value of Post-Registration Studies for Reimbursement Renewal

Post-registration studies describe parameters of real-life clinical practice such as the treated population, conditions of treatment initiation, treatment duration, adherence, associated benefits/risks as well as the impact on treatment strategies, healthcare procedures and on public health. The results of these studies are used in particular for re-evaluation, re-registration or in applications for reimbursement. Since 1997, 134 requests for post-registration studies have been made either by the French Transparency Committee (CT) and/or the Committee for Pricing of Healthcare Products (CEPS) and the results of these studies were taken into account in the re-evaluation of Actual Benefit (AB) or Improvement in Actual Benefit (IAB). During the roundtable discussion on this subject at the National Clinical Pharmacology Meeting held at Giens (France), the difficulties in performing such studies were identified and proposals were made to predict and anticipate requests for these studies but also for the training of physicians.

Combined secondary prevention after hospitalization for myocardial infarction in France: Analysis from a large administrative database

Both French and international guidelines recommend long-term use of betablockers, antiplatelet drugs, statins, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers (ACE-I/ARB) after a myocardial infarction (MI), but data on their combined use are scarce in France. To evaluate the use of combined medication 6 months after hospital admission for MI and the factors that can significantly influence their use. All hospital admissions for MI in France from January to June 2006 were selected from the national hospital discharge database. Data on medications used 6 months before and after hospitalization for patients covered by the general health insurance scheme (70% of French population) were collected from the reimbursement information system. A medication was considered to be used when there were more than three reimbursement applications over the 6 months following the index episode. Comorbidities were ascertained from the use of disease-specific medication reimbursements and registration in the national database of full coverage for 30 long-term disorders. Of the 11,671 patients included, 82% were reimbursed for betablockers, 92% for antiplatelets, 85% for statins, 80% for ACE-I/ARBs and 62% for all four classes. After adjustment, significant underuse was found for women, the elderly and those with several comorbidities. Treatment at a university hospital or high-volume centre, follow-up by a cardiologist and use of revascularization procedures were associated with improved rates of combination therapy use. Overall, use of recommended medications after MI in France is satisfactory, though not optimal. Specific recommendations focusing on subgroups such as older patients or those with comorbidities, as well as information directed towards non-specialized healthcare professionals, should help to improve appropriate use of these medications.

Analysis of 3-year national reimbursement application data on etanercept and efalizumab for psoriasis

Analysis of 3-year national reimbursement application data on etanercept and efalizumab for psoriasis

Promoting prevention with economic arguments – The case of Finnish occupational health services

BackgroundBoth social and ethical arguments have been used to support preventive occupational health services (OHS). During the 1990s it became more common to support political argumentation for occupational health and safety by converting the consequences of ill health at work into monetary units. In addition, OHS has been promoted as a profitable investment for companies, and this aspect has been used by OHS providers in their marketing.Our intention was to study whether preventive occupational health services positively influence a company's economic performance.MethodsWe combined the financial statements provided by Statistics Finland and employers' reimbursement applications for occupational health services (OHS) costs to the Social Insurance Institution. The data covered the years 1997, 1999 and 2001 and over 6000 companies. We applied linear regression analysis to assess whether preventive OHS had had a positive influence on the companies' economic performance after two or four years.ResultsResources invested in preventive OHS were not positively related to a company's economic performance. In fact, the total cost of preventive OHS per turnover was negatively correlated to economic performance.ConclusionEven if OHS has no effect on the economic performance of companies, it may have other effects more specific to OHS. Therefore, we recommend that the evaluation of prevention in OHS should move towards outcome measures, such as sickness absence, disability pension and productivity, when applicable, both in occupational health service research and in practice at workplaces.

Cost-Effectiveness Analyses of Natalizumab (Tysabri®) Compared with Other Disease-Modifying Therapies for People with Highly Active Relapsing-Remitting Multiple Sclerosis in the UK

Natalizumab (Tysabri) is a new disease-modifying therapy that has been shown to be clinically effective in patients with relapsing-remitting multiple sclerosis (RRMS) and has been licensed for use in patients with highly active RRMS (HARRMS). These patients are those who experience higher relapse rates and faster disability progression than the general RRMS population. To estimate the cost effectiveness of natalizumab compared with interferon-beta, glatiramer acetate and best supportive care from various UK cost perspectives. A 30-year Markov model was developed, based on previously published models for multiple sclerosis, to estimate transition between disability states and the probability of relapse within disability states. The model was parameterized with data from the UK Multiple Sclerosis (MS) Survey 2005 and data from the AFFIRM study, a 2-year multicentre, randomized, double-blind, placebo-controlled trial of natalizumab in RRMS patients. Additional data were sourced from the literature. A UK societal cost perspective was used in the base case, with additional cost perspectives considered in the sensitivity analysis. The baseline characteristics for the patient group were taken from the patient population in the AFFIRM study (mean age 36 years, mean time since diagnosis 5 years and a mean Kurtzke Extended Disability Status Scale [EDSS] score of 2.5). The model and its parameterization were designed and developed to support a reimbursement application for natalizumab submitted to the UK National Institute for Health and Clinical Excellence (NICE). Efficacies for natalizumab and glatiramer acetate were taken from clinical trial data, and for interferon-beta from a meta-analysis of clinical trial data. Disutilities from adverse events for each comparator were also included in the model. Outcomes and costs were discounted at 3.5% per anum. Costs for interferon-beta and glatiramer acetate were based on published prices (year 2006 values) under the UK Risk Sharing Scheme, and for natalizumab the UK NHS list price was used. Diagnostic, administration and adverse event costs were also included. The incremental cost-effectiveness ratios (ICERs) were calculated for the base case, and a probabilistic sensitivity analysis was performed to assess the probability of cost effectiveness at different willingness-to-pay thresholds. The ICER for natalizumab compared with interferon-beta was 2300 pound per QALY. Compared with glatiramer acetate, it was 2000 pound per QALY, and compared with best supportive care it was 8200 pound per QALY. From a health and social care cost perspective, the ICERs were 18,700 pound, 20,400 pound and 25,500 per QALY, respectively. At a willingness-to-pay threshold of 30,000 pound per QALY, the probability of natalizumab being cost effective against any comparator from a societal perspective was >89%. If UK society is willing to pay more than 8200 pound per QALY, or Health and Social Services are willing to pay more than 26,000 pound per QALY, this analysis suggests that natalizumab is likely to be a cost-effective treatment for all patients with HARRMS.

Recent developments in pricing and reimbursement of medicines in Ireland

In 2006, the drugs bill exceeded €1.84 billion or approximately 15% of total healthcare expenditure in Ireland. The majority of this expenditure (85%) related to community prescribing. An agreement between the Health Service Executive (HSE) and the Irish Pharmaceutical Healthcare Association (IPHA) on the pricing and supply of medicines to the Irish Health Service came into effect on the 1st September 2006. The new agreement links the price of medicines in Ireland to nine EU states including Belgium, Denmark, France, Germany, The Netherlands, Spain, the UK, Finland and Austria. Following receipt of market authorization a new product will be reimbursed within 60 days of the reimbursement application. However, the HSE reserves the right to assess the cost–effectiveness of new and existing technologies that may be high cost or have a significant budget impact. Where such a review is requested the 60-day rule will not apply. Where a new medicine is subjected to pharmacoeconomic assessment the reimbursement decision will be notified within 90 days of receipt of the reimbursement application. Products will be reimbursed within 40 days of a positive decision. Should reimbursement be refused an appeal may be made to an expert committee whose final decision will be made within a further 90 days. A cost–effectiveness threshold in the region of €45,000/quality-adjusted life year has been adopted. An important component of the IPHA/HSE agreement is the 35% two-stepped price reduction for off-patent substitutable products. The new Health Information and Quality Authority (HIQA) was established under the Health Act 2007 and will lead the development of Health Technology Assessment (HTA) across the health service.

How to Anticipate the Assessment of the Public Health Benefit of New Medicines?

How to Anticipate the Assessment of the Public Health Benefit of New Medicines?

The Role of Childhood Sexual Abuse (CSA) in Adult Cognitive Behaviour Therapy

Sexual abuse in childhood is a pathogenetic factor for psychological disorders. The attention given to this phenomenon varies between therapists and therapeutic schools. The question is how often sexual abuse is recognized as a problem in cognitive behaviour therapy and how this is related to the present symptoms and therapeutic problems. 1223 case reports, written as application for reimbursement of routine cognitive behaviour therapy, were submitted to a content analysis in respect to childhood sexual abuse. Sexual abuse was mentioned in 10.3% of the cases; 59% of female and 50.0% of male victims were abused by relatives. Sexually abused patients showed significantly increased rates of inadequate care and negative life events during childhood. In comparison to controls, cases showed significantly increased rates of “eating disorders” (15 vs. 6; p&lt;.05), “substance abuse/addiction” (16 vs. 6; p&lt;.05), “suicide attempts” (15 vs. 3; p&lt;.01), “strict refusal of sexual partners” (15 vs. 5; p&lt;.05), “frequently changing partners” (21 vs. 3; p&lt;.001), “problems in marriage/partnership” (95 vs. 77; p&lt;.05) and “sexual problems” (51 vs. 24; p&lt;.001). Childhood sexual abuse is a problem, frequently seen in behaviour therapy patients and therefore also warranting special attention in routine patient care. Sexual abuse is understood by cognitive behaviour therapists as an indicator for traumatizing conditions in general during childhood. It is associated with specific treatment problems and therapeutic needs in adulthood.

Reimbursement and clinical guidance for pharmaceuticals in Sweden

Introduction of the new Pharmaceutical Benefits Board (LFN; 1 October 2002) has markedly changed the principles of pricing and reimbursement of drugs in Sweden. The Board is required to make decisions based on information on cost-effectiveness, and pharmaceutical companies must submit economic evaluations when relevant as part of their applications for reimbursement. This study examined experience to date regarding the use of health-economic evaluations and cost-effectiveness information by the LFN. We also describe activities and the use of cost-effectiveness analysis by Swedish local formulary committees organized by the 21 county councils. It is concluded that economic evaluations have supported decision making by LFN, although cost-effectiveness seems to be of varying importance in different situations. While the use of health-economic evaluations and the outcome of decision making by LFN are similar to comparable committees in other countries, there is presently a gap in this sense between the LFN and Swedish local formulary committees. Coordinated decision making is much needed but may be difficult to implement as the perspective, expertise, and objectives of the two public authorities differ.

Policy decision making and outcomes research in drug utilization

Health-care systems all over the world tend to be under permanent review and policy decision making is increasingly driven only by political decisions concerning resource allocation. Drug utilization is a major concern within policy decision making, of relevance to and sometimes even bridging both the pharmaceutical industry and medical community. Outcomes and effectiveness research emphasizes the accountability of the health-care delivery system and focuses on the medium and long-term results of treatment and preventive interventions. With increasing health-care costs and growing concerns about the quality of care, appropriate health outcome measures are essential for assessing the quality, necessity, and effectiveness of health care. These outcome measures are reviewed addressing the influence of evidenced-based medicine and discussing the underlying methods which are applied throughout Europe and the US for reimbursement purposes and application procedures in drug utilization management.