Joëlle M. Hoebert

Do rheumatoid arthritis patients have equal access to treatment with new medicines?: tumour necrosis factor-alpha inhibitors use in four European countries.

PURPOSE To explore the use of the biological tumour necrosis factor alpha (TNFalpha) inhibitors used in the treatment of rheumatoid arthritis as a measure of access to treatment with new medicines. In addition, characteristics both related to national health systems and spending will be assessed to explore possible differences in international utilisation. METHODS Data from four European countries were included: Ireland, The Netherlands, Norway and Portugal. Annual utilisation rates of TNFalpha inhibitors (2003-2007) were expressed as defined daily doses (DDDs)/1000 inhabitants/day. Qualitative data such as country characteristics, national health policy characteristics, guidelines were obtained from the literature. In addition, interviews were held with leading rheumatologists of each country to put obtained results into (cultural) context. RESULTS Utilisation of TNFalpha inhibitors varied widely from 0.32 (Portugal) to 1.89 (Norway) DDDs/1000 inhabitants/day (2007). A major driver for the utilisation of TNFalpha inhibitors seemed to be the countrys total health expenditure (R(2)=0.81). When the use of TNFalpha inhibitors became more established, the association seemed stronger. Differences in health expenditure were nevertheless not the only determinant of usage. Cultural aspects such as difference in recognition of guidelines also come into play when looking at differences in TNFalpha utilisation between countries. CONCLUSIONS The prospects of patients receiving TNFalpha inhibitor treatment depend on the country where they are living. In case uniformity of management and treatment would be considered to provide health benefits, the extent and the causes of variation should feature prominently on future public health agendas.

Reimbursement restriction and moderate decrease in benzodiazepine use in general practice.

PURPOSE To limit misuse and save costs, on January 1, 2009, benzodiazepines were excluded from the Dutch reimbursement list when used as anxiolytic, hypnotic, or sedative. This study aims to assess the impact of this reimbursement restriction on benzodiazepine use in patients with newly diagnosed anxiety or sleeping disorder in general practice. METHODS Was conducted a retrospective observational database study deriving data on diagnoses and prescriptions from the electronic health records–based Netherlands Information Network of General Practice (LINH). We looked for patients aged 18 years and older with an incident diagnosis of sleeping disturbance (International Classification of Primary Care code: P06) or anxiety (P74, P01) between January 2008 and December 2009. Incidence of these diagnoses, benzodiazepine use, and initiation of selective serotonin reuptake inhibitor (SSRI) treatment was compared between 2008 and 2009. RESULTS In total, we identified 13,596 patients with an incident diagnosis of anxiety (3,769 in 2008 and 3,710 in 2009) or sleeping disorder (3,254 in 2008 and 2,863 in 2009). The proportion of patients being prescribed a benzodiazepine after a diagnosis was lower in 2009 than in 2008 for both anxiety (30.1% vs 33.7% P <.05) and sleeping disorder (59.1% vs 67.0%, P <.05), as was the proportion of patients with more than 1 benzodiazepine prescription for both anxiety (36.4% vs 42.6%, P <.05) and sleeping disorder (35.0% vs 42.6%, P <.05). We found no increase in the use of alternative treatment for anxiety with SSRIs. CONCLUSIONS The reimbursement restriction has led to a moderate decrease in the number of incident diagnoses and initiation of benzodiazepine use in patients with newly diagnosed anxiety or sleeping disorder. This finding indicates that in settings where no such reimbursement opportunities exist, physicians have room to reduce benzodiazepine prescribing.

Health policy and systems research in access to medicines: a prioritized agenda for low- and middle-income countries

ObjectivesTo identify priority policy issues in access to medicines (ATM) relevant for low- and middle-income countries, to identify research questions that would help address these policy issues, and to prioritize these research questions in a health policy and systems research (HPSR) agenda.MethodsThe study involved i) country- and regional-level priority-setting exercises performed in 17 countries across five regions, with a desk review of relevant grey and published literature combined with mapping and interviews of national and regional stakeholders; ii) interviews with global-level stakeholders; iii) a scoping of published literature; and iv) a consensus building exercise with global stakeholders which resulted in the formulation and ranking of HPSR questions in the field of ATM.ResultsA list of 18 priority policy issues was established following analysis of country-, regional-, and global-level exercises. Eighteen research questions were formulated during the global stakeholders’ meeting and ranked according to four ranking criteria (innovation, impact on health and health systems, equity, and lack of research). The top three research questions were: i) In risk protection schemes, which innovations and policies improve equitable access to and appropriate use of medicines, sustainability of the insurance system, and financial impact on the insured? ii) How can stakeholders use the information available in the system, e.g., price, availability, quality, utilization, registration, procurement, in a transparent way towards improving access and use of medicines? and iii) How do policies and other interventions into private markets, such as information, subsidies, price controls, donation, regulatory mechanisms, promotion practices, etc., impact on access to and appropriate use of medicines?ConclusionsOur HPSR agenda adopts a health systems perspective and will guide relevant, innovative research, likely to bear an impact on health, health systems and equity.

National medicines policies – a review of the evolution and development processes

ObjectivesContinuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive framework to develop all components of a national pharmaceutical sector. To meet the health needs of the population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to the national situation. This review aims to provide a quantitative and qualitative (describing the historical development) study of the development process and evolution of NMPs.MethodsThe number of NMPs and their current status has been obtained from the results of the assessment of WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa.ResultsThe number of NMPs worldwide has increased in the last 25 years with the highest proportional increase in the last 5–10 years in high-income countries. Higher income countries seem to have more NMP implementation plans available and have updated their NMP more recently. The four case studies show that the development of a NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia provide indicators for monitoring.ConclusionsTo date, not all countries have a NMP since political pressure by national experts or non-governmental organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is just as important as the policy document since the process must create a mechanism by which all stakeholders are brought together and a sense of collective ownership of the final policy may be achieved.

Quality and completeness of utilisation data on biological agents across European countries: tumour necrosis factor alpha inhibitors as a case study.

For optimal decision making on access to and regulations around biologicals availability of national utilisation data is a prerequisite. This study characterises the main categories of critical issues in collecting available national utilisation data on tumour necrosis factor alpha (TNFalpha) inhibitors in different European countries.

Gevolgen afschaffing vergoeding benzo’s

SamenvattingSinds 1 januari 2009 is de vergoeding van benzodiazepinen (benzo’s) in de basisverzekering grotendeels vervallen. Inmiddels zijn de eerste effecten van deze maatregel zichtbaar. Het gebruik van benzo’s is – in tegenstelling tot voorgaande jaren – in 2009 met een zesde gedaald, zo bleek uit cijfers van de Stichting Farmaceutische Kengetallen (SFK). Voor een deel komt dit omdat er minder chronisch gebruikers zijn: SFK laat zien dat hun aantal met 14,5% is gedaald. Een andere mogelijke verklaring is dat huisartsen minder snel benzo’s voorschrijven aan nieuwe patiënten.