Does market exclusivity hinder the development of Follow-on Orphan Medicinal Products in Europe?

Background: We determined whether the market exclusivity incentive of the European Orphan Drug Regulation results in a market monopoly or that absence of another Orphan Medicinal Product (OMP) for the same rare disorder, a so-called follow-on OMP, is a matter of time or market size. In the interest of rare disorder patients better understanding of the effect of the market exclusivity incentive on follow-on OMP development is warranted. Methods: First, the impact of various market-, product- and disease-related characteristics on follow-on OMP development in the EU was determined by comparing rare disorders with an approved OMP and at least one follow-on OMP (N=26), with rare disorders with an approved OMP and no follow-on OMP (N=18). Next, we determined whether manufacturers continued development of a follow-on OMP upon approval of the first OMP for the intended rare disorder. Since in the EU significant benefit of an OMP has to be established, we determined for each follow-on OMP for which development was continued on what grounds significant benefit was assumed by the sponsor. Data were collected from the public domain only. Results: The likelihood of a rare disorder with an approved OMP to obtain at least one follow-on OMP development was strongly associated with disease prevalence, turnover of the first OMP, disease class, diseasespecific scientific output and age of onset. Out of a total of 120 follow-on OMPs only one follow-on OMP could be identified for which development was discontinued upon approval of the first OMP for the same rare disorder. Only a substantial level of discontinuation of follow-on OMP development would have indicated the existence of a market monopoly. Moreover, sponsors that continued development of a follow-on OMP predominantly assumed that their product had an improved efficacy compared to the first approved OMP. Conclusions: This study provides evidence that absence of follow-on OMP development is a matter of time or market size, rather than that the market exclusivity incentive of the European Orphan Drug Regulation creates a market monopoly

Does the chronically ill population in the Netherlands switch their health insurer as often as the general population? Empirical evidence from a nationwide survey study

BACKGROUND: Consumer mobility is an important aspect of a health insurance system based on managed competition. Both the general population and insured with a chronic illness should enjoy an equal opportunity to switch their insurer every year. We studied possible differences in the rates of switching between these two groups in the Netherlands. METHODS: A structured questionnaire was sent to 1500 members of Nivel's Dutch Health Care Consumer Panel (response rate: 47%) and to 1911 chronically ill members of the National Panel of the Chronically ill and Disabled (response rate: 84%) in February 2016. Associations between switching and background characteristics were estimated using logistic regression analyses with interaction effects. RESULTS: In general, we did not find significant differences in switching rates between the general population and chronically ill population. However, a combination of the population and background characteristics demonstrated that young insured with a chronic illness switched significantly less often than young insured from the general population (1% versus 17%). CONCLUSIONS: Our results demonstrated that the group of young people with a chronic illness is less inclined to switch insurer. This observation suggests that this group might either face difficulties or barriers which prevents them from switching, or that they experience a high level of satisfaction with their current insurer. Further research should therefore focus on unravelling the mechanisms which explain the differences in switching rates

The impact of trust in healthcare and medication, and beliefs about medication on medication adherence in a Dutch medication-using population

INTRODUCTION: Trust in healthcare and medication, defined as feelings of reassurance and confidence in the healthcare system or medication, may be a key prerequisite before engaging in the use of medication. However, earlier studies have focussed on beliefs about medication rather than trust as predictors of medication adherence. This study therefore aims to simultaneously explore the relationship of trust in healthcare, medication and beliefs about medication, with medication adherence.METHODS: In a cross-sectional study, an online questionnaire was sent out to 1500 members of the Dutch Health Care Consumer Panel of Nivel in November 2018. Respondents were asked to grade their level of trust in healthcare and medication (scale 1-10). The Beliefs About Medicines Questionnaire (BMQ) for general and specific medication beliefs was used to address beliefs, the Medication Adherence Report Scale (MARS-5) to measure medication adherence. Data were analysed using structural equation modelling (SEM) with a backward stepwise approach. Out of 753 people that completed the questionnaire, 407 people used prescription medication and were included in the analyses.RESULTS: A positive association between trust in medication and medication adherence was found (0.044, p &lt; 0.05). BMQ subscales Overuse (-0.083, p &lt; 0.05), Necessity (0.075, p &lt; 0.05) and Concerns (-0.134, p &lt; 0.01) related with medication adherence. BMQ subscale Harm did not relate to medication adherence.CONCLUSION: Trust in medication and beliefs about medication were both individually associated with medication adherence. Healthcare providers should therefore not only focus on patients' medication beliefs, but also on strengthening patients' trust in medication to improve medication adherence.</p

Does supplementary health insurance play a role in the switching behaviour of citizens in the Netherlands?

BACKGROUND: Several healthcare systems have elements of managed competition in which citizens can choose between multiple insurers. In order for this principle to function properly, all citizens should have equal opportunities to switch insurer. Studies, conducted around 2015, have shown that the supplementary insurance policy is perceived by citizens as a barrier to switching, which could have negative consequences for the intended goals of the system.. We aim to explore whether a supplementary insurance policy still has a restraining role on the opportunity to switch among citizens in the Netherlands from 2015 to 2020. Furthermore, we will examine if the extensiveness of the supplementary insurance policy relates to the switching behaviour of citizens. This element has not been addressed in previous studies. METHODS: We obtained information on the role of the supplementary health insurance policy in the switching behaviour of citizens by sending questionnaires, yearly in February from 2015–2020, to 1,500 members of the Dutch Health Care Consumer Panel (DHCCP) each year. As such, we were able to examine whether having a supplementary insurance policy plays a role in the decision of Dutch citizens to switch insurer. The response rates were consecutively from 2015 to 2020: 60% (n = 896), 47% (n = 703), 44% (n = 659), 50% (n = 751), 48% (n = 715), and 54% (n = 806). RESULTS: Citizens with a supplementary insurance policy switch less often than citizens without one. The extensiveness of the supplementary insurance policy is significantly associated with the decision of citizens to switch insurer; the more extensive citizens are insured, the less often they switch. Additionally, our results show that every year a small group of citizens does not switch insurer because they are concerned that they will not be accepted for a supplementary insurance policy. CONCLUSIONS: Our results indicate that having a supplementary insurance policy holds citizens back from using their opportunity to switch. This contributes to the idea that having a supplementary insurance policy could be experienced by citizens as a barrier to switch. This raises questions about the extent to which the principle of managed competition in the Dutch healthcare system works as intended

Health insurance literacy in the Netherlands:The translation and validation of the United States' Health Insurance Literacy Measure (HILM)

An important criterion for the proper functioning of a managed competition healthcare system, such as operates in the Netherlands, is that all citizens can make well-informed decisions regarding their health insurance policy. In order to achieve this, citizens need certain health insurance literacy skills. It is not known how far citizens in the Netherlands have these skills. The aim of this study is to provide a reliable instrument that measures the health insurance literacy of citizens in the Netherlands. It would be based upon an existing instrument developed in the US. We translated the US Health Insurance Literacy Measure (HILM) into Dutch. Furthermore, we established the psychometric properties of the Dutch version (HILM-NL), and we validated the HILM-NL in a general population sample by sending surveys to members of the Nivel Dutch Health Care Consumer Panel (DHCCP) in February and March 2020. The response rates were respectively 54% (n = 806) and 56% (n = 595). No insurmountable difficulties with equivalence were encountered throughout the translation process. The HILM-NL showed an acceptable level of internal consistency, good test-retest reliability, and a good construct validity. The HILM-NL is a reliable instrument for measuring health insurance literacy among citizens in the Netherlands. With this instrument, it is better possible both to assess how these citizens choose and use a health insurance policy, and also the difficulties they face. It enables citizens in the Netherlands to be supported better in making well-informed decisions on health insurance

Health insurance literacy in the Netherlands: The translation and validation of the United States' Health Insurance Literacy Measure (HILM)

An important criterion for the proper functioning of a managed competition healthcare system, such as operates in the Netherlands, is that all citizens can make well-informed decisions regarding their health insurance policy. In order to achieve this, citizens need certain health insurance literacy skills. It is not known how far citizens in the Netherlands have these skills. The aim of this study is to provide a reliable instrument that measures the health insurance literacy of citizens in the Netherlands. It would be based upon an existing instrument developed in the US. We translated the US Health Insurance Literacy Measure (HILM) into Dutch. Furthermore, we established the psychometric properties of the Dutch version (HILM-NL), and we validated the HILM-NL in a general population sample by sending surveys to members of the Nivel Dutch Health Care Consumer Panel (DHCCP) in February and March 2020. The response rates were respectively 54% (n = 806) and 56% (n = 595). No insurmountable difficulties with equivalence were encountered throughout the translation process. The HILM-NL showed an acceptable level of internal consistency, good test-retest reliability, and a good construct validity. The HILM-NL is a reliable instrument for measuring health insurance literacy among citizens in the Netherlands. With this instrument, it is better possible both to assess how these citizens choose and use a health insurance policy, and also the difficulties they face. It enables citizens in the Netherlands to be supported better in making well-informed decisions on health insurance

Social context matters: The role of social support and social norms in support for solidarity in healthcare financing.

In many European countries, including the Netherlands, the healthcare system is financed according to the principles of solidarity. It is important, therefore, that public support for solidarity in healthcare financing is sufficient in order to ensure that people remain willing to contribute towards solidarity-based systems. The high willingness to contribute to the healthcare costs of others in the Netherlands suggests that support is generally high. However, there are differences between groups. Previous research has focused on mechanisms at the individual and institutional level to explain these differences. However, people's social context may also play a role. Little research has been conducted into this. To fill this gap, we examined the role of perceived social support and social norms in order to explain differences in the willingness to contribute to other people's healthcare costs. In November 2021, we conducted a survey study in which a questionnaire was sent to a representative sample of 1,500 members of the Dutch Healthcare Consumer Panel. This was returned by 837 panel members (56% response rate). Using logistic regression analysis, we showed that people who perceive higher levels of social support are more willing to contribute to the healthcare costs of others. We also found that the willingness to contribute is higher when someone's social context is more supportive of healthcare systems that are financed according to the principles of solidarity. This effect does not differ between people who perceive low and high levels of social support. Our results suggest that, next to the individual and institutional level, the social context of people has to be taken into consideration in policy and research addressing support for solidarity in healthcare financing