The impact of a co-payment increase on the consumption of type 2 antidiabetics - A nationwide interrupted time series analysis.

International literature suggests that co-payment increases are associated with decreased medicine use, although the effects depend on context. We examined the impact of a co-payment increase on the consumption of type 2 antidiabetics in Finland, a country with a comprehensive health and social security system including ceiling mechanisms aiming to protect patients from high co-payment expenditures. We used administrative register data on all reimbursed purchases of antidiabetics during 2014-2018. An interrupted time series design with segmented regression was used to examine the mean monthly purchase per person, measured as Defined Daily Doses (DDDs), before and after the co-payment increase. At baseline, the mean monthly purchase per person of type 2 antidiabetics was 105 DDDs (95% CI 103.8; 106.0;p<0.001) and there was a decreasing trend of 0.2 DDDs per month (95% CI -0.23;-0.13;p<0.001). A statistically significant decrease of 5.6 DDDs (95% CI -7.3;-3.8;p<0.001) was detected after the reform; however, no significant change in the trend was observed. No significant increase was detected in the mean monthly per person purchase of insulins. The results suggest that a co-payment increase decreases consumption of necessary medicines despite the presence of a medicine co-payment ceiling mechanism. Whether the decrease was associated with negative health effects remains to be further investigated.

The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.

Policies and availability of orphan medicines in outpatient care in 24 European countries.

PURPOSE: To assess pricing and reimbursement policies specific to orphan medicines and the availability and distribution settings of ten recently authorised medicinal products suitable for outpatient care with orphan status and centralised marketing authorisation in Europe, and whether patients receive these products free of charge or have to pay some or all of the costs themselves. METHODS: Web survey to authorities and representatives of third party payers in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network in April 2016. RESULTS: In most of the 24 countries, special policies were not implemented in the assessment of reimbursement status (22 countries) or in the pricing (20 countries) of orphan medicines. An average of five of the ten recently authorised products per country were available for outpatient care. Products were dispensed from community pharmacies in eight countries and from health care units in five countries. In four countries, both distribution settings were used. When products were dispensed from community pharmacies, patients typically paid some of the price themselves. Products dispensed from health care units were often free of charge for patients. CONCLUSIONS: Most European countries had not implemented pricing and reimbursement policies specific to orphan medicines. The availability of orphan products varied between countries. It is important to discuss whether orphan medicines should be considered as a separate group in the reimbursement regulations in order to secure patient access to these medicines.

Policies for biosimilar uptake in Europe: An overview.

BACKGROUND: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. OBJECTIVES: The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. METHODS: An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. RESULTS: In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. CONCLUSIONS: Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Utilization of Stimulants and Atomoxetine for Attention-Deficit/Hyperactivity Disorder among 5.4 Million Children Using Population-Based Longitudinal Data.

Use of stimulants to treat attention-deficit/hyperactivity disorder (ADHD) has increased over the past two decades and varies substantially between countries. The objective of this multinational population-based study was to examine utilization of ADHD drugs (stimulants and atomoxetine) including comedication with other psychotropic drugs in the entire child population in the five Nordic countries. We included longitudinal data on dispensed ADHD drugs from five Nordic prescription registers during 2008-2012, which in 2012 comprised 48,296 individuals among 5.42 million inhabitants aged 0-17 years. Prevalence of filling ≥1 prescriptions of ADHD drugs among children aged 6-17 years increased during 2008-2012 from 5.9 to 11.2 and 19.4 to 31.0 per 1000 girls and boys, respectively. Prevalence by country showed that Iceland, Finland and Sweden had a steady increase during the study period, while in Norway the prevalence was quite stable and in Denmark it levelled off from 2010. Use in preschoolers (aged 0-5 years) was rare. Iceland had much higher prevalence and incidence than the other Nordic countries. The incidence of ADHD drug use increased during the study period, from 4.0 to 4.9 and from 1.5 to 2.3 per 1000 boys and girls, respectively. The increasing number of new users levelled off somewhat after 2010. Comedication with other psychotropic drugs was more common among girls (33.9%) than boys (27.0%) and was mainly melatonin, followed by antidepressants and antipsychotics. Overall prevalence of ADHD drug use increased among Nordic girls and boys aged 6-17 years, whereas the incidence increased slightly during 2008-2010 but levelled off through 2012. The substantial differences in ADHD drug use across the Nordic countries and high degree of comedication with other psychotropic drugs underscore the importance of close monitoring of treatment for ADHD among children.

Time Series Analysis on the Impact of Generic Substitution and Reference Pricing on Antipsychotic Costs in Finland.

OBJECTIVES: To analyze the medium- to long-term impact of generic substitution and the reference price system on the daily cost of antipsychotics in Finland. The additional impact of reference pricing over and above previously implemented generic substitution was also assessed. METHODS: An interrupted time series design with a control group and segmented regression analysis was used to estimate the effect of the implementation of generic substitution and the reference price system on the daily cost of antipsychotics. The data have 69 monthly values of the average daily cost for each of the studied antipsychotics: 39 months before and 30 months after the introduction of reference pricing. For one of the studied antipsychotic, the time before the introduction of reference pricing could be further divided into time before and after the introduction of generic substitution. RESULTS: According to the model, 2.5 years after the implementation of reference pricing, the daily cost of the studied antipsychotics was 24.6% to 50.6% lower than it would have been if reference pricing had not been implemented. Two and a half years after the implementation of the reference price system, however, the additional impact of reference pricing over and above previously implemented generic substitution was modest, less than 1 percentage point. CONCLUSIONS: Although the price competition induced by reference pricing decreased the prices of antipsychotics in Finland in the short-term, the prices had a tendency to stagnate or even to turn in an upward direction in the medium- to long-term. Furthermore, the additional impact of reference pricing over and above previously implemented generic substitution remained quite modest.

Cost-related barriers to use of health services and prescription medicines in Finland: a cross-sectional survey.

BACKGROUND: The objective was to examine cost-related barriers to using health services and prescription medicines in Finland. METHODS: A survey that examined adults' experiences of and opinions about the social security system was mailed to a random population-based sample of 5000 Finns aged 18-74 years. The survey assessed households' cost-related barriers to use of health services, prescription medicines and social assistance in the past year. The responses were adjusted for sociodemographic and health predictors by weighting and logistic regression. RESULTS: Responses were received from 1770 households. In total, 18% had experienced at least one cost-related barrier; 11% did not fill a prescription, 8% did not go to hospital and 13% went without another form of treatment. Of respondents diagnosed with a disabling illness or impairment, 32% reported at least one cost-related barrier. Households with below-average income reported barriers twice as often as above-average income households, after adjusting for age and health. Lower income [lowest tertile, odds ratio (OR) 5.0 compared with highest tertile], fair/poor self-assessed health (fair/poor OR 7.1 compared with very good/good), younger age (18-34 years OR 3.8 compared with 65-74 years), lower education (primary OR 1.6 compared with tertiary) and female gender (OR 1.4) were significantly associated with more frequent cost-related barriers. Overall, 34% of households who encountered cost-related barriers had applied for and 17% had received social assistance. CONCLUSIONS: Cost-related barriers were common among respondents with low income and/or poor health. These barriers may thus have a role in creating inequities in access to health care in Finland.

Chronic Comorbidities Contribute to the Burden and Costs of Persistent Asthma.

BACKGROUND: We aimed to study the prevalence of chronic comorbidities in asthma patients and the costs of health care use associated with asthma with comorbidities. MATERIAL AND METHODS: We analysed the prevalence of the four most common chronic diseases in asthma patients in 2008-2014 in Finland. Prevalence of coronary artery disease, diabetes and dyslipidaemia, hypertension, epilepsy, inflammatory bowel disease, rheumatic diseases, and severe psychiatric disease was studied by register of the Social Insurance Institution of Finland. The costs of health care services were collected from the registries maintained by the National Institute for Health and Welfare (THL). RESULTS: Prevalence of asthma was 4.6% in 2014. Diabetes was among the four most common comorbidities in all the age groups. The other common comorbidities were hypertension (≥46 years; 12.9-37.6%), severe psychiatric disorders (age groups of 16-59 years; 1.4-3.5%), and ischaemic heart disease (≥60 years; 10-25%). In patients with both asthma and diabetes, the costs of hospitalization were approximately 169% compared with patients with asthma alone. CONCLUSIONS: Prevalence of asthma increases by tenfold when aging. The comorbidity diversity and rate are age-dependent. Prevalence of diabetes as comorbidity in asthma has increased. Costs of hospitalizations in asthma approximately double with chronic comorbidities.

The impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic medication in Finland.

OBJECTIVE: To assess the impact of reference pricing and extension of generic substitution on the daily cost of antipsychotic drugs in Finland during the first year after its launch. Furthermore, the additional impact of reference pricing on prior implemented generic substitution is assessed. METHODS: A retrospective analysis was performed between 2006 and 2010. A segmented linear regression analysis of interrupted time series was used to estimate changes in the levels and trends in the cost of one day of treatment. Of the study drugs, clozapine belonged to generic substitution already at the start of the study period while olanzapine and quetiapine were included in generic substitution alongside with reference pricing in 2009. Risperidone was included in generic substitution in 2008, before reference pricing. RESULTS: A substantial decrease in the daily cost of all four antipsychotic substances was seen after one year of the implementation of reference pricing and the extension of generic substitution. The impact ranged from -29.9% to -66.3%, and it was most substantial on the daily cost of olanzapine. Also in the daily cost of risperidone a substantial decrease of -43.3% was observed. However, most of these savings, -32.6%, were generated by generic substitution which had been adopted prior. CONCLUSIONS: Reference pricing and the extension of generic substitution produced substantial savings on antipsychotic medication costs during the first year after its launch, but the intensity of the impact differed between active substances. Furthermore, our results suggest that the additional cost savings from reference pricing after prior implemented generic substitution, are comparatively low.

Impact of restricted reimbursement on the use of statins in Finland: a register-based study.

OBJECTIVES: New and expensive medicines are a driving force behind growth in medicine costs, and policies promoting use of less expensive products have been widely introduced. This study investigated the short-term consequences of the restricted reimbursement of expensive statins (atorvastatin and rosuvastatin) on the use of statins in Finland. METHODS: Data on patients purchasing atorvastatin, rosuvastatin, or simvastatin in 2002-2007 were retrieved from the nationwide Prescription Register. Outcome measures included the time trend in the numbers of purchasers and initiators of different statins, the morbidities of new users before and after the new policy, and the proportion of users of expensive statins switching to other statins. RESULTS: After the restriction, the numbers of purchasers of atorvastatin and rosuvastatin dropped, and atorvastatin and rosuvastatin were seldom prescribed as first-line therapy. Before the restriction, 20.9% of new users of atorvastatin and 18.4% of those of rosuvastatin had either coronary artery disease or familial hyperlipidemia. After the restriction the corresponding figures were 28.7% and 26.8%. After the restriction new users of atorvastatin and rosuvastatin were also more likely to use other cardiovascular medicines or antidiabetics or to have previous statin purchases. A total of 57.6% of those using atorvastatin and 49.2% of those using rosuvastatin before the restriction switched to a less expensive statin. CONCLUSIONS: Restricted reimbursement of expensive statins decreased their use. It seems that after the policy new statin treatments have channeled appropriately. Although it is likely that the cost-containment aim of the policy was reached, health and long-term effects are not known.

Antipsychotics and antidepressants: an analysis of cost growth in Finland from 1999 to 2005.

BACKGROUND: Antipsychotics and antidepressants are among the fastest-growing therapeutic classes, but the reasons behind recent cost growth are not clear. OBJECTIVE: The aim of this study was to assess the explicit factors behind ambulatory antipsychotic and antidepressant cost growth in Finland, as well as the relative importance of the factors associated with the drug group-specific cost growth. METHODS: The data used in this study were retrospectively collected from the Finnish National Health Insurance's register on reimbursed drug purchases. The study period ranged from January 1, 1999, through December 31, 2005, and the obtained data included information on the patient identity number, total cost of the purchase, Anatomic Therapeutic Chemical classification code of the purchased product, and defined daily dose amount of the purchase. Using the retrieved data, antipsychotic and antidepressant cost growth was disaggregated into price and volume factors to create a formula that includes factors about the size of the population, patients per population, volume of treatment per patient, and the mean cost per 1 day of treatment. The relative effect of the factors associated with the drug group-specific cost growth was also examined. Because the purpose of this work was to analyze the factors contributing to the cost growth, we disregarded factors that were negative. RESULTS: During the study period, the proportion of antipsychotic users of the total population decreased from 2.4% to 2.2% and the mean cost per 1 day of treatment with antipsychotics increased from euro1.37 to euro2.94. The proportion of antidepressant users increased from 4.8% to 6.3%, and mean cost per 1 day of treatment decreased from euro1.06 to euro0.79. In 1999, the consumption of second-generation antipsychotics accounted for 22% of total consumption, and in 2005 their proportion was 62%. Drug choices among anti-depressants did not change substantially. The total cost growth of antipsychotics and antidepressants was 211% and 19%, respectively. Approximately 80% of the antipsychotic cost growth resulted from the rise in the mean cost per 1 day of treatment. The increase in patients per population accounted for approximately 60% of the antidepressant cost growth. CONCLUSION: This retrospective analysis found that the factors associated with the growing antipsychotic and antidepressant expenditures in Finland from 1999 through 2005 varied between these 2 drug classes.

New chemical entities and their market penetration in Finland during the years 1996 through 2005.

BACKGROUND: There is little empirical information about the role of new chemical entities (NCEs) and to what extent they are being adopted in modern health care. OBJECTIVE: We aimed to investigate which NCEs were launched in Finland during the years 1996 through 2005 and how they penetrated the market in Finland. METHODS: NCEs were identified from Finnish drug compendiums and verified from marketing authorization and drug wholesale databases. Market penetration was determined by extracting data about outpatient drug costs and consumption in the year 2005 from drug wholesale databases. RESULTS: Of the 294 NCEs introduced in 1996 through 2005, 55% were authorized nationally and 45% by the European Commission. Two hundred two NCEs (69%) had pharmacy sales in 2005. Most NCEs were for cancer (19), infections (18), cardiovascular diseases (17), and pain and arthritis (14). NCEs introduced from 1996 through 2005 comprised 38% of total outpatient prescription drug costs and 19% of the total volume of NCEs used by outpatients in 2005. The corresponding figures for the NCEs introduced in 2001 through 2005 were 11% and 4%. All drugs for dementia and multiple sclerosis, all biological drugs for rheumatoid arthritis, and most drugs for erectile dysfunction and osteoporosis were introduced during the study period. The cost of NCEs also accounted for >50% of costs for drugs to treat hyperlipidemia, peptic ulcer, psychosis, and diabetes mellitus. CONCLUSIONS: The use of NCEs was greater when measured in monetary value than in volume. The overall costs of NCEs introduced from 1996 through 2005 were high in several major drug classes, although their share of overall use was modest when measured in volume. The market penetration of drugs introduced during 2001 through 2005 was still rather low in 2005.

Adoption of new antiglaucoma drugs in Finland: impact of changes in copayment.

BACKGROUND: Copayments are common measures intended to control drug expenditures and promote rational prescribing. In Finland, new antiglaucoma drugs start with a high copayment, but once sufficient clinical experience is available, they are reevaluated and can receive a lower copayment status. OBJECTIVE: This study assessed the effect of changes in copayment level on the adoption of 2 antiglaucoma drugs. METHODS: A retrospective analysis was performed from 1997 to 2001 using the Finnish national register of reimbursed drug purchases, which covers approximately 98% of all antiglaucoma drug purchases in the country. There were 172,293 purchases of dorzolamide (plain or combined with timolol) and 281,377 purchases of latanoprost. An interrupted time-series design from approximately 30 months before and 20 months after the change in copayment was used in the analysis. The main outcome measures were the numbers of defined daily doses (DDDs) purchased and the monthly numbers of patients who purchased the study drugs for the first time before and after the change in copayment. RESULTS: A substantial increase in consumption of both dorzolamide and latanoprost was seen immediately after the introduction of the lower copayment. The monthly consumption of dorzolamide was 60,713 DDDs higher and the monthly consumption of latanoprost was 49,330 DDDs higher than expected according to the utilization trend during the higher copayment period. Twelve months later, the observed consumption of dorzolamide was 109% higher and that of latanoprost was 21% higher than if the copayment had remained the same. The number of new patients using the study drugs peaked within 2 months of the lower copayment, but the amount consumed per patient per day remained quite stable. CONCLUSIONS: Decreasing the copayment of a new antiglaucoma drug to the same level as the copayments of alternative drugs accelerated the adoption of these new products in Finland.