The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland

Background Biological drugs are generally expensive and produce a continuously growing share of drug costs. Yet they are essential in the treatment of many chronic diseases. Biosimilars, clinically equivalent to biological originator products, are expected to restrain drug costs in the biological market. Objective This study aimed to examine the impact of the biosimilar market entry on the prices of the reference products in outpatient care in Finland, investigate the impact of biosimilar market entries on price competition among biological medicinal products, and examine how the prices and market shares of outpatient biosimilars have developed in Finland during 2009-2020. Methods This retrospective register study applied data from IQVIA covering national community pharmacy wholesale data between 1 January, 2009, and 31 August, 2020, for somatropin, epoetin, filgrastim, follitropin, insulin glargine, insulin lispro, etanercept, pegfilgrastim, adalimumab, teriparatide, and enoxaparin biosimilars and their reference products, in addition to two relevant insulin products. We determined the monthly wholesale amounts in defined daily doses and wholesale weighted average prices (excluding value-added tax) per defined daily dose for each product. We analyzed the evolution of the price and market shares. We performed a linear segmented regression analysis to examine the impact of the market entry of biosimilars on the prices of reference products. Results The prices of the reference products mainly decreased after the biosimilar entered the market. If the reference product price was not reduced, it was no longer reimbursable after evaluation under the Health Insurance Act, leading to marginal market shares. The changes in the prices of biosimilars were not as remarkable as the changes in the prices of reference products after the biosimilar market entry. For most active substances, biosimilar prices were stable or decreased. The utilization of biosimilars varied widely between different active substances at the end of the observation period. Conclusions Changes in pricing policy and the public reimbursement scheme related to the market entry of biosimilars were the main reasons for the decrease in the prices of reference products. Therefore, biosimilars did not generate genuine price competition between biological products. In many of the drug groups examined, the market shares of biosimilars have growth potential in the future.Peer reviewe

How far are we from a medication use process aiming at well-informed adherent patients with long-term medications in Finland? Qualitative study

Objective Finland is one of the few countries that has established a national Medicines Information (MI) Strategy. The ultimate goal of the strategy is a well-implemented medication use process resulting in well-informed adherent patients. This study aimed at evaluating the implementation of the strategy 3years after its launch. Design The evaluation applied a pragmatic approach and was conducted by interviewing stakeholders involved in the National MI Network enhancing the MI Strategy's implementation. The network comprises national key stakeholders producing and using MI. Data were deductively analysed according to the medication use process of the MI Strategy using the framework method, complemented with inductively derived categories. Setting National implementation of the MI Strategy throughout the healthcare system after the first operational period (2012-2014) in 2015. Participants The members of the National MI Network (n=79/111, participation rate 71%, representing 42/53 stakeholder organisations). Outcome measures A new conceptual framework was developed based on stakeholders' views on well-implemented actions and actions needing development in the medication use process at (1) infrastructure (macro), (2) healthcare professionals (meso) and (3) patient (micro) levels. Results Medication counselling by community pharmacists was the primary implemented action, followed by physicians' actions while starting a new medication, and advice given by nurses. The major development needs concerned (1) poor access to patient information and its transfer in healthcare, particularly the lack of reconciled medication lists and electronic health records (macro); (2) poorly functioning medication use process in home care and social care units, such as nursing homes (meso); and (3) limited patient involvement in their care (micro). Conclusions Far more actions for development than well-established practices in the medication use process were identified. Major challenges found in this evaluation are considered in the ongoing Rational Pharmacotherapy Action Plan 2018-2022 by the Ministry of Social Affairs and Health.Peer reviewe

Progress in patient couselling practices in Finnish community pharmacies

Access restricted by publisherObjective The aim of this study was to assess progress in patient counselling practices in Finnish community pharmacies during a national four-year program (TIPPA) from 2000–2003 promoting enhanced pharmacist–customer communication about medicines. Method A pseudo customer method was applied. Four visits with four different scenarios were conducted in a convenience sample of 60 Finnish community pharmacies of different size and geographic location. In total there were 240 visits during each time point measured (baseline in 2000 and three annual follow-ups, n = 960). The pseudo customers presented three scenarios related to self-medication and one related to a prescription medicine with a new prescription (baseline and the second follow-up) or a repeat prescription of the same medication (the first and the third follow-up). A structured data form customised to each scenario was used to record the interaction. Key findings Baseline scores were generally low. In two of the four scenarios (one self-medication and one prescription) a statistically significant improvement (P < 0.05) was found in total scores between the baseline and the third follow-up. Aggregation of the scores of the three self-medication scenarios did not show any change in counselling practices between the baseline and the third follow-up, measured as mean total scores (P = 0.439). Conclusions Some improvements were found in pharmacists' counselling performance in relation to customers' requests for advice about nasal products and also when prescription scenarios were presented. However, pharmacists' counselling rates were low in relation to a repeat prescription or when a request was made to buy a specific medicine. Further attention needs to be paid to the latter two types of consultation

Psykoosilääkkeiden käyttö iäkkäillä : järjestelmällinen katsaus

VertaisarvioituLÄHTÖKOHDAT Psykoosilääkkeitä määrätään psykoosien lisäksi muistisairaiden käytöshäiriöihin. Tarkastelemme tässä järjestelmällisessä katsauksessa, mitä suomalaisten ikäihmisten psykoosilääkkeiden käytöstä tiedetään. MENETELMÄT Medline-tietokannasta valikoitui 27 artikkelia vuosilta 2000–2015. Selvitimme lääkkeiden käytön laajuutta ja riskejä sekä interventioita käytön järkeistämiseksi. TULOKSET Kotona asuvista iäkkäistä 3–14 % käytti psykoosilääkkeitä, muistisairaista 22–32 %. Laitoshoidossa käyttäjien osuus oli noin 40 % eikä muistisairaudella ollut vaikutusta. Lääkkeen aloittaneista noin 40 %:sta tuli pitkäaikaiskäyttäjiä. Perinteisistä psykoosilääkkeistä on siirrytty atyyppisiin. Käytöllä oli yhteys lisääntyneeseen kuolemanriskiin, mutta tulokset olivat ristiriitaisia. Lääkityksen arviointi kerran vuodessa ei kotona asuvilla vaikuttanut käyttöön. Laitoshoidossa hoitajien koulutus vähensi käyttöä. PÄÄTELMÄT Psykoosilääkkeitä määrätään iäkkäille yleisesti ja pitkinä jaksoina muuhun kuin varsinaisiin indikaatioihin.Peer reviewe

Community Pharmacists' Contribution to Medication Reviews for Older Adults : A Systematic Review

ObjectivesTo identify medication review interventions for older adults that involve community pharmacists and evidence of outcomes of these interventions. DesignSystematic review. MeasurementsCinahl, MEDLINE (Ovid), Scopus, International Pharmaceutical Abstracts, and Cochrane Library were searched for articles published between January 2000 and February 2016. Articles involving community pharmacists in medication reviews for outpatients aged 65 and older were included. Evidence of economic, clinical, and humanistic outcomes of interventions was summarized. ResultsSixteen articles were found that described 12 medication review interventions, of which 6 were compliance and concordance reviews, 4 were clinical medication reviews, and 2 were prescription reviews according to a previously developed typology. Community pharmacists' contributions to reviewing medications varied from sending the dispensing history to other healthcare providers to comprehensive involvement in medication management. The most commonly assessed outcomes of the interventions were medication changes leading to reduction in actual or potential drug-related problems (n=12) and improved adherence (n=5). ConclusionRegardless of community pharmacists' contributions to interventions, medication review interventions seem to reduce drug-related problems and increase medication adherence. More well-designed, rigorous studies with more sensitive and specific outcomes measures need to be conducted to assess the effect of community pharmacists' contributions to reviewing medications and improving the health of older adults.Peer reviewe

Barriers to medication counselling for people with mental health disorders : A six country study

Provision of medication information may improve adherence and prevent medication related problems. People with mental health disorders commonly receive less medication counselling from pharmacists than people with other common long term and persistent disorders. Objective: The objective of this study was to compare and contrast barriers pharmacy students perceive toward providing medication counselling for people with mental health disorders in Australia, Belgium, Estonia, Finland, India and Latvia. Methods: Barriers identified by third-year pharmacy students as part of the International Pharmacy Students' Health Survey were content analysed using a directed approach. Students' responses were categorised as pharmacist related, patient related, health-system related, or social or cultural related. Quantitative data were analysed using SPSS version 14.0. Results: Survey instruments were returned by 649 students. Of the respondents, 480 identified one or more barriers to medication counselling for people with mental health disorders. Patient related factors accounted for between 25.3% and 36.2% of barriers identified by the pharmacy students. Pharmacist related factors accounted for between 17.6% and 45.1% of the barriers identified by the pharmacy students. Students in India were more likely to attribute barriers to pharmacist and social and cultural related factors, and less likely to healthsystem related factors, than students studying in other countries. Conclusion: The nature of barriers identified by pharmacy students differed according to the country in which they studied. Undergraduate and postgraduate pharmacy education programs may need to be amended to address common misconceptions among pharmacy students.publishersversionPeer reviewe

Policy and vision for community pharmacies in Finland: A roadmap towards enhanced integration and reduced costs

Finland’s community pharmacy system provides an example of a privately-owned regulated system being proactively developed by the profession and its stakeholders. Community pharmacists have a legal duty to promote safe and rational medicine use in outpatient care. The development of professionally oriented practice has been nationally coordinated since the 1990s with the support of a national steering group consisting of professional bodies, authorities, pharmacy schools and continuing education centers. The primary focus has been in patient counseling services and public health programs. The services have extended towards prospective medication risk management applying evidence-based tools, databases and digitalization. Research has been essential in informing progress by indicating high-risk patients, medications, practices and processes needing improvement. Despite the commitment of the profession and pharmacy owners, large-scale implementation of services has been challenging because of lack of remuneration, the pharmacy income still consisting primarily of sale of prescription and nonprescription medicines. Policy documents by the Ministry of Social Affairs and Health have supported the extension of the community pharmacists’ role beyond traditional dispensing to promote rational pharmacotherapy. The current roadmap by the Ministry of Social Affairs and Health emphasizes ensuring adequate regional availability and accessibility of medicines, regardless of the future pharmacy system. It also emphasizes the importance of strong regulation on pharmacy business operations and sale of medicines to ensure medication safety. At the same time, the roadmap requires that the regulation must enable implementation of new patient-oriented services and procedures, and further promote digitalization in service provision. Competition and balance of funding should be enhanced, e.g., through price competition, but the risk of pharmaceutical market concentration should be managed. The regulation should also consider influence of the new social and health care system on drug delivery. Year 2021 will be crucial for making long-term political decisions on the future direction of tasks and finances of Finnish community pharmacies in this framework. Government-funded studies are underway to guide decision making. Ongoing Covid-19 crisis has demonstrated the readiness of Finnish community pharmacies to adapt fast to meet the changing societal needs