Vaihtoehtoisia korvausmalleja hammashoidon sairausvakuutusjärjestelmän kehittämiseksi

Tässä tutkimuksessa tavoitteena oli tarjota vaihtoehtoja keskusteluun hammashoidon sairausvakuutuskorvausjärjestelmän uudistamiseksi. Vaihtoehtoisten korvausmallien, porrasmallin ja tilimallin, korvauksia verrattiin vuonna 2009 voimassa olleen taksamallin korvauksiin. Laskelmien avulla arvioitiin, ketkä korvausta saaneet hyötyisivät ja ketkä häviäisivät. Tutkimuksen aineistona oli otos henkilöistä, jotka saivat sairausvakuutuksen sairaanhoitokorvausta yksityisen hammashoidon kustannuksista vuonna 2009. Otoksen koko oli 100 000 henkilöä, joilla oli yhteensä 503 093 toimenpidettä. Aineistossa oli tiedot henkilöille tehdyistä toimenpiteistä, toimenpiteistä maksetuista palkkioista ja saaduista korvauksista. Taustamuuttujia aineistossa olivat sukupuoli, ikä, kotikunta ja valtionveronalaiset vuositulot. Laskelmissa käytettiin kahta vaihtoehtoista korvausmallia: porrasmallia ja tilimallia. Porrasmallissa korvaus nousi, kun asiakkaan kustannukset nousivat. Tilimallissa kaikilla oli käytössään vuosittain samansuuruinen korvaussumma. Tutkimusaineiston todellisille toimenpiteille laskettiin vaihtoehtoisten mallien mukaiset korvaukset. Laskelmissa oletettiin, että henkilöiden toimenpiteet ja toimenpiteiden palkkiot säilyvät ennallaan. Korvausmallit pidettiin kustannusneutraaleina, joten niiden korvaussumma oli korkeintaan vuoden 2009 tasolla. Laskelmat osoittivat, että tilimallista hyötyisi kolme neljästä korvauksen saajasta. Korvausprosentti oli taksamallia korkeampi, kun vuosikustannus eivät ylittäneet 500 euroa. Porrasmallin käyttöönotosta hyötyisi yksi kymmenestä korvauksen saajasta. Korvausprosentti kasvoi, jos vuosikustannus ylitti 800 euroa. Sitä pienemmällä vuosikustannuksella korvausprosentti pieneni taksamalliin verrattuna. Jos sairausvakuutuksen korvausjärjestelmää halutaan uudistaa kustannusneutraalisti ja samalla parantaa edellytyksiä käyttää yksityisiä hammashoitopalveluja, tulisi soveltaa tilimallia porrasmallin asemesta

A comparison of generic drug prices in seven European countries: a methodological analysis

Background Policymakers and researchers frequently compare the prices of medicines between countries. Such comparisons often serve as barometers of how pricing and reimbursement policies are performing. The aim of this study was to examine methodological challenges to comparing generic drug prices. Methods We calculated all commonly used price indices based on 2013 IMS Health data on sales of 3156 generic drugs in seven European countries. Results There were large differences in generic drug prices between countries. However, the results varied depending on the choice of index, base country, unit of volume, method of currency conversion, and therapeutic category. The results also differed depending on whether one looked at the prices charged by manufacturers or those charged by pharmacists. Conclusions Price indices are a useful statistical approach for comparing drug prices across countries, but researchers and policymakers should interpret price indices with caution given their limitations. Price-index results are highly sensitive to the choice of method and sample. More research is needed to determine the drivers of price differences between countries. The data suggest that some governments should aim to reduce distribution costs for generic drugs

De värdesätter livet - i kronor och ören

Myndigheter värderar den ekonomiska nyttan i att rädda ännu ett liv mot förlusten att försaka detsamma. De använder samma måttstock men prislistan skiljer sig åt i olika sektorer. Ett liv vilket som helst har värdet 22 328 000 kronor

A comparison of reimbursement recommendations by European HTA agencies : Is there opportunity for further alignment?

Introduction: In Europe and beyond, the rising costs of healthcare and limited healthcare resources have resulted in the implementation of health technology assessment (HTA) to inform health policy and reimbursement decision-making. European legislation has provided a harmonized route for the regulatory process with the European Medicines Agency, but reimbursement decision-making still remains the responsibility of each country. There is a recognized need to move toward a more objective and collaborative reimbursement environment for new medicines in Europe. Therefore, the aim of this study was to objectively assess and compare the national reimbursement recommendations of 9 European jurisdictions following European Medicines Agency (EMA) recommendation for centralized marketing authorization. Methods: Using publicly available data and newly developed classification tools, this study appraised 9 European reimbursement systems by assessing HTA processes and the relationship between the regulatory, HTA and decision-making organizations. Each national HTA agency was classified according to two novel taxonomies. The System taxonomy, focuses on the position of the HTA agency within the national reimbursement system according to the relationship between the regulator, the HTA-performing agency, and the reimbursement decision-making coverage body. The HTA Process taxonomy distinguishes between the individual HTA agency's approach to economic and therapeutic evaluation and the inclusion of an independent appraisal step. The taxonomic groups were subsequently compared with national HTA recommendations. Results: This study identified European national reimbursement recommendations for 102 new active substances (NASs) approved by the EMA from 2008 to 2012. These reimbursement recommendations were compared using a novel classification tool and identified alignment between the organizational structure of reimbursement systems (System taxonomy) and HTA recommendations. However, there was less alignment between the HTA processes and recommendations. Conclusions: In order to move forward to a more harmonized HTA environment within Europe, it is first necessary to understand the variation in HTA practices within Europe. This study has identified alignment between HTA recommendations and the System taxonomy and one of the major implications of this study is that such alignment could support a more collaborative HTA environment in Europe.Peer reviewedFinal Published versio

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 2Biosimilar and Originator Etanercept in the Outpatient Setting

Background Diverging approaches towards market entry and uptake of biosimilars, even within a country, leads to regional variation in biosimilar use. This is the case in Sweden, where the 21 county councils control the healthcare budget and ofer regional guidance. Objectives This study aimed to analyse the market dynamics of originator and biosimilar etanercept (outpatient setting) in the diferent counties of Sweden, and examine the infuence of local policy measures and practices, in addition to national policy. Methods This study was performed in three steps: (1) a structured review of the literature on (biosimilar) policies in Sweden; (2) analysis of market data on the counties’ originator and biosimilar etanercept uptake (quarter two 2012 to quarter four 2017) provided by IQVIA™; and (3) discussion of fndings in face-to-face semi-structured interviews with the national pricing and reimbursement agency, key experts in the county councils of Skåne, Västra Götaland and Stockholm, and an industry representative. Results Notwithstanding the existence of a national managed entry agreement for etanercept, wide variations in biosimilar market shares between counties wer

Prostate cancer testing in Sweden : the interplay between cost and effectiveness

As a major cause of male deaths in Sweden, prostate cancer constitutes an essential public health issue to the society. Early detection through an organised testing program with the prostate-specific antigen (PSA) test and systematic biopsy (SBx) has not been adopted in most countries due to potential harms from over-diagnosis and over-treatment of low risk cancers. The magnetic resonance imaging (MRI) and a novel serum-based reflex test Stockholm3 are possible two approaches to tackle this problem. This doctoral thesis aimed to characterise the societal economic burden due to prostate cancer in Sweden and assess the cost-effectiveness of prostate cancer testing using MRI with or without the reflex Stockholm3 test. Study I characterised and illustrated the resource utilisation in the diagnostic and care pathways of prostate cancer in Sweden during the calendar year 2016. A prevalence-based cost-of-illness approach was applied to quantify the resource utilisation and related costs by care type in Stockholm using register-based data. Direct healthcare resources used in the primary, outpatient, inpatient, palliative care and the pharmaceuticals were valued by their unit costs. Informal care and productivity losses were valued by the human capital method. The societal costs in Stockholm were estimated to be €64 million, of which the direct healthcare, informal care and productivity losses accounted for 62%, 28% and 10%, respectively. The extrapolated costs to Sweden were estimated to be €281 million. An average costs of €1,510, €828 and €271 per prevalent case were calculated for the direct healthcare, informal care and productivity losses, respectively. The results were sensitive to the exclusion of primary care visits for those without a diagnosis of prostate cancer and the proxy good method for valuing informal care. Study II assessed the cost-effectiveness by microsimulation for: (i) no screening and quadrennial PSA screening of prostate cancer for men aged 55-69 years from a lifetime societal perspective using; (ii) SBx alone; (iii) MRI and targeted biopsy (TBx) for men with a positive MRI result; (iv) MRI and the combined targeted and systematic biopsies (TBx/SBx) for those who had a positive MRI result; and (v) SBx for men with a negative MRI result and the combined TBx/SBx for those who are MRI positive. Based on the test performance estimated from the data included in a recent Cochrane review, the screening strategies could reduce prostate cancer related mortality by 8-10% compared with no screening, but resulted in incremental cost-effectiveness ratios (ICERs) that were classified as high costs per quality-adjusted life year (QALY) gained in Sweden. MRI-based screening with either TBx or the combined TBx/SBx had a lifetime reduction in the biopsy episodes by approximately 40%, compared with screening using SBx alone. These two MRI-based strategies were associated with lifetime reductions in detecting International Society of Urological Pathology Grade group 1 (GG=1) cancers by 17% and 11%, respectively, and both strategies yielded strong dominance over alternative screening strategies. MRI-based screening with TBx was found to have the lowest ICER relative to no screening. This ICER would lead to a 25% reduction when substituting the background health state values reported by the World Health Organisation (WHO) with a value set measured from the Swedish general population. Study III evaluated the cost-effectiveness comparing: (i) no screening and three quadrennial MRI-based screenings with the combined TBx/SBx on men with a positive MRI result given (ii) positive PSA test value; (iii) positive Stockholm3 test at a reflex threshold of PSA≥1.5ng/mL; and (iv) positive Stockholm3 test at a reflex threshold of PSA≥2ng/mL. Based on the data from the STHLM3-MRI invitation-to-screening trial, the adjustment for the test performance using data from the Cochrane review, and employing a lifetime societal perspective, all screening strategies were associated with a prostate cancer mortality reduction by 7-9%. The ICERs of MRI-based screening strategies in relation to no screening were classified as a moderate cost per QALY gained in Sweden. In comparison with screening without Stockholm3 test, MRI-based screening with Stockholm3 at a reflex test threshold of PSA≥2ng/mL predicted a lifetime reduction of MRI examinations and biopsy episodes by 60% and 9%, respectively, and was considered as the optimal choice for prostate cancer screening. The results were robust in the one-way and probabilistic sensitivity analyses. Study IV further assessed the cost-effectiveness of prostate cancer screening using a microsimulation approach for: (i) no screening; (ii) traditional screening pathway using PSA and SBx; and (iii) MRI-based screening using the combined TBx/SBx on men with a positive MRI result. Test performance was estimated by the evidence from the STHLM3-MRI trial with model-based imputations. Applying a lifetime healthcare perspective, the quadrennial screening strategies reduced prostate cancer related deaths by 6-9%. Compared with the traditional PSA screening pathway, the MRI-based screening with the combined TBx/SBx halved the MRI examinations and reduced cancer over-diagnosis by approximately 50%. The use of MRI and subsequent combined TBx/SBx for screening resulted in an ICER that was classified as moderate cost per QALY gained in Sweden and has high likelihood to be more cost-effective than the traditional PSA screening pathway. Expanding the screening ages to 50-74 years would increase the ICER by approximately 34%. In conclusion, substantial economic burden was estimated for prostate cancer in Sweden, with the main costs from the direct healthcare and informal care provided to the patients. This doctoral thesis contributes to the characterisation and illustration of the resource utilisation and costs alongside the diagnostic and care pathways and provides point references for future economic evaluations in prostate cancer testing and treatment. In the context of screening for men aged 55-69 years and compared with no screening, the incorporation of MRI in the screening program with or without a reflex Stockholm3 test yielded reductions in prostate cancer mortality and over-diagnosis over a lifetime period. Assessing cost-effectiveness from a healthcare perspective and using the background health state values from the Swedish general population, the MRI-based screening resulted in higher QALYs and ICERs that are classified as a moderate cost per QALY gained in Sweden. This doctoral thesis suggests that MRI is considered to be more effective and cost-effective in the population-based screening leveraging the evidence from the screening-by-invitation trial than using estimates from diagnostic patient cohorts and MRI-based screening demonstrates higher probability to be cost-effective than the traditional PSA screening pathway. Screening with MRI can be considered as a cost-effective choice for early detection of prostate cancer in Sweden

Apteekkijärjestelmän sääntelyn purkaminen Euroopassa – toimenpiteet ja vaikutukset

Tiivistelmä myös ruotsiksi ja englanniksi.Tiivistelmä myös ruotsiksi ja englanniksi

Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 1Biosimilar and Originator Infliximab in the Hospital Setting

Background Decentralisation of healthcare budgets and issuance of local guidelines means that the use of biosimilars can vary by region within a particular country, for example between the 21 counties of Sweden. Objectives This study aimed to analyse the county-level market dynamics of biosimilar and originator infliximab, which are hospital products, and to examine how local policy measures and practices, in addition to national policy, influenced market dynamics. Methods We first conducted a literature review on (biosimilar) policies in Sweden, then analysed market data provided by IQVIA™ on uptake of originator and biosimilar infliximab within the different counties (Q2 2012 to Q4 2017), including discounts from (tender) contracts. Biosimilar market shares were calculated with volume data (measured as defined daily doses [DDDs]). We then discussed our findings in semi-structured interviews with the national pricing and reimbursement agency, key experts within the county councils of Skåne, Västra Götaland, and Stockholm, and an industry representative. Results Market shares of biosimilar infliximab vary widely between counties (range 18–96% in 2