Reimbursement Levels Research Articles

Prospective payment systems and discretionary coding-Evidence from English mental health providers.

Reimbursement of English mental health hospitals is moving away from block contracts and towards activity and outcome‐based payments. Under the new model, patients are categorised into 20 groups with similar levels of need, called clusters, to which prices may be assigned prospectively. Clinicians, who make clustering decisions, have substantial discretion and can, in principle, directly influence the level of reimbursement the hospital receives. This may create incentives for upcoding. Clinicians are supported in their allocation decision by a clinical clustering algorithm, the Mental Health Clustering Tool, which provides an external reference against which clustering behaviour can be benchmarked. The aims of this study are to investigate the degree of mismatch between predicted and actual clustering and to test whether there are systematic differences amongst providers in their clustering behaviour. We use administrative data for all mental health patients in England who were clustered for the first time during the financial year 2014/15 and estimate multinomial multilevel models of over, under, or matching clustering. Results suggest that hospitals vary systematically in their probability of mismatch but this variation is not consistently associated with observed hospital characteristics.

PHP293 - ORPHAN DRUGS IN GERMANY - LESSONS LEARNED FROM AMNOG, BEST AND WORST PRACTICES AND STRATEGIC IMPLICATIONS

AMNOG has implicated a paradigm shift in the examination of the value of a pharmaceutical and in the setting of an appropriate reimbursement level. Depending on the classification of the benefit category, the pharmaceutical manufacturer negotiates the final refunded price with the payer organization GKV-SV. For orphan drugs, there are specific challenges. Due to the randomness of the disease, subpopulations are small and study data are scarce. This leads to uncertainty about the perceived value of the drug and, thus, to intense and sometimes tough negotiations resulting in high rebates. Pharmaceutical companies planning to introduce new orphan drugs should therefore prepare a sound and stringent strategy well in advance. This research elaborates on arising issues and describes important recommendations for manufacturers facing these challenges. G-BA resolutions and its reasonings for all procedures of orphan drugs were retrieved up until May 31st, 2018 from the G-BA homepage. Based on these published documents, active substance, therapeutic area, indication, extent of additional benefit and negotiated rebate were extracted. To date, 72 benefit assessment procedures of orphan drugs have been carried out, 39 in oncological indications and 15 in indications of metabolic diseases. In approximately 60% of all assessed drugs the G-BA granted a non-quantifiable additional benefit. Only a subpopulation of one drug was assessed with a major benefit. The range of negotiated rebates varies between 14.7% to 72.0%. Since the implementation of AMNOG, the number of benefit assessments of orphan drugs has steadily increased with a peak in 2016. Indications in the therapeutic areas of oncology and metabolic diseases are particularly well represented. Based on the analysis it can be assumed that benefit assessments for orphan drugs become more challenging, in particular for oncological drugs.

PHP223 - TRERAPEUTIC AREAS, A KEY FACTOR FOR HTA AND REIMBURSEMENT DECISIONS, TIMMING AND ACCESS

In 2017, Oncology (93,7 B$), anti-rheumatics 53,3 B$), anti-viral (48,5 B$), anti-diabetes (43,6 B$) and bronchodilators (28,3 B$) had the highest global pharmaceutical sales. This research compare approval, reimbursement level, delays from EMA date and timing trends taken by EU5-countries for approval between 2014-2018 for top 5 pharmaceutical therapeutic areas, analysing their impact in HTA and reimbursement decisions. Using the Prismaccess database we identified oncology, anti-rheumatics, anti-viral, anti-diabetes and bronchodilators indications approved by EMA between January 1, 2014 to Jun 5, 2018. For each EU5 country we review the process, the HTA and reimbursement decisions, the assessment timing since EMA approval, generating tables and figures to facilitate the compression. Delay trends by therapeutic areas were calculated for each country. The study included 171 HTA and reimbursement decisions across United Kingdom, France, Germany, Italy and Spain. HTA advise and reimbursement decisions vary between 70 to 367 days on average count on the country and therapeutic area evaluated since EMA authorization. The percentage of drugs evaluated, drugs reimbursed and timing varies considerably depending on the therapeutic area and the country. HTA and Reimbursement decisions varies substantially among the 5 European countries analysed, but not in the same measure for all the therapeutic areas. In addition, the time used by each agency to evaluate a new drug or indication varies considerably. The time used to evaluate the same new drug or new indication can be tripled depending on the country. The therapeutic area plays a key role in the agility of health technology assessment processes.

PCN329 - OUTCOMES-BASED ARRANGEMENTS IN ONCOLOGY: A LANDSCAPE ANALYSIS

Outcomes-based payment arrangements (OBA) for cancer drugs are used internationally with more limited use in the U.S. These arrangements seek to increase the realized value of pharmaceuticals and decrease value uncertainty for payers. Our objective was to identify and characterize OBAs involving oncology products. OBAs were defined as arrangements between a payer and a pharmaceutical developer where the price or reimbursement level is related to its performance in clinical practice. We used a systematic search, leveraging the University of Washington’s Performance Based Risk Sharing Database that contains information obtained by searching Google, PubMed, and government websites from 1993 to 2018. Included arrangements had a financial or health outcomes related component linked to reimbursement. We collected data on product name, year, country, tumor type, payer, arrangement structure, and outcome measure. We summarized the findings using descriptive statistics. The search yielded 117 oncology-related arrangements for 55 drugs in 12 countries. The majority were from Italy (56%) followed by the United Kingdom and Australia. The U.S. had 3 cases. The most common tumor types were lung (13%), breast (11%), and kidney (9%). The distribution of outcome measures used was clinical (44%), financial/utilization (41%), cost-effectiveness (3%), hybrid (5%) and unknown (16%). 60% were first-in-therapeutic-class molecules in the US and 27% had an orphan designation. The primary clinical outcome measures included tumor response, disease progression, and toxicity. The primary financial/utilization measures included the number of treatment cycles and treatment duration. Arrangement structures primarily used rebates (41%), manufacturer funded treatment initiation (40%), and refunds (24%). 17 drugs in 19 tumor types had OBAs in multiple countries. Outcomes-based oncology arrangements are used in many countries. Arrangements have employed a variety of endpoints, outcomes measures and contract structures. U.S. stakeholders can learn from global experiences to inform further implementation and research moving forward.

Abstract 2225: Limitations on mutation detection for early detection of cancer

Abstract Introduction: Cell-free DNA (cfDNA) has potential utility for early non-invasive detection of cancer. We assess the feasibility of cfDNA mutational assays for early detection based on their physiological and economic requirements. We further review alternative biological signals of early cancer and the potential of machine learning to integrate these signals into reliable diagnostics. Methods: A binomial model was used to assess depth and input requirements, with parameters derived from published data on cfDNA sequencing. Alternative strategies for early detection were assessed by literature review. Results: 30,000x unique coverage is required for 95% sensitivity for 1 mutant read at 0.01% variant allele frequency, requiring 180ng cfDNA input at 50% process efficiency; current sequencing costs and reimbursement levels may make such tests economically infeasible (Table). 5th percentile plasma cfDNA concentration in the screening population is ~2.3 ng/mL, requiring >140mL blood collection for test failure rate <5%. Somatic mutational heterogeneity creates significant specificity challenges. Proteins, RNAs, and compartmentalized macromolecules are more abundant and may overcome cfDNA's issues of quantity, but irrelevant biological processes may confound the data. New techniques in machine learning, including latent variable modeling, may be used to integrate heterogeneous data from multiple sources to overcome these challenges. Conclusions: Mutation-detection assays may not be feasible for early cancer detection due to limited sensitivity arising from low concentrations of cfDNA, heterogeneity leading to specificity challenges, and prohibitive cost. Integrating markers beyond mutations with modern machine learning may provide a potential route to statistically robust biomarker development for early cancer detection. Table. Assay requirements for tumor liquid biopsy and mutation-based early cancer detection. Sequencing cost by panel sizeVAF 95% sensitivityCorrected depthRaw depthInput volume (blood)TEC-Seq1 58 genes 81 kbRazavi et al2 508 genes 2000 KbWES ~20k genes 50,000 KbTumor liquid biopsy0.1%3000x15,000x15 mL$14$340$8300Early cancer detection0.01%30,000x150,000x150 mL$140$3400$83,0001Phallen J, et al. Sci Transl Med. 2017 Aug 16;9(403). 2Razavi P, et al. J Clin Oncol. 2017;35(suppl):abstr 11526.Model parameters: 1) No more than 5% of samples may fail because of insufficient cfDNA quantity; 2) 95% sensitivity to detect one read from any cancer-derived allele, assuming that one is present in the sample; 3) 50% process efficiency: half of the cfDNA molecules in the input blood sample are represented in the sequencer output; 4) 5x oversampling in sequencing for error correction; 5) 100% on-target rate in target enrichment; 6) “$1000 genome” sequencing costs: US $1000/(30 x 3 Gbp) of sequencing bandwidth; 7) only sequencing costs computed; all other costs (labor, equipment, facilities, depreciation, etc.) accounted at $0; 8) panel expansion neither reduces input requirements nor increases sequencing requirements.VAF = variant allele frequency; TEC-Seq = targeted error correction sequencing; WES = whole exome sequencing. Citation Format: Imran S. Haque, Gabriel Otte, Olivier Elemento. Limitations on mutation detection for early detection of cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 2225.

Budget Impact Analysis of Self-Monitoring of Blood Glucose vs. Flash-Continuous Glucose Monitoring in Intensive Insulin Users with Diabetes Type 2 Covered by Medicare and Medicaid

Introduction: Self-Monitoring of Blood Glucose (SMBG) uses capillary blood glucose to measure glycemia in diabetic patients. Recently FDA-approved Flash Continuous Glucose Monitoring (F-CGM) reveals glucose levels when scanned by the reading device. The Centers for Medicare and Medicaid Services (CMS) have announced to reimburse F-CGM at the same level as CGM devices. Aim: This analysis’ objective was to quantify the CMS budget impact (BI) of F-CGM reimbursement in patients with type 2 diabetes (T2DM) on intensified insulin therapy (IIT), and compare it to the BI of conventional SMBG via cost-related break-even metrics. These were chosen because - in the absence of RCT-based, primary endpoint-driven clinical superiority evidence of F-CGM over SMBG for this population (REPLACE study) - they are well-suited to inform budget allocation decisions. Methods: An economic model was developed in Excel. CMS reimbursement/patient co-insurance levels for SMBG and F-CGM were used; data on morbidity, treatment and usage patterns were sourced from the literature and official websites. Different scenarios were simulated to elicit break-even points between F-CGM and SMBG. Results: The annual cost of SMBG with 3.7 tests per day (see REPLACE) is $180 per patient, compared to $2,156 incurred per F-CGM patient, representing a cost difference of $1,976/year or $5.41/day. This implies a budget break-even ratio of 1:12 patients (F-CGM:SMBG). Both technologies would break even at a consumption of 44 test strips per day. A year’s SMBG budget would last only 30 days if spent on F-CGM. Conclusion: With diabetes budgets under pressure, thoughtful spending policies are needed. It is recommended to analyze in detail which T2DM subgroups will benefit most from F-CGM, focusing reimbursement to the latter. SMBG, being an established technology, represents - at current reimbursement levels - an attractive spending option to budget holders. Disclosure M. Stueve: Employee; Self; JnJ GmbH Life Scan. Y.F. Zoellner: Research Support; Self; J&J Medical GmbH, LifeScan.

Medical oncologists\u2019 willingness to participate in bundled payment programs

BackgroundBundled payment programs play an increasingly important role in transforming reimbursement for oncologic care. We assessed determinants of oncologists’ willingness to participate in bundled payment programs for breast cancer. We hypothesized that providers would be more likely to participate in bundled payment programs if offered higher levels of reimbursement for each episode of care.MethodsOncologists from Florida, New Jersey, New York, and Pennsylvania were identified in the AMA database or by patients listed in state cancer registries. Providers were randomized to receive one of four versions of a survey describing bundled payment programs offering different levels of compensation for the first year of localized breast cancer treatment ($5000, $10,000, $15,000, or $20,000). Physicians rated their likelihood of participation in a bundled program on a Likert scale. Logistic regression was used to analyze determinants of likelihood of participation in bundling.ResultsAmong 460 respondents, only 17% of oncologists were highly likely to participate in a bundled program paying $5000 for the first year of care, rising to 41% for the $15,000 program, but falling to 34% for the $20,000 program. Likelihood of participation was higher among oncologists who were male, older, and believed that cancer patients should not be offered high-cost drugs with minimal survival benefit.ConclusionOur results suggest that medical oncologists have limited enthusiasm for bundled payments, and higher payments may not overcome resistance to bundling among a substantial proportion of physicians.

Valuing innovative endoscopic techniques: per-oral endoscopic myotomy for the management of achalasia

Unclear reimbursement for new and innovative endoscopic procedures can limit adoption in clinical practice despite effectiveness in clinical trials. The aim of this study was to determine maximum cost-effective reimbursement for per-oral endoscopic myotomy (POEM) in treating achalasia. We constructed a decision-analytic model assessing POEM versus laparoscopic Heller myotomy with Dor fundoplication (LHM) in managing achalasia from a payer perspective over a 1-year time horizon. Reimbursement data were derived from 2017 Medicare data. Responder rates were based on clinically meaningful improvement in validated Eckardt scores. Validated health utility values were assigned to terminal health states based on data previously derived with a standard gamble technique. Contemporary willingness-to-pay (WTP) levels per quality-adjusted life year (QALY) were used to estimate maximum reimbursement for POEM using threshold analysis. Effectiveness of POEM and LHM was similar at 1 year of follow-up (0.91 QALY). Maximum cost-effective reimbursement for POEM was $8033.37 to $8223.14, including all professional and facility fees. This compares favorably with contemporary total reimbursement of 10 to 15 total relative value units for advanced endoscopic procedures. Rates of postprocedural GERD did not affect the preference for POEM compared with LHM, assuming at least 10% cost savings with POEM compared with LHM in cost-minimization analysis, or at least 44% cost savings in cost-effectiveness analysis (WTP= $100,000/QALY). LHM was only preferred over POEM if both procedures were reimbursed similarly, and these findings were primarily driven by lower rates of postprocedural GERD. The rate of conversion to open laparotomy due to perforation or bleeding was infrequent in published clinical practice experience, thus did not significantly affect reimbursement. POEM is an example of an innovative and potentially disruptive endoscopic technique offering greater cost-effective value and similar outcomes to the established surgical standard at contemporary reimbursement levels.

The healthcare system and the provision of oral healthcare in European Union member states. Part 9: Sweden.

Equally accessible and affordable dental services for all population groups have been a political goal in Sweden for almost a century. All political parties have shared the idea that a person's social background should not have consequences for his or her dental status. Strategic tools to achieve this ambitious goal have been the wide use of publicly provided oral healthcare services, covering even sparsely populated areas, focusing on preventive care and significant subsidies for necessary treatments. Besides free care for children and young adults, oral healthcare is reimbursed from public funds. The public subsidy was particularly generous in 1975-1999 when a 'full clearance' of adults' dentitions was undertaken both by the public and private providers under fixed prices and high reimbursement levels for all treatment measures. Today, preventive oral healthcare for the elderly is given higher priority as most Swedes have been able to keep their natural teeth.

Rural\u2013urban disparities in the utilization of mental health inpatient services in China: the role of health insurance

Reducing rural–urban disparities in health and health care has been a key policy goal for the Chinese government. With mental health becoming an increasingly significant public health issue in China, empirical evidence of disparities in the use of mental health services can guide steps to reduce them. We conducted this study to inform China’s on-going health-care reform through examining how health insurance might reduce rural–urban disparities in the utilization of mental health inpatient services in China. This retrospective study used 10 years (2005–2014) of hospital electronic health records from the Shandong Center for Mental Health and the DaiZhuang Psychiatric Hospital, two major psychiatric hospitals in Shandong Province. Health insurance was measured using types of health insurance and the actual reimbursement ratio (RR). Utilization of mental health inpatient services was measured by hospitalization cost, length of stay (LOS), and frequency of hospitalization. We examined rural–urban disparities in the use of mental health services, as well as the role of health insurance in reducing such disparities. Hospitalization costs, LOS, and frequency of hospitalization were all found to be lower among rural than among urban inpatients. Having health insurance and benefiting from a relatively high RR were found to be significantly associated with a greater utilization of inpatient services, among both urban and rural residents. In addition, an increase in the RR was found to be significantly associated with an increase in the use of mental health services among rural patients. Consistent with the existing literature, our study suggests that increasing insurance schemes’ reimbursement levels could lead to substantial increases in the use of mental health inpatient services among rural patients, and a reduction in rural–urban disparities in service utilization. In order to promote mental health care and reduce rural–urban disparities in its utilization in China, improving rural health insurance coverage (e.g., reducing the coinsurance rate) would be a powerful policy instrument.

Technologies for large-scale umbilical cord-derived MSC expansion: Experimental performance and cost of goods analysis

The translation of cell therapies into clinical practice requires a scalable, efficient and cost-effective manufacturing process. This paper presents an integrated experimental and cost analysis of different cell culture technologies for umbilical cord-derived mesenchymal stromal/stem cell expansion: a multi-layer vessel (ML), a stirred tank bioreactor with microcarrriers (STR), a hollow fiber bioreactor (HF) and a packed-bed bioreactor (PB). The results showed that the cell proliferation rate, expansion fold and harvesting efficiency were highest in HF (36.8 ± 1.7 h; 9.8 ± 1.0 −fold; 100%). The STR, ML and PB achieved a similar level of cell number with high expansion folds (8.8 ± 0.39, 8.7 ± 0.90, 6.9 ± 1.3 −fold, respectively). However, harvesting efficiency was lowest with PB (18% ± 0.77), followed by STR (61% ± 15.7). The cells retained their functional properties post culture in all the technologies evaluated. The experimental results were incorporated into an advanced decisional tool comprising a bioprocess economics model and a stochastic model so as to evaluate the commercial economic feasibility and robustness of different candidate technologies for MSC manufacture. The model predicted that HF would be the least cost-effective option despite its advantageous experimental performance, due to its high consumable and equipment costs. ML ranked first in cost-effectiveness and robustness in this scenario followed by STR. The results also demonstrated how the bioprocess economics model can be used to direct improvements to the culture platforms so as to achieve commercial success according to the reimbursement level.

Medication wasted – Contents and costs of medicines ending up in household garbage

Despite potentially considerable implications for public health, the environment and public funds, medicine waste is an under-researched topic. This study aims to analyse medicines drawn from household garbage in Vienna (Austria) and to assess possible financial implications for public payers. Four pharmaceutical waste samples collected by the Vienna Municipal Waste Department between April 2015 and January 2016 were investigated with regard to their content. The value of medicines was assessed at ex-factory, reimbursement and pharmacy retail price levels, and the portion of costs attributable to the social health insurance was determined. Data were extrapolated for Vienna and Austria. The waste sample contained 1089 items, of which 42% were excluded (non-pharmaceuticals, non-Austrian origin and non-attributable medicines). A total of 637 items were further analysed. Approximately 18% of these medicines were full packs. 36% of the medicines wasted had not yet expired. Nearly two out of three medicines wasted were prescription-only medicines. The majority were medicines related to the 'alimentary tract and metabolism' (ATC code A), the 'nervous system' (ATC code N) and the 'respiratory system' (ATC code R). The medicines wasted had a total value of € 1965, € 2987 and € 4207, expressed at ex-factory, reimbursement and pharmacy retail price levels, respectively. Extrapolated for Vienna, at least € 37.65 million in terms of expenditure for public payers were wasted in household garbage, corresponding to € 21 per inhabitant. This study showed that in Vienna some medicines end up partially used or even completely unused in household garbage, including prescription-only medicines, non-expired medicines and medicines for chronic diseases. While there might be different reasons for medicines being wasted, the findings suggest possible adherence challenges as one issue to be addressed.

Public Health Insurance with Monopolistically Competitive Providers and Optional Spot Sales

Abstract We study the implications of extending public-insurance coverage over differentiated medical products of the same therapeutic group to market outcomes. The public insurer can set the reimbursement level for medical providers and the copayment for the insured for medical care provided under the policy coverage, but cannot directly control providers’ spot sales (outside of insurance) price. In this setup, the price offered by the public insurer to medical providers must maintain their reservation profit from selling on the spot market directly to consumers. We show that the public insurer can manipulate this reservation profit by setting the copayment rate, and thereby promote market welfare while increasing consumers’ surplus due to lower medical prices and lower market entry. The results survive generalizations including moral hazard and incomplete insurance coverage.

Contract Design: Financial Options and Risk.

Introduction:Integrated care systems as well as accountable care organisations (ACOs) in the US and similar concepts in other countries are advocated as an effective method of improving the performance of healthcare systems. These systems outline a payment and care delivery model that intends to tie provider reimbursements to predefined quality metrics. By this the total costs of care shall be reduced. When designing healthcare options contractors are faced with a variety of financial options. The costs of market utilisation are highly relevant for the conception of healthcare contracts; furthermore contract-specific investments are an obstacle to the efficient operation of ACOs.Methods:A comprehensive literature review on methods of designing contracts in Integrated Care was conducted. This article is the second in a row of three that are all published in this issue and contribute to a specific issue in designing healthcare contracts. The first dealt with the organisation of contracts and information asymmetries, while part 3 concludes with the question of risk management and evaluation. The specific research question of this second article focusses on the financial options and reimbursement schemes that are available to define healthcare contracts.Results:A healthcare contract is a relational contract, which determines the level of reimbursement, the scope of services and the quality between service providers and payers, taking account of the risks relating to population and performance. A relational contract is an agreement based upon assumption of a longer timeframe. A major obstacle to the practical implementation of healthcare contracts is the prognosis of the inflows and outflows due to the actuarial risks of the insured population. Financing conditions and reimbursement arrangements that are based on a prospectively determined fixed price, have a significant drawback: it is very difficult to take the differences in health status and the utilisation of distinct insured clientele (panel) into account.Discussion and Conclusion:The first two articles of this series on contract design have shown that complete contracts in healthcare are unrealistic. Healthcare reimbursement contracts are incomplete contracts with a high degree of uncertainty. In incomplete contracts specific contractual regulations are not made for any eventuality. For this reason it is important that the parties agree on the prevention of endogenous risks (asymmetric information after the conclusion of the contract) and on the procedure in the case of unforeseen circumstances (the risks of random, parameter risk and change risks to the healthcare program).

Rural-Urban Disparities in the Utilization of Mental Health Inpatient Services in China: The Role of Health Insurance

Objective: Reducing rural-urban disparities in health and health care has been a key policy goal for the Chinese government. With mental health becoming an increasingly significant public health issue in China, empirical evidence of disparities in the use of mental health services can guide steps to reduce them. We conducted this study to inform China’s on-going health-care reform through examining how health insurance might reduce rural-urban disparities in the utilization of mental health inpatient services in China. Methods: This retrospective study used 10 years (2005–2014) of hospital electronic health records (EHRs) from the Shandong Center for Mental Health (SCMH) and the DaiZhuang Psychiatric Hospital (DZPH), two major psychiatric hospitals in Shandong Province. Health insurance was measured using types of health insurance and the actual reimbursement ratio (RR). Utilization of mental health inpatient services was measured by hospitalization cost, length of stay (LOS), and frequency of hospitalization. We examined rural-urban disparities in the use of mental health services, as well as the role of health insurance in reducing such disparities. Results: Hospitalization costs, LOS, and frequency of hospitalization were all found to be lower among rural than among urban inpatients. Having health insurance and benefiting from a relatively high RR were found to be significantly associated with a greater utilization of inpatient services, among both urban and rural residents. In addition, an increase in the RR was found to be significantly associated with an increase in the use of mental health services among rural patients. Conclusion: Consistent with the existing literature, our study suggests that increasing insurance schemes’ reimbursement levels could lead to substantial increases in the use of mental health inpatient services among rural patients, and a reduction in 3 rural-urban disparities in service utilization. In order to promote mental health care and reduce rural-urban disparities in its utilization in China, improving rural health insurance coverage (e.g., reducing the coinsurance rate) would be a powerful policy instrument.

Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review.

Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries.Methods: A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017.Results: The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application.Conclusions: Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.

Privately practising nurse practitioners' provision of care subsidised through the Medicare Benefits Schedule and the Pharmaceutical Benefits Scheme in Australia: results from a national survey.

Objective Since legislative changes in 2010, certain health care services provided by privately practising nurse practitioners (PPNPs) in Australia have been eligible for reimbursement under the Medicare Benefits Schedule (MBS) and the Pharmaceutical Benefits Scheme (PBS). The aim of the present study was to describe survey results relating to the care provided by PPNPs subsidised through the MBS and PBS. Methods PPNPs in Australia were invited to complete an electronic survey exploring their practice activities. Quantitative data were analysed using descriptive statistics and 95% confidence intervals were calculated for percentages where relevant. Free text data were analysed using thematic analysis. Results Seventy-three PPNPs completed the survey. The most common form of payment reported (34%; n=25) was payment by direct fee for service (MBS rebate only, also known as bulk billing). Seventy-five per cent of participants (n=55) identified that there were aspects of care delivery not adequately described and compensated by the current nurse practitioner (NP) MBS item numbers. 87.7% (n=64) reported having a PBS prescriber authorisation number. Themes identified within the free text data that related to the constraints of the MBS and PBS included 'duplication of services' and 'level of reimbursement'. Conclusion The findings of the present study suggest that PPNPs are providing subsidised care through the MBS and PBS. The PPNPs in the present study reported challenges with the current structure and breadth of the NP MBS and PBS items, which restrict them from providing complete episodes of patient care. What is known about the topic? Since the introduction of legislative changes in 2010, services provided by PPNPs in Australia have been eligible for subsidisation through the MBS and PBS. What does this paper add? This paper provides data on PPNPs' provision of care subsidised through the MBS and PBS. What are the implications for practitioners? Eligibility to provide care subsidised through the MBS and PBS has enabled the establishment of PPNP services. The current breadth and structure of the NP MBS and PBS item numbers have restricted the capacity of PPNPs to provide complete episodes of patient care.

PDB44 - Assessment of Antidiabetic Drugs In France: What Is The Basis For A Reimbursement Recommendation?

The French National Authority for Health (HAS) is responsible for health technology assessment, providing opinions for reimbursement purposes on drugs. Recommendations for reimbursement are based on the Clinical Benefit (CB) score with a 4-point scale from insufficient (no reimbursement) to important (highest level of reimbursement). According to the French legislation, the CB takes into account 5 criteria: disease severity, treatment aim, efficacy/side effects ratio (ranked on a 4-point scale), the drug’s place in the therapeutic strategy and public health impact. We observed that antidiabetic drugs frequently have several CB scores as they’re assessed by (sub)indication and therefore aimed to identify criteria driving the CB appraisals for antidiabetic indications. A retrospective and descriptive study analysing of HAS appraisals for all new antidiabetic (sub)indications assessed between 2010 and 2015 was conducted. For each appraisal, information regarding CB criteria was collected. 89 antidiabetic indications (25 drugs) have been assessed with the following CB 37% important, 25% moderate, 6% low, 31% insufficient. For all assessments, the CB conclusions were: 80% important, 10% moderate, 3% low and 7% insufficient. The efficacy/side effects ranking was correlated to the CB score in 80% of the indications. When HAS concluded that the drug had no place in the therapeutic strategy, the CB was systematically insufficient. Other CB criteria were less decisive: severity of the disease was always important, treatment aims were always symptomatic and only one indication obtained a positive impact on public health. The percentage of insufficient CB in antidiabetic drugs appears to be higher than for all drugs assessment. However, all of these drugs are available as they obtained a favorable opinion for reimbursement in other (sub)indications, questioning the rationale for such a precise assessment. CB appraisal appears to be mostly driven by the efficacy/side effects ratio and the drug’s place in therapeutic strategy.

Patterns in the Diagnosis and Treatment of Osteoporosis in Men: A Questionnaire-based Survey in Central and Eastern European Countries

SummaryTo assess the current practice patterns in the diagnosis and treatment of male osteoporosis based on questionnaires. Questionnaires were presented and filled out by osteoporosis experts from Austria, Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia and Russia. The questions included focused on the proportion of male referrals to DXA, the main reasons for referral, the preferred measurement sites and reference database, the definition of male osteoporosis, needed laboratory investigations, data on calcium and vitamin D supplementation as well as on treatment modalities and their reimbursement rate. Men comprised 5 to 10% of all DXA referrals. The main reasons for referral were low back pain and fractures. Most of the respondents used the International male reference database. The diagnosis of osteoporosis was based mainly on a T-score below −2.5 after the age of 50, but a few respondents added fractures as a necessary condition. Only 1/3 of men visiting DXA sites are expected to have normal BMD. A consensus for the use of laboratory investigations in male osteoporosis is practically lacking. Treatment modalities include alendronate, risedronate, zoledronate, denosumab, rhPTH and strontium (with some restrictions for the latter three). Data on treatment adherence and persistence are generally lacking except for Austria, Romania and Slovakia. The levels of reimbursement vary a lot across countries. Osteoporosis in men is an under-recognized problem in CEE countries, leading to a tremendous gap in the diagnosis and treatment.

Drug Policy in Poland

We presented a general overview of the health care system as well as the pricing and reimbursement environment in Poland. Poland aims to ensure proper access to safe and effective medicines while reducing patients’ share in treatment costs. Nevertheless, the co-payment for pharmacotherapy is still high (more than 60%). The key policymaker and regulator in the system is the Ministry of Health, which is supported by the Polish Agency for Health Technology Assessment and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji), responsible for evaluating applicant drugs, and the Economic Commission, responsible for negotiating the official sales prices and conditions for reimbursement with pharmaceutical companies (e.g., level of reimbursement and risk-sharing scheme agreements). The Agency for Health Technology Assessment and Tariff System dossier is obligatory for reimbursement application and includes the analysis of clinical effectiveness, economic analysis (with the threshold of quality-adjusted life-year established as no more than 3 times the gross domestic product per capita), and the analysis of budget impact. In Poland, only a positive list of reimbursed drugs is published and it is updated every 2 months. The following levels of reimbursement are in use: 100%, 70%, 50%, and lump sum (about €0.8). The first reimbursement decision is given for a period of 2 years only, the second for 3 years, and the third for 5 years. There is no separate budget or special legal regulations for orphan drugs. Generic substitution of drugs is desired but not mandatory. Physicians are not assigned with pharmaceutical budgets. The access to real-world data is limited; the only registers available are for drugs used in drug programs.