„International Research Project on Financing Quality in Health Care” InterQuality WP3 WP3 objectives • The objective of WP3 is to validate pharmaceutical benefit financing (pricing and reimbursement) models, used in: – Tax or social health insurance systems, – Private or mixed health insurance systems. • Specific objectives are: – In the case of both systems, financing models effect on medicines distribution costs, quality of pharmaceutical care, utilization of resources, cost-efficiency and equity of access will be explored and addressed taking into account the needs of different patient groups – On the basis of comparative analysis of existing financing models, recommended pharmaceutical benefit financing model will be proposed. WP3 Tasks description Task 3.1. Comparative analysis of pharmaceutical benefit financing models Task 3.2. Financing access to medicines Task 3.3. Drug distribution financing models Task 3.4. Pharmaceutical Care Task 3.5. Development of recommended model of Pharmaceutical Care Task 3.1. Comparative analysis of pharmaceutical benefit financing models Based on results of a literature review (WP2) key quality dimensions in pricing & reimbursement financing model will be defined QUALITY EQUITY x% EFFECTIVENESS x% Task 3.1. Comparative analysis of pharmaceutical benefit financing models • Perform a literature research to define quality dimensions in tax and social or private insurance jurisdictions – How do we measure effectiveness? • QALY, LYG, DALY, primary vs. secondary endpoints – How do we measure equity? • Kakwani index, Fairness in Financial Contribution, catastrophic healthcare payments etc. – How do we find equity- efficiency trade off? • Social welfare function, fairness weights, a rank-dependent QALY model Input from collaborative partners: detailed characteristics of equity principle perceived by NICE (UK), IQWIG (Ger), AHTAPol (PL), US, others (?) Task 3.1. Comparative analysis of pharmaceutical benefit financing models • Conduct a survey to elicit views/attitudes of general public towards equity-efficiency trade-off in pricing and reimbursement decision making in tax and social or private insurance jurisdictions – How the role of equity principle is perceived in P&R decision making process by general public? – How the role of principle of maximalization of health outcomesis perceived in P&R decision making process by general public? – How general public reacts to equity-efficiency trade offs challenges? Task 3.2. Financing access to medicines Based on a literature review (WP2) a preliminary checklist for assessment of financing access models from a quality perspective will be developed (also including prescription patterns, referral systems, treatment guidelines, co-pay threshold vs. purchasing power, social coverage, end life therapies, rare and ultra- rare diseases and others) QUALITY Private $ x% Public $ x% Task 3.2. Financing access to medicines 1. Define the role of public and private expenditures in tax and social or private insurance jurisdictions • payment models restricting moral hazard (DK) • pharmaceutical pricing regulating schemes (PPRS) • value-based pricing (based on UK experiences) • risk-sharing agreements (mainly based on US input) • comparative effectiveness (US) • HTA • BIA (Ger) Input from collaborative partners: a retrospective database study on the impact of different financing schemes on quality of healthcare Task 3.3. Pharmaceutical distribution financing models 1. Consortium partners (all) will be asked to execute, in the framework of collaborative work, systematic reviews of publications, regarding cost effectiveness of pharmaceutical distribution models The objective is to compare various models of drug distribution, including their impact on: availability of drugs, prices, patient compliance and access to pharmaceutical care Knowledge gained from research should provide answers to important questions, ie.: 2. 3. 1. 2. 3. 4. What are the costs and benefits of direct deliveries? What are the risks and advantages of internet trade in pharmaceuticals? Identification of independent experts , who could answer questionnaires in two or more rounds to be executed according to Delphi method , in the second phase of research Special attention will be paid to comparative analysis of effectiveness of different distribution cost control models: PPRS, government regulated vs. negotiated mark-ups, monitoring and regulation of trade rebates, granted to wholesalers and pharmacists, etc. Task 3.4. Pharmaceutical Care 1. The survey study on the pharmaceutical care financing models in EU and US (budget spendings on pharmaceutical care, quality assurance required, services granted, pharmacists preparing) 2. The literature review of pharmaceutical care effectiveness of pharmaceutical care in EU and US The objective is to provide the comparison of financing models and to assess expected effectiveness of pharmaceutical care. The knowledge gained from the research should provide answer to important questions, ie.: 3. 4. 1. 2. Is the effectiveness of pharmaceutical care connected to the financing model Which pharmaceutical sevices grants the best health care performance Input from collaborative partners: The survey study on the pharmaceutical care financing and functioning models is recommended Task 3.4. Pharmaceutical Care Definition of pharmaceutical care • • • Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve a patient's quality of life . These outcomes are: – – – – cure of a disease; elimination or reduction of a patient's symptomatology; arresting or slowing of a disease process; or preventing a disease or symptomatology. Pharmaceutical care involves the process through which a pharmacist cooperates with a patient and other professionals in designing, implementing, and monitoring a therapeutic plan that will produce specific therapeutic outcomes for the patient. This in turn involves three major functions: – identifying potential and actual drug-related problems; – resolving actual drug-related problems; and – preventing drug-related problems Pharmaceutical care is a necessary element of health care and should be integrated with other elements. Pharmaceutical care is, however, provided for the direct benefit of the patient, and the pharmacist is responsible directly to the patient for the quality of that care Reference: Helper, D.D. & Strand, L.M., Opportunities and Responsibilities in Pharmaceutical Care, Am.J. Pharm.Educ., 53, 7S-15S(1989) Pharmaceutical care - recommendations from the Council of Europe / EDQM • • • • • • • • • • • A better public understanding of pharmaceutical care definition Added value of pharmaceutical care should be clearly demonstrated Cooperation structures are needed to support the multidisciplinary character of pharmaceutical care activities (e.g. information sharing) A list of indicators should be developed (on areas already covered by indicators and on others not yet covered) and on outcomes Consideration should be given to supplementing existing medical coding standards with extensions for pharmaceutical care. Harmonisation of underlying data collection methods is essential to have quality indicators comparable between countries. Patient participation and commitment must be improved (with possibly an indicator to measure it) Medication-related health literacy should be promoted within the general public National healthcare authorities could provide a legal basis for removing the various barriers to the implementation of pharmaceutical care Involvement of different stakeholders in the implementation of pharmaceutical care Healthcare systems need to take account of pharmaceutical care as a working methods for the promotion of the safety and quality of medication use Reference: Pharmaceutical Care: Where do we stand – where should we go? EDQM, 2009 (Pharmaceutical Care Summary of a survey from the Council of Europe) Pharmaceutical care- a practical example of diabetes • Rational – – – – – – – – T1DM and T2DM are complicated chronic conditions that place multiple demands on patients as well as on healthcare providers diabetic population is diverse in terms of age, gender, ethnic origins and socioeconomic status variety of pharmaceutical products are used to manage diabetes by healthcare providers and patients necessity of using more than one kind of insulin and adjusting insulin dosages in between appointments with physicians complications and co-morbidities may involve additional pharmaceutical treatments self-monitoring blood glucose levels and obtaining glucometers and the supplies (‘strips’) from pharmacies people with diabetes tend to see pharmacists more frequently than physicians or other healthcare professionals disseminating in pharmacies information about T2DM that could aid in primary prevention • Evidence of pharmaceutical care effectiveness – – overall improvement in HbA1C (1) multifaceted professional interventions can enhance the performance of health professionals in managing patients with diabetes. The addition of patient-oriented interventions can lead to improved patient health outcomes. interventions that improve regular prompted recall and review of patients (central computerised tracking systems or nurses who regularly contact the patient) can improve diabetes management. (2) 1. Wubben DP, Vivian EM. Effects of pharmacist outpatient interventions on adults with diabetes mellitus: a systematic review. Pharmacotherapy. 2008 Apr;28(4):421-36 2. Renders CM, Valk GD, Griffin S, Wagner EH, Eijk JT, Assendelft WJ. Interventions to improve the management of diabetes mellitus in primary care, outpatient and community settings. Cochrane Database Syst Rev. 2001;(1):CD001481 Task 3.5. Development of recommended model of Pharmaceutical Care 1. 2. 3. Which pharmaceutical services are essential to guarantee the best performance of pharmaceutical care in health care system? Fee for service or pay for performance? What is the most profitable financing model of pharmaceutical care? What is the optimal balance between pharmacists training and authorities supervision to assure the best quality of pharmaceutical care? Task 3.5. Development of recommended model of Pharmaceutical Care 1. 2. 3. Is QALY the best measure of quality of healthcare in tax, social and private insurance pricing and reimbursement models ? Are there any needs for equity weights to be introduced in QALY? What is the optimal balance between private vs. public expenditure in tax, social and private insurance pricing financing access models? Task 3.5. Development of recommended model of Pharmaceutical Care 1. 2. 3. 4. Does the distribution model impact access to medicines? Does the direct distribution improves compliance or leads to decreased prices of medicines? Does the introduction of direct distribution limits the parallel import? Does the introduction of direct distribution reduces pharmaceutical companies expenditures? Task 3.5. Development of recommended model of Pharmaceutical Care - assumptions • Online adjudication of pharmacy claims • Electronic health record (EHR) – dispersed databases (Denmark) – centralized databases (US – PBM, PDP)