Uptake And Diffusion Of Pharmaceutical Innovations In Health Systems

AbstractMultiple interacting factors influence the uptake and diffusion of medicines which are critical to improving health. However, there is a gap in our knowledge on how regulatory policies and other national health systems attributes combine to impact on the utilisation of innovative drugs, and health system goals and objectives.Our review demonstrates that strong regulation adversely affects access to innovation, reduces incentives for research-based firms to develop innovative products and leads to short- and long-term welfare losses. Short-term efficiency gains from reducing pharmaceutical expenditures may actually increase total healthcare costs, reduce user choice, and in some cases, adversely affect health outcomes.Decision makers need to adopt a holistic approach to policy making, and consider potential impact of regulations on the uptake and diffusion of innovations, innovation systems and health system goals.

[1]  S. Schneeweiss,et al.  Impact of reference-based pricing for angiotensin-converting enzyme inhibitors on drug utilization , 2022 .

[2]  R. Atun,et al.  Diffusion of complex health innovations--implementation of primary health care reforms in Bosnia and Herzegovina. , 2006, Health policy and planning.

[3]  R. W. Hansen,et al.  The price of innovation: new estimates of drug development costs. , 2003, Journal of health economics.

[4]  J. Graf von der Schulenburg,et al.  Unintended effects of a cost-containment policy: results of a natural experiment in Germany. , 1997, Social science & medicine.

[5]  C. Huttin,et al.  How the reimbursement system may influence physicians' decisions results from focus groups interviews in France. , 2000, Health policy.

[6]  A. Mcguire,et al.  UK budgetary systems and new health-care technologies. , 2003, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[7]  Panos Kanavos,et al.  Reference pricing for drugs: is it compatible with U.S. health care? , 2003, Health affairs.

[8]  B. Stuart,et al.  Who bears the burden of Medicaid drug copayment policies? , 1999, Health affairs.

[9]  C. Pen.  The Drug Budget Silo Mentality: The French Case , 2003 .

[10]  T. Walley,et al.  General practice fundholders' prescribing savings in one region of the United Kingdom, 1991-1994. , 1997, Health policy.

[11]  S. Schneeweiss,et al.  Clinical and economic consequences of reference pricing for dihydropyridine calcium channel blockers , 2003, Clinical pharmacology and therapeutics.

[12]  A. Fendrick,et al.  Managed care and medical technology: implications for cost growth. , 1997, Health affairs.

[13]  S. Soumerai,et al.  Effects of Limiting Medicaid Drug-Reimbursement Benefits on the Use of Psychotropic Agents and Acute Mental Health Services by Patients with Schizophrenia , 1994 .

[14]  T. K. Hazlet,et al.  Health Services Utilization With Reference Drug Pricing of Histamine2 Receptor Antagonists in British Columbia Elderly , 2002, Medical care.

[15]  P. Langley,et al.  Disease management programs. , 1996, American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists.

[16]  M. Hill,et al.  Report of the Task Force on the Availability of Cardiovascular Drugs to the Medically Indigent. , 1992, Circulation.

[17]  B. O'brien,et al.  Impact of reference-based pricing for histamine-2 receptor antagonists and restricted access for proton pump inhibitors in British Columbia. , 2002, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[18]  F. Goodwin.  Impact of formularies on clinical innovation. , 2003, Journal of Clinical Psychiatry.

[19]  Z. Griliches,et al.  Characteristics of demand for pharmaceutical products: an examination of four cephalosporins. , 1997, The Rand journal of economics.

[20]  H. Grabowski.  Medicaid patients' access to new drugs. , 1988, Health affairs.

[21]  W. Greiner,et al.  Using disease management and market reforms to address the adverse economic effects of drug budgets and price and reimbursement regulations in Germany. , 2003, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[22]  J A Hanley,et al.  Adverse events associated with prescription drug cost-sharing among poor and elderly persons. , 2001, JAMA.

[23]  J. Calfee,et al.  Pharmaceutical Price Controls and Patient Welfare , 2001, Annals of Internal Medicine.

[24]  Dorte Gyrd-Hansen,et al.  International comparison of the definition and the practical application of health technology assessment , 2005, International Journal of Technology Assessment in Health Care.

[25]  M. Ryan,et al.  Charging for health care: evidence on the utilisation of NHS prescribed drugs. , 1991, Social science & medicine.

[26]  J. Paul,et al.  Going into gatekeeping: an empirical assessment. , 1989, QRB. Quality review bulletin.

[27]  Martin McKee,et al.  Analysis of how the health systems context shapes responses to the control of human immunodeficiency virus: case-studies from the Russian Federation. , 2005, Bulletin of the World Health Organization.

[28]  I. Buchan,et al.  Alterations in prescribing by general practitioner fundholders: an observational study , 1995, BMJ.

[29]  S. Soumerai,et al.  The case for a medicare drug coverage benefit: a critical review of the empirical evidence. , 2001, Annual review of public health.

[30]  M. H. Davis,et al.  Prescription drug coverage, utilization, and spending among Medicare beneficiaries. , 1999, Health affairs.

[31]  B. McNeil,et al.  Quality of ambulatory care after myocardial infarction among Medicare patients by type of insurance and region. , 2001, The American journal of medicine.

[32]  D. Heaney,et al.  General practice fundholding: observations on prescribing patterns and costs using the defined daily dose method. , 1993, BMJ.

[33]  M. Mcclellan,et al.  Is technological change in medicine worth it? , 2001, Health affairs.

[34]  L. Pilote,et al.  The effects of cost-sharing on essential drug prescriptions, utilization of medical care and outcomes after acute myocardial infarction in elderly patients. , 2002, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[35]  Stephen B. Soumerai,et al.  Payment Restrictions for Prescription Drugs under Medicaid , 1987 .

[36]  Louise Fitzgerald,et al.  Getting Evidence into Clinical Practice: An Organisational Behaviour Perspective , 2000, Journal of health services research & policy.

[37]  B. O'brien,et al.  The impact of reference pricing of nonsteroidal anti-inflammatory agents on the use and costs of analgesic drugs. , 2005, Health services research.

[38]  J. Puig-Junoy,et al.  Review of the literature on reference pricing. , 2000, Health policy.

[39]  S. Schneeweiss,et al.  Outcomes of reference pricing for angiotensin-converting-enzyme inhibitors. , 2002, The New England journal of medicine.

[40]  M. Pauly,et al.  Health Insurance and the Growth in Pharmaceutical Expenditures* , 2002, The Journal of Law and Economics.

[41]  N. Powe,et al.  A Review of the First Year of Medicare Coverage of Erythropoietin , 1994, Health care financing review.

[42]  T. Walley,et al.  Therapeutic substitution and therapeutic conservatism as cost-containment strategies in primary care: a study of fundholders and non-fundholders. , 1999, The British journal of general practice : the journal of the Royal College of General Practitioners.

[43]  S. Schneeweiss,et al.  Prescription Duration After Drug Copay Changes in Older People: Methodological Aspects , 2002, Journal of the American Geriatrics Society.

[44]  Y. R. Wang,et al.  The Impact of Price Regulation on the Launch Delay of New Drugs - Evidence from Twenty-Five Major Markets in the 1990s , 2003, Health economics.

[45]  A Coulter,et al.  Effect of fundholding and indicative prescribing schemes on general practitioners' prescribing costs. , 1993, BMJ.

[46]  L. Ried,et al.  The Effect of Drug Co-Payments on Utilization and Cost of Pharmaceuticals in a Health Maintenance Organization , 1990, Medical care.

[47]  J. Hurley,et al.  The Effects of Co-payments within Drug Reimbursement Programs , 1991 .

[48]  G. Fattore,et al.  The new pharmaceutical policy in Italy. , 1998, Health policy.

[49]  Louise Fitzgerald,et al.  Innovation in healthcare: how does credible evidence influence professionals? , 2003, Health & social care in the community.

[50]  E. Berndt.  The U.S. pharmaceutical industry: why major growth in times of cost containment? , 2001, Health affairs.

[51]  D. Ross-Degnan,et al.  Utilization of Essential Medications by Vulnerable Older People After a Drug Benefit Cap: Importance of Mental Disorders, Chronic Pain, and Practice Setting , 2001, Journal of the American Geriatrics Society.

[52]  A. Coulter,et al.  The effects of fundholding in general practice on prescribing habits three years after introduction of the scheme , 1995, BMJ.

[53]  R. J. Vogel.  Pharmaceutical pricing, price controls, and their effects on pharmaceutical sales and research and development expenditures in the European Union. , 2004, Clinical therapeutics.

[54]  B. Gunnarsson,et al.  Cost and utilisation of pharmaceuticals in Sweden. , 1997, Health policy.

[55]  N. E. Coulson,et al.  Dynamic aspects of prescription drug use in an elderly population. , 1993, Health services research.

[56]  J. Puig-Junoy.  What is required to evaluate the impact of pharmaceutical reference pricing? , 2005, Applied health economics and health policy.

[57]  S B Soumerai,et al.  Examining product risk in context. Market withdrawal of zomepirac as a case study. , 1993, JAMA.

[58]  J. Mccombs,et al.  Open Access to Innovative Drugs: Treatment Substitutions or Treatment Expansion? , 2004, Health care financing review.

[59]  C. Huttin.  The use of prescription charges. , 1994, Health policy.

[60]  M. Hornbrook,et al.  The impact of increasing patient prescription drug cost sharing on therapeutic classes of drugs received and on the health status of elderly HMO members. , 1997, Health Services Research.

[61]  Reed Ce,et al.  Expanding Medicaid drug formulary coverage. Effects on utilization of related services. , 1990 .

[62]  S B Soumerai,et al.  Withdrawing payment for nonscientific drug therapy. Intended and unexpected effects of a large-scale natural experiment. , 1990, JAMA.

[63]  J M Smith,et al.  A prescribing incentive scheme for non-fundholding general practices: an observational study , 1996, BMJ.

[64]  A. Lyles,et al.  Impact of managed care on prescription drug use. , 1991, Health affairs.

[65]  S. Schneeweiss,et al.  What is Germany's experience on reference based drug pricing and the etiology of adverse health outcomes or substitution? , 1998, Health policy.

[66]  Ian Harvey,et al.  Innovation, Patents And Economic Growth , 2007 .

[67]  J. Denis,et al.  Use of health technology assessment in decision making: Coresponsibility of users and producers? , 2005, International Journal of Technology Assessment in Health Care.

[68]  B. Stuart,et al.  Ability to pay and the decision to medicate. , 1998, Medical care.

[69]  H. Huskamp.  Managing psychotropic drug costs: will formularies work? , 2003, Health affairs.

[70]  A. Avery,et al.  Prescribing cost savings by GP fundholders: long-term or short-term? , 1997, Health economics.

[71]  C. Harris,et al.  Fundholders' prescribing costs: the first five years , 1996, BMJ.

[72]  F. Rocchi,et al.  Current National Initiatives About Drug Policies and Cost Control in Europe: The Italy Example , 2004, The Journal of ambulatory care management.

[73]  Harikesh S. Nair,et al.  Diffusion of New Pharmaceutical Drugs in Developing and Developed Nations , 2004 .

[74]  Jaume Puig-Junoy,et al.  Incentives and pharmaceutical reimbursement reforms in Spain. , 2004, Health policy.

[75]  T. Walley,et al.  Influences of practice characteristics on prescribing in fundholding and non-fundholding general practices: an observational study , 1996, BMJ.

[76]  Elias Mossialos,et al.  Health technology assessment and its influence on health-care priority setting , 2004, International Journal of Technology Assessment in Health Care.

[77]  A. Earl‐Slater.  Regulating the price of the uk's drugs: second thoughts after the government's first report , 1997, BMJ.

[78]  M. L. Burstall.  The management of the cost and utilisation of pharmaceuticals in the United Kingdom. , 1997, Health policy.

[79]  N. Freemantle.  Does the UK National Health Service need a fourth hurdle for pharmaceutical reimbursement to encourage the more efficient prescribing of pharmaceuticals? , 1999, Health policy.

[80]  J. Lexchin,et al.  Effects of Prescription Drug User Fees on Drug and Health Services Use and on Health Status in Vulnerable Populations: A Systematic Review of the Evidence , 2004, International journal of health services : planning, administration, evaluation.

[81]  H. Mcgavock,et al.  How has fundholding in Northern Ireland affected prescribing patterns? A longitudinal study , 1997, BMJ.

[82]  G. Selke,et al.  The German experience in reference pricing. , 1998, Health policy.

[83]  S B Soumerai,et al.  Effects of Medicaid drug-payment limits on admission to hospitals and nursing homes. , 1991, The New England journal of medicine.

[84]  S. Schneeweiss,et al.  Net Health Plan Savings From Reference Pricing for Angiotensin-Converting Enzyme Inhibitors in Elderly British Columbia Residents , 2004, Medical care.

[85]  P. Danzon,et al.  Cross-national price differences for pharmaceuticals: how large, and why? , 2000, Journal of health economics.

[86]  J. Lundkvist.  Pricing and reimbursement of drugs in Sweden , 2001, The European Journal of Health Economics.

[87]  Thomas Mittendorf,et al.  Diffusion of innovations: treatment of Alzheimer's disease in Germany. , 2002, Health policy.

[88]  Mattias Ganslandt,et al.  Parallel imports and the pricing of pharmaceutical products: evidence from the European Union. , 2004, Journal of health economics.

[89]  M. Koopmanschap,et al.  The drug budget silo mentality: the Dutch case. , 2003, Value in Health.

[90]  W. Kymlicka.  The Ethics of Inarticulacy , 1991 .

[91]  Bae Jp.  Drug patent expirations and the speed of generic entry. , 1997 .

[92]  S. Soumerai,et al.  Do open formularies increase access to clinically useful drugs? , 1996, Health Affairs.

[93]  J. Graf,et al.  The German health care system at the crossroads , 1994 .

[94]  A. Hillman,et al.  Financial incentives and drug spending in managed care. , 1999, Health affairs.

[95]  A R Levy,et al.  Impact of reference-based pricing of nitrates on the use and costs of anti-anginal drugs. , 2001, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[96]  Trisha Greenhalgh,et al.  Diffusion of innovations in health service organisations , 2005 .

[97]  W. Manning,et al.  The demand for prescription drugs as a function of cost-sharing. , 1985, Social science & medicine.

[98]  J. Blustein,et al.  Drug coverage and drug purchases by Medicare beneficiaries with hypertension. , 2000, Health affairs.

[99]  B. Stuart,et al.  Patterns of outpatient prescription drug use among Pennsylvania elderly , 1991, Health care financing review.