Commonalities and differences in HTA outcomes: a comparative analysis of five countries and implications for coverage decisions.

OBJECTIVE To identify diverging HTA recommendations across five countries, understand the rationale for decision-making in specific therapeutic categories, and suggest ways forward to minimize these inter-country differences. METHODS A comparative analysis of HTA recommendations for 287 drug-indication pairs appraised by five countries (England, Scotland, Sweden, Canada, and Australia) between 2007 and 2009, including an in-depth analysis of two case studies. Agreement levels were measured using kappa scores. Associations were explored through correspondence analysis. RESULTS Significant inter-country variability in the HTA recommendations exists: 46% of the drug-indication pairs studied received diverging recommendations across countries. The level of agreement between agencies was poor to moderate. Associations between HTA recommendations issued by each HTA body per therapy area (cancer, orphan, CNS) differed from the general pattern observed across the complete sample. Expectations from HTA bodies in terms of relative effectiveness differ depending on the drug and disease's characteristics, although agency-specific guidelines are homogeneous for all treatments. POLICY IMPLICATIONS Distinguishing and accounting for the specifics underpinning individual conditions and their characteristics in HTA processes may constitute a way forward to improved HTA methods, while increasing transparency in the expectations that HTA bodies have in terms of relative effectiveness of the drug depending on these characteristics.

[1]  M. Drummond,et al.  Key principles for the improved conduct of health technology assessments for resource allocation decisions , 2008, International Journal of Technology Assessment in Health Care.

[2]  D. Wanless Securing Our Future Health: Taking a Long-Term View. Conclusions and recommendations , 2002 .

[3]  J. Cairns Providing guidance to the NHS: The Scottish Medicines Consortium and the National Institute for Clinical Excellence compared. , 2006, Health policy.

[4]  Jacob Cohen A Coefficient of Agreement for Nominal Scales , 1960 .

[5]  Finn Børlum Kristensen,et al.  European network for Health Technology Assessment, EUnetHTA: Planning, development, and implementation of a sustainable European network for Health Technology Assessment , 2009, International Journal of Technology Assessment in Health Care.

[6]  Steven Simoens,et al.  A comparative study of European rare disease and orphan drug markets. , 2010, Health policy.

[7]  M. Rawlins De testimonio: on the evidence for decisions about the use of therapeutic interventions , 2008, The Lancet.

[8]  Jing Jing Li,et al.  Using effectiveness and cost-effectiveness to make drug coverage decisions: a comparison of Britain, Australia, and Canada. , 2009, JAMA.

[9]  A. Dupont,et al.  Access to orphan drugs despite poor quality of clinical evidence. , 2011, British journal of clinical pharmacology.

[10]  Steven D Pearson,et al.  Quality, innovation, and value for money: NICE and the British National Health Service. , 2005, JAMA.

[11]  D Lee,et al.  The World Health Organisation , 2001, British journal of perioperative nursing : the journal of the National Association of Theatre Nurses.

[12]  Mathilde Varret,et al.  Molecular analysis and intestinal expression of SAR1 genes and proteins in Anderson's disease (Chylomicron retention disease) , 2011, Orphanet journal of rare diseases.

[13]  M. Drummond,et al.  Ensuring value for money in health care: the role of health technology assessment in the European Union , 2008 .

[14]  P. Bach Limits on Medicare's ability to control rising spending on cancer drugs. , 2009, The New England journal of medicine.

[15]  Reinhard Busse,et al.  Health technology assessment : an introduction to objectives, role of evidence, and structure in Europe , 2005 .

[16]  Andrew Briggs,et al.  Value based pricing for NHS drugs: an opportunity not to be missed? , 2008, BMJ : British Medical Journal.

[17]  C. Mitton,et al.  Centralized drug review processes in Australia, Canada, New Zealand, and the United kingdom. , 2006, Health affairs.

[18]  F. Scherer The pharmaceutical industry , 2000 .

[19]  C. Sorenson The role of HTA in coverage and pricing decisions: a cross-country comparison , 2009 .

[20]  D. Hailey Development of the International Network of Agencies for Health Technology Assessment , 2009, International Journal of Technology Assessment in Health Care.

[21]  H. Huskamp Prices, profits, and innovation: examining criticisms of new psychotropic drugs' value. , 2006, Health affairs.

[22]  D. Eddy Health technology assessment and evidence-based medicine: what are we talking about? , 2009, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[23]  G. Dranitsaris,et al.  Advances in Cancer Therapeutics and Patient Access to New Drugs , 2011, PharmacoEconomics.

[24]  Panos Kanavos,et al.  Assessing the economic challenges posed by orphan drugs , 2007, International Journal of Technology Assessment in Health Care.

[25]  Steve Morgan,et al.  The Common Drug Review: a NICE start for Canada? , 2006, Health policy.

[26]  S. Vegter,et al.  Review of regulatory recommendations for orphan drug submissions in the Netherlands and Scotland: focus on the underlying pharmacoeconomic evaluations. , 2010, Clinical therapeutics.

[27]  Panos Kanavos,et al.  The impact of health technology assessments: an international comparison , 2010 .

[28]  M. Wonder,et al.  Are Australians able to access new medicines on the pharmaceutical benefits scheme in a more or less timely manner? An analysis of pharmaceutical benefits advisory committee recommendations, 1999-2003. , 2006, Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research.

[29]  A. Gerhardus,et al.  Health technology assessments: what do differing conclusions tell us? , 2010, BMJ : British Medical Journal.

[30]  S. Simoens Pricing and reimbursement of orphan drugs: the need for more transparency , 2011, Orphanet journal of rare diseases.