Rationale and Procedure for Oncology Pricing and Reimbursement in England Towse 2014

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The Biotherapy Development Association convened a two-day workshop in January 2014 to assess access to innovative cancer medicines in Europe. This presentation by OHE's Adrian Towse covers the …

The Biotherapy Development Association convened a two-day workshop in January 2014 to assess access to innovative cancer medicines in Europe. This presentation by OHE's Adrian Towse covers the situation in England, examining challenges that are peculiar to England as well as the English experience with issues common across countries.

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  • That is not to say that price flexibility is not important. The 2009 PPRS, negotiated shortly after the OFT Report was published, introduced a one-off ability for a price adjustment or for an outcomes based Patient Access Scheme to address uncertainty about the outcomes associated with a drug. The greatest number of these schemes are “simple discount” arrangements, designed to make a price offer to the NHS that is not revealed to other payers, to avoid changing the list price which is used for reference pricing. There are lots of questions about the sustainability of these schemes, but there is no doubt that they have substantially increased access to new drugs at prices that NICE deems offer value to the NHS.
  • This is an analysis of oncology decisions pre- and post- the CDF. It shows that the number of not-recommended decisions has more than doubled from 24% to 58% at the expense of restricted decisions. Straight approvals (green) have not changed. (Note – my colleagues tell me NICE does not agree with this analysis)One might expect this to happen if the existence of the CDF reduces the willingness of both parties to compromise. Companies have another route into the NHS. The Appraisal Committee might expect patients will still get access to the drug via the CDF if NICE turns it down. There is a global willingness to pay (i.e. outside of the UK) for oncology treatment that is substantially higher than that for health gain in other disease areas. This is the reason why the Government set up the CDF. We need a new process for ultra-orphans as well (HSTs – highly specialised treatments)

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  • 1. The Rationale and Procedure for Oncology Pricing and Reimbursement Decisions in England Adrian Towse BDA1 Workshop: Access to Innovative Oncology Medicines Bonn • 16-17 January 2014 1Biotherapy Development Association
  • 2. Agenda • Pricing and reimbursement (P&R) context • Where are we now? • Issues for HTA in assessing oncology medicines • Value-based assessment and the end-of-life (EoL) criteria • Emerging issues – HTA for companion diagnostics – differential pricing P&R for oncology drugs in the UK 16th January 2014 2
  • 3. UK P&R context • In the UK, companies set prices, NHS decides use • England uses NICE to perform an HTA and recommend on use; Scotland uses the Scottish Medicines Consortium • Hospitals use tenders when relevant • Companies can offer discounts via patient access schemes in England and the Scottish equivalent P&R for oncology drugs in the UK 16th January 2014 3
  • 4. UK P&R context Concerns 10 years ago: (1) poor uptake of new cancer medicines in UK and (2) poor 5-year survival rates in the UK Cancer a priority for the Government NICE assesses all new cancer medicines Introduction of EoL criteria Introduction of Cancer Drugs Fund (CDF) P&R for oncology drugs in the UK 16th January 2014 4
  • 5. Improving UK cancer outcomes • • • • • Higher rates of curative surgery Increased drug use Public health measures Tackling late presentation Increasing speed of primary care referrals P&R for oncology drugs in the UK 16th January 2014 5
  • 6. Richards’ report on drug uptake Brings together IMS data with manufacturers’ own information. Strong industry engagement in data validation. Support and engagement from industry trade bodies. Data findings tested and potential causes of variation explored with a range of UK experts, including clinicians, pharmacists, public health doctors, academics, patients’ representatives and industry Result: the most comprehensive insight to date on international variations in drug usage P&R for oncology drugs in the UK 16th January 2014 6
  • 7. International Variations in Drug Usage Comparison of UK drugs use (by ranking and percentage of 14-country average) Source: Presentation by Sir Mike Richards 2010 7
  • 8. Richards’ international usage report country ranking for cancer medicines classes Number of years on UK market since launch in 2009 0-5 years 6-10 years Rank Country 1 France 2 Switzerland 3 Austria 4 Spain 5 Italy 6 Germany 7 USA 8 UK 10+ years Rank Country 1 France 2 Italy 3 Spain 4 Germany 5 Switzerland 6 Austria 7 USA 8 Sweden Rank 1 2 3 4 5 6 7 8 Country France Austria USA Germany Spain Switzerland Sweden Italy 9 Norway 9 Australia 9 10 11 12 Australia UK Canada 10 11 12 Sweden Canada Norway 10 11 12 13 New Zealand 13 New Zealand Hormonal cancer treatments Rank 1 2 3 4 5 6 7 8 Country Italy Spain Germany France UK Austria Sweden Norway UK 9 Switzerland Canada Norway Australia 10 11 12 Canada Australia USA 13 New Zealand 13 New Zealand Source: Richards, 2010. Extent and causes of international variations in drug usage P&R for oncology drugs in the UK 16th January 2014 8
  • 9. Impact of patient access schemes If all positive decisions since 2009 where a PAS was implemented were assumed to be a “not recommended” decision in the absence of a PAS (bar labelled “without PAS”) the share of not recommended decisions increases to 47% Chart: share of decision outcome for all medicines decisions from 2009 to Q3 2013, with and “without” PAS Source: OHE analysis from data on NICE website P&R for oncology drugs in the UK 16th January 2014 9
  • 10. Trends in decision for cancer medicines before and after establishment of cancer drugs fund (Q4 2010- Q3 2013) Source: OHE analysis from data on NICE website P&R for oncology drugs in the UK 16th January 2014 10
  • 11. Where are we now? Uptake has hopefully improved (new report due out soon) Inconsistency between use of NICE and existence of CDF HTA in cancer has issues Introduction of VBA will throw up further issues, e.g. future of EoL criteria Issues for the future: • Small patient groups for rarer cancers – orphan and “ultra orphan” drugs • Use of companion diagnostics • Different prices for different indications P&R for oncology drugs in the UK 16th January 2014 11
  • 12. Sources of uncertainty • • • Mapping from progression-free survival (PFS) to overall survival (OS) Correcting clinical trial data to account for treatment crossover Complexity of treatment sequencing options Advances in Oncology Modelling: Recent Results from POI Research Posted on 18 September 2012 by OHE News Editor OHE and the Pharmaceutical Oncology Initiative (POI) held a workshop to discuss and debate several key issues in oncology modelling. Participating were more than 50 experts from industry, academia and government. The focus of the workshop was three key technical challenges associated with using clinical trial data for anti-cancer medicines and adapting it, in an unbiased fashion, to support decisions about cost-effectiveness. These are: extrapolating from progression-free survival, correcting for patient crossover, and efficient modelling of different sequences of treatment. http://news.ohe.org/2012/09/18/advances-inoncology-modelling-recent-results-from-poiresearch/ P&R for oncology drugs in the UK 16th January 2014 12
  • 13. Limitations of using QALYs in cancer Sensitivity of EQ-5D to changes in health status of cancer patients Violation of constant proportional trade-off assumption at end of life Using valuations from members of the general population P&R for oncology drugs in the UK 16th January 2014 13
  • 14. Eliciting social preferences: End-oflife findings highlight the challenges Linley and Hughes (2012) Shah, Tsuchiya and Wailoo (2013) P&R for oncology drugs in the UK 16th January 2014 14
  • 15. Authors. journal (date) Shah, Tsuchiya, Hole, Wailoo DSU report (2012) Linley and Hughes Health Econ (2012) Olsen Value in Health (2013) Elicitation Method(s) Responden Mode of t sample admin (n) General population DCE Online survey EoL comparison Life expectancy without treatment 3, 12 ,24 36, 60m (3969) Choice plus trade off questions General population 18 months vs 60 m Online survey Life extension 6 months Findings relevant to EoL EoL was not a significant driving factor (but longest LE 60 months) No evidence of a value premium for EoL (4118) Choice plus benefit trade off General population (503) Online survey Remaining lifetime untreated; Total lifetime untreated; Relative loss in remaining life expectancy (prop shortfall) Source: Rachel Baker, Glasgow Caledonian University No evidence of EoL (proximity to death) premium Total lifetime inequality is most important and ‘trumps EoL’ Not proportional shortfall but absolute loss
  • 16. Authors. journal (date) Pinto Prades et al Working paper 2013 Elicitation Responden Method(s t sample ) (n) WTP PTO 3 survey versions: (820) General population Choice tasks EoL comparison Probability of gains in LE (EoL) QoL (EoL) QoL (non-terminal) Findings relevant to EoL EoL gains valued more highly than gains for non-EoL conditions Respondent split into 2 groups Gains in QoL at Eol more valued than LE gains. Some support for prioritising patients with shorter life expectancy. Face to face 1 year vs 10 year LE (50) Respondents in 2 groups QoL at EoL more valued than LE at EoL. Preparation for death may be important (suddenness). Rowen, Brazier et al HESG (2014) General population Face to face Shah, Tsuchiya, Wailoo Eur J Health Econ (2013) Mode of admin General population DCE (3669) Life expectancy without condition (5, 20, 40, 80) Online survey LE with condition w/out treatment (3m-5 years, 3m-10 yrs,3m-30 yrs, 3m-60 yrs) Source: Rachel Baker, Glasgow Caledonian University Size of the health gain important Coefficient for EoL (as per NICE definition) positive and significant. Not clearly evident in attitudinal questions 1422 respondents possible misunderstood tasks.
  • 17. Institutional processes for the value assessment of new diagnostics Source: Garau, M., Towse, A., Garrison, L., Housman, L. and Ossa, D. (2013) Can and should value-based pricing be applied to molecular diagnostics? Personalized Medicine. 10(1), 61-72. P&R for oncology drugs in the UK 16th January 2014 17
  • 18. Need for flexible pricing and more outcomes-based PAS Garrison et al (2013) Academy of Medical Sciences (2013) P&R for oncology drugs in the UK 16th January 2014 18
  • 19. A reordering of process? Criteria: broader definition of value (risks, benefits) Affordability (BIA) Safety Value for money (CE) Efficacy, effectiveness Overall D-M Framework: Other factors of value to D-M (ethical issues, social values, feasibility of Opportunity costs implementation, unmet needs, innovation value, legal issues …) (value-for-money) Source: Professor Ron Goeree, Director PATH Research Institute, McMaster University P&R for oncology drugs in the UK 16th January 2014 19
  • 20. Conclusions 1. England’s access to innovative oncology medicines has (hopefully) improved as a result of a series of policy initiatives 2. Inconsistencies in policy in England exist, e.g. role of CDF 3. Issues for HTA in assessing oncology medicines 4. Value-based assessment will have a big potential impact on oncology medicines and the EoL criteria 5. Social preferences as well as cost-effectiveness are now at the core of value assessment in HTA, but they are not easy to establish using empirical research 6. Other issues for the future include addressing HTA for companion diagnostics and differential pricing 7. Price flexibility by indication / subgroup and outcomes-based CED/ PBRSA schemes are important to effective use of drugs P&R for oncology drugs in the UK 16th January 2014 20
  • 21. References Academy of Medical Sciences. (2013) Realising the potential of stratified medicines. London: Academy of Medical Sciences. Baker, R. (Glasgow Caledonian University). (2014) Plenary session presentation. Health Economists’ Study Group. Sheffield. 8-10 January 2014. Garau, M., Shah, K., Mason, A., Wang, Q., Towse, A. and Drummond, M. QALYs in cancer: A review of the methodological limitations. PharmacoEconomics. 29(8), 673-685. Garau, M., Towse, A., Garrison, L., Housman, L. and Ossa, D. (2013) Can and should value-based pricing be applied to molecular diagnostics? Personalized Medicine. 10(1), 61-72. Linley, W.G. and Hughes, D.A. (2012) Societal views of NICE, Cancer Drugs Fund, and value based pricing criteria for prioritising medicines: A cross-sectional survey of 4118 adults in Great Britain. Health Economics. 22(8), 948-964. OHE Editor. (2012) Advances in Oncology Modelling: Recent Results from POI Research. OHE News. [blog] 18 September. Available at: http://news.ohe.org/2012/09/18/advances-in-oncology-modelling-recent-results-from-poi-research/ [Accessed 14 January 2014]. Richards, M. (2010) Extent and causes of international variations in drug usage. London: Department of Health. Available at https://www.gov.uk/government/publications/extent-and-causes-of-international-variations-in-drug-usage. Richards, M. (2011) Achieving world class outcomes in cancer treatment. London: Office of Health Economics/ Available at http://www.ohe.org/publications/article/achieving-world-class-outcomes-in-cancer-treatment-3.cfm Shah, K., Tsuchiya, A. and Wailoo, A. (2013) Valuing health at the end of life: An empirical study of public preferences. European Journal of Health Economics. Epub ahead of print. doi: 10.1007/s10198-013-0482-3. P&R for oncology drugs in the UK 16th January 2014 21
  • 22. About OHE To enquire about additional information and analyses, please contact Professor Adrian Towse at atowse@ohe.org. To keep up with the latest news and research, subscribe to our blog, OHE News. Follow us on Twitter @OHENews, LinkedIn and SlideShare. The Office of Health Economics is a research and consulting organisation that has been providing specialised research, analysis and expertise on a range of health care and life sciences issues and topics for 50 years. OHE’s publications may be downloaded free of charge for registered users of its website. Office of Health Economics Southside, 7th Floor 105 Victoria Street London SW1E 6QT United Kingdom +44 20 7747 8850 www.ohe.org ©2014 OHE P&R for oncology drugs in the UK 16th January 2014 22