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The Emerging Picture of “Value
       Based Pricing”
     Kakushin Web-Based Conference
            17 October 2012

              Jon Sussex
            Deputy Director
      Office of Health Economics
             www.ohe.org


                                     1
Agenda

• What we know about UK Government “VBP”
  proposals
• What that might mean in practice
• Centrality of “threshold” concept
• Non-linear pricing etc.
• Conclusions
At the NICE Annual Conference, 11 May 2011,
    Earl Howe (Minister of Health) stated:

 • “What Ministers are seeking are new arrangements to
   encourage the development of drugs to address areas of
   unmet need and bring prices and benefits into line”
 • “We've got to think about moving away from the drugs
   budget and towards a health budget”
 • Ministers “are not too afraid of increasing the drugs budget,
   as such”
“VBP” for all new medicines from 1/1/14
                      1. Pharmacoeconomic
                         evaluation - QALYs
                      2. “Burden of illness”                          July 2011
                      3. “Therapeutic
                         innovation &
                         improvements”
                      4. “Wider societal
December 2010
                         benefits”
                      5. Combined via
                         adjusted £/QALY
                         threshold
   http://www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_128226
“4.10 The Government proposes that the price threshold
structure is determined as follows:
i. there would be a basic threshold, reflecting the benefits
displaced elsewhere in the NHS when funds are allocated to new
medicines;
ii. there would be higher thresholds for medicines that tackle
diseases where there is greater “burden of illness”: the more the
medicine is focused on diseases with unmet need or which are
particularly severe, the higher the threshold;
iii. there would be higher thresholds for medicines that can
demonstrate greater therapeutic innovation and improvements
compared with other products;
iv. there would be higher thresholds for medicines that can
demonstrate wider societal benefits.”
Elements of “Value” internationally
                           E&W   Australia   Canada   France   Italy   Japan   Sweden
Clinical effectiveness                                                     
Cost effectiveness                                                            
Alternatives available /                                         
unmet need
Disease severity           EoL                                                 
New mode of action                                                       
Paediatric                                                               
Cost savings beyond                                                              
health care
Productivity                                                                     
VBP – Taxonomy of approaches
     What elements                     How measured                            How                          How linked to
       of value                         and valued                          aggregated                         price
    • QALYs                           • Natural units                   • Deliberative                    • Formula
    • Other types of                  • Categories                        process                         • Negotiation
      health gain                     • Yes/No                          • Weighted
    • Severity                                                            QALYs
    • ‘Unmet need’                    • Whose                           • MCDA*
    • ‘Innovation’                      values?                         • Net benefit £
    • Wider societal
      impacts

                                                                       *MCDA = Multi-Criteria Decision Analysis

For full info see OHE Research Paper 11/04; Sussex, Towse & Devlin; August 2011 at:
http://www.ohe.org/publications/recent-publications/list-by-title-20/detail/date////operationalising-value-based-pricing-of-medicines-a-
taxonomy-of-approaches.html
How to aggregate the elements of value
                               Pros                             Cons
Weighted QALYs   Incremental QALYS are major      ‘QALYs are not the only fruit….’
                 part of benefit of many          If incremental QALYs are
                 medicines                        small/zero, then other benefits
                 Familiarity of QALYs             forced to be small/zero too
                                                  Need a £ per weighted QALY
                                                  threshold value (opportunity
                                                  cost)
MCDA Points      Includes all categories of       Need a £ per point threshold
                 benefits, including QALYs and    value (opportunity cost)
                 non-QALY health gains, without
                 distortion
                 Pragmatic – used by PCTs
£ Net Benefit    Includes all categories of       Very explicit – valuing each type
                 benefits without distortion.     of benefit separately in £ terms
                 Goes directly to value of each   may be deemed politically more
                 benefit category                 difficult
NICE’s thinking
DH Response to the Consultation
• 5.8 “…we intend to maintain the effect of the funding direction…”
• 5.9 “…there are questions about the impact of medicine prices on
  companies’ decisions on where to allocate investments or conduct
  research…”
• 5.28 “..the Government does not agree that a new medicine should
  be automatically exempted..because its total budget impact is
  ..below an arbitrary threshold..”
• 5.47 “…the benefits of enabling pricing by indication are likely to be
  outweighed by the practical difficulties…explore alternatives..”
• 5.60 “..we recognise the value that incremental developments can
  bring…”
• 5.102 “…we have not ruled out the possibility that there may be a
  role for some type of Patient Access Scheme (PAS) arrangements…”
• 6.5 “Our preference ..would be..to achieve a negotiated
  settlement…”
Estimated NICE threshold ICER (£/QALY) in practice
                Devlin et al. 2010
                           100%


                           90%


                           80%


                           70%                                                                                                          Model         Threshold: ICER giving X% chance of
                                                                                                                                                                      rejection
Probability of rejection




                           60%                                                                                                                         (mean values for other parameter)

                           50%
                                                                                                                                                        50%          25%          75%
                           40%
                                                                                                                                        ICER only     £40,552      £27,066      £54,006
                           30%
                                                                                                                                        Basic Model   £40,345      £27,383      £53,271

                           20%                                                                                                          Min & max;     Min:         Min:         Min:
                                                                                                                                        All models    £40,206      £27,066      £52,856
                           10%                                                                                                                         Max:         Max:         Max:
                                                                                                                                                      £40,721      £27,446      £54,006
                            0%
                                  £0   £10,000        £20,000        £30,000       £40,000          £50,000         £60,000   £70,000
                                                                       ICER (cost/QALY)
                                                 Basic model
                                                 ICER only
                                                 ICER & total pts in RCTs
                                                 Basic with no. RCTs & mean pt numbers disaggregated
                                                 Omitting only Tx and pt group submission
                                                 Omitting only Tx and pt group submission and adding ICER-squared
Estimated threshold: cancer
                                                           Devlin et al. 2010
                           100%

                            90%

                            80%
                                                                                                                           •   ‘Cancer’ dummy
                            70%                                                                                                significant
Probability of rejection




                            60%                                                                                            •   102 cancer decisions
                            50%
                                                                                                              Cancer           included in the
                                                                                                              Not cancer
                                                                                                                               analysis
                            40%
                                                                                                                           •   92 pre-EOL (38 no, 54
                            30%
                                                                                                                               yes); 10 post EOL (7
                            20%                                                                                                no, 3 yes, of which 2
                            10%                                                                                                considered under
                            0%
                                                                                                                               EOL).
                                  £0   £10,000   £20,000   £30,000    £40,000   £50,000   £60,000   £70,000
                                                             ICER (cost/QALY)




                           • The estimate of the threshold (probability of rejection = 50%) is:
                                • £50,139 for cancer drugs
                                • £37,805 for non-cancer drugs
                                • NICE decisions reveal a willingness to ‘pay’ an additional > £10k per QALY gained
                                by cancer patients
“Thresholds” or converting benefits into £

• NB: If benefits include more than QALYs then idea of a
  unique £/QALY threshold becomes redundant
• NHS opportunity cost (OC)
• Social value of a QALY (SV)
• Equal in an ideal world but the world is not ideal
• SV of a QALY in UK appears to be around or a bit above
  NICE’s £20k-£30k range but there is much uncertainty
  as valuations vary wildly across individuals
• If SV>OC then health care budget spending is below
  socially desired levels
Subgroups: multiple prices, a single blended
       price or non-linear pricing?

 Price /
 Cost
                        Demand




           0                     Quantity
Different prices for different indications
           with different values?
• Single ‘blended’ price
• Or different prices for different indications:
  • NICE technology appraisal TA176 for cetuximab
    required a 16% discount when used with
    oxaliplatin (+ 5-fluorouracil and folinic acid)
  • But not for another (+5FU, folinic acid and
    irinotecan) where the patient cannot take
    oxaliplatin
Negotiation and PAS
• Imprecision / uncertainty / multiple indications =>
  plenty of scope for negotiation where the “value
  based price” is a binding constraint

• VBP does not imply no further role for Patient Access
  Schemes and non-linear pricing:
  Government VBP consultation response, July 2011:
  “We have not ruled out … ‘PAS’ arrangements in the
  new system.”
“VBP”: big change or name change?

• Wider scope of benefits and costs taken into
  account
• Chance for more openness or likelihood of
  less?
• Price negotiation for individual medicines, not
  regulation of company profit from total sales
  to NHS
To enquire about additional information and analyses, please
contact Jon Sussex at jsussex@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

Office of Health Economics (OHE)
Southside, 7th Floor
105 Victoria Street
London SW1E 6QT
United Kingdom
+44 20 7747 8850
www.ohe.org
OHE’s publications may be downloaded free of charge for registered users of its
website.

©2012 OHE

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Emerging Picture of Value Based Pricing

  • 1. The Emerging Picture of “Value Based Pricing” Kakushin Web-Based Conference 17 October 2012 Jon Sussex Deputy Director Office of Health Economics www.ohe.org 1
  • 2. Agenda • What we know about UK Government “VBP” proposals • What that might mean in practice • Centrality of “threshold” concept • Non-linear pricing etc. • Conclusions
  • 3. At the NICE Annual Conference, 11 May 2011, Earl Howe (Minister of Health) stated: • “What Ministers are seeking are new arrangements to encourage the development of drugs to address areas of unmet need and bring prices and benefits into line” • “We've got to think about moving away from the drugs budget and towards a health budget” • Ministers “are not too afraid of increasing the drugs budget, as such”
  • 4. “VBP” for all new medicines from 1/1/14 1. Pharmacoeconomic evaluation - QALYs 2. “Burden of illness” July 2011 3. “Therapeutic innovation & improvements” 4. “Wider societal December 2010 benefits” 5. Combined via adjusted £/QALY threshold http://www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_128226
  • 5. “4.10 The Government proposes that the price threshold structure is determined as follows: i. there would be a basic threshold, reflecting the benefits displaced elsewhere in the NHS when funds are allocated to new medicines; ii. there would be higher thresholds for medicines that tackle diseases where there is greater “burden of illness”: the more the medicine is focused on diseases with unmet need or which are particularly severe, the higher the threshold; iii. there would be higher thresholds for medicines that can demonstrate greater therapeutic innovation and improvements compared with other products; iv. there would be higher thresholds for medicines that can demonstrate wider societal benefits.”
  • 6. Elements of “Value” internationally E&W Australia Canada France Italy Japan Sweden Clinical effectiveness        Cost effectiveness     Alternatives available /   unmet need Disease severity EoL    New mode of action  Paediatric  Cost savings beyond  health care Productivity 
  • 7. VBP – Taxonomy of approaches What elements How measured How How linked to of value and valued aggregated price • QALYs • Natural units • Deliberative • Formula • Other types of • Categories process • Negotiation health gain • Yes/No • Weighted • Severity QALYs • ‘Unmet need’ • Whose • MCDA* • ‘Innovation’ values? • Net benefit £ • Wider societal impacts *MCDA = Multi-Criteria Decision Analysis For full info see OHE Research Paper 11/04; Sussex, Towse & Devlin; August 2011 at: http://www.ohe.org/publications/recent-publications/list-by-title-20/detail/date////operationalising-value-based-pricing-of-medicines-a- taxonomy-of-approaches.html
  • 8. How to aggregate the elements of value Pros Cons Weighted QALYs Incremental QALYS are major ‘QALYs are not the only fruit….’ part of benefit of many If incremental QALYs are medicines small/zero, then other benefits Familiarity of QALYs forced to be small/zero too Need a £ per weighted QALY threshold value (opportunity cost) MCDA Points Includes all categories of Need a £ per point threshold benefits, including QALYs and value (opportunity cost) non-QALY health gains, without distortion Pragmatic – used by PCTs £ Net Benefit Includes all categories of Very explicit – valuing each type benefits without distortion. of benefit separately in £ terms Goes directly to value of each may be deemed politically more benefit category difficult
  • 10. DH Response to the Consultation • 5.8 “…we intend to maintain the effect of the funding direction…” • 5.9 “…there are questions about the impact of medicine prices on companies’ decisions on where to allocate investments or conduct research…” • 5.28 “..the Government does not agree that a new medicine should be automatically exempted..because its total budget impact is ..below an arbitrary threshold..” • 5.47 “…the benefits of enabling pricing by indication are likely to be outweighed by the practical difficulties…explore alternatives..” • 5.60 “..we recognise the value that incremental developments can bring…” • 5.102 “…we have not ruled out the possibility that there may be a role for some type of Patient Access Scheme (PAS) arrangements…” • 6.5 “Our preference ..would be..to achieve a negotiated settlement…”
  • 11. Estimated NICE threshold ICER (£/QALY) in practice Devlin et al. 2010 100% 90% 80% 70% Model Threshold: ICER giving X% chance of rejection Probability of rejection 60% (mean values for other parameter) 50% 50% 25% 75% 40% ICER only £40,552 £27,066 £54,006 30% Basic Model £40,345 £27,383 £53,271 20% Min & max; Min: Min: Min: All models £40,206 £27,066 £52,856 10% Max: Max: Max: £40,721 £27,446 £54,006 0% £0 £10,000 £20,000 £30,000 £40,000 £50,000 £60,000 £70,000 ICER (cost/QALY) Basic model ICER only ICER & total pts in RCTs Basic with no. RCTs & mean pt numbers disaggregated Omitting only Tx and pt group submission Omitting only Tx and pt group submission and adding ICER-squared
  • 12. Estimated threshold: cancer Devlin et al. 2010 100% 90% 80% • ‘Cancer’ dummy 70% significant Probability of rejection 60% • 102 cancer decisions 50% Cancer included in the Not cancer analysis 40% • 92 pre-EOL (38 no, 54 30% yes); 10 post EOL (7 20% no, 3 yes, of which 2 10% considered under 0% EOL). £0 £10,000 £20,000 £30,000 £40,000 £50,000 £60,000 £70,000 ICER (cost/QALY) • The estimate of the threshold (probability of rejection = 50%) is: • £50,139 for cancer drugs • £37,805 for non-cancer drugs • NICE decisions reveal a willingness to ‘pay’ an additional > £10k per QALY gained by cancer patients
  • 13. “Thresholds” or converting benefits into £ • NB: If benefits include more than QALYs then idea of a unique £/QALY threshold becomes redundant • NHS opportunity cost (OC) • Social value of a QALY (SV) • Equal in an ideal world but the world is not ideal • SV of a QALY in UK appears to be around or a bit above NICE’s £20k-£30k range but there is much uncertainty as valuations vary wildly across individuals • If SV>OC then health care budget spending is below socially desired levels
  • 14. Subgroups: multiple prices, a single blended price or non-linear pricing? Price / Cost Demand 0 Quantity
  • 15. Different prices for different indications with different values? • Single ‘blended’ price • Or different prices for different indications: • NICE technology appraisal TA176 for cetuximab required a 16% discount when used with oxaliplatin (+ 5-fluorouracil and folinic acid) • But not for another (+5FU, folinic acid and irinotecan) where the patient cannot take oxaliplatin
  • 16. Negotiation and PAS • Imprecision / uncertainty / multiple indications => plenty of scope for negotiation where the “value based price” is a binding constraint • VBP does not imply no further role for Patient Access Schemes and non-linear pricing: Government VBP consultation response, July 2011: “We have not ruled out … ‘PAS’ arrangements in the new system.”
  • 17. “VBP”: big change or name change? • Wider scope of benefits and costs taken into account • Chance for more openness or likelihood of less? • Price negotiation for individual medicines, not regulation of company profit from total sales to NHS
  • 18. To enquire about additional information and analyses, please contact Jon Sussex at jsussex@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 Office of Health Economics (OHE) Southside, 7th Floor 105 Victoria Street London SW1E 6QT United Kingdom +44 20 7747 8850 www.ohe.org OHE’s publications may be downloaded free of charge for registered users of its website. ©2012 OHE