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A COMPARATIVE ANALYSIS OF HTA OUTCOMES IN FIVE
COUNTRIES ACROSS THREE THERAPY AREAS
Cancer, orphan and central nervous system diseases
Authors: Elena Nicod, Dr Panos Kanavos

London School of Economics and Political Science
LSE Health and Social Care




                                    HTAI Conference
                                  Bilbao, 26 June 2012
Agenda
• Background and objectives
• Methods
• Results
• Discussion & Policy implications
Background & objectives
Objectives: Examine and compare HTA recommendations in 5 countries, and
        across 3 therapy areas (cancer, orphan, central nervous system diseases)

        Conceptual framework: It is assumed that HTA outcomes are likely to be similar
        across settings, because the same clinical and safety evidence is considered
        alongside the same methodology

        In practice: HTA recommendations vary greatly across settings1, 2, 3, 4


                                                              Implications
          Coverage decisions may vary across countries in the same geographical region, with
           the same socio-economic level of development, and the same health care systems


              Need to understand why these differences across countries occur

              Need to approximate HTA processes across settings




Sources: 1. Clement 2010; 2. Morgan 2006; 3. Lexchin 2008; 4. Barbieri 2005.
Methods
DATA
• Database: all drug-indication pairs issued between January 2007 and December 2009

• Country selection: England, Scotland, Sweden, Canada, Australia

• Stratification per disease area: WHO ICD10 codes

• HTA recommendation classification: List (“L”), List with Conditions (“LWC”), Do not list
  (“DNL”)
• Selection of disease areas: cancer, orphan, central nervous system indications



ANALYSIS
• Comparison of HTA recommendations across the study countries

• Measurement of the level of agreement between the study countries: Cohen’s Kappa
  score
• Associations between HTA recommendations, HTA bodies, and 3 therapy areas (cancer,
  orphan, central nervous system diseases): two-way correspondence analysis
• Case studies: to understand possible reasons for variations
Results
Database - summary
= 287 drug-indication pairs collected between 2007-2009 in the 5 study countries
Figure represents the HTA recommendations issued in each country


 Scotland
   SMC                       54                          78                              61
  n=193

 Sweden
   TLV                                       79                                      26                 6
  n=111

 Australia
  PBAC                  47                               111                                  52
  n=210

 England
  NICE                 21                                     70                                   19
  n=110

 Canada
CDR/CED        4                        62                                   64
 n=130

             0%                   20%             40%                60%           80%                  100%
 Source: the authors
                                             List       LWC        DNL
Snapshot of our database - orphan therapies
Drug                        Indication                        ICD10      Canada   England   Australia   Sweden   Scotland
                                                                        CDR/CED     NICE     PBAC         TLV      SMC
Dasatinib                   Chronic myeloid leukemia           C92.1      LWC     Ongoing     LWC          L       LWC
Sorafenib tosylate          Renal cell carcinoma               C64       DNL       DNL        DNL         L        DNL
Sorafenib tosylate          Hepatocellular carcinoma          C18-C21    LWC       DNL        LWC        LWC       DNL

Ambrisentan                 Pulmonary arterial hypertension     I27      LWC                  LWC        LWC      LWC
Imatinib mesylate           Chronic myeloid leukaemia           C        LWC       LWC                    L       LWC
Imatinib mesylate           GIST                              C16-18     LWC       LWC                    L        DNL

Lenalidomide                Multiple myeloma                   C90                 LWC        LWC        LWC       DNL

Levodopa / carbidopa        Parkinsons                         G20       DNL                  DNL        LWC       DNL
monohydrate
Miglustat                   Gaucher Disease                    E75.2     DNL                  LWC         L       LWC




Nilotinib                   Chronic myeloid leukemia           C92.1              Ongoing     LWC         L       LWC
Sildenafil citrate          Pulmonary arterial hypertension     I27      LWC                  LWC         L       LWC


Sitaxsentan sodium          Pulmonary arterial hypertension     I27      DNL                  LWC         L       LWC
Carmustine implant          Glioblastoma (newly diagnosed)     C71                 LWC        DNL                   L
poliferprosan
Dasatinib                   Acute lymphoblastic leukemia       C91.0                          LWC         L        DNL


Eculizumab                  Paroxysmal nocturnal               D59.5     DNL                  DNL                  DNL
                            haemoglobinuria
Idursulfase (Iduronate-2-   MPS II, Hunter Syndrome            E76.1     DNL                  DNL                  DNL
sulfatase)
Level of agreement between agencies in the HTA recommendations
measured by kappa scores


                                      CDR          NICE         PBAC             TLV            SMC

                 CDR                    -          0.038         0.165         -0.001          0.062

                 NICE                                -           0.178          0.228          0.105

                 PBAC                                               -          -0.023          0.132

                 TLV                                                               -           0.066

                 SMC                                                                               -
                Source: the authors

                                      Interpretation of kappa score indicators
                     Poor                   Fair         Moderate             Good            Very good

            0                                      0.4               0.6                0.8                   1
                               0.2



     Source: Altman DG. Practical Statistics for Medical Research. (1991) London England: Chapman and Hall.
Associations between HTA bodies and their recommendations
 CORA for all drugs (N=287)                                              CORA for 3 therapy areas (N=141)




Legend: Recommendations/outcomes: L: list; LWC: restrict; DNL: reject;
HTA bodies: TLV - Sweden; SMC - Scotland; CDR - Canada; PBAC - Australia; NICE - England & Wales
Therapy areas: c – cancer; n- central nervous system; o- orphan indications

Source: the authors
Examples of reasons for differences identified in a number of
case studies (e.g. metastatic colorectal cancer, schizophrenia)

Differences are a consequence of:

   • National considerations (e.g. national preferences, costs)

   • HTA processes
       • Evidence (e.g. clinical expertise)
       • Methods (e.g. economic model, choice of comparator)
       • Interpretation (e.g. what constitutes acceptable levels of evidence, clinical
         endpoint)
       • Other considerations (e.g. disease severity, symptomatic/curative, existing
         treatment alternatives, orphan indication)
Discussion &
Policy implications
Inter-country variability in HTA recommendations:

• Low level of agreement between agencies

• Differing associations between:

   • HTA bodies and recommendations issued

   • HTA bodies and recommendations issued per therapy area

• Differences are a consequence of:

   • National considerations (e.g. national preferences)

   • HTA processes (e.g. evidence, methods, evidence
     interpretation, other considerations)
Does it really matter that differences exist across countries?
• Aim of HTA:
   • Efficiency in healthcare resource allocation
   • Value for money
  Therapy X is deemed cost-effective in country A, but not in
  country B because of, for example, different levels of evidence
  presented (e.g. clinical expertise)
  It is individual interpretation of value for money according to
  special circumstances
   What does all this mean for HTA methodologies?
Need to understand why such differences exist: Ways forward

• Identify the reasons for these differences and differentiate
  when they are a consequence of:

   • National considerations

   • HTA processes

• These preliminary findings have demonstrated that it is also
  important to differentiate HTA processes per therapy area
THANK YOU FOR YOUR ATTENTION

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Health outcomes research and measurement

  • 1. A COMPARATIVE ANALYSIS OF HTA OUTCOMES IN FIVE COUNTRIES ACROSS THREE THERAPY AREAS Cancer, orphan and central nervous system diseases Authors: Elena Nicod, Dr Panos Kanavos London School of Economics and Political Science LSE Health and Social Care HTAI Conference Bilbao, 26 June 2012
  • 2. Agenda • Background and objectives • Methods • Results • Discussion & Policy implications
  • 4. Objectives: Examine and compare HTA recommendations in 5 countries, and across 3 therapy areas (cancer, orphan, central nervous system diseases) Conceptual framework: It is assumed that HTA outcomes are likely to be similar across settings, because the same clinical and safety evidence is considered alongside the same methodology In practice: HTA recommendations vary greatly across settings1, 2, 3, 4 Implications Coverage decisions may vary across countries in the same geographical region, with the same socio-economic level of development, and the same health care systems Need to understand why these differences across countries occur Need to approximate HTA processes across settings Sources: 1. Clement 2010; 2. Morgan 2006; 3. Lexchin 2008; 4. Barbieri 2005.
  • 6. DATA • Database: all drug-indication pairs issued between January 2007 and December 2009 • Country selection: England, Scotland, Sweden, Canada, Australia • Stratification per disease area: WHO ICD10 codes • HTA recommendation classification: List (“L”), List with Conditions (“LWC”), Do not list (“DNL”) • Selection of disease areas: cancer, orphan, central nervous system indications ANALYSIS • Comparison of HTA recommendations across the study countries • Measurement of the level of agreement between the study countries: Cohen’s Kappa score • Associations between HTA recommendations, HTA bodies, and 3 therapy areas (cancer, orphan, central nervous system diseases): two-way correspondence analysis • Case studies: to understand possible reasons for variations
  • 8. Database - summary = 287 drug-indication pairs collected between 2007-2009 in the 5 study countries Figure represents the HTA recommendations issued in each country Scotland SMC 54 78 61 n=193 Sweden TLV 79 26 6 n=111 Australia PBAC 47 111 52 n=210 England NICE 21 70 19 n=110 Canada CDR/CED 4 62 64 n=130 0% 20% 40% 60% 80% 100% Source: the authors List LWC DNL
  • 9. Snapshot of our database - orphan therapies Drug Indication ICD10 Canada England Australia Sweden Scotland CDR/CED NICE PBAC TLV SMC Dasatinib Chronic myeloid leukemia C92.1 LWC Ongoing LWC L LWC Sorafenib tosylate Renal cell carcinoma C64 DNL DNL DNL L DNL Sorafenib tosylate Hepatocellular carcinoma C18-C21 LWC DNL LWC LWC DNL Ambrisentan Pulmonary arterial hypertension I27 LWC LWC LWC LWC Imatinib mesylate Chronic myeloid leukaemia C LWC LWC L LWC Imatinib mesylate GIST C16-18 LWC LWC L DNL Lenalidomide Multiple myeloma C90 LWC LWC LWC DNL Levodopa / carbidopa Parkinsons G20 DNL DNL LWC DNL monohydrate Miglustat Gaucher Disease E75.2 DNL LWC L LWC Nilotinib Chronic myeloid leukemia C92.1 Ongoing LWC L LWC Sildenafil citrate Pulmonary arterial hypertension I27 LWC LWC L LWC Sitaxsentan sodium Pulmonary arterial hypertension I27 DNL LWC L LWC Carmustine implant Glioblastoma (newly diagnosed) C71 LWC DNL L poliferprosan Dasatinib Acute lymphoblastic leukemia C91.0 LWC L DNL Eculizumab Paroxysmal nocturnal D59.5 DNL DNL DNL haemoglobinuria Idursulfase (Iduronate-2- MPS II, Hunter Syndrome E76.1 DNL DNL DNL sulfatase)
  • 10. Level of agreement between agencies in the HTA recommendations measured by kappa scores CDR NICE PBAC TLV SMC CDR - 0.038 0.165 -0.001 0.062 NICE - 0.178 0.228 0.105 PBAC - -0.023 0.132 TLV - 0.066 SMC - Source: the authors Interpretation of kappa score indicators Poor Fair Moderate Good Very good 0 0.4 0.6 0.8 1 0.2 Source: Altman DG. Practical Statistics for Medical Research. (1991) London England: Chapman and Hall.
  • 11. Associations between HTA bodies and their recommendations CORA for all drugs (N=287) CORA for 3 therapy areas (N=141) Legend: Recommendations/outcomes: L: list; LWC: restrict; DNL: reject; HTA bodies: TLV - Sweden; SMC - Scotland; CDR - Canada; PBAC - Australia; NICE - England & Wales Therapy areas: c – cancer; n- central nervous system; o- orphan indications Source: the authors
  • 12. Examples of reasons for differences identified in a number of case studies (e.g. metastatic colorectal cancer, schizophrenia) Differences are a consequence of: • National considerations (e.g. national preferences, costs) • HTA processes • Evidence (e.g. clinical expertise) • Methods (e.g. economic model, choice of comparator) • Interpretation (e.g. what constitutes acceptable levels of evidence, clinical endpoint) • Other considerations (e.g. disease severity, symptomatic/curative, existing treatment alternatives, orphan indication)
  • 14. Inter-country variability in HTA recommendations: • Low level of agreement between agencies • Differing associations between: • HTA bodies and recommendations issued • HTA bodies and recommendations issued per therapy area • Differences are a consequence of: • National considerations (e.g. national preferences) • HTA processes (e.g. evidence, methods, evidence interpretation, other considerations)
  • 15. Does it really matter that differences exist across countries? • Aim of HTA: • Efficiency in healthcare resource allocation • Value for money Therapy X is deemed cost-effective in country A, but not in country B because of, for example, different levels of evidence presented (e.g. clinical expertise) It is individual interpretation of value for money according to special circumstances What does all this mean for HTA methodologies?
  • 16. Need to understand why such differences exist: Ways forward • Identify the reasons for these differences and differentiate when they are a consequence of: • National considerations • HTA processes • These preliminary findings have demonstrated that it is also important to differentiate HTA processes per therapy area
  • 17. THANK YOU FOR YOUR ATTENTION

Editor's Notes

  1. Because of these assocaitions – are we comparing like for like.Room for improvementHow do we deal for uncertainties?