Swedish RWE a goldmine?

Transcription

1 Swedish RWE a goldmine? How is Novartis using Swedish RWE to improve decision making? Madlaina Costa, Head Health Economics and Pricing, Novartis Sweden RWE in Europe, Amsterdam 3 rd June 2015

2 Swedish registries a goldmine? Läkertidiningen Sweden, 111,

3 This presentation is designed to Illustrate opportunities and challenges of Swedish registries Discuss two case studies Burden of illness Multidimensional outcome study Looking into the future Evolvement of RWE research Needs to enhance RWE in Sweden 4

4 Evidence needs are increasing RWD contributes throughout lifecycle, across functions and territories Development Growth Phase Mature Phase Now Past Budget impact Post-marketing commitments (safety etc.) Evidence required Unmet need/ disease burden Patient recruitment Adherence Utilization/ prescribing patterns Head to head safety, comparative effectiveness Long-term safety, clinical outcomes Differentiation in sub-populations Target populations Usage Difference Effects of switching on outcomes Differentiate with or vs. protected formulation Understand standard of care Trial design Development Sub- Launch mission Pricing Review New Competition New Indication / Formulation Competitor goes generic Studies: Epidemiology Clinical trial data HE studies Investigator initiated studies Non-interventional studies CER studies Label extension Analysis of real world evidence (RWD/RWE) Source: Adapted from McKinsey PMP practice perspectives on RWD 5

5 Swedish registries National birth death registry National ICD- Inpatient registry Diagnosis (ICD) Birth/ death data Disease Disease specific quality registries (>130) National DRG-Inpatient registry Resource used (DRG) Personal ID number Prescribed medicines National drug registry Different EMR systems Primary care medical records Health care insurance Education, employme nt, Salary National Lisa registry National Lisa registry 6

6 Benefits from Nordic investments in RWE generation and capabilities Close existing knowledge gaps Identify opportunities and hurdles for each Franchise Increased efficiency Maximise value of ongoing and future studies for the Nordic countries Attractive partner for global projects Increased availability of locally generated data Strengthen payer value messages by including RWE Ambition to have broader RWE data for TA at launch Allow for follow-up of our patients Enable innovative pricing agreements 7

7 Case study: Fill existing evidence gaps Close existing knowledge gaps Identify opportunities and hurdles for each Franchise Increased efficiency Maximise value of ongoing and future studies for the Nordic countries Attractive partner for global projects Increased availability of locally generated data Strengthen payer value messages by including RWE Ambition to have broader RWE data for TA at launch Allow for follow-up of our patients Enable innovative pricing agreements 8

8 Case study: Heart failure Burden of illness Scope of retrospective burden of illness study over 2 year Description of HF-REF and HF-PEF population and cardiovascular outcomes Resource use and associated costs Pre-index assessment Comorbidities Index assessment Demographics Comorbidities Clinical parameters Treatment Post-index assessment Clinical outcomes Economic outcomes Pre-Index Period Index date Post-index Period 451 patients 439 patients Ståhlhammar et al and

9 Heart failure analysis Variables collected from different registries Birth death registry: Mortality ICD- Inpatient registry Age, gender Diagnoses, type of heart failure Comorbidities Diagnosis (ICD) Birth/ death data Disease Hjärtsvikt: Age, gender Diagnoses, type of heart failure BP, BMI and other risk factors Lab tests Comorbidities DRG-Inpatient registry Hospitalisation including ER visits Resource used (DRG) Personal ID number Prescribed medicines Drug registry Medication used/refills Different EMR systems Primary care medical records Health care insurance Education, employmen t, Salary Lisa registry Lisa registry 10

10 Results Cost of illness results Resource use and associated costs Hospitalisation driving costs of heart failure Drug costs accounts for 3% 1% 3% 9% 22% 65% Ståhlhammar et al and

11 Follow-up project Ongoing Birth death registry: Mortality ICD- Inpatient registry Age, gender Diagnoses, type of heart failure Comorbidities Diagnosis (ICD) Birth/ death data Disease Hjärtsvikt: Age, gender Diagnoses, type of heart failure BP, BMI and other risk factors Lab tests Comorbidities DRG-Inpatient registry Hospitalisation including ER visits Resource used (DRG) Personal ID number Prescribed medicines Drug registry Medication used/refills Different EMR systems Information from GPs Primary care medical records Health care insurance Education, employmen t, Salary Lisa registry: Socioeconomic variables Lisa registry: Productivity loss 13

12 Follow-up project Ongoing ICD- Inpatient registry Age, gender Diagnoses, type of heart failure Comorbidities DRG-Inpatient registry Hospitalisation including ER visits Birth/ death data Disease Resource Prescribed and used socioeconomic Personal ID number variables medicines (DRG) Diagnosis (ICD) Birth death registry: Mortality Complement with primary care data Hjärtsvikt: Age, gender Diagnoses, type of heart failure BP, BMI and other risk factors Lab tests Comorbidities Drug registry Medication used/refills Different EMR systems Information from MR from GPs Primary care medical records Health care insurance Education, employmen t, Salary Lisa registry: Socioeconomic variables Lisa registry: Productivity loss 14

13 Case study: Allow for follow-up Close existing knowledge gaps Identify opportunities and hurdles for each Franchise Increased efficiency Maximise value of ongoing and future studies for the Nordic countries Attractive partner for global projects Increased availability of locally generated data Strengthen payer value messages by including RWE Ambition to have broader RWE data for TA at launch Allow for follow-up of our patients Enable innovative pricing agreements 15

14 Case study 2: Assessing multidimensional treatment effect and potential new payment models Swedish collaboration project for psoriasis HTA authority (TLV) Pharma Academia Regional decision makers (NT) 16

15 Case study 2: Assessing multidimensional treatment effect and potential new payment models Measure impact on multidemensional well-being Relationship between treatment alternatives, psoriasis, costs and wellbeing Evaluate new payment models for drug treatment based on multidemensional wellbeing 17

16 All is not gold that glitters Challenges with nordic databases Accessability of data Inconsistency in collection of regional primary care data Linkage between National and disease specific databases time consuming Limited PROMs data in registers Confounding factors due to changing enivronment Limited RWE publications considering the wealth of data from Swedish registries 18

17 Looking to the future Structured inclusion of RWE in decision making process Improved follow-up of treatment effect in real world Use of real time data for treatment decisions Alternative payment models for drug treatments 19

18 Conclusion Closer collaboration between academia register holders pharma and decision makers to enhance the use of RWE 20