Delivering Real World Evidence. Canada Let s Get Real!

Transcription

1 Delivering Real World Evidence from Electronic Medical Records in Canada Let s Get Real! Neil Corner Director, Real World Evidence, IMS Brogan Alison Dziarmaga Director, Real World Evidence, AstraZeneca Canada Inc.

2 A focus on Electronic Medical Records 2 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

3 True or False? 1. EMR data does not capture everything some processes are paper based 2. Patients need to provide permission to use EMR data for research 3. There isn t good quality EMR data for Market Research in Canada 4. Data is unstructured and often contains handwritten notes 5. Data does not contain costs 6. Diagnosis codes are just for billing and not captured for medical reasons 7. Observational data from EMR is not a valid research methodology 8. Data from EMR is too expensive and difficult to get 9. There are no tools to provide easy access for data mining 3 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

4 True or False? 1. EMR data does not capture everything some processes are paper based It depends 60% EMR Use 2014 Canada National Physician Survey 50% 40% 30% 20% 10% 0% Use Paper records exclusively Use a mixture of paper and electronic records Use of EMR Use excusively electronic records N=68,177 The majority of systems use both paper and electronic records. The researcher needs to seek out the Electronic patient eco-system 4 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

5 True or False? 2. Patients need to provide permission to use EMR data for research If the personal health information has been properly de-identified and The risk of re-identification tested then this is FALSE. Physician permission is required. [de-identified information is used for secondary purposes, such as research and evaluation, where the recipient of the data has neither the motive nor the intention to re-identify the individuals contained in the data set. In fact, any re- identification would be counter-productive thwarting the agreed upon terms typical of any data sharing agreement. In such situations, the use of de-identified information, rather than personal information, is of great value.] 5 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

6 True or False? 3. There isn t good quality EMR data for Market Research in Canada False 6 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

7 True or False? 4. Data is unstructured and often contains handwritten notes It depends IMS has evaluated multiple EMR vendors data. Some systems contain much unstructured data, the one selected for research by IMS is entirely structured and does not require NLP (Natural Language) software to interpret unstructured data. Eg 94% Rx, 90% diagnoses, 100% labs, 80% smoking status etc 7 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

8 True or False? 5. Data does not contain costs False Data contains the cost of the intervention charged by the physician. Drug costs are added as the DIN is available within the data. 8 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

9 True or False? 6. Diagnosis codes are just for billing and not captured for medical reasons It depends Some EMR vendor software uses ICD-9 just for billing. Other EMR software uses the diagnosis code to determine the information for the patient record. This enables multiple diagnosis codes per visit. 9 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

10 True or False? 7. Observational data from EMR is not a valid research methodology False EMR data has been used by NICE and other HTA bodies in Europe for a very long time and is considered the gold standard for Real World Evidence research. 10 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

11 True or False? 8. Data from EMR is too expensive and difficult to get False Inexpensive: Much cheaper than a study Cheaper than a chart audit Easily accessible: Not just the domain of the academic researcher anymore, data is available to the pharmaceutical industry 11 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

12 True or False? 9. There are no tools to provide easy access for data mining False IMS Evidence 360 cohort builder. Canadian EMR in a simple tool Available in Europe, US too Even the FDA uses it!! 12 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

13 13 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

21 Taking a deeper dive How can EMR support Market Research specifically Here we take a look at diabetes patients. The brand names and classes have been removed to protect the innocent. 21 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

22 Which T2D medications are used for patients with which level of disease severity? New to Brand, Type 2 patients HbA1c distribution, September 2014 % Patien nts 100% 80% 60% 40% 20% 0% 26.9% 27.0% 30.2% > % 51.8% 8.6% 14.0% 17.0% 13.2% 10.6% 12.1% 1% > % 8.3% 11.7% 14.4% 12.6% 16.6% 6% 12.4% 12.6% 12.4% > % 15.5% 6.8% 12.2% 14.6% 20.1% 15.7% 74% 8.8% 12.3% 15.1% 7.4% 88% Drug A (n=1432) Drug B (n=532) Drug C (n=982) Drug D (n=2144) > % IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

23 Which T2D medications are used for patients with renal impairment? 100% New to Brand, Type 2 patients egfr distribution, September % 33.9% 35.6% 27.4% 20.7% % Patie ents 60% 40% 20% 16.6% 33.1% 19.2% 31.2% 17.1% 27.8% 25.4% 17.2% 27.6% 32.0% 90+ > < % 13.7% 0% Drug A Drug B Drug C Drug D (2144) (n=1432) (n=532) (n=982) 23 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

24 Which T2D medications are used for patients with which BMI? 100% New to Brand, Type 2 patients BMI distribution, September % % Patien nts 60% 40% 78.0% 78.7% 7% 83.3% 3% 64.5% to to % 26.2% <18.5 0% 18.6% 17.3% 13.7% 32% 38% 8.9% 3.2% 3.8% 0.2% 0.2% 29% 2.9% 0.4% Drug A (n=1432) Drug B (n=532) Drug C (n=982) Drug D (2144) 24 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

25 Which T2D medications are used for patients with which BP? New to Brand, Type 2 patients Blood Pressure distribution, September % 2.9% 4.0% 2.9% 2.6% 80% 23.8% 24.1% 26.5% 25.8% ents % Pati 60% 40% 73.2% 71.9% 70.6% 71.6% High BP, Stage 2+ High BP, Stage 1 Normal 20% 53.2% 53.3% 53.4% 54.1% % w Normal BP and HTN 0% Drug A Drug B Drug C Drug D (n=1432) (n=532) (n=982) (n=2144) 25 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

26 As expected, patients with more severe renal impairment continue to tend to be older; 98% of Stage 4 egfr patients are age 55+ and 90% are age 65+ New to Brand, Type 2 patients age distribution by egfr, September % 80% s % Patient 60% 40% 20% 0% 20.5% 17.3% 39.3% % 58.5% 29.6% 34.3% % 90% 28.2% 38.7% 31.8% 16.0% 16.7% 13.5% 7.3% 5.7% 5.3% 3.1% TOTAL (n = 1,873) 31.7% <15* (n = 41) (n = 545) egfr (n = 548) % 13.5% 27.3% 31.1% 17.0% % 2.7% 13.9% 37.7% 32.7% 11.1% 13.0% >60 (n = 289) 90+ (n = 446) % IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

27 Of the products in the given class, Drug C continues to attract the highest proportion of patients with hypertension (HTN) 100% New to Brand, Type 2 patients HTN distribution, September % 76.4% 77.2% 78.0% 81.9% 73.6% 71.2% 69.1% 65.4% s 60% % Patient 40% 20% 0% Class (n=4009) Drug A Drug B (n-332) Drug C (n=503) 503)D Drug D (n=552) Drug E (n=271) Drug F (n=68) Drug G (n=127) (n=2144) 27 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

28 Brand A s class share of patients with HbA1c of decreased in September 2014 from its highest reported level in August 2014 New to Brand, Type 2 patients Brand A of Class Share by HbA1c Total < Bran nd A Share (% Class Patients) 25% 20% 15% 10% 5% 0% 16.1% 14.2% 13.3% 12.9% 12.9% 10.9% 9.5% 28 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

29 Brand A of class share continues to have generally minimal variation across BMI segments New to Brand, Type 2 patients Brand A of Class Share by BMI A Share (% Class Patients) Brand 16% 12% 8% 4% 0% Total <18.5* 18.5 to to % 13.7% 14.0% 12.7% 29 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

30 Conclusion EMR data is providing insights not previously available for Canadians The data is statistically robust and easy to access The evidence is used for access purposes and for better understanding the decision points by physicians 30 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference

31 References 31 IMS Brogan and AstraZeneca, presented at The 2015 Canadian Pharma Market Research Conference