Outline of the challenges in developing integrated multichannel (nurse, call centre and web) compliance programmes to support multiple sclerosis patients. Presentation given at numerous conferences in Europe and the USA during 2007. This version presented at EyeforPharma's Patient Compliance and Communications conference, Geneva, June, 2007.

1. Developing Integrated Multi-Channel Compliance Programmes Len Starnes Head of Global E-Business Primary Care, Bayer Schering Pharma

3. Basic assumption

4. Isolated channels SMS & mobile Internet & email Contact centre Case manager VAT Pack & devices Direct mail Patient

5. The integration of multiple interventional channels is more effective in reducing patient non-compliance than the sum of the impacts on non-compliance produced by each of the channels operating independently

6. Rationale… Integration provides more complete and coherent knowledge of a patient’s needs Allowing earlier identification of likelihood of non-compliance Thus enabling more appropriate and more timely interventions to be made

7. Integration in practice Patient signs-up for ‘daily tips’ on coping with SEs Patient calls asking for advice about a severe SE Patient downloads a PDF on SEs management Application software accessed by a case manager All patient interactions and interventions logged Case manager alerted to SEs issue and makes appropriate interventions Secure patient database Patient

8. __________________________________ Collection Integration U tilization Increase compliance Improve health OCs Increase QOL Benefits on 2 levels Personalized patient data __________________________________ Collection Integration Utilization Aggregated, annonymized patient data Improve knowledge of market dynamics and patients’ needs

9. Channel specifics

10. Channel efficacy 5 4 1 3 1 1 1 Patient's decisional balance (pros vs cons) 5 3 1 3 1 1 1 Socio-economic factors 5 3 3 3 3 1 1 Stage of disease 4 4 3 5 5 1 1 Disease and treatment information 5 4 3 3 3 3 1 Drug handling 5 4 3 3 3 3 1 Side-effects 1 4 4 2 1 5 5 Forgetfulness Nurse support Contact centre Voice automation technology Internet & email Direct mail SMS & mobile Pack & devices

11. Channel triple constraints Efficacy Regulatory freedom Cost

12. Behavioural modelling

13. Integrated systems can be made smarter by incorporating constructs from behavioural models such as the Transtheoretical Model of Change to enable them to identify a patient ’ s ‘stage of readiness’ to become non-compliant and to propose stage-specific interventions

15. The business case

17. Data protection and privacy

19. Putting it all together

20. Health warning Integrated compliance projects are not for the faint-hearted

21. Programme objectives Reliably identifying a patient’s risk status Ensuring the patient is always on the corresponding interventional timeline Shifting the patient to a lower risk status and corresponding interventional timeline

22. Week 1 Week 2 Week 3 Week 5 Week 4 Week 1 Week 2 Week 3 Week 5 Week 4 Week 1 Week 2 Week 3 Week 5 Week 4 High risk Low risk Medium risk Interventions & timelines Visit Phone call Mailing

23. Establish a project team Project manager/owner (PM) Lead case manager Channel specialist(s) Medical & additional case managers Corporate Data Protection Officer Business analytics & finance IT functions External consultants Project management specialist IT professional Core Extended External vendor

24. Creating the framework High-level scoping document Channel A Business requirements document Channel B Business requirements document Channel C Business requirements document TMC Business requirements document IT specifications document

26. The business requirements document ‘ Records will be entered into the system software when a patient orders support material from the brandx.yz patient support area’… Typical e-channel functionality statements ‘ Brandx patients will be verified by matching data from the existing patient support database with that extracted from the brandx.yz database’.... ‘ All support material requests will be alerted to users’…

27. Milestone tasks: behavioural modelling Transtheoretical Model of Change (TMC) widely used in health behaviour change interventions Used to predict likelihood of non-compliance and to provide guidance on stage-specific interventions TMC-based software programs can assist case managers such as call centre agents or nurse support staff James Prochaska

29. Example Biogen Developed intelligent call centre counselling software based on a TMC-predictive model* Probably of drop-out p = 1/(1 + e -z ) where z is an index derived from 4 patient-specific predictor variables: - Pros of treatment - Cons of treatment - Educational level - Disability * Berger BA et al, Journal of the American Pharmacists Association, Vol 44, No 4 July/Aug 2004

30. Crucial sub-task: identification & ranking of risk factors etc etc etc Decisional balance Depression Educational level Side-effects Relative ranking How important is the predictor relative to others? Practicality How practical is it to make an intervention? Impactability How much impact can we make on this predictor? Weight How strong a predictor of non-compliance is it? Is it modifiable Yes or no? Risk factor

31. Key algorithm inputs: overall risk-factor weighting RF1 20% RF3 10% RF2 25% RF4 30% RF5 15%

32. Milestone tasks: software selection, development and customization The good news IMCP software is essentially the same as low-level CRM software The bad news It will almost certainly require significant customization

33. Choices Heavyweights Proprietary Develop from scratch Open Source

34. Using and accessing the system in practice Case manager: call centre agent Accesses system directly and continuously Case manager: nurse Does the nurse have access to the internet? Does the nurse use a laptop? If yes, does she take it on visits? Would the nurse prefer to use an offline solution (PDA)?