1. Dispensing Doctors’ Association 20 October 2016
The generic and biosimilar perspective Warwick Smith Director General BGMA & BBA
Dispensing Doctors’ Association
20 October 2016

2. Stuff to cover An introduction Key data Supply chain
Pricing and reimbursement
High cost generics
The Health Service Medical Supplies (Costs) Bill
Biosimilar medicines
Whatever you ask me about ….

3. Introduction

4. Introduction

5. Traditional commodity model
Brand monopoly
Generic competition
Launch of original brand
Development of original brand
Effective patent / SPC protection of original brand
Launch of subsequent generics
Brand
Development of generics
2015 NHS Information Centre data:
Average brand cost £20.79
Average generic cost £4.33
Generic competition reduces NHS costs by more than £13bn pa
Launch of first generic
Brand
Price
Generic

6. Data

7. 90-95% £13bn 1.38% 3.5 Generic medicines Biosimilar medicines 77%
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Typical unbranded generic price reduction vs the originator
Average branded generic price reduction vs the originator
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
£13bn
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
0 – 100%
43%
£3m
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

8. 90-95% Typical unbranded generic price reduction vs the originator
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Average branded generic price reduction vs the originator
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
£13bn
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
0 – 100%
43%
£3m
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

9. Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
3.5
90-95%
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Typical unbranded generic price reduction vs the originator
Average branded generic price reduction vs the originator
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
£13bn
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
0 – 100%
43%
£3m
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

10. 90-95%
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Typical unbranded generic price reduction vs the originator
Average branded generic price reduction vs the originator
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
£13bn
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
0 – 100%
43%
£3m
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

11. 77% Average branded generic price reduction vs the originator 90-95%
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
Average branded generic price reduction vs the originator
77%
Typical unbranded generic price reduction vs the originator
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
£13bn
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
0 – 100%
43%
£3m
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

12. 90-95%
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Typical unbranded generic price reduction vs the originator
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
Average branded generic price reduction vs the originator
Generic medicines
£13bn
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
0 – 100%
43%
£3m
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

13. Supply chain

14. Supply issues The patient Distribution Batch release
Source API
Manufacture finished form
Batch release
Distribution
The patient

15. Supply issues The patient Distribution Batch release
Source API
Manufacture finished form
Batch release
Distribution
The patient
Regional decision making
Transport needs
Competition
Transport needs
Market concentration in far off lands

16. Historic average service levels1
1 Weighted average based on between five and nine members’ data at any one data collection point

17. Pricing and reimbursement

18. Aggregated scheme M data 2012-2016

19. NHS Digital data (2005 – 2015)
Source:

21. Generic medicine reimbursement percentage change compared to average pack price2012-16

22. High cost generics

23. High cost generics
May be good reasons to increase the cost of older products
Price decay over time to unsustainable levels
New regulatory requirements
Choice between investment or discontinuation
Scheme M has always envisaged the Department of Health intervening in prices when competition does not work to protect the NHS
Reference to the competition authorities has always been a backstop.
Very few examples (<2% of generics)

24. The Health Service Medical Supplies (Costs) Bill

25. Health Service Medical Supplies (Costs) Bill
May signal little change
Introduces a level playing field
Regularises DH powers
But not codified
Data provisions are broad
Potential for change as it goes through Parliament

26. Principles of a good generics market
Low barriers to entry
High levels of generic prescribing
High levels of competition
Flexibility in pricing

27. Biosimilar medicines

28. 90-95% £13bn 1.38% 3.5 Generic medicines Biosimilar medicines 77%
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Typical unbranded generic price reduction vs the originator
Average branded generic price reduction vs the originator
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
£13bn
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
0 – 100%
43%
£3m
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

29. 0 – 100% The range of take up of Infliximab across Trusts in England
90-95%
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Typical unbranded generic price reduction vs the originator
Average branded generic price reduction vs the originator
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
£13bn
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
The range of take up of Infliximab across Trusts in England
0 – 100%
43%
£3m
£200,000
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

30. 90-95%
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Typical unbranded generic price reduction vs the originator
Average branded generic price reduction vs the originator
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
£13bn
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)
€50-100bn
0 – 100%
43%
£3m
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Potential annual saving due to adoption of biosimilar infliximab (RCP)
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7

31. £3m 90-95% £13bn 1.38% 3.5 Generic medicines
Annual saving to NHS England of a 1% swing to the greater use of generics
£172m
77%
Typical unbranded generic price reduction vs the originator
Average branded generic price reduction vs the originator
Generic medicines
Proportion of all generics referred to in The Times coverage of high cost medicines
1.38%
£13bn
3.5
Proportion of primary care prescriptions in England filled by generic medicines (NHS reimbursement data)
77.3%
Factor by which prices of a basket of generics in a basket of other European countries exceeds the UK price
Annual cost to NHS England if all medicines were reimbursed at the level of the average brand
Potential annual saving due to adoption of biosimilar infliximab (RCP)
£3m
0 – 100%
43%
£200,000
The range of take up of Infliximab across Trusts in England
The percentage take up of biosimilar infliximab across all trusts
Possible annual savings from a single centre if all patients were switched from originator hGH to biosimilar hGH (2010 data)
Biosimilar medicines
The number of biologic medicines within the top 10 of UK medicines spend
6 out of 10
Biosimilar molecules currently available in the UK market 7
€50-100bn
Potential 5 year savings in the EU5 and the US as a result of the use of biosimilars (IMS)

32. What does the future hold?
Biologics account 6 of the top 10 medicines by spend in the UK
Poses considerable challenges for using high cost but innovative medicines – treat long term chronic conditions
Won’t be solved by a simple price reduction
Need to maximise use and drive uptake
Reduce unwarranted variation in the system

33. Questions?

34. Further information