commissioning chemotherapy services the …...1. 2. gascon p et al support care cancer. 2013;...

Commissioning Chemotherapy Services

The introduction of biosimilars into clinical practice

The Cancer Vanguard is a partnership between

Greater Manchester Cancer Vanguard Innovation, RM Partners and UCLH Cancer Collaborative

Jatinder Harchowal

Chief Pharmacist / Clinical Director

Royal Marsden NHS Foundation Trust

Medicines lead for RM Partners

Cancer Vanguard

Objectives

• Background to Biosimilars use across NHSE

• Cancer Vanguard biosimilar Rituximab project

• Experience and follow-up

• Questions



Cancer Vanguard

• 6 of the top 10 spend medicines are biologics

• Potential to realise savings of £200-300m / year by 2020/21

• Aim for 90% of new patients to be prescribed best value biological medicine within 3 months of launch

• 80% of existing patients within 12 months

Commissioning Framework - Sep 2017

Cancer Vanguard

Variation in the uptake of previous Biosimilars in England



Cancer Vanguard

Biosimilar Rituximab – first in haematology

• Learning from experience from other Biosimilars

• £160m spend (16/17 in NHSE)

• Opportunity to save £70m on cancer indications

• Opportunity with the Cancer Vanguard initiative …

• Use local & national expertise to drive NHSE wide change

Cancer Vanguard

Overview of the Cancer VanguardOne of the recommendations of the National Cancer Strategy was to develop new models of care for cancer. In 2015 the Cancer Vanguard was launched to test and fast-track innovative and new models of cancer care.

The Cancer Vanguard is made up of three systems:

o North West and South West London (led by RM Partners)

o Greater Manchester (led by the Christie)

o West Essex North Central and North East London (led by UCLH)



Cancer Vanguard

The cancer vanguard medicines optimisation team

o RM Partners led a joint piece of work with Sandoz

o Development of a central repository of information for introduction of biosimilars: Identify and engage key clinical stakeholders – FAQs etc

Run education sessions

Involve Patient groups

Develop policies for introduction in local Trusts



Cancer Vanguard

A range of stakeholders we engaged with



• Clinical: Haematologists, Nursing , Pharmacy

Cancer Vanguard

A range of stakeholders to consider




• Pharmacy: Clinical, Purchasing, Formulary, E-prescribing

Cancer Vanguard






• Trust: Formulary and D&TC, Finance

Cancer Vanguard





• Trust: D&TC, Finance

• Professional groups: ESMO, BOPA, Lymphoma Groups

Cancer Vanguard






• Trust: D&TC, Finance

• Professional groups: ESMO, BOPA, Lymphoma Groups

• Commissioners: Local and national (NHSE) - CQUINs

Cancer Vanguard


The critical step



Staff education / Communication

• Delivered as part of vanguard project

• Dedicated classroom sessions for pharmacy, nursing and medical staff

• Assessed impact of education – very positive!

• Don’t underestimate the importance of this

Cancer Vanguard

The How…………



Cancer Vanguard

Staff education / Communication



Cancer Vanguard

Variability is a fact of life• Manufacturing changes can create variability in the biologic

molecule

Vezér B, Zrubka Z et al; CMRO, 2016, 32:829-834

Cancer Vanguard

Staff education on how Biosimilars are developed



Cancer Vanguard

Biosimilars are highly similar• Biosimilars are approved biologics ….demonstrated to be highly

similar to a reference product – numerous batches / over many

years

European Medicines Agency (EMA). Guideline on similar biological medicinal products. CHMP/437/04 Rev 1/2014 [online]. Available from URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf [Accessed 2016 March 18];US Food and Drug Administration. Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product 2015 [online] Available from URL: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf [Accessed 2016 March 18].

Cancer Vanguard

2010 2012

Biosimilar human growth hormone approved in

Japan & Canada

2009

Biosimilar human growth hormone approved in EU

Biosimilar human growth hormone approved in US

2007

1. www.sandoz-biosimilars.com

2. Gascon P et al Support Care Cancer. 2013; 21(10): 2925–2932

3. Romer et al Horm Res 2009; 72(6): 359-369.

4. For full adverse event profiles, please refer to Zarzio and Omnitrope SPCs available at: www.medicines.org.uk/emc

Biosimilar GCSFapproved in EU

2008

Biosimilar GCSF first biosimilar product to surpass reference product usage

2013

Biosimilars are nothing new

Biosimilars are marketed in over 75 countries and now have over 250 million patient-days of experience1

Throughout this period, the safety profile of biosimilars has been consistent with the reference products and the product

class2,3,4

Biosimilars are now in routine use in the NHS, particularly in rheumatology and gastroenterology

Biosimilar etanerceptapproved in EU

20162015

Biosimilar infliximabapproved in EU

2006

Biosimilar human growth hormone approved in EU

Biosimilar human growth hormone

approved in Australia

2005 2017

Biosimilar rituximab approved in EU

Patient Engagement – co-created information



• Joint patient information with Lymphoma Association

• Switching patients were informed in advance, in writing

• We did not re-consent patients

• We did not change the consent process for new patients

Cancer Vanguard

After the clinical and patient support….



• Trust approval

– Policy agreed across all 3 Vanguard sites

– MD, DTC Chair and Chief Pharmacist support

• Pharmacy

– Electronic prescribing systems updated

• Commissioner approval

Cancer Vanguard

Final Case for change to switch to a biosimilar rituximab ….



Cancer Vanguard

Experience to date from RMH and UCLH

• Complete switch to Biosimilar Rituximab for all patients

• End of September 2017 in RMH and UCLH:

– 317 patients treated with biosimilar Rituximab

– 796 infusions

– Mainly grade 1 and 2 reactions in line with originator

• No practical problems noticed



Cancer Vanguard

Current rituximab use in RMH



Cancer Vanguard

0

10

20

30

40

50

60

70

80

Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17

No. of rituximab infusions given at RMH (apr17-oct17)**excluding trial patients and subcutaneous doses

RITUXIMAB (MABTHERA) RITUXIMAB (TRUXIMA)

Branded & biosimilar rituximab spend in RMH



Savings now >£60,000/month

£0

£20,000

£40,000

£60,000

£80,000

£100,000

£120,000

Monthly spend* on Rituximab at RMH Apr 16 - Oct 17*NHS only

RITUXIMAB (MABTHERA) RITUXIMAB (TRUXIMA)

Cancer Vanguard

Rituximab uptake nationally by region

0.0%

10.0%

20.0%

30.0%

40.0%

50.0%

60.0%

70.0%

80.0%

90.0%

100.0%

Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17

Rituximab IV - Biosimilar UptakeNorth East

London

East of England

South West

East Midlands

Yorks & Humber

South East Coast

South Central

North West

West Midlands

National



National uptake: 55%

Cancer Vanguard

Biosimilars: Summary

• Biosimilars developed to be highly similar to their reference

biologic

• Widespread support for switching to biosimilars - now

• Education and information on biosimilars remains key

• New commissioning guidance and CQUINs enablers

• Adoption will only succeed with multi-stakeholder approach

Cancer Vanguard

Reflections of the Cancer Vanguard Approach



Example of collaborative and system wide leadership All documents readily available on website

Replicability of the approach2018 - Trastuzamab and Adalimumab

Pace of delivery not possible without the joint working with Pharmaceutical Industry (non-promotional)

Cancer Vanguard

Acknowledgements

https://cancervanguard.nhs.uk/biosimilars-adoption/

Particular thanks to:

Tim McCarthy, Principal Pharmacist, RMH

Philip Murphy, Sandoz



Cancer Vanguard

https://cancervanguard.nhs.uk/biosimilars-adoption/

Questions?



Cancer Vanguard

commissioning chemotherapy services the …...1. 2. gascon p et al support care cancer. 2013;...

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