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The Royal Marsden
BIOSIMILARS
Jatinder Harchowal
Chief Pharmacist / Clinical Director Medicines
Management and Clinical Support Services
The Royal Marsden
Management of Controlled Drugs, September 2016
Cover
• Background
• The approval process for Biosimilars
• Plans for the introduction of Biosimilars in Oncology.
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My background and interest
• Chief Pharmacist since 2004
• Ealing Hospital
• Brighton & Sussex University Hospitals
• Royal Marsden NHS Foundation Trust
• Lead for medicines optimisation for Royal
Marsden Cancer Vanguard
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Biosimilars
• A Biosimilar is defined as a:
• ‘drug that is similar in terms of quality, safety
and efficacy to an already licensed reference
biotherapeutic product’
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Background to Biosimilars
• Most medicines, like paracetamol, are relatively simple and
easy to produce and copy
• Biologic medicines, like infliximab, are more complicated - the
copies rather than being identical are highly similar, and are
therefore called biosimilars.
• 12 Biosimilar EU approvals since 2006.
• NICE considers Biosimilar medicines to be as effective and
safe as the original branded medicine.
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European Medicines Authority (EMA)
• EMA approved first two MAB biosimilars
• Remsima and Inflectra
• In the application dossiers, they have been shown to be similar to
Remicade (Infliximab), that has been EU authorised since 1999.
• Remsima and Inflectra are recommended for authorisation in the
same indications as Remicade, covering auto-immune diseases:
•
rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing
spondylitis, psoriatic arthritis and psoriasis.
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EMA Approval Process
• A Biosimilar can be authorised if it is a close copy of a
biological medicine that is EU authorised.
• A Biosimilar must ensure similarity to the reference product
with respect to many attributes, such as:
•
amino acid sequence, conformation, post-translational
modifications, immunogenicity, affinity for its ligand or receptor,
and function.
• Must demonstrate that the pharmacokinetics,
pharmacodynamics, efficacy and safety of the Biosimilar are
essentially equivalent to the innovator
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EMA approval
• The therapeutic doses of the innovator drug are already
known so dose-ranging studies not required.
• At least one ‘non-inferiority’ clinical trial is required to
show that there are no significant differences in efficacy
• Following licensing, it is mandatory for manufacturers to
generate additional safety data to meet
pharmacovigilance requirements.
• The key question for biosimilars is not whether
differences exist compared with the innovator, but
whether differences are clinically relevant.
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Number of changes in the manufacturing process after
approval for MABs authorised in rheumatology
•
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Such changes range from change in the supplier of a cell culture media to new
purification methods or new manufacturing sites.
Subtle process changes in the production of an innovator drug occur over time
and result in variations between commercial lots i.e. different batches.
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ABPI
• ABPI position paper on biosimilars.
• The recommendations highlight the importance of:
• Robust patient safety monitoring; to enable compliance
with EU pharmacovigilance legislation
• Clear guidance to educate prescribers and patients to
ensure they are aware of the differences between
biological medicines and chemically developed medicines.
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Cancer Vanguard approach to introduction
of Biosimilars
• Rituximab and Trastuzamab the first Biosimilars in Oncology.
• 2015/16 expenditure
• Rituximab IV > £1.1m
• Trastuzamab >£4.5m
• Recent CQUIN guidance from NHSE about expectations on
Biosimilar use
• Cancer Vanguard has an important role to play……
Overview of Cancer Vanguard
Appointed in October 2015 The Royal Marsden
together with The Christie and UCLH.
One Cancer Vanguard with 3 separate delivery
vehicles all trialling a different model to improve
cancer services over a geography.
Each delivery vehicle already had an existing
Integrated Cancer System which is being
transitioned.
The Christie
The Christie and RM trialling Lead
Provider/pooled budgets. UCLH an Alliance.
UCLH
Total population 10.7 million
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Marsden
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The challenges we face
The aim of the national cancer vanguard programme is to tackle three gaps:
1
Health and wellbeing gap
1 in 2 people will get cancer in their lifetime. Cancer patients are diagnosed too
late, survival is poor, cancer is not prevented. The incidence of cancer is
increasing by about 2% a year and is the biggest cause of death from any disease
in every age group. The shift in lifestyle is increasing the age standardised risk of
cancer.
2
Care and quality gap
Patients receive inconsistent quality of care, long waiting times, widely
varying outcomes, and often poor experience. Where it can be and living with
and beyond cancer is not consistently prioritised.
3
Funding gap
The rising cost of cancer is unsustainable. The cost of delivering the capacity
required to bring forward diagnosis and shift follow up care into the community
is currently prohibitive.
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Cancer Vanguard
• Medicines Optimisation subgroup:
• Using principles of MO and aims of the Vanguard
• Leading on 5 projects across the country
• Test across the Vanguard sites and share nationally
• Key project is introduction of Biosimilars in cancer
• Cost of cancer care is rising 9% each year.
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Key Success Factors to Biosimilar uptake
• Take learning from previous introduction of Biosimilars
• Working with the British Biosimilars Association
• Position the Cancer Vanguard as innovating and leading
the implementation and use of Biosimilars in the NHS
• Develop a toolkit on education and uptake of Biosimilars.
• Clinical engagement and awareness of Biosimilars:
•
•
•
•
Understand the healthcare professional knowledge and gaps
Concerns
Produce a structured and balanced program of education
Lead to the safe and confident use of Biosimilars in right pts
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Key Success Factors to Biosimilar uptake
•
Engagement with stakeholders
• National biosimilars group
• Patient engagement (involvement and satisfaction)
• Commissioner engagement
• Share early adopters experience and best practice
•
Research evaluation
• Real world evidence generation and publication
• Capture clinical, health-economic, Patient reported outcomes
•
Evaluation of impact to patients, services, finances
• Track uptake across country
• Project potential savings
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Example of Patient information
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Management of Controlled Drugs, September 2016
Summary
• More Biosimilars coming to market
• Will offer safe, cost-effective alternatives
• Inconsistent uptake across the country
• First Biosimilars in oncology will be here in 2017
• Cancer Vanguards are preparing an approach based on
education, training, research to help uptake of Biosimilars
• We will share the progress and learning from this
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Acknowledgements
– LPP
– Cancer Vanguard Medicines Optimisation Group
– UCLH Pharmacy team for Patient Information Leaflets
The Royal Marsden
Management of Controlled Drugs, September 2016
Contact details
Jatinder Harchowal
[email protected]
Pharmacy Department
The Royal Marsden NHS Foundation Trust
Fulham Road
London SW3 6JJ