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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. The Royal Marsden 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 The Royal Marsden 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’ The Royal Marsden 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. The Royal Marsden 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. The Royal Marsden 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 The Royal Marsden 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. The Royal Marsden Number of changes in the manufacturing process after approval for MABs authorised in rheumatology • • 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. The Royal Marsden The Royal Marsden The Royal Marsden The Royal Marsden 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. The Royal Marsden The Royal Marsden 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 16 Royal Marsden 17 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. 17 The Royal Marsden 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. The Royal Marsden 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 The Royal Marsden 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 The Royal Marsden Example of Patient information The Royal Marsden 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 The Royal Marsden 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