Impact of new personalised cancer treatments DRAFT- do not ...

Impact of new personalised cancer treatments

Ellie Bloom Strategic Analyst October 2018

CONFIDENTIAL

Contents

4 Executive Summary........................................................ 9 Background, definitions, objectives.................................. 10 Introduction...................................................................

Personalised treatments, genomics, 100,000 genomes project

19 Cancer treatment development and use............................

Development trends, global spending, future trends, treatment inequities

28 Clinical trials.................................................................

Structure, measurements, perceptions, motivations, inequalities

43 Policy and new treatment approval..................................

New treatment approval processes, policy levers, Brexit

58 Experience of PLWC......................................................

Understanding of personalisation, challenges in communication, anxiety

65 Information provision.........................................................

Current provision, future plans, competitor provision

69 Cancer workforce..........................................................

Planning, upskilling, resources

76 Appendix......................................................................

Interviewees and contributors

3

Executive summary

Introduction

? We are currently in a transition era towards personalised medicine. Biomarkers are being used to redefine cancer more precisely across several tumour groups, helping to improve patient outcomes by making more personalised cancer treatment selections. The number of markers has increased dramatically in the last decade.

? Advances in genomics, genetic tests and targeted drugs will enable increasing personalisation of cancer treatments. However, if a treatment is personalised this does not necessarily mean that it is accompanied with the complimentary personalised care.

? Immunotherapy is the newest wave of cancer treatment. The use of these drugs is still limited to specific indications and clinical trials, and they present different side effects and largely unknown longterm effects.

? A Genomics medicine service is being rolled out in England from October 2018 to April 2019 as a result of the 100,000 Genomes project.

Cancer treatment development and use ? There are an increasing number of targeted

treatments in late stage development, at over 700 molecules by the end of 2017, an increase of 64% since 2007. ? Rates of chemotherapy, radiotherapy and surgery vary for different groups of patients in England. Factors including age, deprivation, ethnicity, stage of cancer and gender can influence treatments received by cancer patients.

4

Executive summary (cont.)

Policy ? The main stages that lead to cancer patients using new drugs are Research, Authorisation, Recommendation and Use. The

main bodies involved are the European Medicines Agency (EMA), Medicines and Healthcare Regulatory Agency (MHRA) and National Institute for Health and Clinical Excellence (NICE), with some variation in the devolved nations. ? Drug approval processes vary in the devolved nations, with all following NICE decisions to a degree, but also with Scotland and Wales having their own regulatory bodies and CDF equivalents. These differences can lead to variation in access to cancer treatments across the UK. ? Brexit has the potential to impact the delivery of new cancer treatments, from initial research to delivery in the NHS. Below is a summary of the current processes and the possible areas Brexit will impact.

Current processes

Impact of Brexit

Research funding

EMA/MHRA balance

Customs and trade

NHS

workforce

shortages

Clinical trial recruitment and regulation

Increased NHS budget pressures

5

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