ICR urges continued negotiation after NICE rejection of olaparib for early breast cancer

Statement: The Institute of Cancer Research, London

FOR IMMEDIATE RELEASE, THURSDAY 10 NOVEMBER

ICR urges continued negotiation after NICE rejection of olaparib for early breast cancer

The Institute of Cancer Research, London, is urging NHS-England, NICE and pharmaceutical company AstraZeneca to continue discussions after the disappointing decision not to recommend targeted drug olaparib for women with early-stage, high-risk, inherited breast cancer.

Olaparib cuts the risk of cancer recurrence and improves survival when added to standard treatment for people diagnosed with high-risk early-stage breast cancer who have inherited faults in their BRCA1 or BRCA2 genes – faults now routinely detected through NHS breast cancer and family history genetics clinics.

The draft decision, announced by NICE today (Thursday), means people diagnosed with these forms of early-stage, inherited breast cancer in England and Wales will not yet have access to a cutting-edge treatment that targets the specific biology of their cancer to help them remain free of cancer long term and improve their overall survival.

The decision follows unsuccessful attempts to widen access to olaparib – a drug developed through UK-led and funded science – for a range of cancers linked to BRCA1 and BRCA2 gene mutations, including advanced prostate cancer and advanced breast cancer.

The Institute of Cancer Research (ICR) believes widening access to olaparib will rely on successful negotiation between commercial partners, NHS-England and NICE – to agree a pricing structure which is affordable for the NHS and commercially viable.

One of the barriers has been the difficulty in allowing flexibility in the price of drugs for new indications where the drug is already on the market.

The ICR believes it is essential a solution is found as soon as possible, not only for patients with early-stage breast cancer and BRCA mutations, but also for people with prostate cancer and particular mutations in their tumours.

Olaparib targets the specific biology of the BRCA genes, exploiting a weakness in cancer cells while leaving healthy cells much less affected. The ICR worked with many partners including Breast Cancer Now, Cancer Research UK and industry partners to discover how to use olaparib and other PARP inhibitor drugs for people with mutations in their BRCA1 or BRCA2 genes, or faults in other DNA repair genes.

Researchers from the ICR and The Royal Marsden NHS Foundation Trust then led early clinical trials assessing the benefits of olaparib against cancers with mutations in BRCA1 and BRCA2 genes. Professor Andrew Tutt is lead Principal Investigator and chair of the steering committee for the international phase III OlympiA Trial, coordinated globally by the Breast International Group, which showed the benefits of olaparib for improving early breast cancer survival, and has led to the licensing of olaparib in this context in many countries globally.

Professor Andrew Tutt, Professor of Oncology at The Institute of Cancer Research, London, and King’s College London, said:

“Olaparib is a life-changing drug for patients diagnosed with this kind of inherited early-stage breast cancer. That is why it has achieved a license in many countries, including the UK, and is recommended by independent international clinical guidelines groups. Today’s decision is a missed opportunity to help more people remain cancer free after treatment, live well and survive breast cancer.”

“I would urge the manufacturer, NHS-England and NICE to agree a price for olaparib that is affordable for the NHS and is structured flexibly enough to be commercially viable.”

Professor Kristian Helin, Chief Executive of The Institute of Cancer Research, London, said:

“This is a disappointing decision that will deny people with inherited breast cancer access to a personalised treatment that can improve their survival and help keep them free of cancer in the long term.

“It’s the latest instance where it has not been possible to make olaparib available for people with cancer at a price that the NHS can afford, and it points to wider failings in how we agree drug pricing in England and Wales.

“Targeted drugs like olaparib, which exploit specific faults in cancer and are effective across multiple cancer types, are being held back by out-dated single-price systems. We urge NHS-England and NICE to consider more flexible models of drug pricing, which would allow price to vary depending on a drug’s use, while providing reassurance that new treatments will deliver on their promised benefits. These discussions must go ahead with urgency – for every day that access to olaparib is restricted, people with cancer will lose their lives or see a cancer that could have been suppressed, return.

Ends

Declared interests: The ICR works with a wide variety of companies as the most effective way of developing new cancer treatments for patients – any invention income received is ploughed back into its research. The ICR receives a royalty and other payment from AstraZeneca in respect of sales of olaparib (Lynparza) and other PARP inhibitors. A proportion of these payments is shared with Professor Tutt under the ICR’s Rewards to Discoverers Scheme. Professor Tutt as OlympiA Steering Group Chair has declared these interests and the ICR’s benefits to regulatory authorities.

 Notes to editors:

1. Olaparib for early-stage, high-risk, inherited breast cancer was approved by the MHRA in September 2022, following similar approvals from the European Medicines Agency (EMA) in the EU and the Federal Drug Administration (FDA) in the US.
2. Approximately 300 people per year would have been eligible for treatment with olaparib if NICE had recommended it for this indication.
3. Olaparib, a poly-ADP ribose polymerase (PARP) inhibitor, was the first cancer drug targeted against an inherited genetic mutation, and its development was underpinned by two decades of research carried out by scientists at the ICR.
4. Inherited mutations in the BRCA1 or BRCA2 genes account for 5 per cent of all breast cancers. Women with early-stage breast cancer who have inherited BRCA1 or BRCA2 mutations are typically diagnosed at a younger age.

For more information please contact Julia Bakker in the ICR press office on 02071535396 or julia.bakker@icr.ac.uk. For enquiries out of hours, please call 07595 963 613.

The Institute of Cancer Research, London, is one of the world's most influential cancer research organisations. Scientists and clinicians at The Institute of Cancer Research (ICR) are working every day to make a real impact on cancer patients' lives. Through its unique partnership with The Royal Marsden NHS Foundation Trust and 'bench-to-bedside' approach, the ICR is able to create and deliver results in a way that other institutions cannot. Together the two organisations are rated in the top four centres for cancer research and treatment globally. The ICR has an outstanding record of achievement dating back more than 100 years. It provided the first convincing evidence that DNA damage is the basic cause of cancer, laying the foundation for the now universally accepted idea that cancer is a genetic disease. Today it is a world leader at identifying cancer-related genes and discovering new targeted drugs for personalised cancer treatment. The ICR is a charity and relies on support from partner organisations, funders and the general public. A member institution of the University of London, it is one of the UK’s leading higher education institutions, placing first for biological sciences and second overall in the definitive ‘REF2021’ rankings of UK university research quality, impact and environment, and provides postgraduate higher education of international distinction. The ICR's mission is to make the discoveries that defeat cancer. For more information visit ICR.ac.uk