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NICE announces latest drug decisions – and it's mixed news for cancer drugs

11
Dec
2015

There are mixed feelings at the ICR today as NICE announces its latest decisions on cancer drugs. Our Science Information and Policy Manager, Dr Eva Sharpe, explains the latest announcement.

Posted on 11 December, 2015 by Dr Eva Sharpe

At the ICR we see a bottleneck developing  that prevents people with cancer from accessing new, innovative cancer drugs. The price of these drugs is often the problem as many cancer drugs are blocked by NICE or rejected for the Cancer Drugs Fund (CDF). The UK seems to be struggling to find an effective way to price and fund the expensive new cancer medicines that are now coming to market.

So today’s announcements from NICE seems to bring much positive news with two exciting new cancer drugs approved for use in England. However, it is not all positive as we also hear some very disappointing news for the prostate cancer drug abiraterone.

The Institute of Cancer Research has played a hand in all three of the drugs that NICE has been assessing, so I have been following the decisions closely at the ICR and I wanted to share them with you.

Olaparib and enzalutamide made available

In very exciting news, the first ever cancer drug targeted against an inherited genetic fault will be made available on the NHS.

The PARP inhibitor, olaparib, will be available on the NHS for women with BRCA mutant ovarian cancer, once they have undergone at least three rounds of chemotherapy.

The development of olaparib is underpinned by 20 years of research here at the ICR, starting when our scientists identified the breast cancer 2 gene, BRCA2. Our researchers then proposed a new treatment paradigm, which exploited the weakness of tumour cells with the mutation. You can read more about the development of olaparib in this feature article on how the ICR drove the science behind the pioneering cancer drug.

Earlier this year, Chief Executive of the ICR, Professor Paul Workman, blogged about what had been an incredibly disappointing week for olaparib after it had been both rejected for inclusion on the Cancer Drugs Fund, and not recommended in draft guidance from NICE, over the course of a couple of days.

In the latest stage of the appraisal, NICE showed welcome flexibility in assessing the drug in only a subset of patients who have taken the drug after undergoing at least three rounds of chemotherapy. As these patients access the drug later in the course of their treatment, the drug qualified to be assessed under the less stringent ‘end of life criteria’, which allows a higher threshold for cost effectiveness. When this new approach was combined with the fact that the drug was clearly very effective for patients and incredibly innovative the committee were able to approve the drug.

On the latest decision Professor Workman said: “It’s great news that NICE has changed its decision, and made olaparib available for women with BRCA-mutated ovarian cancer. Its approval by NICE is a defining moment in the history of targeted cancer treatments, although it is still frustrating that under the terms of the judgement patients cannot benefit until they have had at least three rounds of chemotherapy.”

Here at the ICR we’re delighted by the decision, and are looking forward to seeing what else the drug is capable of. Trials are already ongoing looking at olaparib in prostate, breast and gastric cancers. We look forward to seeing what the future holds for olaparib.

There was good news too around the prostate cancer drug enzalutamide, which is currently available on the NHS for men once they have undergone chemotherapy. In today’s decision enzalutamide is approved for use before chemotherapy, increasing options for men with advanced prostate cancer by enabling them to access the drug earlier in the course of their treatment and delay starting chemotherapy.

Professor Paul Workman said: “It is very welcome that NICE has decided that men with prostate cancer can access the drug enzalutamide without having to go through chemotherapy first. The drug, which the ICR and The Royal Marsden helped to develop for patients, has proven benefits for extending life and improving quality of life, and the decision will mean that men can benefit earlier in the course of treatment.”

Prostate cancer drug abiraterone continues to be blocked by NICE

But, in disappointing news, the prostate cancer drug abiraterone has again been turned down by NICE.

If you follow this blog then you'll know that we've been following NICE's appraisal of abiraterone closely over the last couple of years. The drug was discovered at the ICR, and developed it in partnership with The Royal Marsden hospital, and we consider it a real success story for the ICR and a great example of what British science can do.

Abiraterone has been available for men with advanced prostate cancer after chemotherapy in the UK since 2012, but strong evidence now shows that it is effective when used before chemotherapy, extending lives and delaying the time before men have to start on chemotherapy. This key clinical trial was led in the UK by ICR research Professor Johann de Bono, and was considered by the ICR to be one of the most important pieces of research that we were involved in that year.

NICE have been assessing the use of abiraterone before chemotherapy since 2012.The drug was turned down in August this year before pausing the decision to allow the manufacturers Janssen to discuss the price with the Department of Health and submit an amended Patient Access Scheme. The NICE committee reappraised the drug with the new pricing structure, but the draft decision today shows NICE has decided still not to recommend the drug.

The news is particularly disappointing because in October this year the Scottish Medicines Consortium recommended that abiraterone be available before treatment with chemotherapy on the NHS in Scotland for men with advanced prostate cancer.

Professor Paul Workman said: “It is a real blow that NICE has again decided to deny men the innovative prostate cancer drug abiraterone before chemotherapy. Abiraterone was discovered here at the ICR in England, so it is very disappointing that men in England and Wales will not be able to access the treatment – even though in Scotland it has been made available on the NHS. We need to challenge these kinds of inequalities in drug access across the UK.”

This frustrating decision is not the end of the road for abiraterone. The announcement today is a draft recommendation, and it will now go out for public consultation. The ICR is responding to the consultation by saying that there is clear evidence that abiraterone is effective and has much milder side-effects than conventional chemotherapy, giving men many extra months free of disease with better quality of life. Many men with prostate cancer are elderly and not all are fit enough to receive chemotherapy. Restricting abiraterone use to those who have already received chemotherapy will mean that a significant number of men could now miss out on abiraterone altogether.

We hope that the evidence generated during the consultation will be enough to make the committee change their mind. I will let you know what happens next.

Tags

abiraterone prostate cancer ovarian cancer olaparib
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