NICE U-turn on prostate cancer therapy

by Amy Schofield 22. March 2016 10:48

The National Institute for Health and Care Excellence (NICE) has approved a prostate cancer drug that it previously rejected on the grounds of cost.

NICE has made a U-turn and now agreed that the drug, Zytiga (abiraterone), is affordable.

NHS patients in England with prostate cancer will now have early access to the drug that can delay the need for chemotherapy. NICE previously stated that the abiraterone, which originally cost £3000 per month, was not cost-effective in patients with early-stage cancers.

The approval comes after manufacturer Janssen agreed a lower price for the drug as well as submitting fresh data about the drug's effectiveness to NICE.

Abiraterone stops more testosterone from reaching the prostate gland, thereby stifling the tumour. It is currently used following chemotherapy at the end-of-life stage, to give patients a few extra months of life. 

Despite being approved for use on NHS patients in Scotland, the drug had previously been rejected by NICE for early-stage prostate cancer. Patients in England had to turn to their doctors to ask them to apply for the drug through the Cancer Drugs Fund.

The new cost for 30 days' supply of the drug on the NHS in England is £2,300 for 120 tablets.

The hormone therapy will now be offered to more patients and almost 6000 patients are thought to now be eligible each year for treatment with abiraterone. 

 

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Prostate cancer drug breaks NICE barrier

by JoelLane 21. October 2013 11:32

Xtandi web NICE has provisionally recommended Xtandi (enzalutamide) as a treatment for hormone relapsed metastatic prostate cancer.

The Astellas drug, which was launched in the UK in July, is recommended for adults in whom first-line hormonal therapy has failed and whose cancer has progressed during or after docetaxel chemotherapy.

The approval is conditional on a discount agreed in a confidential patient access scheme agreed between Astellas and the Department of Health.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE, said: “There are few treatments available for patients at this stage in their cancer so we are very pleased that we are able to produce draft guidance recommending enzalutamide. It is an effective treatment and it also allows patients to be treated at home as it can be taken orally.”

The NICE decision, if confirmed, would take Xtandi out of the clinical and commercial ‘twilight zone’ of therapies available to NHS patients only via the Cancer Drugs Fund, which will cease to be available at the end of this year.

Xtandi has a unique mechanism of action: it takes effect at three distinct steps in the androgen receptor signalling pathway within cancer cells, reducing their growth and potentially killing them.

Metastatic prostate cancer is incurable, and 72% of patients die within three years of diagnosis. Xtandi has been shown to improve overall survival by 4.8 months relative to placebo, and to be less toxic than the standard treatment (abiraterone).

NICE accepted that the cost per QALY for enzalutamide compared with abiraterone was “associated with some degree of uncertainty” – but it was “satisfied” that the cost per QALY was below the £30,000 threshold.

NICE reverses decision on prostate cancer treatment

by IainBate 27. June 2012 12:13

NICE reverses decision on prostate cancer treatment - Pharmaceutical Field NICE’s decision to recommend the use of Zytiga (abiraterone) in final guidance to treat prostate cancer has left Janssen “delighted”.

The treatment originally failed to get backing from NICE in combination with prednisone or prednisolone after the Institute deemed it to be too expensive – despite its clinical benefits.

However, after Janssen provided additional patient data and a revised Patient Access Scheme (PAS), NICE said it was happy to recommend the treatment as an option for the NHS.

Martin Price, External Affairs Director, Janssen UK, said the company had gone to “significant lengths” to find a solution that allows patients to be treated with the “innovative, UK discovered medicine, routinely on the NHS”.

The decision to recommend the treatment has also been backed by Dr Heather Payne, Consultant Clinical Oncologist, University College London Hospitals. She commented: “This is good news for patients – for whom historically there have been few treatment options available – and also for the patients’ families.”

Zytiga may potentially extend the lives of patients by more than three months. It is now recommended in combination with prednisone or prednisolone as a treatment option for castration-resistant metastatic prostate cancer that has progressed on or after one docetaxel-containing therapy.

Zytiga extended life of convicted bomber

by JoelLane 21. May 2012 10:55

zytiga_janssen resized The life of the man convicted of the Lockerbie bombing may have been extended for two years by Janssen’s cancer drug Zytiga (abiraterone).

Released from a Scottish prison in 2009 on health grounds, Abdelbaset al-Megrahi has died from metastatic prostate cancer years later than was predicted.

The case, which has caused political controversy, highlights the availability worldwide of cancer drugs unavailable in the UK.

Ironically, al-Megrahi’s death came within days of NICE revising draft guidance to approve the use of Zytiga following a price deal with Janssen.

The decision to release al-Megrahi, whom doctors had judged to be within three months of death, was widely criticised – and more so as he remained alive through 2010 and 2011.

Controversy over the safety of his conviction added to the political embarrassment resulting from his extended survival, perhaps the only case in which prolonging life has been considered a negative outcome.

Oncologist Professor Karol Sikora examined Megrahi in prison in July 2009 and said he was at the “end stage” of cancer. He has since commented: “The care he received in Libya helped prolong his life.”

Zytiga is an oral medication for advanced prostate cancer that blocks the synthesis of testosterone in the body.

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Campaigners welcome Zytiga decision

by IainBate 16. May 2012 11:54

Pharma NICE Update NICE’s decision to recommend Janssen’s prostate cancer drug Zytiga (abiraterone) has been backed by patient groups.

Zytiga is now recommended in new draft guidance after further patient data and a revised Patient Access Scheme (PAS) convinced NICE to reconsider its previous rejection of the drug.

Dr Harpal Kumar, CEO of Cancer Research UK, said the decision is “wonderful news for patients” and believes the U-turn reflects “the public’s disappointment at the initial refusal”.

In February this year, NICE failed to recommend the treatment in combination with prednisone or prednisolone after deeming it to be too expensive – despite its clinical benefits.

At the time of the decision, Janssen said it would work closely with NICE to gain a positive recommendation. That included supplying a revised PAS and additional data on a subgroup of patients who may receive the most benefit from the cancer drug.

Janssen also submitted further information on the number of patients for whom Zytiga is licensed, enabling it to be considered under NICE’s end of life criteria.

Professor Johann de Bono from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, who led the pivotal trials of Zytiga, said he was “thrilled” the revised data has changed NICE’s original decision.

“Abiraterone acetate is one of only a handful of life-extending drugs for these men in the UK and, importantly, it can also improve quality of life,” he said. “Some of my patients have been taking abiraterone for several years through a clinical trial and are still pain free.”

Prostate cancer is the second most common cause of cancer deaths in UK men. More than 10,000 men die each year with a further 40,000 men diagnosed annually.

SMC turns down prostate cancer drug

by JoelLane 14. March 2012 12:52

Pf product news The Scottish Medicines Consortium (SMC) has failed to recommend a drug than can prolong the life of sufferers from prostate cancer by three months.

The decision follows provisional NICE guidance not recommending Zytiga (abiraterone) from Johnson & Johnson.

Both authorities determined that the drug’s benefits did not justify its high cost.

Zytiga has been shown to prolong life by up to three months in men with advanced prostate cancer, at a cost of £3,000 a month.

One of Zytiga’s benefits is that it can be taken orally by the patient at home.

The drug will only be available in Scotland through Individual Patient Treatment Requests – a system that makes non-recommended medicines available to individual patients in certain circumstances.

Dr Harpal Kumar, Chief Executive of Cancer Research UK, said: “Abiraterone is an important treatment because patients and doctors value the extra months of life it can give if prostate cancer has come back after chemotherapy.

“We need to find a way for it to be routinely available through the NHS. The SMC must find a better way to ensure drugs that are proven to be effective for patients get approved.”

Following NICE’s provisional guidance in February, health authorities in Wales have approved the use of Zytiga on an interim basis before the final decision.

Cancer Research UK commented that Zytiga should be made available for end of life care, while The Prostate Cancer Charity said the provisional NICE decision “must be overturned”.

Until the final NICE guidance appears, Zytiga can still be approved locally for prescription in England.

Prostate cancer is the most common cancer affecting men in the UK, where it causes 10,000 deaths each year.

NICE under attack over Zytiga decision

by IainBate 2. February 2012 15:14

Pharma NICE Update Cancer Research UK has urged NICE to consider its decision on Janssen’s Zytiga (abiraterone) for the treatment of castration-resistant metastatic prostate cancer.

NICE has issued draft guidance not recommending the use of the treatment in combination with prednisone or prednisolone after deeming it to be too expensive to use on the NHS.

Professor Peter Johnson, Cancer Research UK’s Chief Clinician, says the decision “makes no sense” after the treatment has been shown it can extend the lives of patients by more than three months.

A Patient Access Scheme has been agreed between the Department of Health and Janssen. But, even with this in place, it was not deemed to be a cost effective use of NHS resources.

NICE also said Zytiga did not meet the criteria to be considered under the special arrangements for drugs treating people at the end of their life as the population for which it is licensed can’t be considered small enough.

Sir Andrew Dillon, NICE Chief Executive, says the Institute is “disappointed” not to recommend the treatment for use. “It is an expensive drug and the independent advisory committee that made this decision did not feel the drug provided enough benefit to patients to justify the price the NHS is being asked to pay, even with the discount that the manufacturer has offered,” he said.

Cancer Research UK said that Zytiga has been one of the most requested treatments from the Cancer Drugs Fund due to the value placed upon it by patients and doctors. The charity helped discover Zytiga through its research and will receive royalties if it is used. Royalties, it says, which will then be reinvested into further cancer research.

Professor Johnson believes a way must be found for it, and other expensive treatments, to be made available to patients on the NHS. “At the moment it is too expensive and NICE must find a better way to ensure drugs that are already working for patients get approved,” he added.

Dr Harpal Kumar, Chief Executive at Cancer Research UK, said the charity was “hugely frustrated” that Zytiga was deemed not to offer value for money. “We feel extremely let down that the drug’s manufacturer couldn’t offer NICE a price they could agree on,” he said.

“NICE should take another look at the way they have reviewed the cost effectiveness of abiraterone. We hope this, and a revised offer from the manufacturer, will result in the drug being available to patients who desperately need it.”

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