AZ calls for ‘urgent measures’ after ovarian cancer drug refused

AstraZeneca (AZ) has hit out at the rejection of its ovarian cancer drug Lynparza, which NICE has judged to be not cost effective.

NICE issued preliminary guidance yesterday, saying the data AZ provided wasn't enough to justify Lynparza's price set against benefits for patients.

The UK-headquartered pharma company has strongly criticised NICE and the wider UK system, calling on the government to address access to medicines urgently.

A new, government-sponsored 'Accelerated Access' review is set to publish recommendations by December this year, but AZ says this process is too slow, and faster action is needed.

Targeting ovarian cancer

Lynparza (olaparib) is the first targeted maintenance therapy for patients with platinum-sensitive relapsed (PSR) BRCA-mutated (BRCAm) high-grade serous ovarian cancer – women who have responded to earlier therapy and have a genetic mutation which makes their cancer more aggressive.

Clinical trials has shown that drug can give BRCAm women an extra seven months without the disease progressing compared to standard treatment, and up to two years in some cases.

However the drug has so far failed to show it can help women live longer, even in the BRCAm group, and NICE says the drug costs too much to justify its use on the NHS.

Lynparza's list price is £3,950 for 28 days of treatment; a high price, but typical of many newer cancer drugs. AZ and the Department of Health have agreed a confidential discount (patient access scheme) to lower costs, but this deal can only be used if and when Lynparza is approved by NICE.

The drug also far exceeded the £30,000 threshold for NICE's QALY cost effectiveness measure, coming in at just under £50,000.

The news is particularly bad for AZ, as Lynparza has also just been refused by the Cancer Drugs Fund (CDF), a double rejection which locks it out of England's market completely.

AZ needs Lynparza to be a success in all the major markets, as it rebuilds its business after the loss of key blockbuster products, and successfully repelling Pfizer's takeover bid in 2014.

A 'no' from NICE is observed in countries around the world, and AZ has hit out at NICE and other obstacles preventing new drugs reaching patients in the UK.

In a strongly-worded statement it said: "The draft recommendation by NICE sharpens the contrast between the EMA's approach to accelerating access to personalised medicines that have shown clear and demonstrable clinical benefit in patients with life-threatening disease and very limited alternative treatment options, and the approach of NICE and the CDF."

The company says it supports the government's Accelerated Access to Medicines Review and NHS England's proposals for a 'more sustainable, reformed CDF', but says any resulting proposals won't be implemented until 2016 at the earliest.

It also said NICE's decision was 'inconsistent' with the government's 100,000 Genomes Project, which aims to pioneer the use of genomic data to stratify patient populations and help produce more targeted therapies.

AZ said it was therefore 'calling on the government to introduce urgent transitional measures as soon as possible to ensure patient access to newly licensed medicines that have been approved on the basis of unprecedented early trial data'.

A flawed system or a flawed drug?

Does Lynparza show once again the inflexibility of NICE and the UK's market access arrangements? Or does this represent another failure for AZ's R&D unit, bringing a drug to market which just isn't effective enough? On the first question, it seems everyone in the UK – NICE, frontline clinicians, the government, pharma and patient groups – agree change is needed to a fragmented, dysfunctional system. However, reaching consensus on what is a fair deal for all will be difficult, if not impossible, given the wave of new high priced drugs, and the huge pressure on NHS finances.

On the question of olaparib's value, time will tell, as AZ has its phase III SOLO studies looking at overall survival. The company is investigating the drug in a number of other tumour types, including breast cancer and advanced solid tumours, and in combination with other drugs.

However its data will need to be compelling. There are a number of potential challengers in the field, not least Clovis' rival poly-ADP-ribose polymerase (PARP) enzyme inhibitor drug, rucaparib, which has won FDA Breakthrough Therapy Designation, and has just posted promising data at ASCO.

External link

Resurrected cancer drug faces regulators (Nature, June 2014)