AZ withdraws cancer drug Lynparza from CDF evaluation

Cancer
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On the day that England's Cancer Drugs Fund (CDF) reduced the number of indications it will fund to 59 from 84, AstraZeneca (AZ) announced that it had withdrawn its ovarian cancer drug Lynparza (olaparib) from the CDF evaluation process.

AZ said it had concerns that the CDF procedure was geared more for drugs already on the list and wanted to revise its submission based on discussion with the review panel. The company stressed that it was committed to gaining reimbursement as soon as possible, with Lisa Anson, AZ UK president, saying they "firmly believe in the value Lynparza can offer to patients with BRCA-mutated ovarian cancer".

She stated, "We have been concerned by a number of limitations within the recent re-review process, which has been geared more towards the assessment of those medicines previously on the CDF list than newly-approved medicines like Lynparza. In particular, we feel it is important that emerging evidence should be taken into account in assessing Lynparza's clinical value.

"AstraZeneca will continue to work with the Government, NHS and NICE to implement a sustainable funding model to ensure patient access to the oncology and specialist care medicines of the future, one that achieves early access for patients, cost-effective reimbursement through regular NHS channels and provides clarity of process to industry."

The company believes that, under the original criteria for CDF funding, Lynparza would have been included on the list of routinely-funded medicines, pointing out that one of the original founding principles of the CDF was to enable patients to benefit from regulatory approved cancer medicines, like Lynparza, as they await NICE review.

The drug was granted approval in the US and EU in December 2014 as a first-in-class PARP inhibitor therapy for women with BRCA-mutated ovarian cancer who have previously undergone chemotherapy.

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Linda Banks

13 January, 2015