AstraZeneca says its lung cancer drug still waiting for approval

A last-chance treatment for lung cancer has spent more than 40 months in the Irish approval system for new medicines, according to its manufacturer.

Pharma giant AstraZeneca said it continued to engage with the Health Service Executive over the reimbursement of Tagrisso (osimertinib), which was the only licensed treatment for a rare mutation of lung cancer.

About 11 patients would be eligible to take the drug and are not currently receiving treatment in Ireland, according to the company. It said it was “hopeful of reaching a positive conclusion for Irish patients in the coming weeks”.

AstraZeneca was responding to issues raised by Fianna Fáil TD Marc MacSharry, who said Tagrisso was available to “almost every patient in the EU” but not in Ireland.

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In February 2016, AstraZeneca submitted a reimbursement application for Tagrisso, which is used to treat a mutation of non-small cell lung cancer known as [EGFR]T790M.

The National Centre for Pharacoeconomics (NCPE) recommended against reimbursement, after which the manufacturer submitted updated clinical evidence for the drug. The NCPE then carried out a full assessment but this was “recommissioned” by the HSE after the company submitted more data at the end of the original assessment process.

Cost-effectiveness

Completed in May 2018, this found Tagrisso offered very low probability of cost-effectiveness and said it should not be considered for reimbursement unless cost-effectiveness could be improved relative to existing treatments.

At that stage, the NCPE estimated the cost of the drug at €25-€30 million over five years.

Mr MacSharry claimed the HSE had cited cost-effectiveness and a lack of maturity of clinical data in refusing the treatment “despite being presented with the best commercial offer in Europe and comparable clinical data to other EU reimbursement agencies”.

“Considering that lung cancer is the leading cause of cancer death in Ireland and the incidence of lung cancer is only expected to increase in the coming years, the Government should be prioritising access to the latest lung cancer therapies rather than allowing an outdated reimbursement system to deny access to Irish patients.

“There is something very wrong with our system if our patients are being left behind and denied access to the latest medicines.”