Cancer Committee lets down both Keytruda and Tagrisso

‘Deferred’ and ‘unapproved,’ rather requested MSD to submit additional data

Despite commitment to accept pricing adjustment, AstraZeneca faced opposition from oncologists

Apparently, neither one of Keytruda and Tagrisso won the Cancer Deliberation Committee’s nod.

 

According to the pharmaceutical industry sources on May 1, Health Insurance Review and Assessment Service (HIRA) Cancer Deliberation Committee convened a meeting after postponing it twice due to COVID-19, and decided to ‘defer’ the reimbursement decision on MSD’s Keytruda (pembrolizumab) and ‘unapproved’ AstraZeneca’s Tagrisso (osimertinib).

 

Basically, the reimbursement expansion on immunotherapy Keytruda and targeted therapy Tagrisso would unlikely to happen any time soon in Korea.

 

The Cancer Deliberation Committee reviewed granting reimbursement on Keytruda’s five indications, including as a first-line treatment (monotherapy and combination therapy) for non-small cell lung cancer (NSCLC), monotherapy for second or later-line treatment in bladder cancer, and monotherapy for third or later-line treatment in or refractory classical Hodgkin lymphoma.

 

In March 2017, Keytruda monotherapy has been approved as a first-line treatment in patients with NSCLC.

 

And the MSD Korea has submitted an application for reimbursement approval on the monotherapy indication to be used as a first-line treatment in September 2017, and continued the talk with the government for over two years.

 

Regardless of the effort, the talks fell through in September last year.

 

Considering the health authority’s decision, MSD showed its commitment by submitting unasked-for economic evaluation data on the first-line treatment in NSCLC to seek for the reimbursement expansion.

 

But the Cancer Deliberation Committee rather demanded additional data on reducing the cost and deferred the decision.

 

As for Tagrisso, the result was even grimmer.

 

AstraZeneca Korea has submitted a reimbursement expansion application for the first-line indication of its osimertinib treating epidermal growth factor receptor (EGFR)-mutated NSCLC.

 

Although the company has expressed its assertive intention to reduce the financial burden as proposed by the government, the committee members (oncologists) raised the issues on the treatment’s clinical efficacy and insisted on not approving the reimbursement.

 

The anticancer treatment has been deferred by the committee once already in last October.

 

The committee’s decision then was due to the Asian subset analysis result of the FLAURA Phase 3 trial in Tagrisso, specifically confirming the overall survival (OS) value.

 

The study found the median OS with osimertinib was 38.6 months, 6.8 months longer than first generation EGFR-TKIs, Iressa (gefitinib) and Tarceva (erlotinib).

 

However, hazard ratio (HR) in the Asian subset analysis recorded a value of 0.995.

 

Compared to the standard value of ‘1,’ the value difference of 0.005 meant no significance.

 

Regarding the study result, some academics have questioned the efficacy of Tagrisso as a first-line therapy in Asian race.

 

Meanwhile, others have raised concern over the committee applying double standard as first and second generation EGFR-TKIs, Iressa, Tarceva and Giotrif (afatinib), have been listed for reimbursement as first-line therapies without concrete evidence on the OS.

 

Some also argued the solution is in drug pricing adjustment.

 

Based on the speculations, AstraZeneca also persuaded its headquarters and expressed its intention to adjust the pricing, but the deliberation result was a let-down.