‘Tagrisso’ tenaciously attempts reimb. for 1st line NSCLC

AZ makes a winning bid …applies for insurance benefit after reducing scope to patients with a high treatment need

Eyes on whether the agenda will be put up for deliberation at the Review Committee for Cancer Disease meeting in September...PAG sends a letter of plea to relevant agencies

AstraZeneca Korea is attempting to receive insurance benefits for ‘Tagrisso’ once again after modifying its reimbursement standards.

 

Industry officials said that AstraZeneca Korea had recently reapplied for expansion of insurance benefit for its 3rd generation EGFR TKI Tagrisso (osimertinib) to first-line treatment in non-small cell lung cancer (NSCLC).

 

The key strategy for the approval of insurance benefits this round is in the reduced benefit standards.

 

In its application, AstraZeneca reduced the scope of its reimbursement to provide the benefit to those who have a high treatment need rather than in line with its indication of ‘NSCLC patients whose tumors have EGFR mutations, with exon 19 deletions or exon 21 (L858R) mutations.’ In other words, the company adopted the strategy to increases the justification of Tagrisso’s efficacy and treatment benefits.

 

Narrowing the scope of reimbursement would also naturally allow for a broader discussion on its fiscal impact.

 

Thus, whether the agenda will be put up for deliberation at the Health Insurance Review and Assessment service’s Review Committee for Cancer Disease meeting planned in September is gaining attention.

 

If reviewed, this will be the fourth time the agenda is discussed by the Review Committee for Cancer Disease As the committee passed MSD’s cancer immunotherapy ‘Keytruda (pembrolizumab)’ for the first-line treatment of lung cancer at the meeting in July after 4 years of deliberation, attention is focused on the committee’s decision for Tagrisso as well.

 

Tagrisso, which added its indication for first-line treatment of lung cancer in Korea in December 2018, aimed to expand its reimbursement to the indication in 2019.

 

However, after deliberation by the Review Committee for Cancer Disease in October, the committee decided to defer the decision until the full data from the Phase 3 FLAURA trial that studied the overall survival (OS) of NSCLC patients in first-line is disclosed.

 

Although AstraZeneca had submitted the full FLAURA data and expressed their will to accept most of the cost-sharing plan proposed by the government, the reimbursement fell through due to opposition from committee members (specialists) that there was an issue with the drug’s clinical efficacy.

 

AstraZeneca had attempted to reverse the decision by submitting the OS evidence confirming Tagrisso’s OS benefit in Asian patients from the FLAURA China study, but the committee’s response was, once again, a ‘No.’ After Tagrisso's failure to receive reimbursement in April, 1,713 lung cancer patients and their families sent an appeal to the government, the Korean Association for Lung Cancer, and AstraZeneca, “imploring approval for the first-line reimbursement of Tagrisso.”