AstraZeneca’s drug Tagrisso (ingredient: osimertinib) for the treatment of patients with metastatic epidermal growth factor receptor (EGFR)-T790M mutation might not be able to get an insurance coverage in Korea, local news reports said.
In August, the Health Insurance Review & Assessment Service’s drug reimbursement evaluation committee recognized Tagrisso as “appropriate” for health insurance coverage. However, AstraZeneca Korea recently gave up receiving the final approval due to a large gap between the company’s price suggestion for Tagrisso, and that of the HIRA, reports said.
The two were scheduled to engage in a final negotiation on Friday.
Observers said the HIRA might have tried to set the price of Tagrisso similar to Hanmi Pharmaceutical’s lung cancer therapy Olita, which has the same efficacy with Tagrisso.
However, AstraZeneca reportedly opposed to the HIRA’s logic, saying Tgrisso proved its efficacy and safety through global phase-3 clinical trials, whereas Olita was out on the shelf with a “conditional approval” after completing a phase-2 clinical test. Olita is recruiting patients for a local phase-3 clinical trial.
According to the HIRA’s drug pricing negotiation guideline, the company and the HIRA should complete the negotiation within 60 days from the beginning of the talk. The two sides had met several times before but failed to agree on Tagrisso’s price. If the final negotiation on Friday fails, Tagrisso will not be able to be covered by health insurance.
AstraZeneca has a firm stance on the pricing issue and is even considering giving up the insurance coverage, sources said.
“It’s true our price suggestion is largely different from that of the HIRA. The agency says we should take (the price of) Olita into account, but we regard Tagrisso as a separate issue,” an official at AstraZeneca said. “If we can’t narrow our differences at the last negotiation, we have no other choice but to give up the insurance coverage.”
Tagrisso and Olita are the only therapies that received the government’s approval to treat patients with T790M-mutation lung cancer in Korea. Olita was a hot issue last year because of Hanmi Pharm’s late reporting of a fatal side effect during clinical trials.
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