AZ 'Tagrisso', Positive Outlook for Expanded 'First-Line Lung Cancer Treatment Coverage' Within the Year

Passed Quality Review and Drug Evaluation Committee
Possible Reimbursement Within This Year

Yuhan's 'Reclaza' Faces Fierce Reimbursement Competition

Chemotherapy Combination Clinical Results to Be Revealed at Next Week's World Lung Cancer Conference

The expansion of insurance coverage for AstraZeneca (AZ)'s non-small cell lung cancer treatment 'Tagrisso' (active ingredient osimertinib) as a first-line therapy, which had been stalled, is expected to take place as early as this year. While the latecomer competitor Yuhan Corporation's 'Leclaza' (lazertinib) is rapidly closing the gap, Tagrisso has cleared the second hurdle of the Drug Benefit Evaluation Committee first, regaining an advantage in the race to secure first-line insurance coverage.

AstraZeneca's non-small cell lung cancer treatment 'Tagrisso (active ingredient Osimertinib)'
[Photo by Korea AstraZeneca]

The Health Insurance Review and Assessment Service (HIRA) announced on the 7th that at the 10th Drug Benefit Evaluation Committee meeting of 2023, it decided that the expansion of insurance coverage for Tagrisso as a first-line treatment was appropriate. Cancer drugs must go through the Cancer Disease Deliberation Committee, the Drug Benefit Evaluation Committee, and the Health Insurance Policy Deliberation Committee before insurance coverage can be applied. After overcoming the first hurdle at the Cancer Disease Deliberation Committee in March on the fifth attempt, Tagrisso has now passed the second hurdle. Accordingly, the expansion of insurance coverage for non-small cell lung cancer as a first-line treatment is expected to be possible as early as this year or around January next year.

Tagrisso, developed by AZ, was approved in 2016 as a second-line treatment for patients with locally advanced or metastatic non-small cell lung cancer who had previously been treated with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and developed the EGFR T790M mutation. In 2018, its indication was expanded to first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. In 2021, the indication was further extended to include adjuvant therapy after complete tumor resection.

Since expanding the indication to first-line treatment in 2018, AZ has continuously strived to expand insurance coverage for Tagrisso as the "globally recognized first-line therapy for EGFR-mutated non-small cell lung cancer." However, due to a lack of efficacy analysis studies targeting Asians, it repeatedly failed to pass the first hurdle of insurance coverage expansion at the Cancer Disease Deliberation Committee until it finally succeeded on the fifth attempt in March. Although there were concerns that the nightmare of the Cancer Disease Deliberation Committee might recur as the Drug Benefit Evaluation Committee submission was repeatedly delayed, Tagrisso has now passed the committee again after about six months. Expectations are that if Tagrisso succeeds in entering the first-line treatment market, domestic prescription sales, which were 106.5 billion KRW last year, could increase by three to five times.

The competing new drug Leclaza is also rapidly narrowing the gap and catching up. Leclaza, approved as a second-line treatment in 2021, received approval from the Ministry of Food and Drug Safety (MFDS) for first-line indication expansion in June. Two months later, it passed the Cancer Disease Deliberation Committee, quickly closing a five-year gap and standing on equal footing with Tagrisso. However, with Tagrisso now clearing the hurdle at the Drug Benefit Evaluation Committee, the gap is widening again.

Additionally, AZ will unveil clinical trial results of 'FLAURA2,' which uses a combination of Tagrisso and platinum-based chemotherapy agents such as cisplatin as a first-line treatment for patients with EGFR-mutated non-small cell lung cancer, at the 2023 World Conference on Lung Cancer (2023 WCLC) held in Singapore from the 9th to 12th (local time). This combination therapy is interpreted as AZ's plan to widen the gap again with Leclaza, which was licensed out to global big pharma Janssen and is aiming to dominate the first-line treatment market through combination therapy with 'amivantamab.' The FLAURA2 trial has already released topline data showing a significant improvement in progression-free survival (PFS) compared to Tagrisso monotherapy, with detailed results scheduled to be presented at the plenary session on the 11th.

Meanwhile, the Drug Benefit Evaluation Committee also approved AZ's neurofibromatosis treatment 'Koselugo,' known to cost about 200 million KRW annually. Although it was first submitted to the committee last year after MFDS approval in 2021 and failed, it was reconsidered last month and finally passed after the government and AZ agreed on a financial sharing plan, succeeding on the third attempt.

At the 9th Drug Benefit Evaluation Committee meeting held the previous day, it was decided that while some insurance coverage appropriateness was recognized for hyaluronic acid (HA) sodium eye drops, insurance coverage was deemed inappropriate for exogenous diseases caused by surgery, drug-induced causes, trauma, or contact lens wear. For endogenous diseases such as Sj?gren's syndrome, Stevens-Johnson syndrome, and dry eye syndrome, appropriateness was recognized on the condition that insurance coverage standards set limits on the amount prescribed per patient visit and the total annual prescription amount per patient to ensure proper use.

The domestic hyaluronic acid eye drop market is about 270 billion KRW annually and is expected to exceed 300 billion KRW for the first time this year as the market continues to grow. The industry is relieved that conditional insurance coverage was recognized for endogenous diseases, which account for most of the market, but remains alert to follow-up measures.

This content was produced with the assistance of AI translation services.