Astellas’ two oncology drugs near reimbursement

Padcev, Vyloy clear pricing negotiations after failing CDDC review in February last year

Combination regimen with other companies’ drugs and companion diagnostics posed hurdles…reimbursement now within reach

Astellas Pharma Korea is finally seeing its efforts pay off. Two of its oncology drugs are finally nearing national health insurance coverage after a series of setbacks.

The two drugs are antibody-drug conjugates (ADCs) Padcev (enfortumab vedotin) and targeted cancer therapy Vyloy (zolbetuximab).

Both drugs failed in their first attempts to secure reimbursement last year before succeeding on resubmission. Subsequently, they cleared the Health Insurance Review and Assessment Service’s (HIRA) Drug Reimbursement Evaluation Committee and price negotiations with the National Health Insurance Service (NHIS). However, the last hurdle to reimbursement differed for the two drugs.

Their reimbursement journeys initially followed similar paths. The Cancer Disease Review Committee first reviewed Padcev and Vyloy in February last year, but neither secured reimbursement criteria. Both applications were subsequently resubmitted and succeeded in having reimbursement criteria established at the committee’s October meeting last year.

Padcev drops monotherapy and goes all in on combination regimen

The paths of the two drugs diverged thereafter. The biggest hurdle for Padcev was that its regimen involved combination with another company’s new drug, MSD Korea’s Keytruda (pembrolizumab). The Padcev combination initially failed to clear the Drug Reimbursement Evaluation Committee.

Astellas applied for reimbursement of the Padcev-Keytruda combination in November 2024. After clearing the Cancer Disease Review Committee in October last year, the regimen was deemed appropriate for reimbursement by the Drug Reimbursement Evaluation Committee this April. Astellas immediately accepted the committee’s decision and moved quickly into price negotiations.

The issue was that adjusting Padcev’s price alone would not be enough. While Astellas was the company seeking reimbursement, the combination partner, Keytruda, is an MSD product. The NHIS therefore had to conduct separate negotiations with Astellas and MSD to reimburse the combination regimen.

Keytruda, in particular, is an immunotherapy already reimbursed across multiple cancer indications. Adding the first-line urothelial carcinoma combination regimen required separate adjustments over factors including its additional financial impact on the national health insurance system and projected utilization. Failure to reach an agreement with either company could have halted reimbursement of the entire combination regimen.

As a result, negotiations ultimately ran beyond the statutory 60-day period and, following two extensions, were finally concluded in mid-September. Although the process took longer than expected, MSD’s cooperation was also notable given that the company has already faced repeated price reductions through numerous reimbursement expansions.

Under the final agreement, Padcev received insurance ceiling prices of KRW 970,000 for the 20 mg dose and KRW 1,450,000 for the 30 mg dose. Keytruda is understood to have retained its listed price, with financial-sharing terms adjusted through mechanisms including a risk-sharing agreement. HIRA’s proposed reimbursement criteria currently call for coverage to take effect Oct. 1.

Vyloy overcomes companion diagnostic issue, only to face extended negotiations

Vyloy’s path was no smoother. Approved in Korea in September 2024, Vyloy failed its first Cancer Disease Review Committee review in February last year and was resubmitted for reimbursement in June. It cleared the committee on its second attempt in October, but progress slowed again at the pharmacoeconomic evaluation stage.

More than 6 months passed between the cancer committee decision and review by the Pharmacoeconomic Evaluation Subcommittee. Vyloy cleared the subcommittee in May and was ultimately deemed appropriate for reimbursement by the Drug Reimbursement Evaluation Committee in June, meaning roughly 7 months elapsed between the two committee decisions

Vyloy also faced an issue beyond the drug itself -- the CLDN18.2 companion diagnostic (CDx) required to identify eligible patients rose as another issue. Issues surrounding the companion diagnostic device’s new health technology assessment delayed the drug’s formal Korean launch until March this year, while access to companion diagnostics and its reimbursement fee were also raised as issues during reimbursement discussions.

Even after clearing the Drug Reimbursement Evaluation Committee, the final hurdle proved challenging. Negotiations with the NHIS began in June, but disagreement over an appropriate price prevented the parties from reaching a deal within the original negotiation period, leading to an extension. An agreement was ultimately reached this month after negotiations continued into the final stretch.

As a result, Padcev and Vyloy now stand short of the finish line after reimbursement journeys spanning roughly a year and a half, from their initial cancer committee rejections to extended price negotiations.

Attention now turns to the final reimbursement and what lies ahead for the two drugs: Padcev, which had to navigate the structural complexities of Korea’s reimbursement and negotiation system for a combination regimen involving another company’s new drug, and Vyloy, which faced pharmacoeconomic and companion diagnostic challenges associated with a targeted therapy built around a new biomarker.