Bristol-Meyers Squibb (BMS) is reportedly having a hard time persuading its partner Ono Pharma Korea to resume reimbursement negotiations on Opdivo, an immuno-oncology drug.
On the other hand, Merck Sharp and Dohme (MSD) has begun renegotiations with the Ministry of Health and Welfare on Opdivo’s competitor, Keytruda.
|Immuno-oncology drugs Opdiva and Keytruda|
The health-welfare ministry began negotiations at the beginning of this year with different pharmaceutical companies on three immuno-oncology drugs subject to reimbursement -- Tecentriq, Keytruda and Opdivo. In its course, the ministry entered into pre-negotiations with their makers, proposing the presence of patients’ response as a critical factor for expanding reimbursement.
Roche’s Tecentriq (Atezolizumab) has managed to win expanded payment through bargaining with the ministry, but MSD’s Keytruda (Pembrolizumab) and BMS and ONO’s Opdivo (Nivolumab) still have a long way to go.
Pre-negotiation is a scheme put forth by the government to discuss the reimbursement criteria for treatments that are needed but put big financial burdens on public health insurance. It is designed to make a quick agreement on financial factors and expansion criteria in advance so that drugmakers can speed up the following process of drug price negotiations with the Pharmaceutical Benefits Evaluation Committee and the National Health Insurance Service.
Tecentriq is a latecomer compared to Keytruda and Opdivo but was the first to complete the pre-negotiations in April by agreeing on the government’s proposal on the presence of response. Roche has also finished price negotiation for its drug. The only thing left for the Swiss company is to submit the result to the Health Insurance Policy Deliberation Committee.
As a result of the negotiations, the health authorities will remove the criterion that limits “PD-L1 incidence’ for Tecentriq in the second-line treatment of patients with non-small cell lung cancer and urologic cancer. They also will apply the same payment criteria to Tecentria as that approved by the Ministry of Food and Drug Safety.
On the other hand, MSD and BMS-ONO initially turned down the ministry’s proposal for the “presence of response” as a condition for expanded reimbursement.
Keytruda was aiming to expand reimbursement for four indications, including the first-line treatment of non-small cell lung cancer. Opdivo was seeking to expand payment for seven indications, including renal cell carcinoma and gastric cancer.
The first round of negotiations broke down as both MSD and BMS-ONO rejected the government’s proposal, but the attitudes of the three companies toward renegotiations were starkly different.
The government proposed to have renegotiations to companies of both products, but only MSD agreed to it. Renegotiation between MSD and the government is going on, allowing patients at least to look forward to the possibility of reimbursement for Keytruda in first-line lung cancer treatment.
ONO has taken no action so far, causing rumors that the company may have given up expanding reimbursement for Opdivo. BMS is trying to persuade its partner company, but ONO reportedly remains silent.
“We are ready for renegotiations whenever ONO is willing. Patients certainly need immuno-oncology drugs. Efforts are needed from both the government and pharmaceutical companies for the expansion of the reimbursement,” a health-welfare ministry official said.
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