Why Keytruda’s smile wavers after passing CDRC deliberation

The burden of ‘conditional’ approval… difficulties expected in the next steps of reimbursement - the Pharmaceutical Benefit Appraisal Committee and drug negotiations

CDRC may have passed the agenda due to the pressure of leaving the issue pending …What MSD proposes as an alternative will be key

The drug finally was able to pass deliberations by the Review Committee for Cancer Diseases, but still, the company's smile wavers due to the bitter aftertaste left by the committee’s ‘conditional’ approval.

 

With MSD Korea’s cancer immunotherapy ‘Keytruda (pembrolizumab)’ passing deliberations by the Review Committee for Cancer Diseases in July, industry expectations are rising on the possibility of the drug’s benefit coverage being expanded to first-line in non-small cell lung cancer (NSCLC) However, under the air of anticipation there lies concerns as the Review Committee for Cancer Diseases had put forward a condition for granting the nod to Keytruda.

 

During deliberations, the Review Committee for Cancer Diseases once again mentioned Keytruda’s equity with Tecentriq to MSD Korea, requesting additional modifications to be made to the cost-sharing plan.

 

This indicates that the drug pricing negotiations with the Pharmaceutical Benefit Appraisal Committee or the National Health Insurance Service will act as a variable in the discussion of Keytruda's benefit expansion to the lung cancer indication.

 

The agenda to expand Keytruda’s reimbursement to first-line in lung cancer had been introduced to the Committee for Cancer Diseases meeting 9 times, which took almost 4 full years.

 

As a winning bid, MSD Korea had submitted what MSD Korea’s newly appointed managing director Kevin Peters described as an “unprecedented financial sharing plan” at the last meeting, determined to receive approval this time.

 

Despite such effort, a serious ‘condition’ was attached to the approval.

 

Due to this, some believe that the Review Committee for Cancer Diseases has 'passed' Keytruda's reimbursement mainly due to the ‘burden’ of leaving the agenda pending.

 

This goes to show how much influence the condition to ‘cover the initial 3 cycles’ worth of administration cost’ that Roche Korea had accepted in the reimbursement process of ‘Tecentriq (atezolizumab)’ has in the drug reimbursement process.

 

MSD had repeatedly proposed compromises and revised plans to the government and expressed that their proposal meets the requested condition.

 

However, there is no doubt that the company finds it difficult to accept the 3-cycle cost burden as is.

 

With no time to relish the joy of passing deliberations by the Review Committee for Cancer Diseases, the company immediately convened a meeting to discuss countermeasures.

 

Keytruda's benefit expansion to the lung cancer indication can once again fall through in the process of drug pricing negotiations with the Pharmaceutical Benefit Appraisal Committee or the National Health Insurance Service.

 

How the reimbursement journey for Keytruda will progress after the Review Committee for Cancer Diseases handed over the baton to the next regulators, and whether the government and pharmaceutical company will be able to reach an agreement remains to be seen.

 

An official from the Review Committee for Cancer Diseases said, “We cannot estimate the price cut that would be applied to both drugs based on the ‘visible’ listed price as it is not the actual price.

 

However, the additional discount requested for Keytruda will be quite significant.

 

Although the agenda passed deliberations by the Review Committee for Cancer Diseases, whether the drug will be reimbursed is still unclear.”