Cancer Committee leaves Keytruda confused, now what?

Confusing decision between ‘rejection’ and ‘pass,’ lack of transparency leaves everyone frustrated

MSD to make a call on revised financial plan, the decision on coverage expansion unpredictable

An immunotherapy Keytruda (pembrolizumab) indicated as a first-line treatment on lung cancer is still lost in a thick fog with its attempt to expand healthcare coverage.

 

And it has been three years already.

 

Health Insurance Review and Assessment Service’s (HIRA) Cancer Deliberation Committee was gathered on Aug.

 

26 to deliberate granting healthcare reimbursement on breast cancer treatment Kadcyla, leukemia treatment Venclexta (venetoclax), and Keytruda.

 

The conversations on Kadcyla and Venclexta were relatively simpler, and the committee eventually passed those products.

 

On the contrary, the talk on Keytruda started off with a financial plan the Cancer Deliberation Subcommittee worked on for three meetings to provide the health insurance benefit while lessening the financial burden on National Health Insurance.

 

But, still to the next day of meeting on Aug.

 

27, the pharmaceutical industry was conflicted over the committee’s unclear conclusion either ‘passing’ or ‘rejecting’ the reimbursement decision.

 

Even the press coverage delivered completely contrasting news.

 

◆First question—was the financial plan not good enough?

 

Then what actually went down with the committee?

 

Still, there is no clear answer.

 

But according to Daily Pharm’s investigation, the Cancer Deliberation Committee’s decision on Keytruda was close to ‘differing’ it, yet again.

 

A member of the committee who was present at the meeting commented, “We were not satisfied with the revised financial plan brought to the table.

 

Some even said it was worse than the initial version [MSD submitted to the government body in May, prior to the June Cancer Committee meeting].

 

The company should have put more effort on it.” This is the part, where some were convinced the committee has ‘rejected’ expanding the coverage on Keytruda.

 

Nevertheless, from a commonsensical perspective, the assumption is unconvincing.

 

The subcommittee that first deliberated the financial plan included members not only from the government or financial experts, but also from the Cancer Deliberation Committee.

 

Actually, the pharmaceutical company itself was excluded from the conversation.

 

In other words, the financial plan the subcommittee members, including the Cancer Committee representatives, worked on for three times was technically worsening the financial strain.

 

And if the committee member at the meeting was present at the subcommittee meetings, it means the member was not convinced with the financial plan they worked on.

 

It could be that the Cancer Committee member was skeptical with the way the subcommittee was amending the plan.

 

And regardless of the subcommittee’s settlement, the Cancer Committee could have been largely unconvinced about the plan.

 

In such case, then the decision should have been clear that it was ‘rejected.’ ◆Second question—sending the unsatisfying financial plan back to the company?

 

But they say the conclusion was not a rejection.

 

If it was then the talks on expanding Keytruda’s coverage should have ended, technically.

 

But after the Cancer Committee meeting, HIRA informed that the financial plan would be sent back to MSD.

 

An insider from HIRA said, “The meeting’s conclusion has not been clearly decided, yet.

 

The discussion details would be compiled and sent to MSD as an offer.” In case of rejecting the decision, the government agency could have simply announced so.

 

But HIRA’s action means the coverage could be expanded depending on MSD’s decision to accept the offered financial plan.

 

The Cancer Committee and HIRA’s stories do not coincide.

 

The government has yet to follow with a clear explanation.

 

Putting all clues together, the following can be deducted; The expanded coverage on Keytruda has been heavily demanded by patient support groups.

 

As no clear answer was provided for a long time, the patient group’s fury was directed towards both the government and the company.

 

In such tight spot, the Cancer Committee and the government would have felt pressured to ‘reject’ the decision.

 

Moreover, the last Cancer Committee’s deliberation on Keytruda was an exceptional case; to revise the financial plan, the committee convened the subcommittee and discussed specifically about financial issues without much of a concern on ‘clinical efficacy.’ Even if MSD accepts the revised plan, Keytruda would have to go through the Cancer Committee again, and not skip ahead to Drug Reimbursement Evaluation Committee (DREC).

 

The latest decision could have meant the Cancer Committee was “skeptical about the subcommittee’s revision,” and yet they are “willing to discuss the plan again, after the pharmaceutical company accepts the offered plan.” In other words, the committee passed on the ticking bomb to MSD.

 

As for the company, all eyes are now on the company while they are burdened to make a decision to accept the revised financial plan.

 

A market access expert from a multinational pharmaceutical company pointed out, “Seeing the updates on Keytruda listing talks, it is unlike other anticancer treatment listing process with so many unprecedented happening.

 

The entire procedure is veiled and far from being transparent.

 

The government needs to put down a clearer guideline for the coverage expansion procedure.”