Keytruda faces challenge from 'Steep Slope' CDRC

20 drugs passed CDRC review this year…Keytruda fails

Will bispecific antibody-based new drugs be submitted for review next year?

The Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) is the first and most challenging hurdle in reviewing the insurance reimbursement of new anticancer drugs.

 

A required step toward obtaining reimbursement listing, the committee has been nicknamed a "steep slope," giving many anticancer drugs a hard time.

 

The industry faced significant challenges this year as well.

 

New anticancer drugs from major global pharmaceuticals have been submitted for CDRC review but failed.

 

Yet, some products passed the CDRC and successfully obtained reimbursement or expansion.

 

Medical Time reported this year's review outcomes and next year's key news based on HIRA's CDRC documents and reporting from each pharmaceutical company.

 

It was reported that the HIRA held nine CDRC meetings this year and discussed about the necessity of establishing reimbursement criteria for new anticancer drugs.

 

After the meetings, the CDRC approved around 20 drugs that require establishing or expanding reimbursement criteria.

 

If we were to pick a single treatment that gained attention from the pharmaceutical company and clinical practices, it would be immune checkpoint inhibitors.

 

One of those immune checkpoint inhibitors is AstraZeneca's Imfinzi (durvalumab) and MSD Korea's Keytruda (pembrolizumab).

 

These drugs have been submitted to establish reimbursement criteria for respective cancer types and have been followed to see if they will pass the CDRC review.

 

At this year's CDRC meeting, Imfinzi passed, whereas Keytruda failed.

 

Keytruda will need to submit again for next year's insurance reimbursement approval.

 

In the case of Imfinzi, the drug was approved for requiring reimbursement criteria expansion for the treatment of bile duct cancer at the eighth CDRC meeting held in November.

 

Additionally, Imfinzi's approval also led to the approval of Imjudo (tremelimumab), another treatment for bile duct cancer.

 

Imfinzi will likely be considered for reimbursement for treating bile duct cancer and liver cancer at the Drug Reimbursement Evaluation Committee (DREC) review scheduled for next year.

 

Despite its multiple attempts to obtain reimbursement expansion since last year, Keytruda has not succeeded.

 

In the case of Keytruda, Keytruda has been submitted for reimbursement of almost 17 types of cancer.

 

However, its attempt is stuck at the CDRC due to potentially involving substantial national health insurance finance.

 

As of December 2024, Keytruda was approved for 33 indications in 17 cancer types.

 

It has been submitted to the CDRC for insurance reimbursement of 17 indications.

 

The company has applied for reimbursement of 13 indications.

 

Then, it has added four additional indications, including ▲Gastric cancer with MSI-H ▲Bile duct cancer with MSI-H ▲HER2-positive gastric cancer ▲HER2-negative gastric cancer.

 

In October, MSD Korea submitted a new proposal for financial contributions to expand reimbursement criteria for 17 indications, including gastric cancer.

 

The company has made significant efforts this year to establish these reimbursement criteria.

 

However, the company received a decision of 'reconsideration' for gastric cancer at the year's last CDRC meeting despite suggesting additional financial contributions.

 

As a result, none of the 17 indications passed the CDRC hurdle this year.

 

It has been reported that the members of CDRC were not satisfied with the additional financial sharing proposal presented by MSD Korea.

 

The results indicate that there were more opposing opinions than supportive ones.

 

"Although both are immune checkpoint inhibitors, the situations of Imfinzi and Keytruda are different.

 

Imfinzi focuses on biliary tract cancer and liver cancer, while Keytruda is pushing for reimbursement expansion for 17 cancer types," a university hospital oncology professor and committee member stated.

 

"As a result, Imfinzi's company has proposed a satisfactory financial contribution proposal, but it is challenging for Keytruda's company to present a corresponding plan due to its wide range of indications." "In other words, Imfinzi is focused on biliary tract cancer and liver cancer, where reimbursement expansion is urgently needed, and it has accepted significant financial contribution," professor added.

 

"However, applying this standard to Keytruda, which has 17 indications, won't be easy.

 

The last CDRC meeting only reviewed Keytruda for gastric cancer, and it seems there were more negative opinions about the financial contribution proposal." Additionally, the focus of CDRC discussions in the second half of this year has been on new drugs for blood cancers.

 

This change is related to the recent introduction of bispecific antibody-based therapies for blood cancer in the Korean market, with their active pursuit for committee approval starting at the end of this year.

 

Bispecific antibody drugs indicated for treating blood cancers include ▲Roche's Lunsumio (mosunetuzumab), Columvi (glofitamab) ▲Janssen's Rybrevant (amivantamab), Tecvayli (teclistamab), Talvey (talquetamab) ▲AbbVie's Epkinly (epcoritamab) ▲Pfizer's Elrexfio (elranatamab).

 

Seven drugs received approval in South Korea.

 

Among these, Roche's Columvi, AbbVie's Epkinly, and Janssen's Tecvayli have been submitted for the DREC review.

 

Columvi and Epkinly are treatments for Diffuse Large B-Cell Lymphoma (DLBCL), a type of blood cancer.

 

Tecvayli is a treatment for multiple myeloma.

 

These drugs have been submitted to the DREC review but failed.

 

They all received 'unestablished reimbursement criteria' decision and were not given 'reconsideration.' Consequently, the companies accepted the review result as equivalent to failure.

 

In the case of Columvi, Roche Korea pushed to pass the CDRC this year but failed to establish reimbursement criteria at the CDRC meetings held in July and December.

 

Even the patient organizations have joined the pursuit of requesting the establishment of reimbursement criteria but failed, delaying another attempt next year.

 

Epkinly, which has the same indication as Columvi, was reviewed during this year's final CDRC meeting.

 

However, the decision not to establish reimbursement criteria indicated a challenging reevaluation process ahead.

 

This is the current landscape of bispecific antibody-based therapies held by global pharmaceutical companies.

 

These therapies will become a key focus in next year's CDRC discussions.

 

The discussions on blood cancer treatments may become a key issue depending on the results of next year's meetings.

 

There are increasing demands from clinical fields for the reimbursement of these therapies.

 

Additionally, as discussions surrounding reimbursement for blood cancer treatments intensify, there is an increasing demand for establishing a dedicated discussion body led by the Korean Society of Hematology to address these issues with the HIRA.

 

In response to the growing prevalence of high-cost blood cancer treatments, HIRA expanded the CDRC this year, adding two hematology experts to the panel, now comprising nine members.

 

This move is a response to the rapid introduction of innovative blood cancer therapies by global pharmaceutical companies and the increasing demand for their reimbursement.

 

By incorporating more expert opinions, HIRA aims to enhance discussions surrounding the reimbursement of blood cancer therapies, ensuring that the concerns of clinicians specializing in hematology are better represented.

 

However, clinical practices responsible for treating blood cancer are unsatisfied with the HIRA's decisions.

 

"Two additional blood cancer experts were indeed appointed during the reorganization of the 10th CDRC members.

 

Seven blood cancer experts are on the committee, including one from HIRA, while the remaining six are from university hospitals," Seok Jin Kim, Chair of the Korean Society of Hematology and a hematology-oncology specialist at Samsung Medical Center, stated.

 

Professor Kim pointed out that "Over the past two years, 36 new blood cancer therapies have undergone review, compared to 58 new solid tumor therapies discussed during the same period.

 

Out of the 43 members of the CDRC, only 5.5 members can be considered experts in blood cancer.

 

This composition may not be adequate for evaluating blood cancer cases properly."