Why no news is being heard on reimb extension for Bavencio

that passed CDDC deliberations

In April, CDDC established reimbursement standards for bladder cancer...its deliberation by DREC delayed for 8 months

Agenda pushed back from priority to new reimbursement listings and 2nd-line cancer immunotherapies

HCPs “a reimbursed cancer immunotherapy option is needed as first-line maintenance therapy”

Merck and Pfizer’s cancer immunotherapy ‘Bavencio (avelumab)’ is having trouble expanding its reimbursement in Korea.

 

Although the agenda has passed deliberations by the Cancer Disease Deliberation Committee (CDDC), the follow-up process was sluggish and no progress has been made for 8 months.

 

According to the pharmaceutical industry on the 27th, the indication expansion agenda passed the Health Insurance Reimbursement and Assessment Service's CDDC deliberations in April, after which no news is being heard on its progress.

 

The agenda was at a standstill because it was not presented for deliberation by the Drug Reimbursement Evaluation Committee (DREC).

 

In April, CDDC established reimbursement standards for Bavencio in bladder cancere

The CDDC passed the application submitted by Merck to expand the reimbursement for Bavencio to the bladder cancer (urothelial carcinoma) indication.

 

This was when the reimbursement standards were set for Bavencio as first-line maintenance monotherapy for adult patients with locally advanced or metastatic urothelial carcinoma.

 

However, its reimbursement for the bladder cancer indication is still far off.

 

This is because DREC has not deliberated on expanding the coverage for Bavencio for the past 8 months with no hard plan set for its deliberation in the future.

 

Bavencio is not the only drug that has seen little progress after passing CDDC.

 

Ono Pharmaceutical’s ‘Bratovi’ passed CDDC meetings in January and received reimbursement standards in colorectal cancer, but has not been deliberated by DREC for a year since.

 

AstraZeneca’s ‘Lynparza’ that was set reimbursement standards for the treatment of BRCA-mutated prostate cancer, To list or expand the indication of anticancer drugs for reimbursement, the agenda needs to pass CDDC deliberations and then undergo reimbursement adequacy review by DREC, drug pricing negotiations with the NHIS, and finally pass the Ministry of Health and Welfare’s Health Insurance Policy Deliberative Committee deliberations.

 

In general, the statutory processing period for drug reimbursement evaluations conducted by HIRA's CDDC and DREC is set at 120 days (150 days for RSA drugs).

 

However, with reasons such as requests for supplementary data, the statutory review period has not been properly observed until now.

 

In particular, as the review period for reimbursement expansions is unclear and lower priority than new reimbursement listings, predicting when these agendas will be deliberated is virtually impossible.

 

Also, with the rise of the COVID-19 pandemic and the introduction of high-priced new drugs, fiscal soundness has emerged as an important issue.

 

This is why more and more reimbursement expansion deliberations for existing drugs are falling behind in priority.

 

Bavencio’s indication as maintenance therapy that the company is attempting to expand reimbursement to is a sort of 1.5-line therapy used in patients with urothelial carcinoma who have not progressed after using standard chemotherapy.

 

In the Phase III JAVELIN Bladder 100 trial, the median overall survival (OS) was extended by over 7 months for patients who received Bavencio+BSC compared to best supportive care (BSC) care alone and reduced the risk of death by 31%.

 

The 1-year overall survival rate was 71.4% in the Bavencio group, higher than the 58.4% observed in the comparator group.

 

The delay in DREC’s deliberation of Bavencio for reimbursement as maintenance therapy can also be partially attributed to the existence of other cancer immunotherapies.

 

Currently, other immunotherapies including Keytruda, Tecentriq, and Opdivo also own bladder cancer indications.

 

The specific indications approved may differ for each drug.

 

Keytruda and Tecentriq are used in the first line.

 

However, only patients that are PD-L1 positive and who are not eligible for cisplatin-containing chemotherapy are allowed to use the drugs.

 

In the case of Opdivo, the drug is used as a second-line treatment in patients whose disease has progressed after chemotherapy treatment.

 

Keytruda and Tecentiq can also be used in the second line.

 

Pic of Bavencio

Some cancer immunotherapies are also allowed reimbursement, but only in the second line.

 

Tecentriq, which had been the only drug approved for reimbursement in the second line, was unable to meet the conditional approval requirements set by the MFDS and was removed from the reimbursement list in September, and Keytruda emerged in its place.

 

Tecentriq withdrew all bladder cancer indications after failing to demonstrate an effect for cancer in a Phase III trial.

 

The company’s actions are also expected to affect its approved indications in Korea.

 

As a result, the only reimbursed cancer immunotherapy option is Keytruda in the second line.

 

The industry sees the availability of a reimbursed immunotherapy option, although in the second-line, and the lack of a second-line option after using Bavencio as maintenance therapy as the barriers that interfere with the reimbursement expansion of Bavencio, as immunotherapies cannot be used in later-line therapies after failing treatment with such in previous lines of treatment.

 

However, this means that patients have to wait until disease progression to use immunotherapies in the second line.

 

And not all patients can use immunotherapies with disease progression.

 

Therefore, the opinion has been raised on the need for earlier use of immunotherapies.

 

Professor Se Hoon Park, Division of Hematology/Oncology at Samsung Medical Center, said, “Due to the limited amount of second-line treatment options for bladder cancer, it could be so far as said that no treatment exists for bladder cancer in the second-line, and we hope that the reimbursement adequacy evaluation for Bavencio will soon progress further based on scientific evidence.” Park said, “If a treatment can safely provide clinically significant effect over existing treatments, its reimbursement adequacy should be evaluated under the same standards regardless of whether the treatment is being used for other cancer types or not.” JinYoung Paik, President of the Korea Kidney Cancer Association, said, “Many bladder cancer patients have been asking about Bavencio’s reimbursement due to the lack of other effective treatment options after receiving first-line treatment with chemotherapy.

 

Bavencio is recommended as standard treatment in overseas guidelines and many significant data have been presented on the drug, but many patients cannot use it for economic reasons.

 

I hope reimbursement discussions on Bavencio be progressed soon.”