Patients fume over non-deliberation of Kymriah·Keytruda

Reimbursement of Kymriah and Keytruda were not deliberated Pharmaceutical Benefit Assessment Committee

KAPO “Government and pharmaceutical company should prepare measures to rapidly list new drugs that are directly related to life”

Patients have set out to demand PBAC's prompt deliberation of the new reimbursement listing for Novartis Korea’s cancer immunotherapy Kymriah in acute lymphoblastic leukemia and diffuse large B-cell lymphoma and reimbursement expansion for MSD Korea’s non-small cell lung cancer treatment Keytruda to first-line in NSCLC.

 

The patients expressed strong regrets after it was found that the agenda related to the reimbursement of Kymriah and Keytruda was not put up for deliberation by the Pharmaceutical Benefit Assessment Committee on the 2nd, the last meeting set for this year.

 

On the 1st, the Korea Alliance of Patient Organizations (KAPO) said, “The non-deliberation of the agenda at the PBAC meeting reduces the will to fight the disease and threatens the lives of leukemia, lymphoma, and NSCLC patients in Korea." Novartis had applied for the reimbursement of its leukemia and lymphoma treatment, the CART-T therapy Kymriah, on March 3rd this year through the ‘approval-reimbursement review linkage system,’ and received a conditional nod from the Cancer Disease Deliberation Committee deliberation 7 months later on October 13th.

 

Keytruda, which was listed for reimbursement as a second-line treatment, applied to extend its reimbursement to first-line monotherapy in NSCLC in September 2017 but failed 9 times.

 

After 4 years and numerous attempts, the agenda had finally received a conditional nod at the CDDC meeting on July 14th, 2021.

 

The life expectancy of recurrent·refractory leukemia and lymphoma patients that need treatment with Kymriah is only 3 to 6 months.

 

In other words, patients who cannot bear the non-reimbursed 460 million won cost of the drug are dying waiting for the reimbursement listing.

 

Also, Stage 4 NSCLC patients had borne the 70 million to 100 million won drug cost of Keytruda for the past 4 years to receive treatment or received partial support with their indemnity medical insurance or MSD's non-reimbursement drug cost support program.

 

Others received treatments from hospitals that have been pilot operating the new DRG system or received treatment with another anticancer drug then used Keytruda as second-line with disease progression.

 

KAPO said, “Deliberations on Kymriah and Keytruda have barely passed the CDDC on condition and are being delayed, but this is not due to the clinical efficacy of the drugs.

 

Kymriah and Keytruda are representative drugs that are directly related to life, and there is little controversy about their therapeutic effect.

 

It is just that the drugs’ prices are very expensive and patients so many.

 

The concern over the increased burden on NHI finances, the drug price, and fiscal concerns are what has been delaying the listing of these drugs.” The patient organization stressed that the access to treatments that are directly related to life should not be obstructed due to administrative procedures for reimbursement listing.

 

It said, “Patients who meet the MFDS indication can even now receive non-reimbursed treatment with Kymriah or Keytruda.

 

The harsh reality is that the late-stage patient’s life or death, and extension of life depends on their economic ability, on whether they have the ability to pay for the high priced non-reimbursement cost for their treatments.

 

For new drugs directly related to life such as Kymriah and Keytruda, the government should spend NHI finances to save the patients’ lives first, then decide on how to list and set their drug price through formal procedures as they are doing now.” Currently, no system in Korea allows for the priority use of NHI finances even if the new drugs are directly related to life.

 

Therefore, KAPO demanded that the government and the National Assembly introduce a constitutionally guaranteed 'rapid NHI listing system for new drugs directly related to life'.

 

The organization also plans to propose the introduction of this system as a presidential campaign to presidential candidates.

 

It added, "Pharmaceutical companies develop and market new drugs to save the lives of patients.

 

Also, the nation operates a NHI system to ensure that no citizen is left untreated due to reasons of cost if there are drugs available.

 

To fulfill this objective, we need to quickly complete Kymriah’s reimbursement listing process that has been ongoing for 9 months and Keytruda’s first-line reimbursement that is being discussed for over 4 years.”