We are making all efforts to reimburse ‘Vyndamax’

Hee-Jeong Kim, Rare Disease BU Lead, Pfizer Korea

“Have continuously worked to persuade the head office… will focus on passing the Drug Reimbursement Standard Subcommittee”

“Need to address areas unattended by the reimbursement listing system… rare disease drugs have difficulty demonstrating cost-effectiveness”

김희정 전무

Rare disease patients suffer more due to the 'rarity' of their condition.

 

Due to the small number of affected patients, even drugs that are already available cannot be easily listed for reimbursement due to difficulty in demonstrating cost-effectiveness or predicting their fiscal impact on the NHI budget.

 

Rare diseases are diseases that affect fewer than 20,000 people or those for which the number of affected patients cannot be estimated due to difficulties in diagnosis.

 

As rare diseases are difficult to diagnose and treat and have a significant impact on the life expectancy of the patients, it is imperative to ensure patient access to the treatments.

 

However, due to the small number of affected patients, initiating clinical trials for such treatments in itself is quite difficult.

 

In this context, Pfizer's Rare Disease Busines Unit has been currently exerting all its efforts to list its ‘Vyndamax (tafamidis 61mg),’ a treatment for ATTR-CM (ATTR amyloidosis with cardiomyopathy) for reimbursement in Korea.

 

However, the process has not been so smooth.

 

The company has already failed twice and is now making its third attempt at reimbursing the drug.

 

Dailypharm met with Hee-Jeong Kim, Rare Disease Lead of Pfizer Korea to hear about the company’s position and state of affairs.

 

-In Korea, it is not an exaggeration to say that reimbursement determines the success or failure of a new drug.

 

As much as the government provides good coverage for the reimbursed drugs, this also makes it more difficult for drugs to be listed for reimbursement.

 

Have you felt this while leading the Rare Disease BU at Pfizer? Korea’s strength is in its coverage (range of coverage).

 

Patients in Korea can receive broader benefits in the course of their treatment due to Korea’s consistent policy and predictable supply under the single-payer system, once the drug is listed.

 

Other markets abroad operate under various schemes.

 

Access to new drugs is a little more difficult in Asia than in other regions.

 

In Europe, new drugs are introduced at a relatively faster rate.

 

In Spain, separate funding is operated for each region, and in the UK, the NHS has allocated alternative funding schemes for necessary drugs.

 

The prompt introduction of new drugs is indeed difficult in Korea due to the wide scope of use of NHI finances from the patient’s perspective.

 

The advantages of the single-payer system that I mentioned previously are partially offset by the strict standards set for new drugs.

 

-This is the third attempt at reimbursement for ‘Vyndamax.’ It seems that the company’s determination will be as important as the government's will in obtaining the reimbursement approval.

 

What efforts have Pfizer been making for the reimbursement?’ All employees at Pfizer Rare Disease have a strong desire to deliver the value of Vyndamax’ to patients in Korea.

 

We plan to continue making attempts through various tracks available in Korea.

 

ATTR-CM is a rare disease that lacks studies and trials to identify the exact prevalence of the condition itself.

 

We fully understand the government’s concerns regarding this ambiguity and have continuously been in discussions with our head office to prepare an innovative risk-sharing plan as requested by the government.

 

However, the agenda has not even passed the Drug Reimbursement Standard Subcommittee, therefore, we are not at the stage to discuss the risk-sharing plan being prepared by the company.

 

We did not expect the drug to fail at setting the reimbursement standard stage so many times, therefore, our prime focus is on passing the Drug Reimbursement Standard Subcommittee this time.

 

We will continue exerting our utmost effort at every stage that follows.

 

-What about collaboration with academic societies and patient groups? The academic societies and patients groups recognize the need for the prompt reimbursement of ‘Vyndamax’ and have expressed their opinion to the government several times.

 

Due to the small number of affected patients, it takes a significant time for HCPs to accumulate the expertise required.

 

The Rare Disease BU cannot exist if the company only considers performance and numbers.

 

In this perspective, having a sense of mission seems to be more important in our line of work.

 

Our drug is necessary for further diagnosis of rare diseases, and we are sorry that there is no treatment currently available for use for HCPs and patients in Korea after the patients are diagnosed with ATTR-CM.