Pediatric indication becomes key to sales in Korea

leads both reimbursed and non-reimbursed markets

Saxenda and Eutropin injections lead non-reimbursement market sales in hospitals and clinics

Reimb for Dupixent, Hemlibra to be extended in 2H...speed up reimb to severe pediatric patients

The treatment market for pediatric and adolescent patients have grown rapidly last year.

 

In particular, injections for pediatric and adolescent patients have gained much popularity and raised sales in reimbursed and non-reimbursed markets in hospitals and clinics.

 

The transition from the COVID-19 pandemic to an endemic had increased focus on injections for obesity and growth, which led to great popularity.

 

If the pediatric ‘non-reimbursed’ market had achieved great growth last year, this year, the market for reimbursed treatment for 'severe' pediatric conditions is expected to grow rapidly because major treatments for pediatric patients are attempting reimbursement in the first half of this year.

 

First, Saxenda (liraglutide), the leader in the domestic obesity treatment market, saw rapid growth in sales last year with its expansion to the pediatric indication.

 

#According to the market research institution IQIVA, Novo Nordisk’s Saxenda raised sales of KRW 58.9 billion last year, which is a 62.7% YoY increase.

 

Saxenda’s sales had previously fallen for 2 consecutive years.

 

From KRW 42.6 billion in 2019, sales had fallen to KRW 36.8 billion in 2020, then to KRW 36.2 billion in 2021.

 

However, with COVID-19’s transition to an endemic, its sales had again surged and dominated Korea’s obesity treatment market.

 

Saxenda’s sole lead in the market is expected to continue until new obesity treatments like Wegovy (semaglutide, Novo Nordisk), and Mounjaro (tirzepatide, Lilly) are released to the market.

 

Saxenda’s rapid growth in sales is in line with its indication extension to children and adolescents last year.

 

In December 2021, Saxenda’s indication was extended to treat adolescent patients aged 12 to 18 years with a BMI that corresponds to 30 kg/m2 for adults and weighs over 60 kg in Korea.

 

In other words, the indication expansion to pediatric adolescent patients maximized sales in obesity and growth clinics and hospitals in Korea.

 

The same goes for the growth hormone market.

 

The growth hormone injection market, which had previously consisted of products from domestic pharmaceutical companies, has also grown into a large non-reimbursed treatment market and was evaluated to be sized at KRW 250 billion won last year with rising sales from growth clinics at front-line hospitals and clinics.

 

If the pediatric ‘non-reimbursed’ market had achieved great growth last year, reimbursement extensions of major treatments for major pediatric conditions are expected this year.

 

Key products include Dupixent (dupilumab) and Hemlibra (emicizumab).

 

Both drugs received recognition for their need to extend reimbursement by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee and are undergoing drug pricing negotiations with the National Health Insurance Service.

 

If the pricing negotiations between the NHIS and pharmaceutical companies progress smoothly, the drugs will be able to receive reimbursement extensions within the first half of the year.

 

In the case of Dupixent, if reimbursement extensions are finally made to cover children and adolescents with atopic dermatitis in May, its sales are expected to continue to grow as in the previous year.

 

In the case of Dupixent, sales increased 35% YoY from the KRW 77.2 billion in the previous year to reach KRW 104, but experts predict there is still room for additional growth.

 

The same goes for JW Pharmaceutical’s Hemlibra.

 

Hemlibra is currently only reimbursed to treat patients who show resistance and have antibodies to existing treatments.

 

As most of the Type A hemophilia patients are ‘non-antibody’ patients, this means that only a very few patients are receiving reimbursement for Hemlibra.

 

This is why parents of hemophilia A patients had been continuously raising demand for Hemlibra's reimbursement extension.

 

According to the 2019 Hemophilia White Paper, over 90% of the 1,746 patients with hemophilia A in Korea, 1,589 patients, are non-antibody patients.

 

Drug pricing negotiations are underway after HIRA made the decision to extend reimbursement, and if the negotiations are completed within the first half of the year, non-antibody patients will be able to use Hemlibra with reimbursement as well.

 

Meanwhile, the financial authorities expect the health insurance claims amount to increase rapidly if Hemlibra’s reimbursement is extended to cover non-antibody patients.

 

According to IQVIA, Hemlibra’s sales last year increased 5% YoY from the KRW 7.2 billion to reach KRW 7.6 billion last year.

 

In other words, if reimbursement is extended to cover non-antibody patients, the drug may grow to become a large blockbuster product that brings in millions of won every year.

 

Moreover, the pharmaceutical industry predicts that the drug will become a 'dark horse' in Korea’s hemophilia treatment market which is currently led by GC Pharma if Hemlibra’s reimbursement is extended to cover non-antibody patients.

 

A health insurance official said, “In the case of hemophilia, around 10% are antibody patients, and 90% non-antibody patients.

 

Therefore, if reimbursement for Hemlibra is extended to cover non-antibody patients, the drug’s sales will naturally increase significantly.”