[KH explains] Fear of being short fuels early puberty treatment boom

South Korea’s precocious puberty treatment market has seen rapid growth in recent years, as much as parents’ growing interest in children’s height has led to shortages of the therapies.

Precocious puberty treatment is prescribed to children whose puberty begins before age 8 in girls and before age 9 in boys. Children with early puberty may grow quickly at first compared to their peers, but they often stop growing earlier than usual, causing them to be shorter than average later on. The treatment’s goal is to stop the onset of puberty.

In Korea, precocious puberty treatment has been widely used as they are often advertised as medication to help children grow.

“There are many parents and children visiting local hospitals to check if their children have early puberty,” said a doctor who runs a growth clinic in Seoul on the condition of anonymity. “To a certain extent, early puberty has become a phobia among parents, mainly due to excessive and abusive advertising.”

“It is very common these days that local growth clinics prescribe precocious puberty treatment and growth hormone deficiency (GHD) therapy together as a bundle," said a 43-year-old mother surnamed Jang. Jang's 7-year-old daughter has received both treatments.

The reasoning behind using the two treatments together is so children do not stop growing early, and also at the same time boost growth hormones.

The number of patients who received precocious puberty treatment has rapidly increased over the past two years, according to the Health Insurance Review & Assessment Service data.

Between 2017 and 2019, the number of patients who received precocious puberty treatment increased by around 14 percent. But, between 2020 and 2021, the figure jumped by 22 percent from 136,334 to 166,646.

The total number of prescriptions for early puberty treatment also leapt to 834,893 in 2021, up 62 percent from 514,794 in 2017.

The surging demand has boosted sales for the treatments, usually given as regular injections.

Sales of six major drugs to treat early puberty here -- including Daewoong Pharmaceutical’s Luphere Depot and Takeda Pharmaceutical's Leuplin -- increased from 93.9 billion won ($71.9 million) in 2018 to 122.1 billion won in 2021.

LG Chem is also developing its own treatment, GPP001, amid increasing demand for the treatment in the country. LG Chem received the Korean government’s approval to conduct a phase 3 clinical trial in June last year and aims to launch it in 2025.

Increasing interest in testing for early puberty has also sparked a spike in injections used to diagnose precocious puberty.

But, the country has been suffering from a supply shortage of such drugs for more than a year, particularly after Sanofi in March 2021 stopped its supply of Relefact, an injectable drug used in the gonadotropin-releasing hormone stimulation test.

To solve the supply issue and to prevent possible abuses of diagnostic injections and early puberty treatment, the Ministry of Health and Welfare and the Health Insurance Review & Assessment Service had sought to limit the age of children who can be covered by public insurance for receiving the injections.

Under the rule amendment, only girls and boys who begin puberty before age 8 and 9, respectively, would be covered by the public health insurance, while children who show puberty after the age limit would have to pay out of pocket.

The ministry’s efforts failed after parents sent complaints, according to local media reports.

Usually, a child with early puberty receives a precocious puberty injection once every three to four weeks until they become 11 or 12 years old. When covered by the public health insurance program, an injection costs between 60,000-90,000 won, but the cost increases to 120,000-180,000 won if a child does not meet the requirements for the insurance coverage.

Experts have raised concerns over the increasing demand for early puberty treatment, and warned of possible abuse.

Korea Children's Hospital Association Vice President Choi Yong-jae pointed out that using precocious puberty treatment, together with GHD therapy, could result in unwanted side effects when they are not properly used.

“In the past, there were not many people who received precocious puberty treatment and GHD therapy at the same time, but there are more patients who receive them together these days. There also has been an increase in pediatric patients who report issues with bone maturation,” Choi said.

“There are many cases where doctors prescribe such treatments without background knowledge in the area, and it can cause other issues,” he added.