Koselugo commences prescription with insurance coverage

Passed the Drug Committee (DC) of hospitals such as Asan and Severance

Successfully settled in negotiations for reimbursement pricing at the end of last year…Just two years after approval

AstraZeneca Korea’s Koselugo (selumetinib), a neurofibromatosis treatment, has recently passed the Drug Committee (DC) of tertiary hospitals.

Hospitals have started prescribing Koselugo, a treatment for pediatric neurofibromatosis.

 

AstraZeneca Korea’s Koselugo (ingredient: selumetinib), a neurofibromatosis, has recently passed the Drug Committee (DC) of tertiary hospitals, including Seoul National University Hospital, Samsung Seoul Hospital, Seoul St.

 

Mary's Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital.

 

Some of these hospitals have assigned a prescription code for Koselugo following emergency DC.

 

Koselugo has been listed for reimbursement starting this year.

 

As a result, it is anticipated that more hospitals will be able to prescribe the drug in the future.

 

On the third try, Koselugo passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursement Committee on the 7th of last month and settled in negotiations for reimbursement pricing with the National Health Insurance Service (NHIS) at the end of the year.

 

Koselugo was the first drug to be designated by the ministry as a priority drug under the accelerated review system in October 2020.

 

Subsequently, in May 2021, Koselugo won approval from the Ministry of Food and Drug Safety (MFDS) and was listed for reimbursement after approximately two and a half years.

 

The reimbursement criteria for Koselugo apply to pediatric patients aged 3 to 18 years who have neurofibromatosis Type 1 (NF1) with inoperable plexiform neurofibromas and their condition meets any of the following: ▲Located in the head, neck, or other areas with a risk of airway obstruction or vascular damage ▲Causing compression or functional impairment of major nerves or nerve structures ▲Encasing vital blood vessels or organs, leading to significant functional impairment ▲Physical deformities resulting in motor or sensory dysfunction ▲Severe pain that persists despite the use of neuropathic pain medications, significantly affecting daily life ▲Other conditions where drug therapy is deemed necessary.

 

Until now, patients with neurofibromatosis have relied on general remedies with no specific treatments available.

 

Neurofibromatosis is a rare disorder characterized by tumors that develop in nerve tissue, bones, skin, and other parts of the body.

 

Approximately 85% of cases are classified as type 1 (NF1), resulting from a mutation in the NF1 gene on chromosome 17.

 

The prevalence of NF1 is about 1 in 3,000 individuals.

 

The onset of neurofibromatosis typically starts during childhood.

 

In most cases, the first symptom appears as 1-3cm sized coffee-colored patches on the skin.

 

Around the age of 6, some children develop optic pathway glioma, a type of tumor, and between the ages of 6-10, many children develop scoliosis.

 

In adult patients, Lisch nodules, which are tiny hamartomas affecting the iris, are commonly found.

 

Currently, the treatment regimen for neurofibromatosis involves surgical removal when possible or anti-cancer and radiation therapies.

 

However, even with surgery, these tumors often recur, and most surgeries are major procedures, posing a significant burden on both medical professionals and patients.

 

Particularly in pediatric patients, frequent recurrences may require multiple surgeries, leading to the need for ongoing pain management and potentially resulting in language and motor impairments in many cases.

 

Koselugo is a treatment jointly developed by AstraZeneca and MSD.

 

The drug inhibits the activation of MEK and suppresses the growth of the cancer.

 

In the Phase 2 SPRINT clinical trials that served as the basis for approval, Koselugo achieved an objective response rate (ORR) of 68% by reducing tumor size by 20% or more in treated patients.

 

Furthermore, among patients who showed partial response, 82% maintained their response for over 12 months.

 

Patients who did not receive treatment typically experienced disease progression within 1.5 years, while those treated with Koselugo had only about 15% experiencing disease progression even up to 3 years.

 

“NF1 with plexiform neurofibroma is a severe condition that can involve symptoms such as severe pain, visual impairment, and spinal deformities.

 

Furthermore, it can progress into a life-threatening malignant disease.

 

The listing of Koselugo for reimbursement will be of great help in extending the lives and improving the quality of life for pediatric patients in the future,” Lee Beom-hee, Professor of Pediatric Endocrinology and Metabolism at Asan Medical Center, commented.