Costly orphan drug Lutathera becomes reimbursable

Novartis’ Lutathera (ingredient: Lutetium (177Lu) oxodotreotide), a treatment for neuroendocrine tumors, became reimbursable on Tuesday, reducing patients’ financial burdens significantly.

According to the Ministry of Health and Welfare, Lutathera will be covered by health insurance for the third-line or higher-stage treatment of adult patients with unresectable and well-differentiated somatostatin receptor-positive advanced and/or metastatic gastrointestinal neuroendocrine tumors (GI-NET), starting from March 1.

Also, it will be reimbursable for the fourth-line or higher-stage treatment of adult patients with pancreas neuroendocrine tumors (P-NET).

Lutathera is the world’s first approved radioligand therapy (RLT) for the treatment of GI-NET and P-NET. It is a peptide receptor radionuclide therapy that binds to the somatostatin receptor on the surface of tumor cells and kills the tumor through radiation.

Lutathera won the local marketing approval in July 2020, but its hefty price – about $82,496 annually – made it difficult for patients to use it.

To ensure treatment opportunities for patients, the Ministry of Food and Drug Safety announced a patient support program in March 2021 to cover the drug purchase cost and conduct safety management for 12 months.

Under the program, Novartis provided at least one dose of Lutathera for patients for free, and Korea Orphan & Essential Drug Center (KODC) provided instructions for patients and experts on safe drug use. Also, the government designated a safety manager to check patients’ medication history and side effects.

When the patient support program ended, Lutathera won health insurance benefits.

Professor Yoo Chang-hoon at Asan Medical Center’s Oncology Department said a neuroendocrine tumor (NET) is a rare type of tumor. It takes about five to seven years from symptoms to diagnosis. In many cases, he said one patient sees about six doctors to get an accurate diagnosis.

“If NET progresses, there are few treatment options, and patients have difficulty getting treatment. Lutathera is one of the essential therapies recognized as an international standard treatment.”

In Korea, however, KODC supplied the treatment as an emergency drug for the past year, which still limited the chance for patients to get Lutathera, Yoo noted.

As Novartis Korea will officially supply Lutathera, which became reimbursable, he added that more NET patients would get better therapeutic efficacy and safety.

The reimbursement decision was based on the phase 3 NETTER-1 study and phase 1/2 ERASMUS study.

In NETTER-1, Lutathera lowered the risk of disease progression and death by 82 percent compared to the control drug. It also showed a six times higher response rate and one-year longer overall survival.

NET patients have relatively long morbidity and treatment period compared to people with other types of tumors. As the disease affects the patients’ overall physical and mental health, improving quality of life is an important treatment goal.

Lutathera improved health-related quality of life for up to 84 weeks compared to the control group. In addition, those treated with Lutathera improved symptoms such as diarrhea, fatigue, and pain.