Health ministry to extend insurance to rare-disease drugs from November

The health ministry said Thursday that five drugs for rare and hard-to-treat diseases will come under national health insurance from Nov. 1, extending coverage to adults for a rickets and osteomalacia treatment that had been limited to children.

Crysvita, the drug for hypophosphatemic rickets and osteomalacia, is the most closely watched of the five. The conditions leave bones unable to grow properly or keep them weak because the body lacks phosphate, and the ministry put the adult prevalence at 6.7 patients per million people. Until now only pediatric patients were covered, so patients who reached adulthood stopped treatment and adults who first showed symptoms went untreated.

Oxlumo will be insured for primary hyperoxaluria type 1, a genetic disorder that drives excessive oxalate production, with a prevalence of 1 to 3 patients per million people. It causes calcium oxalate stones, blood in the urine and kidney calcification, and can progress to chronic kidney disease or end-stage renal failure. Apart from liver and kidney transplants, patients had no fundamental treatment option.

Spravato nasal spray is approved for treatment-resistant depression, defined as moderate or worse major depressive disorder that has not responded to at least two other antidepressants. The ministry estimated that about 5 percent of Korean adults have major depressive disorder and that up to 30 percent of them do not respond to existing medication, while citing literature showing suicide risk 20 times that of the general population and seven times that of patients with ordinary depression.

Xcopri, a locally developed epilepsy drug, will be covered for patients whose seizures are not controlled by existing medication. About 30 percent of epilepsy patients fall into that category. The ministry noted that the drug reached overseas markets before Korea, forcing patients to import it for years.

Tibsovo, a targeted cancer drug, will be covered for locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, which is found in 10 to 20 percent of patients with the bile duct cancer. The ministry cited a five-year relative survival rate of 29.0 percent for cholangiocarcinoma against 73.7 percent across cancers generally, the second-lowest among Korea's 10 major cancers. Patients with the mutation previously had no insured targeted therapy beyond conventional chemotherapy.

Patients will pay 10 percent of the cost of the rare-disease treatments and 5 percent for the cancer drug, down from full payment.

"I hope this expansion of health insurance guarantees real treatment opportunities for rare-disease patients, who have drawn little social attention because there are so few of them, and for patients with hard-to-treat conditions who saw no benefit from existing drugs," Second Vice Health Minister Lee Hyoung-hoon said. He added that the ministry will keep strengthening insurance coverage for rare and intractable disease treatments so that no one is left out of care.