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Policy
First year of Rare Disease Support Scheme
by Eo, Yun-Ho Nov 04, 2019 08:13am
The biggest issue of the policy is ‘lack of interest’. ‘Rare disease’ is not a specific categorization, but rather it is designated based on frequency of diagnosis. Korea defines ‘rare disease’ as a disease diagnosed to less than 20,000 people. With small patient size and lack of drug, these diseases are in dire need of new drug. But the voices of small handful of patients are easily lost in the air. At the moment in Korea, 951 diseases are designated as subject for Rare Disease Medical Aid Program, in which 927 of them are eligible for special case benefit. The total of 927 consists of 827 rare diseases as defined by the National Health Insurance special case copayment benefit system, and about 100 more added, as of August 2017, by a rare disease survey reflecting opinions of patients and their families, patient advocacy group, and medical experts. Previously, the government did not have a government-managed rare disease list without sufficient legal basis to back it up. So the size of rare disease patients was estimated according to the special case benefit subject list. Rare and chronic diseases were confused and defined as one keeping rare disease related policy making and researches limited. But growing voices criticized government for neglecting rare disease, and finally the Rare Disease Management Act was enacted in 2016. Since then, the first Rare Disease Management Plan was established, and in September 2018, the Rare Disease Patient Support Scheme was first implemented as more demanded for state-level rare disease patient support like disease management, treatment and prevention. ◆Rare disease patients supported by government:The objective of the Rare Disease Patient Support Scheme was to lessen patient’s financial burden of medical expense. The health authority applied special case benefit on the new rare diseases and expanded eligible disease for low-income patient medical aid. Including the newly designated 100 rare disease, now about 1,800 patients receive special case benefit, annually. Special case benefit system for rare disease patient started from applying 20 percent of copayment rate on artificial kidney dialysis or continuous ambulatory peritoneal dialysis for chronic kidney failure patients, and the benefit continued to expand on hemophilia, Gaucher’s disease, leukemia and cancer patients. But some undiagnosed rare disease patients had been excluded from the special case benefit due to unidentifiable diagnosis and disease code with limited patient size. And from last January, the roster for special case benefit and rare disease medical aid program subject diseases were unified. The revised regulation also stipulated special case benefit for undiagnosed rare disease patients without a disease code. Medical aid subject disease roster expanded significantly from 652 to 927 cases, granting financial support to about 2,600 more patients. Compared to last year, the Rare Disease Medical Aid Program bumped up this year’s budget and allocated about 32 billion won. The Rare Disease Patient Support Scheme includes Rare Disease Diagnosis Support Program to prevent patients from missing adequate treatment timing with difficulty in diagnosis. The diagnosis support program covers patients with Genetic Testing Support subject disease and undiagnosed condition. Also from this year, Rare Disease Regional Care Center Network has been expanded to ten centers, consisting of one Central Support Center and other Regional Support Centers. To sum it up, the Rare Disease Support Scheme mainly focuses on ▲establishing rare disease list and registration system, ▲increasing medical aid to reduce financial burden, and ▲expanding rare disease diagnosis support and Regional Support Centers. ◆Only 5% of diseases have treatment and NHI coverage rate is still low: Despite the government’s effort, some rare disease patients are still struggling to get access to treatment. Only about five percent of rare diseases have treatment developed. Diagnosis and treatment developments are far slower than other general medical conditions, because of small limited number of patients and prospective profit estimated low. And even if better treatments are developed, many of them are unapproved or non-reimbursed, leaving patients hopeless. Without guaranteed National Health Insurance (NHI) coverage on treatment, patients and their families would suffer not only from physical pain, but also with financial strain. More than 80 percent of rare diseases are inherited and patient’s family member show similar conditions. This vicious cycle leads medical expense in one single household to surge exponentially. However, the current Rare Disease Management Act does not specifically stipulate expansion of NHI coverage on rare disease treatments. Related industry claims Korea lacks a legal basis to back policy and regulation to boost pharmaceutical accessibility for rare disease patients catering unique qualities of the disease. Korea may have established a meaningful legislation of Rare Disease Management Act, but in fact, the law does not help many of struggling patients to get better access to drug to this date. Even at the National Assembly Annual Audit session, lawmakers urged the government to enhance NHI coverage on rare disease. Lawmaker Yoon Jong-pil of Liberty Korea Party spoke at Ministry of Health and Welfare audit session and pointed out, “Considering exceptionally limited number of patients and difficulty in developing effective treatment, rare disease treatment should be reviewed with more flexible criteria or they would not be accessible to patients in need”. .Drug pricing department of a multinational pharmaceutical company claimed, “An independent set of reimbursement review criteria should be designed for rare disease treatment as it is impossible to evaluate with common economic sense .And this is why special clause or supplementary article as a part of Rare Disease Management Act should stipulate expansion of coverage on rare disease treatment” .

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