[Reporter's View] A separate fund for new orphan drugs

Bad news for the establishment orphan disease fund

Will the 'establishment of a separate fund,' considered one of the ways to improve patient access to expensive, rare, and intractable disease drugs, become even more difficult with the inauguration of the Lee Jae Myung administration?

 

Jung Eun-kyung, the candidate for Minister of Health and Welfare (MOHW), who is facing a parliamentary confirmation hearing on July 18, stated that "expanding reimbursement coverage should take precedence over establishing a fund" for drugs exclusively for rare and intractable diseases, separate from the National Health Insurance finances.

 

Jung's statement is interpreted as an intention to maintain the traditional method of determining reimbursement for rare disease patients through national support systems, such as 'special calculation and improvement of standards'and catastrophic medical expense support, within the currently available National Health Insurance finances, rather than creating an additional financial "pocket." This is different from the MOHW's previous stance, where it had agreed with parliamentary legislation aimed at accelerating National Health Insurance reimbursement for high-priced, orphan disease treatments through the establishment of a separate fund.

 

Conversely, candidate Jung showed a completely different attitude regarding the creation of a regional essential medical care fund.

 

Jung presented a clear vision, stating, "If appointed as minister, I will push for the enactment and amendment of relevant laws through consultation with ministries, including the Ministry of Economy and Finance, to ensure the establishment of a regional essential medical care fund." Considering that the frequency of approvals for ultra-high-priced new drugs, such as immunotherapy for cancer and rare disease biologics, has increased incomparably compared to the past, Jung's skeptical expression regarding the establishment of a dedicated fund for rare diseases is disappointing.

 

Suppose expensive new drugs are to be reimbursed within the limited National Health Insurance finances and restricted drug expenditure boundaries.

 

In that case, the responsible authorities will ultimately have no choice but to make innovative efforts to diversify drug reimbursement criteria or to cut drug prices for already approved medicines.

 

Reducing reimbursement for already approved drugs would ultimately increase the likelihood of further drug price reductions, which could lead to protests from domestic pharmaceutical companies and a contraction of funds needed for innovative new drug development.

 

This means that a zero-sum game between multinational pharmaceutical companies, which focus on developing new drugs, and Korean pharmaceutical companies, which have a large proportion of generic products, could intensify over National Health Insurance finances.

 

Therefore, establishing a separate fund for rare diseases is a legislative and administrative task that the new government should proactively consider.

 

The MOHW should not exclude the establishment of a separate fund from its policy priorities.

 

Instead, it should actively engage in administrative efforts, gathering wisdom with the National Health Insurance Service, the Health Insurance Review & Assessment Service (HIRA), and the medical community, to persuade the Ministry of Economy and Finance, which opposes the fund for reasons such as uncertainty of efficacy and fairness with other diseases.

 

The National Health Insurance authorities are the only party that should analyze cases from advanced countries, such as the UK's operation of the Cancer Drug Fund (CDF), to ensure patient access to treatments for rare diseases and strive to open the minds of financial authorities.

 

If rare·intractable diseases and rare disease drugs are translated into English, they become 'orphan diseases' and 'orphan drug.' They are pitiful diseases and treatments, like a child who has lost both parents or been abandoned, with no comfortable place to lean on.

 

Currently, bills establishing separate funds to strengthen national responsibility for orphan diseases and treatments are pending in the 22nd National Assembly.

 

These include the package of bills proposed by Representative Seo Myeong-ok of the People Power Party for the establishment of a Cancer Management Fund·Rare Disease Fund (amendments to the Cancer Management Act·Rare Disease Management Act·National Finance Act·Lottery Tickets and Lottery Fund Act), and the package of bills proposed by Representative Jeon Jin-sook of the Democratic Party of Korea for the expansion of National Health Insurance reimbursement for rare and severe disease treatments (amendments to the National Health Insurance Act·Lottery Tickets and Lottery Fund Act).

 

We look forward to a future where Jung, having passed the confirmation hearing and been appointed MOHW, actively engages in persuasion and consultation with the Ministry of Economy and Finance to ensure the passage of the orphan disease fund establishment bills in the National Assembly.

 

In this case, it would be favorable news for patients and caregivers who suffer from the burden of expensive hospital bills and high-priced treatments, as well as for the National Health Insurance finances, which currently bear a heavy burden.