Hidradenitis suppurativa: New drugs have emerged, but patients face a reimbursement barrier

Hidradenitis suppurativa (HS) is a chronic inflammatory disease characterized by recurrent inflammatory nodules accompanied by pain, foul-smelling abscesses, and fistula (tunnel) lesions, which leave permanent scars. This condition is difficult to cure, with symptoms that recur and fluctuate over long periods. Therefore, the treatment goal is to alleviate symptoms and prevent the development of new lesions.

In particular, moderate to severe cases often do not respond to conventional treatments, necessitating surgical intervention alongside biological agents. Biological agents include Humira (adalimumab) and Cosentyx (secukinumab).

Cosentyx was recommended as the first-line biological agent in the latest European guidelines for treating HS published in January this year. However, despite receiving approval in Korea over a year ago, it is not covered by health insurance, which limits patient access.

Against this backdrop, Korea Biomedical Review had a joint interview with Professor Kim Hoon-soo of the Department of Dermatology at Pusan National University Hospital and Ms. Yoon-kyung, who has been living with HS for nearly 30 years, to explore the treatment realities faced by patients with HS in Korea and the importance of improving access to biological agents.

KBR: Hidradenitis suppurativa (HS) is a relatively unfamiliar condition. Could you explain the disease and its prevalence in Korea?

Prof. Kim: The name “hidradenitis suppurativa (HS)” accurately describes the characteristics of the disease. “Suppurativa” refers to the formation of pus, and “hydradenitis” means inflammation in the sweat gland.” This condition was previously named “sweat gland inflammation” because it caused inflammation in sweat-prone, moist areas, such as the armpits, groin, and buttocks.

However, as understanding of the etiology has advanced, it is now recognized as a condition in which inflammation occurs due to the blockage or accumulation of secretions in hair follicles and sebaceous glands, rather than sweat glands. HS is a chronic inflammatory skin disease characterized by chronic skin inflammation in specific areas, the formation and drainage of abscesses, and the resulting pain and discomfort.

Since HS is a relatively new condition in both academic circles and the general public, it is estimated that many patients remain undiagnosed. According to data from the Health Insurance Review and Assessment Service, there were 12,490 cases of HS in Korea last year (8,039 males and 4,451 females). Symptoms typically begin in adolescence and persist into the 40s, with more than half of all patients being in their 20s and 30s, who are often socially active.

KBR: Since the disease is unfamiliar, it must have been difficult to diagnose. How did you receive an accurate diagnosis, and were there any difficulties in the process?

Ms. Yoon-kyung: I am currently in my 40s and have had symptoms of HS since high school. When the symptoms first appeared, I didn't know the name of the disease and suffered for a long time. I visited various hospitals and departments, including general surgery, breast surgery, and dermatology, but the medical staff at the time did not have a good understanding of the disease. I only heard that “there is such a disease,” but I was not informed about its characteristics, progression, or treatment methods.

It was only six years ago that I received an accurate diagnosis of hidradenitis suppurativa. Despite suffering from the condition for over 20 years, I was unable to receive proper treatment because I did not know the name of the disease. Even after the diagnosis, I found it difficult to determine which hospital or medical professional to consult for treatment.

KBR: What treatment process did you go through after the diagnosis?

Ms. Yoon-kyung: While balancing marriage, childbirth, and work, the most difficult period was during my pregnancy. At that time, both armpits were incised about four times each, but due to restrictions on antibiotic use during pregnancy, even at the university hospital, only simple procedures to clean the pus were possible for two to three months.

When I visited two university hospitals and a breast surgery clinic during my pregnancy, the medical staff advised me to continue treatment after giving birth. However, when I returned to the hospital after giving birth, I was told that the lesion had grown too large for treatment. In the meantime, my symptoms worsened, and it became increasingly difficult to continue working. Eventually, I informed my company of my intention to take a leave of absence, but my colleagues couldn’t understand why I needed to take time off due to an abscess, which caused me significant psychological and emotional distress.

In the past, I faced difficulties because I was unaware of treatment options for HS. Now, despite ongoing treatment after diagnosis, the reality that a complete cure is impossible and the fear that the lesions may spread or worsen again are the greatest burdens.

HS is often difficult to diagnose and treat outside of dermatology departments at general hospitals. There are a few dermatologists who can perform surgery, and in some cases, consultation with a surgeon is necessary, which is only possible at general hospitals or large hospitals of a certain size.

Additionally, it is challenging to locate medical professionals with extensive experience in treating this condition. However, it is encouraging that articles introducing national hub hospitals and medical staff capable of treating HS have been published recently, as social awareness of the disease has increased.

KBR: It seems that not only an accurate diagnosis but also the treatment environment is not well established. What are the problems that arise when accurate diagnosis and appropriate treatment are not provided early on?

Prof. Kim: Hidradenitis suppurativa is difficult to cure, and symptoms may worsen and improve repeatedly, causing not only physical discomfort but also psychological and mental stress, such as depression and low self-esteem, over a long period. Therefore, it is crucial to visit a dermatologist for an accurate diagnosis and to establish a treatment strategy.

HS can be suspected when there are five or more lesions, such as erythematous papules, nodules, or abscesses, in areas where hidradenitis suppurativa commonly occurs. HS is most likely to lead to appropriate treatment and disease management when diagnosed by a dermatologist.

A study conducted on 827 patients with HS in 14 countries found that more than half of the patients received an accurate diagnosis from a dermatologist. Additionally, a 2022 study of 1,418 patients with HS in 14 countries found that “initial consultation with a dermatologist” and “use of biological agents” were key factors in improving treatment satisfaction.

KBR: What is the treatment strategy for HS?

Prof. Kim: HS is generally classified into mild, moderate, and severe types, and the degree of discomfort felt by patients varies depending on the extent of the lesions and the site of occurrence. The ultimate treatment goal is not a complete cure but effective symptom control to prevent disease progression and exacerbation.

HS cannot be completely cured through surgical intervention alone. If chronic inflammation persists in the affected area, the disease may progress to a stage where recovery is difficult, such as the formation of fistulas (tunnels), making early treatment crucial. In particular, it is important to initiate drug therapy early before complications arise and, if necessary, combine it with surgical intervention to achieve long-term stable disease management.

KBR: Why is medication important in addition to surgical treatment?

Prof. Kim: Medication is essential because the fundamental goal of treatment is to control inflammation. Surgery is not a cure but a treatment option to remove lesions that are difficult to control with medication. Ultimately, the main treatment strategy is to continue medication after surgery to maintain a mild condition.

KBR: In addition to immunosuppressants, biological agents have recently emerged for this disease. What is the current prescription environment in clinical practice?

Prof. Kim: Biological agents are expensive medications, so treatment should be considered for patients who meet the criteria for insurance coverage. They are primarily considered for patients with moderate to severe disease.

They are only administered to patients who meet specific criteria, such as having lesions in two or more areas rather than a single area, and whose condition has not been effectively controlled despite sufficient treatment with antibiotics or other conventional medications for over three months.

KBR: Given their high cost, there may be challenges in maintaining long-term treatment with biological agents. What has been the experience with biological agent administration and other treatments so far?

Ms. Yoon-kyung: For two years after surgery, I underwent treatment with Humira. However, this was merely a means to delay the worsening of symptoms, rather than a cure. I visited the hospital every two weeks for injections and underwent treatment at both a plastic surgery and dermatology clinic. Despite taking antibiotics and undergoing repeated incision and drainage surgeries, new lesions continued to appear.

Recently, after meeting Professor Kim Hoon-soo, I had the lesion in my right armpit surgically removed and resumed Humira treatment, but the symptoms continue to recur. Currently, the right armpit is relatively stable, but the left side is in poor condition.

I am continuing medication therapy with the hope that the condition does not worsen, but since symptoms continue to appear in other areas, I would like to try new treatments such as Cosentyx.

However, considering the cost of medications, using new treatments is not a realistic option. Even if a new treatment is used, there is no guarantee that the condition will be completely cured, and the effects of treatment vary from person to person. Therefore, from the patient's perspective, it is not easy to bear the high costs and choose a new treatment. In this situation, it is frustrating that there is only one biologic agent that is realistically available (covered by insurance).

KBR: What would you like to emphasize regarding improvements in the treatment environment for HS?

Prof. Kim: Atopic dermatitis and psoriasis are also classified as intractable skin diseases, but the treatment environment has improved with the emergence of new drugs. Following the approval of Humira, Cosentyx has also been approved for the treatment of HS, introducing new treatment options for this condition.

However, since these medications are currently prescribed as non-reimbursable, the high drug costs make prescribing them challenging. For Humira, reimbursement is possible under the severe case exception criteria. We are hopeful that Cosentyx will be included in the reimbursement list by the end of this year or early next year.

Ms. Yoon-kyung: Every time news about the development and introduction of new treatments is announced, expectations rise, but it is unfortunate that access to these treatments is severely limited in clinical practice due to their high cost. We hope that with the attention and support of the public, medical professionals, and government officials, awareness of the disease will improve, and that through the publication of white papers and the establishment of standardized treatment guidelines, more patients will be able to continue treatment in a more effective and supportive environment.

HS frequently occurs in young adults in their 20s and 30s, and it is a disease that can cause a loss of working ability at a time when they should be actively engaged in economic activities, as well as affect military service, childbirth, and childcare, resulting in significant social and economic burdens. Despite this, institutional support for the disease remains inadequate. I’d like to invite various stakeholders to demonstrate broad interest and make sustained efforts to improve the overall treatment environment in Korea, including government-level research support, the development of treatments, and the expansion of insurance coverage to enhance access to treatments.