Patient group, Danish Embassy call for allowing cross-dosing of drugs to treat severe atopic dermatitis

The Severe Atopic Dermatitis Association (SADA), a patient group, and the Embassy of Denmark have decided to join forces to make the government allow the cross-dosing of severe atopic dermatitis medications.

Currently, cross-dosing of drugs is not allowed under the health insurance and reimbursement system, meaning that patients must undergo four weeks or more of first-line topical treatment followed by three months of systemic immunosuppressive treatment failure before they can switch medications.

On Tuesday, the Danish Embassy invited SADA’s operators to listen to the difficulties facing Korean patients and cooperate on ways to improve the situation.

​​“The treatment environment has improved compared to 2018 when Dupixent won insurance benefits, as several highly effective biologics and JAK inhibitors were released in recent years. Still, there are limitations to using various treatments,” said Park Jo-eun, who heads SADA.

“We can only know which medication works best by trying it. However, to get reimbursement and the benefits of the special exemption calculation system, patients with severe atopy in Korea are forced to use their first-choice medication, even if it has side effects or is ineffective,” Park said. “To address this unmet need, the health authorities must allow patients to use all medications freely.”

The Ministry of Health and Welfare and the Health Insurance Review and Assessment Service (HIRA) are positively considering allowing cross-dosing between severe atopic dermatitis treatments.

However, Park resisted the authorities’ move to limit it to just one cross-dosing of biologics and JAK inhibitors, calling for allowing it not just between different medication families but also between different medications within the same drug family.

“Currently, there are six drugs covered by health insurance, but they all differ in price and effectiveness,” Park said. “In the case of atopy, we know that the same drug has different treatment effects for different patients. Therefore, to find the right treatment for you, you should be allowed to cross-drug both between and within families. Restricting cross-dispensing between different drug families is only a half-baked solution.”

“We have made proposals to allow cross-dosing and have held policy discussions with lawmakers. However, the government does not seem willing to listen to patients’ voices,” Park said. “Honestly, we would like to gather in front of the National Assembly again like we did in 2018 when we fought to get insurance benefits for Dupixent.”

The Danish Embassy said it would actively gather the voices of severe atopic patients and suggest suggestions to the Ministry of Health and Welfare, the Health Insurance Review and Assessment Service, and the National Health Insurance Service (NHIS).

According to the Danish Embassy, the Danish Health Agency has recently held policy discussions with HIRA, NHIS, and the Korea Health Industry Development Institute (KHIDI). Next year, it plans to hold workshops with the Ministry of Health and Welfare, NHIS, and HIRA.

“The influence of patient associations is growing in Denmark,” said Mads Friborg, Health & Life Science Counsellor at the Danish Embassy. “The reason for today's meeting with SADA is that we want to include the voice of Korean patient associations in our business plan for next year. We plan to have a workshop with the Ministry of Health and Welfare next year, and we will include the idea that cross-dosing should be allowed to improve the treatment environment for severe atopic dermatitis patients.”

Unlike Korea, Danish patient organizations influence their government’s policymaking considerably, according to Counsellor Friborg.

There are more than 200 patient associations, 102 of which are affiliated with an organization called Danish Patients, Which has a membership of 900,000 patients.

“In addition to educating and counseling patients, Danish Patients organizes social and cultural events, such as awareness campaigns,” Friborg said. “Furthermore, when healthcare legislation is being proposed or amended, Danish Patients members are invited to give their opinions, which are then incorporated into the legislation.”

“Denmark works with patient organizations because all data can help pharmaceutical companies develop new drugs, and doctors have a good resource for researching diseases,” he said.

However, he added that patient organizations in Denmark only started to become active 20 years ago.

“Twenty years ago, it was unheard of for hospitals to adopt the patient voice,” Friborg said. “It was more of a ‘this is what you have to do to cure your disease' kind of thing, but now it's changing to listening to patients and giving them a choice in what to do.”

The Danish company Leo Pharma, which produces a drug for severe atopy, Adtralza, was also present at the meeting.

“Currently, it is known that cross-dosing of severe atopic dermatitis drugs is limited to within a drug family, which means that patients taking Dupixent who are pregnant or nursing mothers have no treatment that they can take even if it is ineffective or has side effects,” a Leo Pharma official said. “To eliminate this blind spot, cross-dosing should be allowed within a medication family, even if it is limited, in addition to between families.”

Currently, no JAK inhibitors are approved for use in pregnant or nursing women, so patients with severe atopic dermatitis were treated with the same biologic, Dupixent, before Adtralza was approved.