Current Reimbursement Conditions for the Dual Inhibitor IL-4/IL-13 Dupilumab
The biologic dupilumab is approved for the treatment of several diseases with type 2 inflammation. What is the current reimbursement situation in key indications? We summarize in the following brief overview.
Dual Action of Dupilumab
The mechanism of action of dupilumab lies in inhibiting the signaling pathways of interleukins (IL) 4 and 13, which are the main drivers of type 2 inflammatory disease (eosinophilic inflammation) in humans. This dual inhibitor leads to a decrease in type 2 inflammation mediators by blocking the IL-4/IL-13 pathway.
Subcutaneously administered dupilumab is currently approved for several indications including respiratory diseases (bronchial asthma, chronic rhinosinusitis with nasal polyposis /CRSwNP/), dermatological issues (atopic dermatitis /AD/, prurigo nodularis /PN/), and chronic inflammatory esophageal disease – eosinophilic esophagitis (EoE).
Treatment of asthma and CRSwNP with dupilumab is newly reimbursed from public health insurance under the following conditions.
Asthma
Dupilumab is reimbursed for adult and adolescent patients aged 12 years and older with severe refractory type 2 (eosinophilic) asthma who are non-smokers and have documented in the 12 months prior to treatment initiation:
a) at least 300 eosinophils/μl of peripheral blood or FeNO ≥ 25 ppb and in both cases having documented at least 2 severe asthma exacerbations in the 12 months prior to starting treatment despite high daily doses of inhaled corticosteroids and added maintenance treatment
or
b) at least 150 eosinophils/μl of peripheral blood or FeNO ≥ 25 ppb and in both cases patients are taking oral corticosteroids at a dose equivalent to at least 5 mg of prednisone daily for at least 6 months prior to starting treatment.
To meet reimbursement conditions, it is necessary to have documented a severe exacerbation by visiting a healthcare facility during its course, even if systemic corticosteroid therapy is administered or increased according to the home treatment plan. Merely reporting an exacerbation is insufficient.
Evaluation of Therapy Effectiveness
Dupilumab therapy should be evaluated every 12 months. If there is no clinically significant reduction in doses of oral corticosteroids while maintaining or improving asthma control, the treatment should be terminated. Furthermore, the number of severe exacerbations is monitored in patients with ≥ 4 severe asthma attacks in the 12 months prior to starting treatment despite high doses of inhaled corticosteroids and added maintenance treatment. If these patients do not see a reduction in severe exacerbations by at least 50%, treatment should also be terminated.
CRSwNP
Dupilumab is newly reimbursed as an add-on therapy to intranasal corticosteroids in adults with severe chronic rhinosinusitis with bilateral nasal polyps following prior endoscopic sinonasal surgery (if not contraindicated) or with insufficient efficacy or contraindication of systemic corticosteroids.
Evaluation of Therapy Effectiveness
Therapy success is regularly evaluated, initially after the first 24 weeks and then at least every 24 weeks.
Based on monitoring success, treatment should be discontinued in cases of insufficient response (defined as failure to achieve a reduction of SNOT-22 by ≥ 8.9 points and a reduction of nasal polyps score /NPS/ by at least 1 at week 24 compared to baseline), worsening of SNOT-22 score by ≥ 9 points or NPS worsening in 2 consecutive assessments within 24 weeks, occurrence of unmanageable side effects, or insufficient patient adherence.
After 24 weeks of treatment, one dose every 4 weeks is reimbursed from public health insurance.
Atopic Dermatitis
Dupilumab continues to be reimbursed for adult patients with severe AD after the failure of at least one modality of conventional systemic immunotherapy (excluding corticosteroids) or for patients with intolerance or contraindication to systemic therapy.
It is also reimbursed for pediatric and adolescent patients with severe AD in whom maximized topical therapy and available modalities such as phototherapy or balneotherapy have failed to control the disease. The prefilled pen is reimbursed in the 12–18 age group, and the prefilled syringe in the 6–18 age group.
Evaluation of Therapy Effectiveness
For both children and adult patients, treatment success is evaluated after 16 and 24 weeks from initiation and then at least every 24 weeks. Discontinuation is considered in cases where at least EASI-50 is not achieved at week 16 or at least EASI-75 at week 24, in case of unmanageable side effects, insufficient adherence to therapy, or a decrease in effectiveness below EASI-50 in 2 consecutive assessments.
For already treated adolescent patients, dupilumab therapy continues after turning 18 without the requirement of previous conventional systemic therapy.
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Sources:
1. Arenberger P. Dupilumab. Remedia 2018; 28 (6): 570–575.
2. Administrative proceedings SUKLS161445/2022. State Institute for Drug Control, 25. 9. 2023.
3. SPC Dupixent. Available at: www.ema.europa.eu/cs/documents/product-information/dupixent-epar-product-information_cs.pdf
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