Immuno-oncology, hATTR and neurology stand out
The Belgian reimbursement update effective 1 May 2026 is a broad one, but not every change carries the same market access signal.
Several updates are administrative, technical or linked to pack listings. Those matter operationally, but they do not necessarily change patient access in practice. The more meaningful shifts sit elsewhere: in immuno-oncology, first-line oncology combinations, hereditary transthyretin amyloidosis, relapsing-remitting multiple sclerosis, epilepsy, and pediatric allergic rhinitis.
Below is a curated synthesis of the changes that are most relevant from a market access perspective.
What changed most meaningfully?
🎗️ Oncology and hematology remain the busiest area
The oncology update contains several substantial access expansions.
Opdivo gains a route-based reimbursement structure.
Nivolumab now has a dedicated reimbursement route for the subcutaneous 600 mg formulation, while the existing paragraph is reframed around intravenous use. The subcutaneous presentation is listed but not yet commercialised. This does not create a new oncology indication as such, but it does separate access by administration route, which is still a meaningful reimbursement development.
Darzalex moves further into first-line multiple myeloma.
Daratumumab is newly reimbursed in combination with bortezomib, lenalidomide and dexamethasone for first-line treatment of adults with multiple myeloma who are eligible for autologous stem-cell transplantation. The update also includes continuation rules after initiation cycles. This strengthens daratumumab’s reimbursed role earlier in the multiple myeloma treatment pathway.
Nubeqa broadens in metastatic hormone-sensitive prostate cancer.
Darolutamide reimbursement is expanded beyond docetaxel-containing triplet therapy. Use with androgen-deprivation therapy alone is now also included, while the triplet option remains reimbursable for patients eligible for docetaxel. That is a real broadening of practical access.
Hetronifly enters first-line extensive-stage small-cell lung cancer.
Serplulimab receives first reimbursement in combination with platinum-etoposide chemotherapy. The product is listed but not yet commercialised. The access signal is clear: another PD-1 option is entering the reimbursed first-line small-cell lung cancer setting.
Rybrevant and Lazcluze create a reimbursed EGFR-targeted combination route.
Amivantamab and lazertinib are newly reimbursed together for first-line advanced non-small-cell lung cancer with specific EGFR mutations. Initial and continuation criteria are separated, with molecular confirmation and stopping rules built into the reimbursement structure. This adds a new reimbursed combination pathway in EGFR-mutated NSCLC.
Keytruda narrows in adjuvant NSCLC.
Pembrolizumab’s adjuvant use after complete resection and platinum-containing chemotherapy for high-risk non-small-cell lung cancer is moved into a continuation-only setting for patients already started before 1 May 2026. That is one of the few clear narrowing signals in the May update.
🧩 hATTR amyloidosis becomes more competitive
The hereditary transthyretin-mediated amyloidosis space sees an important class-level change.
Wainzua receives first reimbursement.
Eplontersen is reimbursed for adults with hereditary transthyretin-mediated amyloidosis with stage 1 or stage 2 polyneuropathy. This adds a new subcutaneous antisense option to the reimbursed hATTR polyneuropathy class.
Amvuttra and Onpattro are repositioned around the new entrant.
Vutrisiran and patisiran criteria are updated to include switching provisions involving eplontersen. The combination and switching restrictions now reflect a broader reimbursed hATTR treatment set.
🧠 Neurology sees both new entry and administrative easing
The neurology update is less spectacular than oncology, but still commercially relevant.
Riulvy receives first reimbursement in relapsing-remitting multiple sclerosis.
Tegomil fumarate is reimbursed for adults with relapsing-remitting multiple sclerosis, with a separate pediatric paragraph. The product is not yet commercialised, but commercialisation announced for 1 July 2026.
Dimethyl fumarate reimbursement is aligned with the new fumarate entrant.
Tecfidera and associated dimethyl fumarate generics are updated to align with the tegomil fumarate structure and allow defined switching.
Several epilepsy products receive practical access simplification.
Lamotrigine expands in pediatric epilepsy, including Lennox-Gastaut syndrome and monotherapy for typical absence epilepsy. Cenobamate, perampanel, brivaracetam and topiramate also see reimbursement wording updates, often moving toward unlimited-validity certificates or standardised application forms.
Levetiracetam moves reimbursement route.
Keppra and levetiracetam brands are delisted from Chapter IV and relisted in Chapter I. This is a shift toward a simpler reimbursement route.
🫁 Pediatric allergic rhinitis gets a notable expansion
Acarizax gains a pediatric severe allergic rhinitis indication.
House dust mite allergen extract is reimbursed for children with severe house dust mite allergic rhinitis, under defined severity and prior-treatment criteria. Renewal is possible for up to two additional 12-month periods and can continue after the patient turns 18.
This is a meaningful pediatric expansion beyond the earlier adult-oriented access setting.
Market access read-out
The May 2026 reimbursement update is broad, but the strongest access signals are concentrated.
Oncology remains the main engine of meaningful change, with new reimbursed combinations, route-based differentiation, and one targeted narrowing in adjuvant NSCLC. hATTR amyloidosis becomes more competitive with the reimbursement of eplontersen and related updates to existing RNA-targeted therapies. Neurology combines a new fumarate-class MS entrant with wider administrative simplification in epilepsy. Pediatric access also expands in allergic rhinitis.
In short: May is not just a technical update month. It contains several real access movements, especially where new reimbursement routes reshape class positioning or earlier-line treatment access.