Reimbursement Series: Anchors Affordable Breakthroughs – AIFA and TLV Expand European Coverage

Europe’s payer environment is accelerating into a new phase of reimbursement-led innovation. In the last week of October 2025, two of the continent’s leading health technology assessment agencies Italy’s AIFA and Sweden’s TLV delivered seven pivotal reimbursement decisions spanning oncology, rare diseases, and biosimilars.

From AIFA’s activation of digital monitoring registries for cutting-edge biologics to TLV’s value-based coverage approvals for high-cost and biosimilar therapies, both agencies are signaling the same transformation: reimbursement is now a dynamic partnership between regulators, payers, and innovators.

Sweden’s Dental and Pharmaceutical Benefits Agency (TLV) has issued three landmark reimbursement decisions that reshape the country’s access landscape. The inclusion of Lojuxta (Chiesi Pharma), Omlyclo (Celltrion Sweden), and Osvyrti (Accord Healthcare) in the national high-cost coverage marks a critical step forward for equitable patient access, biosimilar competitiveness, and rare disease recognition.

Italy’s AIFA mirrored this momentum, activating new reimbursement registries for Tepkinly, Voxzogo, and Lunsumio that strengthen patient access through real-world evidence integration. These decisions reflect a deliberate shift toward managed-entry agreements and data-driven reimbursement, positioning Italy at the forefront of Europe’s value-based access evolution.

These decisions effective from late October to November 2025 demonstrate TLV’s evolving methodology for aligning clinical evidence, cost-effectiveness, and ethical prioritization. The agency continues to refine its use of tripartite pricing agreements, health-economic modelling, and disease-severity thresholds, ensuring that both innovation and affordability coexist within a sustainable national framework.

This article launches the Synopulse’s Reimbursement Series, a recurring editorial feature exploring how European and global health authorities are redefining market access through new evidence frameworks, contracting models, and patient-centric reimbursement principles. Each instalment dissects how value, policy, and pricing converge to shape biotech success.

Lojuxta: High-Stakes Reimbursement for a Rare Disease

Starting from November 1, 2025, Lojuxta (lomitapide) from Chiesi Pharma AB enters Sweden’s high-cost coverage for adults with homozygous familial hypercholesterolemia (HoFH) a severe inherited lipid disorder causing dangerously high LDL cholesterol levels.

TLV recognized Lojuxta as a lifesaving intervention within a population of fewer than 30 Swedish patients, accepting its multimillion-kronor annual treatment cost under its “very high severity” framework. A tripartite agreement between TLV, Chiesi, and Swedish regions lowers effective costs through rebates, ensuring budgetary sustainability.

Clinical data demonstrated that Lojuxta reduced LDL cholesterol by 40% when added to standard lipid-lowering regimens. While TLV acknowledged significant uncertainty due to small-scale evidence, the clinical relevance and patient impact justified approval.

The agency’s decision reflects a broader rare disease reimbursement shift, accepting higher cost-per-QALY thresholds when the unmet need is critical and treatment alternatives are absent. TLV emphasized that Lojuxta’s benefit outweighs uncertainty, enabling meaningful survival and quality-of-life gains.

The agency mandated that all promotional materials explicitly communicate reimbursement boundaries to avoid prescriptive confusion. For Celltrion, this marks a major Nordic foothold in the anti-IgE biologic space.

Omlyclo: Biosimilar Momentum Strengthens Asthma and Allergy Access

On October 28, 2025, Omlyclo (omalizumab) by Celltrion Sweden AB joined Sweden’s reimbursement list, marking a pivotal biosimilar milestone Omlyclo.

A biosimilar to Xolair, Omlyclo secured coverage for both 75 mg and 150 mg doses. The 150 mg strength carries a reimbursement restriction limited to patients with severe allergic asthma or chronic spontaneous urticaria unresponsive to conventional therapies.

TLV determined Omlyclo’s clinical equivalence and cost advantage compared to Xolair, positioning it as a cost-effective biosimilar. At SEK 2,284 per 150 mg dose, Omlyclo represents a direct affordability win in respiratory and allergy care.

TLV required that marketing materials clearly state the reimbursement limitations, ensuring transparency in prescribing. This decision aligns with Sweden’s wider biosimilar acceleration strategy, which emphasizes value-driven access and long-term savings.

For Celltrion, Omlyclo reinforces the Nordic biosimilar foothold, reflecting TLV’s confidence in evidence-backed substitution as a pathway toward sustainable biologic access.

Osvyrti: Expanding Osteoporosis Access Through Biosimilar Reimbursement

Accord Healthcare’s Osvyrti (denosumab) a biosimilar to Prolia also gained inclusion in TLV’s high-cost scheme on October 28, 2025, with a reimbursement limitation mirroring its reference biologic Osvyrti.

Osvyrti is approved for osteoporosis in postmenopausal women and men at risk of fractures where alendronic acid is unsuitable, as well as bone loss in prostate cancer patients receiving hormone therapy. Priced at SEK 1,070 per prefilled syringe, Osvyrti enters Sweden’s reimbursement system as a lower-cost alternative to Prolia.

TLV’s decision was based on cost-minimization analysis, confirming therapeutic equivalence and economic efficiency. Accord must clearly communicate the reimbursement scope in all promotional activities, ensuring clarity for prescribers and patients.

With Sweden’s biosimilar adoption rates among Europe’s highest, Osvyrti’s approval will further reduce biologic spending while broadening treatment reach for vulnerable populations, particularly in aging and oncology-linked bone health.

Italy’s AIFA: Managed Entry Models Strengthen Access

Italy’s Agenzia Italiana del Farmaco (AIFA) published three major web-based registry activations between October 27–28, 2025, each tied to national reimbursement authorization. These registries represent AIFA’s unique managed-entry system, ensuring real-time tracking of clinical outcomes and controlled high-cost access under the National Health Service (SSN).

Tepkinly (epcoritamab) – Reimbursed for Follicular Lymphoma

Under Decision PRES/1402/2025, AIFA activated the Tepkinly LF registry on October 28, 2025, enabling use of Tepkinly (epcoritamab) for adult patients with relapsed or refractory follicular lymphoma after two or more systemic therapies. This marks a critical step in expanding real-world oncology access while capturing granular patient data. Regional centers are now instructed to activate use through the online portal, reflecting Italy’s commitment to outcome-linked reimbursement oversight.

Voxzogo (vosoritide) – Pediatric Rare Disease Expansion

Through Decision PRES/1405/2025, Voxzogo (vosoritide) extended its reimbursed indication to children aged 4 months to 2 years with genetically confirmed achondroplasia. This extension lowers the treatment start age from 2 years, allowing earlier intervention in growth disorders. With a 24-month reimbursement validity and continuous supply guarantee, AIFA emphasizes both cost sustainability and developmental impact. The update positions Italy among Europe’s most progressive payers in pediatric rare-disease access.

Lunsumio (mosunetuzumab) – Registry Update for Broader Inclusion

Decision PRES/75/2025 updated the Lunsumio monitoring registry, expanding eligibility to include grade 3b follicular lymphoma, ECOG 2 patients, and new fields for adverse event reporting. These refinements increase clinical inclusivity and data integrity, strengthening AIFA’s pharmacovigilance system and enhancing post-market transparency.

Summary of AIFA and TLV Reimbursement Actions October 28, 2025

Shajini