Sweden limits Evfraxy reimbursement to osteoporosis and prostate-cancer bone-loss populations
Sweden decided that Evfraxy, a denosumab biosimilar referencing Prolia, should enter the high-cost protection scheme with a restricted reimbursement scope. The Dental and Pharmaceutical Benefits Agency (TLV) relied on European Medicines Agency biosimilar comparability and a cost comparison showing the same cost as the most cost-effective relevant alternative.
Sweden limited Fabhalta reimbursement in C3G after weighing APPEAR-C3G proteinuria data against uncertain long-term model assumptions.
https://www.mattheneus.com/editorial/tlv-fabhalta-iptacopan-c3g-limited-reimbursement-appear-c3g-2026-04-28 #HTA #EvidenceSynthesis #Pharma
Sweden limits Fabhalta reimbursement in complement 3 glomerulopathy after APPEAR-C3G review
Sweden's Dental and Pharmaceutical Benefits Agency (TLV) will reimburse Fabhalta for complement 3 glomerulopathy (C3G) with a narrow limitation, after weighing APPEAR-C3G proteinuria data against uncertain long-term model assumptions.
Swedish Dental and Pharmaceutical Benefits Agency rejects fixed-needle syringe price increase
The Swedish Dental and Pharmaceutical Benefits Agency rejected Becton Dickinson Sweden ABs request for higher reimbursement prices for two fixed-needle 1 ml syringes. The decision turned on benefits-use data, not clinical efficacy, and shows how access-risk claims need quantified reimbursement evidence.
Sweden's Dental and Pharmaceutical Benefits Agency (TLV) rejects Fluttasino reimbursement after model gap
Sweden's Dental and Pharmaceutical Benefits Agency (TLV) rejected Fluttasino reimbursement for chronic rhinosinusitis with nasal polyps after concluding that the submitted economic model did not reflect the expected treatment pathway.
Sweden reimburses Gotenfia with a biosimilar comparator restriction
Sweden's Dental and Pharmaceutical Benefits Agency will reimburse Gotenfia from 28 April 2026 with a restriction tied to etanercept or adalimumab suitability. The agency accepted comparable effect and safety versus Simponi and Gobivaz, then based the decision on medicine-cost comparison.
A small consumable pricing case shows how Swedish HTA scrutiny can turn on evidence for cost justification, even for routine devices.
https://www.mattheneus.com/editorial/tlv-microlance-consumable-cost-evidence-2026-06-23 #HTA #HealthEconomics #RegulatoryAffairs
Swedish reimbursement agency refuses Microlance 3 injection needle price increase
On 22 June 2026, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) refused a price increase for Microlance 3 injection needles. For health technology assessment (HTA) and market-access teams, the decision separates patient-need evidence from economic evidence showing that a product is likely to leave reimbursement without a higher price.
Sweden accepted a reimbursement price increase for lactitol after linking supply continuity to withdrawal risk, a clean example of access pragmatism.
https://www.mattheneus.com/editorial/tlv-importal-ex-lax-lactitol-price-increase-supply-risk-2026-05-18 #HTA #HealthEconomics #Pharma
Sweden raises Importal Ex-Lax reimbursement price after supply-risk review
Sweden approved a higher reimbursed price for Importal Ex-Lax 100-sachet lactitol powder from 1 June 2026 after finding that the product is an important treatment option, that some patients could lack alternatives if it left the benefits scheme, and that current pricing created a credible supply-continuity risk.
A July 2026 TLV withdrawal list shows how package-level reimbursement status can become the immediate market-access risk, even without new clinical evidence.
https://www.mattheneus.com/editorial/tlv-july-2026-medicine-withdrawals-reimbursement-continuity-ledger-2026-06-09 #HTA #RegulatoryAffairs #HealthEconomics
Swedish Dental and Pharmaceutical Benefits Agency lists July 2026 medicine withdrawals from reimbursement
The Swedish Dental and Pharmaceutical Benefits Agency published medicines leaving the pharmaceutical benefits scheme from 1 July 2026 at company request, including Votrient packages and Waran tablets.
Sweden keeps codeine access stable during a licensed-medicine transition, a useful reminder that reimbursement continuity can be the real access question.
https://www.mattheneus.com/editorial/tlv-kodein-extractumpharma-temporary-reimbursement-licensed-medicine-transition-2026-05-13 #HTA #RegulatoryAffairs #Pharma
Swedish reimbursement agency grants temporary subsidy for Kodein ExtractumPharma during licensed-medicine transition
Tandvårds- och läkemedelsförmånsverket (TLV) granted temporary reimbursement for Kodein ExtractumPharma from 13 May 2026 for patients already treated with the product or a replaceable licensed codeine medicine, while the ordinary reimbursement application remains under review.
Sweden accepted a Levaxin price increase to protect supply continuity, showing how HTA and reimbursement decisions can reflect access risk.
https://www.mattheneus.com/editorial/tlv-levaxin-price-increase-supply-continuity-hypothyroidism-2026-06-15 #HTA #RegulatoryAffairs #Pharma
Swedish agency grants Levaxin price increase to protect supply continuity
The Swedish Dental and Pharmaceutical Benefits Agency approved higher reimbursed prices for three Levaxin pack lines after assessing clinical importance, substitutability, and risk of benefit-system exit.
