Insulin Substitution Portugal: Implications of Novo Nordisk’s Discontinuation

INFARMED has informed healthcare professionals about the upcoming discontinuation of several Novo Nordisk insulin products in Portugal and to provide clear guidance on insulin substitution Portugal.

On 30 April 2026, INFARMED issued Circular 045/CD/100.20.200 announcing that Novo Nordisk Portugal will cease commercialization of five insulin products effective 31 December 2026. The affected insulins include Actrapid Penfill, NovoRapid PumpCart, Insulatard Penfill, Mixtard 30 Penfill, and Levemir. According to the official INFARMED notification, no new patients should start these products, and current users must transition to suitable alternatives under medical supervision.

Pharmacokinetic Differences Demand Individualised Plans

The most critical aspect of insulin substitution Portugal lies in the significant pharmacokinetic variations between the discontinued products and their replacements. Insulin detemir (Levemir), for instance, has a duration of action under 24 hours with a peak at 6–8 hours, while possible substitutes such as insulin glargine 300 U/ml or insulin degludec offer substantially longer coverage. Patients using Actrapid or Mixtard 30 will need to switch to either remaining human insulin options or faster-acting analogues with different onset and peak profiles. The guidance stresses individualized dose adjustments, intensified glucose monitoring in the initial weeks after switching, and thorough training on new delivery devices.

National Clinical and Economic Framework

The INFARMED circular, developed with the National Commission for Pharmacy and Therapeutics (CNFT), follows the Portuguese National Formulary hierarchy and incorporates both clinical evidence and relative treatment costs. Substitution tables distinguish between same-molecule alternatives in different presentations and analogue options, always prioritising the best cost-effectiveness relationship while maintaining efficacy and safety standards.

Vulnerable Populations Require Extra Caution

Special attention is given to pregnant women with gestational diabetes and patients receiving intermediate-acting corticosteroids. In these groups, the move from intermediate-acting human insulin to long-acting analogues can significantly alter daily glycaemic patterns, necessitating closer follow-up.

Health Economic and Market Implications

This large-scale therapeutic substitution will generate valuable real-world evidence on the clinical and economic outcomes of switching between human and analogue insulins. While the transition may generate short-term increases in monitoring and consultations, the guidance encourages the use of more cost-effective options among clinically suitable alternatives, including biosimilar glargine products where appropriate.

The withdrawal also highlights the importance for manufacturers to maintain comprehensive insulin portfolios in mature markets. Market access authorities must ensure that all recommended substitutes remain fully reimbursed and that device-related costs do not create barriers for patients. Careful stock management instructions aim to prevent hoarding and unequal distribution across the country.

Insulin substitution in Portugal therefore represents not only a major clinical transition but also a significant test of the Portuguese health system’s ability to manage large-scale product discontinuations while protecting patient outcomes and controlling costs.