by Francesca Romana Pezzella and Hanne Krarup Christensen

Alteplase has been added to the WHO Model List of Essential Medicines as a result of World Stroke Organization 30 stroke experts task-force who applied the WHO for including it in the Model List of Essential Medicines.

Since 1977 World Health Organization (WHO) has been publishing every two years the Model List of Essential Medicines (EML), which consists of a list of medications considered the minimum medicine needs for a basic health-care system….” that satisfy the priority health care needs of the population.”  The core EML contains the most efficacious, safe and cost-effective medicines for relevant conditions selected based on current and estimated future public health relevance, and potential for safe and cost-effective treatment; whereas the complimentary EML covers priority diseases that require special facilities, equipment, and/or training.

The alteplase entry in the EML represents a unique opportunity to improve treatment for stroke patients in Europe and worldwide:

  • as countries frequently use the EML (to date more than 150) to help develop their own local lists of essential medicine, the presence of alteplase in the list it will facilitate registration and use (alteplase is not available in one-third of countries-LIMCs- worldwide)
  • the presence of alteplase in the EML empowers patients right to equal access to stroke care
  • UN –members states are encouraged to guarantee intravenous thrombolysis for free or develop sustainable co-payment model

In Europe, alteplase entry in the WHO EML is a compass to development and implementation of stroke care.

The socioeconomic impact of stroke is considerable, with an annual cost in Europe of up to €45bn. Moreover, there are significant variations in the quality of stroke care in Europe.  Based on the ESO, ESMINT, EAN and SAFE survey, the estimated mean number of stroke units was 2.9 per million inhabitants (95% CI 2.3–3.6) and 1.5 per 1,000 annual incident strokes (95% CI 1.1-1.9), respectively.  The average thrombolysis treatment rate was only 7.3% of incident ischaemic stroke patients (95% CI 5.4–9.1), and 1.9% for endovascular treatment (95% CI 1.3–2.5).

However, countries with the highest rates reached proportions of treated patients of 20% and 6%, respectively.

In this framework  Alteplase entry  in the WHO EML empower  the culture of stroke care in European countries and gives a new higher meaning to stroke advocacy and stroke professionals commitment to stroke victims  and public health. The chain of stroke care encompasses prevention, acute treatment, stroke unit care, rehabilitation and life after stroke; entry of Alteplase into the WHO EML represents a strong support to this important part of the chain of care. The position of stroke has been strengthened through significant initiatives from the WHO: stroke has rightfully had its own single block under diseases of the nervous system in the ICD11. Further, in the Global NCD Action Plan Appendix 3, stroke units rehabilitation and thrombolysis are now mentioned as recommended treatments. This latest step is now including alteplase on the EML list as well as core drugs for stroke prevention.

As we all know, stroke is not cured by just giving the drug: giving alteplase requires organization and training. The EML is also to ensure implementation of such services to ensure safe and effective use of Alteplase in both high and low resource regions.

As other good news for the stroke community, the new EML also increases the options for stroke prevention: it now lists fixed-dose dual combinations of antihypertensives and the four direct oral anticoagulants (dabigatran, apixaban, edoxaban, and rivaroxaban) as essential medicines.

This strategic advance from WHO supports our professional struggle to set up structures ensuring the needed care for all patients with stroke. Through the professional knowledge within stroke organisations including ESO, we must in collaboration lift the level of care for future stroke patients in all settings.