Adaptive pathways – faster access for end users to innovative medicines?
The precondition for a medicinal product to receive a marketing authorisation is that the product is effective, safe and of high quality. Market access and particularly end-user access to new innovative medicinal products takes often a long time, even over a decade. Time is usually just that commodity that a patient with a serious or rare disease does not have at their disposal. A solution to this problem is sought through the adaptive pathways pilot project launched by the European Medicines Agency (EMA).
Adaptive pathways – what is it about?
In March 2014, the EMA announced that they will be launching an adaptive pathways pilot project with the purpose of accelerating patient access to new medicinal products in case of diseases with high medical need for new treatments. After several different phases, six new medicinal products out of a total of 34 applications were selected in the final EMA pilot project.
Adaptive pathways process is based on an existing European Union regulatory framework for medicines and the purpose is to improve the timely access for patients to new medicinal products. The process would provide new products with a possibility to receive a conditional approval based on early clinic data either in a limited indication or patient population. After this, the results would be confirmed by utilising, in addition to clinic research data, Real World Data based on the actual usage of the product related to its effectiveness and safety. On the basis of the received data, the indication of the product could be potentially expanded. Adaptive pathways process builds on early involvement of both patients and health-technology-assessment bodies in discussions on a medicine’s development.
Adaptive pathways – what does it involve?
The preliminary report of the pilot project is intended to be published in the first quarter of 2016, and the end report concerning the six products is expected by the end of 2016, once the scientific evidence has been peer-reviewed.
An accelerated marketing authorisation and market access alone would not currently mean that all needy patients would have quicker access to the product. Since increasingly more new medicinal products are self administered, prior to authorised reimbursement they might be inaccessible for the majority of patients due to high prices. After the potential early market access of the product, a question arises concerning the payer of the treatment and how products that received market access through the adaptive pathway process would be treated in national reimbursement systems.
How the eventual adoption of adaptive pathways process would impact the pricing and reimbursement processes and system in Finland is yet completely unclear. In order to accelerate the marketing authorisation process and the market access of medicinal products, attention should be paid to the reassessment of national medicinal reimbursement processes and their grounds. The adoption of the process would also require further cooperation between the industry, decision-making authorities and patients.
In Finland, cooperation between the industry and authorities has become closer in recent times, and for example, the Pharmaceuticals Pricing Board has organised the first hearing event for pharmaceutical companies. Companies were reserved a possibility to present their current information on ambulatory care medicines under development and those that might access the market in the coming years as well as on new eventual indications of products already in the market. The Pharmaceuticals Pricing Board has also reported deepening cooperation with patient organisations by taking into account the role of patient organisations in a more extensive manner as part of the processing of medicine reimbursement applications.
Winds of change are in the air, and the preliminary prognosis is that the gusts of wind benefit the patients.
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