2024-12-03 17:21:00
35% of the Fund for Innovative Medicines is not used.”It’s a shame that the regions didn’t seize this opportunity.” thus Anna Maria Mancuso, president of Salute Donna Odv and coordinator of the Group ‘Health is an asset to be defended, a right to be promoted’, comments to Adnkronos Salute on the data from the Ihe – The Swedish Institute for Health Economics report released today in Rome on the occasion of the conference dedicated to the contribution of innovation to the treatment of lung cancer, promoted by Msd.
“We should also try to include conditional innovative drugs in the Fund – adds Mancuso – because they could be a solution for accessing those therapies that are not yet considered innovative but which are within the fund”. On the issue that after 6 years innovative drugs leave this Fund, the group ‘Health is a good to be defended, a right to be promoted’ presented an amendment to the Budget law which provides for “considering an innovative drug for up to 10 years and not 6. We are waiting for it to be approved by the Budget Committee”,but it is indeed a job “done together”. In this way “a drug used and considered innovative for lung cancer, which turns out, for example after 7 years, to be innovative for another type of pathology” can be used as innovative and not as a compassionate therapy. “Sometimes – he clarifies - compassionate therapies are used precisely as it is indeed not possible to access certain innovative drugs for pathologies othre than those that have been indicated”.
Unluckily “the access times to drugs are quite long: just think that they have to pass 3 levels, namely EMA, AIFA”, respectively the European and Italian Agency, “and the Regions”. Time is precious, “it is life”, especially for a cancer patient. It is indeed about shortening the process, reducing bureaucracy and speeding up access to treatments “as, once they are authorized by the EMA and then by AIFA - underlines Mancuso – the Regions may not even be included in the approval in the handbooks for innovative drugs : there is already AIFA – he concludes – which does it at a national level”.
How can patients advocate for faster access to innovative cancer treatments?
Interview with Anna Maria Mancuso: Addressing the Challenges of Accessing Innovative cancer Treatments
Time.news Editor: Thank you for joining us today, Anna Maria Mancuso, president of Salute Donna Odv and coordinator of the Group ‘health is an asset to be defended, a right to be promoted.’ Your insights on the current state of the Fund for Innovative Medicines are invaluable,especially as we consider the implications for lung cancer treatment. Let’s dive in.
Q: Recent reports indicate that 35% of the Fund for Innovative Medicines remains unused. Why do you believe the regions are not seizing this prospect?
Anna Maria Mancuso: It’s quite unfortunate that such a notable portion of the fund is left untapped. There appears to be a disconnect between the intended use of these funds and the actual on-ground application. Many regions are possibly unaware of the available innovative therapies or may face bureaucratic hurdles that discourage them from utilizing the fund effectively.
Q: Your call to include conditional innovative drugs in the Fund raises an interesting point. Can you elaborate on how this could enhance access to necessary therapies?
mancuso: Absolutely. By including conditional innovative drugs within the Fund, we can facilitate access to therapies that may not yet be classified as innovative, but still hold potential for patient benefit. This adjustment could bridge the gap for many patients awaiting treatment options that are simply not recognized due to their current status.
Q: You’ve emphasized the need for extending the innovative drug classification period from 6 to 10 years. Why is this change so critical?
Mancuso: Extending the period of classification is crucial because medical advancements can often reclassify a drug’s effectiveness in treating different conditions over time. For instance, a drug that treats lung cancer may later prove beneficial for another type of cancer. If we restrict access to these drugs after six years, patients miss out on possibly life-saving therapies. This amendment we proposed to the Budget Committee seeks to address that very issue.
Q: Access times to new treatments can be lengthy. What are some specific barriers contributing to these delays?
Mancuso: the approval process involves multiple levels—first, the European Medicines Agency (EMA), then the Italian Medicines Agency (AIFA), and regional approvals. Each step adds layers of bureaucracy, which can be detrimental when time is of the essence for cancer patients. Speeding up this process is critical; time truly is life for those awaiting treatment.
Q: how can we improve the system for faster access to innovative therapies?
Mancuso: There must be a concerted effort to reduce bureaucracy. Once a treatment is authorized by EMA and AIFA, it’s essential that regions are aligned in their approval processes. Streamlining communication and ensuring timely updates in regional handbooks for innovative drugs are vital steps that can significantly cut down waiting times for patients.
Q: Considering these challenges, what practical advice would you provide to readers, especially those affected by cancer?
Mancuso: I encourage patients and their families to stay informed and advocate for their rights when it comes to accessing innovative treatments. Engaging with healthcare policies, understanding the approval processes, and pressing for timely access to therapies can make a difference. It’s also important to collaborate with organizations like ours,which are dedicated to safeguarding health rights and promoting innovative medicine.
Time.news Editor: Thank you, Anna Maria Mancuso, for your insights. The challenges in accessing innovative cancer treatments are indeed complex, and your expertise shines a light on the urgent need for systemic improvements.
