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Monday 24th July 2017

Innovative pathways for innovative treatments in metastatic melanoma

Innovative pathways for innovative treatments in metastatic melanoma: conclusions from the panel discussion organized at 13th EADO Congress in Athens on 4th May 2017

At the Special session at 13th EADO Congress in Athens, on Wednesday 4th May, 2017, panel discussion on innovative pathways for innovative treatments in metastatic melanoma were discussed. The session was moderated by Claus Garbe, EADO President and Ana-Maria Forsea and Lidija Kandolf Sekulovic, EADO Board members.

The latest data on access disparities in Europe were first presented by Lidija Kandolf Sekulovic. Based on the data from a recent EADO study, it is estimated that more than 5000 patients do not have access to these medicines leading to inevitable difference in survival of this patients based on the country of residence.

Further, some initiatives of the ESMO (European Society for Medical Oncology) EU Policy Committee were presented by Rosa Giuliani, ESMO representative at the EMA Healthcare Professional Working Party (HCPWP), and in the Stakeholder Forum (Healthcare Providers group) of HTAN (Health Technology Assessment Network). From her experience as a practicing oncologist, there are several barriers for the equal access not only between countries, but also within countries at the regional, local and even at the hospital level. In her opinion, a common European process for registration, health technology assessment and market access is key to control disparities in access to medicine. This requires the collaboration on the development of European policies which will ensure the outcome of EU centralized assessment on access to innovative medicines will be acknowledged in any EU and EU candidate countries.

Melanoma Patient Network Europe, MPNE, initiatives were presented by its founder and president Bettina Ryll, who is also the current ESMO Patient Advocates Working Group Chair. Work by MPNE showed that Melanoma patients struggle to access innovative medicines all over Europe, albeit to different degrees and for different reasons. While in Western Europe, access issues were linked to drug utilization-like inappropriate prescribing or restrictions of locally or even nationally held budgets, access in Central and Eastern Europe was hampered more up-stream, as by protracted reimbursement discussions as well as arbitrary access schemes, like a set number of patients treated without reference to the number of patients in need. Bettina Ryll concluded that effective actions for access needed to match this underlying complexity and diversity of the problem as simplistic concepts were bound to fail.

Also, initiatives of European federation of Pharmaceutical Industries and Associations (EFPIA) for better and timely access initiatives were presented by Alexander Roediger, Policy Lead Oncology for Europe, Middle-East, Africa and Canada of MSD. Today, much less people die of cancer because of better prevention, earlier diagnosis and more treatment options. However, the cancer challenge will remain: Cancer cases are intertwined with demographic change and the latter is likely to continue.  In addition, new treatment options have or will become available which haven’t been available before.  Finally, yet not everyone has benefited equally from progress. “A single stakeholder alone cannot meet the challenge”, said Alexander Roediger. Flexibility and collaboration are the two priorities for future cancer care. More flexible processes will improve equal and fast patient access. Collaboration between all stakeholders will help to ensure sustainable cancer care.

The following conclusions were made after the panel discussion on the priority measures necessary to improve the current situation:

  • Professional oncological organizations should continuously collaborate with each other to initiate and maintain an early dialogue between patients, patients advocates, HCPs/Academia, industry, regulatory and HTA bodies and payers that is necessary for timely, equitable and affordable development of new drugs and medical technologies. In this line, The European Association of Dermatologic Oncology establishes the EADO Task Force for Access to Innovation in Skin Cancer Care aiming at engaging with all stakeholders in the effort to alleviate the disparities in the whole spectrum of skin cancer care across Europe.
  • Practicing physicians must take an active role through involvement in professional oncological organizations to start and maintain a dialogue with European and national policy makers, patients’ organizations and the pharmaceutical industry to improve the access to innovative medicines for their patients. In this regard, education of practicing oncologists is necessary to ensure basic understanding of the process of drug approval and reimbursement in order to be able to actively participate in the process.
  • In a short-term raising awareness of national and European authorities about the current situation is necessary. Innovation is needed beyond drug development, to enable flexible patient access solutions between governments, payers and the pharmaceutical industry, e.g. Managed Entry Agreements. A clear understanding is needed on what is possible and sensible to be achieved at European level (e.g HTA, value assessment) and what is necessary to be achieved at national level, in country-adapted way (e.g. transparency of prioritizing and pricing decisions), as different steps of the process are regulated at different levels, from EU to regional, local and even center based level. National healthcare systems should actively adapt and be more flexible in ensuring access in the fast developing oncology market.
  • Also, a better implementation of early access and compassionate use programs and international participation in clinical trials is needed. The regulatory framework for insuring widespread and equitable access to early access programmes, compassionate use schemes and international clinical trials should be reinforced at European level.
  • In a long-term, the development of European framework for joint relative efficacy assessment can create synergies. Combined with pricing and reimbursement processes adapted to current developments in innovation it can accelerate fast and equal patient access. Also, more sustainable pricing that will not jeopardise the process of innovation is needed to ensure timely access.
  • An active involvement of patients’ representatives throughout the entire process of development, marketing authorization and pricing and reimbursement of medicines is needed, as well as in providing early access through expanded-access and compassionate-use programs and clinical studies.
  • Joint efforts of all stakeholders will be necessary to develop innovative pathways for timely and affordable access to innovative medicines in oncology.

In conclusion, the data presented emphasized the need to strengthen current efforts, and highlighted the future possibilities in reducing disparities in quality cancer care between European countries. Stronger involvement of academia in drug research and development, stronger involvement of patients advocates in the whole process continuum, stronger efforts from pharma companies towards more sustainable pricing of life-saving drugs, and higher transparency and regional cooperation among national governments to ensure sustainable licensing, pricing and equitable drug access have been indicated as necessary measures by the panel participants. Providing fair access to quality healthcare, including access to innovative medicines for all patients with metastatic melanoma is a fundamental right and it should be a commitment of EU Member states and candidate countries, but also of public healthcare systems outside of the EU.


Prof. Lidija Kandolf Sekulovic                                                        Prof. Claus Garbe

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