France’s New ATU Process: Why only truly innovative therapies should now apply

By Nicola Allen, Associate Director & Andrea Bernardini, Analyst Email: nallen@partners4access.com or abernardini@partners4access.com The French Authorisation for Temporary Use (ATU) was originally established in 1994 [1] to enable pharmaceutical companies to sell certain medicinal products prior to marketing authorisation and reimbursement negotiations. The original ATU program has since evolved into six different pathways with overlapping…

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India’s new draft national policy for rare disease and the road to accessing gene therapies

By Ciaran Cassidy, Snr Analyst Email: ccassidy@partners4access.com With one of the fastest-growing economies and the second largest population in the world India is a market of increasing interest to the biopharmaceutical industry.1,2 However, the potential for access to innovative rare disease therapies, such as gene therapies, is not particularly well supported by the central government…

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4 key trends changing the access landscape through to 2025

By Jens Leutloff, Senior Consultant Email: jleutloff@partners4access.com Partners4Access  asked payer experts from France, Germany, Italy, Spain, and the Nordics what the key trends are for market access by 2025. Besides the financial challenge posed by high-cost innovative therapies, they will also influence how other drugs will be looked at. An increasing number of innovative therapies…

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Driving patient access for treatments targeting rare genetic disorders in the Middle East

By Ciaran Cassidy, S Analyst Email: ccassidy@partners4access.com At the World Orphan Drug Conference (WODC) this year Dr Maryam Matar presented on the success of the UAE genetic disease association (UAEGDA), an organisation which she founded in 2006 and currently chairs. The UAEGDA is a non-governmental organisation focused on controlling genetic disorders prevalent in the United…

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Under the microscope: Orphan Drug incentives in Europe

By Chloe Sheppard, Analyst Email: csheppard@partners4access.com The European Commission is imminently expected to publish a report evaluating the pros and cons of the EU Orphan and Paediatric Legislation introduced 20 years ago. The regulation has so far had success towards its primary goal to incentivise the development of orphan medicinal products (OMPs) for patients living…

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France to place restrictions on Nominative ATU

By Erfan Akbraian, Analyst Email: eakbraian@partners4access.com France’s National Agency for the Safety of Medicines and Health Products (ANSM)1 governs the early access program called autorisation temporaire d’utilisation (ATU). The ANSM are expected to implement changes set by the French social security law to the nominative ATU program later this year to ease the cost burden…

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Cancelled meetings and assessment delays: HTA bodies are revising priorities in response to COVID-19

By Nicola Allen, Associate Director Email: nallen@partners4access.com The priorities of health technology assessment (HTA) bodies are evolving as health care systems around the world are seeking to manage the strain of the Covid-19 pandemic and the biopharmaceutical industry are rising to the challenge to find an effective treatment. Initially, agencies moved in-person meetings to teleconferences…

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