Will the latest changes of the Bulgarian pricing and reimbursement policy have finally an impact?

By Akshay Kumar, Partner & Andrea Bernardini, Analyst Email: akumar@partners4access.com abernardini@partners4access.com Bulgaria introduced multiple reforms to their healthcare system since 2011. This included the introduction of health technology assessments in 2015. However, evidence has shown that these reforms have had so far little impact on improving effectiveness of care, patient access to treatments or cost containment.  …

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…

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…

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…

Portfolio access agreements – Lessons learnt from Vertex Pharma’s Orkambi

By Jack Rawson, Analyst Email: jrawson@partners4access.com Road to commercialization of Vertex’s CF portfolio The European Commission recently approved Vertex’s combination regimen Symkevi (tezacaftor / ivacaftor; marketed as Symdeko in the US). This is their third disease- modifying Cystic Fibrosis (CF) drug on the market.  The first was Kalydeco (ivacaftor) in 2012, which was the first…

Partners4Access Briefing: November 2018 update on the European Commission regulation proposal on health technology assessment

By Christina Poschen, Consultant Email: cposchen@partners4access.com Background Since 2004, the European Union’s centralised drug approval is in place, allowing manufacturers to submit just one application to gain marketing authorisation in all European Union Member States. Although there were voluntary agreements and working groups to further harmonize health technology assessment, so far, there are 28 different systems…

Partners4Access expands top leadership with new appointment

Partners4Access has announced the appointment of Alison Kneen as Vice President of International Operations to lead its rapidly expanding Market Access Orphan Drug Specialist team. Alison brings extensive international market access experience built over the last 27 years from previous roles with IQVIA; Principal and Head of Market Access Strategic Consulting, as well as during…