Is Spain becoming a cost-effectiveness market for biopharma?

By Ciaran Cassidy, Snr Analyst Email: ccassidy@partners4access.com On the 25th of July, the AEMPS of Spain published the first Therapeutic Positioning Report (Informe de Posicionamiento Terapéutico, IPT) including both a clinical and a cost-effectiveness assessment.1 The Coordination Group of the National Health System (NHS) Drug Evaluation Network (REvalMED) evaluated Pfizer’s Talzenna® (talazoparib) as monotherapy for…

NICE’s 5 year strategy looks towards a dynamic future

By Jayne Watson, Senior Analyst Email: jwatson@partners4access.com In April, the National Institute for Health and Care Excellence (NICE) launched its 5 year strategy, outlining their key priorities between now and 20261. The launch of the strategy comes at an interesting time when government and healthcare authorities globally are considering their priorities. The UK is in…

Comparing cost-effectiveness outcomes of cell and gene therapies across HTA organisations

By Chloe Sheppard, Senior Analyst & Max Rex, Consultant Email: csheppard@partners4access.com mrex@partners4access.com Cost-effectiveness analyses, as part of Health Technology Assessments (HTAs) for new therapies, appear to be growing in importance across Europe. These analyses are already required in many markets within and outside of Europe for HTAs, including Canada, England, and the Netherlands. In future,…

Patient Centricity in HTA: Fact or Fable?

By Erfan Akbraian, Analyst Email: eakbraian@partners4access.com In recent years there have been discussions to shift to a multi-stakeholder approach and increase early communication amongst key stakeholders to ensure appropriate access of advanced therapy medicinal products (ATMPs). With an increasing number of ATMPs for orphan diseases in the pipeline, there is a need for health technology…

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…