Many medicinal products looking to launch are rejected for reimbursement in France. A manufacturer must convince the Transparency Committee that their product is safe, effective and offers added value relative to alternative treatments for successful market access. In this blog, we summarise the reasons for negative reimbursement decisions in 2017 and discuss common pitfalls manufacturers […]
Market access workshops, roundtables and payer advisory boards provide vital input and cross-functional alignment on scenario planning, pricing, access and evidence strategies for pharma and medical technology companies. In this blog post we discuss how well-facilitated virtual workshops can meet the same strategic objectives of face-to-face meetings. We got into the business of offering virtual […]
On 22 June 2018, Ireland joined the Beneluxa Initiative on Pharmaceutical Policy. What has the initiative accomplished to date, and what will the addition of a fifth member mean for the future? Introduction to the Beneluxa Initiative The Beneluxa Initiative aims to improve patient access to innovative drugs in Belgium, the Netherlands, Luxemburg, Austria and now […]
Scotland is set to ease access to medicines for patients suffering from an ultra-rare condition. From the beginning of October this year, all medicines that target ultra-rare diseases (fewer than 1 case in 50,000 people) and that the Scottish Medicines Consortium (SMC) decides are clinically effective will be reimbursed through NHS Scotland for a minimum […]
Patient-reported outcome measures are increasingly important in the assessment of treatment regimes, both for regulatory approval and for market access. However, selecting the most appropriate measure and interpreting the data can be challenging.
In order to support effective decision making and deliver sustained returns in a complex, dynamic healthcare environment, pharmaceutical, biotech and medical device companies need an expert-led market access strategy that considers the changing nature of the real-life marketplace. These strategies should not only focus on achieving the commercial objectives for a product but also enable […]
An important change has been made to Canada’s Common Drug Review (CDR) program, which will be effective from the 2nd April 2018. It means that: CDR assessments can potentially proceed concurrently with Health Canada reviews. It should eliminate major delays between Health Canada’s approval and the final reimbursement recommendation. It further aligns the processes of […]
The Prescribed Specialised Services Advisory Group (PSSAG) is a Department of Health expert committee. It was established in 2013 to provide ongoing advice to MPs on whether specialised services should be nationally commissioned by NHS England, rather than locally by Clinical Commissioning Groups (CCGs).
Approximately 30 million people live with rare diseases in Europe. In a drive to improve treatment for people with these complex conditions, a cross border cooperation via Directive 2011/24/EU “Patient’s rights in cross border healthcare,”1 has provided a framework for the development of European Reference Networks (ERNs).
Gaining reimbursement for rare and specialist diseases can be challenging, primarily because small patient populations restrict the size of clinical trial cohorts. This limits the clinical evidence available to support a drug through the health technology assessment (HTA) process. Other factors, such as diagnosis, capturing long-term data, and defining patient populations can also hinder market […]