Healthcare is under substantial economic strain: with estimates that healthcare spending in OECD countries could increase to 6% of GDP by 20501. Reimbursement decisions for high-cost drugs are often the subject of public and political debate while less media attention is given to the funding of the overall healthcare infrastructure. However, is it in patients’ […]
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 […]
Many policy makers, physicians and patients complain about the prices of new pharmaceutical products. The pharmaceutical industry has recognised this perception, and though industry associations and individual companies have tried to explain why pharmaceutical companies need to charge the prices they do, this is failing.
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 […]
The Republic of Ireland has become the first country in Europe to switch a whole population suffering from Haemophilia A and Haemophilia B from short-acting clotting factors to new generation, extended half-life (EHL) therapies. This news highlights the importance of a good tendering strategy to ensure market access.