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 […]
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.
In 2015, Lord Carter published an independent report on operational performance and productivity for the UK national health service (NHS)1. Recommendations outlined how the NHS could save £5 billion by improving operational consistency between trusts. Over the last 18 months, the NHS has set about implementing these recommendations and, in January 2017, a new procurement […]
With rising treatment prices and healthcare spending, payer organisations are making efforts to contain costs, with the unintended consequence of putting up treatment access barriers. Hence, there is a growing interest in more innovative agreements, such as performance-based (reimbursements tied to conditions around producing outcomes or bridging evidence gaps), finance-based (rebates/discounts for excesses in agreed-upon […]
2017 saw the National Institute for Health and Care Excellence (NICE) board, with input from the NHS England Specialised Services Commissioning Committee, agree to a change that will have a substantial impact on both patients and the companies bringing ultra-orphan drugs to market. In this article we consider what is going to change and how […]