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 […]
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).
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 […]
Biobetters are biologics that have been improved compared to the marketed originator, for example in efficacy, safety, tolerability or dosing regimen. For regulatory approval, biobetters must meet the same data requirements as all other originator products, whilst only a reduced clinical data package is needed for biosimilars (Table 1). This produces time pressure for biobetters […]
With the need to contain healthcare costs, payers often adopt selection criteria aimed at limiting the brands that are reimbursed and the price of those products. In some cases focus on cost containment can compromise patient access to new and innovative treatments. The need to establish a balance between cost containment and patient access pushes […]
Thomas Mueller, Head of Pharmaceuticals at the Federal Joint Committee (G-BA), stated at the Pharma Pricing and Market Access Congress in London, February 2017, that the association of orphan drug status with high prices cannot continue and that the only way for orphan drug pricing to go is down. Yet, due to the small target […]
The number of unmet needs, whether clinical, economic or humanistic, remains high in oncology, especially for patients with metastatic conditions. With positive clinical trial results in many cancer types, including melanoma, colon cancer, lung cancer, Hodgkin’s disease, leukaemia, and others, immuno-oncology therapies are offering patients a new treatment alternative.1 Interest in immuno-oncology has been piqued […]
According to many payers, the high prices of oncology medicines are not sustainable and there remains a gap between drug price and value.1 The rising costs of drug development, increased clinical demand and the need to recoup the cost of failed products, have led to new cancer treatments that come with a high price tag. […]