Market Access Strategy
Canada looks to reduce time between regulatory approval and reimbursement recommendations for prescription drugs

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 […]

Rare Disases
Breaking news! New changes to commissioning of specialist and rare disease services in England

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).

Patients with rare disease to benefit as cross border capacity is built in European centres of excellence

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).

Market Access Rare Diseases
Using new initiatives to drive access to products for rare diseases

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 […]

Market Access Strategy
Ireland – the first country in Europe to make a landmark decision for Haemophilia patients

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.

Does the NHS benchmarking tool (PPIB) mark an end for confidential discounting?

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 […]

Innovative pricing and contracting options

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 […]

bringing ultra-orphan drugs to marke
Ultra-orphan drugs and NICE

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 […]

Biobetters: Market access opportunity?

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 […]

Outcomes-Based Pricing
Enabling market access through outcomes-based pricing

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 […]