Moving together: Is there a global convergence in drug evaluation?

Biopharma companies have long been global entities, taking advantage of the benefits of debate and information sharing between sites in different cultures, countries and economic structures. In response to this, and to the progress in digital communications, payers are also becoming global players, sharing information and learning from one another.

Is there a global convergence in drug evaluation?
Is there a global convergence in drug evaluation?
The economic downturn has led to payers reducing the levels of reimbursement, for example limiting reimbursement to subsets of approved indications based on efficacy and cost-effectiveness through health technology assessments (HTAs), and the use of copayments and tiered formularies. These changes are increasingly leading to convergence.

"Europe is becoming more like the USA and the USA is becoming more like Europe," says Carsten Edwards of Brandtectonics Access, a global healthcare consultancy.

Health Technology Assessments

The increase in limitations in access to drugs in both the public and private sector, as a result of economic restrictions, has led to an increase in the data expectations from payers.

One example of convergence is in health technology assessments (HTAs), the assessment of pharmaceuticals, devices and procedures for efficacy, safety and cost effectiveness, as well as the social and ethical impact. These began in Australia in 1993, and have spread throughout the world – the International Network of Agencies for Health Technology Assessment (INAHTA) has 46 member agencies, in Europe, the Americas and Australasia. The major HTA agencies are:

•    National Institute for Health and Clinical Excellence (NICE) – England (the UK also includes the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy Group (AWMSG)
•    Pharmaceutical Benefits Advisory Agency (PBAC) – Australia
•    Pharmaceutical Management Agency of New Zealand (PHARMAC)
•    Swedish Council on Technology Assessment in Health Care (SBU)
•    German Agency for HTA at the German Institute for Medical Documentation and Information (DAHTA @DIMDI)
•    Haute Autorité de santé (HAS) – France
•    Canadian Agency for Drugs and Technologies in Health (CADTH)

While there is an overall degree of convergence, differences in approach will always remain. "In the UK and Australia, for example, HTAs focus on cost per QALY (quality-adjusted life year), whereas other countries, such as France, focus more on clinical benefit, but all require some level of cost-effectiveness data," says Jim Furniss, Director, Global Market Access Strategy, Bridgehead International, UK, a strategic consultancy partner to the biopharma industry.

"HTAs are evolving fast, with some form happening in most of the European markets," says Edwards. "HTAs are under consideration in China, and in the USA, the bigger health insurance companies have their own HTA units, through this information is commercially sensitive, so it is not publically available."

"Though comparative effectiveness research is growing in the USA, there does not seem to be a move towards centralised and mandatory HTAs or a specific template – the aim is simply to make evidence available, rather than to restrict access," explains Furniss.

Read the second part of Moving together: Is there a global convergence in drug evaluation?

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