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Week in Review editorial: Health technology assessments start to bite

The past week has seen pharmaceutical companies posting generally positive financials, but lurking behind the scenes is a far more worrying trend - GW Pharmaceuticals and

The past week has seen pharmaceutical companies posting generally positive financials, with the two largest companies, Pfizer and GSK, posting increased sales despite problems with generic erosion and health scares over top selling drugs, respectively.

But lurking behind the scenes is a far more worrying trend. Smaller companies have come up against regulatory blocks on their top pipeline products over health technology assessments (HTA), which examine the economic and technical validity of a new drug.

Canada's Biovail is reeling from its failure to secure FDA approval for its Wellbutrin XL timed-release antidepressant, a successor to the firm's existing formulation. The FDA's decision was unconnected with the safety or the efficacy of the drug, but was based on a technical disagreement over the methodology used in Biovail's pharmacokinetic studies.

In the UK, GW Pharmaceuticals withdrew its EU application for Sativex, following demands by UK regulators for additional data in support of the MS and cancer pain treatment. The new data was demanded from a purely technical point of view and the company has been asked that analyses be carried out in a prospective way rather than in a post-hoc manner, which is effectively a more focused Health Technology Assessment (HTA).

UK Prime Minister, Gordon Brown, is an exacting figure when it comes to analysing places where cost savings could be made and will not rely solely on third party analyses. The country can definitely expect a revisit on NHS spending.

For now, the UK pharmaceutical industry has only had to contend with the National Institute for Health and Clinical Excellence (NICE). However, balancing commerce and science is a tough challenge facing health economics. In the developed world, healthcare systems are in crisis because of increasing costs incurred by innovative new biologic treatments for difficult-to-treat diseases.

Now, HTA agencies are bringing in far more specialised eyes to scrutinise clinical and pharmacoeconomic data from clinical trials: pharmacists; insurance plan managers, members of formulary committees; clinicians; hospital managers; public health officials; and employers.

With pressure now being applied from the HTA direction, even a positive opinion from NICE does not automatically mean a drug will be approved for use in the NHS. Elsewhere, this form of economic and clinical analysis is being watched with great interest by the US, Italy, France and Germany, which are all facing healthcare funding crises.

The message to the pharmaceutical industry is becoming clear: get the processes behind your trial designs right first time and you will have the data to justify drug costs, not just to decision makers, but to society as a whole.

26th July 2007


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