Desmitificando el costo de desarrollo de un nuevo medicamento.

The cost of drugs is in the headlines following the decision by NHS watchdog NICE that a new cancer treatment should not be funded.

 Its cost? More than £90,000 per patient for an extra six months of life. But how are such figures reached? 

The drug - trastuzumab emtansine - was developed by Roche. 

And for commercial reasons it has so far not revealed the methods behind its pricing strategy. 

Lab testing and trials 

But to really understand the cost of developing a new drug you have to go back to the very earliest stages of the process.

There are a number of important milestones in the journey - and at each point development can come to a halt if the treatment is found not to be viable. 

Drug development essentially begins in the lab with research on animals, such as mice. 

Only one in 10 potential treatments in the lab actually reach the clinical trial stage on humans. 

And from there only a fifth will make it through all three phases. The most common reasons for discontinuation are the effect of the treatment being too weak, the side-effects too great or the market for the treatment too small. 

Overall costs 

Then comes the regulatory and marketing stage. It is a process that takes at least a decade for most drugs - and is therefore a costly process. 

The Association of British Pharmaceutical Industry estimates it costs £1.15bn on average to get a drug to market. 

That is in line with what most academics have estimated, including the Office of Health Economics. 

But its report, The Research and Development Cost of a New Medicine, published in 2012, warned that working out average costs should be treated with caution as they could vary greatly depending on where the treatment was targeted. 

The study said costs in cancer and neurology tended to be the highest because of the lower success rates and longer development times. 

Nonetheless, the report said, only about 10% of the overall cost was actually accounted for by the lab tests and clinical trials - the so-called research and development end. 

A more important factor is the cost of capital - that is related to the fact that the money has to be found upfront many years before the pharmaceutical firm sees anything back. (Más)

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Desmitificando el costo de desarrollo de un nuevo medicamento.

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