Pharma experts doubt new drug testing system

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16 Jan, 2011 Updated Sun 16 Jan 2011 15:34 CEST
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As Germany introduces a new regime for assessing medicines when they come to the market, two major figures in the system have spoken out saying that patients are being put at risk with expensive, unproven drugs.

“Patient care is suboptimal,” said Wolf-Dieter Ludwig, chairman of the German Medical Association’s medicines commission.

AstraZeneca’s blood thinner Brilique is the first drug to undergo the new assessment process which came into force at the start of the year. This process was introduced by Health Minster Philipp Rösler in order to save money as well as to break the pharma industry’s monopoly over setting prices.

The manufacturers have to submit a dossier of information on the new drug including results from clinical studies, to the joint commission of healthcare insurers and physicians, the G-BA.

This body then makes decisions about how much the statutory health insurers will pay for the drug – based largely on how much patients are expected to benefit, and what other treatment options are available.

Yet the dossiers only include data from clinical trials, which are limited in terms of how many people are involved, and how far they represent the total population.

Rainer Hess, head of the G-BA said this weekend that the introduction of the rapid assessment – which has to be completed in three months – was a great step forward in making new drugs available to patients. But he criticised the fact that a drug can remain on the market even if it is shown to be no better than what is already on offer.

The real test of how much a drug can offer patients cannot be done in three months, he admitted, saying that it can take years before statutory authorities get a proper impression – and then decide whether to fund a drug.

“A drug can be assessed seven or eight years after entry onto the market and be removed from reimbursement lists,” he said.

The problem is that there is no obligation on the manufacturers to prove the use of their products.

Even if the G-BA call for such a proof, “It can take years longer for this to be produced, years in which the medicine can be prescribed at the expense of the statutory insurers,” said Hess.

“This means that the patient can be treated with a drug for years after a license is granted – a drug which has not been sufficiently examined for superiority over other drugs, or for safety,” added Ludwig.

The G-BA will hold an extraordinary meeting on Thursday to decide on steps to try to close holes in the process.




2011/01/16 15:34

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