NICE backs Iressa after Astra sets fixed cost

from Reuters 27.05.2010, Ben Hirschler

AstraZeneca Plc's cancer pill Iressa has been recommended for use in the National Health Service (NHS) after the drugmaker agreed an unusual fixed cost deal.

The arrangement highlights the mounting pressure on firms to agree favourable "patient access schemes" in order to win approval from the National Institute for Health and Clinical Excellence (NICE), which decides if drugs are cost effective.

Iressa will be supplied at a fixed cost of 12,200 pounds, irrespective of the duration of treatment, and there will be no charge for patients who are treated for less than three months.

"It has been designed to ensure value for money for the NHS and to enable the budget impact to be predicted more accurately," said AstraZeneca spokeswoman Abigail Baron.

While NICE does not negotiate or set prices, it does take special offers into account when deciding whether to recommend drugs for reimbursement on the NHS.

In future the watchdog could play a more direct role in determining prices under government plans to move to a system of "value-based pricing."

NICE said on Thursday its draft recommendation on Iressa, which is also known as gefitinib, was open to consultation before publication of final guidance later this year.


The agency had asked AstraZeneca in January for information on Iressa. This was provided along with the new pricing offer.

Lung cancer is one of the most common cancers in Britain, with around 38,000 people diagnosed every year. The most common type is called non-small cell lung cancer.

Iressa -- a once-daily pill -- was approved by European regulators last July for adults with locally advanced or metastatic lung cancer whose tumours have an EGFR mutation.

A mutation in the epidermal growth factor receptor (EGFR) is a characteristic occurring in around 13 percent of lung cancers in Europe, and studies have shown these types of tumours are particularly sensitive to Iressa.

The European regulator's decision effectively revived the fortunes of a drug that had been largely written off after it failed to show significant benefits in the overall population of lung cancer patients in a clinical tests five years ago.

In Britain, NICE has already recommended various injectable treatments for lung cancer, but Carole Longson, health technology evaluation centre director at NICE, said Iressa offered an advantage because it is taken in tablet form.

Separately, NICE said it had also recommended Roche's

established cancer drug Xeloda as a first-line treatment for inoperable advanced gastric cancer, when used in combination with platinum-based chemotherapy.

Gastric, or stomach, cancer affects approximately 8,200 people in Britain every year.

(Editing by David Holmes)


New reference pricing rule in Greece

After much debate the Greek Ministry of Economy, Competitiveness & Shipping has announced a new reference pricing law for pharmaceuticals. The struggling Greek economy is looking for opportunities to realize savings in the health care sector and has introduced a decree of mandatory price reductions. Depending on wholesale price reduction from -3% to -27% (drugs of over €100.01) will be implemented. Orphan drugs and blood derivates are excempted from that decree. This is supposed to be a temporary measure. At the same time a referencing rule of the lowest three countries in the Eurozone is being discussed and for orphan drugs three lowest plus Uk. I must say it is very confusing..it will be interesting to follow how this unfolds.