A breakthrough lung cancer drug developed by UK scientists, which passed final clinical trials this week, might not be available on the NHS because it has been deemed too expensive by the drugs watchdog, it has emerged.
AstraZeneca’s experimental Tagrisso treatment passed final clinical trials on Monday after it was shown to materially increase the life expectancy of people suffering from a form of lung cancer.
But the medication, which was so effective in early trials that US and European regulators allowed Tagrisso to be administered to patients before studies were completed, has been rejected by the UK’s drugs gatekeeper as not cost effective enough to fund on the NHS.
The National Institute for Health and Care Excellence (Nice), which determines which drugs patients can access via the health service, said in a preliminary report in June that Tagrisso should not be funded on the NHS or included in the cancer drugs fund.
The decision is, however, out for consultation. That means Nice could reverse its recommendation after it examines additional trial data later this month.
Lisa Anson, president of AstraZeneca UK and Ireland, has called on Nice to make the drug routinely available on the NHS, pointing out that several other European countries, including France, Germany, Sweden, Denmark, Netherlands, Luxembourg and Croatia, have already approved the drug for use in their health systems. She also criticised Nice for being too slow in making its decisions.
“Tagrisso is clinically effective and we have shown that. We recognise there has been some uncertainty because of the speed of its development, but we were still very disappointed with the draft guidance," she said.
“I do believe the new data we are submitting is compelling and that Nice will make the right decision."
Tagrisso, which treats patients with a type of lung cancer that is especially resistant to treatment, is the fastest oncology development programme in the industry, having gone from human trials to approval in less than three years.
Also known by its clinical name osimertinib AZD9291, it is one of six cancer medicines AstraZeneca hopes will rebuild its sales following patent losses on older drugs. AstraZeneca says Tagrisso could eventually generate revenues of $3bn a year.
The drug was also the first to be approved under the regulator's accelerated access scheme, which speeds up authorisation of drugs deemed to be either of major public interest or for which there is unmet need.
NHS patients are currently eligible for Tagrisso, but only because AstraZeneca agreed to fund treatment through a compassionate use programme in February for six months, to allow Nice and the NHS time to work through funding issues. The programme will end on August 2.
“Our frustration in the UK is it takes longer for Nice to agree on the same data set that other markets have had and granted access to," said Ms Anson.
“This is about making sure patients get early access to breakthrough therapies, particularly for drugs invented in the UK. That is the goal of the new cancer drugs fund and we support that. However, we still call on the Government to reform Nice.”
A spokesperson at Nice said: “Osimertinib (Tagrisso) has shown early promise, however the long-term benefits it could have on overall survival and quality of life are uncertain. This is a preliminary decision which is out for consultation. The manufacturer can request to submit further evidence which the committee can consider before they reach a final decision.”
Early tests also suggest that Tagrisso can cross the blood brain barrier and reduce the size of brain lesions, which occur i