Osimertinib, which was only licensed in February this year, has been recommended by the National Institute for Health and Care Excellence (NICE) in draft guidance to treat a particularly aggressive form of lung cancer.

This follows a previous refusal on the grounds of cost per course.

Earlier this year, NICE said reforms to the Cancer Drugs Fund would help deliver faster access to effective cancer treatments.

Osimertinib is the first drug to benefit from the new arrangements.

Professor Carole Longson, director of the health technology evaluation centre at NICE said “For the first time, we are able to give patients access to a promising new cancer treatment whilst more evidence is gathered on its effectiveness. This is the system working as it should.”

A NICE appraisal committee first looked at the drug in May and concluded that although osimertinib had shown early promise, the long term benefits were unclear and it could not be considered cost effective.

After that decision, AstraZeneca who market the drug put forward newer evidence from ongoing studies as well as further analyses of the available data.

The NICE committee still felt that the new data was not strong enough to say for certain if osimertinib was value for money.

As the studies were gathering more information on the long term effectiveness of osimertinib, they decided it could be included on the CDF.

Osimertinib will now be available immediately as a second-line option for people with advanced non-small-cell lung cancer that has a specific mutation, known as EGFR T790M-positive.

The drug works by targeting cancer cells directly meaning patients suffer less severe side effects than with other chemotherapy. People take it as once a day as a tablet.

In trials almost twice as many patients responded to osimertinib compared with another chemotherapy treatment. It also stalled cancer progression by an extra four months.

Around 300 patients will be eligible for treatment with osimertinib every year.

Under the new CDF arrangements, cancer drugs that receive a draft positive NICE recommendation will immediately be funded by NHS England.

Dr Jonathan Fielden, NHS England’s director of specialised commissioning and deputy national medical director, welcomed the decision: “This shows the benefits of strong commercial, patient focused discussions really delivering for patients.”

Paula Chadwick, chief executive of Roy Castle Lung Cancer Foundation, described the decision as a ‘breakthrough’:  “This new type of targeted therapy is an exciting development in the treatment of lung cancer. For many of our patients and their families this is a breakthrough moment – a recognition that these new medicines can truly benefit people with an advanced form of the disease.

“We welcome the announcement – it is good news for patients with the appropriate type of lung cancer. We hope this paves the way for further positive decisions for lung cancer patients across the UK.”

Source: NICE