Boehringer Ingelheim must provide more data to justify the cost of its diabetes drug Jardiance if it wants the drug to be routinely used on the NHS in England.
The National Institute for Health and Care Excellence (NICE), which provides treatment guidance to the NHS, did not back the use of Jardiance (empagliflozin) to control blood sugar levels in people with type 2 diabetes in draft guidance, despite acknowledging the treatment’s effectiveness in this area.
Prof Carole Longson, director of the NICE Centre for Health Technology Evaluation, said: “There is good evidence which shows that empagliflozin is clinically effective. But we need more information to demonstrate that it is cost effective when compared with other treatments the NHS already provides.”
Jardiance – a once-daily oral drug – is part of a class of new diabetes treatments known as SGLT-2 inhibitors, which work by increasing the amount of sugar passed out of the bod through urine.
Two SGLT-2 inhibitors have been recommended by NICEs so far: AstraZeneca’s Forxiga (dapagliflozin) – backed in May last year, and Johnson & Johnson’s Invokana (canagliflozin), which was recommended earlier this summer.
Both drugs area already making headway in the UK due in part to their potential in combination therapies, and AZ has even launched the combination pill Xigduo in the UK. This drug combines Forxiga and standard diabetes therapy metformin.
The negative draft guidance is a blow to Boehringer as it tries to catch up on the competition in the UK, although the company now has a chance to discuss the decision with NICE during a consultation process.
Boehringer recently overcame problems with Jardiance in the US where the FDA had questioned deficiencies in the manufacture of the drug. The company has addressed these issues and Jardiance was approved in the US early this month joining the already-approved Invokana and Forxiga.
Commenting on NICE’s guidance, a Boehringer spokesperson said: “NICE’s initial recommendation is a ‘Minded not to recommend’ following the first committee meeting for Jardiance held on July 29, 2014.
“‘Minded not to recommend’ is standard NICE language and means simply that NICE require more information before making a decision.
“It is NOT an indication of the outcome of the process. The ACD requests further information from the Alliance concerning the economic analysis in time for the next Appraisal Committee meeting on September 24, 2014.”