Cost regulators are minded to refuse patients with untreated chronic lymphocytic leukaemia access to Roche’s Gazyvaro on the National Health Service.

The National Institute for Health and Care Excellence has today published preliminary guidance rejecting the drug because of uncertainties in the data.

“Although Gazyvaro (obinutuzumab) is a clinically effective treatment, there were too many uncertainties in the company’s submission and we cannot be confident that it is an effective use of NHS resources,” said Sir Andrew Dillon, NICE chief executive, explaining the decision.

The Appraisal Committee noted that the most likely incremental cost-effectiveness ratio (ICER) for Gazyvaro/chlorambucil compared with chlorambucil monotherapy was £31,000 per QALY gained, £28,000 per QALY gained compared with chlorambucil/MabThera (rituximab), £49,000 per QALY gained compared with bendamustine monotherapy, and £48,000 per QALY gained compared with bendamustine/MabThera, but it also said because of uncertainties these figures were likely to be higher. 

“With limited resources we need to ensure that each treatment we recommend gives patients not only the best care but is also of the best value to the NHS,” Sir Andrew stressed.

Gazyva was the first drug with breakthrough therapy designation to receive FDA approval, on the back of trial data showing that, in combination with chlorambucil, it achieved progression free survival of an average of 23 months versus 11.1 months for patients taking the latter alone.

Approves new heart attack test

In better news for the firm, new diagnostic guidance issued by NICE recommends the use of high-sensitivity troponin tests - such as Roche’s Elecsys - alongside an early rule-out protocol to speed up the assessment process for around 700,000 people attending A&E every year in England with chest pain and suspected acute coronary syndrome (ACS).

The guidance should benefit around 300,000 people presenting with suspected AMI each year who do not show characteristic ECG findings and need further tests to establish the cause of their chest pain, Roche said, noting that early diagnosis using high-sensitivity troponin assays could save NHS England over £200 per patient by limiting unnecessary admissions.

The Swiss drugmaker also stressed its Elecsys Troponin T hs assay is up to 100 times more sensitive than standard troponin tests.