Why did NICE redact survival data from these clinical trials of a breast cancer drug?
NICE redacted clinical trial data on cancer patient survival even though its counterparts in Germany and France made similar data publicly available, a report released today shows.
The report by UK charity HealthWatch reviews assessments of the use of the drug palbociclib (Ibrance) for advanced breast cancer conducted by three different European health technology assessment agencies (HTAs) in order to gauge these agencies’ comparative levels of transparency and identify best practices in HTA transparency.
The report aims to contribute to informing ongoing discussions about the shape of a possible future European HTA agency. It may also be of interest to those following the current controversies about the value of using progression-free survival as a primary end point in clinical trials of cancer drugs.
Overall, the assessment processes of the three HTAs have a high level of transparency. The literature suggests that many other European HTAs do not meet the high transparency standards set by NICE (England & Wales), IQWIG (Germany) and HAS (France).
NICE redacted some efficacy data from its drug assessment reports. Disclosure of similar data by the other two HTAs shows that such redactions are not inevitable.
All three groups of medical experts in the UK, Germany and France looked at the same evidence, but nonetheless all reached different conclusions. A key factor was whether or not they considered progression-free survival in and of itself to confer meaningful benefits on patients with advanced breast cancer. (NICE concluded that it does, IQWIG concluded that it does not.)
European-level HTA assessments. Any future European-level HTA assessments should raise the bar on transparency by matching or exceeding the strongest transparency policies and practices of the individual Member State that is most advanced in that area. Notably, European-level HTA should adopt IQWIG’s approach of routinely publishing all clinical trial data used within its assessment reports.
NICE redactions. In the short term, NICE should put into place a system that automatically un-redacts all clinical trial data cited in its documents after a 12 month embargo period. In the medium term, NICE should follow the positive example of its German counterpart and stop redacting any clinical trial data in the first place.
NICE patient group involvement. NICE should follow up on its recent pledge to take into account concerns about undisclosed industry funding for patient groups in the ongoing review of its conflict of interest policies.
Till Bruckner, founder of TranspariMED, said:
“NICE should stop redacting data from clinical trials. Patients and doctors need to be able to see the full evidence on the benefits and harms of cancer drugs to make informed treatment decisions, and taxpayers have the right to see exactly what their money is paying for. Any future European-level HTA assessments should raise the bar on transparency by routinely publishing all clinical trial data used within assessment reports, as the German HTA already does.”
The author of the report is not an oncologist. Neither HealthWatch nor TranspariMED take any position regarding whether or not palbociclib should be used for the treatment of advanced breast cancer.
Note: The report was commissioned and funded by HealthWatch, a UK charity that promotes science and integrity in healthcare, and written by TranspariMED founder Till Bruckner. HealthWatch’s press release and the report are both available online. The report focuses exclusively on HTAs’ technical assessments. Pharmacoeconomic assessments, pricing negotiations, or reimbursement decisions by NICE and HAS are beyond its scope.