Re: AANS/CNS Comments on Washington State HTA Review of Novocure and
Pharmacogenetics
Dear Mr. Morse:
On behalf of the American Association of Neurological Surgeons (AANS), the Congress of Neurological
Surgeons (CNS), and the Washington State Association of Neurological Surgeons (WSANS), we
appreciate the opportunity to provide comments regarding the Washington State Healthcare Authority
(WCA) Health Technology Assessment (HTA) program decision to place Novocure and
pharmacogenetics on its 2015 proposed list of technologies to review. As such, we would like to share
the following remarks.
Literature
We strongly agree that safety, quality, and cost are important considerations for any procedure and
understand the agency’s requirement to balance these considerations. We believe the early
evidence for Novocure and pharmacogenetics is promising but studies are on-going and we would
recommend that you wait to place these technologies on the program’s agenda until additional
scientific evidence becomes available.
NovoTTFTTM [NovocureTM]
Specifically for Novocure, Tumor Treating Fields (TTFields) delivered by the NovoTTF-100ATTM
System in combination with standard-of-care temozolomide chemotherapy was recently assessed in
a Company sponsored phase III trial [EF-14] with 2:1 randomization. Interim analysis of the first 315
patients, representing approximately 50 percent of the targeted study population, was presented on
November 15, 2014 at the Society for Neuro-Oncology Annual Meeting. The patients treated with
TTF demonstrated a significant increase in progression free survival compared to temozolomide
alone (median PFS of 7.1 months compared to 4.0 months, respectively, hazard ratio=0.63,
p=0.001); and a significant increase in overall survival compared to temozolomide alone (median
OS of 19.6 months compared to 16.6 months, respectively, hazard ratio=0.75, p=0.034). Based on
the interim analysis results, the Independent Data Monitoring Committee (IDMC) for the EF-14 trial
recommended that the trial be stopped early and that Novocure provide access to TTFields for
patients on the temozolomide alone arm. This was granted by the FDA. We anticipate that a full
review of the study and publication of the results will be completed in the next few months
…
Read full letter here
