Australians - here's your opportunity to support the listing of GAZYVA (Obinutuzimab) on the PBS - Deadline is Wed 11th June!

[AussieNeil]

GAZYVA, a new anti-CD20 monoclonal antibody in combination with Chlorambucil, is now Therapeutic Goods Administration (TGA) approved for the treatment of previously untreated Australian CLL patients. It is NOT YET on the Pharmaceutical Benefits Scheme (PBS), but Roche has made a first time submission for Gazyva to Australia's Pharmaceutical Benefits Advisory Committee (PBAC) - the body that recommends what should be on the PBS.

You can support this submission via on line comment to the PBAC.

PBAC has been knocking back many new cancer therapies because they are considered too expensive for the value delivered, but Roche has good evidence of benefit of the GAZYVA + Chlorambucil combination for people with CLL from their CLL11 GAZYVA study...

GAZYVA + Chlorambucil:

* More than doubled Progression Free Survival (PFS) vs Chlorambucil alone (26.7 vs 11.1 months)

* Provided nearly 1-year improvement in PFS vs MabThera (Rituximab) + Chlorambucil (26.7 vs 15.2 months)

As the PBAC site says:

"Your comments are welcome whether you are a patient, carer, member of the public, health professional or member of a consumer interest group."

Comments must be submitted on line by next Wednesday the 11th of June. PBAC will review all submissions and make a decision at their July meeting. (They only meet three times a year.)

On line submission:

health.gov.au/internet/main...

Background information:

PBAC's role, Meeting Agenda and Consumer Comments

health.gov.au/internet/main...

Steven M. Horwitz, MD, Memorial Sloan Kettering Cancer Center in 2014-NCCN-Guideline-Updates

“The most significant changes are the addition of two newly approved agents for chronic lymphocytic leukemia, obinutuzumab and ibrutinib. That’s quite a lot in a single year. These drugs have the potential to make major changes in how we treat patients, particularly as we have more important non-chemotherapy options."

onclive.com/publications/ob...

CLL11 Trial

clinicaltrials.gov/show/NCT...

Overview

roche.com/med-cor-2013-11-0...

ASH 2013 Article

cancernetwork.com/ash-2013/...

Dr Sharman presented slides on the benefit of this combination in his recent ASCO presentation:

healthunlocked.com/cllsuppo...

FDA approval was given 7 months ago:

healthunlocked.com/cllsuppo....

Plus much more if you do a site search for Gazyva or obinutuzimab

Thanks for your support!

Neil

[AussieNeil Partner Administrator]

I hope our Australian membership - whether on watch and wait or in remission and welcoming the addition of an alternative treatment for when their remission ends, have taken the opportunity to submit their opinion on listing GAZYVA on the PBS

I found the submission process very easy to work through and I particularly liked the guidance text provided for each of the questions.

Neil

[AussieNeil Partner Administrator]

Australia's Pharmaceutical Benefits Advisory Committee (PBAC) has assigned GAZYVA + Chlorambucil into the category "1st Time Decisions Not to Recommend" for first line treatment of CLL patients in their July 2014 meeting because they considered it wasn't cost effective. Here's the full extract of the reasoning behind that decision:

"The PBAC rejected the submission to list obinutuzumab on the PBS for the treatment of CLL in patients with comorbidities as the submission failed to demonstrate that obinutuzumab was cost effective. The economic model submitted by the sponsor was unsuitable as a basis for determining the cost-effectiveness of obinutuzumab in the requested treatment setting.

On the basis of direct evidence presented by the submission, the comparison of obinutuzumab plus chlorambucil and rituximab plus chlorambucil over a median follow-up of 18.7 months, resulted in:

An improvement in median progression free survival of 11.5 months.

Approximately 29 fewer patients per 100 having progressed.

Approximately 10 fewer patients per 100 requiring further anti‑leukaemia therapy.

On the basis of direct evidence presented by the submission, for every 100 patients treated with obinutuzumab plus chlorambucil, in comparison to rituximab plus chlorambucil, over a median duration of follow-up of 18.7 months, there would be:

Approximately 16 additional grade 3 to 5 infusion-related reactions;

Approximately 7 additional episodes of grade 4 neutropenia but no additional episodes of infection (all-grade infection);

Approximately 7 additional episodes of grade 3 to 5 thrombocytopenia."

While GAZYVA + Chlorambucil is approved for use in Australia by the Therapeutic Goods Administration, patients will not have the cost subsidised by the government Pharmaceutical Benefits Scheme (PBS). That also means that patients requesting this treatment are unlikely to benefit from their treatment centre having previous experience with this drug combination.

Perhaps there will be a resubmission...

Neil

[Cllcanada Top Poster CURE Hero in reply to AussieNeil]

How disappointing. We are just beginning the funding recommendation process here in Canada.

Based on current U.S. costs Gazyva is about $42,000 for 6 rounds according to some sources, which is about double the cost of rituxan, which will loose its patient shortly.

It will be interesting to see what happens to costs as biosimilars enter our markets in the next few years...

I suspect the cost of rituxan will remain constant, and will be slowly replaced by the fast infusion subcutaneous version....

Gazyva... I don't know...

Follow the Canadian fund process here...

pcodr.ca/wcpc/portal/Home/F...

~chris