Biotech Strategy Blog

Commentary on Science, Innovation & New Products with a focus on Oncology, Hematology & Cancer Immunotherapy

Posts tagged ‘comparative effectiveness’

This afternoon at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Fort Lauderdale saw the long-awaited briefing on the National Eye Institute Lucentis v Avastin comparative effectiveness trial in AMD.

I wrote in a previous post about the CATT results published in the New England Journal of Medicine.

I also tweeted from the briefing, but must add the disclaimer that live tweeting is tough and none of my tweets should be relied upon for accuracy.

What did I learn from the briefing (aside from the fact that ARVO’s technology vendors have real challenges in not being able to light a room properly, set up wifi and get a projector to work):

  • The CATT study was set-up before anyone knew what the price for Lucentis was.
  • No mention was made in the briefing today about comparative cost – but isn’t that what everyone thinks this study is about?
  • No mention was made of how you balance the cost benefits against the trade-off of the higher risk of serious adverse events that was seen.
  • When asked what they would give to a relative, most of the panel answering Q&A “punted” and said they would discuss the data with the patient, and try and get them to make an informed decision.
  • Only Dan Martin from Cleveland Clinic stuck his neck out and said if the patient asked him to make the choice of what to take, he would use Avastin over Lucentis – this statement clearly resonated with the audience (he received a big round of applause)
  • Two year data is already available and some of it was shown today, with no difference in death rate at 2 years between Lucentis or Avastin. The two year data will be published this time next year.
  • The study was not adequately powered to look at the serious adverse events (SAE), which means the statistically significant difference in SAEs may never be truly understood.

Overall, my impression from the briefing is that Lucentis is not identical to Avastin, although functionally the benefits from both appear broadly comparable with no statistical significance between them in terms of visual acuity gains. No mention was made of when you might use one drug over the other (if at all).

Lucentis did have some benefits over Avastin such as a lower retinal thickness at one year compared to the other three treatment groups, which was statistically significant. Both drugs produced an immediate and substantial decrease in retinal fluid, but more eyes were completely dry with Lucentis.

My thoughts are that the debate over Lucentis v Avastin is like the difference between a brand versus a generic, they are similar in terms of efficacy but not identical. While that’s perhaps an over-simplification given that in this case one drug is FDA approved and the other is not, those who want a brand and can afford it will buy a brand, while others may prefer the “generic” for cost reasons.

Will the Lucentis v Avastin decision be any different? If you can afford Lucentis through your insurance you may choose to take that, otherwise Avastin is another option for AMD.  Weighing cost versus slightly higher risk of SAE’s (for which there’s no adequate explanation showing causality) is how I would approach this decision.

It was interesting to note that the follow-up will continue and two year results will be published this time next year. They may shed further light on the serious adverse event differences, but I suspect that given the way the study is powered, this issue may not be resolved any further.

My overall take is that there is nothing compelling in the data to suggest that any ophthalmologist that is using bevacizumab off-label will switch patients to ranibizumab. Off-label Avastin use in wet AMD received an official NEI endorsement from the CATT study and will continue.

Equally those who are happy with Lucentis will not switch to Avastin on the back of this study, given that the Lucentis data appeared slightly better in places.  The controversy will no doubt continue and other studies comparing Lucentis v Avastin will add further insight.

 

I recently attended the annual meeting of the American Society of Hematology (ASH) in Orlando so thought I would share my general impressions (in no particular order):

Convention Center Food was Poor:

The food at the Orange County Convention Center reminded me of an airport – desperate choices, poor quality and overpriced.  As for no Starbucks or decent coffee shop, civilization has yet to reach Orlando! The Peabody hotel across the road had coffee shops that offered a $3 single espresso shot, but they ran out of pods on the Monday morning – faced with the overwhelming demand that seems to have not been anticipated!  Memo to Starbucks – look into a convention center franchise.

Cramming all the science in one day doesn’t work:

People go to a meeting such as ASH for many reasons – networking, business development, education, investigator meetings, but in the end, it is a scientific meeting.  The meeting ran from Saturday to Tuesday, yet nearly all the oral scientific program (biology and therapy) was crammed into one day of simultaneous sessions on the Monday – tough if you wanted to cover a product or pathway that targeted multiple therapeutic areas, many of which ran at the same time.

The Poster hall was like a graveyard:

You can tell I didn’t think this was a great meeting. Every time I went into the aircraft like hangar where the posters were housed, I ended up chilled to the bone. It certainly didn’t encourage spending much time there, and I was disappointed that a surprisingly high number of presenters did not attend the poster presentation receptions, when they were supposed to be available to answer questions.  Nobody seemed to check if anybody showed up, to me the whole point of a poster is being able to discuss it.

Why not publish the slides from the oral science presentations?

ASH, unlike ASCO does not make the slides of oral scientific presentations available online, so if you didn’t make notes, or break the rules (and risk being ejected) by taking an illegal picture on your phone or camera, then you missed it.  Abstracts are often submitted months in advance before the final data is analyzed, so by not making the slides available after the meeting, science to me is being hampered especially given the overlap of sessions on the Monday.  If an abstract is presented and published, the scientific information should be available to be shared. Isn’t that what science is about?  ASCO have it right, their virtual meeting program is outstanding.

Hospitality lives on – but only if you are an international doctor:

US doctors attending their annual meeting, are warned not to accept a free cup of coffee at an exhibitor booth if their state or employer prohibits the acceptance of such “gifts”, while foreign physician attendees are wined and dined.  You see signs for hospitality centers for European doctors or desks in hotels for company sponsored groups of foreign doctors – hard to believe there’s ethically not something wrong with these double standards.

A lack of quality educational materials:

While the free pen and notepad have long since gone the way of the dinosaur, this year there was noticeably fewer educational material to take away.  The debate as to whether doctors should pay for their own CME continues, but I do think many in the industry miss the opportunity by not providing educational material on the science, pathways and mechanism of action of new products.

The “Super Friday” is still alive:

Multiple industry sponsored satellite symposia (AKA “Super Friday” sessions) took place before ASH, with several at the Peabody Hotel. I have to say the food at the one I attended on personalized medicine was excellent, one of my best meals in Orlando.  They are not cheap to run: not only do 800-1000 people get fed, but a hotel room with audio-visual equipment has to be hired, a panel of experts are paid to talk about a topic, and many of the attendees come away with a glossy brochure.  Could this money be better spent elsewhere?  ASH has a large education component to it, and it was interesting to note that what the ASH education program committee chose as important topics to talk about and what the industry chose, were pretty different.  That is perhaps not surprising – after all if you choose the topic of the satellite symposia and it’s of relevance to your product, indirectly you are trying to influence prescribing behavior, otherwise why else would you fund it?  There is no such thing as a free lunch or dinner.

Multiple Myeloma was a hot topic:

There was a lot of interest in clinical trial results in MM.  The use of a maintenance therapy, and attempt to turn this into a chronic disease was a widely discussed topic, however many old drugs such as thalidomide have nasty side effect profiles such as peripheral neuropathy, while newer drugs such as lenalidomide are expensive but appear to only incrementally increase survival.  Results from multiple combinations of drugs and induction therapies were presented, I was left with the impression that although there is progress, there is still no major breakthrough in this disease area.

Nobody wants to talk about cost effectiveness:

The 800 lb gorilla in the room for hematology/oncology is the comparative effectiveness of one treatment versus another i.e. it’s cost/benefit, yet nobody wants to talk about it.  Take for example the treatment of CML, should you treat with imatinib (Gleevec) which has outstanding long-term survival data over several years thanks to the IRIS trial, or use a second-generation tyrosine kinase inhibitor (TKI) such as dasatinib or nilotinib that is around twice the price, more potent and slightly more effective but obviously we don’t yet know if it improves 5 or 10 year survival yet over imatinib.  Nobody wanted to talk about price – physicians currently live in an ivory tower.

If you are interested in information on what the hot scientific news was at ASH, then I encourage you to look at the excellent posts (here & here) published by my colleague on Pharma Strategy Blog.

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