"NICE slaps down Roche's Avastin for ovarian cancer"

December 18, 2012 | By Tracy Staton

U.K. watchdog says drug's benefit isn't worth the cost

Avastin has struck out at NICE again. The U.K. cost-effectiveness watchdog says it's not inclined to back the blockbuster Roche drug as a treatment for ovarian cancer. NICE said Avastin simply doesn't deliver enough value for the money.

The sticking point lay in Avastin's ability--or lack thereof--to extend patients' lives. NICE allowed that the drug did hold off the spread of disease in some patients. But whether patients actually live longer isn't clear, the agency said. The refusal in ovarian cancer follows a similar decision in breast cancer in July.

On balance, officials concluded that Avastin's clinical benefits in ovarian cancer aren't significantly better than those of other drugs--or at least not enough to justify the premium. "There was no evidence ... that the clinical benefit of the treatment justifies its cost, when compared to existing treatments," NICE Chief Andrew Dillon said in a statement.

Whether Roche would propose a reduction large enough to tip the balance remains to be seen. It's clear, however, that the Swiss drugmaker is keen upon extending Avastin's use into new indications; in fact, its hopes for use in ovarian cancer amount to hundreds of millions of dollars. NICE's decision could be influential here, and not only in the U.K. Other governments often look to the agency for guidance in setting their own health-service formularies.

fiercepharma.com/story/nice...

19 Replies

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  • That really really angers me. I know a lady in the States who has been receiving Avastin for the last 16months and its has stopped her tumours from progressing. It's working brilliantly for her.

    Grrrrrrrrrr

    Jackie

  • She has Ovarian btw

  • Well done, Bellabee, I am so glad you posted this. You have got the ball rolling ...all the way to Westminster?

    I read this in the paper earlier, I cannot believe that NICE can approve Avastin for other cancers and not ovarian cancer. Let's hear about the success stories about Avastin on this blog. I am due to see my MP in the New Year and I suggest all of us who feel this is another set back in possibilities for OC treatment, write to our MPs and state our views.

    There seems to be some really serious shaking up of the cancer services in our counties in the NHS reforms. Although GP commissioning may mean some women are treated fairly and given all the possible opportunities, it may be that some of us are not in the right post code area. If Avastin is going to be rationed, what will this mean for us all?

    We all have access to the Internet and it's surprisingly easy to find your MP and email him or her. I am planning on doing this, wonder who else will?

    Go girls!

    Love Wendy xx

  • PS , PRchick .......see what I mean about awkward old biddies ;-) . Biddie Power ........ YEAH :-D

  • I would be happy to write or email our MP, please could you give me and maybe some others a few guide lines about what to say. If you can set out the points I will write it on my day off.

    Love Babs x

  • Hi Babs! How is work going? I hope it's still good to be back?

    I will just be giving a brief history of what has happened to me. This may be framework you can use, but I always find its better to speak from the heart........ I am sure you will! Here is a framework I will use:

    My story, a brief personal account

    Experience of chemo

    Outcomes, how I am at present

    Hopes for the future

    How I feel about Avastin as a possible way of giving more quality of life and time

    I will end by asking MP to try to use his influence in any discussions on helping patients with OC to get the very best treatments in the re-shaped NHS.

    I will try to keep it as brief as poss, as I've found they tend to glaze over when

    Faced with a lot of reading! ;-)

    Hope this helps

    Love Wendy xx

  • So this one begs for a response from ovacome and, dare I say it, some real life quotes from OC ladies even if anonymous. Volunteering as a helper if you need it, oh ovacome organiser gods, though am sure you have your own PR bods happy to be extra resource if it helps. How frigging dare NICE effectively say that each individual is irrelevant? How dare they take choice away?

    Grrrrrrr

    Sue

    (An old biddy in training, learning from the best)

  • a bit more detail...not the final decision apparently...so pressure might have an impact

    Roche’s Avastin Fails to Win NICE Ovarian Cancer Backing

    By Naomi Kresge - Dec 18, 2012 12:01 AM GMT.

    .

    Roche Holding AG (ROG)’s anti-tumor drug Avastin failed to win the backing of the U.K.’s health-cost regulator as a treatment for advanced ovarian cancer in a draft decision released today.

    The National Institute for Health and Clinical Excellence recommended against using the drug at the dosage for which it’s currently licensed, the agency said today in an e-mailed statement. The existence of two different dosages -- the licensed dose of 15 milligrams per kilogram of body weight, plus a smaller dose often prescribed by doctors -- made it difficult to say for certain how effective the medicine is, NICE said.

    Although Avastin used together with paclitaxel and carboplatin chemotherapy did seem to help delay the cancer’s spread, “it was unclear whether this translated into an overall survival benefit,” Andrew Dillon, NICE’s chief executive, said in the statement. “There was no evidence to show that the clinical benefit of the treatment justifies its cost, when compared to existing treatments.”

    Ovarian cancer is among the diseases Roche has said will drive growth for Avastin, the Basel, Switzerland-based company’s second-biggest-selling drug last year. The ovarian cancer market in the U.S., France, Germany, Italy, Spain, the U.K. and Japan may more than triple to $1.4 billion in the next decade, research firm Decision Resources said on Dec. 10.

    Roche’s Disappointment

    “Roche is disappointed that, as part of its review, NICE did not consider the entirety of evidence that was presented to them for Avastin as a first-line treatment of advanced ovarian cancer, and will continue to work with NICE to secure a positive recommendation for Avastin in this setting,” spokeswoman Silvia Dobry said in an e-mailed statement.

    Avastin treatment for a 65-kilogram (143-pound) U.K. patient with advanced ovarian cancer costs about 36,000 pounds ($58,000) at the licensed dose, according to NICE. Roche didn’t submit a proposal to the U.K. Department of Health to make Avastin more cost-effective, the agency said. Some companies offer to reduce prices by as much as 50 percent, NICE Chairman Michael Rawlins said this month.

    The agency said it would give a final ruling on the drug next year.

  • Just to put a spanner in the works, Professor Hani Gabra insists Avastin is no more effective than dose-dense weekly Taxol and he would recommend that. I think we should look at the wider picture here. In countries where health care is covered by private insurance it doesn't much matter whether they use the more expensive Avastin option or dose-dense weekly Taxol.

    I'm happy to join the throng and help with research and enquiries if this helps as for the moment I'm keeping an open mind about the options.

    I for one think that drugs should be manufactured by not-for-profit companies. It makes me sick that friends in the medical profession are taken on jollies abroad with their whole family just in order to persuade them to prescribe particular drugs.

    Hope this isn't too controversial. I don't want to upset anyone.

    xxx Annie

  • Hear Hear Annie!

  • I am following this thread with great interest, and would point out that some of us with OC cannot have weekly does of Taxol due to severe allergic reactions to it. I am only siting here on my iPad alive due to second line treatment with gem/Carboplatin and Avastin. My recent CT scan shows no visible cancer at the moment and I had heard that outstanding results were being achieved with Avastin. I think that the issue at the moment is there is a lot of politics going on at the moment as the NHS want to drive the cost of Avastin down.

    Wendy x

  • Dear Wendy

    Your post is really interesting to understand the wider implications. It's vital that people are given the treatment they need but equally important to look at cheaper alternatives if they're effective.

    I'm really heartened to hear you've had such success witjh Gem/Carboplatin and Avastin. Let's hope others who need this combination get it.

    xx love Annie

  • FYI I also posted this on the Inspire forum - here's a link to see what was said there...

    inspire.com/groups/ovarian-...

  • Whippet - some similar views on the Inspire thread.

  • I still think the issue it is about health for the individual. A this point after huge amounts of targeted cancer research it is unsurprising that the advances are smaller and possibly only applicable for a smaller number of individual cases, and about longer term survival rate increments not vast change-the-standard treatment breakthroughs. They simply don't come along often. That should be a factor in their deliberations, but is not.

    The whole culture of drug decision making and clearance for funded use is at issue here. While they persist in looking at value for money across the board first they ignore the imperative to be able to build individualised treatment solutions for PEOPLE. We are seeing this far, far too often.

    NICE is effectively a committee, a talking shop, and as such makes compromise decisions that make the majority around the table feel satisfied and, most importantly, not exposed. Safe, political decisions.

    Meanwhile a lottery fir life continues and some who could use Avastin are not allowed. They have a right to the optimal combination for THEM, as a citizen of the UK, a taxpayer and contributor to the NHS coffers, and as a human being.

  • hear hear - tell that to Alex Salmon!

  • I remain dubious about avastin because annecdotal evidence may not be showing actual effectiveness of the drug. From what I have read avastin extends life for some people for a few weeks! It is not necessarily effective for everyone and there is no knowing before it is prescribed whether it is going to work for an individual. I want quality time now not pie in the sky.

    I know a lot of people swear by it and I do not object to them getting it if they can but I do object to the drug giants profiting from our fears!

    I trust my oncologists and surgeon to recommend the best available treatments for me which will give me the best quality of life now, after all I am not medically qualified and cannot fully comprehend all the research results.

    I am happy to make sensible lifestyle changes to help my treatment and I will take supplements that do no harm and may be of benefit but all the drugs are poisons and can damage healthy tissue so I have to make a measured assessment of benefits vs costs and decide for myself what I am prepared to put up with and if the outcome is going to be worth the side effects.

    Meanwhile time to tackle the breast lump in January!

    Love M

  • Hi Everyone,

    Well I have been waiting for this - There is an added controversy to the story, and one which I do feel needs challenging.

    There were tow big trials for Avastin in the first line setting. One in The USA, where they used a dose of 15 mg/kg, and the European one which used half the dose. The USA study completed first, and thus this was the data that Roche used to get the drug licenced, however even given the fact that it's licence is for 15 mg/kg, clinicians are using 7.5.

    The SMC (in Scotland) and NICE have said that they can only consider the data at the higher dose because they are only able to look at treatments within in the licenced indication. The SMC have said that at the lower dose Avastin is cost effective!

    Ovacome will be spending the next few weeks to discuss this with various people!

    Just to pick up on a few points raised above. Ovacome does not recommend specific treatments, however we believe that all active treatments should be available so that clinicians and women can choose what is right for the individual.

    Avastin has been proven to be more effective in certain circumstances, thus we would advocate that for some women Avastin should be available to them.

    No one should be concerned about access at the moment. Even if this provisional decision stands, then Avastin will still be avaliable via the CDF (Until that ends next year)

    Re doctors jollies - Whilst this no doubt occurred in the past, the Association of British Pharmacological Industries (ABPI) has banned such practices for quite a few years now. These days you are lucky to be able to even see a pen on their exhibition stands!

    We will keep you posted as any more news comes in. If anyone has any suggestions for our submission to NICE, please do let me know.

  • Well I am the lass who is in this edition of the Ovacome magazine.... I was on weekly taxol and three weekly. Carboplatin for 6 cycles with major surgery I between... As discussed by Annie whippet ( above) and professor Gabra ( at last year's members meeting) ,following the Japanese paper/trial was shown to be as effective as Alvastin.

    My OC never rested or gave me a break... Indeed 9 weeks later I went into bowel obstruction as OC tumour pushed from outside my large bowel in.. And ca125 went from 128 to 900 was (2089 at diagnosis.)

    With the obstruction I was treated with chemotherapy and steroid pump to make tumour shrink ( which it did after 3 weeks ) . I also was accepted for funding to start Alvastin and have had 3 doses so far. My chemotherapy is due to be completed in 6 weeks, so I will know how effective Alvastin will be when not partnered with chemo....

    But even if all flares up again I have been given the opportunity to have this drug, had I not then I would have appealed and appealed, in the hope that anything would help me with this chronic condition OC. I believe it will give me longevity and I thank whoever for granting this.... I will happily be an advocate and am now a ROCC( regional OC coordinator with Ovacome) and start a new support group in Berkshire at the end of this month.... I will be vocal and will target whoever I need to x

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