NICE drug approval and The Cancer Drug Fund

[HAIRBEAR_UK]

How novel treatment technologies are presented to organisations like NICE for approval is very important. I heard yesterday of one drug company that chose not to go to NICE as their QALY score and NICE cost justification would probably prevent approval. So the Cancer drugs fund has been picking up the tab for this drugs use by clinicians. However with this fund soon going in England there is concern. Here in Wales we are familiar with this issue as we do not have such a fund available.

Gaining NICE approval is going to be even more important in the light of the changes to the cancer drugs fund. As I mentioned in an earlier thread this is available to access licensed drug ahead of approval or if not considered cost effective by NICE. David Cameron is using this as an election issue and pledged to extend this in England

” Prime Minister David Cameron said the CDF had been a "massive success" and added that should he be re-elected he would recommend that it be continued beyond 2016.”

CANCER DRUGS FUND 'TO BE EXTENDED' UNTIL 2016 bbc.co.uk/news/health-24304351

To help people understand how NICE appraise a drug I have posted below information .

Starting with what is most important to NICE the “ QALY “ score

,nice.org.uk/newsroom/featur...

This is about how NICE measure effectiveness and cost effectiveness: the QALY

With the rapid advances in modern medicine, most people accept that no publicly funded healthcare system, including the NHS, can possibly pay for every new medical treatment which becomes available. The enormous costs involved mean that choices have to be made.

It makes sense to focus on treatments that improve the quality and/or length of someone's life and, at the same time, are an effective use of NHS resources.

NICE takes all these factors into account when it carries out its technology appraisals (TAs) on new drugs. Our expert review groups (comprising both health professionals and patients) examine independently-verified evidence on how well a drug works and whether it provides good value for money.

To ensure our judgements are fair, we use a standard and internationally recognised method to compare different drugs and measure their clinical effectiveness: the quality-adjusted life years measurement (the ‘QALY').

HOW IS THIS CALCULATED?

Although one treatment might help someone live longer, it might also have serious side effects. (For example, it might make them feel sick, put them at risk of other illnesses or leave them permanently disabled.) Another treatment might not help someone to live as long, but it may improve their quality of life while they are alive (for example, by reducing their pain or disability).

The QALY method helps us measure these factors so that we can compare different treatments for the same and different conditions. A QALY gives an idea of how many extra months or years of life of a reasonable quality a person might gain as a result of treatment (particularly important when considering treatments for chronic conditions).

A number of factors are considered when measuring someone's quality of life, in terms of their health. They include, for example, the level of pain the person is in, their mobility and their general mood. The quality of life rating can range from negative values below 0 (worst possible health) to 1 (the best possible health). (See the box below for an example of how this works in practice.)

WHAT ABOUT COST EFFECTIVENESS?

Having used the QALY measurement to compare how much someone's life can be extended and improved, we then consider cost effectiveness - that is, how much the drug or treatment costs per QALY. This is the cost of using the drugs to provide a year of the best quality of life available - it could be one person receiving one QALY, but is more likely to be a number of people receiving a proportion of a QALY - for example 20 people receiving 0.05 of a QALY.

Cost effectiveness is expressed as ‘£ per QALY'.

Each drug is considered on a case-by-case basis. Generally, however, if a treatment costs more than £20,000-30,000 per QALY, then it would not be considered cost effective

[MartyR]

Nick,

So I suppose the "offer" on the interweb for CAL-101 (GS-1101, Idelalisib) would be classed as --> non-cost effective.

10mgUSD 120In stock

50mgUSD 470In stock

200mgUSD 1270 In stock

Typically a daily dose is 150mg x 2

So for a year - $470 x 3 x 2 x 365 = just over $ 1,000,000.00

Although, this doubtful site does offer "massive discount for bulk orders" and NO guarantee of the tablets contents!

Regards,

Marty

[HAIRBEAR_UK Founder Admin in reply to MartyR]

I would wait to see what price the new drugs are set at although there is a lot of talk that they will be way off base, I think it is counter intuitive to believe they will not be able to retail them to their market. I guess we watch and wait and keep pushing for more.

Expert clinicians will find a way to access what they feel is the best treatment for you available at the time.

Hope

[Mikey47 in reply to HAIRBEAR_UK]

Hi Nick,

That was my Bournemouth consultant, Helen McCarthy, who chaired that UKCLL Forum meeting.

Mikey

[HAIRBEAR_UK Founder Admin in reply to Mikey47]

I have been following your on-line treatment story Mikey, thanks for this it is good to know you found a clinician with CLL expertise. The CLL Forum is very active and far reaching. Coincidentally I noticed that the second session and third were also chaired by Dr Nilma Parry Jones she works out of the same county as me in our little principality of Wales. It was a well attended event , I find it fascinating watching the clinical/scientific community come together from all parts of the UK and overseas guests to share their knowledge and work together. For me as well as learning and updating a good time to catch up with those working on projects in the pipes with us in CLL Support..

Nick

[Mikey47 in reply to HAIRBEAR_UK]

Thanks to you Nick for bringing us all this feedback info. Yes, Helen said there were about 150 people there.

[HAIRBEAR_UK Founder Admin in reply to Mikey47]

Hi Mikey

I will try to write a little more for everyone. I'm flying the flag again for little ol Wales as Cardiff Scientist Dr Elisabeth Walsby won the Catovsky prize for her study on the migration of primary CLL cells across the vascular endothelium which she modeled and characterised in a novel in vitro circulation system.

After the January CLLSA patient talks Dr Walsby presented this for the first time . fascinating and such dedication. makes me proud to know we have all these incredible people behind us.

Nick

[Kwenda]

Perhaps Nick the thing that might help us is that you wrote ‘ new drugs ‘, in the plural .

There are several new drugs for CLL in the pipeline, and thus hopefully some competitive pressures will keep the cost of these drugs within reason. If we had only a single new patentable drug I would be extremely concerned.

Dick

[HAIRBEAR_UK Founder Admin in reply to Kwenda]

Hi Dick yes as new drugs move further along the pipe prices will come. but as Chris mentions there are no new competing technologies arriving at the same time so competition may be less of an issue than them realising their market. It does make me feel hopeful, each of these different technologies will probably have very different applications to address the heterogeneity of the CLL community. the picture is unfolding as is the testing capability.

Submissions are also in with NICE here in the UK for Obinutuzumab now ahead of licence issue by the EHA the scope commences next week. for Obinutuzumab plus Chlorambucil for first line ahead of final CLL11 data coming at Ash in December. this is another promising potential combination for those unable to tolerate Fludarabine based therapies.

again this is ahead of licence issue and final data as NICE hold scoping meetings well in advance of the final remit from the Department of Health to NICE on this technology.to gain input from organisations representing patients, carers and service users .

The new drug are trickling into the system Hope

[Cllcanada Top Poster CURE Hero]

There will be a couple of drugs next year coming to market, obinutuzumab and ibrutinib likely. Idelalisib will be behind these two, by a year or so, perhaps.

They are very different, and I see no competition between them.