Tuesday, May 15, 2007

Cancer Drug Access

Access to cancer drugs stayed in the news this weekend with the BBC reporting the results of its survey of 180 UK cancer specialists on their views. They are anxious about access to new treatments on the NHS and they are anxious about NHS patients having to pay for NHS-administration of non-NICE approved treatments.

Mens Sana also posted about access to Tarceva, Docetaxel and Pemetrexel.

My weekend reading was the Karolinska Institute report on EU access to cancer drugs we cited here.

Research at Columbia University in the USA, cited in the report, has shown that access to more cancer drugs is directly correlated to increased one and five year survival rates. It is in the interests of cancer patients to have access to new drugs as quickly as possible.

On the situation in the UK, where the authors reported access to new drugs was one of the worst in the European Union, it made disturbing reading. I will cite come examples …

Drug regulatory and approval regimes differ widely. For EU members the first step is for the drug to be approved by Committee for Human Medical Products (CHMP). Although this approval process is not meant to take more than 180 days, the reality is a median of 418 days. The approval process then passes to national authorities, clearly leading to further delays in patient access.

In the UK these national approvals are considered by three authorities – for Wales, the All Wales Medicine Strategy Group (AWMSG), for Scotland, the Scottish Medicines Consortium (SMC) and in England, the National Institute for Health and Clinical Excellence (NICE).

The report states that referral time to NICE “can be up to 18 months and this is prior to the beginning of any review”. The report does not cite referral times to the SMC but in my calculations below I will use the same..

Budgetary allocations for new treatments are not planned during England NICE evaluations so it is only after NICE has granted approval that budgetary planning for the next financial year (April to March in the UK) can take place. Knowing a little bit about the bean counters, I can I imagine that a drug approved in March 2007 (probably earlier), will not be approved for April 2007 but will only be approved for April 2008. Let us make budgetary planning six months/180 days.

The NICE review/approval time averages is 62 weeks, SMC is 12 weeks.

England:

EU CHMP 418 days + referral to the national authority 72 days + NICE review 434 days + budgetary planning 180 days = 1104 days = 3.02 years

Scotland:

EU CHMP 418 days + referral to the national authority 72 days + SMC review 90 days + budgetary planning 180 days = 760 days = 2.08 years

One year in the life of a cancer patient is a long time.

Move to Scotland. Is Scotland negligent? Methinks not. Is Switzerland, not a member of the EU, and with excellent cancer drug uptake and treatment rates negligent? Methinks not.

Dr. Crippen has reported on a cancer patient moving from England to Scotland for treatment. Potentilla – I´m happy you´re there!

Let us move on …

Cancer research

In the US public (and I´m taking that to mean state) funding of cancer research is seven times that of the EU. Fair enough. In the EU cancer research funding is 50/50 split between state and charities. The UK, within the EU, is the highest investor in cancer research, with the charities contributing more than the average 50%.

Yet this report illustrates that the UK lags behind other EU countries in terms of the ability of cancer patients to access new drugs.”

Political factors

And this perhaps is the most horrific of all …

In the UK, in-patient care is taken into consideration for the funding of hospitals.The more in-patients the better for a hospital´s budget request. So although there is an oral form of 5-fluorocil, used in the treatment of colorectal and breast cancers, this is not advantageous to hospital budgets, so the IV form continues to be used even though it is disadvantageous to the patient – and I will go on to say disadvantageous to the economy as a whole as the patient’s labour hours are withdrawn, s/he occupies a bed, eats on the hospital etc.

2 comments:

mens sana said...

Hi Angus

although there is an oral form of 5-fluorocil, used in the treatment of colorectal and breast cancers, this is not advantageous to hospital budgets, so the IV form continues to be used even though it is disadvantageous to the patient

I wouldn't believe all you hear on this one. There are disadvantages to the oral form (capecitabine) which are seldom quoted. The company which makes it (Roche) has a very effective marketing campaign, but if you go to the US, many leading internationally famous oncologists will tell you that they regard fluorouracil IV as standard of care

Angus said...

That's interesting given the report's perspective that the oral form is preferable. Would be interested to hear more on the oral form's disadvantages. Just goes to show how difficult it is to weed out the mis/disinformation. Many thanks.