Bob Evans, finance director for Wrexham Local Health Board, said, “Generally it is our approach to go wholly with Nice-approved drugs. Whenever Nice approves we will fund, but we don’t tend to fund anything else outside of Nice.

Last year we did fund Herceptin a few months ahead of the Nice decision, because a number of other authorities had already agreed to provide it so we didn’t want to get into a situation where Wrexham residents were disadvantaged.”

He added that the cost of funding Herceptin in 2006-07 (to date) was £44,345.

Jennie Willmott, head of commissioning and planning for Monmouthshire Local Health Board, said, “We commission services to meet Nice recommendations, so any high cost drugs approved by Nice, we negotiate with our providers and expect them to prescribe. Any request to fund high-cost drugs that are not Nice-recommended, the LHB would not approve.”

Kate Morris, associate clinical director, of Cardiff Local Health Board, said, “Cardiff LHB, on an annual basis, gives Cardiff and Vale NHS Trust a sum of money for both non-Nice appraised high cost drugs and those that have been subject to Nice and All Wales Medicines Strategy Group approval. The trust then manages the spend and prioritise patients on behalf of the LHB. Individual requests that come directly to the LHB for consideration for additional funds are referred back to them for inclusion in the prioritisation process.”

Kate Morris, associate clinical director, of Cardiff Local Health Board, said, “Cardiff LHB, on an annual basis, gives Cardiff and Vale NHS Trust a sum of money for both non-Nice appraised high cost drugs and those that have been subject to Nice and All Wales Medicines Strategy Group approval. The trust then manages the spend and prioritise patients on behalf of the LHB. Individual requests that come directly to the LHB for consideration for additional funds are referred back to them for inclusion in the prioritisation process.”

On a cost-per-case basis, in the last year, Conwy LHB has agreed funding for:

Desferrioxamine – a drug to absorb iron in those needing frequent blood transfusion for a form of leukaemia, for four new patients at a cost of £10,000 each per year.Rituximab for rheumatoid arthritis. One patient has received funding at a cost of £15,000 for a year of treatment

Herceptin (via the North Wales risk sharing scheme, pending the Nice appraisal). Three patients in Conwy received funding costing £30,000 for each course

Docetaxol for prostate cancer. Two patients received funding prior to recent Nice guidance, at a cost per course of £12,000
Cetuximab – funding was agreed for two patients prior to Nice guidance at a total cost of £26,000

Macugen for age-related macular degeneration. One patient was funded for treatment in Liverpool at a cost of £6,500.
Efalizumab at a cost of £9,000 a year for the treatment of Guillian Barre syndrome.

Dr Martin Duerden, medical director of Conwy LHB, said, “Many new drugs are portrayed as miracle treatments and as ‘better than has gone before’, but often at the time of launch there is very little evidence to support such claims.

To get a drug licensed the drug company only has to show that the drug is better than a placebo and often information based on comparison with the best established treatment is lacking. Another important caveat is that safety data of new drugs is usually very limited.

Some clinicians can be very enthusiastic, and pass this enthusiasm onto their patients, while the rest of the health community does not share this enthusiasm.

Some cancer drugs may, at most, only extend survival for one or two months at considerable expense and sometimes inconvenience to dying patients – this money might be better invested in developing ‘end of life care’ and palliative services. All these things need to be taken into account and evaluated.

Ultimately if a patient feels very strongly they should receive a new drug we try to respond to this request and allow treatment – in the case of cancer treatments, given the full facts away from the hype, some patients choose not to receive such treatments.”

Carmarthenshire NHS Trust funded the following licensed medicines prior to Nice approval or guidance from the All Wales Medicines Strategy Group, between September 2005 and December 2006:

Glyceryl trinitrate ointment (Rectogesic) for pain relief to replace an unlicensed product. In 2006 105 issues were made at an additional cost of £2,400.

Escitalopram for generalised anxiety disorder to replace venlafaxine, which had been restricted in December 2004. DesmoMelts, an anti-diuretic, to replace desmopressin tablets at the same cost.

Triptorelin, a hormonalhormonal therapy for prostate cancer, which was approved to replace a product unlicensed for this condition No additional costs.

Trusopt Mimims – approved to replace a product less suitable for intra-operative use, at no additional cost.

Exemestane – a hormonal therapy also known as Aromasin – 34 issues were made at a cost of £3,100 in 2006. Nice guidance was issued for this in November 2006.

Clopidogrel, an anti-platelet drug for patients with heart problems. Estimated cost for 100 patients per year is £3,700.

A spokeswoman said the local health board agreed to fund Herceptin last year, in accordance with advice received through the South-East Wales Cancer Network Board.

The estimated cost of the drug is being risk shared by a number of LHBs in South-East Wales and estimated costs are currently being finalised.

A spokeswoman for Swansea NHS Trust said, “The trust only uses drugs which it is commissioned to use – that a local health board or Health Commission Wales has agreed to fund. However, there are times when a clinician may want a patient to have a licensed drug which has not been Nice approved, often involving cancer patients. In these cases the trust contacts the relevant commissioner to see if they will fund the drug.”

A spokesperson for Swansea Local Health Board said, “The commissioning for rare or complex diseases is the responsibility of Health Commission Wales (HCW).

The treatment of these conditions will often require the potential use of drugs which are new to the market, are relatively high cost and are awaiting Nice appraisal – for example pemetrexed for mesothelioma.

Where the LHB has received a request to fund any drugs associated with these rare or more complex diseases the request has been forwarded to HCW for their consideration.

It is important to note that many of the high-cost drugs have more than one therapeutic use and it may be that only one has been Nice approved.

It is likely therefore that in providing funding to the trust that new indications without Nice approval have been funded.The LHB does not hold information on the individual patients where the drug has been used, for these newer, non-Nice indications. With the position adopted by the three cancer networks in Wales the LHB did fund trastuzumab (Herceptin) for adjuvant breast cancer ahead of Nice guidance. This was for approximately eight patients at a cost of £160,000 per annum.

In addition to Nice, LHBs must provide funding for drugs appraised by the All Wales Medicines Strategy Group with a positive outcome.”The local health board has funded:

Cetuximab for colorectal cancer – eight patients at a cost of £60,000 per annum.

Bortezomib (Velcade), for multiple myeloma – one patient at a cost of £10,000 a year.

Bexorotene for one patient with advanced stage cutaneous T-cell lymphoma at a cost of £25,000 a year.

This is an historical agreement following NHS re-organisation.

The spokesperson added, “Currently the LHB has been asked to fund a number of patients for the drug Erlotinib (corr) for lung cancer, to date no funding has been agreed for this treatment.”

Paul Miller, chief executive of Velindre NHS Trust, a specialised trust which cares for cancer patients from across Wales, said, “Velindre Cancer Centre has a small amount of funding available to provide drugs outside the nationally agreed treatments advocated by Nice and the All Wales Medicines Strategy Group.

This funding is generally used in two ways – to treat patients with rarer conditions where there is evidence from clinical trials of efficacy but it is unlikely that Nice will give guidance and where Nice guidance is expected soon. In the latter case the patients would need to fall within the scope of the expected guidance and their treatment could not reasonably be deferred until the guidance was received.

The mechanism for allowing this use of expensive drugs outside Nice is for the consultant to apply to the Velindre High-Cost Drugs Committee, which meets weekly and consists of the director of cancer services, the medical director, two senior consultants and the chief pharmacist.”

In the last year the following treatments have been allowed prior to Nice guidance:

Herceptin for early breast cancer (average cost £21,000 per patient)

Docetaxel (Taxotere) for metastatic prostate cancer (average cost £4,800 per patient)

Oxaliplatin for treatment of early colorectal cancer (average cost £6,000 per patient)

Capecitabine for early colorectal cancer (average cost of £2,200 per patient)

Thyrogen for patients with thyroid cancer, before they undergo treatment with radioactive iodine (cost £465 per patient).

Mr Miller added, “If Velindre NHS Trust feels it cannot fund a treatment, the patient’s LHB is asked whether it wishes to consider funding and some LHBs have recently allowed us to use erlotinib (Tarceva) for the treatment of patients with certain lung cancers.”

This year the local health board has approved funding for the following drugs:

Tarceva for four patients at a cost of £54,000
Alemtuzumab, which is used to treat chronic lymphocytic leukaemia, for two patients at a cost of £24,000

Pemetrexed, a treatment for mesothelioma, for one patient, costing £12,800.

A spokesperson said, “In terms of overall prescribing, the majority of drugs used in both primary and secondary care have not been through Nice.

Equally those that have been Nice-d are largely drugs used in secondary and tertiary care which NHS trusts and Health Commission Wales would hold the financial detail for.

Velindre Hospital is the main provider of cancer services for Rhondda Cynon Taff residents. It has a panel which reviews an individual clinician’s request from a governance perspective and would then refer to Rhondda Cynon Taff LHB, if it did not have the funding available to support a request that they felt was clinically appropriate.”

The local health board has funded:

Velcade (bortezomib) for one patient at a cost of £3,583 this year

Tarceva for two patients at a cost £1,725 in 2006-07, so far. One patient received the drug in 2005-06 at a cost £5,661.

A spokesperson said, “The All Wales Medicines Strategy Group (AWMSG) will take into account the Nice future work programme, including the Single Track Assessment (STA) process, when considering whether a product will be appraised.

AWMSG will not normally consider appraising a product if Nice intends to publish its final appraisal of the same product within an 18 month period. AWMSG can issue guidance on drugs which have yet to be Nice-d. Once Nice guidance is received, that supercedes the AWMSG guidance.

In the absence of AWMSG or Nice guidance individual prescribers should exercise their clinical judgment unless there is evidence not to do so in the light of particular circumstances of an individual patient.”

A spokesperson for the local health board said, “All Cancer services are funded through a risk sharing scheme of which Merthyr LHB pays a share – the lead commissioning LHB is Blaenau Gwent.

Health Commission Wales also fund a selected list of drugs. It would not be straightforward for Merthyr LHB to identify which drugs are funded, which are licensed and which are Nice-approved and information relating to patient numbers would be held at the prescribing trust (normally Velindre).

In relation to those patients requiring treatment, individuals are assessed and treated on a case-by-case basis dependent on need.”

The local health board and Pembrokeshire and Derwen NHS Trust have funded the following drugs in the last year:

Velcade for three patients, at a cost of £3,068 per cycle.If the drug is tolerated, five cycles of treatment are given

Cetuximab for four patients, at a cost of £3,966 for the first eight weeks. If effective treatment can be provided for up to 18 weeks.

Xolair (omalizumab) for two patients at a cost of approximately £2,500 per 16 weeks.

Treatment with this drug for asthma is dependent on patient’s weight and approval is for initial 16 weeks’ trial.

What is it for
A first-line treatment for kidney cancer

Why is it better
Sutent is an alternative to the current form of immunotherapy (interferon alpha) available, but trials have shown that it is more effective. Sutent can shrink tumours by as much as 30%, whereas interferon alpha is only associated with a 6% shrinkage

When was it licensed
Sutent was licensed for use as a first-line treatment in January 2007, and as a second-line treatment in July 2006

When will it be appraised by Nice
No date set

How many patients in Wales could benefit
Approximately 300

Cost
£2,000 per patient per month

What is it for
Patients with non-small cell lung cancer whose cancer has come back after, or not responded to, at least one course of chemotherapy.

Why is it better
The manufacturers claim erlotinib is at least equivalent to docetaxel(corr) (another lung cancer drug) in terms of overall survival and that patients spend a longer period in progression-free survival on erlotinib, compared with docetaxel.When was it licensed: The European Medicines Evaluation Agency granted a licence in September 2005.

When will it be appraised by Nice
Nice has recommend that funding is refused on the grounds of cost-effectiveness, although a second appraisal committee meeting will be held in April. The Scottish Medicines Consortium approved NHS funding for patients in Scotland in June 2006.

How many patients in Wales would benefit
About 80% of lung cancers diagnosed are non-small cell lung cancers – the treatment would be suitable for some of these patients.

Cost
£6,800 per course of treatment

What is it for
Used in the treatment of patients with advanced renal cell cancer when standard therapy has not helped to stop the disease or is considered unsuitable.

Why is it better
Trials have shown that sorafenib can make the cancer stop growing for longer than people taking a placebo. It has also been found to slow the growth of advanced kidney cancer.

When was it licensed
The European Commission approved the use of sorafenib for advanced renal cell cancer in 2006.

When will it be appraised by Nice
The drug is on the list of provisional appraisal topics produced by the Department of Health. The All Wales Medicines Group is due to appraise it in March.

How many patients in Wales would benefit
Not yet known.

Cost
No information available

What is it for
Mesothelioma, a fatal tumour caused almost exclusively by asbestos exposure.

Why is it better
Although not a cure, it is the only licensed medicine for mesothelioma. The treatment has been shown to improve survival in randomised trials and is used around the world

When was it licensed
November 2004.

When will it be appraised by Nice
Nice has already ruled that Alimta is too costly to be prescribed on the NHS. Appeals against the decision have been upheld and final guidance expected later this year.

How many people in Wales could benefit
1,900 in the UK die every year – 607 men and 86 women died in Wales from the disease between 1981 and 2000.

Cost
£8,000 per course, and £25,000 for a full treatment.

What is it for
A drug for myeloma, it causes a build-up of protein within the cancer cells which causes them to die.

Why is it better
Some trials have shown that it has stabilised the disease in two thirds of patients who had already tried other treatments.

When was it licensed
Spring 2004

When will it be appraised by Nice
Nice has concluded that Velcade is clinically effective in the treatment of relapsed myeloma. But it said that the benefits are not great enough to offset the additional costs when compared to the existing treatment of high dose dexamethasone(corr). Appeal hearing on this decision to be conducted February 2007. In Wales, Velcade was approved by their regulatory authority, the All Wales Medicines Strategy Group in 2005. However any Nice guidance will replace this.

How many people in Wales could benefit
In 2003, 261 people were diagnosed with multiple myeloma. In 2004, there were 173 deaths.

Cost
Around £18,000 per patient

What is it for
Both drugs are monoclonal antibodies, a new generation of “biological” drug of the same class as Herceptin, targeted at advanced bowel cancer. Avastin works by starving cancerous tumours of blood thus preventing their growth. Erbitux is used to stop the proliferation of cancer cells after chemotherapy has failed.

Why is it better
Avastin can extend life expectancy by an average of five months. Erbitux found to extend life expectancy by at least four months for 50% of patients, and to shrink tumours by 50% in a quarter.

When will it be appraised by Nice
Nice decided, in January 2007, that Avastin should not be routinely used as a first treatment option for bowel cancer that has spread. Erbitux was approved for use by the All-Wales Medicines Strategy Group in March 2006. But Nice has said it should not be used. A review may not be carried out until 2009.

How many people in Wales could benefit
Bowel cancer kills almost 50 people a day in the UK. Each year, there are about 18,700 new cases in men, and nearly 16,200 cases in women (13% of all cancers). Wales has around 2,000 cases a year and around 1,000 deaths, though mortality has steadily decreased. It is estimated that about 25 patients a year in Wales would benefit from Erbitux.

Cost
Avastin £16,824 per patient, Erbitux £11,739 per patient.