PHARMACOECONOMICS

-Tracey Wright-

The licensing of J3-interferons for the treabnent of multiple sclerosis (MS) has created a dilemma for the UK National Health Service (NBS). There is now a therapy available for a disease where management has traditionally been limited to symptomatic treaments; however, it comes with a large price tag attached. At a time when rationing is becoming a reality in the NBS, how has the issue of interferon-~ prescribing been handled and how are patients with MS faring? Delegates at a recent British Association of Pharmaceutical Physicians meeting· heard from representatives of 1 party involved in this debate - the pharmaceutical industry.

Interferon-J3-1 b ['Betaferon'; Chiron, Schering] was the first interferon-~ to be licensed in the treatment of MS. Since its UK launch in 1995, 'Betaferon' and the other (3-interferons that followed have rarely been out of the news, having become a byword for rationing in today's NHS, according to Dr Jackie Napier, asso­ciate medical director for Schering Health Care Ltd.

Little before 1993 Up until 'Betaferon' was first licensed in the US

in 1993, only symptomatic treatments were available for MS; e.g. courses of corticosteroids, muscle relaxants and antidepressants.

'Betaferon' reduces the frequency and severity of MS relapses in both relapsing-remitting and secondary progressive MS, says Dr Napier. Data indicate that the drug reduces the frequency of relapses by about 33% overall, and diminishes the severity of relapses by around 50% in the relapsing-remitting form and by about 30% in the secondary progressive form where relapses are a less prominent part of the disease. It has also been shown to significantly delay disease progression in terms of disability by up to 12 months in a 2-year study - and this benefit applied to patients over a wide disability range, added Dr Napier. Over the course of this study, around 33% fewer patients receiving 'Betaferon' became wheelchair bound, compared with placebo recipients.

As a direct consequence of these benefits, patients with MS treated with 'Betaferon' spend significantly less time in hospital and have a reduced need for corticosteroid therapy. There is also a marked reduction in MRI** disease activity, which is evident from the first month of treatment and underpins the fact that this is not a symptomatic treatment, says Dr Napier. Rather, 'Betaferon' is actually having a direct effect on the disease pathology.

At what cost? Against this background of clinical benefit lies

the issue of cost. The cost to the NHS of 'Betaferon' therapy is £9674.40/patientlyear, reports Dr Napier. She believes this cost is in line with the cost of the drug in other countries and also with the cost of the 2 interferon-(3-1a products licensed for MS and the cost of other interferons used in different diseases.

The high unit cost of 'Betaferon' reflects a number of factors: • the expense of MS clinical trials • the complex and small-scale synthesis involved • the impact of high transportation costs given that

there are only 3 licensed production sites worldwide. However, in the UK, the cost also includes access

to the 'Betaferon Care Programme' which gives

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patients with MS access to high-quality patient educa­tion and support materials, as well as all the injection materials provided as part of the cost of the product; i.e. syringes, wipes and needle disposal unit, explains Dr Napier. Perhaps more importantly, patients have access to MS specialist nurses (based at hospital neurology units) who provide 24-hour support and training to both patients and carers.

Drugs a small fraction of total cost A study undertaken in 1995 (before any ~-interferons

were licensed for MS) showed that MS cost the UK £1.2 billion per annum but that NHS costs contributed only 12.8%. Most of the cost reflected lost earnings, lost tax revenues, social service costs and those costs borne by patients and their families. Notably, only 1.3 % of the NHS cost consisted of drug costs - a reflection of how few drug therapies were available and that what was available was relatively inexpensive.

From an NHS perspective, untreatable diseases are low cost, comments Dr Napier, and cost benefit is correspondingly dimcult to demonstrate in new areas where comparisons are made against a 'best practice' which consists of doing very little in terms of medical intervention. Where savings can be demonstrated through less disability, those savings may not accrue to the NHS but may accrue to other government departments.

A complicating factor is that there is a high prevalence of MS in the UK, which is partly a function of the high population density and partly a function of latitude (MS becomes more prevalent the further the geograph­ical shift north of the equator). Of the 85 000 cases of MS, around 78% have 1 of the 2 subtypes for which 'Betaferon' is licensed (relapsing-remitting, 45% of

* 'Is the pharmaceutical industry providing the NHS with medicines it canafford?'[London, UK; 31 Marchl999).

** magnetic resonance imaging

Inpharma* 26 Jun 1999 No. 1193

5

6 PHARMACOECONOMICS

cases; secondary progressive, 33%). The crude mathe­matics used by some health authorities to calculate the cost of treating 78% of their MS patients with 'Betaferon' (at a cost of £1 0 OOO/patient/year) produced very high estimates (e.g. up to £1 billion annually). In reality, only 10-20% of the MS population are going to be both suitable for treatment with 'Betaferon' and willing to accept a treatment that involves injections, notes Dr Napier. This range is based on experience in other countries and input from opinion leaders in this field. An additional problem limiting access to and uptake of this drug is that the UK has fewer neurologists per capita than most other developed nations (1 neurologist for every 230 000 people or every 327 patients with MS).

What progress since launch? Things started off promisingly enough with the

UK Department of Health issuing an executive letter [EL(95)97J requesting that purchasing authorities and providers work with general practitioners, neurologists and patient advocacy groups to develop and implement a hospital-based prescribing approach for interferon-f3.t Implicit in that executive letter is the requirement that patients be treated according to clinical need, says Dr Napier. However, the reality in 1999 is far different, she adds.

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~ 8 '0 CD C> os 4 C ~ &. 2 01

, Betaferon • uptake across Europe

• Region 1 compri ••• Iman market. in both Europe, luch .1 Belgium and Luxembourg, and el .. wh.,.., IUch u New Z •• land and AUltralia.

Patient access to f3-interferons is the lowest in Europe by a very wide margin. 'Postcode prescribing'* is the norm and there are huge geographical variations in access. Most telling is the finding that only 1 in 3 UK neurologists has ever prescribed an interferon-f3 for MS. Of those who have prescribed f3-interferons, almost 50% have fewer than 5 patients receiving such products.

Across Europe, the uptake of 'Betaferon' is between 5 and 10% of the MS population, whereas in the UK, uptake is < 1 % [see figure]. If the other f3-interferons licensed in Europe are considered, uptake of all f3-interferons in continental Europe is between 10 and 12%; the figure for the UK remains at < 2%. Dr Napier considers this to be 'an absolutely shocking state of affairs for a developed country' .

I"pharma- 26 Jun 1999 No. 1193

According to Dr Napier, the emphasis within the NHS seems to be on reasons not to prescribe the f3-interferons: • The efficacy of J3-interferons is considered 'unproven'

- despite the availability of data for> 2000 patients involved in randomised controlled trials published in peer-reviewed journals.

• The acquisition cost is high and the cost benefit is uncertain.

• There is a lack of patient demand. Dr Napier sees an element of unfairness in allocating resources on the basis of how vocal patient groups are.

• Purchasers and prescribers are waiting for moreibetter data, and UK vs US data The latter point was part of the drive to conduct

the much discussed 'National Trial' of f3-interferons. While the plan was discussed for 3-4 years, interest seems to have died down, says Dr Napier. In her opinion, the rationale for conducting a further placebo­controlled trial involving all the f3-interferons seems questionable, given the data already published and peer-reviewed, and the fact that the drugs have been licensed. Those resources the NHS would have commit­ted to a national trial could instead be directed towards treating patients with a clinical need.

The advent of the National Institute for Clinical Excellence (NICE) was partly responsible for the declining interest in a national trial. Many purchasers and prescribers are now waiting for a decision from NICE before deciding on funding for the f3-interferons.

Rethink resourcing in the NHS It is very clear that the NHS is going to have to

look carefully at how it targets resources. A key hurdle that must be overcome is the insistence on focusing solely on the high-cost, low-volume products, while it is the lower-cost, high-volume products that consume the majority of resources and are potentially the bigger problem.

Dr Napier illustrated this point with the example of UK expenditure on statins [HMG CoA reductase inhibitors]. The UK market for statins currently stands at about £310 million annually (with £132 million spent on a single product) and 33% of eligible patients are treated with statins. Is the NHS getting value for money for this level of investment, she asks.

Interestingly, < 20% of patients prescribed statins achieve target lipid levels because of underdosing and poor compliance. Contrast this with an estimate of £10 million annually to prescribe all 3 licensed f3-interferons to eligible patients. Compliance is typically high in this highly motivated patient group (around 97%). Also, patients with MS are carefully monitored, therefore, it seems likely that the results achieved in the community will match those achieved in the clinical trial setting, says Dr Napier.

t While not a directive, CUI executive letter does contain advice that the UK Secretary ofStateJor HealJh expects to beJollowed.

t fostcode prescribing is the term usedJor afragmented MIS where patients are allowed or denied access to par1icuJar drugs on the basis of each local hedth authority's priorities.

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