Memorandum by Cephalon UK Limited (PI
1. Cephalon welcomes the opportunity to
give evidence to the Health Committee inquiry into the influence
of the pharmaceutical industry on health policies, health outcomes
and future health priorities and needs.
2. Cephalon is a research based pharmaceutical
company founded in 1987. Our mission is to discover, develop and
market innovative products to treat sleep and neurological disorders,
cancer and pain. The company employs nearly 2,000 people worldwide,
75 of these being based in the UK, including commercial, research
and regulatory functions.
3. To balance the inherent risk in drug
development, our business strategy is based on a model of combining
in-house research and development capabilities with acquiring
and marketing innovative, high growth products. Cephalon is a
small pharmaceutical company committed to providing patients and
the medical community with novel therapies to treat unmet medical
4. Cephalon is a member of the Association
of the British Pharmaceutical Industry (ABPI) and is active in
the small companies' forum.
5. In line with our mission, the main focus
for drug innovation lies within sleep and neurological disorders,
cancer and pain. Sleep disorders are a major contributing factor
to fatal road accidents, heart disease, lost productivity and
impaired quality of life for hundreds of thousands of patients
in the UK. Cephalon has developed and markets the first non-stimulant
treatment for excessive sleepiness associated with chronic pathological
conditions including narcolepsy, obstructive sleep apnoea/hypopnoea
syndrome (OSAHS) and moderate to severe chronic shift work sleep
6. Another first in class, we have the only
prescription medicine approved in the world for the treatment
of breakthrough pain in opioid tolerant cancer patients.
We are conducting an 800 patient clinical trial
evaluating an oral kinase apoptosis inhibitor (prevents cell death)
for the treatment of Parkinson's disease that has the potential
to slow the progression of this debilitating brain disorder. By
uncovering the cell signalling pathways that command a cell to
survive and divideor, conversely, to dieCephalon
is paving the way for novel therapeutics.
7. As a pharmaceutical leader, Cephalon
invests around 28% of its sales revenue in research and development,
equating to about $300 million this year. This investment is key
to building a balanced pipeline of new chemical entities, new
indications and product enhancements. Most of the research to
date has been conducted in the USA, though there is increasing
involvement in the UK.
8. We are collaborating with Cognitive Drug
Research Limited in the UK to study the degree to which a new
product affects cognitive function in the treatment of excessive
9. All activities based around information
provision and promotion are conducted in line with the ABPI code
of practice which prohibits the advertising of prescription only
medicines to the general public.
10. A team of 26 sales people are involved
in our activities in the UK and Ireland across neurology and pain
divisions. Promotion is principally to physicians in the secondary
care setting though this activity is now broadening to include
a wider audience in the evolving NHS. The sales team is supported
by a small marketing function, training department, NHS Affairs
manager and three medical information pharmacists.
11. Our medical information pharmacists
are able to respond quickly to requests for information from both
healthcare professionals and the public in the form of both verbal
and written information.
12. Websites are available for both the
public and healthcare professionals in the UK and USA.
13. Due to the small nature of the company,
Cephalon employs the services of external professional organisations
to work with us on programmes of raising public and professional
awareness of our therapy areas. They co-ordinate a Working Group
on Sleep Disorders and assist in securing media coverage. External
creative companies are utilised to advertise our products and
services to healthcare professionals.
14. Being a small company with limited market
access, and operating in therapy areas which do not appear in
Government priorities can be a significant barrier to success.
This lack of critical mass often means that the innovative areas
in which smaller companies operate do not achieve the high profile
and share of voice with policy makers that the larger companies
15. Around 40% of our promotional budget
in the UK is spent on medical education. This includes attending
national and international congresses, the production of training
CD-Roms, patient information leaflets, other clinical resources
as a service to medicine and unrestricted research grants. Cephalon
collaborates with patient groups and charitable trusts in providing
information and supporting national events. Such joint activities
include disease awareness programmes, publications about disease
management and programmes and campaigns designed to improve the
health and social care of people living with specific diseases.
16. In our experience, MPs and others are
very interested in these areas once we have the opportunity to
bring them to their attention, because there is a strong public
interest case to be heard.
17. All products and materials are subject
to review by the Medicines and Healthcare Products Regulatory
Agency (MHRA). For any product that the company holds a marketing
authorisation, Cephalon is under an obligation to report any adverse
drug reactions (ADRs) according to a set of criteria including
seriousness, expectedness and relatedness/causality. Submission
of such reports must take place within 15 days of the notification
of an ADR and is in line with legal and corporate responsibilities.
These are reported to the global product safety department in
18. Our products have licences either granted
in the UK or through mutual recognition across Europe.
19. We comply fully with all regulations
governing our products.
20. Where company products have been assessed
by the National Institute for Clinical Excellence, Cephalon has
registered as a stakeholder and taken an active role in the consultation
process. On a more regional level, the company has also made submissions
to the Scottish Medicines Consortium (SMC) and the Midland Therapeutic
Review and Advisory Committee (MTRAC).
21. In the absence of an in-house pharmacoeconomic
function, Cephalon looks outside the organisation for independent
economic reviews of products by those with the necessary expertise
and we find this to be effective.
22. Despite excessive sleepiness affecting
more people in the UK than Parkinson's disease and multiple sclerosis
combined, there are currently no National Service Frameworks,
guidelines from the National Institute for Clinical Excellence
(NICE) or Department of Health policy papers governing the treatment
of sleep disorders.
23. Untreated cases of obstructive sleep
apnoea/hypopnoea syndrome (OSAHS) are costing the NHS £432
million per year. This figure is based on the fact that 80% of
patients are unaware of their condition and do not seek treatment,
leading to hospital admissions and treatment for related conditions
such as cardiovascular disease.
24. The incidence of traffic accidents among
people with an untreated sleep disorder remains highpeople
with OSAHS have been shown to be 7-12 times more likely to have
a road traffic accident than those without the disorder. 20% of
accidents on motorways in the UK are caused by excessive sleepiness.
The estimated cost to society of a single fatal road accident
in the UK is £1.25 million.
25. The Quality Adjusted Life Year (QALY)
is a recognised measure to gauge a patient's quantity and quality
of life. One year of perfect health life expectancy is worth one
QALY, with the score operating on a sliding scale in which zero
equals death. The cost per QALY of treating obstructive sleep
apnoea (OSA) with continuous positive airway pressure (CPAP) is
between £1,500 and £4,400. To put this into perspective,
renal dialysis costs £26,000 per QALY and chemotherapy treatment
for non small cell lung cancer £15,000 per QALY. NICE regards
spending of under £30,000 per QALY as cost effective, but
in spite of the relatively low cost of improving the quality of
life of patients with OSA, sleep clinics are being closed, and
those which remain lack adequate funding, with patients often
waiting 12 months for treatment.
26. Cephalon, in partnership with the Sleep
Apnoea Trust, supports the activities of a Working Group on Sleep
Disorders, chaired by Alice Mahon MP. The Group seeks to improve
diagnosis and treatment of sleep disorders that remain one of
the most under-diagnosed and under-treated group of medical conditions,
although excessive sleepiness is a major contributing factor to
fatal road accidents, and drastically impairs the quality of life
of sufferers and their families.
27. Despite MPs in the Working Group continuing
to enquire of the Department of Health as to whether there are
plans to develop national guidelines on sleep disorders, we have
been unable to elicit an answer. Neither have we been able to
establish which civil servant/minister has responsibility for
sleep disorders. In January 2003 Alice Mahon MP raised the issue
of sleep disorders in the Commons, with the then Leader of the
House, Robin Cook.
Mrs Alice Mahon (Halifax): Has my right hon Friend
the Leader of the House seen early-day motion 410, on avoidable
accidents caused by sleep deprivation?
That is a very serious subject. From the answers
that I have received from the Department of Health, it is clear
that many primary care trusts and hospital trusts do not take
the matter seriously. They do not offer a cost-effective treatment
that could save many lives on our roads, as the majority of accidents
are caused by people who suffer from sleep apnoea. Will my right
hon Friend find time for a debate on what is a very serious matter?
Mr Cook: My hon. Friend raises a matter about
which she has expressed concern on the Order Paper. She makes
some important statistical points about the importance of the
disorder. I am sure that Ministers at the Department of Health
will want to make sure that the NHS responds to the problem properly.
I shall ensure that they write to her setting out the strategy
for dealing with this disorder.
28. Despite receiving this assurance from
a senior Government minister, no strategy has been forthcoming.
Since sleep disorders are clearly an important issue and treatment
of them is both clinically and cost effective, the Sleep Working
Group is pressing on with this work to seek a comprehensive strategy
and proper NHS response. We are sure Ministerial undertakings
of this kind are made in the best of faith. It is, however, unfortunate
that the market place seems to be overly crowded with voices seeking
the ear of government.
29. Given the particularities of smaller
pharmaceutical companies such as Cephalon and of those like us
who work in novel and innovative therapeutic areas we would be
delighted to give oral evidence to the inquiry if invited.