Select Committee on Health Written Evidence


APPENDIX 10

Memorandum by Cephalon UK Limited (PI 23)

INTRODUCTION

  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 needs.

  4.  Cephalon is a member of the Association of the British Pharmaceutical Industry (ABPI) and is active in the small companies' forum.

DRUG INNOVATION

  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 disorder.

  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 divide—or, conversely, to die—Cephalon is paving the way for novel therapeutics.

THE CONDUCT OF MEDICAL RESEARCH

  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 sleepiness.

THE PROVISION OF DRUG INFORMATION AND PROMOTION

  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 experience.

PROFESSIONAL AND PATIENT EDUCATION

  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.

REGULATORY REVIEW OF DRUG SAFETY AND EFFICACY

  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 the USA.

  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.

PRODUCT EVALUATION, INCLUDING ASSESSMENTS OF VALUE FOR MONEY

  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.

CASE STUDY: RAISING AWARENESS OF SLEEP DISORDERS

  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 high—people 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.





 
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