PRESS RELEASE
NICE recommends newer antipsychotic drugs as one of the first line options for schizophrenia.
NICE has recommended to the NHS in England and Wales that newer, (atypical) antipsychotics should be considered alongside the existing traditional medicines as a one of the first choice options to treat people with newly diagnosed schizophrenia.Many people with schizophrenia currently take established 'typical' antipsychotic medicine. These 'typical' drugs have been available for a number of years and there benefits and side effects are well known. NICE is clear that if an individual is taking a 'typical antipsychotic' and is achieving good control of their condition, without unacceptable side effects then they should not change medication. The decision as to what are unacceptable side effects should be taken following discussion between the individual and the clinician responsible for their care.
The guidance recognises the importance of working together in determining care and medication when managing schizophrenia. It is clear that the individual and the clinician should make the choice of antipsychotic drug jointly following a discussion on the relative benefits of each of the drugs and their side-effects. The individual's advocate or carer should be consulted where appropriate.
Anne-Toni Rodgers, Communications Director, said, " At any time between 2 and 10 people out of every one thousand in England and Wales are affected by schizophrenia. This is a distressing condition for the individual and their families and carers. It is estimated that the direct treatment costs for schizophrenia to the NHS in England and Wales are over £1 billion pounds per year, around 3% of the NHS budget. Hospitalisations account for the majority of this expenditure, and 5% is spent on medicines. The established antipsychotic medicines are relatively inexpensive, at about seventy pounds [£70] per person per year, and they do control the symptoms of schizophrenia, but like all medicines they have can have side effects. For some patients theses side effects can be more isolating and socially unacceptable than the schizophrenia itself. These side effects may include shaking or trembling, muscle twitches or spasms that can be permanent or can disappear after stopping the drugs. Other side effects may be blurred vision, a dry mouth, weight gain or fits. For many people these traditional medicines control the symptoms of their schizophrenia without side effects, however for others the side effects they experience are so distressing that they may stop taking their medicine which means the symptoms of their schizophrenia can become uncontrolled to the extent that they require hospital care".
"The newer 'atypical' antipsychotics are as effective at controlling symptoms as the traditional drugs, and they can have fewer side effects, but they cost on average about one thousand two hundred and twenty pounds [£1220] per person per year.
The independent committee carefully considered the clinical and cost effectiveness of these newer medicines in the management of schizophrenia. For some patients these medicines will provide real benefits. NICE estimates that by making these drugs available as one of the options for people newly diagnosed with schizophrenia, or for those who are currently experiencing unacceptable side effects from their existing treatment the increase in drug costs to the NHS, in England and Wales, will be about seventy million pounds [£70 million] per year. However the use of these newer medicines, as in the guidance, is expected to result in a shift away from inpatient hospital care to residential or community care, which is less expensive. Ten years ago it was estimated that the indirect costs of schizophrenia in the UK were about 1.7 billion pounds. If the use of these newer agents, alongside the more traditional medicines, enables more individuals with schizophrenia to live independently there could be substantial savings to the economy as a whole".
"The recommendations made today mean that people with schizophrenia in England and Wales can, with their clinician, decide which of these treatments is likely to be best for them and that the NHS will fund the most clinically and cost effective medicines".
"I must stress that it is important that antipsychotic medicine should be initiated as part of a comprehensive package of care that addresses the individual's clinical, emotional and social needs, and any treatment decisions should be made jointly by the individual and those responsible for their treatment and care."
"Finally some individuals have evidence of treatment-resistant schizophrenia, this is suggested by a lack of satisfactory clinical improvement despite the sequential use of the recommended doses for 6 to 8 weeks of at least two antipsychotics, at least one of which should be an atypical. For these individuals it is important that a medicine called clozapine is provided at the earliest opportunity".
Ends
Notes for editors
Schizophrenia
1. Schizophrenia has a wide range of symptoms. These include hallucinations (often hearing voices), delusions (false ideas that do not respond to reasoned argument), muddled speech and thoughts, and, very rarely, catatonia (prolonged rigid postures or outbursts of repeated movement). People with schizophrenia may also experience 'flattening' of their moods, which means that they don't have any strong emotions, don't feel motivated to do anything and become detached from their social situation.
2. Schizophrenia can follow a 'relapsing and remitting course', which means that symptoms come and go, or it can be 'chronic and progressive', which means that symptoms are persistent (are present all the time) and get worse over time. Schizophrenia can occur at any age, but it is rare before puberty and most common in late adolescence and the early twenties. It affects between about 2 and 10 people in every 1000 in the general population. Schizophrenia is thought to be slightly more common in men than in women.
3. The treatment and care of people with schizophrenia involves a comprehensive package of care that aims to address all of the person's clinical, emotional and social needs. Antipsychotic drugs are the most common type of medicines used to treat schizophrenia, but they form just a small part of the overall care given.
Atypical (newer) antipsychotics
4. Antipsychotic drugs are believed to work by changing the activity of chemicals that transmit messages in the brain. The main chemical they work on is called dopamine.
5. There are two groups of antipsychotic drugs: the older 'typical' drugs such as haloperidol and chlorpromazine, and the newer 'atypical' drugs amisulpride, olanzapine, quetiapine, risperidone and zotepine). The main difference between these two groups of drug is the side effects they may cause and their price.
6. All antipsychotic drugs can cause side effects but these will be different for each patient and each drug. The side effects may include shaking or trembling, and muscle twitches or spasms, these side effects can be permanent or they can disappear after a person stops taking the drugs Antipsychotic drugs can also cause blurred vision, increased pressure inside the eye, dry mouth and eyes, constipation, urinary retention, sexual dysfunction (for example impotence and loss of sex drive) increased levels of prolactin (a hormone), fits, sedation and weight gain. Some antipsychotics are also associated with heart problems, for example changes to the heartbeat.
NICE guidance
7. The choice of antipsychotic drug should be made jointly by the individual and the clinician responsible for treatment based on an informed discussion of the relative benefits of the drugs and their side-effect profiles. The individual's advocate or carer should be consulted where appropriate.
8. It is recommended that the oral atypical antipsychotic drugs amisulpride, olanzapine, quetiapine, risperidone and zotepine are considered in the choice of first-line treatments for individuals with newly diagnosed schizophrenia.
9. The oral atypical antipsychotic drugs listed above should be considered as treatment options for individuals currently receiving typical antipsychotic drugs who, despite adequate symptom control, are experiencing unacceptable side effects, and for those in relapse who have previously experienced unsatisfactory management or unacceptable side effects with typical antipsychotic drugs. The decision as to what are unacceptable side effects should be taken following discussion between the patient and the clinician responsible for treatment.
10. It is not recommended that, in routine clinical practice, individuals change to one of the oral atypical antipsychotic drugs if they are currently achieving good control of their condition without unacceptable side effects with typical antipsychotic drugs.
11. In individuals with evidence of treatment-resistant schizophrenia (TRS), clozapine should be introduced at the earliest opportunity. TRS is suggested by a lack of satisfactory clinical improvement despite the sequential use of the recommended doses for 6 to 8 weeks of at least two antipsychotics, at least one of which should be an atypical.
12. A risk assessment should be performed by the clinician responsible for treatment and the multidisciplinary team regarding concordance with medication, and depot preparations should be prescribed when appropriate.
13. Where more than one atypical antipsychotic drug is considered appropriate, the drug with the lowest purchase cost (taking into account daily required dose and product price per dose) should be prescribed.
14. When full discussion between the clinician responsible for treatment and the individual concerned is not possible, in particular in the management of an acute schizophrenic episode, the oral atypical drugs should be considered as the treatment options of choice because of the lower potential risk of extrapyramidal symptoms (EPS). In these circumstances, the individual's carer or advocate should be consulted where possible and appropriate. Although there are limitations with advanced directives regarding the choice of treatment for individuals with schizophrenia, it is recommended that they are developed and documented in individuals' care programmes whenever possible.
15. Antipsychotic therapy should be initiated as part of a comprehensive package of care that addresses the individual's clinical, emotional and social needs. The clinician responsible for treatment and key worker should monitor both therapeutic progress and tolerability of the drug on an ongoing basis. Monitoring is particularly important when individuals have just changed from one antipsychotic to another.
16. Atypical and typical antipsychotic drugs should not be prescribed concurrently except for short periods to cover changeover of medication.
Information on NICE
17. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from 10 am 6 June 2002.
18. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
19. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. The Institute produces guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.
20. NICE was established to
21. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. The Institute supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.encourage faster uptake of clinically & cost effective new treatments,
promote more equitable access to treatments (new or existing) of proven clinical and cost effectiveness
promote the better use of resources in the NHS, by focussing resources on treatments which achieve most health gain in relation to the NHS/PSS resources expendedpromote the longer-term interest of the NHS in the development of innovative treatments for the future.To date NICE has issued 43 technology appraisal guidance, on 164 researchable topics.
13 have recommended routine use of the technology
26 have recommended selective use of the technology
4 have recommended research use only
Some of these guidance have been cost saving, others required investment to implement. The estimated cost of implementing are between £541 and £590 million.
22. Topics for the NICE work programme are selected by the Department of Health and the National Assembly for Wales. NICE advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, audit tools are produced for use in the clinical setting.
