The Pharmaceutical Journal Vol 267 No 7178 p867
15 December 2001

National Institute for Clinical Excellence:
NICE to improce impact statements

The National Institute for Clinical Excellence is working to improve its statements on the impact its guidance has on the National Health Service, ANDREW DILLON, chief executive, NICE, told conference participants.

"The institute will engage local organisations in looking at the impact NICE guidance has on resources," Mr Dillon said. He added that NICE does not underestimate the effect the tidal wave of guidance produced by NICE had on local organisations.

"To date, NICE has issued over 30 technology appraisals and it has another 42 in various stages of development, of which 22 are scheduled to be published before the end of March 2003," he said. In addition, NICE has 30 clinical guidelines in simultaneous development and plans to issue in the region of 18 guidelines each year.

Peter Homa, chief executive, Commission for Health Improvement, said that without exception, even in the most troubled organisations, CHI has found examples of really good practice. He added that there were lessons to be learnt from CHI reviews for everyone working in the NHS. The key themes that had come from CHI's first 50 reviews were that

• Clinical governance policies were not uniformly implemented
• Attitudes of personnel were generally reactive rather than proactive
• There was a poverty of systems to guide local decisions
• Learning and good practice were not shared between organisations
• There was a preoccupation of personnel with their own organisation rather than the network of services

Mr Homa went on to describe some of the future responsibilities of CHI, which included looking more closely at components of clinical governance and the extent to which they are expressed locally. He told conference participants that CHI would have completed 70 per cent of its reviews of acute NHS services by March 2002, and that it would be launching a programme to look at other services, including primary care, mental health and ambulance services.

Implementing guidance: a European perspective

Professor GÜNTER OLLENSCHLÄGER, director, Agency for Quality in Medicine, Germany, described the difficulties of implementing national guidance in Germany, which has a regional governance system. "In Germany, we are faced with a huge gap between knowledge and practice of evidence-based medicine . . . less than a third of doctors working in primary care are aware of key recommendations for the management of hypertension." He added that, in Germany, guidelines were not formulated according to standards and were more academic-based than practice-based.

There was also a problem with guidelines being issued that had differing recommendations. To deal with this, a clearing approach was being developed in Germany. "Out of more than 130 [German, English and French] guidelines for the management of hypertension, only 11 met criteria for our appraisal and only six were truly evidence-based," he said.

Top down and bottom up approaches need to come together to implement guidelines successfully, Professor Ollenschläger said. The system in Germany is decentralised and regional governments compete with each other, making implementation difficult.

Dr STEFANO CAPRI, University of Florence, Milan, said that from the start of 2002 there would be an obligation within Italian regional governments to contain drug expentiture at a maximum of 13 per cent of the total health budget. "Each region will be free to decide cost containment measures," he said. Dr Capri explained that the reimbursement system for medicines in Italy was still organised at a national level but that each region would be able to decide reimbursement levels for a list of drugs. "This will raise problems of equity," he said.

At present, pharmaceutical companies were required to negotiate with the central regulatory body to set the price of each new drug. This negotiation would result in the drug either being reimbursed or not, in which case the company was free to decide on the price. The decision to reimburse was based on several factors, including the social burden of the disease involved, the impact that prescribing the new medicine would have on both drug and total health expenditure, the drug's cost-effectiveness and the innovation behind the new medicine.

Limits on prescribing a new drug might also be set, for example, so that only patients enrolled on a registry for a particular disease would be entitled to receive prescriptions. This had occurred in the case of infliximab and etanercept, which could only be prescribed for patients with rheumatoid arthritis resistant to methotrexate.

Reimbursement might also be dependent on diagnostic testing, for example, only patients with familial hypercholesterolaemia were entitled to statins free of charge. Other patients had to pay.

Reactions to the reforms in Italy had not been positive, said Dr Capri. The pharmaceutical industry did not like them because they now had to negotiate with individual regions to set prices for new drugs. Clinicians and patients were not happy either because they felt that there would be many health systems in place, each with different agreements in terms of resources and practice.