PJ Online | P&MM | Scheme publicly puts to the test the industry’s confidence in its own drugs

Prescribing & Medicines Management
page PM4
December 2004

Features

Scheme publicly puts to the test the industry’s confidence in its own drugs

Debbie Andalo describes a programme in which GP practices in North Staffordshire teamed up with a drug company with the aim of reducing patient risk of coronary heart disease, reducing costs to the NHS and meeting Government clinical targets

Future programmes

The outcome guarantee programme was deliberately designed around statins because, according to Professor Chapman, the drug has simple and obvious “proven markers” which are the levels of cholesterol. So, could a similar programme be developed for other prescribed drugs? Professor Chapman is confident that will happen. He added: “Providing you have proven markers and the programme meets local health needs and fits in with local health policy.” He is currently in the process of discussing future programmes, which focus on two clinical areas with four pharmaceutical companies including Pfizer. He would not go into detail because negotiations were still ongoing but he predicted a decision would be made within the year.

A unique partnership between the pharmaceutical industry and the health service is helping to reduce patient risk of coronary heart disease, saving the NHS money and meeting government clinical targets at the same time. The scheme, which has now been rolled out to 17 primary care organisations across the UK, publicly puts to the test the confidence that the industry has in the ability of its own drugs. If the drug involved in the programme fails to meet clinical targets which are set by independent academics, the drug company has to repay the drug costs to the NHS. Stephen Chapman, professor of prescribing studies at the department of medicines management at Keele University, who developed the programme, said: “This is a win-win situation for everybody involved.”

Coronary heart disease

Professor Chapman piloted the programme around the prevention of coronary heart disease and the prescription of statins. The pilot was tested on practices in North Staffordshire because the district had one of the highest levels of cardiovascular heart disease in the country and was one of the lowest users of statins. Professor Chapman said: “There was a need for the local health economy to do something urgent about cardiovascular disease and to adopt best practice but they didn’t have the resources to do it.”

The solution, according to Professor Chapman, was to develop a new kind of partnership with the private sector which would benefit both sides. He was keen that the scheme should be transparent and was not dependent only on a drug company sponsoring practice nurses running a CHD clinic. Professor Chapman said: “I don’t believe that the alternative option, which would have been to use drug company sponsored nurses, is a model which works. When a sponsored nurse goes into a practice, it doesn’t matter what people say, there is an increase in that particular drug being prescribed. There is a lot of anecdotal evidence to support that. What we wanted to do was develop a more open and transparent system which was based on the premise that we will help you, the drug company, find the patients but if you want us to use your drugs these are the conditions we impose.”

With this framework in mind, Professor Chapman designed an “outcome guaranteed programme” and invited drug companies to become involved. Pfizer took up the challenge. Professor Chapman developed a matrix which had a series of clinical targets, reflecting a reduction in cholesterol, which the Pfizer statin, atorvastatin, had to meet.

Pfizer agreed that if its drug failed to achieve the targets, which reflected the targets of the National Service Framework for Coronary Heart Disease, then it would reimburse the NHS for the cost of atorvastatin which had been prescribed. At the same time Pfizer agreed to pay for the cost of practice nurses to draw up a register of patients at risk from coronary heart disease and to run CHD clinics to monitor those patients whom GPs had identified as potentially benefiting from being prescribed statins. GPs were free to prescribe patients on the programme whatever statin they wanted although the cash reimbursement from Pfizer for failure to hit the programme’s clinical targets only applied to atorvastatin.

The pilot involved 27 practices which between them identified 1,408 patients who were at risk of CHD; 877 were prescribed statins and 669 were still taking them at the end of the programme. Of these, 402 patients met the clinical targets. All patients whose dose was titrated according to the outcomes guarantee matrix achieved the target, so Pfizer did not have to reimburse the NHS for the cost of its statin. The initiative also improved patient compliance — with a success rate of 80 per cent. Professor Chapman said: “This is extraordinary for statins but I think it was achieved because these patients were being carefully monitored and had regular contact with a nurse.”

Professor Chapman was keen to emphasise that the GPs involved in the pilot had complete clinical freedom to prescribe the statin of choice. He said: “We did a qualitative survey of GPs and none of them had a sense that they felt under any obligation to prescribe atorvastatin — au contraire they thought that it was an open and transparent process.”

Benefits for the drug company

The outcome guarantee programme brings cost savings for the NHS because drug wastage is reduced and the drug company contributes to the costs of chronic disease management in primary care. National service framework targets are met and patient compliance increases, which reduces their risk of heart disease. But what are the benefits to the drug company, which is prepared to risk the reputation of its product and faces financial penalties if the clinical targets are not met? According to Professor Chapman the rewards are many. The company wins a very public vote of confidence in its own drug and is involved in a partnership with the local health service, rather than remaining on the outside looking in.

He said: “The company has the opportunity for its drug to be tested and proven, doctors become aware that the drug exists and it gives the company market access and a share of the market.” Richard Lomas, who led the pilot programme for Pfizer, was also quick to sing its praises. In a statement he said: “Many people who could benefit from statin treatment do not receive it. This is often due to resource issues as it can be difficult to manage statin use in primary care to the best benefit of NHS budgets. The programme provided a solution in the form of a best practice framework for ensuring that patients who needed treatment had access to it, and that NHS resources were used responsibly to help more patients reach the targets set out in the NSF for CHD.”