Devices vs Drugs - Reimbursement may remain the bottleneck to change.

Monitoring developments within the medical device and drugs markets increasingly highlights examples of how advances in devices technology can provide alternatives to drug use. In certain cases a one-off surgical procedure involving the utilization of a medical device can mean the abandonment of a patient’s need for a lifetime of drug therapy. Although the clinical benefits of device utilization may have been demonstrated, device manufacturers find themselves nevertheless burdened with a reluctance on the part of governments to allow reimbursement and with physicians unwilling to embrace change in clinical practice. Advances in the cardiology field lend themselves to a discussion around this theme.

Implantable Cardioverter Defibrillators - Expanding their use in heterogeneous healthcare markets.

Since the testing of the potential for the prophylactic use of implantable cardioverter defibrillators (ICD) was investigated in the MADIT (Multicenter Automatic Defibrillator Implantation Trial) trial, the number of indications for ICD implantation have increased. Subsequent to the findings of the MADIT trial a number of studies endeavoured to analyse the increase in ICD implantation volumes worldwide. The greatest impact on implantation volumes has been seen in the USA where reimbursement mechanisms are more favourable than in other countries

The European Working Group on Cardiac Pacing (EWGCP) collects data from national registration centres and its latest set of data refers to ICD implant volumes for the year 1997 (Pacing Clin Electrophysiol, 2001 May;24(5):863-8) which suggests that data obtained from 2,887 hospitals in 20 European countries reflects the total number of ICDs per million population has a median value of 14. Initial ICD implants per million population was 11. Only 3 of 16 countries were found to implant a total of 30 or more ICDs per million population. The following table represents ICD implantation figures taken from a Health Technology Assessment report presented to the UK Department of Health.

Whatever the source of implantation numbers, the ratio figures show a trend recognized by a number of studies, which is that of France and the UK being at the bottom of the European pack with regard to ICD implants per million. The primary factor in these countries is the limitation on reimbursement for these procedures. The severity of this limitation is most notable in France and widely recognized as the key stumbling block to ICD implantation in that country. Although various studies have now sought to highlight and confirm the greater cost-effectiveness of ICD implantation versus drug treatment, the lack of harmonisation in the evaluation procedures for drug and device treatments means that the benefit/risk ratio is not evaluated sufficiently prior to marketing authorization of devices. Reimbursement of ICD devices is hampered significantly in France and is a source of frustration for cardiologists (Le Heuzey, JY and Guize, L, Therapie, 1999 Mar-Apr; 54(2);197-201).

A key to improving reimbursement potential for ICDs in the expanding indications for which they are deemed of clinical benefit is to provide compelling and widely accepted cost-effectiveness data which reinforces the viewpoint that ICD implantation has a significant benefit over competing drug treatments. The National Institute of Clinical Excellence in the UK reports the number of implants in 1999 as 17 per million of the population. In 1999, the number of implants of ICDs was 185 per million of population in the USA, 67 in Germany, 25 in Italy, and 12 in France. The average for Western Europe was about 30.

Table 1: ICD implants per million for selected regions, 1998

A number of high profile studies apart from MADIT have sought to do this. Two studies, AVID and CIDS assessed the use of ICDs in secondary prevention of sudden cardiac death (SCD) after a sustained ventricular arrythmia. While these studies confirmed the increased clinical benefit of ICD use versus antiarrhythmic drug therapy, the cost-effectiveness ratios are much less compelling. MADIT found a 54% reduction in total mortality that, over 4 years of follow-up, translated to 0.80 life-years added by the ICD for a cost-effectiveness ratio of $27,000 per life year added. The CIDS investigators found a 20% reduction in total mortality, corresponding to a gain in survival of 0.23 life-years (over 6 years) and a cost-effectiveness ratio of $139,000 per life-year added. The preliminary cost-effectiveness ratio from the AVID trial was $62,190 per life-year added. The primary determinant of ICD cost-effectiveness is the degree to which it adds to life-expectancy, and the result of this is that optimum selection of patients should maximize the cost-effectiveness of the ICD. This is likely to become a particularly important consideration for the companies which market ICD devices in the European market where gauging the likelihood of reimbursement in the heterogeneous healthcare systems in Europe becomes more difficult.

However, as studies in the UK highlight, cost-effectiveness analyses can generate a level of concern within health departments. In the UK there is an understanding of the increasing demand for ICD implants within cardiology. This makes its affordability and cost-effectiveness a local, regional and national issue. There have been no agreed UK guidelines for use of ICD. For local districts there has been an agreed number of ICD implants per head of population that was derived from debate and consensus between cardiologists locally and the Health Authorities. Most Authorities are understood to be operating at 10 ICD implants per million population.

The policy implications of the increased implantation of ICDs are considerable. According to a UK health technology assessment exercise, demand for ICD therapy would rise by 2.5 times if patient criteria used in the AVID trial were to be applied. On the basis of data collected in the Midlands in the MAVERIC trial, 52% of patients presenting to cardiology units with sustained ventricular arrhythmia not related to myocardial infarction would satisfy the AVID criteria. If the AVID criteria were to be introduced in the UK, 1000 patients per year would receive ICD at a cost to the NHS of £24 million (an increase from 10 to 18 ICD implants per million of population). If each and everyone of those patients presenting to the cardiology units in the MAVERIC trial were to receive ICD the annual implant rate would be 35 per million. This would again cost almost double that anticipated for the AVID criteria.

Sub-groups of patients with the highest relative risk for SCD (survivors of cardiac arrest, low left ventricular ejection fraction) are a small proportion of the total population burden of SCD, making identification of those patients that could potentially most benefit from ICD difficult.

In 2001, a Task Force on Sudden Cardiac Death, of the European Society of Cardiology published its review on SCD in order that for rare and previously unknown diseases the recognition of high risk patients who were felt to benefit from ICD implantation and drug therapy might be classified and identified.

The utility and benefit of ICDs is undisputed in many quarters, and there is increasingly limited argument for the use of currently available antiarrhythmic drugs in treatment of potentially high-risk patients. However, what may be perceived as a traditional bias by governments towards use of pharmaceuticals versus device treatment impacts negatively on the expanded use of ICDs. As previously stated this seems to be especially true in France. In spite of this, extending the information on clinical efficacy and association with cost benefits has the potential to sway the argument for reimbursement in the French market. More robust cost-effectiveness data is requested by key decision making bodies such as NICE in the UK which would have, what HBS Consulting believes, a significant impact on the release of funding to support the expanded use of ICDs in that country. Current NICE guidelines support the consideration of ICD implantation in the major SCD at-risk populations of coronary artery disease patients. With the update on guidelines anticipated for September 2003, the market participants who already have input in the supply of cost-effectiveness data to support revised guidelines would do well to evaluate their information supply strategies in the UK. The objective in that country as well as in Germany, Italy and France is to reverse the bias for drug treatment in favour of ICD implantation. The atmosphere is right within Europe to affect some of the changes necessary to elicit favourable reimbursement and budget allocation scenarios in the key country markets. Utilising the work undertaken by an increasingly powerful lobby of cardiologists (European Society of Cardiology Task Force) and marrying that with more compelling and entirely relevant cost-effectiveness data seems to be the logical way forward. The development of this market is vital in terms of patient benefit and in the revenue expansion opportunities it affords for the companies operating within it.

Other therapy options in the cardiology field which are likely to have an increasing impact and where reimbursement mechanisms in the European markets may need to be addressed are highlighted in the following table.

There is a detectable trend emerging within certain sectors of healthcare where the use of traditional drug therapy is under threat from the devices sector. In certain areas of the cardiology field, as discussed within this article this trend is increasingly favoured by positive clinical trials data. Device manufacturers are faced with the considerable challenge of facilitating this change by both enforcing government reviews of clinical trial data and backing up this information with cross industry supported cost-benefit analyses. There is a danger also that the dominance of the market by larger medical device manufacturers may lead to a degree of complacency when it comes to the development of new ideas. Device manufacturers need to encourage and nurture the development of innovative technologies in this area that will allow them to supplement technology development in-house with relevant future alliance opportunities with small to medium enterprises.