Emerging importance of health economics and patient outcomes

By Innovex

Across Europe the impetus to measure patient outcomes and demonstrate positive health economic benefits is intensifying. Jacco Keja, Managing Director and Practice Leader at Quintiles Consulting, Visiting Professor Life Sciences Pricing, Erasmus University, looks at the emerging opportunities for pharma companies within this environment.

Healthcare systems are accountable for a significant proportion of public funds and yet most data available relate only to the number of patients being seen and what treatment they are receiving. There is relatively little reference and transparency to how successful those treatments are in terms of quantifiable patient outcomes and value-per-Euro spent.

Healthcare service commissioners need this information in order to maximise the benefit of resources at their disposal, and decision makers are increasingly requiring outcomes data as a basis for allocating funding.

In the UK, for example, the National Health Service (NHS) receives in excess of £100bn (€126.6bn) which is why the Office of Health Economics duly considers it “reasonable” to expect that within five years, patient outcomes data will be collected for the majority of NHS activity. The Department of Health has already introduced its ‘Operating Framework for the NHS in England 2008/09’, which requires the routine reporting of patient outcomes in certain therapy areas.

Any pharmaceutical company ready to supply such data to healthcare stakeholders in the key markets will gain an advantage, as a valued partner. However, the collection and presentation of this data in its most useful format is frequently difficult.

In the German health service, for example, the budget structure means that it is not easy for companies to demonstrate the economic advantage of their products and services. Clinic budgets are structured differently from budgets for registered GPs; "cost effectiveness" can therefore take on different meanings from one case to another.

The latest moves to tighten the price regulation show that the sphere in which the industry operates is becoming increasingly difficult. The pharmaceutical industry is now regarded as one of the most tightly regulated industry in the world. To ensure that the products can be sold, the companies now have to successfully negotiate with myriads of decision makers in the health service and regulatory system.

The importance of health outcomes data

The focus on healthcare outcomes data is spreading across Europe, with several markets now seeking a regular supply of patient outcomes and health economic information. In the past – until just a few years ago – pharma companies would only submit this kind of data to the pricing and reimbursement authorities around the time of product launch. Most of this was based on projections from clinical studies, however it was recognised that while trials had a high internal validity their external validity was relatively low.

Pharma’s needs, lie in gathering and presenting the data needed to support convincing cases on a rolling basis, when the product is already on the market. It is unrealistic to generate this from ongoing clinical studies as they would need to run indefinitely, requiring too much time and money. Companies may choose to undertake observational studies and set up a registry, yet the limitations in using only generic Quality of Life instruments like Euroqol-5D outcome forms in the clinical and economic evaluation of healthcare suggest that there is a more effective way to gather and present this data.

Due to the variety of patient populations physicians encounter, e.g. patients having different co-morbidities, results produced in a controlled study are not always replicated in the real world. Also therapy adherence in clinical studies versus day-to-day practice might widely differ. Because of this we have seen a tremendous increase in formal requests from European payors for more detailed ‘real-life’ information. As these requirements evolve, pharma companies need to respond by demonstrating knowledge of how therapeutic interventions affect the budgets of individual healthcare stakeholders.

To make any progress in this increasingly complex market, it is important to find new possibilities to inspire stakeholder confidence.

Sales reps working in primary medical care are able not only to inform the physician about a product but was also able to build on this physician's confidence in the pharmaceutical industry. Many companies have already started to restructure their sales force capacities to meet changing demands in line with the increase in highly specialised medicines appearing on the market, such as oncology or multiple sclerosis treatments.

But they also need to re-think and restructure the sales and marketing strategies to ensure the best possible results based on accountable data. <0}

Public, national health economic models need to be translated into much more regional, ‘local budget impact’ models. People with the appropriate skill sets – perhaps a hybrid of a secondary care sales rep and pharmacy economist – should then deliver this information in a meaningful and impactful way.

The most effective way to achieve this objective is the adoption of alternatives to the classic marketing incentives, setting up health management projects and demonstrating the real obligation for companies to improve patients’ quality of life.

A way forward for pharma

The introduction of new “health management” solutions focused on the patient offers significant advantages throughout the health service, particularly for patients.

This involves the deployment in healthcare systems of expert Clinical Nurse Educators and highly trained Nurse Advisers. The purpose of these Clinical Educators and Nurse Advisers is essentially to provide personalised information as well as help patients follow their treatment in the most appropriate way whilst conforming with national and international guidelines, and also to gain a more in-depth knowledge of their illness and their treatment.

This approach improves not only the results of their treatment but also their health in general. Eliminating problems arising from poor concordance also helps the health service to lower costs thanks to the reduction in the number of patients relapsing, deteriorating and/or requiring hospitalisation.

It is essentially a combination of disease management with real-life data generation. This is crucial, for all kinds of therapies, because it tackles the issues of patient understanding and compliance. Unfortunately, therapies are not always used in the optimal way, but using this type of approach provides a positive step towards eliminating this.

The need for such services is now more and more widespread. In Italy, to try and reduce fixed costs connected to the pharmacies’ promotional activities and succeed in winning emerging opportunities in the specialist “secondary care” sector more effectively, companies have gradually reduced the number of sales people in the field of "primary care". This trend is of importance to a significant portion of the market and is set to continue. It has been estimated that the number of pharmaceutical representatives working in the primary care sector in Italy could be reduced by 30-40% by 2011.

Employing specialist advisers to work within a healthcare system not only improves patient concordance with treatment regimens, but also provides access to the information which reflects the most beneficial outcomes.

This kind of data will support the use of chronic treatments in particular, such as multiple sclerosis, cancer, diabetes and rheumatoid arthritis. These and high cost treatments are more likely to appear on payors’ radar screens, as the markets are younger and less genericised.

The health management approach is as good as a registry or observational study with the advantage that you are also improving delivery of therapy and therefore patient outcomes – and in that sense it is more acceptable. It is gaining strong support from health economists from the point of view that it is a win–win way of bringing health economics into practice in Europe.

With this level of economic information, Europe’s health systems can make more robust resource allocation decisions. A registry approach can lead to various protocol issues; there is always an internal struggle between the clinical departments, which want anonymised trials, and those interacting with the payors and decision makers who look at new therapies in a broader light.

In line with the transformation of the health service to become more patient-focused, this approach could also significantly contribute to improving the image of the pharmaceutical industry with the media and in public opinion.

The near future offers both opportunities and challenges to pharmaceutical companies, who are promoting products in the primary and secondary care sectors. In time, specialist products aimed at specific areas of treatment – like oncology, multiple sclerosis and cardiovascular diseases – are likely to become the principal market drivers. Until then, however, many other European markets, will continue to be influenced by changing dynamics and the measures introduced by the government to contain public health service spending.

Ultimately, the need for pharma to provide relevant and timely data on health outcomes and health economics is becoming more urgent. Innovex and Quintiles Consulting can provide scientific and integrated solutions which will yield benefits for all stakeholders in healthcare.