The fresh outlook

Evidence-based medicine and health outcomes will change the face of marketing

Healthcare systems in their current form are unsustainable. Fundamental changes to the financing structures and services are inevitable as rising costs and quality issues become major concerns across the developed world.

In a recent report by Capgemini, patients, physicians, industry, employers, health plan managers and hospital managers all said that the healthcare system requires radical change, as dissatisfaction would increase over the next few years due to concerns about prescription drug prices, increased out-of-pocket costs and the possible rise in the number of uninsured patients (especially in the US).

The report also highlights the increasing importance placed on health outcomes for the pharmaceutical industry.

More than 85 per cent of key healthcare stakeholders surveyed believe that the implementation of cost/benefit analysis, standardised treatment programmes and evidence-based treatment guidelines for common conditions will play a key role in the future delivery of healthcare.

Evidence-based medicine for treatment decisions and more provisions for chronic patients were ranked by pharma as the first and third most important changes, respectively, to have a significant impact.

Such health outcomes will not only enable all stakeholders to contain costs but will increase the quality of healthcare as treatments will be tailored to suit individual patient needs across the entire continuum of care, from prevention to outpatient and inpatient costs.

Outcomes vs costs
Evaluating health outcomes requires the integration of clinical, epidemiological, and economic data with a view to comparing costs (drug costs, healthcare costs, adverse drug reaction costs, time costs) with outcomes (improved health, improved quality of life, less functional impairment, improved patient satisfaction, less use of healthcare resources, fewer production losses, patient preferences).

Such evaluations can be used to rank medical interventions within and between various categories of illness, making it possible to identify the options that maximise health outcomes at a given cost.

It is impossible, however, to assess the relationship between the monetary value of these effects and their costs without establishing a direct link with society's willingness to pay for this outcome by defining an acceptable ratio of costs Vs outcome (the highest-ranking option is not necessarily the best choice).

The primary purpose of implementing health outcome measures is to provide decision makers in healthcare (doctors, officials, or politicians) with a key part of the information they require in order to allocate scanty resources wisely.

All stakeholders in healthcare should agree on common standards to measure health outcomes and such standards will be defined for all major diseases based on evidence/information available.

When delivering healthcare services in the future, providers will have to accept and respect the rules of evidence-based medicine.

Pharma's chance
A growing number of legal and regulatory issues intended to improve drug safety have resulted in longer clinical trials and new requirements for post-launch studies.

Alongside this trend, dramatic increases in the use of certain classes of therapy have directed payers' attention towards pharma companies, making them a target of cost-containment measures, such as rebates and price discounts.

The 'blockbuster' business model, which has been remarkably successful over the past 20 years or more, is now encountering major challenges and pharma companies are spending escalating sums of money promoting their products.

However, return on investment (RoI) is waning, which is due partially to the lack of effectiveness of traditional promotional and marketing techniques. At the same time, both physicians and patients look for cost-effective drugs that improve health outcomes and, increasingly, demand data that show proven product benefits.

ebm in marketing
Today, the pharma industry is embracing an evidence-based approach to a variety of issues in drug development and commercialisation to counteract the lack of effectiveness of traditional marketing.

The Institute of Medicine's defintion of evidence-based medicine (EBM) is the most widely accepted: 'EBM is the conscientious and judicious use of current best evidence from clinical care research in the management of patients.'

This focus on health outcomes and clinical evidence will have a two-fold impact on the pharma industry: firstly, it will enable companies to further substantiate the value of a therapy, or identify additional benefits, such as improvements in quality of life and cost-effectiveness; secondly, it will draw clear distinctions in efficacy between the medications in the same class.

Consequently, the size of patient target groups might decrease, as off-label use is being reduced, yet the effectiveness of a drug for the target group will become more evident. The process also prevents the introduction of interventions with unproven efficacy that may do more harm than good, or whose good is achieved at unreasonable or unacceptable costs.

Marketers are starting to adopt health and economic outcomes evidence to support key marketing messages, as the identification and appropriate presentation of clinical evidence will support them in enhancing product commercialisation.

Based on the target audience and marketing objectives, evidence-based information used may vary, though all information needs to be presented as targeting specific needs and objectives:

Prepare prescribers: demonstrate and communicate efficacy and safety (serious adverse events, drug adverse effects) of competitor and own products in patients where the proposed drug will have an advantage, especially in particular populations, or refractory patients

Prepare buyers: collect and prepare evidence (pharmacoeconomic and/or quality of life) which relates to competitors, particularly in special populations,
or refractory patients

Protect investment: pharmacovigilance should be instituted with literature monitoring, which positions product managers to react quickly in the face of post-launch safety challenges and respond to routine issues for submission of required periodic safety update reports to agencies

Prepare to extend the influence of a drug: supplemental indications should also be studied, requiring post-marketing clinical trials designed in such a way that the extended use and influence of a marketed drug can be demonstrated.

Finding evidence
Careful selection of the best evidence to support marketing in differentiating a product is crucial. A systematic review of medical literature pertaining to a particular disease or treatment allows a product manager to use clinical trial databases to:

• document natural history, medical need and standard of care

• explore dosing/scheduling for efficacy and safety

• seek subgroup effects across trials

• accumulate data on rare patients and rare outcomes

• maximise programme efficiency in challenging settings

• support early termination of long-term trials

• compare safety and efficacy directly or indirectly

• explore new outcomes or indications for pipeline or marketed drugs.

The resulting health outcome messages will address: quality of life, costs (direct and indirect), treatment satisfaction, well-being, functioning, work loss/productivity, stress, physical impact and symptoms.

Several companies have commissioned systematic reviews of literature to assist product defence by quantifying incidence rates for certain adverse events in trials. This serves as a valuable component in a pharmacovigilance programme for products after launch, but is essentially reactive pharmacovigilance.

A better course would be to invest in evidence for proactive pharmacovigilance. Relevant information may already be available, obviating the need to reinvent the wheel. Product managers should seek explicit, reproducible and comprehensive data sources, not simply information that has been formulated by cherry-picking and opinion. It is important to remain proactive in the identification of appropriate data.

A fuller service
The move towards health outcome-driven systems will not be easy; changes will be required in terms of infrastructure and behaviour from the regulators, providers and consumers alike.

Although some governments already have initiatives underway that encourage stakeholders to focus on health outcomes, more needs to be done to provide accurate information, and necessary incentives to all stakeholders.

In particular, electronic medical records combined with e-prescribing are likely to become key elements. Electronic medical record systems are penetrating Europe very quickly, and the technology has already been implemented, for example, in 90 per cent of primary care practices in Norway, Sweden and Denmark.

As healthcare systems start to be driven by health outcomes, the pharma industry will need to carefully manage how to deal with this much changed environment.

The overall value that a pharmaceutical product delivers should not be focused solely on the efficacy, safety and pricing transparency of treatments, but must also in the future take into account product-related services that will help physicians to improve the treatment of outcomes for their patients.

Pharmaceutical manufacturers will have to demonstrate clear pharmacoeconomic advantages of new treatments even more explicitly and proactively.

Improving collaboration with healthcare payers, providers and patient groups will be key to creating a truly integrated healthcare environment that will help to yield better health outcomes.

The Author
Dr Simone Seiter is the managing consultant of Capgemini Deutschland GmbH, and G nther Illert is vice president at Capgemini. He heads up the Central European Life Sciences Business Unit