How Evidence Based Medicine is Impacting Global Clinical and Reimbursement Practices - Pharmaceutical Executive

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How Evidence Based Medicine is Impacting Global Clinical and Reimbursement Practices



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Evidence-based medicine (EBM) is fast becoming one of the key concepts in clinical and reimbursement practices in the developed world, recently embraced by medical practitioners, policy-makers, and the general public, most notably in the UK. Globally speaking, however, EBM remains unproven, although a number of current trends—such as the rising need for healthcare and pharmaceutical cost-containment—are driving higher acceptance of the practice. These are the findings of Arrowhead Publishers' publication Evidence-Based Medicine: Current Use and Future Impact on Global Clinical and Reimbursement Practices.

EBM-based decisions draw on clinical experience and evidence (both of published and test-stage data), professional expertise and skills, as well as patient values and expectations. Nevertheless, the practice has been criticized for excessive focus on individual decisions and for not using the best data, given that some of it is outdated, unknown, or simply left out because physicians are pressed for time. On a more practical level, EBM guidelines and recommendations have come under criticism for denying some treatments in the public sector, while some clinicians resent the loss of individual decision-making freedoms. 

The US Still Learning
In many countries, including the US, EBM is already viewed as an essential component of clinical practice, though much of the research aimed at developing clinical guidelines is currently being conducted at the state, as opposed to the federal, level. For example, the California Workgroup on Alzheimer's Disease Management—funded by the state of California—has produced the Guidelines for Alzheimer's Disease Management, which incorporate recommendations on medical, pharmacological, and psychosocial interventions. The Guidelines were published following a collaborative effort of healthcare providers, consumers, and academics, as well as professional and volunteer organizations and purchasers of healthcare, using evidence from literature along with expert consensus.

In the US, EBM is also applied by a number of key stakeholders within the country’s health system. Hospitals, for example, have mostly focused on patient safety from the point of view of medical errors, with programs to improve order and entry management systems and to monitor the volume of prescriptions.  Similarly, disease management companies are using EBM to tailor their coverage, grounding their decisions in evidence collated by national organizations.

For its part, the US government is promoting EBM primarily via the Agency for Healthcare Research and Quality (AHRQ). One of its initiatives is the National Guideline Clearinghouse, which publishes a weekly updated database of clinical practice guidelines, with the view to increasing their use (see Table 1). Finally, accrediting agencies, such as the Joint Commission on the Accreditation of Healthcare Organizations, use EBM in their accreditation process; some employers actually require this certification from health plan providers.

In Europe, EBM has evolved beyond the formation of clinical guidelines. The UK is regarded as a pioneer in the use of EBM in pharmaceutical reimbursement, through the creation of its National Institute of Clinical Excellence (NICE). While its guidelines are not legally binding, the recommendations on pharmaceutical and medical treatment made NICE are generally followed for the purposes of reimbursement within the UK’s National Healthcare Service (NHS). While UK doctors are free to prescribe any drug licensed by the country’s regulatory agency, they usually await NICE endorsement, illustrating the body’s formidable status in the medical community.

Australia’s Therapeutic Goods Administration is also extremely active in terms of cost/benefit determination of pharmaceutical reimbursement. The state program for pharmaceutical reimbursement is the Pharmaceutical Benefits Scheme (PBS), which accounts for around 90 percent of total pharmaceutical market by value. Drugs are included in the PBS listing on the basis of clinical benefits, safety, and cost-effectiveness, while prices are set by the federal Department of Health and Ageing following consultation with the Pharmaceutical Benefits Pricing Authority.

This assessment of pharmaceutical cost-effectiveness means that the prices of branded drugs in Australia are between 30 and 45 percent lower than their equivalents in Western Europe, with clear—but inverse—implications for both pharmaceutical manufacturers and the public healthcare funding.

Similarly, Canada already requires that all marketing authorization applications include scientific evidence confirming a product's safety, efficacy, and quality. While drug formularies vary widely between its provinces, the need for cost containment in this socialist-type healthcare system means that the pharmaceutical reimbursement environment is likely to become tougher in coming years.

The Daunting Task
Clearly, the path ahead for EBM is far from smooth. Problems include information gaps, caused in part by the preference for randomized, controlled trials over the higher quality studies of interventions and treatment tools, as well as by the lack of studies of certain diseases and disorders. Moreover, the pace of medical and scientific advances will continue to pose major challenges to timely incorporation of EBM, as will the reluctance of health and medical professionals to take orders.

However, as socio-demographic changes and the rise of biotechnology—among other factors—have increased pressure on available healthcare resources, policymakers and purse-holders are becoming much more interested in “rational” and “value for money” treatment options. Theoretically, EBM is a particularly strong candidate for use in the reimbursement process. For example, EBM can determine the level of clinical effectiveness of a drug, which can in turn be used as a benchmark for reimbursement. However, individual genetic and disease-specific variations evidently represent a major obstacle to using EBM as a generalized tool.

While extremely valuable as a theoretical concept, EBM does have some practical limitations. Patients’ and physicians’ preferences, compounded by political and financial barriers, have resulted in less-than-optimal application of EBM tools. Additionally, the conflict between patients’ demand for the latest and best pharmaceuticals and technologies and the need for the creation of more cost-effective financing of healthcare continues to represent a major barrier to creating a more efficient system.

Nevertheless, given the huge potential for matching needs with resources, many experts agree that EBM will become the gold standard for the use of public healthcare funds. In the future, a higher degree of discussion and consensus between the interested parties will be crucial for the use of. However, the task is daunting. The sheer quantity and complexity of data and research tools will require considerable human and technological resources. The use of information technology (IT) provides a useful base for compilation of EBM-based guidelines for individual medical practitioners. In the UK, computerized decision-support systems are already in place, with physicians assessing research in light of their patient’s unique circumstances and therapy preferences.

Given the opposing forces exerting pressure on EBM’s practical applicability, one can expect its future usage to be patchy, rather than universal. Key factors determining its applicability will be the particular medical field, idiosyncrasies of individual markets, and the influence of both professional and public opinion. Pharmaceutical companies are continuously adapting to changes in the operating environment, as illustrated by the UK’s example of “pay-for-results,” where a drug manufacturer agreed to refund treatment costs if its product failed to induce clinical improvement in patients. Firms operating in the US can take note of such developments, especially given the tightening financial resources available within both federal and private-sector budgets.

Striking the Right Balance
Overall, EBM is a good start to providing the best care for patients. Consequently, the practice has been integrated in many educational activities, with studies showing that it has improved knowledge as well as attitudes of clinicians. However, challenges remain—not least in the sense of changing behavior. While the body of evidence is available, its applicability cannot be ensured until physicians are willing to accept it. Moreover, patients’ values and understanding must be considered as key components of the process in providing the best care.

On a final note, caution will have to be exercised in terms of how detailed clinical guidelines should be, not only because of the sheer volume of evidence, but also due to the public and professional resistance against the prescriptive nature of EBM. While recommendations for treatment of specific conditions and the use of drugs in various therapeutic areas are certainly a positive development, the sheer expanse of clinical guidelines is a danger in itself, requiring constant updating as well as fostering a certain dependency in physicians, who may minimize their own research and possibly beliefs in individualized patient care.

Sidebar: Programs of the Agency for Healthcare Research and Quality (AHRQ)
The Agency for Healthcare Research and Quality is the main federal agency in charge of improving the ‘quality, safety, efficiency and cost-effectiveness of health care for all Americans. Its central programs include the following:

  • Evidence-based Practice Centers (EPCs) are tasked with reviewing relevant scientific literature and researching methodologies to interpret evidence. The centers produce reviews that are used to formulate clinical practice guidelines, practice policies, quality measures, and policy decisions by decision-makers, as well as support the US Preventive Services Task Force and Technology Assessment Program.
  • National Guideline Clearinghouse (NGC) is a database of evidence-based clinical practice guidelines, which provides objective information for decision-makers. The database currently contains over 2,000 individual summaries, which can be accessed by both the general public and professionals. Sources of clinical guidelines are numerous national medical organizations, which draw together experts in their respective fields.
  • Centers for Education and Research on Therapeutics is a program aiming to: 1) increase awareness of both the uses and risks of new drugs, biological products, and medical devices; 2) provide clinical information to both public and private users, including patients and the government; and 3) improve quality of care while reducing its cost through identification of appropriate use of drugs, biological products and medical devices.
  • The US Preventive Services Task Force (PSRF) is an independent panel of private-sector experts in primary care and prevention. The Task Force is charged with reviewing the effectiveness of preventive services, such as immunizations and producing risk-based recommendations based on age, gender and other factors for individual services.

The Technology Assessment Program publishes assessments of the clinical utility of medical interventions for the Centers for Medicare & Medicaid Services (CMS). The assessments are used as the basis for national coverage decisions.

 

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