Comparative Effectiveness Research – a bright future for Patient Empowerment!

How often have you been prescribed a drug for which the brand name version has been deemed medically necessary and irreplaceable by the generic version? How often have you found yourself sitting in the doctor’s office required to choose between two treatment options you have no clue about other than knowing that they ‘may potentially’ cure your health condition? How often have you opted for a prescribed medical treatment, drug or a device only because it is covered by your insurance without giving a second thought to whether you actually need the medical intervention or can instead improve your condition by simple lifestyle changes? As a healthcare provider, you must have often felt the need to have access to a consolidated, authoritative and advanced repository that links geographically widespread clinical trials, research & surveys on any condition to health outcomes of patients belonging to diverse race, ethnicity, age-groups and disability or chronic condition categories. As a health insurance policy maker willing to promote better health outcomes, you must have aspired to cover patient enablement as a plan provision moving above and beyond covering treatment and preventive care. The real need of the hour is empowering patients, providers and policymakers with advanced, high quality, reliable & affordable evidence-based information which can help everyone ‘own their decisions’. Comparative effectiveness research that has the federal blessings looks like the first step in a long journey of holistic empowerment in healthcare!

Health Care Reform’s answer to Patient Empowerment

The Patient Protection and Affordable Care Act (PPACA) includes landmark legislation that aims to significantly increase accessibility to evidence-based information thereby improving healthcare quality and reducing costs. The establishment of a Patient-Centered Outcomes Research Institute (PCORI), as required by Section 1181(b) of the bill proposes the use of an ambitious methodology known as Comparative Effectiveness Research (CER) which is designed to inform healthcare decisions by providing evidence on the effectiveness, risks and benefits of different treatment options. The evidence is generated from research studies that compare protocols for treatment, care management & delivery, drugs, medical devices, diagnostic tools, procedures, surgeries, or other means to treat, manage, diagnose or prevent various health conditions.

Critical Success Factors for CER

The concept of using a federally backed research methodology to consolidate information about medical options and compare the same definitely sounds promising. However, policymakers, healthcare providers and health insurance companies need to think creatively on how this research methodology can be translated into true ‘patient empowerment’, better health outcomes and eventually to a reduction in unnecessary healthcare spending. Some of the critical questions that emerge are as follows:

1. How do we market the concept of CER to patients?
2. How do we refine CER findings to create effective, relevant and patient-centric information?
3. How can the raw CER database be used to build analytical tools that are powered by technology yet driven by individual patient health characteristics?
4. What is the role of health insurance companies in CER?

Creating CER proponents

Our biggest challenge is to create loyal believers of CER out of patients who are habituated to never questioning the doctor’s judgment. We would also face stiff resistance from patients who believe the most expensive treatment is always the best and hence are rarely open to explore other options! We can’t find better ambassadors than the doctors themselves, who can best present the CER case! The mechanisms could be anything from personal messages posted by the doctor on social networking sites to an informal chat in the doctor’s office or even flyers, all highlighting the benefits of CER. A question that might often be asked is to justify how the CER findings are any superior to other Internet resources. The federal authority under which CER will operate definitely gives it tremendous credibility, probably even lacking in millions of Internet resources. FDA comes to mind as a classic example of a U.S. government agency that is highly regarded for its decisions about public health and safety. Some success stories from CER research done in the past (see Table I for examples) and how the findings helped individuals make better, more informed health decisions could also be highlighted.

Another marketing strategy could be for doctors to be equipped with working pilots of enhanced tools which use the CER raw database – some examples of such tools are outlined in later sections.

What is needed to make CER findings effective and patient-centric?

Although CER has come under the spotlight just recently, federal agencies like Agency for Healthcare Research and Quality (AHRQ), National Institutes of Health (NIH), Department of Defense (DOD) and Veterans Health Administration (VHA) have been conducting CER for last several years. Due to the critical emphasis of the federal government on the ‘patient-centered’ aspect of CER results, it is imperative that the CER findings targeted for the patient population are precise and patient-friendly, yet free of technical jargon. Table I examines the content of some existing CER patient guides published by AHRQ, NIH and VHA. Additional AHRQ guides can be accessed at

http://www.effectivehealthcare.ahrq.gov/ehc/

Table I: Illustration of existing patient-specific CER guides

AHRQ seems to have organized its current CER findings in the most patient-oriented format and allows the patient to search them based on research methodology. If required, patient can access the descriptive details of the clinical trials/research.  Patients have the capability to submit suggestions for research and comment on research that has been completed. The NIH and VHA CER findings seem to be primarily provider oriented.

Table II provides a detailed qualitative comparison of the CER guides being published by these institutes currently which could help the PCORI develop standard templates for publishing CER findings post-reform

Table II: Comparative analysis of existing patient-specific CER guides

Transforming raw CER data into consumer-driven analytical tools

As the CER database continues to evolve, there is tremendous scope for utilizing the same and building consumer-centric analytical tools which effectively leverage the Health 2.0 movement. In order to control costs, it is imperative that such tools are either built with federal funding or the federal government strikes a deal with private companies that already market such tools.

Individual CER findings will be primarily based on randomized clinical trials and research, requiring further probing to provide individualized results. Instead of having to keep abreast with all CER developments, people would be more willing to enter their health characteristics and history into a tool that will scan through a rich CER database and as a result, create a personalized outline of potential health risks, precautionary measures, healthy lifestyle alternatives, existing health conditions that need immediate monitoring as well as the most suitable medical interventions. The tool should be able to generate periodic alerts based on changes in personal health conditions or enhancements to the CER database. This personal health map can be further integrated with other tools that can evaluate the plan coverage provisions for each health condition and maybe even propose more cost-effective insurance alternatives. To promote CER, the government could partner with private companies that create innovative healthcare solutions to offer subsidize solutions to the public like health risk assessment, telemedicine, personal health tracking, personal automation, wellness etc. The Health 2.0 movement, which is at the core of such solutions, will indeed prove to be a major catalyst in integrating innovation with CER!

Role of insurance companies in CER

Ongoing historical claims information provided by health insurance companies will be a critical input to the CER database. This information will help ‘personalize’ the randomized clinical trials to a large extent by providing actual usage information on drugs, procedures, preventive services, therapies and other medical intervention by people with diverse health conditions, ethnicities, age groups, geographical regions, social and economic statuses.

As CER gains popularity, there will be immense pressure on insurance companies to revamp their coverage policies. The CER findings may be open-source; however the advanced personalized health assessment tools created on the foundation of CER will definitely come at some cost. In order to promote efficient usage of these tools, the R&D of these concepts must be backed by appropriate provisions in health insurance policies. It is worth clarifying that insurance companies should not base their coverage decisions on CER findings; for e.g. a drug or medical procedure that ranks better over another in a CER finding being covered while others are not is unwanted practice and will interfere with provider decision-making. However, some incentives must be provided to a doctor, for example, who uses tools that create CER-based care considerations for each patient periodically. Patients who use in-house tools to monitor chronic conditions like diabetes (avoiding unnecessary routine doctor visits) and at the same time keep themselves informed about healthy lifestyle alternatives to expensive medical treatments via various CER avenues should either receive coverage for using these advanced tools or must be provided incentives in the form of lower premiums.

Conclusion

There are obviously many threads that have to be woven together very artistically to create the desired usage pattern for CER over time. Whichever way we implement, the ultimate goal should be patient enablement and empowerment. Policymakers, health insurers and technology companies need to build the legal, administrative and structural framework of CER. Providers will need to play an extremely pivotal role as they will be consumers of CER (by getting access to latest medical innovations, advancements and comparative studies) as well as the most trusted advisors who can encourage their patients to fully understand & embrace CER and use it effectively to seek the best health outcomes! If CER can create such a positively collaborative decision making relationship between doctors and patients, we will truly be at a juncture of re-writing history!

About The Author

Nandini is a Healthcare Business Consultant working with Infosys Technologies Ltd., a leading Fortune 500 company. She is proficient in a wide range of business areas with expertise in Consumer Segment lead management, quoting, underwriting, enrollment, billing, accounts receivable and member maintenance. She has collaborated with leading healthcare clients to help them implement complex CMS mandates and created enhanced competitive product designs for Medicare plans. A very strong understanding of how the sales funnel can be effectively channelized to generate Marketing Analytics has helped her run critical initiatives to drive better marketing campaigns and ensure higher return on investment in the future.

She has authored several white papers on topics ranging from “Functional Storyboards: Requirement Elicitation Tools for COTS evaluation” to “Can an Expert System help in Software Project Pricing Decisions”

She is an avid reader of fiction, scientific thrillers and philosophy and strongly believes that reading is the most effective way of expanding your knowledge horizons. Being appraised of the latest happenings in the healthcare industry, pioneering initiatives, strategizing and leading teams to the stated goals is what she cherishes most of her professional career.

She is certified in SCJP and AHIP.