Adding Comparative Effectiveness to Formulary Evidence

October 2010, Vol 1, No 5

An interview with Brian Sweet, RPh, MBA

In May 2010, the health benefits company WellPoint, Inc, announced a policy of using comparative effectiveness research (CER) as part of the firm’s formulary decision-making process. This is not surprising given the emphasis on CER after the dedication of $1.1 billion for these efforts in the American Recovery and Reinvestment Act of 2009, but for WellPoint Chief Pharmacy Officer Brian Sweet, RPh, MBA, this is both a natural development in the company’s evolution as well as a reflection of the times. We were curious to know how the CER formulary policy has played out so far for this early adopter, so we asked Mr Sweet to discuss the preliminary outcomes and lessons learned.

What is the genesis of the WellPoint CER formulary process?
WellPoint had been working with Healthcore, Inc, a Delaware-based clinical outcomes research firm, since the late 1990s, before ac quiring the company in 2003. Healthcore re searchers study the real-world safety and effectiveness of drugs, medical devices, and care management interventions to support evidence-based medicine, product development decisions, coverage decisions, and overall cost-effective care. Our alliance with them has been helpful in identifying the data elements missing from traditional research efforts that would be used for coverage decisions and how they could be added to comparative effectiveness efforts. Healthcore researchers are kept separate from the WellPoint Pharmacy & Therapeutics (P&T) Committee, however, to avoid any conflict of interest.

Why this change now?
Data beyond that produced by randomized clinical trials (RCTs) are needed. Although RCTs have strong science and produce very good evidence, they possess significant limitations that don’t give us insights as to what could happen when the drug is released into the real world.

In addition, using these types of outcomes reflects the global call for better outcomes data that has occurred over the past 15 to 20 years, as witnessed by the National Institute for Health and Clinical Excellence in the United Kingdom and like-minded health economic efforts in Australia and Toronto, Canada.

How does the WellPoint outcomesbased formulary work, and how does it differ from other types of formularies?
Rather than focusing on surrogate markers that a physician would use to track progress in clinical practice, such as whether a drug lowers blood pressure or hemoglobin A1C, WellPoint instead looks at end points such as did heart attack or stroke rates go down, were the number of nephropathies or retinopathies reduced, did we put people back to work, did we keep them out of the hospital, did we reduce the emergency department visit rate, or did we improve their quality of life? Clinical markers are important, but they don’t always correspond to an end point that matters to patients. The basis of the formulary is that we are utilizing end points that really matter to patients to make coverage decisions.

In terms of the mechanics of the process, WellPoint has a formal drug information specialist team (comprised of pharmacists and doctors of pharmacy) that regularly monitors and evaluates the literature, the US Food and Drug Administration website, other government websites, and the websites of pharmaceutical firms. They also monitor the drug pipeline using approximately 30 informational sources to keep up with new drugs, as well as new indications for existing drugs. The drug evaluation team rates both clinical and cost impact on a scale of 1 to 3, because we understand it’s about value, not just clinical end points. Employers are concerned with improving the health and productivity of their members, and these improvements have a direct impact on their costs.

To further draw in the real-world perspective, Healthcore has developed the Integrated Research Network, which registers practicing physicians in both general practice and specialties (eg, rheumatology, cardiology, endocrinology, psychiatry, oncology, and gastroenterology) to serve as subject matter experts on a particular study. These physicians will advise on the types of data to be collected, record clinical information, and participate in prospective and comparative effectiveness studies.

In addition, WellPoint consults with national physician communities that weigh in on the type of evidence that would be appropriate for making a healthcare decision. The process is an open one, and we have been very transparent in publishing what we accept as evidence in making a coverage decision.

As part of the CER process, the Institute of Medicine established a priority-setting agenda. Did WellPoint do the same?
WellPoint works with Healthcore to prioritize research efforts, including annual planning on drug categories to be reviewed and identifying where RCTs might be leaving gaps in outcomes or safety information. Although we don’t do a CER study for every drug category, we do focus on the ones with these information gaps, or if there is something that has a really highprofile impact on our population.

What, if anything, are your customers saying about your use of CER? Do they even notice or care?
Although most employer customers are not aware of this procedural shift, it has caught the attention of the drug industry. Our newly published formulary criteria detail what kinds of studies are appropriate, how they will be graded, and what studies will be thrown out. But at least 1 customer so far has renewed with WellPoint because of this CER effort. In this age of health reform, everyone is asking for better health and productivity and better value for their healthcare dollar, and nothing can inform us better than this type of work.

How often is CER incorporated into the WellPoint decision-making process?
Roughly 50% of our reviews at this point include some sort of CER/total cost of care/health outcome analysis. We do select 2 to 3 categories of drugs each quarter that would be suitable for this work, and focus on them. Whether CER is used depends on the drug category and the answers we are getting with traditional research.

What have been the early lessons learned regarding using CER?
As CER and observational studies become more common, it is essential to have appropriate critical appraisal and evidence review standards. Until this happens, there may be instances where poorly designed studies are used to make decisions or well-designed CER studies are thrown out. It is for this reason that we emphasize the transparency of our guideline process, where it is clear what comprises a well-designed study and what evidence will be accepted in the process.

Second, we wouldn’t ever want to see a CER study in itself be used to make a decision. Randomized trials are still the gold standard for efficacy, safety, and tolerability, and where these fall short regarding health and productivity data, CER studies can add to the body of evidence. But CER observational and claims data also have limitations, so decision makers will need to look at the entire body of evidence, and then triangulate around to ensure we’re making the best decision with the evidence today.

Third, coverage or formulary decision evaluations should never be time stamped; instead, these should draw on a continuous quality improvement model. We make provisional decisions based on available evidence, and then review new evidence as it comes out— even if it is a month later, we’ve got to do the right thing so we protect the health and safety of our members.

How available so far is the CER evidence you want to use?
Although CER data are available, we’d like to see more. Most (90%) of the evidence reviewed by the WellPoint committee is coming from randomized trials, but the body of CER evidence should increase in the next several years.

Has using CER caused you to expend more resources (ie, finding, interpreting, and evaluating) on these studies compared with traditional studies?
WellPoint has retained the same number of drug information evaluators, but did add 2 CER style analysts late last year to help analyze data and bring them to the WellPoint P&T Committee. In addition, Healthcore has been adding resources in health outcomes and comparative effectiveness research.

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