Full article reprinted from "The Pink Sheet"- October 28, 2008
Read about why WellPoint's updated formulary submission guidelines aim to give drug companies more detailed advice on submitting information on a drug's cost-effectiveness and its impact on pharmacy and medical budgets...
Full article reprinted from "The Pink Sheet"- October 28, 2008
WellPoint Seeks More Quality Of Life, Cost Data In Formulary Submissions
WellPoint's updated formulary submission guidelines aim to give drug companies more detailed advice on submitting information on a drug's cost-effectiveness and its impact on pharmacy and medical budgets, as well as its effectiveness in improving patients' quality of life.
WellPoint released its Outcomes Based Formulary guidelines in early October and held an "all-pharma" teleconference to explain the new assessment criteria on Oct. 9. Separate guidelines are available for new products and for re-evaluation of products. They supersede formulary guidelines previously issued in September 2005. WellPoint said a year ago that it was working on revising its guidelines.
WellPoint's influence in the medical benefit market is substantial; it serves more members in the U.S. than any other health insurer through its Blue Cross and Blue Shield affiliations and its UniCare plan. It also serves 22.5 million Medicare beneficiaries.
In an interview, Brian Sweet, WellPoint's chief pharmacy officer, described the essential changes the company has made to its formulary submission guidelines.
"The main changes that we've made are that we have increased our transparency of the type of information that we're looking for when drugs come to market, and what type of information we will critically appraise related to studies, about what is a good study, a well-designed study, what types of studies will we use in health care decisions, and which ones we'll not," Sweet explained.
Guidelines Not Mandatory For 2009
Because the new guidelines were issued late in the year, WellPoint is not going to make them mandatory for 2009. Instead, the company will spend the next several months gathering feedback from manufacturers in one-on-one meetings.
Sweet said the guidelines could become mandatory in 2010, but that the company wants to give manufacturers "at least six or eight months to work with the guidelines, and then ask for additional feedback, and see where we stand as far as their ability to comply. Even with the dossiers that we're receiving, the data points being filled in - are they able to comply with the format, etc.? And then we'll make some decisions about 2010 and beyond."
The guidelines seek to explain to manufacturers "where are the pitfalls that often we see in studies that get thrown out and don't help us make good decisions," Sweet said.
"The other main area of focus is, really, additional information about the type of information we want around quality of life, health outcomes, productivity information and medical costs offsets, so that we can start to look at drugs from a total cost of care perspective and a total quality of care perspective."
Sweet made it clear that the surrogate endpoints manufacturers often submit to pharmacy and therapeutics committees as part of a drug's dossier are not very helpful in determining a drug's overall usefulness; what is needed is information on the real impact a drug is having on a patient's life.
Making A Drug's Case In QoL Terms
The guidelines stress the importance of presenting quality of life data that can be empirically evaluated, thus placing a new importance on elements of clinical trials that are not often pursued with the same rigor as safety and efficacy endpoints.
"Surrogate endpoints that would measure things like blood pressure or cholesterol levels, although important for monitoring and for working with physicians to help manage the patient, are not necessarily as useful when we're making health care decisions as real health outcome data that shows that people are back at work, improving in their health, and not absent and productive in their daily lives."
The new formulary guidelines contain several chapters related to clinical and cost outcomes, including "clinical assessment and outcomes claims," "cost-outcome assessment and product claims," and "budget and system impact claims."
The guidelines state that WellPoint "expects manufacturers to present the case for their product in quality of life terms. Manufacturers should consider patient-reported outcomes and quality of life as the default outcome measures in cost-effectiveness claims."
QoL Claims Should Be "Empirically Evaluable"
Quality-of-life claims should be "presented in empirically evaluable terms with scores representing clinically meaningful differences in evaluating alternative treatment interventions." Claims expressed as patient-reported outcomes need to be presented in a way that can be monitored and validated.
WellPoint gives this advice on cost-outcome assessment: "WP is only interested in models that generate empirically evaluable claims within a relatively short timeframe relevant to the range of potential comparators within that disease state."
The guidelines say the company will give the most weight to modeled claims for cost-effectiveness that are "based directly upon one or more well-conducted, controlled, active comparator, clinical effectiveness/efficacy trials."
But the guidelines describe the cost-effectiveness assessment for a drug as only the "first step" in meeting WellPoint's information needs. "Manufacturers are also asked to provide estimates, over each of the three years following formulary listing, of the impact of the product on the pharmacy budget, the medical budget, the total costs of treatment, and outcomes for patients in that disease or therapy area."
WellPoint is concerned with looking at the overall impact of a drug on per-member-per-year costs of treating patients in that disease or therapy area. Manufacturers will need to determine the characteristics and number of patients expected to use the new product, what the impact on resource utilization would be, and from there provide estimates of the overall or net budget impact of therapy changes.
Based on feedback from drug companies thus far, Sweet said, "I think the manufacturers are appreciating that we've become more transparent in the type of information we're looking for ... because it only helps them to better design studies while the drugs are in development, and get the data points available that help us make better decisions."
- Scott Steinke
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