WellPoint Plans CER Guidance, Building On Progress With Outcomes Data

WellPoint believes its discussions with drug manufacturers about patient outcomes have improved in the 18 months since it published technology assessment criteria focusing on that topic. Now it is updating its criteria to include how to submit results from comparative effectiveness research.

The updated guidelines are expected to be published by the end of the year. They will outline a more formal, explicit process to review CER data WellPoint often looks for already.

The health insurer, long a leader in developing a transparent drug coverage evaluation process, published its "Outcomes-Based Formulary" in October 2008, emphasizing the need for patient outcomes data in drug dossiers submitted to its pharmacy and therapeutics committee (¹ (Also see "WellPoint Seeks More Quality Of Life, Cost Data In Formulary Submissions" - Pink Sheet, 27 Oct, 2008.)). WellPoint provides pharmacy benefits to more than 27 million plan members.

"Since we published in October of '08, we have seen the quality of submissions of information from the manufacturers actually improve," Brian Sweet, WellPoint's chief pharmacy officer, said in an interview. Many manufacturers in the past year and a half have started to incorporate the kind of data WellPoint is seeking earlier in the trial design and are now sometimes collecting the information in Phase IIIb trials, so that WellPoint can see some of the information before the drug comes to market.

Nonetheless, the insurer sees room for improvement. "Even though we're asking for this type of patient-oriented outcomes that matter, we're still seeing most of the data that comes through the door being focused on efficacy, safety and tolerability, which are the standards that the FDA uses," Sweet said.

"So there's a lot of work to do still in just improving the quality and the substance of the data that's coming out of clinical trials, and we're still having many conversations with manufacturers when we don't see that outcomes data," he said. "We have a discussion with them about the fact that we'd like to see them find a way to analyze either real-world setting data or retrospective health outcomes studies to get to things like quality of life, productivity, total cost of care, medical cost offsets."

One new development since WellPoint released the criteria is that it has created a way to have confidential discussions with manufacturers about data needs for drugs in development.

Around October 2009, the company came up with a formal process that includes agreements regarding nondisclosure of confidential information and other parameters for how information may be used. The process allows WellPoint to have an open dialogue with manufacturers.

The system was put in place through WellPoint subsidiary HealthCore and is called Open Architecture.

It "basically allows the manufacturer to have a dialogue with not only HealthCore, but also our key medical and pharmacy clinicians who are helping us make formulary decisions," Sweet explained. "And we put them in a room, and then the manufacturer, while the drug is in Phase II or early in Phase III ... could ask questions about, 'Here's the type of information we're currently investigating on this drug. What other type of data would you like to see?'"

He said about a dozen of the larger manufacturers have been participating in this process, since they "have really sophisticated and highly focused outcomes research groups that really look at these types of information. It's the bigger ones that have the capabilities and the resources to do it."

"I expect that we'll be getting a lot more requests for these types of meetings, because I do think manufacturers see the value in understanding what a payer would want to see in a drug when it comes to market," Sweet added.

Conducting Outcomes Research Internally

WellPoint already conducts comparative research on patient outcomes with drugs through HealthCore. It acquired HealthCore in 2003 following a research partnership.

The company has created an integrated research network which involves practicing physicians in markets where it has health plan membership and is focused on collecting clinical data at the point of care, providing "observational-style, real-life" information, Sweet said.

For example, WellPoint's current formulary reflects outcomes studies conducted with HealthCore in 2009. They examined utilization patterns and total cost of care with drugs for osteoporosis, chronic obstructive pulmonary disease, asthma and migraine.

Specifically, WellPoint came to the following conclusions:

With bisphosphonates for osteoporosis, WellPoint analyzed more than 26,000 members taking Merck's Fosamax (alendronate), Warner Chilcott's Actonel (risedronate) and Roche's Boniva (ibandronate). Data showed lower compliance, higher fracture rates and higher total cost of care for Boniva compared to the other two drugs. So WellPoint moved Boniva to tier 3 on its formulary and now requires failure on either Fosamax or Actonel before putting patients on Boniva. The company believes its clients could save up to $1,000 per member per year in pharmacy and medical costs because of the change.

In COPD, WellPoint analyzed 8,000 members using Boehringer Ingelheim's Atrovent (ipratropium), Pfizer/Boehringer Ingelheim's Spiriva (tiotropium) and Boehringer Ingelheim's Combivent (ipratropium/albuterol). After one year, the company found that Spiriva and Combivent were associated with lower hospitalization rates and lower cost of care. By making those two drugs more accessible on its formulary, the company believes its clients can save $3,000 per member per year in pharmacy and medical costs.

In migraine, WellPoint looked at more than 35,000 members newly started on migraine drugs and found that GlaxoSmithKline's Imitrex (sumatriptan), AstraZeneca's Zomig (zolmitriptan) and Merck's Maxalt (rizatriptan) were associated with the most favorable utilization patterns and lower overall migraine-related treatment costs. Based on the data, WellPoint made those three drugs preferred over other treatment options.

In addition, its plans lifted prior authorization requirements on oral asthma drugs based on results of another study (² (Also see "WellPoint CE Study Results In Coverage Adjustment For Oral Asthma Drugs" - Pink Sheet, 31 Aug, 2009.)).

Guidelines On Comparative Effectiveness Coming

WellPoint is working on a new set of technology assessment criteria that will include information on how to submit findings from comparative effectiveness research.

"Sometime this year we should have additional technology assessment criteria developed and be a little bit more explicit in a few areas that we think need to be fleshed out a little more," Sweet said.

The updated criteria "will be more focused on some of the comparative effectiveness information that we're looking for, which ... we haven't been as explicit about documenting just because we've been ... working with it for only a few years," he added.

The concept of comparative effectiveness research gained a boost in the new health care reform law, which creates an independent institute with joint private and federal funding to guide and oversee CER (³ (Also see "Senate Considers Revised Comparative Effectiveness Plan In Reform Bill" - Pink Sheet, 7 Dec, 2009.)).

WellPoint's new guidelines, Sweet said, "will focus on nonrandomized trials, so things like what the [independent CER] agency would be producing. What type of information do we want to see and how are we going to grade it when it is developed? How are we going to evaluate it? You have to have a system and a process. That's what we're going to be publishing."

In general, Sweet said the new criteria will be "no different than what we're actually doing. It's just kind of being more formal about what it is we're actually doing ... how we're doing it, what type of information, and just being transparent."

The company even sees the opportunity for its internal research to contribute to the efforts of the new CER institute. "I think the integrated research network I described ... clearly can be an engine that could be used by the agency doing comparative research, because we can bring more data and more capabilities and resources to the table."

Sweet believes drug manufacturers already are focusing more on understanding the value of their drugs through this kind of research. "You're going to see a lot more investment on their part over the next several years focused on comparative effectiveness research, outcomes information, health economic and total cost of care information," Sweet said. "We view this as really something that we need to be collaborative with them on."

- Scott Steinke ( ⁴ [email protected] )