CER: Use, Controversy Both Growing

June 2010, Vol 1, No 2

Even before enactment of national healthcare reform initiatives, development and implementation of a variety of comparative effectiveness research (CER) was well under way, even if it was not specifically called comparative effectiveness. Humana’s recent Medical Coverage Policy for taxanes, for example, is an organizational-level initiative based on a comprehensive comparative clinical and cost review. The payer prefers documented failure to meet treatment goals or intolerance of conventional, generic paclitaxel (Taxol) prior to the use of other branded taxanes in most indications where taxanes are used.1 Regence BlueCross BlueShield, covering beneficiaries in Idaho, Oregon, Utah, and Washington, provides another example of a CER model with its Medication Cost Integration formulary, which premiered in February of this year. The innovation of this formulary is that it formally integrates medical and pharmacy benefits, assessing oral and injectable cancer drugs together. The resulting patient cost share levels are not established by whether the drug/biologic is accessed at the retail pharmacy or physician office, but rather by internal comparative research across a drug’s clinical, safety, and cost aspects.

WellPoint recently announced its own formal organizational-specific CER process, establishing an outcomes- based formulary.2 WellPoint has published distinct criteria of how formulary decisions are made, with consideration of clinical data sources ranging from randomized controlled trials to observational studies. Once efficacy for a product is established based on what WellPoint determines to be a high-quality randomized controlled trial, observational studies may then be considered as part of an overall review when those studies are “scientifically credible” and their potential biases have been minimized. The final evaluation will result in a rating of the data as “useful,” “possibly useful,” or “not useful.”3 In its criteria, WellPoint states that “a more expensive medication can be less expensive overall if the member’s health is improved, resulting in use of fewer healthcare resources.”

Another possible form of comparative effectiveness is that for oncology clinical pathways. Pathways for breast, colorectal, and lung cancers have been in place in individual oncology practices and at commercial payers for the past several years, with the trend increasing for development of more pathways across additional tumor types such as lymphomas andleukemias. Most pathway initiatives to date have been “conventional,” based upon collaboration between physicians and payers and utilizing the framework of tumor-specific guidelines from the National Comprehensive Cancer Network. The result has been selection of a limited number of treatment regimens for each tumor type and/or stage of disease. The idea is to reduce treatment variability for a given tumor, while maintaining appropriate clinical outcomes coupled with lower cost to the payer and the patient.

Value Picture Requires Long View

Finally, as Steven Weinberger from the American College of Physicians notes in this article, a physician/ patient interaction that considers the full clinical and financial situation is truly at the heart of generating the best “value” for the patient. A 2007 survey of 114 oncology practices across the United States (produced in collaboration by the American Society of Clinical Oncology and the Administrators in Oncology and Hematology Assembly) identified the type and level of services offered to the patient by the practice. The survey documented that, even at that point in time, 86% of practices surveyed “evaluated the physician’s treatment plan in the context of a patient’s insurance coverage and financial resources.”4

Although these cancer-based examples exist, there is no doubt that larger, more comprehensive changes with CER are coming, as outlined in this article. No matter what the focus for change, there are several questions that require honest, objective answers as change is considered and implemented, including some that are quite controversial: 

  • How will payers and organizations rank the evidence for drugs and biologics that demonstrate noninferiority, if the data demonstrate limited incremental benefit related to adverse events or cost of care?
  • What standardization, if any, can be derived to compare data across the growing number of observational trials—and is standardization required?
  • How will decisions around hospice be integrated into CER decisions for the patient with metastatic disease, and will end-of-life decision points become more apparent through CER?

No matter the changes, it remains paramount that any analysis includes patient-centric variables related to access to care and compliance, along with all other clinical, safety, and cost factors.

References

  1. Humana Medical Coverage Policy: Taxanes—Abraxane®, Taxotere® and Taxol® (nab-paclitaxel, docetaxel and paclitaxel). March 25, 2010. http://apps.humana.com/tad/tad_new/Search.aspx?searchtype=beginswith&docbegin=T. Accessed May 20, 2010.
  2. WellPoint, Inc. WellPoint is first health benefits company to release CER guidelines for use in evaluating pharmaceuticals. www.wellpoint.com/pdf/CERGuidelines.pdf. Accessed May 20, 2010.
  3. WellPoint, Inc. Use of comparative effectiveness research (CER) and observational data in formulary decision making evaluation criteria. www.wellpointnextrx.com/shared/noapplication/f1/s0/t0/pw_b145032.pdf. Accessed May 20, 2010.
  4. DaVanzo J, Doherty J. Evaluating support services in office-based oncology practice: collaboration between ASCO and AOHA. J Oncol Prac. 2007;3(4):204-207.

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