Delivering Evidence-Based Value to Cancer Patients

Specialty Pharmacy Times spoke with Dr. Neubauer to discuss the intricacies of clinical pathways, including how to reconcile a drug's cost and benefits, the importance of making evidence-based decisions, when to deviate from recommended treatment pathways, and why he thinks all health plans should pay for the routine costs of clinical trials.

McKesson Specialty Health and The US Oncology Network recently announced that Marcus Neubauer, MD, will take on the role of medical director of Oncology Services for McKesson Specialty Health starting March 1, 2013. He will continue his work on clinical pathways development through McKesson’s New Value Pathways for Cancer Care and help ensure that they are in alignment with National Comprehensive Cancer Network (NCCN) guidelines.

The goal of this new initiative is to enhance best practices for evidence-based patient care “and enable new forms of transparent provider and payer relationships,” according to a McKesson press release from late last year.

Specialty Pharmacy Times spoke with Dr. Neubauer to discuss the intricacies of these pathways, including how to reconcile a drug’s cost and benefits, the importance of making evidence-based decisions, when to deviate from recommended treatment pathways, and why he thinks all health plans should pay for the routine costs of clinical trials.

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SPT: Is precision medicine the future of cancer management?

Dr. Neubauer: It is an emerging component of cancer management. For some cancers, we know enough information about cancer-causing mutations (targets) that therapy can be designed based on the detection of the target. For other cancers, we don’t have this knowledge, and we will use conventional chemotherapy (or what has been shown to work best).

SPT: Companion diagnostics tests are not 100% foolproof. What are some problems you foresee with the use of these types of tests?

Dr. Neubauer: You are correct, they are not foolproof. There are some pitfalls. Sometimes it is hard to obtain enough tissue or the specimen isn’t processed correctly. The companion tests tend to be very expensive and sometimes they are not covered by insurance and are unaffordable to patients. Companion tests tend to focus on one mutation or abnormality, and often cancer is a series of gene mutations either at presentation or as disease progresses. Still, for some well established measurable targets, the corresponding agent should not be used unless the companion diagnostic test is done and identifies the target as present.

SPT: What are the requirements for an oncology drug to be included in a clinical pathways program? How can drug manufacturers prove the value of their drug to payers?

Dr. Neubauer: Our clinical pathways program is designed to maximize the value of cancer care. To address value, you must address efficacy, toxicity, and cost. The greater the efficacy, the more tolerable the cost. We base our pathways on efficacy first. If 2 drugs are equal in efficacy, we identify the one that is less toxic and/or less expensive. All of our pathways are built on thorough reviews of the literature with a preference for high levels of evidence.

SPT: When is it not a good idea to follow an approved clinical pathway?

Dr. Neubauer: We believe in eliminating unnecessary variation. We believe that in cancer care there is too much variation, which risks safety, increases costs, and yet doesn’t improve outcomes. So we believe that, if pathways are constructed properly, about 80% of patients for a given type of cancer should be treated on pathway. Yet, there are circumstances where a patient is best suited by being treated off pathway. We term this an exception. We allow exceptions, but we ask for a reason for the exception, and we track exceptions.

SPT: Do clinical pathways restrict physicians from prescribing medications not included in a pathway program? When should a physician deviate from this type of standardized model?

Dr. Neubauer: Clinical pathways direct physicians to the highest value choices for their patients based on an extensive review of the literature. Yet, as described above, there are situations where patients are best suited being treated outside a pathway. In other words, the best value for the patient might be an off-pathway treatment regimen. Physicians are clearly permitted to make this choice for a patient. However, the reason we track pathway exceptions is because sometimes off-pathway choices are not really evidence-based and the value to a patient is debatable.

SPT: Should payers be required to pay for a targeted treatment, even if the driver mutation occurs in a tumor where formal regulatory approval for this indication has not yet occurred?

Dr. Neubauer: It depends on the evidence. If the evidence in the literature is strong, then I think a payer should be asked to pay. However, the field of personalized medicine is exploding, and the information available is not always substantiated or peer-reviewed. There can be a tendency to test a multitude of targets, see if any exist, and then prescribe a drug that has been shown in some way to “work.” This type of evidence is shaky, and I don’t think payers should bear this type of cost burden since diagnostic tests and targeted agents are very expensive.

SPT: Will the physician bonuses to follow approved pathways be enough to incentivize providers? Could these incentives ever deter physicians from prescribing a more effective (albeit expensive) oncolytic?

Dr. Neubauer: I think oncologists should get compensated for the hard work they do treating very serious illnesses. By adhering to pathways, they will be providing the highest value of care so the incentives tend to be aligned with payers. I don’t think doctors will choose to withhold an effective medicine from a patient, but they may withhold a medicine that has not shown to be particularly effective, at least in a substantive way, when they otherwise might have gone ahead and “tried” the medication for their patient if they weren’t following pathways.

SPT: By not covering investigational agents and off-label uses of certain drugs for cancer, do payers run the risk of prematurely eliminating some of the most effective therapies or those with the best outcomes?

Dr. Neubauer: I think all payers should pay for the routine costs of clinical trials. This simply is a part of oncology care. It drives the field forward for future patients and sometimes uncovers treatments that aren’t effective. Covering the routine costs of clinical trials doesn’t even really cost more than paying for established treatment. Almost half of the drugs used now for cancer therapies are “off label.” Payers should pay for off-label drugs if the evidence is valid. A payer that is too restrictive in their coverage rules will, indeed, run the risk of turning down coverage for an effective therapy for a cancer patient. So there needs to be a balance. Physician driven clinical pathways help strike this balance between efficacy and cost, resulting in high value.