NCCN Unveils New 'Evidence Blocks' Initiative

Roxanne Nelson BSN, RN

October 21, 2015

The National Comprehensive Cancer Network (NCCN) has released its new value initiative — the NCCN Evidence Blocks, which have now been published within new versions of the NCCN Clinical Practice Guidelines in Oncology for Chronic Myelogenous Leukemia and Multiple Myeloma.

The blocks are intended as a visual representation of five key value measures that provide important information about specific recommendations found in the NCCN Guidelines: efficacy, safety, quality of evidence, consistency of evidence, and affordability.

"We have received feedback from providers who use NCCN guidelines that they would like more information regarding the rationale for the recommendations," said Robert W. Carlson, MD, chief executive officer, NCCN, at a press briefing held during the recent NCCN 10th Annual Congress on Hematologic Malignancies.

"Patients would also like additional information that will allow them to participate in shared decision making and make better and more informed decisions about therapy options," he said. "And in response to the rising costs of cancer care, numerous stakeholders have also requested that a new measure, affordability, be added to the level of evidence historically included in the guidelines."

To address these issues, NCCN has developed a novel system to provide additional information about the rationale underlying specific recommendations.

To develop the Evidence Blocks, NCCN panel members scored each measure using a standardized scale from 1 to 5, with 1 being the least favorable and 5 the most favorable. For efficacy and safety, panel members used both clinical experience and published data, while for quality and consistency they used the panel members' knowledge of the data supporting the treatment. Affordability was rated using the panel members' knowledge of the overall cost of the regimen.

After the data was analyzed, the final scores were then used to build the 5 x 5 table that constitutes the NCCN Evidence Block for the specific intervention, with each column corresponding to an outcome characteristic. From left to right the outcome characteristics are efficacy (E), safety (S), quality and quantity of evidence (Q), consistency of evidence (C) and affordability (A). The rows of the block are shaded in from bottom to top representing the corresponding score for each measure.

 

"The affordability measure has generated the most discussion from NCCN experts and other stakeholders," explained Dr Carlson. "Affordability is the total cost of care surrounding a specific recommendation."

This includes not only the drug cost, but supportive care such as antinausea medicine, cost of administration, and management of toxicities.

Defining Value

The Evidence Blocks are designed so that users can quickly scan a group of potentially appropriate interventions and then make treatment recommendations based on what is most important to the patient. Some patients may be mostly concerned about side effects, for example, while for others, cost will be a priority.

"Value has many definitions," explained Dr Carlson, "and the individual patient definition of value we believe is the most important."

This type of presentation of the data allows the healthcare provider and patient to make their own determination of value, he noted. "Value for one patient may be quite different than value for another patient."

As an example, a 25-year-old woman with a high risk form of breast cancer and two small children will focus almost exclusively on the efficacy of a particular treatment, and toxicities and cost will be less important. In contrast, Dr Carlson pointed out, an 85-year-old woman who comes in with an identical breast cancer will most likely be focused on quality of life, toxicity, and cost, and less so on efficacy.

"We believe that both of these perspectives are important and valid," he said.

Designed to Facilitate Discussion

Treatments are further divided into "preferred regimens" and "other regimens," explained George Somlo, MD, from City of Hope Comprehensive Cancer Center of Duarte, California, and a member of the NCCN Guidelines Panels for Breast Cancer and Multiple Myeloma.

"They are preferred because they have a high level of evidence," he said at the briefing, noting that drugs in this category have been well studied in large phase 3 trials.

The blocks are not designed to make decisions but rather to get a better understanding of the likely outcomes and the goals of care, and to stimulate conversation and shared decision-making between the patient and the healthcare team. "There is still a role here for a physician to have a discussion," he said.

As an example, he pointed out an evidence block in which combination bortezomib and dexamethasone is scored exactly the same as lenalidomide and dexamethasone. "You have the same efficiency score, the same level of evidence, quality of life, side effects, and financial implications," Dr Somlo said. "So this is where the guidelines, the physician advice and the discussion with the patient comes into line."

By the end of 2015, NCCN expects to publish NCCN Evidence Blocks for systemic therapies (not surgery or radiation therapy) in the NCCN Guidelines for Breast, Colon, Non-Small Cell Lung, and Rectal Cancers. NCCN Evidence Blocks for systemic therapies are expected to be contained within the complete library of NCCN Guidelines by the end of 2016.

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