4

Patients

Important Points Highlighted by the Speaker

•    Varying claims about the usefulness of genomic tests can be extremely confusing to patients.

•    People with cancer need ways to get their questions answered by health care providers at the point of clinical decision making.

•    Severe illnesses may require different rules and guidelines than less severe illnesses.

•    Conversations regarding the development of new diagnostic tests should begin with the needs of the patient, not with how to get reimbursed for a test or treatment.

The National Coalition for Cancer Survivorship (NCCS) was founded in 1986 to advocate for quality cancer care. It is survivor led—its bylaws require that a majority of the board of directors have a personal cancer diagnosis—and it has created and promoted the language of “cancer survivorship” as an alternative to “patient” or “victim.”

Mark Gorman of NCCS noted that cancer survivors have rising expectations with respect to genomic and other tests. They see these technologies as potentially guiding them toward more effective treatment and reducing the time they spend on ineffective therapies. However, they do not under-



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4 Patients Important Points Highlighted by the Speaker • Varying claims about the usefulness of genomic tests can be extremely confusing to patients. • People with cancer need ways to get their questions answered by health care providers at the point of clinical decision making. • Severe illnesses may require different rules and guidelines than less severe illnesses. • Conversations regarding the development of new diagnostic tests should begin with the needs of the patient, not with how to get reimbursed for a test or treatment. The National Coalition for Cancer Survivorship (NCCS) was founded in 1986 to advocate for quality cancer care. It is survivor led—its bylaws require that a majority of the board of directors have a personal cancer diagnosis—and it has created and promoted the language of “cancer survi- vorship” as an alternative to “patient” or “victim.” Mark Gorman of NCCS noted that cancer survivors have rising expec- tations with respect to genomic and other tests. They see these technologies as potentially guiding them toward more effective treatment and reducing the time they spend on ineffective therapies. However, they do not under- 29

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30 GENOME-BASED DIAGNOSTICS stand the complexity of genomic tests and there is confusion about their true usefulness. POLICY POSITIONS NCCS has adopted several specific positions on matters involving genomic diagnostic tests. It supports vigorous FDA oversight of these tests but with the recognition that a clearly defined regulatory pathway is needed, especially for companion diagnostics. The main concern is that uncertainty in the current regulatory environment will lead to inefficiency and slow progress. NCCS is also very concerned about finding ways for people with cancer to get their questions answered by health care providers at the point of clinical decision making. Cancer treatment planning is a very complex process that is becoming even more complex. People need information and time to understand the implications of the choices they are offered. ISSUES OF CONCERN Cancer care is at the forefront of the development and use of genomic diagnostic technologies, said Gorman. As a cancer survivor, he wants these diagnostic tests to reduce uncertainty and help in the management of resources. This requires coordinated care and a full understanding of the use and implications of these tests by care providers. Many people seek out second opinions, and it is not uncommon for the pathologist at a second cancer center to have a different conclusion from the initial diagnosis. Questions then arise as to whether the pathology has been correctly interpreted and whether a patient might have to face repeat tests and costs. Without trust in the entire care team to properly advise a patient’s treatment, this may prove to be a significant obstacle for moving these new technologies forward. Severe illnesses may be different from less threatening illnesses with regard to testing and may require different rules, Gorman pointed out. If investigational interventions begin to enter clinical practice, the sub- ject of that intervention should know that information, Gorman said. This knowledge will temper expectations and may affect choices. However, if this is a pathway that is used, then the interventions should be done in a manner that will generate evidence. Collection of evidence does not need to be through a randomized controlled trial, but it should be systematic, he said. Gorman warned, though, that use of the investigational system needs to be properly vetted to avoid setbacks that can undermine patient trust, harm the field, and delay progress. Third-party oversight may be useful in this regard.

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31 PATIENTS Finally, Gorman pointed out that cancer survivors have become very frustrated with conversations about how to bring the best care models and goals to widespread use that begin with the question, How can it be paid for? “Personally, I prefer a dialogue that begins with the question, ‘What do patients and cancer survivors need?’ Then we move on to the questions of how can incentives be aligned to realize it.”

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