Wednesday, December 17, 2014 3:00pm-4:30pm EST National Coalition for Cancer Survivorship...
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Transcript of Wednesday, December 17, 2014 3:00pm-4:30pm EST National Coalition for Cancer Survivorship...
Wednesday, December 17, 20143:00pm-4:30pm EST
National Coalition for Cancer Survivorship
Post-Training Webinar
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
How FDA Review Activities Affect Cancer Patients
Elizabeth Goss
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
FDA and Cancer Patients• FDA undertakes four main activities that affect
cancer patients:oDetermines if protocols submitted under an
investigational new drug (IND) application are safe to proceed
oApproves cancer drugs and biological products for commercial marketing
oWorks with pharmaceutical companies to manage production and to address safety issues that arise
oPermits access to investigational drugs or biological products on a compassionate use basis
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Standards for Approval
• To obtain approval of a new drug or biological product, a pharmaceutical manufacturer must:oDemonstrate effectiveness with acceptable safety in
adequate and well-controlled clinical trialsoGenerate information for a product label that: • Defines the patient population for treatment with
the drug• Provides adequate information to enable safe and
effective use of the product
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Expedited Review• FDA will expedite the review of new products when that is
appropriateo May grant “breakthrough therapy” status to promising drugso May give priority review status to certain therapieso May approve cancer drugs according to accelerated approval
standards• The investigational cancer therapy must affect a surrogate
endpoint other than mortality or irreversible morbidity• The surrogate endpoint must be reasonably like to predict
clinical benefit• Additional studies must be completed to confirm the
clinical benefit of the drug
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
FDA and Diagnostic Tests• FDA has proposed a plan for regulatory review of tests that
are used to diagnose disease or guide treatment• Plan is a reversal of long-standing FDA practice of
forgoing review of certain diagnostic tests• FDA is acting to provide greater assurances about the
reliability and utility of tests that diagnose cancer and other diseases and that guide treatment• New plan is risk-based; some tests would be subject to
minimal review and others to more aggressive review• Regulatory plan will be phased in over years• Plan is not final but is open for public comment
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Expanded Access and Compassionate Use
• Expanded Access and Compassionate Use:• Means of providing patients access to investigational, or
unapproved, therapies• Require the engagement of treating physician, FDA, and
the company developing the new drug• Manufacturers may decline to provide compassionate
access for a number of reasons• Decisions related to expanded access and
compassionate use require a difficult balancing of the needs of the individual and the interests of the community for completion of clinical trials and approval of new drugs
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Discussion Questions•Are changes in the compassionate use and expanded access standards necessary to improve responsible access to unapproved therapies for cancer patients?
•Should incentives be provided to or requirements imposed on drug manufacturers to enhance patient access to unapproved therapies?
Opportunities for Reforming Cancer
Care Delivery Shelley Fuld Nasso
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
IOM: Cancer Care in Crisis• IOM concluded in 2013 that cancer care is not
adequately:oPatient-centeredoAccessibleoCoordinatedo Evidence-based
• The strains in the system are exacerbated by:oAging populationoRising cost of cancer careoComplexity of cancer careoReliance on family caregivers
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Current State of Cancer Care• Buy and Bill system and the “business” of medicine
oManaging inventoryoUsing profit margin to fund other services to patients
• Silos that systematically prevent coordination of care• Payment reform models will allow practices to
innovate without reliance on volume• Patients/survivors/advocates need to be at the
table when discussing care delivery improvements
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Delivery & payment reforms essential to quality improvement• NCCS considers changing the conversation
between doctor and patient as the essential foundation of delivery reform• Payment reforms must be aligned to improve
communication, treatment decision-making, symptom management, and coordination of care
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
NCCS Principles for Patient-Centered Payment Reform• Reward quality of services, not just
quantity• Require shared decision-making and a
cancer care planning process, including advance care planning• Promote evidence-based care by
encouraging adherence to guidelines, quality measures, and standards of care• Include consideration of clinical trial
options, where appropriate, in the care planning discussion
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
• Communicate patient cost-sharing responsibilities as part of the care planning process• Include protections against underutilization or
overutilization • Incorporate outcome, process, and patient-
reported outcome measures, developed with input from patients• Ensure that therapeutic innovations will be
rapidly incorporated into the standard of care• Reimburse for coordination of care, from
screening through survivorship
NCCS Principles for Patient-Centered Payment Reform
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Discussion Questions• How would you change the way the cancer care
team interacts with patients? • Can you provide advice about how office visits
might be changed? • How chemotherapy administration might be
changed? • How cancer treatment side effects are
communicated?
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Current Experiments in New Payment
ModelsElizabeth Goss
Efforts to Improve Cancer Care• General movement away from volume-based care and
payment• Emphasis on care planning and coordination• Reliance on practice guidelines• Changes in the processes of care to enhance patient-
centeredness (shared decision-making, 24-hour clinical response, prevention of emergency department visits and inpatient admissions)• Performance-based payments for providers• Quality measures to assess care delivery and patient
outcomes
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Incentives and Pressures for Change• Practices undertaking reform on their own
oPatient-centered oncology medical home• Professional societies identifying strategies for reform
oEpisodes of care• CMS Innovation Center has designed a Medicare episode-of-care plan that retains fee-for-service
and incorporates payments for practice transformationoVoluntary for private payersoVoluntary for physicians
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Discussion Questions• Does the movement away from volume-based care result in
less care? Does this change affect quality of care?• Are new payment reform systems consistent with the effort
to provide personalized cancer care?• What level of transparency is necessary in payment reform
efforts? oDisclosure of the payment reform effort? Disclosure of
performance-based payments?oDisclosure of how the new payment system affects
patient costs?
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Measurement of Quality to Protect
PatientsShelley Fuld Nasso
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Measurement of Quality to Protect Patients
• Quality is the right care, at the right time, for the right reason• Quality varies and is inadequate within our own system, by provider,
state and region• Measurement is a way to evaluate and improve care provided by
hospitals, doctors, health plans and other health care entities based on accepted national guidelines or evidence
• Types of measures: process, outcome, patient experience, structural• Measures for cancer should be
o Understandable, meaningful, and usable by consumerso Outcomes-focusedo Based on patient and/or family/caregiver-generated health data
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
• Symptoms, quality of life and functional status• Choose based on value/meaning to patient• Standardize methodology, demonstrate
reproducibility, gather benchmark standards• Examples-
oPainoNauseaoSatisfaction with healthcare providers
Patient Reported Outcomes
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Discussion Questions• Are current quality assessment measures adequate to
assess care and protect patients?• What information is meaningful to patients in assessing the
quality of cancer care delivered?oProcesses of careo Experience of careoOutcomes – survival, quality of life
• What information should be measured and publicly reported to help patients in choosing providers and hospitals for their cancer care?
©2014 National Coalition for Cancer Survivorship. All Rights Reserved.
Next Steps
Thank You