California

Roundtable

Convening leading members of the oncology community in California to discuss precision medicine and identify proposed policy solutions to improve outcomes for people with cancer.

24 attendees, including multiple cancer advocacy organizations, oncologists, legislators, researchers, patient advocates, biotechnology experts and science officers, and two representatives from the Personalized Medicine Coalition gathered at the California State Capitol to consider whether advances in precision medicine are supported by current policies.

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PRECISION MEDICINE ROUNDTABLES

Topics

The discussion focused on barriers to precision medicine access in cancer care, emphasizing potential solutions and next steps across four key topics:

Bureaucracy
Clinical
Reimbursement
Technology

Bureaucracy

Barrier:

  • Lack of new authorization requirements may limit testing access, particularly with BRCA testing where stringent requirements for hereditary testing may be mistakenly implemented for those only requiring the BRCA companion diagnostic. Lifetime limits on genetic tests may prevent a patient who has previously received germline BRCA testing to be re-tested for a somatic mutation.

Policy Solution:

  • Eliminate lifetime and annual limits on testing
  • Allow pathologists greater latitude with ordering life-saving tests
  • Eliminate test redundancy by improving data collection and linking tests
  • Implement parity in screening and testing for men and women
  • Standardize full multiple gene testing

Clinical

Barrier:

  • Precision medicines are quickly being approved, challenging health professionals to stay abreast of new treatments and testing requirements to improve treatment decisions.

Policy Solution:

  • Set standards for continuing medical education
  • Embrace next generation sequencing, and test as much up front
  • Improve health education quality and access
  • Strengthen the pipeline of future practitioners via early access to STEM education – particularly in underserved communities – and make medical school more affordable
  • Involve college administrators to upscale curriculums to serve emerging technology
  • Address shortage of genetic counselors

Reimbursement

Barrier:

  • High standards for demonstrating clinical and economic utility can pose coverage and payment challenges for treatment informed by novel diagnostics.

Policy Solution:

  • Streamline and standardize prior authorization
  • Standardize prior authorization forms
  • Standardize comprehensive, cost-effective early testing
  • Align health policy to screening quality measures

Technology

Barrier:

  • Laboratories are increasingly outsourcing testing to reduce investments in new platforms and expertise, which complicate turnaround time, sample collection and shipping.

Policy Solution:

  • Allow pathologists to order tests vs waiting for authorization by oncologists
  • Establish registries to collect and analyze data to identify trends in precision medicine treatment
  • Give HCPs access to real-time and historical results to avoid repeat biopsies, costs and delays
  • Promote greater access to labs and hospitals where testing can occur
  • Incentivize FDA-approved tests instead of designated companion diagnostics

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