Challenges and Opportunities for Innovation and Partnerships in the Diagnostics Industry
In September 2014, CHI members Genomic Health, Roche, and Thermo Fisher Scientific sponsored CHI‘s 6th Annual Diagnostics Summit. The summit brought dozens of the bay area’s leading diagnostics companies together to discuss the regulatory climate affecting the industry. CHI is proud to present this blog post written by CHI member Genomic Health:
In mid-Sept., CHI brought together leaders in the diagnostics industry for a dynamic discussion during CHI’s 6th Annual Diagnostics Summit at Thermo Fisher Scientific. Genomic Health’s Chief Medical Officer, Phil Febbo, Senior Director of Government Affairs, Danielle Scelfo, and cancer survivor and patient advocate, Laurie Levin, were amongst a group of medical diagnostics experts and thought leaders at the meeting, discussing the latest technologies, such as next generation sequencing, and the importance of making these technologies available and accessible to patients.
Phil Febbo, M.D., shared a glimpse of potential developments in next generation sequencing (NGS), including the benefits and hurdles this complex technology faces when applied to the clinical and patient world. Genome sequencing has quickly advanced over the past decade, making current costs a fraction of what it was years ago ($10M to less than $10k in just 5 years) and allowing NGS to be a practical and feasible tool in analyzing the complexity of cancer.
There is no dispute that NGS is the sequencing tool of the future, but research is still needed to understand how to use this tool most efficiently and how having such large amounts of genetic data translates into clinically actionable information for the patient. Technologies today provide us with the key information to help refine and individualize therapy for a patient, and it will be very interesting and exciting to see how NGS can push our current knowledge and understanding of cancer to the next level.
Genomic analysis has enabled a deeper understanding of the underlying biology of tumors and has paved the way for the development of numerous tools to help us better identify which patients will have the best response to which therapies. Using genomic information, companies like Genomic Health improve the approach to cancer care, providing answers to not just how to treat a patient’s cancer, but also at what point in their care should those treatments be given.
Has this changed the way pharma approaches their research efforts?
Quite possibly. For the pharmaceutical industry, the cost of developing new and innovative therapies will continue to rise (the cost of developing a drug is now estimated to be between $1.5 billion to more than $1.8 billion), and payers are requiring more efficacy evidence and outcomes data before they are willing to reimburse for these medications. As a result, more companies are looking towards companion diagnostics as a way to help refine and enhance their research efforts earlier in development. As these collaborations become more common, what one could see is the evolution of a new niche space in this industry – companion therapeutics.
Nevertheless, as far as NGS has advanced, many questions still remain. For example, can anything be done with all the available information? And if so, how long will it take? How much will it cost? For whom?
As Danielle Scelfo explained, these are the questions on top of everyone’s mind. In our changing healthcare system, all payers – public, private and employer – need clinical and economic data to consider reimbursing for any service. However, a simple yes-no reimbursement answer is not the only issue the diagnostics industry must face, it’s also about having a conversation with payers to determine how much a test is actually worth. The cost of running NGS has dropped significantly over the past decade, but simply knowing a patient’s genome is very different from translating that information into something clinically actionable.
Being able to designate a value for diagnostic services has been a difficult and confusing process for payers and diagnostic companies alike. Because of these issues, the diagnostic industry is leading the charge to advocate for evidence- and value-based reimbursement, making commitments to data generation and publication-development and investing in data analytics to prove to payers the value of their technology and its impact on the patient. Genomic Health, for example, has been successful because they were able to answer the key questions for breast cancer patients and physicians, such as whether or not chemotherapy would be beneficial in a patient’s treatment plan. By addressing this unmet need in the cancer community, the company has been able to broadly commercialize and receive coverage for their breast and colon products, and they continue to advance its efforts to drive adoption and reimbursement of its prostate test by investing in decision impact and observational studies, as well as conducting clinical utility studies that highlight the value of their technology.
To conclude the day’s discussions, Laurie Levin, cancer survivor and advocate, spoke from the patient perspective, sharing her story and how diagnostics helped with her personal treatment decisions. At age 58, she was already a non-Hodgkin’s lymphoma survivor of 31 years. During a routine mammography, she received abnormal results and a biopsy later confirmed – breast cancer. She underwent radiation for the second time, had a lumpectomy, and started hormonal therapy, but chemotherapy was the big question. Given her age and having already received chemo for her lymphoma, she wanted to avoid additional chemo. Upon the suggestion of her doctor, Laurie had an Oncotype DX test to help determine the likely benefit of receiving chemotherapy. She was relieved when her Recurrence Score result of 17 indicated that she had a relatively low risk of her cancer returning. With these results and in close consultation with her oncologist, Laurie opted to forgo chemotherapy. “There are so few resources that can give you that degree of guidance, direction and information to make your treatment decisions,” Laurie said. “I felt like science was really taking care of me.”
Laurie’s story is just one example of how advances in diagnostics and technology are helping patients in new and invaluable ways, and this is only the beginning. As our science continues to excel, all healthcare stakeholders – researchers, manufacturers, physicians, payers, and most importantly patients – must partner together to ensure the technologies we develop can reach the patients that need it.