The challenges of last year tested all of us. Whether you were like me and adjusting to homeschooling your children while juggling a job that was no longer “nine to five” or deciding whether to go to your doctor’s office for an ailment other than COVID-19 symptoms, it was a tough year. It will take time from once we become vaccinated to get back to normal in a post-pandemic world.
Looking back, one of the positives of 2020 was the high-profile adoption and use of real-world data and evidence. Last year COVID-19 crippled the world rapidly, and healthcare professionals across the spectrum found themselves flying by the “seat-of-their-pants” to save lives. Clinical experiences immediately kicked in, and a community of peers sharing results across the globe were finding ways to treat symptoms and compress hospital stays. Each day the world learned more about this “novel” virus as we struggled to treat, contract trace, and contain it, and protect our loved ones and communities from further spread.
In June of last year, the U.S. Food and Drug Administration (FDA) announced its participation in the COVID-19 Diagnostics Evidence Accelerator. The multi-stakeholder collaborative project has a goal to advance the development of diagnostics in response to this public health emergency and to harness real-world data to help inform the agency’s pandemic response. We also saw real word data in big tech when Apple and Google joined together to enable COVID-19 contact tracing on your smartphone to help mitigate community spread.
Clinical evidence drove the exploration of using existing therapies in antivirals, cellular therapies, and immunotherapies – many of which remain active clinical trial candidates for COVID-19. Processes, treatment protocols, and most importantly, patient outcomes, have evolved significantly over time due to the sharing of real-world experiences.
So why does this matter? There are numerous missed opportunities for real-world data, evidence, and insights to drive improved healthcare outcomes. While this is broadly acknowledged, I would like to shine a light on the larger opportunity for us all.
As we’ve explored in previous blog posts, changes to cancer treatment regimens are driven by results from clinical trials, scholarly articles published in peer-reviewed journals, and ultimately approval from a regulatory body (e.g., FDA). With all these sources of insight, you might expect immediate adoption of new evidence-based medicine. Wrong.
For example, Bavencio® (Avelumab) from Pfizer and Merck KGaA is the first anti-PD-L1 in combination with Inlyta® (Axitinib) approved by FDA for first-line treatment of patients with advanced renal cell carcinoma (RCC). A phase III study showed combination significantly lowered the risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with Sutent® (Sunitinib Malate). The combination is approved based on phase III data in an overall population that included patients regardless of PD-L1 expression and across favorable, intermediate, and poor prognostic groups. There is valuable data backing up the clinical utility claims.
Despite this compelling clinical evidence, our view of covered lives through Eviti in 2020 shows that only 7% (20 of 286) of patients who receive Inlyta® for RCC also received Bavencio®. Why isn’t Bavencio® (Avelumab) being prescribed with Inlyta® (Axitinib) for these patients?
Is it a provider education opportunity? A payer authorization issue? Or an issue with drug pricing?
There are other examples. Take a look at Piqray® (Alpelisib) from Novartis. Approximately 40% of patients living with HR+/HER2- breast cancer have a PIK3CA mutation. PIK3CA mutations are associated with tumor growth, resistance to endocrine treatment, and a poor overall prognosis. Piqray® targets the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer. Progression-free survival nearly doubles in patients with PIK3CA mutation (SOLAR-1 study (5.7 mos. to 11 mos.)).
Despite this compelling clinical evidence, our view of covered lives through Eviti in 2020 shows that only 3% (51 of 1685) of patients who likely show this mutation receive Piqray®. If you follow the clinical evidence, the use of this drug should be much higher.
So, what do we take from this?
As we assess healthcare in the U.S., one that ranks 1st in spend but 27th in outcomes, we see yet another example of how data can drive positive outcomes for patients.
But here is the real question – is healthcare a right or a privilege?
Regardless of your view, meaningful adoption of real-world data and evidence has the ability to transform our industry, and NantHealth is here to help drive that change.