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Revisiting Biosimilars and Molecular Testing in Oncology

Jake B. Guinto, PhD, Manager Oncology Drugs & Biologics

Three NCCN Trends™ Kiosk surveys were conducted at the NCCN 18th Annual Conference: Advancing the Standard of Cancer Care™. This is the first of three installments of results, which will be featured in NCCN eBulletin. This issue highlights data from the first NCCN Trends™ Kiosk survey on Biosimilars and Molecular Testing. Summaries of the 2nd and 3rd NCCN Trends™ Kiosk surveys will be shared in the April 8, 2013 NCCN eBulletin. NCCN Trends™ Kiosk surveys are designed to keep readers informed of the patterns of oncology care, treatment preferences, and other key topics pertinent to oncology stakeholders.

In April 2011, the National Comprehensive Cancer Network® (NCCN®) hosted an invitation-only policy summit, NCCN Oncology Policy Summit: Biosimilars – Regulatory, Scientific, and Patient Safety Perspectives. The policy summit provided a forum to discuss issues surrounding biosimilars and culminated in a white paper titled, "NCCN Biosimilars White Paper: Regulatory, Scientific, and Patient Safety Perspectives," which was published as a JNCCN – Journal of the National Comprehensive Cancer Network supplement in September 2011. Later that year, in July, NCCN held a policy summit on the topic of molecular testing, NCCN Oncology Policy Summit: Molecular Testing - Effectiveness, Efficiency, and Reimbursement. The result was the publication of a white paper titled, "NCCN Molecular Testing White Paper: Effectiveness, Efficiency, and Reimbursement," as a JNCCN – Journal of the National Comprehensive Cancer Network supplement in December 2011. Both of these summits examined their respective topics from clinical, scientific, and coverage policy standpoints.

Both biosimilars and molecular testing continue to be significant considerations in oncology care today. Therefore, to gain a better understanding of the current state of biosimilars and molecular testing, NCCN conducted an on-site NCCN Trends™ survey at the NCCN 18th Annual Conference in Hollywood, FL from March 13 – 15, 2013. The survey respondents included a mix of oncology stakeholders (e.g. physicians, nurses, pharmacists, and others [n=74]) and focused on the familiarity of developments surrounding biosimilars and the frequency of molecular testing in oncology, among other topics.

A previous NCCN Trends™ survey conducted at the NCCN 16th Annual Conference suggested that the familiarity of developments pertaining to biosimilars is low (NCCN eBulletin, April 18, 2011, "Biosimilars: More Education is Needed"). To determine whether this trend remains, NCCN asked participants to rate their familiarity with developments for biosimilars, including recent legislation that provides an approval pathway for non-innovator (e.g. "generic") manufacturers to introduce copies of biologics through an abbreviated review process.

According to the results, familiarity with developments for biosimilars remains low. As shown in Figure 1, the majority of respondents (72 percent) were either 'Not at all familiar' to 'Slightly familiar' with developments for biosimilars. Fifteen percent of the respondents were 'Somewhat familiar', with only 14 percent of respondents being 'Moderately familiar' to 'Extremely familiar.'

On the topic of molecular testing, a previous NCCN Trends™ survey conducted in March 2012 suggested that challenges still remain in the integration of molecular testing in oncology (NCCN eBulletin, February 11, 2013, "NCCN Trends™: An Evaluation of the Use of Companion Diagnostic Testing and Targeted Therapies"). To assess molecular testing use, NCCN asked participants how often they utilized a molecular test available with an oncology agent before prescribing therapy to patients. According to the results, 65 percent of the respondents 'Often' to 'Always' utilize a molecular test that is available with an oncology agent. Twenty-two percent of the respondents 'Sometimes' utilize a molecular test, with 13 percent 'Seldom' to 'Never' utilizing a molecular test with an available oncology agent.

In summary, the familiarity of the developments for biosimilars remains low, with 72 percent 'Not at all familiar' to 'Slightly familiar' with biosimilar developments. Since biosimilars will affect the treatment patterns of biologics used to treat patients with cancer, it would behoove oncology stakeholders to gain a greater understanding of the latest policies relating to biosimilar development. As for molecular testing, although the survey represented a small sample size, results may suggest integration of molecular testing among the practices of oncology stakeholders; however, there is still room for improvement.

In April 2013, NCCN will hold the invitation-only policy summit, Evolving Policy Issues in Oncology – Revisiting Biosimilars and Molecular Testing, to examine how the landscape on biosimilars and molecular testing has changed since 2011. The Summit will bring together patients, providers, policy-makers, industry, payers, government, and other stakeholders for an in-depth discussion about biosimilars and molecular testing, review the newest guidance documents and regulatory requirements, examine payer viewpoints and practices, and discuss the future of these important topics.

NCCN Trends™ is a survey-based analytics tool from NCCN that focuses on how clinicians in the United States and abroad deliver cancer care. NCCN Trends™ surveys pose questions regarding topics including, but not limited to, patterns of care, and awareness and utilization of various treatment modalities, as well as key topics impacting oncology stakeholders.

Data is gathered through brief electronic surveys to more than 200,000 health care providers who access the NCCN website on a frequent basis and express interest in responding to NCCN Trends™ Surveys. These clinicians consist of practicing physicians in diverse practice settings, including academic/research cancer centers, community hospitals, and private practices. Survey participants also include pharmacists, nurses, and other oncology stakeholders.

To learn more about NCCN Trends™ Surveys and Data, to commission a survey, or to discuss a customized survey, please contact Jake B.Guinto, PhD, Manager, Oncology Drugs & Biologics.