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In Multiple Myeloma, Janssen’s Darzalex Posted Significant Gains Over the Past Six Months, but May Face an Increasingly Restrictive Payer Environment

According to a new report from Spherix Global Insights, provider reimbursement anxiety and escalating out-of-pocket costs, as patients live longer and use these therapies for even more extended periods of time, are primary issues that could become barriers to increased use of Darzalex, although future projections still look strong.

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Exton, PA. October 31, 2018 / PRNewswire / – In a recent survey of 103 oncologists and hematologists, Spherix Global Insights, an independent market analytics firm, found that payers may be playing an increasing role in therapy sequencing in multiple myeloma (MM). 40% of the surveyed respondents report that payers have a high degree of influence in determining which brands are prescribed, and one-fifth report that MM is a more restrictive segment than other areas of oncology. Alarmingly, this group also reports that 16% of their MM patients are not receiving optimal treatment due to restrictive managed care policies, but in many cases the denials and restrictions are related to physician’s requests to prescribe off-label regimens. When it comes to specific brands, Janssen’s Darzalex and Takeda’s Ninlaro are associated with the highest degree of payer scrutiny.

Despite potential payer pressure, 50% of the surveyed oncologists/hematologists report a recent increase in their use of Darzalex, which corresponded to a significant increase in the overall number of patients being treated with the drug compared to the previous wave of research, which was conducted six months prior. Importantly, respondents expect this trend to continue in the near term, largely due to use of Darzalex in earlier lines of therapy. 17% of the respondents reported increased use of BMS’ Empliciti in the past three months, and while there was not a significant shift in patient share over the past six months, oncologists/hematologists indicate that there is a sizeable runway for Empliciti with a maximum peak share nearly four times as high as current use. To achieve this, or to move closer to its potential, BMS will have to overcome physician perceptions about a lack of robust clinical data and uncertainty where Empliciti fits in the growing field of agents used for relapsed/refractory MM. Some relief might be on the way with the FDA’s pending sBLA approval (granted a priority review with an action date of December 27, 2018) for Empliciti in combination with pomalidomide and dexamethasone for patients with relapsed/refractory MM who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

The Spherix study further explored comparative patient profiles for leading brands – looking at age, line of therapy, transplant eligibility, risk stratification, other agents in the regimen, managed care influence, and the treatment approach that would have been taken had the brand not been available. In addition, barriers to each brand were analyzed to shed light on those concerns that are more easily resolved (lack of familiarity, positioning) and those that may be more difficult to overcome (safety and tolerability concerns, overall clinical profile, preference for mode of administration). Overall satisfaction was significantly higher for Celgene’s Revlimid, Takeda’s Velcade, and Darzalex compared to Amgen’s Kyprolis, Celgene’s Pomalyst, Novartis’ Farydak, Empliciti, Ninlaro, and generic bortezomib.

Familiarity with pipeline agents increased overall compared to the prior wave, with the highest familiarity associated with agents already commercially available in other indications such as AbbVie/Genentech’s Venclexta and BMS’ Opdivo. Close to one-third of the respondents report high familiarity with Karyopharm’s selinexor, with 38% calling this agent an extremely appealing new treatment option. Karyopharm Therapeutics recently announced that the FDA has accepted filing with Priority Review and assigned an action date of April 6, 2019 for its NDA seeking accelerated approval for selinexor as a new treatment for patients with penta-refractory MM. Respondents reported in Spherix’s first national survey conducted earlier this year that penta-refractory patients presented the most difficult clinical challenge and highest unmet need of any setting in MM. Upon approval, robust adoption and use is expected. Upcoming surveys will provide deeper insight into development of selinexor and other pipeline agents.

Of course, CAR T-cell therapy has been surrounded by a buzz, but surveyed respondents are largely divided regarding the risk-benefit profile and the cost-effectiveness of these agents in MM. Amgen recently presented interim results from a Phase I/II study for AMG 420 in R/R MM showing a 100% complete response rate in five patients, which compares favorably to other BCMA-targeting therapies including the B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor T-cell (CAR-T) gene therapy bb2121 from Celgene. The development of AMG 420 adds yet another contender into the field of immunotherapy for treating the disease. RealTime Dynamix™ will continue to track and report on hematologist/oncologist attitudes and opinions of this potentially ground-breaking new therapeutic approach.

About RealTime Dynamix™
RealTime Dynamix™: Multiple Myeloma (US) is an on-going independent report series tracking the evolution of this dynamic market. The next wave of the study will be published in Q1 2019. For more information about our coverage of the multiple myeloma market or how to subscribe, contact

About Spherix Global Insights
Spherix Global Insights is an independent business intelligence and market research company, specializing in renal, autoimmune, neurologic and rare disease markets. Our aim is to apply our commercial experience and unique relationships within core specialty markets to translate data into insight, enabling our clients to make smarter business decisions.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Lynn Price, Immunology Franchise Head

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