Recent Label Revisions Related to Constipation and Hypertension Generate Minimal Drag on the Decision to Prescribe Amgen/Novartis' Aimovig as a Preventive Treatment for Migraine

EXTON, Pa., Aug. 18, 2020 /PRNewswire/ -- Distinctive prescribing patterns and drivers of brand selection among the subcutaneous (SC) calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) for the prevention of migraine have begun to emerge after two years of availability. First-to-market Amgen/Novartis' Aimovig remains the most frequently prescribed CGRP mAb, with recent label revisions related to constipation and hypertension having minimal impact on real world prescribing patterns. While Teva's Ajovy finally appears to be enjoying a commercially relevant lift thanks to the recent launch of its autoinjector device, Eli Lilly's Emgality now struggles to clearly stand out from the competition on the standard metrics – although its unique episodic cluster headache indication may offer a more persuasive point of differentiation.

Chart review data from 1,003 patients recently prescribed a new preventive therapy, specifically a CGRP mAb or AbbVie's Botox, provided by 230 migraine specialists and neurologists in Spherix's RealWorld Dynamix™: Preventive Treatment Switching in Migraine (US) service, indicate Emgality was losing out on more than half of its potential share to other preventive therapies – more so than Aimovig or Ajovy.  When Aimovig was selected over Emgality, less managed care hassle and expectations of greater efficacy were the most common reasons. Ajovy, on the other hand, was successful in stealing share from Emgality due to the availability of starter kits in physicians' offices and the Teva brand's unique quarterly dosing frequency. With audit data representing new prescription volume at the time of fielding, it is noteworthy that brand share in this patient segment suggests that Emgality's lead over Ajovy may be narrowing.

To remain competitive, Eli Lilly should continue to highlight Emgality's unique expanded label with indications for both the preventive treatment of migraine and the treatment of episodic cluster headache. Highlighting the impact of Lilly's clinical development program, physicians who agree that the cluster headache indication makes them more willing to prescribe Emgality for migraine prevention did indeed prescribe the brand to almost twice as many patients as did those physicians who disagree with the statement. A potential halo effect from the cluster headache indication may also be seen in the type of patient being prescribed Emgality, who tend to have longer migraine attacks, greater delay in return to normal function, and higher migraine-associated disability and impact scores, compared to competitors. However, there appears to be a disconnect between brand selection drivers and patient types, as patients who required a regimen change due to efficacy issues are actually significantly less likely to switch to Emgality compared to those who switched due to a non-efficacy reason.

While both Aimovig and Emgality initially launched with autoinjector devices, Ajovy was only available for administration with a prefilled syringe for the first two years postlaunch. As a result, patients who administered Ajovy on a quarterly interval needed to administer three consecutive injections. In late April, Teva launched their Ajovy autoinjector in an attempt to level the playing field – a tactic that appears to be already paying off. Among patients who were prescribed Ajovy in May/June, 60% and 80% of patients administering the once-monthly dose and the quarterly dose, respectively, had used the autoinjector. While Emgality's autoinjector (repurposed from Trulicity) had been a point of differentiation for the brand, it is noteworthy that preference for the Teva autoinjector was as influential as dosing frequency flexibility when Ajovy was selected over Emgality.

The FDA has twice revised the Aimovig label within the past year, adding Warning and Precaution sections related to the risk of severe constipation and worsening hypertension. Although physicians perceived tolerability concerns, specifically constipation, to be a frequent and distinctive reason for Aimovig discontinuations in Spherix's parallel RealTime Dynamix™: Migraine (US) quarterly report series, audit data show a very low overall discontinuation rate for Aimovig prior to the addition of the most recent preventive therapy. 

Among those who did discontinue Aimovig, tolerability and safety concerns actually drove fewer Aimovig discontinuations compared to Ajovy, Emgality, or even Botox. Indeed, expectation of a better tolerability profile was equally likely to play a role in selecting Aimovig over an SC CGRP mAb competitor and vice versa during the brand selection process. However, low safety risk, while infrequently cited, was slightly more associated with the selection of Emgality and Ajovy over alternative Aimovig. In the end, patients with comorbid gastrointestinal disease were significantly less likely to have been prescribed Aimovig, to the benefit of Ajovy and Lundbeck's Vyepti. Perceptions of tolerability and safety profile differentiation appear to have, with the exception of avoiding Aimovig in patients with relevant comorbidities, a minimal impact on clinical decisions.

About RealWorld Dynamix™
RealWorld Dynamix™ is an independent, data-driven service unmasking real patient management patterns through annual reports based on chart audits of ~1,000 patients. The report uncovers the "why" behind treatment decisions, includes year over year trending to quantify key aspects of market evolution, and integrates specialists' attitudinal & demographic data to highlight differences between stated and actual treatment patterns. The second annual audit of RealWorld Dynamix™: Preventive Treatment Switching in Migraine (US) published last week and the first annual audit of RealWorld Dynamix™: Acute Treatment Switching in Migraine (US) will publish in November.

About RealTime Dynamix™
RealTime Dynamix™: Migraine (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave. The 9^th wave of research will publish in September 2020.

About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

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

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Kristen Henn, Business Development Manager
Email: [email protected]
www.spherixglobalinsights.com

SOURCE Spherix Global Insights

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