How COVID-19 Has Affected Launches of New Oncology Therapies in the U.S.

Ben Hohn, Judith Kulich, and Swarna Mehrotra co-authored this article with Matt Furlow.

Periodically, ZS assesses factors impacting oncology launches in the U.S. and globally. Biopharma companies anticipating launches of new oncology therapies over the course of 2020 can take learnings from launches that have occurred so far in 2020 and inform launch expectations and adaptations accordingly. Several months into the COVID-19 pandemic, we’ve taken a look back at how the pandemic has impacted launches of new oncology therapies (that is, new applications rather than supplementary applications), answering three critical questions along the way:

1. How has the pandemic impacted FDA approval timing relative to expectations (PDUFA dates)?

In short, it hasn’t, at least yet. The table below summarizes 2020 FDA approvals of new oncology therapies; no approvals have been delayed relative to expected PDUFA dates. In fact, the majority of approvals have been granted prior to expected PDUFA dates, in some cases coming even three to four months prior.

Click image to enlarge

On the surface, the fact that the FDA has consistently delivered decisions on time or prior to stated PDUFA dates during the pandemic could be surprising, considering the effort devoted to advising developers of potential COVID-19 treatments and vaccines as well as a shift to virtual modes of collaboration. However, the FDA Oncology Center of Excellence’s Richard Pazdur has firmly expressed the FDA’s commitment to cancer patients: “We’re here for you. We’re pushing this forward. We haven’t lost our momentum or our dedication to cancer patients." ¹ Innovative programs developed by the FDA like Real Time Oncology Review have also helped make review processes more efficient.

For new oncology therapies that are expecting decisions from the FDA in Q3 and Q4 of 2020, it is possible that delays due to COVID-19 may start to occur, especially if evaluation of submissions requires in-person visits to manufacturing sites outside of the U.S. (or other activities impacted by the pandemic). From what ZS has observed from approvals thus far in 2020, however, decisions regarding therapies addressing relapsed unresectable/metastatic and/or biomarker-directed indications likely will continue to come in advance of PDUFA dates. In contrast, cell and gene therapy submissions routed through CBER may see delays as effort is focused on SARS-CoV-2 vaccines.

2. How has the pandemic impacted launch timing following FDA approval and launch approaches?

While there have been notable examples of non-oncology U.S. launches delayed due to the COVID-19 pandemic such as Zeposia, Palforzia, Xiaflex and Ongentys, new oncology therapy launch timings have largely followed FDA approvals. For example, Eli Lilly launched Retevmo for RET+ NSCLC and thyroid cancer shortly after FDA approval with a virtual rollout while sales teams were grounded. When asked about the decision to launch, Anne White, president of Lilly Oncology, said: “Given the critical nature of the treatment, the company will launch the drug immediately despite the challenging commercial dynamics.” ² Based on ZS analysis, other 2020 new oncology therapy approvals have taken similarly urgent, virtual approaches. Sarclisa’s launch in multiple myeloma may be a slight exception ³, but Sarclisa’s HCP website does have functionality to request contact from a representative.

With the COVID-19 pandemic far from resolved in the U.S. and new hot spots emerging in specific geographies, new and ongoing oncology launches may require tailoring to needs and restrictions of specific geographies (even when considering virtual approaches). Esperion is one non-oncology example. The company trained its field team on digital tools and ways of marketing and reducing virtual calls in geographies more impacted by COVID-19.

3. How are biopharma companies that are launching new oncology therapies adapting launch strategy and tactics in light of COVID-19?

Both patient and provider preferences have evolved over the course of the COVID-19 pandemic.

Patient preferences:

• More comprehensive remote care: With a shift to telemedicine, there are potential gaps in education around diagnosis, treatment and compliance.
• More digital content and greater virtual engagement: Patients are seeking more than ever to educate themselves digitally and connect with other patients virtually.
• More engagement with patient support programs and a desire for assurance around access to treatment.

Provider preferences:

1. Personalized, 1:1 engagement through virtual channels with field representatives when face-to-face engagement is not permitted or feasible.
2. Digital content that addresses uncertainties associated with the COVID-19 pandemic. Continuity of drug supply and mitigation of clinical trial challenges are particular areas of concern.
3. Continued engagement with the treater community. Providers are using virtual formats like video conferencing, webinars and digital conferences to stay connected with peers.

ZS-commissioned research with patients and providers also suggests that a “return to normal” is not expected until Q2 2021 at the earliest, indicating that these preferences will persist for some time. Based on these evolving preferences and 2020 launches and with input from ZS practice leaders, we’ve identified three over-arching themes for adapting launch strategy and tactics for new oncology therapies:

1. Engaging with customers based on their specific preferences and meeting their tailored needs: For example, Seattle Genetics is emphasizing patient support by delivering Tukysa flexibly to patient-preferred locations by collaborating with specialty pharmacies. Seattle Genetics is also offering a dedicated nurse support service for patients through specialty pharmacies.
2. Transforming digital and virtual through omni-channel engagement: To support the launch of Tabrecta, Novartis beefed up its physician website so that “doctors will be able to get much more than they could typically get,” according to EVP of oncology Ameet Mallik.⁴ Eli Lilly Oncology (for Retevmo) and Incyte (for Pemazyre) are also supporting virtual peer-to-peer programs to facilitate oncologist engagement with thought leaders and encourage knowledge-sharing.
3. Adapting field teams to orchestrate personalized, cross-channel engagement: Biopharma companies like Deciphera are launching new oncology therapies to improve key go-to-market strategies and developing more remote detailing capabilities. Novartis has also given its sales associates real-time engagement tools and built additional digital portals to improve customer engagement.

From examining the new 2020 oncology therapy approvals and launches, the lessons are clear: Be prepared to act quickly, adapt to a virtual world and customize to the specific needs of patients and providers.

References

1. https://pink.pharmaintelligence.informa.com/PS142396/US-FDAs-Oncology-Center-In-The-Lockdown-Business-As-Usual
2. https://scrip.pharmaintelligence.informa.com/SC142192/Lilly-Moves-Ahead-With-Retevmo-Launch-In-A-Challenging-Environment
3. https://www.reuters.com/article/us-health-coronavirus-usa-pharmaceutical/new-drug-launches-stalled-by-covid-19-pandemic-idUSKBN2425I0
4. https://www.fiercepharma.com/marketing/novartis-leans-into-digital-for-mid-pandemic-lung-cancer-launch

Matt Furlow is a manager within ZS’s oncology vertical. Ben Hohn and Judith Kulich are principals at ZS and leaders of the Pipeline & Launch Strategy practice. Swarna Mehrotra is a ZS consultant.