cancer progress revisited: making sense and ct fioc b ... · evaluatepharma world preview 2017, ......

Cancer Progress Revisited: Making Sense and C t f IO C b d th i V lCents of IO Combos and their Value

• Moderators:– Joel S. Sandler, PhD, Associate

Principal, Defined Health– James T. Lee, PhD, Senior , ,

Consultant, Defined Health• Panelists:

– Roger Longman CEO RealRoger Longman, CEO, Real Endpoints

– Kapil Dhingra, MBBS, Founder & Managing Member KAPital& Managing Member, KAPital Consulting

Cancer Progress Webinar by Defined HealthJune 27, 2017

Cancer Progress and Companion Whitepaper Discussed the Evolving Role of IO Combinations and Their Value

• Among the many topics discussed at this year’s annual Cancer Progress meeting, perhaps the two most salient were emerging p p g gimmuno-oncology combination regimens and concerns about whether and how the market will bear their associated costs.

• It was clear that from a strategic standpointIt was clear that, from a strategic standpoint, large and small drug developers alike are looking to better understand how optimally to position their therapeutic candidates within this rapidly evolving landscapethis rapidly evolving landscape.


www.cancerprogressbydh.com/

Checkpoint Inhibitors Have Ushered in the Modern Age of Cancer Immunotherapy, With Near-Term Growth Driven Largely By CPIs

♦ Though efforts to unleash the human immune response against cancer have long been underway, it was only relatively recently, with the launch anti-PD1/L1 mAbs, that safe and effective modalities have been able to validate this protracted endeavor.

♦ Such immune checkpoint inhibitors (CPIs) have rapidly infiltrated multiple cancer settings and are projected to substantially grow the oncology market


p ojected to substa t a y g o t e o co ogy a etin short order.

EvaluatePharma, DH insight; *2012-2022

Next-Wave Combos Emerging as Therapeutic Strategies to Collectively Unleash the Immune Response for More Patients

• While numerous IO and non-IO modalities have and are continuing to emerge, one could argue that their

Potential Checkpoint Inhibitor Combinations

g , ggreatest potential ultimately resides in the context of combinations with immunotherapies, namely CPIs.

Surge of CPI Combination Studies in the Past 18 months


Immunity. 2013 Jul 25;39(1):1-10; Oncotarget. 2014, Dec 30;5(24):12472-50; Evaluate Pharma

Indeed, Pharma Has Been Pushing a Number of Competitor Programs Through the Clinic, Including Anti-PD1/L1 “Me-Toos”,

Novel Combos and Next-Gen ModalitiesNovel Combos, and Next-Gen Modalities


Adis R&D Insight, Thomson Reuters Cortellis; DH Analysis ; EvaluatePharma; NVS, Novartis; AZN, AstraZeneca/MedImmune; BMS, Bristol-Myers Squibb; ROC, Roche/Genentech; CELG, Celgene; JNJ, Johnson & Johnson; MRK, Merck & Co; PFE, Pfizer; AMG, Amgen; GSK, GlaxoSmithKline; MRK KGaA, Merck KGaA; SNY, Sanofi/Regeneron; LLY, Eli Lilly; TAK, Takeda; BAY, Bayer; ABV, Abbvie; *Agents may be double counted if they are being jointly developed by two large pharma companies †Celgene is collaborating with MedImmune (AZ) for development of durvalumab in heme malignancies **EU only

IO Pushing Oncology Way Out in Front vs. Other Therapeutic Areas, Both in Terms of Projected Market and Sales Growth

• A recent report from EvaluatePharma posits that oncology will remain the most dominant therapy segment in 2022 with an expected annual growth of 12.7% per year and sales reaching $192.2bn in 2022. Growth driven by CPIs, namely marketed anti-g $ y , yPD1/L 1 mAbs Keytruda, Opdivo, Tecentriq, Imfinzi, and others.


EvaluatePharma World Preview 2017, Outlook to 2022

However, With Such a Crowded Pipeline Comes the Expectation of Increased Returns Subsidized by an Already Overburdened

Customer BaseCustomer Base


Roche Presentation

Frameworks and Other Tools Arming Payers and End-Users With Unprecedented Level of Information and Leverage to Help Guide

Decision MakingDecision Making• An emerging practice to address premium pricing in the cancer arena is the shifting of

risk from payers to providers and even patients, who are at the same time being armed with so-called value framework models.

• These, along with additional instruments such as oncology care models, clinical pathways and bundled payments, are providing US payers with a new-found degree of leverage in pricing negotiations.

Value Framework (Organization)

Criteria

Scorecard (ASCO)

• Evaluates what the clinical benefit is using a scoring algorithm based on parameters such as clinical benefit, toxicity, tail of the survival curve, palliation, quality of life and treatment free interval Based on these criteria a net healthquality of life, and treatment-free interval. Based on these criteria, a net health benefit score is considered in relation to cost.

Evidence Blocks (NCCN) • This framework focuses on how expert clinicians rate a treatment’s value and it takes into account efficacy, safety, the quality and quantity of evidence.

Value Assessment • Considers the societal value of a therapy and this model mimics the NICE model Framework (ICER)

pywhich uses cost per QALY and at a certain threshold

DrugAbacus (Peter Bach, MSK)

• Considers dollars per life-year, toxicity discount, novelty, cost of development, rarity of the illness, population burden, unmet need and prognosis

RxScorecard ( )

• Tool to assess the value of marketed and pipeline drugs using a proprietary f


ASCO 2016 Annual Meeting, July 2016 Edition, Vol. 11, Issue 7; Value Tools at ASCO 2016: Building a Framework for Prime Time (Part 2)

(RealEndpoints) algorithm, in-depth analysis of publicly available data.

Pharma Responding to Health Economic Issues and Pushback Against High Drug Costs, but Will it be Enough?

• Though historically regarded as anathema, bold & proactive value-based approaches to pricing of newly-launched brands could afford competitive advantages to drug-makers.

• Indeed Pharma is kicking the tires on novel contracting schemes but how widely willIndeed, Pharma is kicking the tires on novel contracting schemes, but how widely will they be adopted, and will it be enough?


Avalere: Outcomes Based Contracting Presentation (2017); mmm-online.com

Some Questions to Get Us Started• What are some emerging themes in terms of competitive dynamics and

positioning strategy in this new post-PD1 world?

So e Quest o s to Get Us Sta ted

• How can drug developers be more proactive with regards to increasingly expensive IO combination regimens?

• Will the future landscape be characterized by incrementally-improved (and pricey) combos, or is there opportunity for a next wave of disruption? What level and forms of innovation is the market willing to bear?

– IO combos?

– CDx-guided IO?

– Targeted therapy?

Earl detection/inter ention?– Early detection/intervention?

… AND QUESTIONS FROM OUR VIRTUAL AUDIENCE ARE WELCOME


Cancer Progress Revisited: Making Sense and C t f IO C b d th i V lCents of IO Combos and their Value

• Moderators:– Joel S. Sandler, PhD, Associate

Principal, Defined Health– James T. Lee, PhD, Senior , ,

Consultant, Defined Health• Panelists:

– Roger Longman CEO RealRoger Longman, CEO, Real Endpoints

– Kapil Dhingra, MBBS, Founder & Managing Member KAPital& Managing Member, KAPital Consulting


cancer progress revisited: making sense and ct fioc b ... · evaluatepharma world preview 2017, ......

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