Access, Reimbursement, and Provider Perspectives in Immuno ... · Educational Objectives of This Webinar Develop a greater understanding of the evolution of immuno-oncology (I-O)

Access, Reimbursement, and Provider Perspectives in Immuno-Oncology

April 25, 2018

Confidential Property of Promidian Consulting © 2018 2

Educational Objectives of This Webinar

Develop a greater understanding of the evolution of immuno-oncology (I-O) and the role I-O plays in the commercial oncology landscape today

Appreciate the clinical development of I-O to date, the strong efficacy demonstrated, and the challenges to providers that remain

View I-O and the reimbursement environment from a payer’s perspective, including the challenge that any new cancer drug brings to insurance companies

We want today’s webinar to be interactive


Our Faculty

Michael Bishop, MDProfessor of MedicineDirector, Hematopoietic Stem Cell Transplantation Program The University of Chicago Medicine

Jeff LiepmanExecutive Vice President Promidian

Dr. X, MD*Medical Director Large Health Insurance Company

*Panel member wishes to remain anonymous.

Don SharpePresident

OBR

Immuno-Oncology Landscape and TrendsJeff Liepman, Executive Vice President, Promidian

April 25, 2018


Objectives of the SessionObjectives of the Session

Confirm the emergence of I-O as a unique, powerful treatment option

Explore a case study of chimeric antigen receptor T-cell (CAR-T)therapy, the latest addition to I-O

Define opportunities and challenges of the rapidly evolving I-O landscape


Emergence of Immuno-Oncology

Over the last 20 years, immuno-oncology emerged as a promising option in cancer treatment, with many more exciting advances on the way.

2000 2020

I-O

Ap

pro

vals

Time

Immuno-Oncology is at an Inflection Point of Innovation

Today

Provenge

Yervoy

Gazyva

Blincyto

Opdivo

Keytruda

Darzalex

Unituxin

Imlygic

Empliciti

Tecentriq

Kymriah

Yescarta

Imfinzi

2010

Pre I-O(Pre-2009)

I-O Infancy(2009-2018)

I-O Acceleration(2018+)

open clinical trials in I-O

2,000

companies working on cell therapies 40

Illustrative


How Immuno-Oncology Is Different

Immuno-oncology products leverage the body’s own immune system to fight cancer; these therapies offer a number of unique benefits but also present some challenges.

Leverages Immune SystemReduced risk compared to other therapies, such as chemotherapy or radiology

EfficacyImproved response rates, overall survival and durable responses

Upside of I-O Complexities with I-O

One and doneCurative aspect to CAR-T therapy and other I-Os

Unique logisticsExtended manufacturing, delayed reimbursement

Immuno-toxicities Careful AE management required (i.e., cytokine release syndrome)

High costs Expensive therapies, ancillary healthcare expenditures


CAR-T Case Study: Initial Observations

FDA approved the first two CAR-T therapies in 2017.

(Novartis) (Kite/Gilead)

IndicationAcute lymphoblastic

leukemia (ALL)Relapsed refractory large B-

cell lymphoma (NHL)

Efficacy ORR 82.5%, CR 63% ORR 72%, CR 51%

Manufacture Time 21 days 17 days

Price$475K outcomes-based

indication specific$373K per use withoutperformance measures

DistributionDistribution centers next to airports to expedite shipping;

controlled launch to select number of centers

Availability* ~40 sites and counting~39 sites and counting, with plans for community setting

COE = center of excellence; CR = complete response; ORR = overall response rate*Number of CAR-T-certified centers was obtained from Kymriah and Yescarta websites accessed on April 22, 2018.


Limited number of capable “COEs”

Patients are too sick to travel

Patient coinsurance burden

CAR-T Case Study: Uptake of CAR-Ts

Roughly 60 sites of care around the US are certified to administer Kymriah and/or Yescarta.

*Number of CAR-T-certified centers was obtained from Kymriah and Yescarta websites accessed on April 22, 2018. Map was created using easymap.com.

Kymriah and Yescarta Commercial Sites*

Factors Limiting the Number of Patients Treated

Reimbursement and administration delays

Waiting lists at some “high volume” sites

Other therapies readily available


Reimbursement guidelines and support tools

Technology-enabled reimbursement hub

Preemptive engagement, messaging, and shared learnings

Command-center hub and patient operations support (field-based)

Field tools and services to offer “white glove” service

Product-specific scenario planning

Early education and engagement with new prescribers

Case studies and “dry run” experiences with key customers

Customer coordination and AE protocol support

Creative vendor support (i.e., digital, patient support)

Customer profiling and engagement strategy

Onboarding support tools

Early/proactive onboarding interactions and management

Customer mapping, segmentation, and strategy

Differentiation strategy, messaging, and tactics

Addressing Cell Therapy Nuances

Nascent Technology Differentiation

Protracted Onboarding of Treatment Sites

Considerable Adverse Event (AE) Management

Requirements

Enthused Yet Naïve Adopters

Unprecedented Manufacturer-to-Patient

Logistics

Case-Based Reimbursement


What Is Coming Next

The I-O landscape will continue to evolve, while challenging the healthcare ecosystem to keep up.

Therapeutic Advances

Payment Model Evolution

Permeating Data Analytics

Patient Involvement

Identifying ways to differentiate products Helping establish standardized data-driven protocols

that show benefit within specified patient groups

EXPECTED CHANGE POTENTIAL MANUFACTURER PLAYS

Forming early partnerships with public and private payers to establish mutually beneficial terms

Constantly evaluating payment model options

Taking on data analytics initiatives large enough to drive meaningful change, yet not so large as to create organizational or data “paralysis”

Developing patient portals/services that can assist all parties with decision-making and management of therapy (i.e., apps, communities, other tools)

Provider Perspectives in Immuno-OncologyDr. Michael Bishop, Professor of MedicineDirector, Hematopoietic Stem Cell Transplantation Program The University of Chicago Medicine

April 25, 2018

We are unable to share Dr. Bishop’s slides(they have been removed from this presentation).

Access and Reimbursement Perspectives in Immuno-OncologyDr. X, Medical Director, National Health Insurance Co.

April 25, 2018


Cancer immunotherapies show promise, but the jury is still out.

The cost of I-O therapy is and will continue to be high, and payers are still working to best manage it.

The reimbursement environment will likely get more restrictive—and more creative—and that has implications for drug manufacturers.

Key Points for Today’s Discussion

1

2

3


Cancer Immunotherapies Promising But Not Yet Perfect

Immuno-oncology is still in its infancy.

Clinical trial data shows great promise (e.g., CAR-T therapies), but the benefits have not yet been broadly realized.

Trial data is on a relatively small scale, with few patients.

Long-term data is limited, (i.e., the first patient treated with CAR-T therapy is <6 years out).

Data is very limited regarding long-term survival and quality-of-life endpoints.

The curative impact has not been demonstrated on a large scale.

This makes it difficult for payers to determine the true value of these therapies… at least for now.

1


Cost-Related Challenges, Payer Considerations2

I-O therapies are costly.

Novartis’s Kymriah and Kit/Gilead’s Yescarta are $475,000 and $373,000,* respectively

Some therapies—like CAR-T—involve additional healthcare expenditures, resulting in a total cost outlay of two to three times the product’s WAC.

In-patient hospital stays

Treatment logistics

Associated chemotherapies

Co-morbid conditions, toxicity, and side-effect management

I-O therapies present a new economic model that the healthcare system has not fully figured out.

Costs

Challenges in determining value (lack of robust data)

New coding considerations

The complexity of the space is likely to continue, as the pipeline is robust.

Approximately 600 gene therapies for cancer in pharma pipelines

Approximately 40 companies working on CAR-T therapies alone

*WAC, per treatment


The Reimbursement Environment and Its Implications

Most I-O therapies have coverage, but access has been problematic in some cases.

Waiting lists at key treatment centers (e.g., Mayo, MD Anderson), but Centers of Excellence are key to getting better post-release data and ongoing studies

Treatment delays based on case-by-case reimbursement issues

Different reimbursement approaches will be needed, and we are beginning to see some clarity emerge regarding direction.

Novartis’s outcomes-based contracting for Kymriah

CMS decision regarding outpatient reimbursement rate for Yescarta

As the market grows, payers are likely to become more restrictive, but there is also room for innovation and creativity.

Outcomes-based and risk-sharing agreements

Installment payment plans

Creative financing approaches

Conditional coverage initially, requiring post-marketing assessments

Federal program?

Other ideas?

3


Consider and engage payer perspectives early, as payers are increasingly requesting payer-relevant endpoints in early trials

Follow-up long term: gather and report data on long-term survival

Develop data on disease burden to make clearer economic arguments

Gather data to better identify the patients and sub-populations most likely to benefit

Engage with the treatment centers early and effectively

Develop better drugs! (P.S., it does not have to be a cure!)

Parting Thoughts for Biopharma Companies

Payers must be able to compare efficacy with standard(s) of care to determine value and reimburse effectively. Data with many newly launched therapies is not yet robust enough to do that.


Conclusion

Thank you to our generous sponsor:

Jeff Liepman, Executive Vice President

C: 908-334-2087E: [email protected]

This webinar has been archived on the OBR website (www.obroncology.com)

Documents

Access, Reimbursement, and Provider Perspectives in Immuno ... · Educational Objectives of This Webinar Develop a greater understanding of the evolution of immuno-oncology (I-O)