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CALL TO ACTION DURING THE ICER REVIEW

Sick.Cells, a non-profit organization, aims to empower the sickle cell disease (SCD) community by influencing policy makers and healthcare providers to improve treatment and care. Learn how you can participate in the ICER review and have your voice heard.

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CALL TO ACTION DURING THE ICER REVIEW

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  1. CALL TO ACTION DURING THE ICER REVIEW ELEVATING THE VOICES OF THE SICKLE CELL DISEASE COMMUNITY Updated: 9/3/2019

  2. WHO WE ARE • Sick Cells is a non-profit organization that seeks to elevate the voices of the sickle cell disease (SCD) community and their stories of resilience. • We work with fellow allies across the country to influence policy makers, educators, employers, healthcare administrators and healthcare providers to act to improve treatment and care for the SCD population.

  3. WHAT IS ICER? • ICER (the Institute for Clinical and Economic Review) is a • non-profit research organization. • ICER evaluates new, innovative drugs and reports on the • clinical and economic value of the drug. • By engaging stakeholders—patients, doctors, drug makers, insurers, and others — they aim “to seek better ways to help patients gain sustainable access to high-value care.” • More information about ICER can be found on their website. • Please note: Contributing information or advice to ICER is in no way an endorsement of their work.

  4. HOW DOES ICER DETERMINE “VALUE”? • Using health economics, ICER determines the value and effectiveness of a drug by answering these questions: • How well does the drug work? • How much better is than what we already have on the market? • How much could it save us? • How much could it cost to treat everyone that needs it? • Each ICER report includes information on the patient experience and patient views to broaden the understanding of the value of the drug and help compare the risks and benefits of the drug to other care options.

  5. WHY IS THIS IMPORTANT FOR SCD? • Thanks to years of advocacy, funding, and research, the landscape for SCD is rapidly changing. Innovation is bringing new options for SCD: • Novartis’ crizanlizumab is currently being review by the FDA under priority status. • GBT’s voxelotor is expected to be submitted to the FDA by the end of the year. • As new therapies emerge into the market place, price, access, and coveragebecome important. Often these decisions are made without the involvement of patients and families.

  6. WHY IS THIS IMPORTANT FOR SCD? (cont.) • On Friday, August 9, ICER announced they will be evaluating crizanlizumab (Novartis) and voxelotor (Global Blood Therapeutics) for the treatment of sickle cell disease. • With guidance from stakeholders — including patients, advocacy groups, and clinical experts— ICER will be calculating a price for these drugs that reflects the degree of improvement expected in long-term patient outcomes. • US insurance companies can use ICER’s reviews and outputs to make decisions on whether they will fund the new drugs. • This is the first time ICER will conduct an assessment of a treatment for sickle cell disease.

  7. HOW CAN YOU PARTICIPATE IN THE ICER REVIEW? • The ICER report development will take appx. 8 months • During the report development, the community will have the opportunity to: • Give input about SCD from the patient, caregiver, and clinician perspective • Make comments on the draft documents • Register to make oral comments at the meeting • Attend the public meeting

  8. Evidence Review & Analysis Finalize Meeting Materials Scoping Document Public Meeting Final Report ICER’S TIMELINE FOR SCD REVIEW Release Date: 3/12/20 Release Date: 4/16/20 Meeting Date: 3/26/20 Public Comment: 1/22/20 - 2/19/20 Public Comment: 8/30/19 - 9/20/19

  9. Scoping Document Evidence Review & Analysis Finalize Meeting Materials Public Meeting Final Report ICER’S TIMELINE FOR SCD REVIEW • Public Comment on Scoping Document: • Aug 30th – Sept 20th • The Draft Scoping Document provides an overview of the population, interventions, comparators, outcomes, timeframe, and setting of care that will be included in ICER’s assessment. • The Draft Scoping Document will be posted for public comment for three weeks, during which anyone can comment on the proposed scope to help ensure that the report is most relevant to the community.

  10. Evidence Review & Analysis Finalize Meeting Materials Scoping Document Public Meeting Final Report ICER’S TIMELINE FOR SCD REVIEW • Public Comment on Draft Evidence Report & Voting Questions: • Jan 22nd – Feb 19th • The Draft Evidence Reports shows ICER’s assessment of the effectiveness and value of each therapy included in their review. ICER will also post the discussion questions to be used during the public meeting. • These will be posted for public comment for four weeks.

  11. Finalize Meeting Materials Evidence Review & Analysis Scoping Document Public Meeting Final Report ICER’S TIMELINE FOR SCD REVIEW • Evidence Report and Responses to Public Comments: • March 12, 2020 • The Evidence Reports and Responses to Public Comments will be published on their website. These will detail any changes that were made in response to the public comments. • The Meeting Agenda will also be posted in March, in preparation for the public meeting.

  12. Evidence Review & Analysis Finalize Meeting Materials Public Meeting Scoping Document Final Report ICER’S TIMELINE FOR SCD REVIEW • Oral Comments at the Public Meeting: • March 26th, 2020 • ICER will present the Final Evidence Report to a non-governing advisory board composed of provider groups, public and private payers, patient groups, and purchasers. • Patients and community members are invited to speak at the public meeting. Those wishing to speak at the meeting must contact ICER via email during the public comment section and provide the name, title, and organization of the speaker.

  13. Evidence Review & Analysis Finalize Meeting Materials Final Report Scoping Document Public Meeting ICER’S TIMELINE FOR SCD REVIEW • Oral Comments at the Public Meeting: • April 16th, 2020 • Final Evidence Report and Meeting Summary will be published to ICER’s website. • These are the final materials that will be utilized by payers and other stakeholders.

  14. ICER’S DRAFT SCOPING DOCUMENT • Go to https://icer-review.org/topic/sickle-cell-disease/ • Review the “Sickle Cell Disease: Draft Scoping Document”

  15. GET INVOLVED! Ensure your voice is heard during the ICER review! Join Sick Cells to help engage with ICER and ensure the communities voice is heard: Comment on ICER’s Draft Scoping Document. Public comments are due by September 20th! Fill out Sick Cell’s “Input for ICER” Survey. Sick Cells is collect patient, family, and clinician input that can be utilized by ICER during their value assessment. Please fill out our survey! Email us at mjalowsky@sickcells.org. Sick Cells will be sharing resources and updates along the way. Stay connected with us!

  16. QUESTIONS? Ashley Valentine CEO, Sick Cells avalentine@sickcells.org Maggie Jalowsky Program Manager, Sick Cells mjalowsky@sickcells.org Adrienne Shapiro Board Member, Sick Cells adrienne@axisadvocacy.org

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