Mark Trusheim will lead the discussion "Could Gene Therapy Value-Based Purchasing Become Common Thanks to the New CMS Rule on Medicaid Best Price?" at ISPOR 2022 (May 15–18), featuring Michael Ciarametaro, Dorothy Hoffman, and Michael Sherman. Meeting registration is open now.
Kim Caldwell, Michael Ciarametaro, and Mark Trusheim hosted an education session titled "Gene Therapy Value-Based Purchasing and the Impact of Medicaid Best Price Changes" at AMCP ’22 Chicago on March 30.
Jane Barlow and Brendan Hayes participated in the Great Lakes Hemophilia Foundation's Comprehensive Gene Therapy Symposium on November 30.
Casey Quinn participated in the HTX Expert Forum on November 25.
Jane Barlow will join the Alliance for Innovation in Integrated Healthcare (AIIH) Summit in NYC: Impact of Cell and Gene Therapy panel on October 11. She will also join the AMCP Nexus 2021 in Denver, in a session "Addressing Gene Therapy Financial Challenges: A survey of emerging market solutions" with Michelle Harika on October 19.
Mark Trusheim participated in the Advanced Regenerative Manufacturing Institute fall meeting on October 7, presenting FoCUS's reimbursement research. On October 22 he participated in the McKinsey CGT Roundtable and the APEC Finance Ministers' Meeting on October 28.
Jane Barlow discussed FoCUS emerging market solutions research at the Huron Virtual Roundtable discussion "Unlocking the Full Potential of Outcomes Based Contracting Work for CGT: Collaborate or Compete?" on September 22.
Mark Trusheim participated in the ASCGT Policy Forum panel "The Status of Medicaid Coverage and Access for Gene and Cell Therapies" on September 22, and on September 28 he led the roundtable "Preparing for 2022 regulatory change and the performance-based contracting explosion" for the Reuters Cell and Gene Therapy USA meeting. On September 30 Mark spoke in the OHE Master Class Adaptive Pathways: Generating Evidence of Value.
Mark Trusheim participated in the World Orphan Drug Congress USA 2021 on August 25–27.
Mark Trusheim participated in the BCBSA 2021 Specialty Pharmacy Conference on July 20–21.
On April 12 Mark Trusheim led a workshop for ISPOR, entitled “Adaptive Reimbursement: Innovating for Patient Access and Better Outcomes for All”, including Angela Banks Vice President, External Affairs, UnitedHealth Group; Ron Potts, MD; Medical Director Quality Improvement Kaiser Permanente, Chief Medical Officer, INTERLINK; and David Strutton, PhD, VP, Global Pharmaceuticals & Policy Research, Center for Observational and Real-World Evidence, Merck & Co. Mark recaps the panel in this AJMC update.
Mark Trusheim spoke at the 2nd Annual Gene Therapy for Blood Disorders meeting on March 11, in a session called, “Evaluating Different Payment Models for Different Blood Indications.”
Mark Trusheim participated as a panelist in the BioNJ Cell & Gene Therapy Market Access Program on February 17, 2021. The program was recommended for legal, compliance and regulatory professionals within the pharma/biotech industry.
Mark Trusheim spoke at a California Life Sciences Association briefing on January 26. The briefing was well attended, and the audience included California state legislators.
On December 3 Jane Barlow moderated the panel "Reimbursement Models for Cell and Gene Therapies" at the 16th Annual Trade and Channel Strategies 2020 Innovative Pharmacy and Distribution Models Driven by Market Dynamics, Product Type, Site of Care and Reimbursement Virtual Event.
Mark Trusheim and Jane Barlow participated in the FDA / CMS Summit on December 7–9. Mark participated in a panel entitled "Addressing Reimbursement Barriers for Cell and Gene Therapies", and moderated the panel "Examine Value-Based Payment Models in the Wake of the Pandemic". Jane participated in the panel "Realizing the Full Promise of RWE in Drug Development" PDF Overview.
Mark Trusheim joined the MACPAC Technical Advisory Panel to explore specific models to help states manage their Medicaid drug spending. MACPAC convened the advisory panel for three virtual discussions between October and January. Topics included the current drug pipeline and potential effects on Medicaid costs, alternative payment models for high-cost drugs, and opportunities and barriers associated with those models.
Mark also participated in the APEC Virtual Policy Dialogue on Rare Diseases in Chile & the Asia-Pacific cohosted by The APEC Rare Disease Network and the Chile Ministry of Health on December 9 and 10, and again on December 15 hosted by the Malaysia Ministry of Health.
…and Mark participated in the virtual MedCity INVEST Precision Medicine conference, December 9-11.
Jane Barlow spoke at the Oxford Global Cell Series virtual conference on October 7 in the panel "Realizing the Full Promise of RWE in Drug Development"; on October 20 she participated in "Successful gene therapy manufacturing and commercialization – a round table discussion" at the Cell & Gene Therapy Bioprocessing & Commercialization virtual conference; on October 27 she participated in "Precision financing solutions for gene & cell therapies" hosted by the National Association of Managed Care Physicians Value Based Care Council; on October 28 she spoke at the 4th Annual Gene Therapy for Rare Disorders Europe conference in the session "Bridging the gap between market access and patient access".
John Glasspool and Terry Cothran participated in a panel discussion hosted by the National Organization for Rare Disorders, "Covering High-Cost Therapies: Implications for Rare Disease Patients and Payers," on October 29
Mark Trusheim was quoted in an AJMC Sidebar "CMS Seeks to Fix Medicaid Best-Price Barriers in Value-Based Contracting for High-Cost Therapies in Medicaid", highlighting progress and remaining potential obstacles in the proposed new CMS rule to address Medicaid Best Price barriers for high-cost therapies. (Download the NEWDIGS FoCUS public comment on the rule)
Also, Mark has joined the Advisory Board for the Coalition for Affordable Prescription Drugs (CAPD) value in medicine meetings.
On behalf of the NEWDIGS initiative / FoCUS Project, project team members submitted comments on the recent CMS Proposed Rule supporting Value-Based Purchasing (VBP) (CMS-2482-P). With active input from an engaged set of our cross-sectoral members, we focused on the Proposed Rule as an important step forward in enabling outcomes-based contracting by addressing several Medicaid Best Price methodology challenges. We encouraged further efforts to promote use of the full range of precision financing solutions by addressing additional barriers for payment over time and subscription approaches. In addition, we suggested a number of areas where additional regulatory clarification or innovation would be helpful in regards to the approaches suggested in the Proposed Rule. Download the NEWDIGS comment (PDF)
On July 13 Mark Trusheim participated in a webinar hosted by the Institute for Gene Therapies entitled “CMS Proposed Rule on Value-based Purchasing”. Watch the recording
Mark Trusheim was quoted in the AJMC article "CMS Issues Rules to Promote Value-Based Contracting, Pay for High-Cost Therapies in Medicaid"
Mark Trusheim, Danielle Rollman, and Shannon Baumann (bluebird bio) spoke in the BIO Digital session on Precision Financing for Durable and Curative Therapies moderated by John Glasspool
Mark Trusheim, Michael Sherman (Harvard Pilgrim Health Care), Annie Kennedy (Everylife Foundation), and Lauren Nelson (AveXis) spoke on the Alliance for Regenerative Medicine panel on June 2nd, Value-Based Payments 101 (Video)
Mark Trusheim at The Global Orphan Drug Congress 2020, May 1 in Oxon Hill, Maryland
Jane Barlow participated in a live virtual event hosted by Axios on the impact of coronavirus on biomedical innovation and treatments like gene therapies. The discussion also featured FDA's Director of the Center for Biologics Evaluation and Research Dr. Peter Marks and Rep. Scott Peters (D-CA). See the recording at Axios.com.
Mark Trusheim at Eye for Pharma Philadelphia 2020, April 15–16
Jane Barlow at MedImpact 2020 in Carlsbad, March 23–25
Mark Trusheim at Hanson-Wade 4th Annual Gene Therapy for Rare Disorders, March 30 in Boston
February 21, Mark Trusheim participated in the 2020 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR in Orlando.
February 13, Mark Trusheim participated in the FasterCures Data Collection Challenges Workshop in Washington, DC.
February 7, Danielle Rollmann attended the Medicaid Innovations Forum in Orlando and represented FoCUS in a panel titled Guiding the Future of Pharmacy Benefits: Adapting to Gene Therapy and Ultra High-Cost Drugs to Make Leading-edge Care Affordable.
February 6–7 Mark Trusheim spoke at the BCBSA/Aspen Institute Advanced Therapies event in Washington DC.
On January 23, Mark Trusheim presented at Pfizer in New York City, and on January 29 he will participate in the MassBio Policy Breakfast in Boston.
December 4, John Glasspool was on a panel with Rena Conti discussing The Science, Policy, and Potential of Cell and Gene Therapies at the Alliance for Health Policy 2019 Signature Series: Solving for Health event in Washington, DC. A video recording of the panel, with supplemental materials, is available online.
December 6, Mark Trusheim presented at the Brocher Foundation Value Creation in Precision Medicine workshop in Hermance, Switzerland.
December 7-9, Jonathan Salcedo presented a poster on The Total Direct Cost of Healthcare in the United States in Patients with Sickle Cell Disease: A Propensity Score Matched Analysis at the American Society of Hematology Annual Meeting in San Diego, California.
December 12, Jonathan Salcedo presented at CBI’s BioMAN 11th Annual Biomanufacturing Summit on Technology and Innovation for Sustainable Manufacturing of Advanced Therapy Medicinal Products in Cambridge, Massachusetts.
Jane Barlow and Brendan Hayes presented “Novel Therapy Access Update: Structural Considerations” at Hemophilia CANEXTions in California on November 5.
Colin Young and Daniel Mytelka each had presentations at the American Society of Gene & Cell Therapy (ASGCT) Policy Summit on November 5 in Washington, DC.
Daniel Mytelka was invited to participate in the prestigious Medicaid and CHIP Payment Advisory Commission Roundtable on November 6 in Washington, DC.
Mark Trusheim presented at the Financial Times Global Pharmaceutical & Biotechnology Conference in London on November 11–12, and he presented at the World Orphan Drug Congress, Europe 2019 in Barcelona on November 14
Danielle Rollmann presented “Cell & Gene Therapy Pipeline” at the Canadian Organization for Rare Disorders (CORD) Access to Innovation Conference on November 19 in Toronto.
John Glasspool spoke on a panel at the National Health Council’s Washington Representatives Retreat on November 21 in Annapolis, Maryland.
Two of our team members were at the Association of Managed Care Practitioners (AMCP) Nexus in Maryland. Jane Barlow presented “Alternative Payment Models: Transitioning to Pay for Value” on October 30 and on October 31 Jonathan Salcedo had a poster presentation on “Pediatric Inpatient Costs of Select Orphan Conditions with Potential Gene Therapy Launches: A Cross-Sectional Analysis of 2016” which was based on the work for our May Research Brief. Jonathan, Susan Trieu, Réka Shinkle, and Jennifer Bulovic received the Bronze ribbon for their poster!
Mark Trusheim presented "Innovative Payment Models in Practice in U.S." for the event "Gene Therapy: A challenge for the National Health Service, an opportunity for patients" in Rome at the Giovanni Spadolini Library of the Senate of the Republic, Hall of Parliamentary Acts. On October 21 he and Krishna Komanduri, MD participated in the Association of American Cancer Institutes' CAR-T Symposium panel "Exploring the Value and Cost-Effectiveness of CAR T-Cell Therapy" in Washington, DC, and October 29–30 he participated in DIA's "Master Protocol Workshop" in Bethesda, Maryland.
Jane Barlow participated in the workshop "Real World Evidence to Drive Acceptance and Uptake of Cell and Gene Therapy: Lessons and Best Practices" at Cell & Gene Therapy Meeting on the Mesa, on October 3.
FoCUS therapy pipeline projections were referenced in PwC's article "Gene therapies require advanced capabilities to succeed after approval" and Drug Channels's article "How Express Scripts Plans to Disrupt the Emerging Cell and Gene Therapy Channel"
Mark Trusheim spoke at the Duke-Margolis Value-Based Payments Consortium conference on September 11, and the Financial Times Pharma Pricing and Value Summit on September 26.
Jane Barlow and Colin Young each make presentations at the 2019 Managed Care Risk Association Annual Conference on September 17, and on September 25 Jane spoke at the Huron Consulting Group Cell and Gene Therapy Roundtable.
Casey Quinn spoke at the Cell and Gene Therapy Bioprocessing and Commercialization Conference on September 12 and at the FasterCures Patient Access to Cell & Gene Therapy Stakeholder Workshop on September 24.
Jonathan Salcedo's abstract submission for the AMCP Nexus 2019 Poster Exhibition, “Pediatric Inpatient Costs of Select Orphan Conditions with Potential Gene Therapy Launches: A Cross-Sectional Analysis of 2016,” was selected for a Bronze ribbon.
Mark Trusheim spoke at the Rare Disease Innovation and Partnering Summit, on a panel entitled, "Delve Into the Evolving Reimbursement Landscape and Developments in Payer Policy" on June 14 in Boston, Massachusetts.
Mark Trusheim speaks at ISPOR Annual Meeting
Trusheim spoke on the panel "Is Affordability Driving a Need to Revolutionize Drug Pricing?", which was moderated by Colleen M. Flood, F.R.S.C., Director, University of Ottawa Centre for Health Law, Policy and Ethics, Ottawa, ON, Canada, and also featured Muna Bhanji, RPh, Senior Vice President, Global Market Access, Merck; Meindert Boysen, PharmD, MSc, Director, Centre for Health Technology Evaluation, NICE, Manchester, UK; and Lou Garrison, PhD, Professor Emeritus, The Comparative Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, WA, USA.
Casey Quinn at World Federation of Hemophilia gathering
Through its relationship with the National Hemophilia Foundation, FoCUS was invited to make a presentation on April 4th in Montreal at the World Federation of Hemophilia 2nd Gene Therapy Round Table. Research Advisor Casey Quinn presented on a panel about reimbursement and paying for gene therapies. (At the same meeting, FoCUS pipeline projections were shown by an FDA representative.) Quinn helped connect FoCUS to a wide range of people at the meeting including regulators, payers, developers, and of course patients, from the US and around the globe.
FoCUS project members at Academy of Managed Care Pharmacy (AMCP) Annual Meeting
Jane Barlow, Terry Cothran, Paul Jeffrey, Susan Trieu, Ed Pezalla, and Kim Caldwell gave talks at the conference in late March in San Diego.
FoCUS at the Hansen Wade 3rd Annual Gene Therapy for Rare Disorders conference
Michael Sherman, Mark Trusheim, Kevin Mayo, Marianne Hamilton Lopez, Brendan Hayes, and Colin Young participated in the three day conference in late March which focused exclusively on overcoming the late-stage commercial challenges drug developers face when delivering gene therapies to market. Sherman and Trusheim each gave presentations; Mayo, Trusheim, and Hayes were in panel discussions; Hamilton Lopez led a workshop; and Young presented a poster, "Investing in a biotech revolution: analysis of clinical trials and financial investments in CAR-T and TCR therapies for the treatment of cancer".
Dr Jane Barlow, Senior Advisor to FoCUS, delivered the address “How Curative, High-Cost Therapies Bring Challenges to the Reimbursement Landscape” at the Academy of Managed Care Pharmacy (AMCP) Nexus 2018 conference. Learn more and watch the recording