CGT, Accelerated Approvals, Prepping for AXS24, SDOH

We Will Be at AMCP 2024…

Valuators and Entrée Health are excited to attend AMCP 2024 next week.

Lori Wood , Tony Gibson , Kimberly Tsai, PharmD , Rachel Geismar Dorfman , Gina Effisimo-Watt , and Cora Meese, MBA look forward to meeting you at the conference to discuss market access, pharma, biotech, CGT, and more.

See you in New Orleans!

…and we are Speaking at Asembia’s AXS24

Life-changing biopharma products are launching daily, and payers are increasingly reluctant to cover the high costs. That makes it more important than ever to incorporate a smart market access strategy into your plan.

Join Kevin Cast , Cora Meese, MBA , Dina Steinfurth , and Andrew Udell at Asembia’s AXS24 Summit as they discuss optimizing market access and commercialization for biotech product launches. Learn how leveraging multiple integrated partners can prepare your organization for a successful pharma product launch. ?

Plus: Our teams are available for meetings during the conference.

See you in Las Vegas!

Pre-AXS24 Checklist for Market Access Teams

Asking the right questions internally prior to Asembia’s annual conference helps market access teams maximize their efforts.?

To get the most out of Asembia’s AXS24, we created a pre-conference checklist:

• Are your reimbursement, distribution, and patient journeys streamlined, consistent, and comprehensive?
• Is your patient support program network set up for success?
• Are you getting the most out of your PBM contracts?
• Have you reviewed your contracts to ensure your services are within Fair Market Value?
• How well are your value messages resonating with all formulary decision-makers (not just payers)?
• Could your pull-through strategies be more effective?
• Are your market access communications contributing to health equity goals?
• How are you leveraging data insights and analytics to optimize your market access strategy??
• How are you enhancing your strategy through qualitative insights??
• Are you getting the most out of your customer strategy??

If you are unsatisfied with any of your answers and want to optimize your market access strategies, contact Dina Steinfurth to schedule a meeting during AXS24.

New Episode of The IDI Podcast

Listen to Elisa Remoundos?of Entrée Health discuss the role?market access?plays in?health equity and pharma.

“I think that what we’re starting to see in certain clients is that there’s a need to bring the human side to the communications they’re delivering to payers,” said Remoundos, SVP and Group Creative Director at Entrée Health . “Oftentimes, it was just very mechanical in how we created payer value propositions. You needed to have established your burden of disease, and then talk about your clinicals, and then talk about the economic data.”

Listen on Apple:?https://podcasts.apple.com/us/podcast/social-determinants-of-health-and-market-access/id1630221502?i=1000651027214

Listen on Spotify: https://open.spotify.com/episode/1lswSkEDFwGkNRFzvtxC6a ?

CGT Takes Center Stage at Reuters Conference

Cell and gene therapies, with their unique set of challenges, drove much of the conversation at the recent Reuters Pharma USA event in Philadelphia. ?

Lori Wood, Kevin Cast, and Douglas Bock attended and left with five takeaways:

1. CGT companies still rarely ?discuss or are aware of the requirement to secure commercial launch plans. Much time is spent discussing the growth of the market and the future of CGT, but rarely on how to get the product paid for and into a patient.
2. One common concern about CGT heard from payers at the conference is that they pay to “cure” a patient, but the patient changes jobs two years later and is covered by a different payer – who, in turn, gets the benefit of the high cost incurred by the first payer.?This has caused countless ideas about approaches like blockchains to follow a patient for years after treatment so each payer would pay off a few years of the “mortgage” of the drug cost.
3. There’s room to reframe this argument to show that these high, up-front costs are affordable, cost-effective, and analogous to other very high-cost, one-time treatments that receive far less resistance in the market.
4. Value-based agreements and outcomes-based contracts were widely discussed, but few use them. Attendees remarked that they need more risk-sharing and easier data interpretation. The unique nature of CGT is driving greater interest in VB agreements; employers are seeing stop-loss carriers carve out gene therapy in the meantime.
5. Attendees also emphasized the need to know where your clinical trials are occurring, and they were excited by the possibility that natural-language processing makes understanding clinical notes a reality.

Does Accelerated Drug Approval Help Patients?

Fully 41% of cancer drugs granted accelerated approval from 2013 to 2017 did not improve overall survival or quality of life in confirmatory trials after more than five years of follow-up, according to a new JAMA study.

“Most cancer drugs granted accelerated approval did not demonstrate benefit in overall survival or quality of life within five years of accelerated approval,” the authors write. “Patients should be clearly informed about the cancer drugs that use the accelerated approval pathway and do not end up showing benefits in patient-centered clinical outcomes.”

More findings from the study :

• 22% of the 46 indications with more than five years of follow-up (approved 2013-2017) were withdrawn
• 43% demonstrated a clinical benefit in confirmatory trials
• Time to withdrawal decreased from 9.9 years to 3.6 years
• Time to regular approval increased from 1.6 years to 3.6 years

Three Takeaways from the Study

1. The study’s findings will likely increase scrutiny of the FDA’s accelerated drug approval program, which has faced some headwinds lately.
2. Market access teams may find that while accelerated approval for their products may yield coverage, access will not be as easy a lift. The value story will need more development as further clinical trials and real-world data become available and support broad access. Patients, additionally, will need more education to better understand the ramifications of taking cancer drugs via FDA accelerated approval.
3. Pharmaceutical manufacturers should not expect payers and risk-bearing entities to accept accelerated approvals at face value. Likewise, market access should be on the lookout for changes to the FDA accelerated approval program.

Patient Advocacy Certification for John Hennessy

Let’s all give a HUGE round of congratulations to our colleague John Hennessy, who earned his BCPA credential and is now a Board Certified Patient Advocate!

Offered by the Patient Advocate Certification Board, Inc. (PACB) , the BCPA is earned by passing an exam. It is earned to serve patients and their families who need assistance with some portion of their journey through the healthcare system.

“In the complex world of healthcare decisions, a patient or healthcare advocate is the supportive companion everyone needs,” the PACB notes. “They ensure the client, patient, or family fully grasp the crucial issues, understand their rights, and feel emboldened to voice their own perspectives.”

When he’s not advising pharma and biotech market access teams, John Hennessy spends an incredible amount of time advocating for cancer patients and their families. He is passionate about reminding manufacturers, payers, and providers that patients need support and help navigating their unique care journey.

We are so honored to count you as a colleague, John!

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