groupH’s discussion on TPP Development and Indication Prioritization took place at the NPP Summit Boston on October 16, 2023.
Erik Holzinger and Iain Clark talked through 2 project case studies focusing on pre-clinical or early-stage clinical stage by sharing client views on project timing and project learnings.
Please click on the here to view document.
NPP Summit_TPP Development and Indication Prioritization PDF
groupH has analysed what is known about the Inflation Reduction Act (IRA) of 2022, which constitutes a major legislative effort to address drug pricing and Medicare expenditure. We developed a simple easy-to-use model, which assesses the risk of any of the three parts of the IRA applying to a product that is either already on the market or still in development.
The IRA model has been developed based on primary market research with senior US market access experts and secondary analysis. The model and its associated white paper was first presented during the Fierce Biotech NPP Summit in Boston in October 2023.
Please click here to access the paper.
Please click on the image below to access the model.
Realistic net-prices and peak-patient-shares are key requirements for providing early commercial direction for assets whose clinical profile might not yet been finalised. Early to mid-stage commercial decision-making benefits from specialised tools that have been specifically developed for this purpose.
During the past year groupH developed an evidence-based Peak-Patient-Share tool (a.k.a. the Devil’s Advocate Tool) that was presented at the ephmra (European Pharmaceutical Market Research Association) Conference 2022.
The tool is now available and free-to-use on groupH’s website:
The requirement for the tool and its methodology is described in a comprehensive and downloadable guide document – groupH ephmra Paper
Please contact us for any questions, clarifications or for a customised tutorial or webinar.
5 mins video summary on Devil’s Advocate Tool
The North American Neuro-Ophthalmology Society’s (NANOS) 48th Annual Meeting took place on February 12-17, 2022 in Austin, Texas
In collaboration with Cambridge University and Gensight Biologics, groupH published a poster at the conference based on the findings of a qualitative study to explore the impact of Leber Hereditary Optic Neuropathy (LHON) on patients’ and their relatives’ lives. LHON is a rare condition which leads to blindness and disability in teens and young adults.
Please click on the image to view the poster
groupH has developed a simple US gross-to-net discount model including a proof-of-concept validation. This simple tool estimates applicable gross-to-net contracting discounts in the context of early-stage commercial assessments in the US market. The model has been developed based on in-depth primary market research with senior payers and secondary analysis. This paper was first presented during the EphMRA annual conference in June 2021.
Please click on the image below to access the paper
A groupH team has worked with the AMR Global R&D Hub over the last 12 months to produce data and analysis for a report on epidemiology and revenue projections for two therapeutics and two diagnostics in the Gram-negative space.
Click on the image below to read the full report, delivering commercial insights into novel treatments and diagnostics to combat antimicrobial resistance
Earlier in the year, we reviewed the reimbursement challenges that CAR-T therapies are experiencing in the US, assessed some of the proposed solutions, and outlined Payers’ expectations from next-generation CAR-T therapies. Click here to see the original analysis.
CMS published a memo providing an update to CAR-T reimbursement in early August that included a number of changes: (1) increased NTAP payments, (2) loosened coverage by dropping the coverage with evidence development (CED) requirement, and (3) reimbursement of off-label use.
While news headlines generally implied that CAR-T therapies will be fully covered and reimbursed, groupH analysis shows that this is far from the case. We found that the increased NTAP payment is still inadequate, and furthermore, is offset by a reduced outlier payment.
Please click here to download a few slides outlining the key points from the CMS memo, and our take on how this impacts the reimbursement of CAR-T therapies.
Email morris.paterson@groupH.com to arrange an in-person presentation with your team.
