As many of us are in 'Spring Dissemination' mode, I want to share how we work to build value propositions, and how achieving this pre‐launch can help.
As products get ready for their initial launch, or approval of a new indication, the team wants to build a value story. Unfortunately, for many of us, pre‐approval also means uncertainty about indications, labelling and price. So, what is the best strategy? A comprehensive one!
In the US, many health plans request an "AMCP dossier" which may include three types of models: cost‐effectiveness models, budget impact models, and other financial models. The basic differences between these types of models are reviewed below.
- Cost‐effectiveness models are useful to assess the overall risk‐benefit and value of therapies compared with other interventions. While called 'effectiveness' models, those based on pre‐launch (clinical trial) are actually 'efficacy' data which were designed to test whether or not a product worked in the narrow population under study in the development program. JeSTARx Group President Jim Smeeding was active in the ISPOR drug cost task force to develop guidelines for good research practices in Costeffectiveness analysis in 2010 and brings a great deal of experience to the table.
- Budget impact models do not include the full impact on clinical and patient outcomes but can be useful for estimating system‐wide (e.g., pharmacy and medical) budget impacts. These models are commonly used by payers to derive projected per member per month [PMPM] costs by estimating drug costs, healthcare cost offsets, and adverse event costs, as well as the expected utilization in the healthcare system. Our team at the JeSTARx Group has partnered with several clients to develop their Budget impact models.
- Financial models are often developed by payers internally for contract negotiations. They often lack clinical effects and other economic consequences, but typically include drug costs, network or other discounts, rebated, co‐pays, and other benefit design. Most of the JeSTARx Group work on financial models are confidential to our clientsuntil they choose to share them!
Work conducted by the JeSTARx team is often published and cited in both cost effectiveness and budget impact models for our research partners, and sometimes their competitors. For all of these models one needs to understand the impact of the condition‐and that's where we excel. While some databases are good at estimating direct costs, our research often uses real data to estimate the direct costs, the indirect costs, and the reduced productivity associated with conditions, and at different stages for progressive conditions. We are currently finalizing our research on the 'stages' of Hepatitis‐C (HCV) for presentation at Academy Health in San Diego‐as well as a manuscript on the same topic.
We were fortunate to connect with many of you over the phone, through web meetings, or live in Tampa at the AMCP and NASP meetings. There are a number of you we haven't talked to recently. We are filling in our calendars for the ISPOR Montreal meeting and the AHIP meeting in Seattle. Let's find a time for us to meet with you!
We know that sometimes your data and research needs can't
wait. We are here to help! Please give me a call (office 973‐208‐
8621) or email me at RBrook@JeSTARx.com to discuss.