What is a Field Reimbursement Manager (FRM)?
A field reimbursement manager (FRM) is a field-based team part of the market access organization that is tasked with helping provider’s offices navigate reimbursement issues for the drug that the FRM is supporting. FRMs will partner with sales representatives to identify and help resolve any issues providers may have in getting the drug approved for their patients. They are often linked to patient support programs (hubs) and can serve as a conduit to linking those services to providers in order to make reimbursement easier.
...
What is Value Based Contracting (VBC)?
Value based contracting refers to contracts between pharmaceutical manufacturers and payers which tie payment for the drug to a predefined outcome. Value based contracts can be structured around a lot of different outcomes including potentially clinical outcomes or measures such as adherence and persistence. Typically, there are certain levels set for the outcome of interest with changes in rebate amount tied to falling in specific ranges.
...
What is an Expanded Access Program?
An expanded access program allows for patients and providers to get access to a drug that is not yet approved for a specific use outside of enrolling in a clinical trial. Also called “compassionate use”, it allows patients who may not qualify for or disinclined to join one to get access to a potentially life-saving or impactful drug nonetheless. The FDA has to approve specific applications for expanded access.
...
What is a Patient Access Scheme (PAS)?
A patient access scheme (PAS) is a confidential discount agreement between a pharmaceutical manufacturer and a payer. The term is similar to drug rebates in the US, but PAS is more commonly used in areas with single payer systems and especially the UK.
The details of a PAS are come to following negotiation between the manufacturer and payer and may involve set ceilings as determined by local HTA bodies (such as NICE in the UK).
...
What is a Patient Support Program?
A patient support program (PSP) is set up by a pharma company to provide various services to providers and patients for a specific drug. The services provided can vary but may include support in navigating the reimbursement processes of payers, clinical support services (including support for the patient on how to appropriately use the drug, follow-up calls to see how they are doing, etc.), free drug provisions especially when a patient is first starting a drug (and prior to insurance company approval for reimbursement), etc.
...
What is Pharmaceutical Information Exchange (PIE)?
Pharmacuetical Information Exchange refers to the ability for pharma companies to communicate certain information about investigational agents (unapproved drugs) with population health decisionmakers (PHDMs) such as payers. This can include both clinical information as well as healthcare economic information (HCEI). PHDMs have particular interest in this information as it helps them plan for upcoming products including assessments on how it may impact their budgets, etc.
...
What is a payer value deck?
A payer value deck is a key deliverable for value and access (payer marketing) teams constituting key information about a product, relevant disease characteristics including prevalence of the indicated population(s), and potentially some high-level economic information. Payer marketing teams create value decks for use starting day 1 of a launch of a drug following approval- market access account executives will use the deck for promotional presentations to payer customers.
...
What are AMCP and Value Dossiers?
Payers around the world require data on product clinical trials, disease state burden, health economics, and other relevant information as part of the process of evaluating whether or not to cover a drug for reimbursement- this information is often shared in the form of a compendium (or dossier) developed by the manufacturer seeking reimbursement. Dossiers are a standard launch deliverable and are created and shared by manufacturers depending on the processes and laws in a given country.
...
What is the Medicaid “Best Price” Provision?
“Best Price” is a requirement for manufacturers to offer Medicaid plans the lowest price that is being offered to all payers (Veterans Affairs, Department of Defense, and Medicare Part D are excluded) in the United States. In addition, there is a defined minimum rebate that must be met- the lower of the “best price” and the minimum rebate would apply to a given drug.
...
What is cost effectiveness?
Cost effectiveness is a way to estimate the value a drug brings to society. It is commonly required in health technology assessment submissions outside the US (especially in Europe) in order to obtain approval for reimbursement from national payers.
Cost effectiveness models are typically developed by HEOR teams at pharmaceutical companies in accordance with guidances set forth by HTA bodies and health economic expert bodies such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
...