What is brown bagging? Brown bagging refers to situations in which patients get a specialty medication from a specialty pharmacy outside of the hospital or provider’s office where it will be administered. The patient picks up the medication as they would for typical outpatient prescriptions (including payment of any out-of-pocket cost they are responsible for) and then brings it with them to the hospital or provider’s office to be administered. ...
What are quality measures? Quality measures are validated metrics used by various organizations to assess specific process or health outcomes in the real world. They can be used in order to assess how well an entity is doing in caring for specific populations and some payers, namely the Centers for Medicare and Medicaid (CMS) services, use them to influence reimbursement. The ultimate goal of quality measures is often to improve clinical outcomes as well as give consumers information on how certain plans or providers might compare. ...
What is a treatment sequencing model? A treatment sequencing model attempts to incorporate data from different clinical or real world studies in order to understand how different treatment sequencing strategies may impact patient outcomes in specific populations. This is particularly important to understand in therapeutic settings in which there are multiple options and no clear consensus on the right order of medications to use. Treatment sequencing models can help inform decisionmaking in these settings by incorporating data from clinical trials or real world studies while attempting to reduce biases associated with comparisons when no direct comparison (randomized controlled trial or other head-to-head study) exists. ...
What is a Patient Reported Outcome (PRO)? A patient reported outcome (PRO) refers to a validated survey instrument that is used to systematically collect patient-relevant information directly from a patient. Each PRO is specifically designed and validated to measure something specific, with language being tested formally in order to ensure that it is generally interpreted consistently by the population of interest. Clinical trials and HEOR studies may incorporate PRO measures in order to capture information directly from patients on things like health-related quality of life (HRQoL), symptoms, pain, etc. ...
What is FDAMA 114? FDAMA 114 refers to part of the FDA Modernization Act which calls on FDA to provide guidance to pharma companies on the communication of healthcare economic information (HCEI) with population health decisionmakers (PHDMs) including payers. The 21st Century Cures Act further built on the initial legislation and has led to multiple guidances from FDA on the appropriate communication of HCEI with PHDMs including what types of information are appropriate, when it is okay to proactively communicate certain information as well as what it is not okay to communicate. ...
What is buy and bill? “Buy and bill” refers to the process by which providers get reimbursed for drugs that are administered to the patient in the office. As the name implies, a provider purchases the drug on their own and keeps the inventory on site until a patient needs it. At that point, they would administer the drug to the patient and then bill the insurance company (typically under the medical benefit) for the drug price plus the administration fee. ...
What is Wholesale Acquisition Cost (WAC)? Wholesale Acquisition Cost (WAC) is one of several pricing metrics commonly used in the United States for drugs. The WAC reflects the price that companies charge the wholesaler, which is typically the first point of sale. WAC prices are published in the Micromedex Red Book.
What is Drug Pricing? Drug pricing is the process by which the list price of a drug is determined. It is usually led by pricing personnel who work within the market access group and use a variety of techniques to recommend potential prices for a new drug. Ultimately, the final pricing decision is often made by executive leadership including potentially the CEO. Amongst the considerations that pricing personnel consider are results of various market research that is conducted to gauge what providers and payers think about the drug candidate and how they would react at various price points as well as the pricing of competitor drugs. ...
What is Payer Marketing (Value & Access)? Payer marketing (often also called ‘value and access’) is a function that falls under market access that is tasked with owning the payer communications strategy for a particular brand. As part of this remit they own development of most materials used by the account executive field team including the product value deck, any disease state materials, potentially tools to help discuss elements of cost, etc. ...
What is Utilization Management Criteria (UM Criteria)? Utilization management (UM) criteria are restrictions that payers put on drugs which restrict how and when they will pay for them for their beneficiaries. Criteria can take many forms including step edits in which certain other medications may be required to be tried prior to reimbursement for a particular drug and prior authorization requirements in which a provider must provide additional documentation justifying use of specific drug. ...