What is an Integrated Evidence Generation Plan (IEGP)? An integrated evidence generation plan is a synergistic and aligned plan for the generation of new data across various groups in a pharma company. It reflects an approach in which the process of generating new data for a drug is a collaborative (rather than siloed) approach starting with identification of data gaps, early planning, and going all the way through study execution and publication. ...
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 is patient-level data? Patient-level data contain information on individual people including potentially information on demographic characteristics (such as age and sex), comorbidities, treatment histories, and medical histories. When used for research purposes these data are usually deidentified using techniques which theoretically make it impossible (or extremely hard) to re-identify and equate any given observation in the database with a real life person. Sometimes, deidentified patient data is also referred to as anonymized patient level data (APLD). ...
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 a Standard Response Letter? A standard response letter is a pre-written and approved response that Medical Information teams have prepared for commonly asked or expected questions. For any given drug product, there will be a number of standard response letters compiled at the time of drug approval with more added over time as needs change. Letters often cover commonly asked questions about clinical data, but can also include information about pharmacokinetics, health economic data, and other relevant scientific data. ...
What is an Awareness Trial Usage (ATU) study? An awareness trial usage (ATU) study is a form of market research in which the aim is to get an idea of how many prescribers of interest are aware of the product being tested, how many have newly tried it, and how use is. Each ATU study is done at a point in time, but will often be repeated over time to see trends in the points of interest. ...
What is a Master Visual Aid? A master visual aid (MVA) is a core deliverable for the brand marketing team and the key piece that sales representatives use in their interactions with providers. It usually contains the key messages for the brand along with key data on the drug. It is also typically visually appealing with vibrant images related to the theme of the messaging. The final messaging and content are carefully chosen, usually the winner of several concepts and many iterations that go through a considerable number of reviews and market research testing. ...