SERVICES
EVIDENCE GENERATION
Economic modelling is a focal point of the economic evaluation of a new health technology, since it supports the decision making by bringing together the evidence on costs, outcomes and epidemiological data. Economic models can have the form of a global health technology assessment (HTA) tool, which is built for reimbursement purposes, or otherwise more concise but equally useful early-models, to assist with business development scenarios. Our team has extensive experience in economic modelling (cost-effectiveness, budget impact models) in a number of disease areas and undertakes de novo model building as well as adaptation of global models for use in the local markets.
HEALTH ECONOMICS &
OUTCOMES RESEARCH SERVICES
EVIDENCE REVIEW
AND SYNTHESIS
We provide rigorous systematic literature reviews and synthesis of clinical and economic evidence via meta-analysis, network meta-analysis, indirect comparison and matching adjusted Indirect comparison (MAIC). We use appropriate methodology which best fits your data and elevates your research.
Outcomes research enables capturing the value of healthcare interventions and services. The experience and preferences of patients for health care interventions, as well as clinical outcomes, including patient reported outcomes (PROs) is a focal point of this strand of research.
Our outcomes research tools include a variety of analytical approaches such as utility elicitation and Patient Reported Outcomes.
Patient reported outcomes (PROs): Patient-reported outcomes (PROs) have been defined as “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” A wide variety of PROs tools have been developed and used in clinical practice. PROs are often recorded in clinical trials, using validated instruments (PROMs) to measure the impact of the intervention as perceived by the patient.
Our team can guide you, via an evidence-based approach, through the choice of the appropriate PRO tools for use in clinical trials or general policy decisions.
PATIENT REPORTED
OUTCOMES
(PROs)
PATIENT REPORTED
EXPERIENCE MEASURES
(PREMs)
Patient experiences have become a key quality indicator for healthcare. Measuring and analyzing experiences is considered a tool to support improvement in healthcare quality governance, public accountability, and patient choice. Pharma Easy Access has experience in patient satisfaction studies, patient journey research and patient-perceived disease burden experience. The elicitation methods we use are adaptable to each specific objective and research nature. They might involve position papers, advisory boards with patient advocates, social media analysis & gathering, focus groups and systematic literature review. Each method used is specially designed to meet the specific objective and satisfy client’s need, leading to successful reimbursement.
REAL WORLD EVIDENCE & DATA ANALYTICS
Real-world evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of Real-World Data (RWD). Findings from pre-registration clinical trials (CTs) do not reflect accurately real-world clinical practice settings, due to their stringent eligibility criteria. RWE studies complement the data of CTs, providing data from the general patient population. RWE studies provide further information on the course of the disease, and product effectiveness and safety. RWE can be generated utilising various data collection designs such as randomized trails, observational studies and patient registries. The data collected will support value demonstration, product positioning and provide stakeholders involved with reimbursement with information required to assess the value proposal.
The RWE solution provided include both Qualitative & Quantitative Research Methodologies:
MARKET ACCESS SERVICES
PRICING &
REIMBURSEMENT ADVICE
Our experience in pricing and reimbursement systems of many European countries and several disease areas enables us to provide strategic guidance for your product and prepare a plan for a successful negotiation.
Value propositions and value dossiers (VPVD) enable pharmaceutical industry to demonstrate the comparative advantage of their products over the standards of care to HTA organisations, to realise successful market access of their products.
Value propositions and value dossiers are prepared through a comprehensive synthesis of supporting evidence on the clinical, economic and humanistic value for the new intervention. The VPVD are constructed with the aim to provide a meaningful value proposition, with clear and concise messages for dissemination to the relevant departments (sales, marketing and market access) as well as to health authorities and medical societies.
VALUE PROPOSITION
& VALUE DOSSIERS
REIMBURSEMENT
DOSSIERS
Reimbursement dossiers are part of the value dossiers and are constructed by taking into account the national or regional requirements of the HTA bodies. The product benefits (innovative, therapeutic, and quality of life) are demonstrated through cutting edge analytical tools such as economic modelling and clinical trials. The reimbursement dossiers aim at positioning the product in a strategic manner for an HTA submission.
Pharmecons can support you during the reimbursement price negotiation with the Greek Pharmaceuticals Negotiation Committee. We can help you through various steps of the process such as:
- the preparation of the necessary argumentation in order to support your value proposition
- Set up of mock-up negotiations to prepare the composition, structuring, roles and coordination of your negotiation team
- In-person presence during the Negotiation meeting
NEGOTIATION
STRATEGY
MEDICAL DEVICES & DIGITAL HEALTH
ASSESSMENT OF
MEDICAL DEVICES
Medical Devices Regulation (MDR) and CE mark are the basic prerequisites for the commercialization of a medical device or digital technology in Europe. Based on EMA manufacturers can place a CE (Conformite Europeenne) mark on a medical device once it has passed a conformity assessment. Similar to medicines, there are prioritization criteria for medical devices covering unmet medical need. The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device. Based on MDR each medical device developer mostly need to have:
1) Quality System describing the Standard Operating Procedures (SOPs).
2) Technical Report of the new technology.
3) Clinical Effectiveness of the new technology vs. the Standard of Care (SoC).
4) Safety Assessment.
Pharmecons Easy Access can guide you around the MDR and the required procedures for a complete CE mark application and Reimbursement of the new medical technology.
Digital health is a broad multidisciplinary field including applications and devices utilizing technology in healthcare systems, and ranging from smartphone applications to medical devices. A digital transformation can help meet the changing needs of patients and the public. It can serve as a catalyst for a team-based approach to deliver quality and co-ordinated health services. This is particularly important with ageing populations, a growing chronic disease burden and rising expenditure.
Pharmecons Easy Access can provide you with support for building an overarching digital strategy and help you build institutional and operational capacity. Pharmecons can help you gain reimbursement of your medical device, by developing the required documentation and negotiating reimbursement with the Health Authorities.
In addition, we can develop customized smartphone applications enabling patients to record data on the signs of their disease, which can be transmitted to the attending physician in order to facilitate decision-making on the treatment and course of their patients’ disease, remotely.
PHARMACO VIGILANCE
24/7 contact person for recording AEs
We can provide you with 24/7 availability to record safety cases and transmit them to you within the deadlines required by your procedures, including during holidays and vacation periods.
Reporting of AEs
We will record the cases and report them to you via any means provisioned by your procedures, including entering the case in your company’s PV reporting tool.
Local literature service
Our company can perform local literature search for safety cases at the frequency provisioned by your procedures, according to an agreed list of local journals and congresses and keywords relevant to your products.
Educational Materials
Pharmecons Easy Access will undertake the procedure of local translation of the RMMs, obtain CA approval, or/and distribute the materials according to the approved distribution plan.
Personnel Training
We can prepare the slide kit required for induction and annual refresher training to your personnel, and also deliver the presentation, providing you with the training log as required by your procedures.
SOPs
Our company can undertake writing of SOPs required, or/and review and update of your current SOPs to ensure compliance with current standards and alignment with the procedural documents of your HQ or the MAH, as required.
TRAINING & WORKSHOPS
Pharmecons Easy Access has a wide experience in the organization of seminars and trainings based on the needs of each client. Some of the high valued workshops are the following:
SCIENTIFIC COMMUNICATION
We create and deliver medical communication solutions that bring data to life and drive behavior change across the healthcare community. We partner with our medical affairs clients to support the conversion of scientific knowledge into actionable insights. Most of our communication activities focus on: