PharmaLex broadens market access and HEOR reach
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The key to unlocking market access, is the ability to look beyond the science, to understand the market dynamics that will shape the future and drive value
To gain market access in pharma and remain competitive, pharmaceutical and medical technology manufacturers must be able to demonstrate clinical and economic evidence to providers, healthcare decision-makers and payers.
In the past, market access for a medicine depended almost exclusively on efficacy and safety. These factors are still critical, but today, clinical differentiation and its effects on healthcare outcomes and resource utilization / optimization require more comprehensive approaches. Today, more than ever, pharmaceutical companies must demonstrate how a new drug improves patient outcomes, reduces the burden of the healthcare system as a whole and is worth its price. To satisfy these criteria, pharmaceutical manufacturers have gradually expanded their strategies ‘beyond the pill’ to build initiatives that take a more holistic view of patient treatment, provide better real-life evidence and therefore a stronger value proposition for decision makers.
For payers and market access stakeholders, the medicine value proposition encompasses the optimal combination of disease need, clinical efficacy and economic impact that achieves market access at an optimal price, in the appropriate setting, by validating and communicating the need for treatment and the value of utilizing the medicine in question in the right setting and to the right patient. To do so, market access activities have expanded significantly beyond pricing and reimbursement, and include other elements such us digital therapeutics, better integration of health/patient reported outcomes in healthcare decisions, or even value-based strategies amongst others.
In the increasing yet infant space of digital therapeutics, the challenges start early on when trying to reconcile the technology, the therapeutic objectives and the regulatory requirements for commercialization. The implications of MDR, go far beyond regulatory compliance, as it can impact the go to market strategies and associated revenue streams. Additionally, can hamper the potential data monetization strategies when appropriate, as well as other growth aspiration, and we look at it from that point of view, and can advise you on best alternatives according to your company and solution’s reality.
We can help you navigate the increasingly complicated legislative and market environment. Each stakeholder has their own particular interest in a product, and we can help you communicate the value of your product to stakeholders.
Common challenges
- Heterogenous approaches and policies and processes across countries
- Complex regulatory and reimbursement pathways, varied evidence requirements and long procedural timelines pose risk to successful access and launch
- Lack of consistently maintained, integrated information resources
- Expensive and time-consuming country market research requiring multiple resources to procure data that may not be current
- Increasing use of MEAs (managed entry agreements) significantly impacting pricing and reimbursement negotiations
- OVERALL: there is growing disconnect between key stakeholders- Industry, Payers, Physicians and Patients – leading to lack of alignment on what constitutes value and, consequently, driving price pressures
The right strategy is the difference between success and failure. It is imperative to ensure that your clinical development plans are aligned with your commercial goals and the market landscape realities. Failure to do this costs time and money.
Staying one step ahead
- We utilize our experience of over 25 years building up knowledge and recognition in the pharma, biotech and medical devices industries
- We help clients navigate the increasingly complicated regulatory environment to enable them to develop a stronger value offering and concomitant value story for payers
- Our global network of local experts ensures we understand the local nuances which is vital for a successful outcome
- Every solution is tailored to the client’s specific needs to provide patients with value-based healthcare and improve clinical outcomes
- We look beyond the science to increase success in market access and ultimately benefit patients
Market access for a drug once depended almost exclusively on efficacy and safety. Whilst these factors are still critical, clinical differentiation and its effects on cost effectiveness is gaining importance.
The importance of understanding your market
- What is the level of competition
- Perception of clinical landscape and the influence of therapeutic area (TA) and disease type on profitability
- Understanding the impact of unmet needs
- The degree of personalization
- Use of HTAs to examine the consequences of using a healthcare technology by considering the medical, social, economic and ethical issues
- Identifying payer priorities, uncertainties and preferences
- How to demonstrate value
The requirements of the market constantly change. Rising drug spending and increased desire for expenditure controls are a consistent theme and with governments under pressure to fund high-cost, innovative therapies, which often launch with limited clinical trial evidence, payers are looking towards new and enhanced reimbursement processes which align drug funding with patient value. Today, more than ever, pharmaceutical companies must demonstrate how a new drug improves patient outcomes, reduces the burden of the healthcare system as a whole and is worth its price.
The rise of digital health and value-based healthcare
- Digital health is a growing market but there is limited understanding of market access / go-to-market strategies
- New legal procedures for the assessment of medical devices of higher risk classes (2b and 3) impose new challenges for market access and reimbursement
- The market access requirements for products which fall into this category are very different from the usual market access regulations, including the distribution network
- At the same time, the demand for value-based healthcare is increasing and it is important to not only embrace new technologies but ensure it can be demonstrated that healthcare is more sustainable, affordable and patient-orientated
The future of market access is changing. New products and technologies are being introduced which are influencing the future market. We deliver expert knowledge on clinical data, define the value generation of medications or devices and have full understanding of global regulatory requirements as well as market access regulations – all product types are being worked on including borderline products and new digital health services.
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What our clients say
Hard working and there when you need them
Europe based large biotech
Regulatory Manager
Regulatory Manager
Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected
Small US Biopharmaceutical Company
Sr Director Regulatory Affairs CMC
Sr Director Regulatory Affairs CMC