For the Innovative Industry in the Healthcare sector, the role of Market Access should be to remove any hurdle that prevents or hinders patients from receiving available (commercialized) technologies at the right time, either by minimizing barriers to access or by generating opportunities.
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Market access: strategic objective and operational activity
Adequately assessing the conditions and needs of the market to be entered is an essential element to increase the probability of successful access and to be able to approach a price and conditions of use that are optimal for the business objectives. The ultimate business goals of a therapeutic innovation is not to enter the market (a necessary condition) but to be used (purchased) in a broad manner in accordance with its value for the different agents in the system, and which allows it to generate the expected return on investment throughout its life cycle. For this, Market Access has to play an active role throughout the product life cycle: from clinical development to post-patent expiry.
We offer global solutions covering the entire product lifecycle
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Market Access Challenges
When discussing Market Access, you must first tackle some of the challenges:
As healthcare systems attempt to optimize drug spending, there is a higher burden of proof to justify pricing and produce evidence of outcomes.
The industry has grown adding more players as well as stakholders to navigate around. This means there is now a broader set of external stakeholders that need to be understood and engaged with as many of these key players did not have the relevant they currently have.
The environment has turned more complex due to the differing expectations and considerations at a country level. The key to success for this challenge are adaptive strategies with intimate understanding of the decision drivers.
Another common challenge is the silo mentality. The fragmented view makes it difficult to demonstrate the full value of money for innovations. This is caused by the inherent healthcare structure and the poor communication amongst stakeholders.
Having explained the challenges in order for an organization to be prepared for any unforseen circumstance it is important to take into consideration the following points:
More Stake Holder to Navigate
There is now a broader set of external stakeholders that need to be understood and engaged with.
Many of today´s key players did not have the relevance they currently have.
The stakeholder environment is becoming even more complex with differing expectations and considerations at a country level.
Adaptative strategies with intimate underestanding of decision drivers is key to success.
The fragmented view makes it challenging to demonstrate the full value of money for innovations.
Caused be the inherent healthcare structure and poor communication amongst the stakeholders.
What Organizations Needs
Addressing fundamental payer questions requires a timely and long – term strategic plan as well as a team with cross – functional expertise and unparalleled understanding of the stakeholder enviornment and access strategies. We are prepared to undertake any challenges due to our vast range of services that start with the initial steps of market access strategy & planning all the way to patient access to the innovation. Throughout the product timeline we also complete pragmatic value dossier, pricing and reimbursement assessments and stakeholder management.
Unlocking Market Access
- 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
Beyond The Science
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
Understanding The Market Dynamics
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.
Shaping The Future
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.
Market Access Services
Health economics and outcomes research (HEOR)
To achieve an effective patient access to the innovation, the product must demonstrate value to the funder, the payer, the clinicial, and the patient. We develop different types of health economic models from Early-Phase to highly complex. Demonstrate the economic value.More Info
Market Access Strategy
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.More Info
Pricing and Reimbursement
Being a global company with an extensive geographical reach, thus far, PharmaLex can carry out these evaluations in Europe, Australia, Canada and US.More Info
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