No longer a milestone - Market Access as a mindset
| Sep 9, 2011
“Market Access” currently has many interpretations and its description is often one of perspective. Depending on whom you ask, it might be considered a department in a company,a goal to be achieved at launch, or a study to be commissioned along the way.
Historically, it was represented as obtaining ‘reimbursement’; as clearing the “fourth hurdle” in the path to achieving a successful product launch. It was often tracked and measured as a stable milestone achieved post launch.
In today’s environment, the thought of only ‘four hurdles’ seems rather simplistic.
The path to achieving Market Access can include hurdles related to:
- Funding and reimbursement status and level.
- Achieving and sustaining price level both gross and net.
- Managing utilization and budget impact through volume controls.
- Establishing patient eligibility and place in therapy through protocol or guideline development.
- Managing treatment duration through starting and stopping rules.
- Shifting cost to patients.
- Sharing risk to manage uncertainty.
- Re-pricing based on international referencing.
Market Access now is the terminology that reflects an evolving set of marketplace challenges and differentiated regional and therapeutic area needs.
No longer a static outcome to be tracked across countries, Market Access is a dynamic state that is successfully maintained by applying a mindset and an approach that begins in early development and spans the product lifecycle. It is the foundation for reaching patients and for garnering the “reward for innovation” that is sought by pharmaceutical companies. Market Access as a strategic function reflects the goal of getting the right drug to the right patient at the right time while ensuring reward for innovation and sustainability of provision.
Alignment of the Value Proposition with product positioning, supported across Value Domains.
The Market Access mindset and approach starts in early development with the overall Market Access objective in mind and aligns with the key product development stages. It begins with understanding unmet needs from a treatment value view point; that value must be identified, validated and optimized in early development, quantified and substantiated through full development, adapted and communicated during launch implementation, and then captured, defended and enhanced through the product lifecycle.
Clinical development plans need to substantiate medical benefit and be aligned with a value proposition. That value proposition can be defined from the perspective of a growing array of stakeholders and is typically supported by evidence across several value domains: medical/therapeutic benefit, patient /caregiver benefit, including QoL and utility and economic benefit.
The probability of achieving market access begins with the following considerations in early development:
- How can we characterize the unmet need? This should be identified across indications, geographies and patient populations. Is the unmet need based on a clinical endpoint or is it related to another value domain such as high cost, diminished quality of life, high caregiver burden etc?
- How will value be substantiated and what is the value proposition by stakeholder group and indication? The potential for incremental improvement needs to be identified across value domains.
- What trial design and which endpoints can optimize clinical outcomes and value substantiation? What are the appropriate clinical trial inclusion criteria?
The end goal is optimizing market access and payer value by identifying the right patient, right drug, right dose for the right duration beginning in early development.
Remember, the clinical trial inclusion criteria are the best gift a company can provide to a reimbursement authority. Those criteria essentially pre-write the potential reimbursement restrictions.
Let us know your views and we will be continuing the conversation in weeks to come.