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Market Access & Strategy Planning

Market Access and Reimbursement

We provide strategic planning tools and methods to improve market access, demonstrate the added value of products, and conduct reimbursement assessments. Our services are tailored for digital healthcare, MedTech and Pharma companies looking to complete their Health Technology Assessment submission, and secure recommendations or endorsements from national and regional healthcare programs. Our team conducts critical reviews of existing health economics models and Health Technology Assessment (HTA) evidence materials, as well as assisting in the implementation of global health economic models and HTA bodies’ specific guidelines.

What is Included

Methodological and Strategic Advice

Demonstrating the value of innovative products or services is a crucial step in achieving entrance to target healthcare markets with maximum market share. An optimal market access outcome would be defined as ensuring products are prescribed to, used by, or accessible to the right patients, easily, in a timely fashion, and at the optimized price. We also understand how important it is for Pharma and MedTech companies to achieve maximum reimbursement for their innovative medicine, device, or healthcare digital service. To achieve this, we conduct early market access assessments that will assist in the correct positioning and pricing of our clients’ products. Such health marketing intelligence assessment includes:

• Early market access strategy planning: By understanding our clients’ competitors and gaining valuable insights on the dynamics and trends of the target healthcare market, we help you to ensure that you can correctly place your product for maximum profitability and accessibility.

• Product pricing assessment: Appropriate pricing of a product, device, or therapeutic procedure is required to achieve optimal market access and profitability. We understand the financial and time investment required to develop an innovative product or service, and we want to aid you in achieving the maximum return on that investment while also ensuring that your product is accessible to all eligible health consumers.

The OPTIMAX Access team will help you to OPTImize the price of your product and MAXimize access to your product.

Preparation for Formal HTA Scientific Advice

Scientific advice to prepare your HTA submission
The HTA submission is a necessary step to provide policymakers, investors, and consumers with information on a new drug or medical device to inform reimbursement decisions. The HTA is a comprehensive assessment of the properties, and the effects, both direct and unintended, of a healthcare product. Its submission to the regulatory bodies governing your market is the first step in achieving reimbursement or recommendation for an introduction to that market.
We are proud to count among our team some of the best clinicians and research analysts in Europe, whose expertise has been proven over the years. They, along with other team members, will provide our clients with the support to succeed in this process by:

• Devising evidence generation plans: our scientific team will collate the evidence required to demonstrate the clinical effectiveness and safety of our clients’ products, as well as their cost-effectiveness.

• Conducting regulations compliance assessment: Our experts conduct research on the regulations a given health technology is subject to in target healthcare markets and formulate recommendations to ensure it is compliant and legally acceptable.

• Social and ethical impact assessment: Our team carefully assesses our clients’ health technologies’ social impact and ethical imprint to ensure that they are acceptable, not only by healthcare providers and clinical workers, but also by the public.

Critical Review of your HTA Submission

Our experts help our clients develop a solid portfolio of evidence materials to help achieve the optimal results from their HTA submission. Our HTA submission critical review service has been established to help our clients secure maximum acceptance, reimbursement, and profitability for their health technologies. Because we understand that such reviews are not “one-size-fits-all” processes, our consultants get to the core of your evidence to deliver you an accurate, tailored review of your material. They then formulate recommendations for you to improve your HTA submission case. For this, we conduct:

• Evidence assessment: We review the evidence materials that you currently have and assess their impact on your HTA results. We review clinical studies, social impact, and ethical assessment documents. These reviews enable our experts to present our clients with specific recommendations on how to better demonstrate the effectiveness, and cost-effectiveness, of their technology.

• Advise on dossier composition: It is crucial that the most high-impact evidence is presented in the correct manner, to highlight key benefits of the technology to HTA bodies. Our consultants perform extensive reviews and analyses of our clients’ HTA dossiers and assist them in compiling and presenting this information in the most appropriate way.

Review, Critique and Development of HEOR Evidence Generation Plans (e.g. clinical trial design and outcomes assessment/instrument selection, payer evidence planning)

Our multidisciplinary team can assist our clients in designing evidence generation plans with a view to producing the evidence required for subsequent HTA submissions. We assist our clients in:

• Clinical study design: It is important to generate robust data to demonstrate a product’s effectiveness and safety, and a well-designed clinical study is central to this. Our team of researchers and clinicians assist our clients in designing clinical studies from start to finish.

• Outcome assessment/instrument selection: Assessing appropriate outcomes and selecting the correct instruments and indicators to measure these outcomes is crucial for any research study. Our team will assist you in ensuring that the most relevant outcomes are explored in the most appropriate way.

• Payer evidence planning: Ensuring that your product is accessible to the maximum number of eligible health consumers begins with payer engagement. Compiling appropriate evidence is essential to secure engagement from payers. Our consultants assist our clients in devising payer evidence plans to generate the data that matters most for payers.

Review and Critique of Existing Economic Models and HTA Evidence materials

Health economic modeling is used to inform and aid decision-makers in healthcare. Health economic modeling helps decision-makers to understand the health-related and economic impact of a given medicine, device, or service on the healthcare sector and society in general. Health economic models can be used at different stages of health technology development to demonstrate a product’s potential cost-effectiveness. This presentation of cost-effectiveness is central to any HTA submission. Our team contains highly experienced health economists whose knowledge in the area has been proven over the years. Our experts review, make recommendations and support our clients’ existing HTA evidence materials and models including:

• HTA Modeling: Presenting your analysis results clearly and in a concise fashion, while ensuring that your analysis is clinically and methodologically robust. Your HTA modeling will be reviewed to make sure that it draws on the best modeling framework for different decision scenarios.

• Disease modeling: Demonstrating that your health technology will have an impact in slowing or eradicating the spread of a disease is an important consideration during the HTA submission process. Our experts will review your disease modeling and support its improvement.

Learn more about the Optimax Access modeling here.