Welcome to the Frequently Asked Questions page of Justin Stindt Consultants, your expert consulting agency in the Pharma, Biotech, MedTech, and eHealth sectors. Here, we address common inquiries about complex market access landscapes, including the nuances of health technology assessments, pricing, and reimbursement strategies in various countries. As an international consulting firm, we aim to clarify the dynamics of drug and medical device market access, reimbursement processes, and the roles of pivotal agencies in different countries.
Specific Questions about Justin Stindt Consultants
1. What areas of expertise does Justin Stindt Consultants possess?
Justin Stindt Consultants is an agency specializing in the pharmaceutical, med-tech, and biotech industries.
Our company specializes in Strategy & Market Access advisory services for these industries. We have extensive international experience in all major EU markets, the USA, Japan and selected emerging markets, as well as a strong network of payers and clinical experts built and maintained via hundreds of engagements.
2. What differentiates Justin Stindt Consultants from other consulting firms?
Justin Stindt Consultants is an agency specializing in the pharmaceutical, med-tech, and biotech industries.
Our key difference is that we deliver specific, in-depth insight on payer-resonating evidence to create robust value propositions and strategies and we support their implementation. We are down to earth and work with clients of all sizes, from early-stage start-ups to global pharma companies.
Many of our consultants have experience working in the industry and we are used to working in a hands-on manner. Rather than just sending a report over and thinking “Job’s done”, we help our clients implement solutions. Whether this requires redacting e-mails to HTA bodies or accompanying clients to meetings with payers and HTA bodies.
Some clients even give us power of attorney to represent them in interactions with payers and HTA bodies, e.g. biotech clients who do not have employees speaking the local language. Our global network of payers, clinical experts, and partners enable us to provide support in all major EU markets, the USA, Japan and selected emerging markets.
3. Your expertise aligns with what I'm looking for. What are the next steps?
The easiest way to contact us is to click on the “Contact our experts” button at the top of our webpages. You can also contact us directly via our email address info@jstindt.com. Let us know how we can help you and we will be in touch shortly. If you are still interested in our services, we will create a project proposal which is always free of charge to match your expectations and to discuss the start of the project. There will not be any binding commitment until both parties sign a contract.
4. Does the agency only work in English?
Our services are typically delivered in English, but we have the capability to accommodate clients in French, German, Italian or Spanish.
Additionally, we offer translation services to convert documents from these languages into English or vice versa. For example, while P&R dossiers typically need to be submitted in the local language, we often elaborate draft versions in English to enable global teams to review & input and then translate into local language for submission.
General Questions: Market Access
1. What does market access entail in the healthcare industry?
Market Access encompasses all the essential activities required to facilitate patient access to medical products, such as medicines, medical devices, and life science technologies. This process involves identifying the needs of healthcare payers and devising solutions to address those needs. Market Access is intimately linked with the notions of Pricing & Reimbursement and Health Economics.
2. How can a company prepare for market access in the healthcare industry?
To prepare for market access, Justin Stindt Consultants recommends following these steps:
- Collect the right data: Identify how studies and other evidence-generation activities should be designed to yield data that will resonate with payers through payer advisory boards and scientific advice meetings with HTA bodies and KEEs
- Craft the Payer Value Proposition: Identify the value messages that will move the needle for key decision-makers to define the most compelling value proposition through payer research or advisory boards
- Define a P&R strategy: Assess payer willingness to pay for your product through analogue benchmarking, reference pricing and, ideally, payer research in order to achieve broad patient access at a sustainable price
- Articulate the Value Proposition: Develop and present a Pricing & Reimbursement / Health Technology Appraisal dossier that communicates the product’s value proposition to payer customers
- Identify and engage the relevant stakeholders: conduct a stakeholder mapping and build and execute an engagement plan
- Navigate the HTA and price negotiation processes: Prepare for and participate in the Health Technology Appraisal and price negotiation processes until the signature of an agreement and publication of the approved P&R conditions
3. Why is it crucial to thoroughly prepare for a market launch in each country?
It is important to prepare for a market launch in each country because different countries have varying requirements, processes, regulations, legal frameworks, market opportunities, and payer priorities and expectations.
Proper preparation ensures that a product can effectively navigate these unique challenges. For example, while countries such as France and Germany place highest emphasis on comparative clinical effectiveness, other markets such as the UK focus on cost-effectiveness / cost-utility assessments.
4. Why should a company prioritize market access early in its product development phases?
A company should prioritize market access early in its product development phases because it significantly impacts the success of pricing and reimbursement for the product. Early in the lifecycle of the product, companies decide what evidence will be collected and how. It is crucial at this point to ensure evidence collected will resonate with key HTA decision-makers which will positively impact their willingness to pay.
Understanding the payer perspective early on is also essential for companies trying to prioritize indications. The earlier market access considerations are incorporated, the more flexibility a company has to adapt its strategies and evidence-generation plans to meet payer and market demands effectively in terms of pricing, reimbursement, and access to the product.
5.Why should a Market Access strategy be planned in advance by a healthcare company that intends to out-license its product?
Market Access activities should be prioritized early in the product development phases to optimize the P&R potential and avoid access delays (some activities are country-specific and require substantial lead time to complete) that could hamper negotiations with potential partners.
Furthermore, being able to understand the willingness to pay for its products (the P&R potential) enables a company to forecast the potential sales/cashflows to estimate the value of its product in order to negotiate the out-licensing agreement terms with its potential partners.
6. How long before launch should Market Access activities be started?
Industry best practice constitutes embedding the needs of payer customers right from the early stages of product development. When approaching the launch phase, several important preparations need to be made in advance to enter the market under the best conditions.
As a general rule, we recommend starting to plan early advice meetings 18 months before the start of the pivotal trial design, dossier preparation 24 months before the expected launch of the product, and a lead time of 6 to 9 months for other market access activities such as licensing and financing rounds.
7. Why should medical devices companies also prepare for their market access?
Obtaining the CE mark in Europe (the regulatory process) allows the medical device to be marketed in EU countries, but does not guarantee payers’ willingness to reimburse and pay. Therefore, medical device companies need to ensure that they have a compelling value proposition for payers so that they are willing to pay for the companies´ products.
They need to understand the value drivers for key decision-makers in order to assess whether their products meet the needs and expectations of decision-makers, or what evidence-generation activities would be required to meet those needs and expectations.
8. Are there early access program opportunities so that patients can have access to products prior to marketing authorization?
Early access programs and compassionate use initiatives provide patients with earlier access to medicines before full market approval. France and Italy have reimbursed early access programs while compassionate use can be accepted in many markets such as Germany. These programs also allow for further evidence generation in addition to earlier patient access.
Key definitions
1. What is a Payer?
A payer in healthcare sector refers to stakeholders who have a decisive influence over the pricing and reimbursement status of medicines, medical devices, and life science technologies. While some people argue that HTA bodies technically do not pay for healthcare products (and are rather payer influencers), they have a decisive influence on the P&R conditions and therefore fit our definition of payers.
2. What is a pricing and reimbursement (P&R) Dossier?
The dossier comprises a comprehensive compilation of evidence and documents required by the country specific authorities that provide crucial clinical and economic information about medicines, medical devices, and life science technologies.
The contents of the dossiers encompass administrative details, along with extensive data on the products’ therapeutic positioning, their value added (i.e. quality, safety, and effectiveness compared to the current standard of care), economic considerations (i.e. cost-effectiveness and/or budget impact), etc.
This information is required by HTA and price negotiation authorities in all markets, including the EU markets and the United States.
3. Who are TAEs/KEEs/KOLs?
Key Opinion Leaders (KOLs) / Key External Experts (KEEs) or Therapy Area Experts (TAEs) in the pharmaceutical industry are highly knowledgeable and respected specialists who engage with various stakeholders, for example professional societies developing treatment guidelines and as external experts for HTA processes.
They also provide invaluable insights to pharmaceutical companies to ensure that evidence generation activities and strategies reflect the latest state of scientific knowledge and treatment patterns. Justin Stindt Consultants engages with KOLs/KEEs/TAEs based on their expertise and as an important source of insight for pharma, biotech and medtech companies.
4. What is HEOR?
HEOR, or Health Economics and Outcomes Research, is a crucial function within pharmaceutical and life sciences companies.
Its main role is to provide evidence of the value of medicines, medical devices, and life science technologies to healthcare decision-makers. HEOR assesses the relationship between actual treatment outcomes and economics, usually considering clinical trial data, financial factors, quality of life, and patient satisfaction. Common outputs of Health Economics and Outcomes Research (HEOR) are cost-effectiveness or cost-utility models and analyses leveraged by decision-makers in the healthcare industry to inform their decision-making about medicines, medical devices, and life science technologies reimbursement and treatment accessibility.
5. What is compassionate use?
Compassionate use refers to the provision of therapy to a patient before it has received marketing authorization.
This approach is typically employed for patients with an urgent high unmet medical need (i.e. there are no viable alternative treatment options available and treatment cannot wait).
Regulatory agencies can approve these programs prior to Marketing Authorization if specific conditions are met. Patients are usually selected on an individual basis.
