Healthcare Market Access in Pharma & Medical Devices

"In international trade, market access refers to a company's ability to enter a foreign market by selling its goods and services in another country." [1]

Market access in the pharmaceutical industry means the ability for a medical product to be available for sale to end users, such as patients, physicians, or hospitals. It also means that the product is reimbursed either fully or partially by the payer.

"Pharmaceutical spending in the United States, Canada, and the EU is growing. Public payers cover a large portion of these costs and have responded by instituting various pricing and access policies to limit their expenditure." [2]

In order for a medical drug to be allowed to be marketed, it must go through a complex and time-consuming process of registration and approval from regulatory agencies, such as the FDA in the United States or the EMA in the European Union. Once approved for use in the EU each country's HTA body will then negotiate on price and conditions for market entry.

Market access consultancy in the pharmaceutical industry is critical to the success of the drug and the manufacturing company because it facilitates the ability to better design effective commercialisation and communication pathways for patient access to healthcare products.

Global market access enables pharmaceutical companies to make their drugs and technologies available to patients in different countries at the right price. For patients, market access to pharmaceuticals means access to evidence-based treatments and technologies that can help them manage their diseases or improve their quality of life. The need for access to pharmaceuticals, especially for patients with chronic diseases, can be critical to maintaining their health and prolonging their lives. However, high drug prices and difficulty accessing medications can limit patients' ability to get the treatment they need in time.

The market access procedure is an important mechanism that helps improve patient care and contributes to the development of the pharmaceutical industry as a whole:

• The market access procedure allows companies to market their products, which increases the availability of drugs and medical technology for patients. This is especially important for those patients who suffer from rare or severe diseases (ex. oncology) for which there are not enough drugs available.
• To get access to the market, companies have to do a lot of research and testing to prove the effectiveness and safety of their products. This helps improve the quality and effectiveness of drugs and medical technology, which increases their effectiveness in treating diseases.
• Market competition encourages pharmaceutical companies to innovate in the development of new drugs and medical technologies. This creates more effective and safer products, which improves patient care.
• Competition. High levels of competition in the marketplace can make market access difficult for new manufacturers or limit market access for existing manufacturers.
• Market access can reduce the cost of drugs and medical technology through competition among manufacturers. This can help patients who cannot afford expensive drugs get the treatment they need.

Global market access for pharmaceutical products can be limited by a number of factors, including:

• Legislative regulation. Different countries and regions have different regulations and procedures for the registration and evaluation of pharmaceutical products, which can make market access difficult. In some cases, regulations may be too strict, which can lead to delays in bringing new products to market.
• Intellectual Property. The availability of patents and other intellectual property rights can limit market access to other manufacturers, which can increase the price of products and reduce their availability.
• Finance. Developing and launching new pharmaceutical products is a costly process that requires significant investment in research and development as well as manufacturing and marketing. This may result in some products not being available to most patients.
• Competition. High levels of competition in the marketplace can make market access difficult for new manufacturers or limit market access for existing manufacturers.
• Market conditions. Economic factors, such as market demand, may limit market access for some products.
• Technical Capability. Difficulty in producing certain products may limit market access for new producers or increase production costs.

Pharmaceutical companies face many barriers to market access. Among them are:

• Cost considerations and pricing pressures. Pharmaceutical companies face significant price pressures, especially from governments, insurance companies, and patients. High drug prices can be a factor that makes it difficult for patients to access the drugs they need.
• Obstacles related to reimbursement and coverage. Reimbursement and coverage systems are becoming increasingly complex. This can make it difficult to obtain funding and coverage for drug development and manufacturing.
• Increasingly complex regulatory requirements. The need to comply with regulations can significantly slow down the process of obtaining approvals to sell and distribute drugs.
• Changing healthcare policies and strategies can lead to changes in drug coverage as well as drug requirements. This can affect the availability and profitability of pharmaceutical products.

"Market access contracts have developed in this context of budgetary difficulties where the notion of opportunity cost has come into its own. Public payers have become increasingly demanding, both in terms of the level of residual uncertainty in clinical trials and the quality of evidence." [3]

Market access counselling helps pharmaceutical manufacturers in several ways:

• Market Potential Assessment. Consultants can conduct a market analysis and assess the potential for demand (number of patients) for a particular product or service. This helps manufacturers make informed decisions about entering the market and developing access strategy for their products.
• Preparation of necessary submission documents and product registration requests can speed up the process of obtaining marketing authorisation and allow a faster launch of the product in the market.
• Developing a pricing strategy, taking into account factors such as competitors in the market, production costs, and expected demand for the product. This will help determine the best price for the product and make it more competitive.

Consulting companies can also provide a wide range of digital tools to gain market access, including:

• Modeling. This is the process of creating mathematical models that can be used to predict clinical trial results, estimate drug costs and determine the most effective marketing and product promotion strategies.
• Data analysis and analytics using available machine learning and statistical analysis techniques to help companies identify trends and understand market needs.
• Estimating economic value. Consulting companies can conduct economic studies to determine the economic value of a product, including estimates of the costs and benefits associated with treating diseases that a new product is intended to treat.
• Communication support. Consultants can help manufacturers develop a communications strategy for the product, including developing messaging, training staff, and preparing presentations to regulators.

Digital tools can greatly improve the process of gaining market access for pharmaceutical products, making it more transparent and efficient.

Communicating value to healthcare stakeholders is the process of communicating to stakeholders how a new medical product can improve the quality of life of patients and what its economic benefits to healthcare are. It is an important step in gaining access to the pharmaceutical product market because healthcare stakeholders, such as insurance companies and government health authorities, can influence purchasing decisions about the product.

Communicating value can include:

• conducting clinical trials;
• cost-effectiveness demonstrations;
• evaluating economic performance and value modelling.

Market access consultants can help pharmaceutical companies develop value communication strategies and use digital tools to demonstrate product value.

"Efficiency and transparency of pricing and reimbursement (P&R) rules and procedures as well as their implementation in South-eastern Europe (SEE) lag substantially behind Western European practice. Nevertheless, P&R systems in SEE are rarely critically assessed, warranting a detailed and wider-encompassing exploration." [4]

Pricing determines how much a company can charge for its products. If product prices are too high, it can limit patients' access to treatment, especially if treatment is not reimbursed by insurance companies. In this case, the company could lose customers and revenue, which could affect their financial sustainability and ability to invest further in research and development. Companies need to make sure their price leads to cost-effective interventions being adopted.

Reimbursement determines how much of the cost of treatment will be covered by insurance companies and the government. If reimbursement amounts are low , it may limit patients' access to treatment, especially for those who do not have insurance or for those who live in poor countries. In this case, the company may face limited demand for its products, which could affect its revenues and opportunities for further investment in research and development.

Thus, companies must consider the relationship between pricing, reimbursement and market access to ensure that their products are available to patients, while maintaining financial sustainability and opportunities for further development. Digital tools, such as web-based health economic models and data analysis, can help in this regard by determining the optimal price for a product, which will allow the company to achieve product commercialisation while ensuring that the product is available to patients.

Digital tools can also collect and analyze information on the cost of treating different diseases and the reimbursement of treatments in different regions and countries. This will help companies determine the best pricing and reimbursement strategies for different market conditions and even different markets (countries).

In addition, digital tools can be used to conduct economic studies and assess the cost-effectiveness and budgetary impact of healthcare products. This will help manufacturers prove the value of their products to healthcare stakeholders and increase their chances of successful market access.

Market access is a key factor for pharmaceutical companies that want to provide patients with access to their products and treatments. However, this process is not always straightforward, forcing companies to employ various strategies to overcome barriers and gain market access.

Gaining market access for pharmaceutical products will help:

• Building strong relationships with payers and providers. Long-term partnerships allow companies to improve rapport with payers and healthcare providers, and convince them of the value of their products.
• Demonstrating the value and effectiveness of healthcare products. Companies must conduct research and demonstrate evidence-based clinical effectiveness and cost-effectiveness of their products to convince payers of their value.
• Investing in real-world evidence generation and research results. Investing in research and getting real evidence of the effectiveness of their products will help companies build trust in their products.
• Collaborate with patient groups and advocacy organizations to collect important insights and data for (Health Technology Assessment) HTA submission. This is necessary to understand patient needs and improve access to their products. Prepare a solid Health Economics and Outcomes Research (HEOR) strategy.
• Adopt and develop technological innovation. Using digital tools and technological innovation to streamline processes and improve the effectiveness of a company's value demonstration appeal to payers and healthcare providers. Digital tools are also becoming popular in the real world data (RWD) collection. "As of 2021 RWD and real-world evidence (RWE) appear now as complementary to traditional randomized controlled trials (RCT), that remain the gold standard of the evidence." [5]

Recently, there have been a number of new trends in market access for pharmaceutical products, which are related to factors such as:

• changing consumer demands;
• the development of digital health technologies;
• increased emphasis on patient-centered care and collaborative decision-making;
• the rise of value-based payment models;
• evolving regulatory frameworks and policies.
• emerging need to supply (RWD)

The growing importance of digital health technologies is becoming increasingly apparent in the field of pharmaceuticals. They are being used to improve the efficiency and accuracy of diagnostics, develop innovative medicines, and monitor the effectiveness of treatments. Digital technology is also reducing the time and cost of research and development of new drugs.

Increased emphasis on patient-centered care and collaborative decision-making is another important trend affecting the pharmaceutical industry. Most patients want to be included in decisions about their care and want their needs and preferences taken into account.

The rise of value-based payment models is an important trend in pharmaceutical market access. Such payment models are based on the premise that the payer, whether the government, the insurance company, or the patient themselves, pays for a drug not just because it is on the market, but because it actually benefits the patient and the health care system as a whole.[6])

Evolving regulatory frameworks and policies also play an important role in pharmaceutical market access. Policy decisions and regulatory changes can affect drug availability and pricing, as well as new drug research and development processes.

All of these trends suggest that consumers of medicines are becoming increasingly demanding about the quality and efficacy of medicines, as well as their availability and price.