What Is Market Access in Pharma and Why Is It Important?
Learning and understanding all things related to market access in health economics is a key factor in choosing the best therapy and the most suitable drugs for patients in an increasingly complex pharmaceutical industry.
An effective market access strategy could help pharmaceutical and biotechnology companies solve challenges pertaining to product pricing, perception of payers, and the creation of value for stakeholders for optimizing product commercial success.
Definition of Market Access in Pharma
Market access processes ensure that patients get the proper treatment and benefit from rapid and maintained access to drugs at the right price.
New medicines and healthcare services can be priced fairly and reimbursed with adequate market access planning. At the same time, pharma companies can create value by communicating essential information to stakeholders involved in the adoption and funding of drugs.
Why Is Market Access important?
In recent times, Health Economics and Outcomes Research (HEOR) has tried to breach the knowledge gap in the healthcare field.
The reasoning behind HEOR is that there is an absence of information about how treatments and clinical trials work and translate to the real-world setting.
As a result, pharma and biotech companies need to develop effective market access strategies to keep therapies, drugs, and solutions affordable for consumers while providing access to treatments as soon as possible. This is crucial in the healthcare systems of the United States and the European Union, but pharmaceutical market access is equally important in emerging markets.
Internal and External Market Access Processes
There are internal and external processes that impact market access. At a national level, it includes the health technology assessment (HTA); at the local level, Drugs and Therapeutics committees. In addition, the research and development processes guide investment decisions of drug development in order to manage the high costs.
Pharma and biotech companies may launch new products based on a commercial launch excellence process, which prepares them and the market for the branded product.
The value aspect of market access processes addresses the following elements:
- Identification of value based on payer customer insights.
- Communication of value to the R&D and commercial decision gates; thus determining what gets done and how.
- Creation of value using clinical and health economic outcomes and research (HEOR) data.
- Linking the global level requirements to the needs at the local country level.
- Adaptation to specific market access customers at national and regional levels, taking into consideration the uniqueness of each healthcare ecosystem.
It is worth noting that companies that operate outside the European Union and wish to release their batches of a medicinal product in any of the member states may face significant entry barriers. Companies need to obtain a certification from a Qualified Person (QP), who needs to be on a license known as a Manufacturer’s / Importation Authorisation (MIA).
Communication of Value to Healthcare Stakeholders
Before the patient population can have access to a drug, the manufacturers need to effectively communicate the value of the new medicine to their stakeholders. Pharmaceutical and medical technology manufacturers who seek to remain competitive need to demonstrate clinical and economic evidence to decision-makers, payers, and providers.
The process can differ considerably between countries. As an example, the role of the market access within this process can be described with the following steps:
- Regulatory approval. The manufacturer needs to obtain permission from regulators to sell the drug. For example, if the manufacturer is from the United States, it requires approval from the Food and Drug Administration (FDA), while the European Medicines Agency (EMA) supervises European manufacturers.
- National pricing and reimbursement. In some countries, the price and the target population need to be agreed upon beforehand so patients can access it.
- Local negotiations or prescribing guidelines. The decision-makers at a regional or local level, such as hospitals, and the local prescribing guidelines, can prevent access to a specific drug for various reasons.
- Clinician’s prescribing decision for an individual patient. Lastly, the clinician has the final word to decide whether to prescribe the drug to a patient. Previous patients’ responses, local guidelines, and other factors could influence the decision made by healthcare professionals unrelated to economic impact.
Market Access, Pricing, and Reimbursement Relationship
There is a close relationship between pricing, reimbursement, and market access.
- Market access makes sure that the drug can be prescribed to the appropriate patients.
- The pricing is the published price that needs to be paid to the manufacturer. Some countries set the price by looking at the prices of other countries, such as the United Kingdom, Germany, and France. Different elements can be added or subtracted from the price, such as discounts and agreements negotiated with the payer.
- The reimbursement ensures that someone prescribing a drug can be reimbursed for that expense. In short: gaining payment for the drug. Since health technology assessment systems (HTA) are applied differently in each country, it is constantly developing and changing.
Applications of Artificial Intelligence in Market Access
Speeding up the acquisition and analysis of medical evidence, clinical trials data, and market information will be at the center of the application of artificial intelligence (AI) in market access. AI could reduce several human-intensive hours and obtain further insights.
The increasing need for information to evaluate the clinical development process and the market access metrics of new drugs is an important aspect that machine learning can work on.
Industry experts can train machine learning models (ML) using real-world data and evidence to alleviate two challenges faced by companies: forecasting patient outcomes for a given treatment and defining clinically meaningful patient subgroups through clustering methods. However, the adoption of AI is in its early stages and will consequently produce new challenges and barriers both from an ethical and technical perspective—privacy being one of them.
The use of private data has dramatically increased in recent years, and medical data is susceptible to regulations and government oversight.
All data originating from health technologies, life sciences research, pharmaceutical research, and medical practice areas need extra consideration and strict procedures by market access teams using AI to protect people’s privacy.
Artificial intelligence will take a more active role in the healthcare industry. It will address more critical questions in the future, including algorithms that will be able to model patient outcomes and contribute to the relationship between pricing, reimbursement, and market access of medicines.