Healthcare Market Access: Trends and Strategies for Pharma Companies
Bringing a new drug to market is a lengthy and expensive process that can take up to 14 years and cost up to $2 billion, according to 2022 data. The process involves several steps such as drug discovery, preclinical and clinical trials, regulatory filings and post-marketing surveillance.
Despite significant investment, more than one-third (36%) of all new products introduced to the market in the U.S. fail to meet expectations. One of the major factors that determine the success or failure of a product launch is the strategy and implementation of market access.
Market access in pharmaceuticals
Pharmaceutical market access means that manufacturers, distributors, and end users can freely sell and buy drugs in a country or region. This concept includes both physical and administrative barriers that can make medicines inaccessible to people.
Physical barriers include:
- Inadequate infrastructure (lack of pharmacies, distribution centers, warehouses and other facilities);
- lack of information about the availability of medicines in pharmacies, their prices and characteristics;
- difficulties in transportation of medicines to remote or hard-to-reach areas.
Administrative barriers include:
- licensing;
- the need to register medicines with state authorities;
- regulation of drug prices by the state.
If drug manufacturers and distributors cannot freely sell and buy medicines, it can make it difficult for people to access the medicines they need. This can lead to higher prices, a reduced range of products, and poorer quality of care.
On the other hand, pharmaceutical companies need access to the market in order to sell their products and make a profit. Without market access, companies will not be able to realize their potential and help people who need medicines.
Current trends in health market access
The healthcare market access field is constantly evolving due to a number of factors, including:
- technological innovations such as digital therapies, artificial intelligence (AI) and machine learning (ML);
- value-based pricing – payers are increasingly demanding pricing for new healthcare products and services;
- patient empowerment – patients are becoming more informed and involved in their own medical decisions;
- health technology assessment (the process of evaluating the clinical, economic, and social impacts of new health technologies) – payers are increasingly using HTA to inform their reimbursement decisions.
The changing healthcare landscape has a number of implications for market access. Here are some of the key trends in healthcare market access to watch for in 2023 and beyond:
Digital Therapeutics Development.
Digital therapeutics are software applications that are used to treat, control or prevent disease. They are becoming increasingly popular as a way to provide more personalized and convenient patient care. Market access teams should be prepared to support the launch and reimbursement of digital therapeutics.
Using AI and MO to improve market access outcomes.
AI and MI can be used to improve market access outcomes in a variety of ways, such as by identifying new market opportunities, predicting payer coverage decisions, and developing more effective market access strategies. Market access teams that can leverage AI and ML will have a competitive advantage.
Patient Engagement.
Patient engagement is essential to successful market access. Market access teams need to develop strategies to reach and engage patients and understand their needs and preferences. This will help them develop more effective market access strategies and improve patient outcomes.
Value-based pricing.
Market access teams now need to be able to demonstrate the value of their products in order to be reimbursed. This means they need to collect and analyze data on the clinical and economic outcomes of their products. They must also be able to clearly and concisely communicate the value of their products to payers.
Health Technology Assessment (HTA)
HTA has a number of implications for market access. First, it means that market access teams must be prepared to submit their products for HTA consideration. This requires them to collect and analyze a wide range of data on the clinical and economic outcomes of their products. Second, market access teams must be able to communicate the results of OMT reviews to payers in a clear and concise manner.
In addition to these trends, market access teams also need to be aware of the specific challenges facing the healthcare industry in their region or country. For example, in the United States, market access teams are facing increasing pressure to reduce healthcare costs. In Europe, market access teams face challenges due to the fragmentation of the healthcare system (the European healthcare system is made up of different national systems, each with its own rules, policies, and reimbursement mechanisms).
Strategies for pharmaceutical companies to gain market access
Experts in pharmaceutical market access consulting suggest using various strategies to gain market access for pharmaceuticals. Some of the most common strategies include:
Early engagement with payers
Engaging with payers early in the drug development process can help pharmaceutical companies understand payers’ needs and priorities, and design clinical trials that generate the data payers need to make positive reimbursement decisions.
Use of evidence-based data
Real-world evidence (RWE) is data on the utilization and effectiveness of health care products and services in real-world settings. RWE can be used to support market access efforts by demonstrating the value of a new drug, identifying patient populations with the greatest unmet needs, and monitoring the safety and effectiveness of the drug. Evidation, a platform designed to support clinical trial recruitment, enables researchers to not only identify and recruit suitable participants but also gather real-world, ongoing data throughout the study. This real-time data collection allows for more dynamic and adaptable trial designs, improving both enrollment rates and study outcomes.
Optimize pricing and reimbursement
Pharmaceutical companies need to carefully consider pricing and reimbursement strategies to ensure that their drugs are affordable and accessible to patients. This includes understanding payer reimbursement criteria, gathering evidence to support amount claims, and effectively negotiating with payers.
Access to key opinion leaders (KOLs)
KOLs are healthcare professionals with expertise in a specific disease area or area of therapy. KOLs can play an important role in shaping market access strategies by influencing payer decisions and shaping patient acceptance.
Market access partnerships
Pharmaceutical companies can partner with a variety of healthcare stakeholders, such as payer organizations, healthcare provider organizations, and patient advocacy groups, to improve market access for their drugs.
In addition to these specific strategies, pharmaceutical companies also need to develop a robust market access strategy tailored to their specific products and markets. This strategy should identify key stakeholders, key challenges and key strategies to overcome them. Pharmaceutical companies also need to invest in the people and resources they need to effectively implement their market access strategies.
Case studies
Market access strategies are crucial for pharmaceutical companies as they ensure the success of new therapeutic drug launches.
A prime example of a successful market access challenge is Novartis and its drug Kymriah. Kymriah is a CAR-T cell therapy developed by Novartis for the treatment of acute lymphoblastic leukemia (ALL). Kymriah is a very expensive drug and Novartis has faced significant challenges in gaining market access for it. In addition, patients were unable to receive the drug at the beginning of the launch due to manufacturing failures.
Novartis utilized a number of strategies to address these challenges, including:
1. Early engagement with payers. Novartis engaged with payers early in the development of Kymriah to understand their needs and priorities. Novartis also worked with payers to develop value-based pricing and reimbursement models.
2. Obtaining real-world data. Novartis collected real-world evidence to demonstrate the clinical and economic value of Kymriah. This evidence included survival data for patients treated with Kymriah and cost savings associated with Kymriah treatment.
3. Patient Assistance Programs. Novartis established a program to help patients who could not afford to pay for Kymriah treatment. This program helped to improve patient access to the Kimria clinic and reduce Novartis’ treatment refusal rate.
As a result of these strategies, Novartis was able to gain market access for Kymriah. The drug is now available to patients in a number of countries and has become the standard of care for ALL treatment.
This is just one example of a company successfully addressing market access issues. There are many other examples and the strategies used vary depending on the specific product and market. However, the key to success is developing a robust market access strategy and engaging payers early in the drug development process.
Conclusion
Market access is critical to the success of pharmaceutical companies. It affects the ability to introduce innovative products and services, as well as the ability to compete and deliver value to patients. Companies that fail to effectively access the market risk missing out on opportunities for growth and development.
In addition, the healthcare market is constantly changing, and companies that do not adapt their strategies may find themselves falling behind. Information on the latest trends and innovations in the field is a key resource for making informed decisions.
