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Market Access

Why was Market Access born?

equipo2

Camilo Castañeda MD
Neurologist
President Ispor Colombia
Project director
NeuroEconomix

Why was the market access born? What new demands and challenges within health systems led to its development? What disciplines nurture it? And why is it so important to show the value of a health technology?

Since the late 1990s, countries around the world have strengthened their policies to optimize the use of resources, especially regarding the containment of health spending.

 

They have achieved this by incorporating strict measures for the recognition and payment of new molecules, among which the following stand out:

 

  1. Establishment of requirements for the marketing of drugs, such as efficacy and safety (1),
  2. Economic evaluation in health
  3. Requirement of certificates of Good Manufacturing Practices,
  4. Price regulation at different points of technology management (2,3).

 

With the appearance of controls and standards related to the clinical practice of health professionals, the generation of protocols and clinical practice guides, and the production of new technologies that provide greater therapeutic value, it seeks to optimize the use of resources when within health systems and extend coverage to patients.

 

This has clearly represented an important challenge for the pharmaceutical sector, since it must:

  1. Innovate faster
  2. Be rigorous in showing value therapeutic treatment of its products, with technical arguments, to regulatory entities.
  3. Adapt to each country's pharmaceutical policy (4), especially pricing, and remain sustainable and indeed profitable (5).

 

In this search for alternatives to stay in the market competitively and profitably, pharmaceutical companies have developed new areas within themselves, with an interdisciplinary nuance, that allow them to adapt intelligently to changes in health systems - enter them and stay, efficiently- (3).

 

These new areas, which arise from articulating different technical, legislative, and commercial elements within pharmaceutical organizations - and which have the mission of guaranteeing a access effective and sustainable market for health technologies - they are called departments of Market Access.

 

The concept of Market Access (MA) It was first introduced by the World Trade Organization, defining it as the competitive market relationship between local products and products imported into a country.

 

The objective of defining and developing this concept was to define rates and regulations that would allow regulating the entry of new goods to the market of a nation in a competitive manner (5).

 

This concept was quickly adopted in the pharmaceutical sector with regulations such as health registries, which allow products, both national and foreign, to be marketed in a market under more or less equal conditions, with some differences inherent to management, such as costs. import and some specific rates for certain products (5).

 

Access to the health market has great challenges since it has important differences with other sectors and markets in a society. Here I outline some differences:

 

I warn, for the most purists, that all of them have exceptions.

 

  1. The one who orders the medicine (doctor) is not the same one who pays for it (government, most of the time), nor the same one who takes or applies it (patient).
  2. There is asymmetry of information and training. Through more searches on Google and social networks, the doctor was trained for about a decade and in most cases knows more about the disease and treatment than patients. Obviously, it must be recognized that the digital age has made patients much better informed and key players in decision-making in health.
  3. The primary objective of the health sector is not to be profitable (or at least it should not). The main objective is to give well-being and health to a population. Clearly, all healthcare systems aim to be efficient and sustainable.
  4. Consuming services and technologies from the health sector is not a pleasure that people seek. Most of the time it is due to a need. In other words, an illness or disease appears to a citizen and the person needs to be diagnosed and treated appropriately. No one (or at least almost no one) goes around looking for a colonoscopy just for the fun of it.

 

Along the same lines as the previous point, there are health systems or models based on prevention. They implement their strategies focused on preventing these "ailments and diseases" from arriving. This makes people less sick and live better and, in some cases, consumes fewer resources.

 

Different authors have defined MA in the pharmaceutical and medical device sector. For example, Kumal et al. define MA as the process that ensures that all patients have rapid and continuous access to the appropriate treatment at the right price (3).

 

 

 

For their part, Dixon et al. define OM as a set of strategies, activities and processes that the pharmaceutical and medical device industry develops to ensure that their products are recommended, available and priced appropriately for a specific healthcare system (2).

 

In any case, the MA is a work area multidisciplinary, where different functions of the companies intervene, such as:

 

  1. Supply Chain,
  2. monitoring and compliance with regulatory matters,
  3. the generation of tools and the search for clinical and pharmacoeconomic evidence,
  4. marketing,
  5. commercial channels and key accounts (2,3),
  6. negotiation strategies

 

The integration of different actors in OM management does not only occur within pharmaceutical companies; externally, different actors are also integrated (see figure 1) (3).

 

Actores-gestión Market Access

As can be seen in the figure, in recent years, with the inclusion of new actors in the management of health technologies, such as patients, unions and civil society, the newly developed area of MA has evolved with speed, changing the way decisions are made, from a traditional price-based perspective, to a new perspective based on therapeutic value (3).

 

MA strategies are complex and dynamic. These change according to the therapeutic area of interest of each company. Research in this regard shows how treatments for metabolic diseases that affect a large population and whose clinical benefits do not vary much between therapeutic alternatives, require very different access strategies to cancer treatments that are expensive and whose effectiveness can vary significantly between different types of tumors (6).

 

In conclusion, the area of Market Access A pharmaceutical company must develop multidisciplinary strategies that allow it to capitalize on the opportunity to enter a particular market with a specific product.

 

You will need to identify the key stakeholders and understand what structure of access it is appropriate, measurable and sustainable.

 

In addition, it must face the challenges of its implementation. Both the strategies and their implementation must evolve and adapt to changing health systems and environments, especially in Latin America.

 

All this in order to add real value for patients, obtain this recognition from different decision makers, as well as remain competitive and profitable over time..

 

It is clear that the birth of OM is associated with the need to reconcile and respond to several elements:

 

  1. A dizzying increase in innovation in health, tied to a rising cost of these technologies and services.
  2. The need for health systems to optimize patient outcomes and use of resources.
  3. The need to demonstrate value with increasingly technical arguments, coming from disciplines such as evidence-based medicine and pharmacoeconomics.
  4. The emergence of new relevant actors and decision makers in the health sector with particular interests and incentives (6).

 


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References

1. Kahveci R, Oortwijn W, Godman B, Koç EM, Tibet B. Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries. In: SEEd srl, editor. Pharmaceutical Market Access in Developed Markets. Torino; 2018. p. 223–54.

2. Dixon T, Denny J, Nermeen A, Federico L, Hong L. Market Access, Pharmaceutical Pricing, and Healthcare Costs. Clin Pharm Educ Pract Res. 2019; 249–59.

3. Kumar A, Juluru K, Thimmaraju PK, Reddy J, Patil A. Pharmaceutical market access in emerging markets: concepts, components, and future. J Mark Access Heal Policy. 2014; 2 (1): 25302.

4. Serra-Bosch JC. Everything you need to know about Market Access and Institutional Relations. Domínguez J, Serra JC, editors. Profit Editorial; 2019.

5. Toumi M. Introduction to Market Access for Pharmaceuticals. Journal of Chemical Information and Modeling. Taylor and Francis Group; 2017. 287 p.

6. Siegal Y, Shah S. Optimizing market access How therapeutic area dynamics could influence strategy. Deloitte Insights [Internet]. 2019; 45 (1): 150–9. Available from: https://www2.deloitte.com/us/en/insights/industry/life-sciences/pharmaceutical-pricing-market-access.html

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