27 February 2013

Pharmacoeconomics of personalized medicine

Personalized medicine: Healthcare of the future?

Galina Galkovskaya, "Weekly Pharmacy" www.apteka.ua according to the materials www.sciencebusiness.net ; www.who.int ; www.cost.euPersonalized medicine is a relatively new direction, implying the use of methods of patient–oriented therapeutic and diagnostic impact.

In other words, this is a targeted diagnosis and treatment of the patient in accordance with the results of the study of his genetic profile. Personalized medicine is based on modern technologies (genetic, pharmaceutical, diagnostic and information and communication), and its main task is the individual treatment of the patient within the public health system. Instead of the somewhat outdated "one medicine for all" approach, doctors use information about the human genome, molecular markers of specific diseases when conducting targeted therapy and optimizing treatment strategies. It is expected that the implementation of these approaches in the long term will contribute to significant cost savings, however, at the first stage of the introduction of personalized medicine, healthcare costs will significantly increase, which is the main barrier to its implementation.

It is known that some medications can be effective for one patient and have virtually no effect on the condition of another. The reason for this is the genetic characteristics of patients that affect the metabolism of drugs. One of the most interesting areas of medical development is treatment based on the individual characteristics of a person's genetic profile. It is likely that in the future treatment regimens will be formed based on these data. However, personalized medicine is not only targeted therapy, but also a whole range of actions aimed at identifying the risks of developing certain diseases at a time when a person is still healthy, and the implementation of measures that contribute to the preservation of his health.

Currently, the barriers to the introduction of personalized medicine are quite large. Among them, the increase in diagnostic costs, the need to equip medical institutions with modern equipment that will provide adequate information and communication support. For this reason, it is important to understand what benefits for healthcare will be provided by the implementation of personalized medicine.

This publication examines 2 serious socio-medical problems highlighted in the Vlerick Leuven Gent study – breast cancer (breast cancer) and acute coronary syndrome – in the context of the introduction of personalized medicine. The choice of these objects is determined by different mechanisms of pathogenesis, and therefore by the approaches used in such diseases: genetic factors play an important role in the development of breast cancer, while in the case of acute coronary syndrome, the fundamental factor is the patient's lifestyle. This will allow us to consider a wider range of approaches used in personalized medicine, as well as evaluate their positive and negative sides.

In the studies below, one of the main tools of the Health Technology Assessment method will be used – the returned year of full life (quality-adjusted life year – QALY), as an integrated indicator of the effectiveness of treatment. QALY 0 means a fatal outcome, and QALY 1 means a saved year of full life. This indicator is used as a unit of measurement that allows you to justify the choice of different treatment methods with different costs.

The RMJ modelIn the breast cancer model, the goal was to use "smart" diagnostic approaches to stratify patients into different risk groups.

The simulated system was aimed at: identifying women with an early stage of the disease and treating them with modern methods that allow achieving a good effect; reducing the costs of the healthcare system due to early diagnosis of this pathology; reducing the number of patients with late-stage breast cancer, whose treatment requires high costs.

The study used data obtained in the UK, since in this country all women over the age of 50 must undergo regular screening. When identifying the risk of developing the disease, the patient was referred for additional tests, based on the results of which, if necessary, additional diagnostic studies or treatment regimens were prescribed.

The results of the analysis of the personalized breast cancer treatment model indicate the possibility of significant cost savings due to the introduction of a stratifying system that will allow patients to be divided into risk groups, as well as justify reducing the frequency of screening for those patients whose risk of developing the disease is low. In addition, such a system will focus on women with identified risk factors, such as family history or mutations in the genes responsible for the development of breast cancer.

Stratification into risk groups was carried out taking into account indicators of genetic risk and medical history containing complete information about the patient's health status, using a special program that analyzes risks in automatic mode. To identify the genetic risk of developing the disease, the SNP test (Single nucleotide polymorphism diagnostic test) was used - a genetic test that allows detecting mutations in certain genes.

Simulation models were formed on the basis of the 2011 guidelines on breast cancer therapy adopted by the National Institute for Health and Quality of Care in the UK (National Institute for Health and Clinical Excellence). The researchers assumed that at the beginning all the women were not ill with breast cancer. Under the given initial conditions – 100 thousand patients and the duration of the program – 25 years, in this model it was demonstrated that the average cost of breast cancer treatment decreased by 37% (Fig. 1). In total, according to this model, savings of 84 euros per year per 1 patient can be achieved. However, taking into account the fact that today mortality from breast cancer in developed countries is lower than it was before, the impact of this approach on the health of the entire population is not significant: only a slight increase in QALY indicators over 25 years has been noted (Fig. 2). How can this be explained?


The average cost of treatment of 1 patient with breast cancer for 25 years
Source: research "Health for All, Care for You", Vlerick Leuven Gent School of Management


QALY indicators in the treatment of breast cancer for 25 years
Source: research "Health for All, Care for You", Vlerick Leuven Gent School of Management

A significant reduction in costs is associated with more active involvement in the treatment of women in the early stages of the disease, which, accordingly, allowed to reduce the number of patients with late stages of breast cancer, the cost of therapy of which is significantly higher. In particular, cost reduction became possible due to the fact that when using this approach, there was a significant decrease in the number of patients with late-stage breast cancer with metastases (by 62%), and the number of identified patients with a precancerous condition also increased (by 56%). In addition, the use of chemotherapy decreased by 19%. And the use of radiation and hormone therapy in the early stages of the disease increased by 75%.

However, due to the fact that modern expensive methods of treatment (therapy with the use of monoclonal antibodies) are quite effective, the impact of this approach on the survival of women in a multi-million population remains hardly noticeable.

What conclusions can be drawn about the value of personalization in breast cancer? The above technologies are a cheaper way to combat breast cancer. The resulting result, in terms of survival, will remain at the same level, but the cost of treatment will significantly decrease, which is important for the budgets of health systems. In addition, computer modeling demonstrates that "smart" diagnostics contributes to better detection of the disease in the early stages, when breast cancer is easier to treat.

Model of acute coronary syndromeIn the acute coronary syndrome model, it was analyzed whether personalized measurements at the stages of examination and follow-up could help reduce the number of patients requiring intensive care.

Undoubtedly, an active lifestyle plays an important role in preventing the development of acute coronary syndrome. In light of the fact that each patient has his own risk profile, the ability to prescribe special exercises in combination with new diagnostic and monitoring technologies can take treatment to a new, more personalized level. The study examined the impact of 3 factors on the costs of healthcare systems and the health of patients: an active lifestyle, GROWTH (Point-of-care testing – a bedside test) and remote monitoring. The main goal was to divide patients with chest pain into those who are at risk of developing acute coronary syndrome and those who do not need resuscitation. Various studies have demonstrated a significant reduction in the number of cases of acute coronary syndrome by an average of 10% due to an active lifestyle. Educational campaigns aimed at popularizing such must be implemented for a long time in order to be effective, and this, in turn, requires considerable costs.

POCT is a new approach that allows diagnostics to be performed directly at the place of treatment and not to refer the patient to a medical institution, which is important not only from the point of view of reducing diagnostic costs, but also from the point of view of increasing the number of patients committed to treatment.

Remote monitoring is especially important for people who have suffered acute coronary syndrome, since they are at risk of developing a recurrence. Adherence to statin treatment in order to reduce cholesterol levels in the blood is an important element in preventing the development of the disease, but, unfortunately, patients often neglect doctor's prescriptions, because it takes a considerable time to achieve the desired effect. In this context, remote monitoring systems are especially important, providing automatic reminders and alerts to medical staff in case a patient is at risk of developing a recurrent complication from the cardiovascular system in the form of acute coronary syndrome.

The researchers estimated that monitoring 1 patient will cost 1.2 thousand euros per year and will reduce the number of hospitalizations by 10%. At the same time, doubling compliance (compliance – the degree to which a patient fulfills a doctor's prescriptions; measured as a percentage, for example, by the ratio of the number of prescribed and actually taken pills – VM) from the current level of 34% can have a significant impact on the cost of treatment.

The model showed a reduction in the cost of treatment of each patient by more than 3 thousand euros (46%) compared to the existing system (Fig. 3). At the same time, the annual QALY indicator in the simulated system was 3.6% higher compared to the existing one (Fig. 4).


The cost of treatment of 1 patient with acute coronary syndrome for 25 years
Source: research "Health for All, Care for You", Vlerick Leuven Gent School of Management


QALY indicators in the treatment of acute coronary syndrome for 1 year
Source: research "Health for All, Care for You", Vlerick Leuven Gent School of Management

In the simulated population, there was a significant increase in the number of people who managed to avoid the development of acute coronary syndrome (250%). The decrease in the number of cases of unstable angina was 13%, stable – 15%. In addition, a 15% decrease in the number of emergency calls was shown; 59% – angioplasty operations; 17% – shunting; 14% – the use of medicines. The number of patients in need of rehabilitation in specialized centers decreased by 13%.

The study shows that remote monitoring is especially important for patients who have suffered acute coronary syndrome. It should be noted that the greatest savings can be achieved by using remote monitoring: when investing 160.5 million euros per year on equipment, a total of 824.5 million euros can be saved over the same period.

General conclusionsThe above points to the different importance of personalization in cardiovascular diseases and breast cancer.

As this study has shown, prevention is more significant in the context of cardiovascular diseases, and not only the possibility of saving money, but also a positive impact on health is noted.

Thus, when forming a business project of a personalized healthcare system, it is necessary to take into account that the timing of the implementation of programs (and, consequently, profit) will vary depending on the spread of certain diseases, as well as providing the population with medical care. When using these models in practice, the benefits obtained will be greater than those shown in the simulation, since the researchers did not take into account some parameters, in particular the impact on the economy of how many people remained healthy and capable of full-fledged work.

The main advantages of personalized medicine are to reduce the costs of the healthcare system in the long term and improve the health of the population as a whole. The latter can be achieved by stratifying patients into different risk groups, where low-cost methods of prevention or treatment can be applied at early stages. Thus, it is possible to achieve a reduction in the number of patients who need expensive treatment of certain diseases at late stages, which in general will contribute to reducing costs in the health sector and improving the health of the population.

Portal "Eternal youth" http://vechnayamolodost.ru27.02.2013

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