Sustainable Development of the Health System through the Prism of

Patient Participation in HTA in Bulgaria

Claudia I. Georgieva

, Antonia Y. Yanakieva

and Alexandrina Vodenicharova

Department of Health Technology Assessment, Faculty of Public Health, Medical University - Sofia, Bulgaria

Keywords: Patients, Health Technology Assessment, Sustainable Development, Health System.

Abstract: Background: Several countries worldwide are developing policies aimed at patient participation in healthcare

as a critical element for sustainable development in the field. HTA is an essential part of sustainable

development strategies, and patient involvement as an expert is a mechanism for ensuring transparent, fair,

and equitable healthcare. Aim: The study aims to determine the readiness of patients and patient organizations

in Bulgaria to be included in the HTA process and outline the challenges for their implementation. Materials

and Methods: The study was based on two questionnaires conducted from September 2019 - May 2020. They

involved 563 patients and 53 patient organizations in the Republic of Bulgaria. Various analytical approaches

have been applied for data processing. Results: Patients in Bulgaria are willing to participate in the HTA

process. The survey proves that 67.1% of the respondents would participate in training organized for them.

64.2% would meet with representatives of the HTA institution. 61.2% are willing to assist in the preparation

of HTA strategies and work plans. The main challenge for implementing patients in the process is the low

level of competence in the field, which does not allow equal participation in HTA. For this purpose, it is

necessary to conduct training campaigns and promote the process among patients in our country and allocate

funds to support the inclusion of patients in HTA. Conclusions: Stimulating close cooperation between

patients, HTA institutions, manufacturers, and users of health technologies is the basis for the modern health

system's sustainable development.

1 INTRODUCTION

The sustainable development goals are now steering

the global health and development agendas (Hone,

2018). There is an extensive body of literature

available on sustainable development. Definitions

vary, but in the main they draw out environmental,

economic and social dimensions of the concept,

emphasizing that progress to date has been achieved

at huge cost. The 2005 UK sustainable development

strat- egy sets out five principles (HM Government.

Delivering sustainable development together: shared

UK principles for sustainable development, 3 March

2021) which resonate strongly with the practice of

public health:

 living within environmental limits;

 ensuring a strong healthy and just society;

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https://orcid.org/0000-0002-3738-6598

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https://orcid.org/0000-0001-6418-2788

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https://orcid.org/0000-0002-4133-0132

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 achieving a sustainable economy;

 promoting good governance;

 using sound science responsibly (Adshead,

2006).

Health status in general, as well as, the mortality

rate at various stages of life in developed, developing,

and least developed countries vary based on several

factors. The government/health insurance/private

funds (out-of-pocket, NGOs, private corporations)

spending in health (health expenditures) are few of

the factors that mortality rate varies greatly from

country to country (OECD. Health spending

(indicator), 3 February 2021).

Life expectancy, the morbidity of the population,

quality of life are among the indicators that determine

how effectively a health system functions

(Department of the Environment, Food and Rural

Affairs. Sustainable development indicators in your

Georgieva, C., Yanakieva, A. and Vodenicharova, A.

Sustainable Development of the Health System through the Prism of Patient Participation in HTA in Bulgaria.

DOI: 10.5220/0010586400730080

In Proceedings of the International Scientiﬁc and Practical Conference on Sustainable Development of Regional Infrastructure (ISSDRI 2021), pages 73-80

ISBN: 978-989-758-519-7

pocket. London, 27 February 2021). Among the main

goals of the National Health Strategy of Bulgaria is to

reduce mortality and increase life expectancy while

ensuring the sustainability of the implemented

measures and policies, allowing 2025 Bulgaria to

reach the current European average levels of

demographics (National Health Strategy 2020, 3

March 2021). One of the plan's priority policies to

achieve these objectives is to build and manage a fair,

sustainable development, and efficient health system

focused on quality and results (Ministry of Health of

the Republc of Bulgaria Action Plan for

implementation of the National Health Strategy 2020,

8 March 2021). One of the modern approaches for

implementing the development strategy is the

inclusion of the patient's experience and opinion in

decision-making at different health policy levels. The

process includes integrating patients' competencies at

various decision-making levels and other state

institutions, the National Health Insurance Fund,

HTA institutions, professional organizations, and the

non-governmental sector.

The concept of sustainable development health

care is defined by elements, among which the patient

occupies an important place, namely:

1. The health literacy of the population and the

resulting choices for leading a healthy lifestyle,

sharing responsibility for disease prevention, active

participation of patients in treatment, shared with the

professional skills and care of medical professionals,

skills and readiness for taking care of personal health;

2. Awareness of the population and knowledge of

the rights and obligations of patients;

3. Active participation of patients, which are also

leading aspects for establishing the concept of

sustainable development.

4. An adequate level of health literacy gives

patients self-confidence and confidence in dealing

with illness and making decisions concerning their

health. Personal choice is a leading moral aspect for

establishing the concept of sustainable development

healthcare development.

Health Technology Assessment (HTA) plays an

essential role in decision-making and the allocation of

available resources in modern health systems. Health

technology assessment (HTA) is the process of

systematic evaluation of the properties and effects of

health technology, focusing on its direct and expected

impact and its indirect and unintended consequences

(HTAGlossary, 27 February 2021). The goals of

HTA are achieved by assessing health technologies

against their clinical effectiveness, cost-effectiveness,

safety, social and economic characteristics (EUR-

ASSESS Steering Committee, 13 Desember 2020)

(Government of Australia. Review of Health

Technology Assessment in Australia, 16 November

2020). HTA has evolved as a key element to support

the distribution of healthcare budgets (Priftis, 2017).

In this sense, the HTA process is an essential part of

sustainable development strategies, and patient

participation as an expert is a mechanism for ensuring

transparent, fair, and equitable healthcare.

Specific practical benefits for the sustainable

development of the health system through the prism

of patient participation in HTA can be identified,

namely:

 Fairness - the status of patients as an equal

party in the HTA process, along with other

stakeholders and access to strategies that allow

effective engagement, would prove to the

general public that the decisions taken

regarding the evaluation and reimbursement of

essential health technologies are a fair and just

process;

 Equality - the participation of patients in HTA

contributes to the equality of all those in need,

understanding the specific health problems. In

a balanced health system, resources are

distributed fairly among all consumers;

 Legitimacy - patient participation in HTA

contributes to greater transparency,

accountability, and trust in healthcare decision-

making;

 Capacity building - overcoming the barriers to

patient participation in HTA and joint work

between patients and HTA institutions would

contribute to the sustainable development of

the field based on capacity building of experts

in HTA decision making (Guidance for patient

involvement in HTA, 20 September 2020).

HTA contributes to the distribution and

expenditure of financial resources in the health sector

in growing consumption conditions. The main idea of

the assessment is to give evidence-based point of

view to policy-making (Georgiev, 2017). The

inclusion of the patient as an equal party in HTA is

essential for achieving a balanced health system and

the sustainable development of health care in general.

That is why the present study focuses on patients in

Bulgaria. It is interesting to study their attitudes and

real opportunities for inclusion in HTA.

2 METHODS

The study aims to show patients' attitudes to

participate in the HTA process and the challenges

before their implementation. Involving patients in the

ISSDRI 2021 - International Scientiﬁc and Practical Conference on Sustainable Development of Regional Infrastructure

process would encourage open communication

between different stakeholders in HTA.

The object of this review is patients and patient

organizations in the territory of the Republic of

Bulgaria. The study is multicomponent and complex.

The first component includes research and

analysis of information provided by patients about the

HTA process in Bulgaria. We collected the data based

on a questionnaire in open pharmacies. The survey

questions were answered by 567 patients with various

diseases, giving information about their level of

awareness regarding HTA, their willingness to share

experience and point of view, and to assist HTA

institutions.

The second component includes a survey among

patient organizations in Bulgaria on their point of

view and position related to patients' inclusion in

HTA. Based on 53 responding organizations,

demographic characteristics, general knowledge, and

interest in HTA, activity in training, preparation of

reports, etc., were analyzed.

The survey was conducted in the period

September 2019 to May 2020. Various analytical

approaches have been applied for data processing.

Descriptive statistics are mainly used. Quantitative

variables are represented by the arithmetic mean

(Mean) - a characteristic for estimating the central

trend and a standard deviation (SD) - a characteristic

for estimating the scattering. For categorical

variables, the results are presented by absolute

frequencies (n) - the number of units in a single group

and relative frequencies (%) - the number of units in

a single group relative to the total number of units in

the population.

The Chi-square test or Fisher's Exact Test were

also performed - to study the relationship between

descriptive (category) data with two or more

categories. The study established a connection

between the survey's different questions by

determining Spearman's rho rank correlation

coefficient.

3 RESULTS

Surveyed patients were 567, of which 62.8% (356

patients) were men and 37.2% (211 patients) were

women. The average age of men is 45.03 years, and

women are 48.87 years (Table 1).

Table 1: Age and gender structure of the respondents (Mean

- arithmetic mean, SD - standard deviation, Min - minimum

value, Max - maximum value).

Gender N %

Age

Mean SD Min Max

Male 356 62,8 45,03 12,89 22,00 81,00

Female 211 37,2 48,87 14,21 18,00 86,00

Total 567 100,0 46,46 13,51 18,00 86,00

The majority of respondents have higher

education - 60.5%, 37.4% have primary, and 2.1%

have secondary education (Figure 1).

Figure 1: Educational status of the respondents.

The active patients who took part in the study

were mainly aged between 41 and 60 years. These are

people of active working age, carriers of the disease

(acute or chronic), or disease symptoms. The study

shows that patients with this profile would be most

useful for the HTA process.

To be included in evaluation procedures, it is

crucial to what extent the average patient is familiar

with HTA. 43% of respondents show a complete lack

of knowledge in the field, and 37.4% - "somewhat

low" awareness. The data show that most respondents

are not familiar with the concept of HTA (Figure 2).

Figure 2: Level of knowledge of the concept of Health

Technology Assessment.

Statistical analysis reveals a relationship between

the level of competence in the field of HTA and the

age of patients. The confidence interval p<0.001

indicates the result's statistical significance (Table 2).

2,10%

37,40%

60,50%

Primaryeducation

Secondaryeducation

Highereducation

Veryhigh

High

12%

Somewhatlow

37%

Missing

43%

Sustainable Development of the Health System through the Prism of Patient Participation in HTA in Bulgaria

The respondents indicate the highest level of

knowledge of the process under the age of 31. 14.9%

state that they have knowledge at a "very high" and

18.4% in a "high" degree. With age, the percentage of

patients who know the process to a more significant

extent decreases. Younger patients have greater

access to information technology and social

networks. This access allows easier finding of

information and communication with various

specialists, which is essential for higher competence.

There is a tendency for the age group of patients to

increase the percentage of respondents with "low" or

"missing" awareness in the field of HTA.

Table 2: Relationship between the level of knowledge of the concept of HTA and the respondents' age group.

Аge group

Up to

years

31-40

years

41-50

years

51-60

years

Over

years

Very high 13

(14,9)

(8,7)

(2,9)

(9,4)

(5,8)

<0,001

High 16

(18,4)

(18,3)

(5,0)

(8,6)

(10,5)

Somewhat low 20

(23,0)

(32,5)

(40,0)

(52,3)

(32,6)

Missing 38

(43,7)

(40,5)

(52,1)

(29,7)

(51,2)

Total 87

(100)

126

(100)

140

(100)

128

(100)

The situation is similar with patient organizations.

For most of them, the concept of HTA is relatively

little known. 38% show "low" and 10% "very low"

competence in the field (Figure 3).

Figure 3: To what extent is your organization familiar with

Health Technology Assessment?

The lack of knowledge and interest on the part of

patient organizations is mainly due to the fact that

they have not had contact or need so far to contact an

HTA institution. 67% of the respondents have never

participated or were not interested in HTA

procedures, and 19% have taken part in such activities

from 1 to 2 times (Figure 4).

Figure 4: Has your organization been directly involved in

making specific health technology assessments?

The results clearly show a low level of knowledge

of the HTA process by patients and patient

organizations in Bulgaria. The lack of information is

also the first challenge for the implementation of

patients in the process. It can overcome the Bulgarian

patient's low factual competence by organizing

training that will increase both their level of

competence and society as a whole. Only in this way

could the patient be an equal member of HTA

committees in decision-making and contribute to

sustainable development in the sector.

Several countries around the world are setting a

positive example in this regard. The Center for Drug

Evaluation (HTA) is the main body in Taiwan dealing

with HTA procedures in which the patient is active.

The institution organizes training seminars for

patients, focused on the legislative framework and the

rules for implementing HTA in the country. Part of

10%

38%

Ican'tjudge(therehasbeen

anysuchneedsofar)

Verylow

Low

High

Veryhigh

67%

19%

12%

Never

From1to2times

From3to5times

Оver5times

ISSDRI 2021 - International Scientiﬁc and Practical Conference on Sustainable Development of Regional Infrastructure

the initiatives to stimulate patient participation is the

convening of an international conference discussing

the global experience in HTA to support and promote

patient activity in local HTA procedures (Center for

Drug Evaluation (CDE), Taiwan, 20 September

2020).

The agency's main priority in Australia

(Australian Department of Health and Aging) is to

decide on the reimbursement of medical devices. The

country's health system's sustainable development is

linked to the profitable consumption of private health

funds. The patient's inclusion guarantees the

observance of public values and compliance with

ethical, legal, and financial norms. The HTA

institution finances a "Health Forum", where patient

representatives (based on illness, membership in

patient organizations) are selected to participate in the

HTA process. "Health Forum" is a place where

patients can exchange experiences with each other,

raise their awareness in the field, and get acquainted

with the methodology of HTA in an understandable

and accessible language (Government of Australia,

16 November 2020).

Of interest for the study is the extent to which

patients in Bulgaria have participated in decision-

making affecting their own health statuses, such as

upcoming manipulations, health activities, or choice

of health technology (Figure 5). 25.7% have never

faced such decisions, and 32.6% say they have met a

selection of different alternatives to a "low" degree.

25.9% were patients who reported a "high" degree of

participation in this type of activity.

Figure 5: Degree of participation in decision-making

concerning forthcoming manipulations or health activities

(needs) related to the patient's own health condition.

The analyzes established a statistically significant

relationship between the frequency with which

patients participated in decision-making and their

educational status (the level of statistical significance

p<0.001) (Table 3). Patients with the lowest

education level most often made decisions in a

"somewhat low" group - 75%. Among patients with

higher education, "high" and "somewhat low" activity

is reported to approximately the same extent when

participating in decision-making affecting their

personal health - 29.2% and 29.4%, respectively.

Patients with secondary education most often answer

"lack" participation in such activities - 36.8%.

Table 3: To what extent have you been involved in

decision-making concerning upcoming manipulations or

health activities (needs) related to your health condition?

Primary

education

n(%)

Secondary

education

n(%)

Higher

education

n(%)

Very high 2 (16,7) 13 (6,1) 74 (21,6)

<0,001

High 1 (8,3) 46 (21,7) 100 (29,2)

Somewhat low 9 (75) 75 (35,4) 101 (29,4)

Missing 0 (0) 78 (36,8) 68 (19,8)

Total 12 (100) 212 (100) 343 (100)

Trends show that the majority of patients have not

been involved in making decisions about their health.

The lack of such practices is dictated by established

medical institutions' policies or passivity on the part

of patients.

In order to be honored by experts in decision-

making, the patient must be willing to share personal

experiences and experiences gained in the course of a

disease or care to a loved one with specific disease

symptoms. 40% of patients state that they are fully

prepared, and 37.9% have a "very high" degree of

readiness to share their experience and opinion on

issues affecting their health. (Figure 6). There is a

willingness on the part of patients to openly share

their experience in different approaches to treatment

and therapy.

Figure 6: Willingness of patients to share experiences and

opinions about their medication or therapy.

It has been proven that in order to achieve

sustainable development in the field of healthcare

with the active participation of patients, it is necessary

to conduct training activities.

To the question "Do you want to participate in

pieces of training or seminars organized by an HTA

Very

high

16%

High

26%

Somewhatlow

32%

Missing

26%

Very

high

38%

High

40%

Somewhat

low

19%

Missing

Sustainable Development of the Health System through the Prism of Patient Participation in HTA in Bulgaria

institution?", 42.9% answered with a "high" degree of

desire to participate, and 24.2% have a "very high"

desire. "Somewhat low" and "no" willingness to

participate indicate 22.2% and 10.8%, respectively

(Figure 7). The majority of the surveyed patients

would participate in pieces of training organized by

an HTA institution. Patients today are open to new

knowledge. They want to enrich their healthcare

knowledge to more easily overcome the disease or

disease symptoms with which they live.

Figure 7: Patients' desire to participate in training or

seminars organized by the HTA institution.

The survey proves that 67.1% of all respondents

would participate in training organized for them,

64.2% would meet with representatives of the HTA

institution, and 61.2% are willing to assist in

preparing HTA strategies and work plans (Figure 8).

Figure 8: Willingness of patients to engage in activities

related to HTA.

To the question "What is your attitude to

participate in the Health Technology Assessment

process? 46.4% of the respondents give a "high"

answer. "Very high" is the attitude of 18.5% (Figure

9). The majority of respondents have a positive

attitude to participate in the process and are ready to

be involved as an active part in decision-making in

HTA.

Figure 9: What is your attitude to participate in the Health

Technology Assessment process?

The willingness of institutions to cooperate is

largely linked to the patient's desire for his voice to

be heard and contribute to the health sector's

sustainable development. The general attitude is that

the patient has the right to express their views on the

therapy and to share any inconveniences, side effects,

or unpleasant sensations during treatment. Patient

participation in HTA would lead to active

communication and dialogue with the specialist and

selecting the best therapeutic approach. Such an

attitude is precious for HTA institutions because the

inclusion of the patient's point of view ensures open

communication between stakeholders and ultimately

the most rational decisions in the field.

One of the next challenges to the useful inclusion

of patients in HTA is the lack of sufficient resources

(tangible and intangible). Patient organizations were

asked if they had the funds to fund staff to engage in

the HTA process activities. 86% of them state that

they do not have the financial means for such

activities. Only 14% of the respondents have the

necessary funds (Figure 10). Despite the availability

of time, desire, and human resources (patients,

members of the organization), this is not enough.

Additional funds are needed to engage staff to plan

and implement HTA methodologies in participation

in the process. Additional funds are required both for

a direct financial incentive for other staff and for

increasing the knowledge and competence in HTA

practices. Additional funding will allow participation

in training, seminars, purchase of specialized

literature, consulting, etc.

Figure 10: Does your organization have the resources to

fund staff involved in coordinating and contributing to the

Health Technology Assessment process?

Very

high

24%

High

43%

Somewhat

low

22%

Missing

11%

67,10%

64,20%

61,20%

Patientswouldliketake

apartintrainings

organizedforthem

Patientswouldliketo

meetwith

representativesofthe

HTAinstitution

Patientsarewillingto

assistinthepreparation

ofHTAstrategiesand

workplans

Very

high

18%

High

47%

Somewha

tlow…

Missing

14%

86%

Closertoyes

Closertono

ISSDRI 2021 - International Scientiﬁc and Practical Conference on Sustainable Development of Regional Infrastructure

In several countries, patient participation is

financially supported by providing fees for seminars,

transport costs, seat fees, hotel stays, etc. The Dutch

Health Care Institute (the Dutch HTA agency)

conducts an open and transparent process through

collaboration between patients and professionals,

ensuring the reimbursement of patient costs

associated with their involvement in the process.

Patient organizations were asked what they see as

a basic need in their organization for more effective

involvement in HTA. 52% categorically stating

"compiling registers of patients and their

diseases"(Figure 11). 31% believe that one of the

main needs of patient organizations to participate in

HTA is "increasing knowledge and competence in

HTA methodologies". Many believe that they need a

"financial incentive from public authorities to provide

information on HTA" - approximately 15%.



Figure 11: What do you see as your organization's basic

needs for more effective involvement in HTA processes?

4 DISCUSSION

The main goal of the HTA process is to provide

quality, safe and effective health technologies in the

presence of limited resources. Decision-making in

HTA must ensure optimal spending of the financial

resources available to a country's health system. At

the same time, society's vital needs must be met,

which will ensure the health, prosperity, and well-

being of citizens, which is the basis for the sustainable

development of health care in modern countries.

Involving the patient in the HTA process is key to

achieving the principles of sustainable development

in healthcare, namely fair distribution of health

resources, equal access to health care, quality health

technologies with optimal financial resources. The

sustainable development of healthcare links the

economic with the ecological efficiency of social

production. It affirms the principle of equality and

justice by increasing human possibilities and civic

consciousness.

One of the main challenges to the sustainable

development of healthcare is strengthening patients'

participation and role in the care of their health by

increasing health literacy, health responsibility, and

public solidarity. The study shows that patients in

Bulgaria desire and are willing to cooperate with

institutions through their perspective and experience.

Still, the main obstacle to this is the low competence

and knowledge related to the methods of HTA. 43%

of the respondents lack any knowledge in the field,

and 37.4% have insufficient knowledge. At this level

of competence, patients in Bulgaria would not be able

to participate as a legitimate party in the process if

they are not further trained for this purpose.

Patients show a willingness to increase their

knowledge in the field, aware of their contribution to

society, and the chance to help other patients with

their personal experience. The analysis proves a

positive attitude of patients to participate in the HTA

process. In 46.6% of patients, the attitude to

participation is "high", and in 18.5%, it is "very high".

Against this data's background, 25.7% of Bulgaria

patients have never participated in decision-making

affecting their health, and 32.6% have participated in

such activities to a somewhat low degree. The lack of

experience on the part of patients in the choice of

healthy alternatives can be another challenge for the

health system and HTA institutions due to the

impossibility of building patients' capacity with

expert opinion.

The creation of registers is of paramount

importance for patient organizations' work and their

effective participation in HTA. To be of maximum

benefit to the process, HTA institutions must target

patients appropriately. When assessing a specific

health technology, participants must have some

"technical" knowledge. Usually, these are patients in

the field they represent (orthopedics, urology,

cardiovascular diseases), providing expert opinions

Increasingthetime

availableto

employees/expertsto

engagemoreactively

withHTA

Financialincentivefrom

publicauthoritiesto

provideinformationon

HTA

Increasingknowledge

andcompetenceinHTA

methodologies

Compilingregistersof

patientsandtheir

diseases

15%

31%

52%

Sustainable Development of the Health System through the Prism of Patient Participation in HTA in Bulgaria

and advice from the patient's perspective living with

the disease.

In summary, the contribution of patient

participation in HTA to achieving sustainable

development in the health sector requires several

legislative changes to stimulate the consideration of

the patient's point of view in his treatment. Changes

are needed in the health policy of medical institutions

and health institutions in the direction of active

involvement of patients in the treatment process,

choice of therapy, treatment specialists, procedures,

and manipulations to become a legitimate participant

in HTA.

5 CONCLUSION

The involvement of patients in healthcare and, in

particular, in the general practice of development and

evaluation of health technologies allows new and

valuable products to be developed and to be directly

addressed to patients and their unmet needs. Patients'

participation in the HTA process is an initial step to

be recognized as a key figure in revealing the

evaluated health technologies' full value. Stimulating

close cooperation between patients, HTA institutions,

manufacturers, and users of health technologies is the

basis for the modern health system's sustainable

development.

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