Health technology assessment in the Balkans: opportunities for a balanced drug assessment system

Figures & data

Figure 1. Three paradigms (archetypes) of health technology assessment.[4,8] Country abbreviations are according to ISO 3166-1 standard. Note: Countries are indicated at the paradigm they are closest to, but cannot be regarded as archetypes themselves as they show very important individual variations even within a paradigm.

Figure 2. Reasoning behind a balanced assessment system (BAS) in middle-income countries.[4]

Figure 3. Appropriate methodology and a properly designed process together lead to effective support and transparency.[4]

Table 1. Example of a BAS evaluation grid for a hypothetical country in the Balkan region (developed on the basis of [4]).

Simplified economic evaluation
(1) Indicators of cost-effectiveness	1.1. The medicinal product has been found to be cost-effective by one or more leading international assessment bodies in the indication submitted for reimbursement, or the medicinal product has been found to be cost-effective by a local study for the national health care system in the indication submitted for reimbursement.	High weight	Mutually exclusive with 1.2.
	1.2. The medicinal product has been found to be cost-effective by one or more leading international assessment bodies in part of the indication submitted for reimbursement, or the medicinal product has been found to be cost-effective by a local study for the national health care system in part of the indication submitted for reimbursement.	Medium weight	Mutually exclusive with 1.1 and has lower value.
(2) Accessibility with public funding in peer countries	2.1. The medicinal product is reimbursed through public funds in at least five European countries.	Medium weight	Mutually exclusive with 2.2.
	2.2. The medicinal product is reimbursed through public funds in less than five European countries.	Low weight	Mutually exclusive with 2.1 and has lower value.
(3) Budget impact	3.1. Local budget impact analysis has found the medicine to reduce direct health care expenditures (considering all relevant budgets).	High weight	Mutually exclusive with 3.2.
	3.2. Local budget impact analysis has found the medicine to reduce indirect health care expenditures.	Medium weight	Mutually exclusive with 3.1 and has lower value.
Assessment of the value for patients and society
(4) Therapeutic value added	4.1. The medicinal product has been found to offer significant therapeutic benefit by one or more leading international assessment bodies, or the medicinal product offers significant improvement over the comparator therapy/ies in the primary endpoint as evidenced by at least one phase III randomized clinical trial.	High weight	Mutually exclusive with 4.2.
	4.2. The medicinal product has been found to offer modest or medium therapeutic benefit by one or more leading international assessment bodies, or the medicinal product offers modest or medium improvement over the comparator therapy/ies in the primary endpoint, or substantial improvement in a secondary endpoint, as evidenced by at least one phase III randomized clinical trial.	Medium weight	Mutually exclusive with 4.1 and has lower value.
	4.3. The medicinal product has a significantly more favourable side-effect profile than the comparator therapy/ies, considering frequency, severity and health burden of side effects.	Medium weight	Mutually exclusive with 4.3.
	4.4. The medicinal product has a somewhat more favourable side-effect profile that the comparator therapy/ies, considering frequency, severity and health burden of side effects.	Low weight	Mutually exclusive with 4.4 and has lower value
	4.5. The manufacturer has been able to substantiate superior real-life therapeutic effectiveness for the medicinal product in comparison to the real-life effectiveness of comparator therapy/ies, in international studies or data analyses covering sufficient patient numbers.	Low weight
	4.6. The manufacturer has been able to substantiate that the medicinal product improves ease-of-use (convenience) for patients in comparison to comparator therapy/ies.	Low weight
	4.7. The active substance has been in established use internationally for at least 15 years in the same pharmaceutical form and dose strength.	Medium weight
(5) Ethical considerations and health policy priorities	5.1. The reimbursement application is submitted in an indication which has previously been declared a primary public health priority by state authorities.	Low weight
	5.2. The medicinal product has been registered for the treatment of an orphan disease or paediatric indication.	Low weight
	5.3. No new active substance has been admitted into reimbursement in the relevant therapy area for the last 24 months.	Medium weight

Figure 4. Balanced assessment system (BAS) in middle-income countries.[4]

Table 2. Example for decision-rules in a BAS evaluation.[4]

Total score (calculated as the simple sum of individual scores)	Decision rule
Score < first cut-off point	Not reimbursable
First cut-off point < score < second cut-off point	Conditional reimbursement with programmed reimbursement review within 18–24 months or
	reimbursement with outcome guarantee by the manufacturer
Score > second cut-off point	Unconditional reimbursement

Figure 5. Possible simplified scheme for the evaluation and listing process in a Balkan country (modified from [4]). Notes: (1) The process only applies to pharmaceutical reimbursement decisions. Price-only applications may be managed in their current form. In the long run, administrative price setting for non-reimbursed drugs may even be abolished. (2) Numbers in circles show deadlines in calendar days. (3) Abbreviations: PRB – pricing and reimbursement body, HTAG – health technology assessment group (associated with PRB).

Dankó D. Health technology assessment in middle-income countries: recommendations for a balanced assessment system. J Market Access Health Policy. 2014;2:2–10.

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Dankó D. How can value be measured and valued? Paper presented at: ISPOR 5th Asia-Pacific Conference; 2012 Sep 2; Taipei, Taiwan.

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