Open Access

Drug pricing and reimbursement decision making systems in Mongolia

  • Gereltuya Dorj1Email author,
  • Bruce Sunderland2,
  • Tsetsegmaa Sanjjav3,
  • Gantuya Dorj4 and
  • Byambatsogt Gendenragchaa5
Journal of Pharmaceutical Policy and Practice201710:11

DOI: 10.1186/s40545-017-0098-6

Received: 8 December 2016

Accepted: 4 February 2017

Published: 27 February 2017

Abstract

Background

It is essential to allocate available resources equitably in order to ensure accessibility and affordability of essential medicines, especially in less fortunate nations with limited health funding. Currently, transparent and evidence based research is required to evaluate decision making regarding drug registration, drug pricing and reimbursement processes in Mongolia.

Objective

To assess the drug reimbursement system and discuss challenges faced by policy-makers and stakeholders.

Methods

The study has examined Mongolian administrative documents and directives for stakeholders and analysed published statistics. Experts and decision-makers were interviewed about the drug pricing and reimbursement processes in Mongolia.

Results

Decisions regarding Mongolian drug registration were based on commonly used criteria of quality, safety, efficacy plus some economic considerations. A total of 11.32 billion Mongolian National Tugrugs (MNT) [5.6 million United States Dollars (USD)] or 12.1% of total health expenditure was spent on patient reimbursement of essential drugs. The highest reimbursed drugs with respect to cost in 2014 were the cardiovascular drug group. Health insurance is compulsory for all citizens; in addition all insured patients have access to reimbursed drugs. However, the decision making process, in particular the level of reimbursement was limited by various barriers, including lack of evidence based data regarding efficacy and comparative cost-effectiveness analysis of drugs and decisions regarding reimbursement.

Conclusions

Drug registration, pricing and reimbursement process in Mongolia show an increasing trend of drug registration and reimbursement rates, along with lack of transparency. Limited available data indicate that more evidence-based research studies are required in Mongolia to evaluate and improve the effectiveness of drug pricing and reimbursement policies.

Keywords

Drug pricing policy Reimbursement Cost Pharmaceuticals Mongolia

Introduction

Mongolia is an East-Asian country bordered with Russia and China. It is the 19th largest country in the world with an estimated area of 1,566,460 km2. After the collapse of the Soviet Union, Mongolia has undergone radical change in financial support for health, education and social security. Despite steady economic growth with promising developments occurring in the last 15 years, recent statistics show that infectious diseases are no longer the leading cause of morbidity, instead lifestyle, behaviour –dependent diseases, including circulatory system diseases, cancer and injuries have become the leading causes of mortality and morbidity [1].

During the years of socioeconomic transition in Mongolia, total health expenditure (THE) as a share of Gross Domestic Product (GDP) has increased from 3.3% (1995) to 5.4% by 2010 [2, 3].

Despite existing government regulations, inappropriate use of medicines [4] and high drug costs are evident in Mongolia [5]. Although illegal, people can purchase prescription medicines, including antibiotics without prescription from some private pharmacies [6, 7]. Previous reports have indicated lower out of pocket (OOP) expenses with about 10% of outpatients and 16% of inpatients paying OOP fees for hospital visits in 2011 [8]. However, the study did not specify whether these fees were for medicines or treatment.

Overview of the Mongolian health sector

The Mongolian health sector is regulated by the Ministry of Health (MOH), the Ministry of Finance (MOF), the Ministry of Human Development and Social Welfare (MOHDSW), the Ministry of Education and Science (MOES), the regulating agency -General Agency for Specialised Inspection (GASI) and former government implementing agencies such as the Department of Health (DOH), the Department of Physical Culture and Sport (DOPS), and the city/aimag (provincial) health departments.

The MOH and MOHDSW are the third-party payers involved in purchasing and resource allocation in health care. The government health budget is managed by the MOH, and the Health Insurance Fund is managed by Social Insurance General Office (SIGO- under the MOHDSW). The fund for social health insurance (HI) is a single national insurance fund that uses its local branches to collect revenue and pay for insured care and it has been a stable source of health financing in Mongolia since 1990s. In addition to having government agency status, the SIGO is also overseen by the Social Insurance National Council (SINC) appointed by the State Great Khural.

Despite having a low share of THE, it is the only health financing mechanism that exercises some elements of contracting and purchasing. The government is the dominant player in making HI decisions therefore it is used as a substitute for the government budget.

Pharmaceutical sector in Mongolia

The Division for Pharmaceutical and Medical Devices of the MOH is responsible for oversight of the main functions of the pharmaceutical sector policy, regulation and coordination. The Division for Health Inspection of the General Agency for Specialized Inspection ensures compliance with major laws and legislation as it relates to quality assurance and distribution inspection. A Human Drug Council consisting of experts in the field and representatives of all relevant ministries leads the pharmaceutical sector, particularly in the development of standards, guidelines and procedures, including drug registration. The Drug Regulatory Unit is responsible for technical work for the Human Drug Council including the registration of medicines and medical devises, licensing of specialists and providers, issuance of import and export licenses, monitoring and reporting adverse drug reactions, monitoring medicines marketing and advertisement, promoting rational use of medicines and developing a national pharmacopeia and standards. In addition, a Special Permission Committee of the MOH monitors the functional activities of drug producers and grants approval for manufacturing, importing and selling drugs in Mongolia (Figs. 1 and 2).
Fig. 1

Organizational structure of the Mongolian pharmaceutical policy and regulation. Note: Human Drug Council and Special Permission Committees are expert professionals

Fig. 2

Proportion of reimbursed drugs, by pharmacological classification (Billion MNT), 2014 (adapted from Health Indicators of Mongolia, 2014)

The drug reimbursement decision is approved by the Health Insurance Fund (HIF), which is incorporated within the General Department of Social Insurance and it is regulated by the Ministry of Human Development Social Welfare of Mongolia.

The Drugs Act of Mongolia was promulgated in 1998 and aimed to ensure good quality, effective and safe drugs were available to the Mongolian population. Following the Drug Act, the National Drug Policy of Mongolia (NMPM) was adopted in 2000, revised and approved by the State Great Khural in 2014. Ministerial legislation corresponding to reimbursement includes the Health Insurance Law, approved by the State Great Khural 2015 and the Resolution on the List of Essential Medicines to be reimbursed by the HIF, approved by the National Committee on Social Insurance of Mongolia in 2016.

The Policy regulates the procurement, manufacturing, financing, quality assurance, distribution, and appropriate use of drugs. In order to ensure the availability of the most essential medicines at all levels, the government has adopted an Essential Drugs List, developed on the basis of recommendations by the World Health Organization (WHO). This List has been available since 1991 and it has been revised several times with the seventh being completed in 2014 [9].

The procurement of health products including medicines for only public health facilities (hospital pharmacies) is regulated by the Law on Public Procurement and Guidelines approved by the MOH. Tertiary-level health facilities and aimag health departments have their own tendering committees. Ulaanbaatar city carries out a tender for all its district hospitals in the urban area. Medicines procured and sold at private retail pharmacies are supplied by wholesaling companies, however the government has no regulation on price.

The Mongolian pharmaceutical sector is predominantly dependent on its manufacturing and private business organizations due to 100% privatization of all pharmaceutical wholesalers. Mongolia was defined as a low-income country with THE of 556 billion MNT or 2.6% of GDP in 2013 [10], hence evidence based decision making and optimum use of available resources is of high importance.

Drug distribution system in Mongolia

Most of the imported drugs sold in Mongolia come from the Russian Federation, China, India and other eastern European countries. Drug supply companies and pharmacies must be licensed in order to undertake drug supply functions. With the accelerating growth of the private sector, the drug supply business has proven to be very successful. Currently, 1190 pharmacies are operating all over Mongolia and 75% of the private pharmacies have one or two branches. There were 306 pharmacies working under the drug revolving fund (DRF) initiative [1]. According to the latest report, 24 drug factories were officially permitted to operate as drug manufacturers and their share was approximately 12% (66 Billion MNT) of the total local pharmaceutical market [11]. There were 591 new drugs (salts or dosage forms), 48 raw materials registered and the registration period was extended for a total of 428 drugs in 2014 [11].

The latest survey on medicines prices and affordability in Mongolia was completed using WHO methodology in 2010 and it reported that the affordability of the lowest priced generics and most sold generics in the public sector was good for most conditions, with standard treatment costing 1 days' wage or less. Treatments costing more than 1 days' wage of the lowest paid unskilled government worker included a pack of 30 amlodipine tablets to treat hypertension (1.6 days) [5]. In the private sector, the majority of treatments cost less than the daily wage of the lowest paid government worker when the lowest price generics were used. Hypertension treated with enalapril (10 mg cap/tab) for 30 days costs 2.5 days’ wages, simvastatin (20 mg cap/tab) 30 days 2.7 days’ wages are clearly unaffordable even when generics are used.

The price of medicines has not been regulated by the Government since 1997 and a 10% value-added- tax (VAT) was introduced in 1999. Taxes, duties and other government charges applied to medicines include 5% customs duty for imported medicines. In the private sector, add-on costs represent 90.1% of the final patient price for imported originator brands, 115.5% for imported generics, and 74.4% for locally produced generics. Registration fees do not differ between originator brands and generic equivalents. However, registration fees are lower for locally produced than for imported medicines; hence the government encourages local production.

There are no public pharmacies, except those located in public hospitals whose service is limited to inpatients. Furthermore, the government controls dispensing fees for reimbursed essential medicines and some data are available to support the insurers view on the dispensing fee.

The drug reimbursement system and health insurance scheme have been developed since 1994. The latest revision of the list for reimbursed essential drugs was approved by the SHI in 2016 [12]. The main purpose was to expand the range of health insurance benefits and ensure greater access to essential drugs in primary health-care services by the insured population which is compulsory for all population groups [12].

To date, insured ambulatory patients have access to a total of 134 essential drugs partly reimbursed by the Health Insurance (HI) providing that these drugs were prescribed by a family doctor (in urban settings), village (soum) hospital doctor or district (bagh) feldsher (in rural settings) and dispensed by a HI designated or contracted pharmacy.

A list containing the cost of certain essential drugs is also available once it has been approved by the HI. This list gives the maximum price level for certain drugs provided to insured ambulatory and stipulates how much of this cost should be covered under HI. A decision to include the drug in the reimbursement list is based on mortality and morbidity rates for the last 2 years and drug consumption listed by pharmacological classification. No further information of specific analysis for reimbursement decision making was available.

Drug reimbursement funding is an important expenditure to ensure the budget is used optimally. However, there is a lack of detailed information in regards to drug pricing and reimbursement decisions in Mongolia. Considering the importance of clear and transparent processes for drug pricing and government funded reimbursement, this study has aimed to examine the pharmaceutical drug pricing and reimbursement decision making in Mongolia.

Methods

Documents relevant to drug reimbursement

Existing documents regarding drug reimbursement, selection and procurement of essential medicines, appropriate use of medicines including regulations enacted by the Mongolian Government, legislative documents and published internal regulations of the Human Drug Council, Ministry of Health of Mongolia (MOH), Pharmaceuticals and Medical Devices Division, (MOH), Social Health Insurance Office (SHIO), and the Division of Finance and Insurance, the Ministry of Finance, Mongolia (MOF), including approved State Policy on Medicines and Medical Devices (2014), Health Law (2010), regulation to reimburse essential medicines by the Health Insurance, approved by the Health Insurance Subcommittee, National Social Insurance Committee, #03, 2011, anupdated list of reimbursable essential medicines, Health Insurance Subcommittee, National Social Insurance Committee (2013.07.31), General requirement for pharmacies in Mongolia, MNS 260:2011,#13 Regulation for registration of medicines, raw materials, biologically active compounds in Mongolia, approved by the Health Minister, 2015 were reviewed by all authors in this study. More documents in relation to the statistics and published data related to drug pricing and drug reimbursement, published and unpublished annual reports reimbursement of medicines, including Mongolian statistical annual report, National Statistical Office, Annual report of Health Insurance Office, Survey of medicine prices, availability, affordability and price components in Mongolia, 2012 [5] were collected and reviewed.

In addition, websites of several organisations and agencies including drug regulatory authorities were examined for relevant information and reports. The search was complemented by hand searches of bibliographies and, in the case of doubt, by telephone and email communication with the institutions themselves.

Interviews

In order to collect more detailed information on the decision making process and evaluation methods, key stakeholders including the authorities and officers in charge of drug registration, procurement and reimbursement including the Head of Pharmaceuticals and Medical Devices Division, Health Insurance Office, Head of Allocation and Monitoring of Health Budget, Ministry of Finance, Human Drug Council Member, Officer in charge for drug procurement services, policy implementation, MOH were interviewed. The interview consisted of questions regarding information about the respondent [13] and reimbursement, including the (i) assessment, (ii) appraisal and (iii) decision making processes. Assessment included the quantification of the clinical, pharmacotherapeutic efficacy and pharmacoeconomic value of a drug. Appraisal sought to gauge society’s willingness to pay for a drug by weighing assessment outcomes against other (societal) criteria which reflect health system objectives. Decision making was defined as a value judgement from a broader societal perspective, considering the health system policy objectives as well as non-health care related objectives.

The interview guide (in Mongolian) was piloted with four potential respondents to ensure the validity; technical functioning, relevance and understanding of the questions. No major omissions were identified. These responses were not used further in the study.

As Mongolian versions of the documents are available, the study engaged two professional translators to complete translations from Mongolian to English and vice-versa to assure accuracy and minimize any possible bias. These translators were unknown to each other [14]. The author made adjustments resulting from any inconsistencies. (Data are available upon request from the corresponding author).

Data analysis

Standard descriptive statistics were used to summarize demographic data and responses to the interviews. Questions regarding the frequency of assessment, appraisal and decision making were answered. All documents were analysed in a qualitative matter and according to an analytic informational framework that had been developed in advance. Results were summarised narratively and presented in a related manner. Comparisons between groups were performed using the Chi-square test, logistic regression or Kruskal–Wallis test with a pairwise comparison as appropriate. A p value of <0.05 was taken as being significantly different.

Results

Drug registration process in Mongolia

All drugs used in the country are registered once agreement and authorization by the Human Drug Council has been given. The General Agency for Specialized Inspection (GASI) is in charge of ensuring that only registered drugs enter the market for public use. Locally manufactured drugs are registered for 2 years, whereas imported drugs are given a 4-year (regular registration) or 5-year (fast-track registration) period. The drugs should be of a good quality, compliant with good manufacturing practice (GMP) regulations to qualify for registration. The applicant must prepare documents including data regarding efficacy, safety and adverse events, comparative efficacy with similar drugs, approval history, contraindications, warnings, precautions, monitoring parameters, pharmacokinetics, patient compliance and information of cost, insurance and freight (CIF) cost for registration.

All medicines should be registered in the State Medicines Register which is divided into two categories as medicines available with and without prescription (over-the-counter, OTC).

Drug reimbursement process in Mongolia

Detailed analysis of HI statistics indicates that 11.32 Billion MNT (5.59 Million USD) was spent on reimbursement of essential drugs, and that half of the reimbursement was spent on cardiovascular agents (5.579 Billion MNT) in 2014 (Table 1). Considering the health indicators, the prevalence of cardiovascular diseases is listed as priority causes of mortality and morbidity [1].
Table 1

Drug categories and reimbursement data for essential drugs for the year 2014

Number

Drug

Dosage

Dosage form

Package size

Maximum retail price MNT

Reimbursement value (%/)

Reimbursement from HIF/MNT/

Total quantity (thousand)

Total reimbursed/mlnMNT/

 

1. Analgesics, antipyretics, non steroidalantiinflammatory drugs

1

Acetyl salycilic acid

100 mg

tablet

100

1500

66,7

1000

1,145,655

11.4

 

10

3000

50

1500

4,041,900

4.9

 

30

2000

50

1000

432,918

1.4

150 mg

10

3500

57,1

2000

364,000

0.6

300 mg

10

5000

60

3000

14,472

4.3

2

Diclofenacsodium

25 mg

tablet

10

750

66,7

500

22,714

4.6

50 mg

10

750

66,7

500

195,847

36.7

75 mg

10

7500

53,3

4000

0

0

100 mg

10

1500

66,7

1000

0

0

50 mg

suppositorium

10

1500

66,7

1000

9912

0.9

100 mg

2

2500

80

2000

45,015

45.9

20 гp

gel

1

4000

50

2000

0

0

3

Ibuprofen

200 mg

tablet

12

5000

60

3000

115,355

28.8

400 mg

 

10

1500

66,7

1000

996,263

99.3

100 ml

syrup

1

8500

58,8

5000

41,235

205.6

4

Indomethacin

25 mg

tablet

30

1800

55,6

1000

51,436

2.6

  

20

1200

83,3

1000

0

0

5

Paracetamol

500 mg

tablet

10

250

40

100

64,506

0.6

 

12

1200

50

500

3373

0.1

100 mg

suppositorium

10

250

57,1

2000

13,264

2.6

100 ml

suspension

1

1000

61,5

4000

1015

4.1

3%-90 ml

syrup

1

3500

50

3000

529

1.6

6

Tramadol

50 mg

tablet

10

3300

60,6

2000

88,245

17.6

 

Sub total

      

7,647,654

473.8

 

5.2 Antiinfective agents

 

5.2.1 Beta-lactame antibiotics

25

Amoxicillin

125 mg

syrup

1

4000

50

2000

3547

7.4

250 mg

 

1

7000

57,1

4000

293,886

30.1

125 mg

 

10

5000

60

3000

  

250 mg

 

10

1500

62,5

1000

293,886

30.1

500 mg

 

10

2000

50

1000

5,062,806

56.9

26

Amoxicillin + clavulanic acid

100 ml

syrup

1

10,000

50

5000

1799

8.9

156.25 mg/5 ml

 

1

8100

61,7

5000

5179

25.8

228.5 mg/5 ml

 

1

7200

69,4

5000

602

3

125 mg/60 ml

 

1

5000

80

4000

1980

7.9

156.25 mg

tablet

10

7500

60

4500

5179

25.8

312.5 mg

 

10

10,000

50

5000

  

375 mg

 

16

15,200

52,6

8000

  

625 mg

 

10

16,000

62,5

10,000

442,351

439.8

27

Phenoxymethylpenicllin

250 mg

tablet

10

850

58,8

500

6800

0.3

28

Cefadroxil

500 mg

capsule/tablet

10

3800

65,8

2500

8244

2.1

 

Sub-total

      

6,126,259

638.4

 

5.2.2 Other antiinfectiveagents

29

Clarithromycin

500 mg

tablet

14

21,000

47,6

10,000

494,548

351.9

250 mg

 

14

15,400

51,9

8000

145,636

83.2

30

Doxycycline

100 mg

capsule/tablet

10

2150

69,7

1500

21,097

3.2

31

Metronidazole

250 mg

tablet

10

350

85,7

250

147,898

3.7

500 mg

 

10

1500

71,4

1000

67,655

10.8

500 mg

suppositorium

6

3000

66,7

2000

2199

0.7

32

Chloramphenicol

250/500 mg

capsule

10

1200

83,3

1000

145,020

14.3

33

Sulfamethoxazol + trimethoprim (trimexasol)

480 mg

tablet

10

1000

50

500

85,087

43.2

240 mg/5 ml-60 ml

suspension

1

2500

80

2000

949

3.1

34

Ciprofloxacin

250 mg

tablet

10

3000

66,7

2000

98,752

46

500 mg

 

10

4500

66,7

3000

  

35

Azithromycin

100 mg-5 ml

suspension

1

11,600

69

8000

7245

58

250 mg

capsule

10

9000

55,6

5000

1,134,303

63

200 mg/5 ml-20 ml

suspension

1

15,000

66,7

10,000

  
 

Sub total

      

2,350,389

681

 

5.3 Antifungal agents

      

36

Griseovulvin

125 mg

capsule

10

800

62,5

500

868

0.04

37

Fluconazol

50 mg

capsule

7

9100

54,9

5000

155,658

111.1

38

Clotrimasol

100 mg

vaginal tablet

6

3000

66,7

2000

38

0.08

500 mg

 

1

3500

57,1

2000

  

20гp

cream

1

2500

80

2000

296

0.6

15гp

 

1

2200

68,2

1500

84

0.1

10гp

 

1

2800

71,4

2000

146

0.3

39

Nystatin

500,000 unit

Coated tablet

20

2500

80

2000

3620

3.6

500,000 unit

Vaginal suppositorium

10

2800

71,4

2000

1704

0.3

2,500,000 unit

 

10

2600

76,9

2000

10,475

2.1

 

Sub total

      

172,889

118.3

 

5.4 Antiviral agents

40

Aciclovir

200 mg

tablet

20

4500

66,7

3000

120,741

19.5

5%-5гp

ointment

1

3000

66,7

2000

2044

4.1

5%-2гp

cream

1

12,500

80

10,000

1020

10.2

41

Ribavirin

200 mg

capsule

20

12,000

66,7

8000

5760

2.3

42

Lamivudin

150 mg

tablet

10

6000

66,7

4000

355

0.1

 

Sub total

      

129,920

36.1

 

6. Medication for migraine prophylaxis

43

Propranolol

40 mg

tablet

50

3000

66,7

2000

40,677

1.6

 

Sub total

      

40,677

1.6

 

9. Drugs acting on blood

 

9.1 Hematinic agents

49

Ferlatum

60 mg

tablet

10

1500

66,7

1000

7501

0.8

50

Ferrovitum

162 mg + 0.75 mg + 7.50 mg

capsule

30

5400

55,6

3000

121,772

12.2

51

Folic acid

5 mg

tablet

100

4000

50

2000

31,828

0.6

 

Sub total

      

161,101

13.6

 

10. Cardiovascular agents

 

10.1 Drugs for Angina pectoris, schemic heart diseases

      

52

Atenololum

50 mg

tablet

30

3000

66,7

2000

330,066

21.9

100 mg

tablet

10

2000

50

1000

31,812

3.2

53

Verapamilum

40 mg

tablet

50

3500

57,1

2000

16,038

0.6

54

Glycerilumtrinitratum

6.4мu

tablet

25

4750

63,2

3000

5082

0.6

55

Isosorbidumdinitratum

5 mg

tablet

20

900

55,6

500

80,812

2

56

Nifedipinum

10 mg

tablet

50

2500

80

2000

809,139

32.3

57

Inozinum

200 mg

tablet

50

2200

68,2

1500

1,250,837

37.4

 

Sub total

      

253,786

98

 

10.2 Drugs for arrhythmia

58

Amiodarone

200 mg

tablet

30

7500

66,7

5000

50,865

8.5

 

10.3 Antihypertensives

59

Hydrochlorthiazidum

25 mg

tablet

30

3000

66,7

2000

7869

0.5

 

10

1200

83,3

1000

6557

0.6

60

Methyldopa

250 mg

tablet

50

12,000

66,7

8000

60,237

9.6

61

Amlodipin

5 mg

tablet

30

16,200

61,7

10,000

1,578,754

525.8

10 mg

tablet

30

30,000

50

15,000

6,135,264

3059.5

62

Enalapril

2.5 mg

tablet

20

3000

66,7

2000

25,525

2.5

5 mg

tablet

30

3900

76,9

3000

310

0.1

10 mg

tablet

30

5400

74,1

4000

1260

1.7

20 mg

tablet

30

8100

61,7

5000

1580

2.4

63

Lozartan

25 mg

tablet

28

10,500

76,2

8000

190,397

54.4

50 mg

tablet

28

14,000

71,4

10,000

1,105,003

393.7

100 mg

tablet

28

28,600

52,4

15,000

 

0

64

Lizinopril

5 mg

tablet

14

5500

54,5

3000

 

0

10 mg

tablet

14

7000

57,1

4000

 

0

20 mg

tablet

14

8500

58,8

5000

 

0

 

Subtotal

      

9,112,756

405.9

 

10.4 Heart failure

65

Digoxin

250mkg

tablet

30

3000

66,7

2000

6269

0.4

 

Sub total

      

6269

0.4

 

10.5 Lipid lowering drugs

67

Simvastatin

10 mg

tablet

30

13,200

60,6

8000

65,260

17.4

20 mg

tablet

30

22,000

45,5

10,000

322,778

107.6

40 mg

tablet

30

36,000

50

18,000

587,264

352.3

 

Sub total

      

975,302

477.3

 

14. Diuretics

77

Spirinolactone

25 mg

tablet

20

4200

71,4

3000

344,164

51.5

78

Furosemide

40 mg

tablet

30

800

62,5

500

23,333

38,410

 

Sub total

      

346,497

38461.5

 

21. Vitamins and minerals

125

Ascorbucacidm

50 mg

tablet

10

200

50

100

 

0

126

Vitamin B complex

100 mg + 200 mg + 300mkg

dragee

60

3200

62,5

2000

 

0

100 mg + 200 mg + 300mkg

coated tablet

10

1700

58,8

1000

 

0

250 mg + 250 mg + 1000mkg

tablet

10

3600

76,9

2000

88,708

17.6

127

Calcium gluconate

500 mg

tablet

10

250

40

100

59,066

0.6

128

Calcium glycerphosphate

500 mg

tablet

10

1200

83,3

1000

18,354

0.2

129

Polivitamine

50 mg

dragee

50

300

33,3

100

78,739

0.2

150 mg

syrup

1

8000

50

4000

66,666

264.4

500 mg

Coatedtablet

10

1200

83,3

1000

18,794

1.9

130

Nicotinamide

50 mg

tablet

10

800

62,5

500

15,518

0.8

131

Pyridoxine

20 mg

tablet

10

400

75

300

740

0.02

132

Retinolumpalmitatum

20 mg

dragee

10

1100

45,5

500

18,678

0.9

 

12,000 IU

capsule

10

900

55,6

500

10,868

0.5

133

Ergocalciferol

15,000 IU 1 ml

solution

1

4500

66,7

3000

553

1.7

134

Thiamine

50 mg

tablet

 

700

71,4

500

1150

0.1

 

Sub total

      

88,708

17.6

A detailed analysis of reimbursed cardiovascular drugs indicated that the highest was for amlodipin (3,059,489,957 MNT) and the lowest was for enalapril (69,266 MNT). In terms of analgesics, antipyretics, non-steroidal anti-inflammatory drugs, the most reimbursed item was ibuprofen syrup 9,205,575,118 MNT) and the least dispensed item with reimbursement was paracetamol tablets (12 pack, 140,486 MNT) (Table 1).

The proportion of pharmaceutical expenditure has been relatively stable ranging from 12 to 14% of total health expenditure in the last 5 years, whereas the reimbursement provided by the HI has steadily increased over the last 6 years. The revised list of reimbursable essential medicines contained a total of 134 medications prescribed by a legal prescriber/physician the reimbursement level has ranged from 40 to 83.3% of the cost of the medicine. This list indicates the maximum retail price that a retail pharmacy can charge. This indicates that the government is fixing the total cost of these medicines charged by retail pharmacies.

The latest statistics indicate that the population coverage has increased to 99% which means essentially the whole population is covered for essential drugs [1].

Until 2014, there were no price control mechanisms specific to generic drugs, however the latest revision of the NDPM indicates that the maximum price of essential medicines shall be regulated by the Government [15]. Therefore the only price control is on reimbursed essential medicines in Mongolia.

Discussion

This study has indicated that the Mongolian drug registration process is based on commonly used decision making criteria that are applied in many countries [13, 16]. These criteria include safety, efficacy and some economic aspects. Official reports and documents also have shown that Mongolian HI operates with some advantages, including a 92.2% of insurance coverage in Mongolia [2]. However, due to low payment in regards with salary (lowest: 192000 MNT or 101.3 USD) and pension (lowest: 145.200 MNT or 87 USD), the health care benefits of an estimated 1.33 million MNT or 798 USD per person annually are reported to be rather weak [17].

As acknowledged in many other countries, the drug reimbursement process is a very challenging task shared by various authorities with different interests [18]. The Ministry of Health of Mongolia works towards delivering quality health care and increased efficacy and accessibility of drugs to all patients, whereas the Ministry of Finance and Ministry of Human Development and Social Welfare aim to increase the health insurance coverage with limited health funding. However, HI involvement in the decision making process, the use of evidence-based data, including post marketing analysis, cost-effectiveness analysis are lacking. The different aspects and number of various institutions involved leads to complexity in the current system which can have a negative impact on health care delivery, including increased OOP payment for drugs. Obviously, this is a major point where the vast array of government departments and offices involved must make the system fragmented and avoid much duplication.

The funding source of pharmaceuticals in Mongolia was analysed and the non-government sources including the donor organizations and patient OOP, played a minimal role for total pharmaceutical expenditure (TPE) (4.8%) whereas government sourced fund (tax) was the highest (80.4%) [19]. No data are available on private health funds in Mongolia. Previous findings reported that OOP payments for health services have increased from 14.5% of the THE in 1995 to 41.4% in 2010. However, data in regards to OOP payments for pharmaceuticals were not available [19, 20]. The WHO reviewed the total expenditure on pharmaceuticals in different countries and compared by GDP. The median expenditure for pharmaceuticals in European region was 13% and Asian countries spent approximately 35% of total health expenditure on pharmaceuticals. However, the data represent both public and pharmaceutical expenditure [20]. The comparison of proportion of pharmaceutical expenditure in different regions indicated that Mongolia had the lowest public pharmaceutical expenditure (11.6%) [20].

It is widely accepted that modern health technology assessment methods should be used in such processes [21]. Successfully implemented health technology assessment programs including the evaluation of efficacy, comparative cost-effectiveness of medical interventions and published clinical guidelines as can be seen in Australia [22], Canada [23] and UK [23]. Even though it is difficult to create a system that satisfies all stakeholders, the Mongolian pharmaceutical sector needs to expand its assessment processes and report more relevant data in order to allow the analysis of the pharmaceutical sector and develop coordinated systems for decision making in drug reimbursement.

Limitations

The lack of evidence-based data on private health fund and OOP payment for pharmaceuticals as well as the price components for locally produced or imported medicines, including lack of cost-effectiveness data limit study results to generalize for the pharmaceutical sector in Mongolia.

Conclusions

Drug pricing and reimbursement of essential medicines is an important task shared by many different authorities, including Ministry of Health and Sport and Ministry of Finance in Mongolia. Periodical reports of the drug registration process, average registration duration and decisions for drug registration are available. However, there is a lack of publicly available reports for the reimbursement decision making process, whereas only information related to drugs that can be reimbursed is made publicly available once consensus has been reached. Price negotiation, budget impact and cost-containment are essential elements for a drug reimbursement process. To allocate resource efficiently in Mongolia is an important and challenging task. Currently the overall system is too complex and there is a lack of accessible data to permit a detailed analysis of the pharmaceutical sector, which is necessary to drive decisions.

Abbreviations

CIF: 

Cost, insurance and freight

DOH: 

Department of Health

DOPS: 

Department of Physical Culture and Sport

DRF: 

Drug Revolving Fund

GASI: 

General Agency for Specialised Inspection

GDP: 

Gross Domestic Product

GMP: 

Good manufacturing practice

HI: 

Health Insurance

HIF: 

Health Insurance Fund

MNT: 

Mongolian National Tugrug

MOES: 

Ministry of Education and Science

MOF: 

Ministry of Finance, Mongolia

MOH: 

Ministry of Health of Mongolia

MOHDSW: 

Ministry of Human Development and Social Welfare

NMPM: 

National Drug Policy of Mongolia

OOP: 

Out of pocket

OTC: 

Over-the-counter

SHIO: 

Social Health Insurance Office and the

SIGO: 

Social Insurance General Office

SINC: 

Social Insurance National Council

THE: 

Total health expenditure

TPE: 

Total pharmaceutical expenditure

USD: 

United States dollar

VAT: 

Value-Added-Tax

WHO: 

World Health Organization

Declarations

Acknowledgement

We would like to acknowledge Dr.Naranchimeg and Dr.Batjargal for providing some useful information. Also, we thank the Division of Pharmaceutics and Medical Devices, Mongolian Ministry of Health and Sport, Ministry of Finance and Health Insurance of Mongolia for their feedback.

Funding

None.

Availability of data and material

Please contact author for data requests.

Authors’ contributions

Gereltuya Dorj (GD) - Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data. Drafting the article and revising it critically for important intellectual content. BS- Drafting the article and revising it critically for important intellectual content. Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data. ST -Statistical analysis of the study results and review. Drafting the article and revising it critically for important intellectual content. Gantuya Dorj (GD)- Drafting the article and revising it critically for important intellectual content. Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data. BG - Drafting the article and revising it critically for important intellectual content. Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data. All authors read and approved the final manuscript.

Competing interests

The authors declare that they have no competing interests.

Consent for publication

Not applicable.

Ethics approval and consent to participate

Not applicable.

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Authors’ Affiliations

(1)
Department of Clinical Pharmacy and Pharmacy Administration, School of Pharmacy and Biomedicine, Mongolian National University of Medical Sciences
(2)
School of Pharmacy, Faculty of Health Sciences, Curtin University of Technology
(3)
School of Pharmacy and Biomedicine, Mongolian National University of Medical Sciences
(4)
Department of Epidemiology and Biostatistics, School of Public Health, Mongolian National University of Medical Sciences
(5)
ISPOR Chapter Mongolia

References

  1. Ariuntuya S, Narantuya Kh, Davaajargal S, Enkhjargal TS, Unurtsetseg T. Health Indicators of Mongolia Ulaanbaatar Mongolia Health Department of Mongolia 2014 [cited 10/10/2015]. Available from: http://www.chd.mohs.mn/images/pdf/sma/uzuulelt/eruul_mendiin_uzuulelt_new_size_8_font_12_curuv.pdf.
  2. Tsolmongerel Tsivaajav, Evlegsuren Ser-Od, Bulganchimeg Baasai, Ganbat Byambaa, Shagdarsuren. O. Health Systems in Transition Mongolia Health System Review Issue 2, 2013Google Scholar
  3. Ministry of Health Mongolia. Annual report of Ministry of Health Mongolia. 2014.Google Scholar
  4. Dorj G, Hendrie D, Parsons R, Sunderland B. An evaluation of prescribing practices for community-acquired pneumonia (CAP) in Mongolia. BMC Health Serv Res. 2013;13(1):379. Available from: http://www.biomedcentral.com/1472-6963/13/379.
  5. Chimedtseren M. Survey of medicine prices, availability, affordability and price components in Mongolia. 2012.Google Scholar
  6. Nakajima R, Takano T, Urnaa V, Khaliun N, Nakamura K. Antimicrobial use in a country with insufficient enforcement of pharmaceutical regulations: a survey of consumption and retail sales in Ulaanbaatar, Mongolia. Southern Med. 2010;3(1):19–23. Available.Google Scholar
  7. Dorj G, Sunderland B, Hendrie D, Parsons R. Parenteral medication prescriptions, dispensing and administration habits in Mongolia. PLoS One. 2014;9(12):e115384. Available.View ArticlePubMedPubMed CentralGoogle Scholar
  8. Oyungerel. Hospital services costing survey at aimag and district health facilities. Ulaanbaatar; 2011.Google Scholar
  9. Ministry of Health Mongolia. Essential Drug List of Mongolia, 5th revision. Ulaanbaatar; 2009.Google Scholar
  10. World Bank. How we Classify Countries. World Bank; 2013 [cited 21/05/2013]. Available from: http://data.worldbank.org/about/country-classifications.
  11. Mongolia MoHaSo. Pharmaceutical indicators of Mongolia. 2014.Google Scholar
  12. Mongolia MoHaSo. Reimbursed medicines list of Mongolia. 2014.Google Scholar
  13. Oortwijn W, Mathijssen J, Banta D. The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries. Health Policy. 2010;95(2):174–84. Available.View ArticlePubMedGoogle Scholar
  14. Harkness JA, Schoua-Glusberg A. Questionnaires in translation, 1998 DEUGoogle Scholar
  15. Ministry of Health Mongolia. National Drug Policy of Mongolia. 2002.Google Scholar
  16. Ansaripour A, Uyl-de Groot CA, Steenhoek A, Redekop WK. The Drug Reimbursement Decision-Making System in Iran. Value in Health Regional Issues. 2014;3:174–81. Available.View ArticleGoogle Scholar
  17. Group OB. The Report: Mongolia 2014. 2014.Google Scholar
  18. Soumerai SB, Ross-Degnan D, Fortess EE, Abelson J. A critical analysis of studies of state drug reimbursement policies: research in need of discipline. Milbank Q. 1993;71(2):217–652.Google Scholar
  19. Dorj G. International Society for Pharmacoeconomics and Outcomes Research Public pharmaceutical expenditure of Mongolia 2015. Philadelphia, PAGoogle Scholar
  20. Bennett S, Quick JD, Velasquez G. Public-private roles in the pharmaceutical sector: Implications for equitable access and racional drug use. In: Public-private roles in the pharmaceutical sector: Implications for equitable access and racional drug use: OMS; 1997.Google Scholar
  21. Attaran A. How do patents and economic policies affect access to essential medicines in developing countries? Health Aff. 2004;23(3):155–66. Available.View ArticleGoogle Scholar
  22. George B, Harris A, Mitchell A. Cost-effectiveness analysis and the consistency of decision making. Pharmacoeconomics. 2001;19(11):1103–9. Available.View ArticlePubMedGoogle Scholar
  23. Eichler HG, Kong SX, Gerth WC, Mavros P, Jönsson B. Use of Cost‐Effectiveness Analysis in Health‐Care Resource Allocation Decision‐Making: How Are Cost‐Effectiveness Thresholds Expected to Emerge? Value Health. 2004;7(5):518–28. Available.View ArticlePubMedGoogle Scholar

Copyright

© The Author(s). 2017