Decision No. 2701/QD-BYT dated June 22, 2017 of the Ministry of Health promulgating the working regulation of drafting committee, editing team and specialized teams, and rules and criteria for formulation of the circular promulgating the list, ratio and payment conditions for modern medicines covered by health insurance

THE MINISTRY OF HEALTH

Decision No. 2701/QD-BYT dated June 22, 2017 of the Ministry of Health  promulgating the working regulation of drafting committee, editing team and specialized teams, and rules and criteria for formulation of the circular promulgating the list, ratio and payment conditions for modern medicines covered by health insurance

Pursuant to the Law on Health Insurance;

Pursuant tothe Government’s Decree No.105/2014/ND-CPdated November 15, 2009 elaborating andprovidingguidelines forsome articles of the Law on Health Insurance;

Pursuant to the Government’s Decree No. 75/2017/ND-CP datedJune 20, 2017 defining functions, tasks, powers and organizational structure of the Ministry of Health;

At the request of theDirector Generalof Department of Health Insurance,

DECIDES

Article 1.The working regulation of drafting committee, editing team and specialized teams that formulate the Circular promulgating the list, ratio and payment conditions for modern medicines covered by health insurance (Appendix 1) is promulgated. The working regulation provides a basis for drafting committee, editing team and specialized teams to cooperate in performing the assigned tasks.

Article 2.Rules and criteria for formulation of the circular promulgating the list, ratio and payment conditions for modern medicines covered by health insurance (Appendix 2) is promulgated. The rules and criteria provide a basis for editing team and specialized teams to draft instructional Circulars and the list of medicines which will be submitted to the drafting committee for decision.

Article 3.This Decisiontakes effect on the signing date.

Article 4.The amendment to the working regulation, rules and criteria for compilation of the list of medicines shall be decided by the head of the drafting committee in conformity with organization and activities of the drafting committee, editing team and specialized teams.

Article 5.Chief of the Ministry Office, leaders of Departments affiliated to the Ministry of Health; heads of authorities and units whose members join the drafting committee, editing team and specialized teams and those mentioned in the Decision No. 1629/QD-BYT dated April 26, 2017 of the Ministry of Health shall implement this Decision./.

For the Minister

The Deputy Minister

Pham Le Tuan

APPENDIX 2

RULES AND CRITERIA FOR COMPILATION OF THE LIST OF MODERN MEDICINES COVERED BY HEALTH INSURANCE
(To attach with the Decision No.2701/QD-BYTdated June 22, 2017 of the Minister of Health)

Article 1. Rules for compilation of the list of modern medicinescovered by health insurance

1.General rules:

a) Conform to and boost the implementation of the policy for reasonable, safe and effective use of medicines.

b) Rely on the current list of essential medicines of Vietnam and World Health Organization (WHO).

c) Satisfy the need for treatment of diseases while taking into account the disease situation, protect rights of health insurance participants and capacity of the health insurance fund in each period, ensure openness and transparency.

d) Utilize the lists of medicines enclosed with the Circular No.40/2014/TT-BYTdated November 17, 2014.

2.2.Rules for naming medicines inthe list of modern medicinescovered by health insurance

a) Medicines shall be listed under the names of active ingredients with the nomenclatureINN (International Non-proprietary Name),the medicines without the nomenclatureINNshall be listed under the names licensed; brand name or trade name must not be listed.

b) Only administration route shall be listed, the content and dosage form must not be listed.

c) In case of combination medicine: the content of each active ingredient must be specified.

Article2.Criteriaforremoval, addition or adjustmentofamedicineon the list of modern medicinescovered by health insurance

1.Criteria for removal of amedicinefrom the listenclosed with the Circular No. 40/2014/TT-BYT dated November 17, 2014

a) A medicine that satisfies one of the following criteria shall be removed from the list of medicines covered by health insurance:

-The medicine is not licensed in Vietnam except for emergency medicines, antidotes and rare medicines.

-The medicine is a herbal medicine or traditional medicine.

-The medicine is not recommended for use by WHO or the Ministry of Health of Vietnam or prestigious international medicinal and pharmaceutical associations and pharmacy authorities of one of the ICH countries.

-There is no evidence or clear evidence of efficacy.

-There is a warning about safety of the medicine; the medicine underwent an assessment which concludes that its benefits no longer outweigh its hazards.

b) The combination medicine: Apart from the abovementioned criteria, the combination drug that satisfies all the following criteria shall be removed from the list:

-There is no sufficient scientific evidence for efficacy and safety of the combination drug;

- The combination medicineisnot licensed in ICH countries;

- The combination medicineisnot included in the list ofmedicines covered by health insurance ofcomparable countries (Thailand, Philippines, Indonesia).

2.Criteria for addition of new medicines to the list of modern medicines covered by health insurance

a) The medicine is included in the 6^thlist of essential medicines of Vietnam or the 20^thlist of essential medicines of WHO and licensed by the Drug Administration.

b)The medicinethat is notincluded in the6^thlist of essential medicines of Vietnam or the20^thlist of essential medicines of WHOmust satisfy all general criteria and satisfy one of the following specific criteria:

* General criteria:

-The medicine is modern medicine or biopharmaceutical;

-The medicine is issued with the certificate of registration by the Drug Administration; in case of antidotes, rare medicines, emergency medicines, radiopharmaceuticals and tracers, certificates of registration or import licenses are required;

-The medicine is recommended in the guidelines for the diagnosis and treatment of the Ministry of Health or WHO or prestigious international medical and pharmaceutical associations;

-The medicine is proposed by the Departments of Health, health facilities, pathology associations and health organizations and is required to have a product document providing sufficient information according to the form provided in Appendix 4 enclosed with theOfficial DispatchNo.7891/BYT-BHdated November 02, 2016 of the Ministry of Health;

*Specificcriteria:

- First linemedicine isincluded in the guidelines fortreatment,is reallynecessary to be included in the list enclosed with the Circular No.40/2014/TT-BYTwhile analternative medicineis yet to be available on the list.

-For the first line medicinethat isincluded in the guidelines fordiagnosis andtreatmentand a medicine with the same effect is available on the list enclosed with theCircular No. 40/2014/TT-BYT, it must satisfy the following criteria:

(i) The medicine has the evidence for economic evaluation of pharmaceuticals: conduct an economic evaluation of pharmaceuticals and add the medicine when:

+ the scientific evidence of the cost - effectiveness of the medicine compared with the medicine included in the guidelines for diagnosis or treatment of drugs or the medicine already included in the list enclosed with theCircular No. 40/2014/TT-BYT is provided. Priority shall be given to reliable researches (if any) conducted in Vietnam. If researches have not been available in Vietnam, a systematic evidence review of countries in the region must be available;

+ An assessment of budget impact has been conducted in Vietnam;

+  Reliability of research method and results is assessed by the pharmaco-economic team; it is assessed according toCHEERSorPRISMAchecklists.

(ii) The medicinedoes not have the evidence for economic evaluation of pharmaceuticals:consider the clinical efficacy and treatmentcost, and add the medicinewhen:

+the clinical efficacy appears outstanding and treatment cost is not higher than that of the medicine onthe list enclosed with the Circular No. 40/2014/TT-BYT; or:

+ the clinical efficacyappears the sameand treatment cost is notlowerthan that of the medicineonthe list enclosed with the Circular No. 40/2014/TT-BYT; or:

+ the clinical efficacy appears outstanding and treatment cost is higher than that of the medicineonthe list enclosed with the Circular No. 40/2014/TT-BYTbut it is used for some special users (e.g. children aged below 06, etc.) or special cases (e.g. emergency treatment, serious patients, etc.).

-For the medicine that is not a first line one included in the guidelines for diagnosis and treatment, it shall be added to the list when satisfying criteria such as first line medicine used for treatment, payment shall be only made if an alternative medicine is not available after the failure of treatment or in case of intolerance to first line medicines.

3.Criteria for consideration of medicines of which payment conditions and insurance coverage ratio need to be specified

All medicines that are included in the list enclosed with the Circular40/2014/TT-BYTand proposed medicines shall be considered to specifypayment conditions and insurance coverage ratioif the following criteria are satisfied:

a) The medicine has a high cost with leads to high treatment cost.

b) The medicine has many indications, including supplemental indications or unclear efficacy and is proved to be clinically ineffective. The supplemental indications shall be restricted and may be excluded from insurance coverage. Such medicines shall have their indications specified in some diseases or users or insurance coverage ratio shall be specified to ensure uniformity in terms of drug use, payment of health insurance and prevent drug abuse.

4.Criteria for criteria forexpansion of insurance coverage

A medicine will be covered by insurance at hospitals of lower grade if the following criteria are satisfied:

a) The medicine isincluded in thetreatment planof the Ministry of Health or WHO or prestigiousinternationalmedical and pharmaceutical associations,is reallynecessary and no alternative medicine is available at the hospital of lower level;

b) The medicine shall be used in a safe, reasonable and effective manner within the capacity of the hospital of lower grade/level;

c) The medicine has clear efficacy, is included in the guidelines for diagnosis and treatment of theMinistry of Health or WHO or prestigiousinternationalmedical and pharmaceutical associationsand is recommended for use at the hospital of such grade/level;

d) The medicine is proposed bythe Departments of Health, health facilities, pathology associations and health organizationsand is required to havea product document providing sufficient information according toform provided inAppendix5enclosed with the Official Dispatch No.7891/BYT-BH dated November 02, 2016 of the Ministry of Heatlth.

Article 3.Procedures for considering the criteria for removal, addition and adjustment of a medicine on the list of modern medicinescovered by health insurance

1.Procedures for considering the criteria for removal of a medicine

2. Procedures for considering the criteria foraddition of a new medicine

3. Criteria for consideration of medicines of which payment conditions and insurance coverage ratio need to be specified

4.Procedures for consideration of criteria forexpansion of insurance coverage