Quyết định 2701/QD-BYT

DECISION

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 MINISTER OF HEALTH

Pursuant to the Law on Health Insurance;

Pursuant to the Government’s Decree No. 105/2014/ND-CP dated November 15, 2009 elaborating and providing guidelines for some articles of the Law on Health Insurance;

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

At the request of the Director General of 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 Decision comes into force from the day on which it is signed.

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 are responsible for the implementation of this Decision./.

APPENDIX 2

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

Article 1. Rules for compilation of the list of modern medicines covered 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-BYT dated November 17, 2014.

2. 2. Rules for naming medicines in the list of modern medicines covered by health insurance

a) Medicines shall be listed under the names of active ingredients with the nomenclature INN (International Non-proprietary Name), the medicines without the nomenclature INN shall 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.

Article 2. Criteria for removal, addition or adjustment of a medicine on the list of modern medicines covered by health insurance

1. Criteria for removal of a medicine from the list enclosed 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 medicine is not licensed in ICH countries;

- The combination medicine is not included in the list of medicines covered by health insurance of comparable 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^th list of essential medicines of Vietnam or the 20^th list of essential medicines of WHO and licensed by the Drug Administration.

b) The medicine that is not included in the 6^th list of essential medicines of Vietnam or the 20^th list of essential medicines of WHO must 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 the Official Dispatch No.7891/BYT-BH dated November 02, 2016 of the Ministry of Health;

* Specific criteria:

- First line medicine is included in the guidelines for treatment, is really necessary to be included in the list enclosed with the Circular No. 40/2014/TT-BYT while an alternative medicine is yet to be available on the list.

- For the first line medicine that is included in the guidelines for diagnosis and treatment and a medicine with the same effect is available on the list enclosed with the Circular 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 the Circular 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 pharmacoeconomic team; it is assessed according to CHEERS or PRISMA checklists.

(ii) The medicine does not have the evidence for economic evaluation of pharmaceuticals: consider the clinical efficacy and treatment cost, and add the medicine when:

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

+ the clinical efficacy appears the same and treatment cost is not lower than that of the medicine on the 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 medicine on the list enclosed with the Circular No. 40/2014/TT-BYT but 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 Circular 40/2014/TT-BYT and proposed medicines shall be considered to specify payment conditions and insurance coverage ratio if 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 for expansion of insurance coverage

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

a) The medicine is included in the treatment plan of the Ministry of Health or WHO or prestigious international medical and pharmaceutical associations, is really necessary 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 the Ministry of Health or WHO or prestigious international medical and pharmaceutical associations and is recommended for use at the hospital of such grade/level;

d) 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 form provided in Appendix 5 enclosed 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 medicines covered by health insurance

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

2. Procedures for considering the criteria for addition 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 for expansion of insurance coverage