Procedure for drafting and amendment of a list of medicinal products of the Estonian Health Insurance Fund and the content of criteria for establishing the list and evaluators of compliance with the criteria, and establishment and rules of procedure of a medicinal products committee
Passed 19.12.2017 No. 59
This regulation is established on the basis of subsection 43 (3) of the Health Insurance Act and in accordance with subsection 43 (31) of that act.
Part 1 General Provisions
§ 1. Scope of application
The regulation establishes the procedure for drafting and amendment of the list of medicinal products of the health insurance fund (hereinafter the list of medicinal products) and detailed content of the criteria provided in subsection 43 (2) of the Health Insurance Act and evaluators of compliance with the criteria, and the drafting and rules of procedure of a medicinal products committee.
§ 2. Proceeding for drafting and amendment of the list of medicinal products
The administrative proceeding regulated by this regulation is carried out by the Estonian Health Insurance Fund (hereinafter the health insurance fund) considering the provisions of the Administrative Procedure Act. In order to carry out the aforementioned proceeding, the health insurance fund will establish a specialist committee (hereinafter the Medicinal products committee) following a procedure provided in this regulation.
§ 3. Medicinal product and manufacturer of medicinal products
(1) Special formulae consumed on the basis of medical indications and food additives used for treating inherent metabolic disorders are considered equal to medicinal products.
(2) A person to whom a marketing authorisation of a medicinal product has been issued is equal to a manufacturer of medicinal products.
(3) A manufacturer of medicinal products is represented by an authorised person or another person under a notarized power of attorney of the manufacturer of medicinal products.
§ 4. Application of procedure for supplementing the list of medicinal products
(1) Part 2 of the Regulation is applied in the event of application for:
1) entry of a medicinal product with a new active ingredient and administration method into the list of medicinal products;
2) amendment of compensation amount for a medicinal product entered into the list of medicinal products;
3) adding a new diagnosis for a medicinal product entered into the list of medicinal products.
(2) Part 3 of the Regulation is applied in the event of application for:
1) supplementing of the list of medicinal products with a medicinal product in comparison to which a medicinal product with the same active ingredient and administration method is already listed, or for which a directive by the management of the health insurance fund satisfying the application in regard to a medicinal product with the same active ingredient and method of administration has entered into force;
2) supplementing of the list of medicinal products with a medicinal product that (or in comparison to which a medicinal product with the same active ingredient and method of administration) has been excluded from the list of medicines due to expiry of marketing authorisation or lack of marketing or price agreement.
(3) Part 3 of the Regulation is also applied in the cases mentioned in clause (1) 1) of this section if the application is initiated by the State Agency of Medicines or the Ministry of Social Affairs or the proceeding is initiated by the health insurance fund.
Part 2 General procedure for supplementing the list of medicinal products
Chapter 1 Application for entry of a medicinal product into the list of medicinal products
§ 5. Submission of an application
(1) The proceeding for entering a medicinal product into the list of medicinal products begins with the submission of an application to the health insurance fund.
(2) An application for entering a medicinal product into the list of medicinal product is submitted by a manufacturer of medicinal products.
(3) An application cannot be submitted if at least 6 months have not passed from the completion of procedures regarding the same medicinal product.
(4) A manufacturer of medicinal products shall report all known circumstances of significance in regard to the processing of the application.
§ 6. Submission of an application and formal requirements
(1) An application, together with supplementary documents, is submitted on an electronic data carrier in two identical copies in a format viewable with Acrobat Reader or Microsoft Office software, or in another written form.
(2) If the application or its annexes include mathematical models for reasoning the information included in the application which cannot be used for modelling with Microsoft Office software, software for modelling the application with the necessary rights of intellectual property and other rights for the parties of the procedure shall be enclosed with the application for using the software in processing of the application.
(3) The application form is provided in an annex to the Regulation.
(4) The application and annexes thereto are in Estonian, except for copies of articles and scientific research.
(5) The annex to the application may be presented in English if the application concerns a medicinal product necessary to treat rare illness as defined in the Regulation (EC) No 141/2000 of the European Parliament and of the Council on Orphan Medicinal Products (OJ L 18, 22.1.2000, p. 1).
§ 7. Annexes to the application
(1) Annexes to an application include the following:
1) description of the area of use in Estonia on which issuing of a medicinal product on discount conditions is based (including the number of patients, treatment methods used, analysis regarding the possible retail sale volume of the medicinal product, and the predicted retail sale of the medicinal product for 3 years);
2) medical results expected from the use of the medicinal product (e.g. life-saving, symptomatic, improving the quality of life, etc.) with references to scientific publications and research, as well as copies to the referenced scientific publications and research;
3) description of the optimal duration of dosing and using the medicinal product;
4) description of side effects of the medicinal product and medical-economic evaluation to those, first of all the influence of the side effects to the quality of life; additional research necessary for the optimum use or prevention of side effects;
5) wholesale purchase prices of all packages of the medicinal product and estimated changes in the prices for 3 years;
6) pharmacoeconomic analysis of using of the medicine according to the instruction for Baltic countries published on the web page of the health insurance fund for pharmacoeconomic evaluation of medicinal products, relying on information provided in clauses 2 and 4 of the present section;
7) an overview of all scientific publications regarding the medicinal product;
8) a confirmation regarding the lack of additional information;
9) a copy of a document proving a right of representation;
10) other documents established by the legislation.
(2) Pharmacoeconomic analysis on the use of the medicinal product does not have to be adapted to the conditions in Estonia if it is a medicinal product used for treating a rare illness as defined in subsection 6 (5) of the Regulation.
(3) Annexes to the application shall meet the actual situation as at the date of submitting the application. A confirmation regarding the lack of additional evidence may be as at 60 days prior to the submission of the application.
(4) The health insurance fund and the State Agency of Medicines may request additional information and documents if those are necessary for correct and quick solution of the application.
(5) The run of proceedings is suspended for a period not exceeding 60 days until the health insurance fund or the State Agency of Medicines receive the information and documents provided in subsection 4 of this section. The health insurance fund or the State Agency of Medicines informs the other parties of the procedure to a proceeding of the suspension of proceeding terms and termination of the suspension at the earliest opportunity.
§ 8. Acceptance and checking of an application
(1) The compliance of an application with the requirements established in the Regulation is checked at the health insurance fund. In the event of a shortcoming, a period for elimination of the shortcoming shall be assigned within 15 days. The period shall not be shorter than 10 days or longer than 60 days.
(2) The calculation of the period of the procedure shall stop from the moment of assigning a term for elimination of the shortcoming until the elimination of the shortcoming by the manufacturer of the medicinal products.
(3) The health insurance fund submits an application without shortcomings to the State Agency of Medicines within 15 days.
§ 9. Amendment and withdrawal of an application
(1) A manufacturer of medicinal products has a right to amend an application at his own disposal, submitting a new annex to the application to replace the annex to the application provided in clauses 7 (1) (1)–(4) and (6) of the present Regulation.
(2) In the event of an amendment to the application, processing terms shall be calculated from the submission of the amendments.
(3) The health insurance fund informs the State Agency of Medicines of an amendment to or withdrawal of the application.
Chapter 2 Opinion of the State Agency of Medicines and health insurance fund
§ 10. Opinion of the State Agency of Medicines
(1) The State Agency of Medicines prepares a written opinion on the application within 30 days from the arrival of the application at the State Agency of Medicines.
(2) In preparation of the opinion, the State Agency of Medicines may use non-staff experts. The names of the experts are not published.
(3) The State Agency of Medicines immediately submits the opinion to the health insurance fund and the manufacturer of the medicinal products.
§ 11. Criteria for the opinion of the State Agency of Medicines
(1) The State Agency of Medicines shall rely on the following criteria in its opinion:
1) the description and prevalence of the disease on which the issuing of the medicinal product on discount conditions is based, importance of pharmacotherapy in treating of the disease;
2) existence of other medicinal products and treatment methods for the disease on which the issuing on discount conditions is based;
3) scientifically proven effectiveness of the medicinal product, including a comparison to other medicinal products and treatment methods;
4) scientifically proven safety of the medicinal product, including a comparison to other medicinal products and treatment methods;
5) optimum dosing of the medicinal product and duration of use, and a need to receive other medicinal products and treatment or diagnostic procedures during the treatment, including a comparison to other medicinal products and treatment methods;
6) information regarding the use of the medicinal product under application and other medicinal products used for the disease on which the issuing on discount conditions is based in Estonia and in other countries;
7) possibility and consequences of misuse and excessive use of the medicinal product;
8) necessity and possibility of establishing limitations to prescribing of the medicinal product on discount conditions to ensure the rational use of the medicinal product.
(2) The State Agency of Medicines relies on the information provided in the application and other information, including epidemiological, statistical and clinical information.
§ 12. Opinion of the health insurance fund
(1) The health insurance fund prepares a written opinion on the application within 30 days from the arrival of the opinion of the State Agency of Medicines at the health insurance fund.
(2) In preparation of the opinion, the health insurance fund may use non-staff experts. The names of the experts are not published.
(3) The health insurance fund immediately submits the opinion to the manufacturer of the medicinal products.
§ 13. Criteria for the opinion of the health insurance fund
(1) The health insurance fund shall rely on the following criteria in its opinion:
1) information regarding the facilitation and use of the medicinal product under application and other medicinal products used for the disease on which the issuing on discount conditions is based in Estonia and in other countries;
2) economic justification of using the medicinal product, including a comparison to a disease on which the issuing of other medicinal products and treatment methods on discount conditions is based;
3) possibility and economic consequences of misuse and excessive use of the medicinal product;
4) necessity and possibility of establishing limitations to prescribing of the medicinal product on discount conditions to ensure the economically reasonable use of the medicinal product;
5) estimated retail sale volume of the medicinal product;
6) correspondence of listing of the medicinal product to the financial means of medical insurance, considering the cost of the medicinal product under application in other countries of the European Union, first of all in in the Republic of Latvia, Republic of Lithuania and Republic of Slovakia, and principle provided in subsection 25 (3) of the Health Insurance Act.
(2) The health insurance fund relies on the information provided in the application and other information, including epidemiological, statistical and clinical information.
Chapter 3 Establishment and rules of procedure of a medicinal products committee, proceeding an application in the Medicinal Products Committee
§ 14. Medicinal products Committee
(1) The Medicinal Products Committee (hereinafter the committee) is an advisory committee of the management of the health insurance fund established by the health insurance fund.
(2) The aim of the committee’s activities is to give opinions to the management of the health insurance fund regarding amendments to the regulation of the minister responsible for the field established under subsection 42 (21) and subsection 43 (1) of the Health Insurance Act, deletion of medicinal products from the list, amendments to the reimbursement percentage or highest price of a medicinal product, or establishment of or amendments to limits for the use of a medicinal product.
(3) The committee has up to eight members who are confirmed by the management of the health insurance fund. Representatives or alternate members of the following stakeholders belong in the committee:
1) Estonian Medical Association;
2) Estonian Family Doctors Association;
3) Institute of Family Medicine and Public Health of the University of Tartu;
4) Estonian Chamber of Disabled People;
5) Estonian Patients Association;
6) Ministry of Social Affairs;
7) State Agency of Medicines;
8) Health insurance fund.
(4) The person preparing the opinion of the health insurance fund or the State Agency of Medicines may be a member of the committee.
(5) If necessary, the committee may include experts in the work of the committee.
§ 15. Rules of procedure of the committee
(1) The work of the committee is governed by the chairman or, in their absence, their alternate member.
(2) If a member of the committee is absent, their organisation or department of administration is substituted by an alternate member with a registered right to vote.
(3) The management of the health insurance fund appoints the chairman of the committee chosen from the members of the committee.
(4) The chairman of the committee decides:
1) involvement of external experts in the work of the committee;
2) invitation of representatives of stakeholders to the discussion of items on the agenda.
(5) The health insurance fund organises the administration of the committee.
(6) The work format of the committee is a meeting which may be held electronically.
(7) The venue for a committee meeting is the location of the health insurance fund, unless the person calling the meeting has determined otherwise.
(8) Committee meetings are recorded in minutes. The chair and secretary of the meeting sign the minutes. The health insurance fund forwards the meeting minutes to the members of the committee electronically to be reviewed and confirmed within 14 days as from the meeting. Each member of the committee confirms the minutes within five days as from receiving it.
(9) The following data are entered into the minutes:
1) time and place of the meeting;
2) names of participants;
3) names of the chair and secretary of the meeting;
4) meeting agenda;
5) names of persons who made a presentation on the items on the agenda;
6) content of the discussion held during the meeting;
7) wording of the opinion of the committee which was put to vote during the meeting, along with the voting outcome;
8) circumstances requested to be included in the minutes by a member of the committee and other relevant circumstances.
§ 16. Committee meeting
(1) Regular committee meetings are held pursuant to the work plan of the committee.
(2) A meeting invitation is sent to the members of the committee via e-mail 14 days prior to the meeting. Meeting agenda are annexed to the invitation.
(3) The meeting has quorum if more than half of the members of the committee are present. If necessary, the chairman of the committee appoints a new time and place for the meeting.
(4) Meeting materials are made electronically available to the members of the committee at least seven days prior to the meeting.
(5) A meeting is carried out pursuant to an agenda; participating in a meeting using video conference or another modern means of data communication is allowed. The agenda may be amended during a meeting if there is urgent need.
(6) The meetings are private; however, concerned persons may attend meetings if this has been coordinated with the chairman of the committee.
(7) Opinions of the committee are formed based on consensus or by simple majority, abstentions are not allowed, all dissenting opinions are recorded in minutes. In case of equality of votes, the chairman of the committee, or if they are absent, their alternate member, has the casting vote.
§ 17. Submission of opinions and objections
(1) Opinions of the health insurance fund and the State Agency of Medicines shall be forwarded to the committee.
(2) A manufacturer of medicinal products may submit to the committee a written opinion in regard to the opinion of the State Agency of Medicines and health insurance fund within 15 days from the submission of the opinion of the State Agency of Medicines and the health insurance fund.
(3) If the manufacturer of medicinal products has substantive objections to the opinion of the State Agency of Medicines or the health insurance fund that have not been submitted before, the committee may request the submission of additional opinion from the State Agency of Medicines and the health insurance fund in regard to the objections of the manufacturer of medicinal products within 15 days. The committee shall inform the parties of the procedure thereof, and the period of processing the application shall be suspended until the arrival of the additional opinion of the State Agency of Medicines and the health insurance fund.
§ 18. Summoning and appearance to a meeting of the committee
(1) The manufacturer of the medicinal products or their representative who can appear at a meeting may be summoned to a meeting of the committee. If a person cannot attend the meeting upon an invitation for a significant reason, he/she shall immediately inform the committee thereof.
(2) If a manufacturer of medicinal products or a party of the procedure or another invited person does not attend the meeting for a significant reason, the committee meeting may take place without him/her.
§ 19. Opinion of the committee
(1) In providing of an opinion, the committee shall rely on the criteria established in subsection 43 (2) of the Health Insurance Act, and subsection 11(1) and subsection 13 (1) of the Regulation.
(2) The opinion of the committee shall be in writing and with justifications. The opinion of the committee may be conditional. The justification needs to include considerations for not accepting the opinion and objections of the manufacturer of medicinal products and a third person.
(3) If the following of the committee’s opinion would cause an increase in the expenses of the Estonian Health Insurance Fund or a redistribution of financial means, the opinion shall include the financial calculations showing the covering of additional costs or a method of redistribution of financial means within the prescribed expenses for compensation of medicinal products in the budget of the Estonian Health Insurance Fund.
(4) If the opinion of the committee provided in subsection 2 of this section was conditional with regard to the price of the medicinal product and the manufacturer of the medicinal products wishes to meet that condition, the run of the proceedings is suspended until a draft of the price agreement is forwarded to the manufacturer of the medicinal products.
(5) Opinion of the committee shall be immediately forwarded to the manufacturer of the medicinal products.
§ 20. Solving of an application
(1) The management of the health insurance fund solves the application whilst taking into account the opinion of the medicinal products committee within 180 days as from filing the application to the health insurance fund, excluding the days during which the period of the administrative procedure had been suspended under the legislation.
(2) The health insurance fund shall consider criteria provided in subsection 43 (2) of the Health Insurance Act, and subsection 11 (1) and subsection 13 (1) of the Regulation in solving of the application.
(3) The management of the health insurance fund may consider the following ancillary conditions in making their decision:
1) a right to change the decision if information regarding new properties or erroneous use of the medicinal product appear;
2) a right to change the decision if the manufacturer of medicinal products has violated a price agreement, has not concluded a price agreement by the term provided in the directive, or has not fulfilled an additional obligation associated with the directive;
3) restriction of prescribing the medicinal product only by doctors of the relevant profession;
4) age limitation to patients for whom the medicinal product is prescribed;
5) restrictions based on medical criteria;
6) limitations to the duration of prescribing the medicine.
(4) The health insurance fund shall immediately forward the decision to the manufacturer of medicinal products and to the Ministry of Social Affairs.
§ 21. Supplementing the list of medicinal products
(1) If the decision of the management of the health insurance fund to satisfy the application of the manufacturer of the medicinal products has not been annulled pursuant to the procedure and by the term provided by law, the medicinal product shall, upon proposition of the supervisory board of the health insurance fund, be included in the list of medicinal products no later than within six months from the expiry of the term of disputing.
(2) If the health insurance fund and the manufacturer of the medicinal products have not entered into a price agreement during the term specified in subsection 1 of this section, the medicinal product is not entered into the list of medicinal products. The health insurance fund shall notify the Ministry of Social Affairs of price agreements which have not been entered into and the term of which will expire in one month.
Part 3 Simplified procedure for amendment of the list of medicinal products
§ 22. Submission of an application
(1) The simplified procedure for entering a medicinal product into the list of medicinal products begins with the submission of an application to the health insurance fund.
(2) Provisions of sections 5 and 6 of the Regulation are applied to the submission of the application, taking into consideration subsection 4 (3) of the Regulation.
§ 23. Application of provisions
(1) Provisions of sections 8 and 9 of the Regulation are applied to the acceptance and checking of an application, leaving it unprocessed, and withdrawal of an application.
(2) An application with shortcomings is not forwarded to the State Agency of Medicines. Provisions in subsection 9 (3) of the Regulation shall not be applied to the amendment and withdrawal of an application.
§ 24. Solving of an application
(1) The management of the health insurance fund solves the application within 90 days from submission of the application, excluding the days during which the period of the administrative procedure had been suspended under the legislation.
(2) Upon solving of an application, the health insurance fund considers the criteria provided in subsection 43 (2) of the Health Insurance Act.
(3) Upon the solution of an application in regard to the criterion of compliance with the financial means of health insurance, the health insurance fund shall also consider the following:
1) in the event of a generic medicinal product, the fact that the generic medicinal product is at least 30% cheaper than the original medicinal product with the same active ingredient entered into the list of medicinal products;
2) in the event of a biologically similar medicinal product, the fact that the said medicinal product is at least 15% cheaper than the original medicinal product entered into the list of medicinal products;
3) in the event of a secondary medicinal product, the fact that the medicinal product with secondary marketing authorisation is at least 10% cheaper than the original medicinal product entered into the list of medicinal products;
4) after the establishment of a reference price in a group of medicinal products with the same active ingredient and method of administration, the fact that the price of the medicinal product upon solving of the first three applications is at least 10% cheaper and upon solving of the following applications, not higher than the price of the cheapest medicinal product entered into the list of medicinal products.
(4) Upon satisfaction of an application, the management of the health insurance fund may consider ancillary conditions provided in subsection 20 (3) of the Regulation.
(5) Before making a decision, the health insurance fund may prepare a thorough opinion in accordance with and under the conditions provided in sections 12 and 13 of the Regulation and request an opinion from the State Agency of Medicines and the committee.
(6) In solving of an application, the health insurance fund may ask additional clarifications from the applicant.
(7) The health insurance fund may submit an application to request the opinion of the committee, if:
1) the satisfaction of the application may cause an increase in the expenses of the health insurance fund above the expenses prescribed for compensation of medicinal products in the budget of the health insurance fund;
2) the decision is of principle importance for the Estonian policy of medicinal products.
(8) Provisions of sections 20 and 21 are applied to the decision of the health insurance fund and updating the list of medicinal products.
§ 25. Processing of an application by the committee
Provisions of division 3, part 2 of the Regulation are applied to the processing of an application by the committee.
Part 4 Exclusion of a medicinal product from the list, amendment of the percentage of compensation applied to a medicinal product or establishment or amendment of restrictions on the use of a medicinal product
§ 26. Submission of and requirements to an application
(1) The procedure of exclusion of a medicinal product from the list, amendment of the percentage of compensation applied to a medicinal product or establishment or amendment of restrictions on the use of a medicinal product starts by submitting a relevant application to the health insurance fund.
(2) An application may be submitted by every manufacturer of medicinal products, the State Agency for Medicines or another interested person. The procedure may be initiated by the health insurance fund.
(3) The application is submitted electronically or by another written means.
(4) The need for exclusion of a medicinal product from the list, amendment of the percentage of compensation applied to a medicinal product or the establishment or amendment of ancillary conditions for using a medicinal product shall be justified in accordance with the criteria established in subsection 43 (2) of the Health Insurance Act.
§ 27. Operations upon receiving an application
(1) Immediately after the initiation of a procedure for exclusion of a medicinal product from the list, amendment of the percentage of compensation applicable to a medicinal product or establishment or amendment of restrictions on the use of a medicinal product the health insurance fund asks an opinion from the manufacturer of medicinal products for whose product the application was submitted and from the State Agency of Medicines with written evidence of the justification for the exclusion of the relevant medicinal product from the list, amendment of the percentage of compensation applicable to a medicinal product or establishment or amendment of restrictions on the use of a medicinal product.
(2) The State Agency of Medicines is not included in the procedure and the health insurance fund does not present a written opinion if the procedure for exclusion of the medicinal product from the list or decreasing of the percentage of compensation was initiated for the following reasons:
1) the medicinal product is not marketed or the marketing authorisation or price agreement has expired;
2) the price of the medicinal product is more than twice the maximum price established for it and the prices of all other medicinal products with the same active substance and route of administration;
3) the medicinal product has been classified among OTC medicinal products;
4) establishment or amendment of restrictions on prescribing the medicinal product is based on a need to unify the restrictions on prescribing medicinal products with the same or equal active ingredient.
(3) Circumstances for which an opinion is desired and a term for providing an opinion shall be specified in the request provided in subsection 27 (1), considering the scope and complexity of the fulfilment of the request.
§ 28. Opinion of the health insurance fund, the State Agency of Medicines, and the manufacturer of medicinal products
(1) The health insurance fund and the State Agency of Medicines may provide a common opinion.
(2) The health insurance fund and the State Agency of Medicines may include experts. The names of the experts are not published.
(3) If a manufacturer of medicinal products has not submitted an opinion in timely manner, it shall be considered that they support the exclusion of the medicinal product from the list of medicinal products, amendment of the percentage of compensation applied to the medicinal product or establishment or amendment of restrictions on the use of the medicinal product.
§ 29. Application of provisions
(1) The provision of chapter 3 of part 2 shall be applied to exclusion of a medicinal product from the list of medicinal products, amendment of the percentage of compensation applied to the medicinal product or establishment or amendment of restrictions on the use of the medicinal product, except in the events provided in subsection 27 (2).
(2) The provisions of sections 20 and 21 shall be applied to the solution of an application and amendment of the list of medicinal products.
(3) The minimum time to the exclusion of a medicinal product from the list of medicinal products due to the expiry of marketing authorisation is 3 months from the relevant time.
Part 5 Application of provisions
§ 30. Repealing a Regulation
Regulation No. 123 of 8 December 2004 of the Minister of Social Affairs, “Procedure for drafting and amendment of a list of medicinal products of the Estonian Health Insurance Fund and the content of criteria for establishing the list and evaluators of compliance with the criteria” is repealed.
§ 31. Entry into force of the regulation
The regulation will enter into force on 1 January 2018.
Jevgeni Ossinovski
Minister of Health and Labour
Marika Priske
Secretary General
Annex Application to enter a medicinal product into the list of medicinal products
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