Cost-effectivenes assessment

Marketing authorisation holder or its authorised representative is entitled to receive opinion of the State Agency of Medicines (hereinafter – Agency) regarding the assessment of therapeutic efficacy and cost-effectiveness of a medicinal product (active substance/ international nonproprietary name (INN)). This opinion may be submitted to the National Health Service for inclusion of a medicinal product in the list of reimbursable medicinal products.

The Agency issues its opinion:

• for medicinal products (active substance/ INN) or combined medicinal products not included in the list of reimbursable medicinal products;
• for medicinal products included in the list of reimbursable medicinal products if the conditions for reimbursement are under review in relation to reimbursement for a new diagnosis or patient group.

The opinion of the Agency on the cost-effectiveness assessment is not required:

• if the combined medicinal product consists of active substances/ INN that are included in the list of reimbursable medicinal products and the applicant applies for reimbursement for the same diagnoses and patient groups for which the individual active substances/ INN are reimbursed;
• if the medicinal product has already been submitted to and evaluated by the National Health Service for the same diagnoses and patient groups;
• if the National Health Service invites to submit the application for the generic medicinal product (active substance/ INN) for which the patent protection has been expired.

Documents

In order to receive the opinion on therapeutic efficacy and cost-effectiveness of a medicinal product, please submit an application (download the application form) to the Agency together with the following documents:

• clinical trial summary with an indication of unrestricted access to the full texts of those trials or the relevant publications and their annexes in human-readable format, that provide evidence on efficacy and benefits of the medicinal product for the diagnosis and patient group indicated in the application in comparison with alternative (standard) treatment available in Latvia;
• pharmacoeconomic analysis compliant with the guidelines for economic evaluation of medicinal products;
• the economic model, if used for pharmacoeconomic analysis;
• at the applicant’s discretion – financial proposal in order to improve cost-effectiveness of a medicinal product in comparison with standard treatment available in Latvia.

Documents should be submitted to the Agency via e-mail to info@zva.gov.lv (documents should be signed with an e-signature). If you are a user of Latvian e-address, please use the e-address for communication.

If the aforementioned documents are not prepared in accordance with the laws and regulations regarding preparation of electronic documents, they must be submitted in paper format at the Agency’s customer service center, Room 11 (address: Jersikas iela 15, Riga), in addition, the electronic version must be sent via e-mail.

In preparation of the opinion the Agency performs:

•  therapeutic assessment by evaluating
• results of published clinical trials or joint clinical assessment reports drawn up in accordance with Article 9 of Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU regarding therapeutic efficacy within the pharmacotherapeutic group or diagnosis indicated in the application, related to mortality rate or time to disease progression, incidence of chronic disease, onset of disability, decrease in the number of hospitalizations, improvement in health status in comparison with other available treatments;
• compliance with treatment schemes (hereinafter – treatment schemes) and international treatment guidelines, as well as assessments carried out in other countries;
• position of medicinal product in the treatment scheme for the particular condition (for example, first-line or second-line treatment, target patient groups),
• economic assessment in accordance with the guidelines on economic evaluation of medicinal products,
• evaluation of the opinion of stakeholders (including professional associations of doctors or medical institutions and patient organizations), if such have been received.

  The following information is included in the opinion:

• name of a medicinal product and active substance, ATC code, pharmaceutical form, strength and mode of administration;
• disease, indicating code of diagnosis according to the ICD-10 classification, and target patient group, if submitted for use in a specific patient group;
• conclusion on the comparative efficacy of a medicinal product;
• conclusion on cost-effectiveness of a medicinal product within the context of the healthcare system;
• the views of professional doctors’ associations and patients’ organisations, if received;
• special considerations (if any) to be taken into account when evaluating a medicinal product for inclusion in the list of reimbursable medicinal products.

The Agency shall issue the opinion electronically by sending it to applicant’s e-mail address within 120 days after receipt of the application, excluding the time from issuance of the invoice until its payment, as well as time required for receipt of additional information. The opinion shall be published on Agency’s website no later than 5 working days after the opinion has been sent to the applicant.

Additional information

Cabinet Regulation No 899 “Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for the Outpatient Medical Treatment” does not foresee the re- evaluation of Agency’s opinion.

Useful information

When preparing the application, please also pay attention to the following aspects:
-    if a submission is made for several strengths/ package sizes of the medicinal product, they shall be reflected in a single application form;
-     if the medicinal product under evaluation is to be used in combination with other specific medicinal products (e.g. other target therapies, etc.), it is recommended that these medicinal products are also indicated in Section 3 of the application form “Information on medicinal products”;
-     the diagnosis and patient group indicated in the application form correspond to the diagnosis and patient group for which the pharmacoeconomic evaluation of the medicinal product has been performed;
-    the information referred to in the clinical trial summary is identifiable and can be found on publicly accessible websites (otherwise, full publications of the documents and additional annexes shall be attached);
-    if the medicinal product has undergone a joint clinical assessment in accordance with the requirements of Regulation No 2021/2282, this shall be indicated in section 5 of the application form “Information accompanying the application”;
-    if the pharmacoeconomic analysis has been performed by using a modelling technique, the model shall be submitted electronically, and it should be verifiable and editable. Data sources of the clinical and cost items, as well as detailed information on cost items must be indicated.

The Agency also allows the submission of information in English, with the exception of the following documents/sections of the documents:

• application for the assessment of the cost-effectiveness of a medicinal product, in particular the section “Diseases for the treatment of which the medicinal product is to be assessed”- diagnosis, patient target groups,
• summary of the pharmacoeconomic analysis and its conclusions.

Cabinet Regulation No 899 “Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for the Outpatient Medical Treatment” does not foresee the re- evaluation of Agency’s opinion.