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 generic medicinal product name (active substance). 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 with a generic name or a combination of generic names 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.
In order to receive the opinion regarding therapeutic efficacy and cost-effectiveness of a medicinal product, please submit an application (download application form) to the Agency together with the following documents:
1) Clinical trial summary and publications, indicating reference to the source with the evidence for efficacy and benefits of the specific medicinal product for the relevant diagnosis and patient group in comparison with another alternative therapy available in Latvia;
2) Pharmacoeconomic analysis compliant with the guidelines for economic evaluation of medicinal products;
3) At the applicant’s discretion – proposal for financial participation in order to improve parameters of cost-effectiveness in comparison with standard therapy available in Latvia.
Documents should be forwarded to the Agency via e-mail to email@example.com (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 requirements of normative acts regarding preparation of electronic documents, they must be submitted in paper format at the Agency’s client service centre, 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:
1) Therapeutic assessment by evaluating
- published clinical trial results regarding therapeutic efficacy benefits within the pharmacotherapeutic group or diagnosis, related to mortality or time until disease progression, incidence of chronic disease, onset of disability and decrease in the number of hospitalisations, improvement in health condition in comparison with other available therapies;
- compliance with treatment schemes (hereinafter – treatment schemes) and international treatment guidelines for the specific condition established by professional associations of doctors, as well as other assessments performed in foreign countries;
- position of medicinal product in the treatment scheme for the particular condition (for example, first-line or second-line treatment, target patient groups);
- compliance of pharmaceutical form and strength with the treatment scheme;
- conformity of the packaging with the treatment course;
2) Economic assessment in accordance with the guidelines on economic evaluation of medicinal products
3) Evaluation of the opinion of third party stakeholders, if such have been involved
The following information is included in the opinion:
- name of medicinal product and generic name, 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;
- opinion on the comparative efficacy of medicinal product;
- opinion on cost-effectiveness of medicinal product within the context of the healthcare system;
- special considerations (if any) in assessment of 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 application, excluding the time from issuance of invoice until payment of invoice, 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.
The fee for this service is stipulated by the paid service pricelist of the Agency (Article 86 of the Annex).
Regulation No. 899 of the Cabinet of Ministers of the Republic of Latvia "Procedures for the Reimbursement of Expenditures for the Acquisition of Medicinal Products and Medical Devices Intended for the Outpatient Medical Treatment" (adopted on 31 October 2006)