General principles
	Main tasks of SMPRA
	Formation of the Positive list

Application for reimbursement of a pharmaceutical product

Application fees

General principles of the reimbursement system of pharmaceuticals are set in the Regulation of Cabinet of Ministers of the Republic of Latvia No.899 of 31 October 2006.

The reimbursement of pharmaceuticals shall be provided according to the character and severity of the disease. Diseases are listed in the Appendices No.1 of the Regulation No. 899 of 31 October 2006.

The following reimbursement categories according to the character and severity of the disease are applied: 100%, 90%, 75%, 50%.

The pharmaceuticals eligible for reimbursement are listed in the Positive list elaborated by the State Medicines Pricing and Reimbursement Agency (SMPRA).

Reimbursed pharmaceuticals are prescribed by family doctors and certain specialists who have agreement with Health Compulsory Insurance State Agency.

Reimbursement is provided through pharmacies on the basis of a special reimbursable prescription, patients having to pay only the co-payment in the case of 90%, 75% or 50% reimbursement or getting the pharmaceuticals without payment in the 100% reimbursement case.

The main criteria for a pharmaceutical product to be reimbursed are:

1. the burden of the disease;
2. the therapeutic value of the product;
3. the cost-effectiveness data;
4. impact on health care budget.

To bare the growing expenditure on pharmaceuticals, reimbursement system is based on a range of cost-containment measures:

Supply side measures:

1. a limited list of reimbursable pharmaceuticals;
2. fixed prices for a certain period (up to 2 years);
3. reference pricing mechanism for therapeutically interchangeable products.

Demand side measures:

1. fixed budgets for doctors;
2. special reimbursement conditions for most expensive pharmaceutical products;
3. patient co-payment;
4. Rational pharmacotherapy guidelines.

The Positive list

Positive list consists of 3 parts according to following criteria:

List A - pharmaceuticals are grouped in clusters of interchangeable pharmaceutical products.
Pharmaceutical products are considered to be interchangeable if they:

• have the same indications;
• have the same method of administration;
• have no clinically relevant differences in effectiveness and side effects;
• are intended for the same patient group.

The reference price for each cluster is the price of the cheapest product. Products are clustered according to the presentation form, dosage and package size.

List B - contains pharmaceutical products, which are considered not to be interchangeable.

List C - contains pharmaceuticals, which are considered not to be interchangeable and: 1) cost per patient per year exceeds 3000LVL / 4270€; 2) special medical restrictions cannot be applied to bare the expenditure.

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State Medicines Pricing and Reimbursement Agency is a Governmental Agency under the Ministry of Health, established by the Government in 1998. The tasks, responsibilities and working procedures are set in the Regulation of Cabinet of Ministers of the Republic of Latvia No.1007 of 7 December 2004.

Main tasks of SMPRA:

	to elaborate the Positive list of reimbursable products;
	to make the decisions on reimbursement of pharmaceutical products;
	to set a reasonable price for reimbursement based on comparison of costs within active substance, pharmaco-therapeutic group or indication;
	to make the decisions on reimbursement conditions of a pharmaceutical product;
	to elaborate Rational Pharmacotherapy Guidelines based on the evidence data form clinical trials, comparative therapeutic and cost-effectiveness data;
	to elaborate and promote projects on the development of the reimbursement system;
	to collaborate with doctor’s and pharmacist’s professional associations;
	to analyze the information on prescription of reimbursed pharmaceuticals;
	to collaborate with relevant institutions in other countries.

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Formation of the Positive list

The holder of the marketing authorization (thereinafter called the applicant) has the right to submit a written application for the reimbursement of the pharmaceutical product to the SMPRA.

Pharmaceuticals submitted shall:

	has to be registered by the State Agency of Medicines or by the EU Centralized Procedure or parallely imported according to regulations;
	be classified as “prescription only” (OTC products are not reimbursed);
	have an approved indication relevant to diseases listed in the Appendices No.1 of the Regulation No.899 of 31 October 2006.

The following documentation and information shall be included in the application:

	Name of the applicant, address, phone, fax of the applicant, name, position, address of the contact person;
	Account information;
	Trade name of a pharmaceutical product, registration No, registration date;
	Name of active substance given by INN, ATC code;
	Concentration, pharmaceutical form, package size, recommended daily dosage of a pharmaceutical product;
	Manufacturer’s (CIP) price of a pharmaceutical product in currency and lats, proposal for the price as a basis for reimbursement in lats;
	Information about different trade names of a pharmaceutical product in other countries;
	Reimbursement indications/conditions.

A special form of application has to be filled out.

The following documentation and information shall be added to the application:

	A copy of the marketing authorization;
	Summary of clinical trials, copies of published clinical trials (with reference to data source) presenting the therapeutic value of the pharmaceutical product in comparison with other alternative treatments (for a new active substance);
	Information about manufacturer’s prices of the product in the country of origin and other European countries in EUR;
	Pharmaco-economic analysis in compliance with the Baltic Guideline for Economic Evaluation of Pharmaceuticals (for a new active substance);
	Budget impact analysis based on the estimated annual sales volume within reimbursement system. Budget impact analysis for a new active substance is a part of the pharmaco-economic analysis;
	Justification for the price increase (in case of a re-application);
	Confirmation of the continuous availability of the applicable product on the Latvian market;
	Power of attorney of the holder of the marketing authorization, if application is submitted by the authorized person.

Criteria for inclusion:

	Therapeutic value of the product based on the evidence level from published clinical trials;
	Relevance to the treatment schemes and international guidelines for the treatment of the disease;
	Place in the treatment scheme of the disease (e.g. first/second line treatment, specific patient group);
	Relevance of the dosage, pharmaceutical form and package size to the treatment course;
	Justified price, based on the comparison with other available treatments and prices in other Baltic and European countries;
	Cost-effectiveness data; relevance of pharmaceutical expenditure with expected therapeutic effectiveness;
	Budget impact.

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