Read the untranslated law here: https://www.vestnesis.lv/ta/id/111208
Cabinet of Ministers Regulations No. 418, Riga, 14 June 2005 (pr. 35. § 28) Outpatient treatments and medicines for the purchase of medical equipment for the refund order Issued in accordance with article 4 of the law on the treatment of i. General questions 1. Rules provide outpatient treatments of medicines and medical equipment purchase expense allowance (hereinafter referred to as the compensation procedures).
2. the compensation arrangements include a set of measures that ensure the patient a chance to buy the medicines and medical devices, the purchase of which by such terms to be covered from the State budget Act of the current year the purchase of medicinal products granted compensation funds (hereinafter referred to as the purchase of medicines compensation funds).
II. basic principles of compensation procedures 3. the purchase of medicinal products, taking into account the nature of the disease and the severity, in accordance with these rules shall compensate the patients who have been diagnosed with any of the rules referred to in annex 1 of the diseases and the need to use the eligible list of the medicinal products or medical devices. The purchase of medicinal products is compensated for by applying the following categories of compensation: 3.1 category I — compensation to 100% in the treatment of the disease without the use of the medicinal product is not possible to maintain the patient's vital functions;
3.2. Category II: 90% refund if relevant disease treatment without drug use is difficult patient vital signs maintenance;
UR3.3.III category: 75% refund if treatment of the disease without the use of the medicinal product is not possible to maintain the patient's current state of health;
3.4. Category IV – refund 50% when the treatment of the disease requires the use of the medicinal product, in order to improve the patient's health condition.
4. Medications and medical devices to include in the list of medicinal products eligible to be deleted from the list of medicinal products, the amount of countervailable (special medicine or general name together with a trade mark or name of the manufacturer and medical device names) created and maintained, as well as the rules referred to in annex 1 of rational pharmacotherapy disease recommendations for acquisition of medicines compensation system developed in medicine prices, a government agency.
5. The eligible list of medicines consists of two sections: (A) and (B) of the list list. Lists the type according to the following principles: (A) list 5.1 include interchangeable drug names in the name of general medicine, medicine or diagnosis of the Group farmakoterapeitisk and interchangeable medical devices according to nosa Kuma this provision in paragraph 27 above;
5.2. (B) to include in the list of medicinal products and medical devices, which list names are not interchangeable in the pharmaceutical or medical equipment.
6. Medicines that contain the list of medicinal products, the countervailable must be: allow for UR6.1.iek in the Republic of Latvia to the list of medicinal products authorised or registered in one of the European Medicines Agency in the registration procedure or parallel imported in accordance with the laws and regulations on the import and distribution of medicinal products, or you must have permission to import and distribute drugs in the territory of the Republic of Latvia in accordance with article 10 of the law of Pharmacy 7;
6.2. classified as prescription drugs in accordance with the laws and regulations on the classification of the medicinal product;
UR6.3.re to the indication that meet these rules referred to in annex 1;
6.4.uz specific time for a specific price or the pharmacy price, which is the cheapest pharmacy price of medicines interchangeable within the Group (hereinafter referred to as the reference price), approved by the national agency of prices of medicines on the basis of the medicinal products or medical devices registration holder (owner), its authorized representative, medicine or medical equipment wholesaler, or its authorised representative proposed wholesale sales price of medicinal products (hereinafter referred to as the compensation base price) for which the medicinal product sold in the drugstore.
7. medical devices that contain the list of products eligible should be: UR7.1.re to the health statistics and medical technologies State Agency;
7.2.uz specific time for a specific pharmacy or reference price, the price the State Agency of medicines based on compensatory base price.
8. the Glycemic teststrēmeļ acquisition of pregnant women and children, as well as stoma care medical equipment purchase apply 100% of compensation. Other eligible medicines included in the list of medical equipment purchase costs (irrespective of the diagnosis concerned the amount of the refund applicable) offset by 50%.
9. Homeopathic medicinal products eligible shall not be included in the list of medicinal products.
III. For medicinal products and medical devices eligible for inclusion in the list of medicinal products guiding principles 10. To assess the drug and medical devices into the eligible list of medicines, drugs or medical devices registration holder (owner), his authorised representative, medicine or medical equipment wholesaler, his authorized representative (hereinafter applicant) shall submit the medicine price national agency a written application.
11. The applicant is responsible for the documentation attached to the application in the message. On application of registration of medicine price in the national agency, the applicant is not entitled to amend, on its own initiative the information referred to in the application. The applicant has the right to submit additional information. If, after receipt of such information requires the application of the registered repeated expertise, drug prices, a government agency has the right to request the applicant to submit a new application.
12. If the product is included in the Republic of Latvia in the list of medicinal products authorised or registered in one of the European Medicines Agency in the registration procedure or medical device has been registered with the health statistics and medical technologies State Agency, the applicant the application shall be accompanied by the following documents and information: 12.1. patent or specific supplementary protection certificate for medicinal products with the term of validity;
12.2. the medical devices-medical device description of the Latvian language;
UR12.3.ori ģinālaj medicinal products — applicant approved clinical trials summary and copies of publications when referencing a source that demonstrates the benefits of these products compared to other alternative therapies available in Latvia;
12.4. medicines or medical devices the manufacturer's sales price of the country concerned and the Member States of the European Union and, in particular the Bank of Latvia exchange rate at the date of the application;
12.5. the impact on the State budget, including the calculation of comparative therapy, patient groups and the target number of patients, as well as the calculation of the potential compensation procedures in Latvia and to medicinal products marketed medical devices and forecast turnover;
12.6. farmakoekonomisko calculation in accordance with the provisions in annex 2 economic evaluation of medicines approved guidelines (if submitting a new drug to the General name of the eligible list for medicinal products);
12.7. the compensation base price improvement reasons (if the resubmitted application);
12.8. a statement that will provide a permanent drug and medical devices on the market to include it being the end of the period of the eligible list of medicinal products;
12.9. a medicine or medical device registration certificate holder (owner) of the issued token, if the application is lodged by the holder of the registration certificate (owner) authorized representative;
12.10. a document showing that the applicant business regulatory legislation in the order is registered with the register of enterprises, as well as the right of representation of an identity document.
13. Where medicinal products are imported and distributed in the territory of the Republic of Latvia in accordance with article 10 of the law of Pharmacy 7 application, the applicant shall be accompanied by the following information: 13.1 use of medicinal products in the language of instruction in Latvian and in their original language;
13.2. the wholesale price and the currency of the country of the exporting country and, in particular the Bank of Latvia exchange rate at the date of the application;
13.3. in the receipt that will ensure a permanent presence of the medicinal product on the market until the end of the period of inclusion in the list of products eligible;
shall UR13.4.apr on potential compensation procedures in Latvia to medicinal products marketed in the amount of the forecast turnover (in LCY) and the number of patients;
13.5. the State Agency of medicines authorisation for the import of unregistered medicinal products issued by the holder of the power, if the application is lodged by the authorized representative.
14. Where a medicinal product is imported in parallel, the applicant the application shall be accompanied by the following information: 14.1. producer price country and the exporting country's currency and, in the form laid down by the Bank of Latvia exchange rate at the date of the application;
14.2. in the receipt that will ensure a permanent presence of the medicinal product on the market until the end of the period of inclusion in the list of products eligible;
shall UR14.3.apr on potential compensation procedures in Latvia to medicinal products marketed in the amount of the forecast turnover (in LCY) and the number of patients;
14.4. the parallel importer's issuing authority, if the application is lodged by the authorized representative.
15. Application for revision of the conditions for compensation, the applicant shall be accompanied by the following documents and information:
15.1. clinical research summary and copies of publications that demonstrates the benefits of these products compared to other alternative therapies available in Latvia for a specific diagnosis (according to international statistical and classification of health problems (ICD-10), World Health Organization, 1992) and the target group of patients;
15.2. the impact on the budget, including the calculation of comparative therapy, patient groups and the target number of patients, as well as the calculation of the potential compensation procedures in Latvia and to medicinal products marketed medical devices and forecast turnover;
15.3. farmakoekonomisko calculations in accordance with Annex 2 to the US in the economic evaluation of medicines of nātaj guidelines, demonstrating cost effectiveness and patient diagnosis specific target group.
16. the price of the medicinal product, in addition to the National Agency provisions these 10, 12, 13, 14 and 15 above documents and information have the right to request the applicant to submit a decision to the necessary additional information, showing compliance with this provision 20. criteria referred to in paragraph 1.
17. The applicant drug price national agency pays the Bill, drawn up under public service pricing. The Bill includes: application fees 17.1. medicines and medical equipment for inclusion in the list of medicinal products eligible;
17.2. the fee for the application for review of the conditions of compensation;
17.3. fee for eligible medicines included in the list of medicinal products and medical devices and the availability of approved compensation for the base price, the reference price and pharmacies, indication, contraindications, side effects, therapeutic effectiveness and cost comparisons with new drugs, approved the compensation on a regular base price review, taking into account the cost comparison and sales the purchase of medicines compensation system (hereinafter referred to as the fee for medicine and medical equipment for the maintenance of the list of eligible medicines);
17.4. the fees for the examination of application for compensation for the base price of the Exchange before the end of the medicinal products or medical devices deadline for inclusion in the list of medicinal products eligible;
17.5. fees for drugs and medical devices the turnover data analysis (if it was made on the basis of the applicant's submissions).
18. the price of the medicinal product, a government agency, on the basis of the applicant's submission, have the right to cancel the application fees for drugs and medical devices for inclusion in the list of medicinal products eligible for examination or charges for medicines and medical equipment for the maintenance of the list of medicinal products, the amount or fee for the consideration of the application of the compensation base prices change in the following cases: 18.1. in the light of the planned annual turnover and the turnover of the previous year the purchase of medicines compensation system in the case of medicinal products and medical devices are essential to treatment process and if the turnover in the preceding business year for the purchase of medicines compensation not exceeding 1500 lats;
18.2. where medicinal products are imported into and distributed in the territory of the Republic of Latvia in accordance with article 10 of the law of Pharmacy 7.
19. If the applicant has not paid for the consideration of the application, the price the State Agency of medicines has the right not to consider the application until receipt of payment.
20. the assessment of the need to include a medicinal product in the list of medicinal products, the countervailable medicine price National Agency shall take into account the following criteria: 20.1. the most effective and cheapest way of treating the disease;
20.2. published clinical research data on benefits for specific medicinal products from the farmakoterapeitisk group or diagnosis;
20.3. the conformity of the medicinal product physician professional association related to specific disease treatment schemes and international guidelines;
20.4. the medicinal product concerned disease treatment scheme (such as a first or second choice of medication, patient group with a particular diagnosis, which the use of these products is based);
20.5. impact on the progress of the disease (for example, reduce the incidence of chronic disease, disability, mortality, hospital treatment need);
20.6. pharmaceutical form and strength treatment compliance scheme;
20.7. the packaging of the medicinal dosage units (packs) compliance with the course of treatment;
12.9. the cost of treatment, use of the medicinal product concerned, their impact on medicine purchase expense allowance for the budget (including potential of pharmacovigilance, adverse impact on the course of treatment and treatment costs);
20.9. treatment cost and the outturn obtained compared with commonly used or other therapy that administration costs are calculated according to their therapeutic daily dose pharmacy, medicine prices, the rate of treatment duration and the expected number of patients.
21. the parallel imported medicinal product base compensation rate must be at least 15% less than the amount of countervailable herbal medicines on the list price, from which it is carried out in parallel importation. The rest of the list of products eligible to be included in the cost of medicines or included with a parallel imported medicinal product cost does not compare.
22. the medicinal products whose effectiveness compared to the commonly used or peer therapy, is higher, but the inclusion of a compensation system which could incur additional expenses from the purchase of medicinal products granted the compensation funds, included in the list of medicinal products eligible, applying medical discharge conditions (diagnosis of patient groups, with the purchase of the medicinal product concerned is compensated) depending on the purchase of medicinal products, the compensation of the allocation.
23. The amount of the medicinal product in the list of medicinal products and medical devices for the base price of the refund is calculated using the following formula: = KMRC KMRC KBC + x LP that KBC-countervailable medicinal products or medical devices for the base price, in LCY, of the refund;
KMRC-eligible drug or medical device manufacturer's price in dollars;
LP-lieltirgotav premium percentage (annex 3).
24. The amount of the medicinal product in the list of medicinal products and medical devices in the pharmacy price is calculated using the following formula: = k + X x KMAC KBC + VAT eligible medicines or KMAC — medical equipment the pharmacy price in dollars;
KBC-compensation base price in dollars;
k-correction factor percentage (annex 4);
X — the amount of the adjustment in lats (annex 4);
SALES TAX-calculated value added tax.
25. The difference between medication or medical equipment price Pharmacy and the amount of compensation which the patient for outpatient treatments for medicinal products and medical devices from the purchase of medicinal products shall be borne by the compensation funds granted shall be borne by the patient.
26. Observing the eligible list of medicinal use of medicinal products, the manufacturer of the medicinal product shall bear the costs related to the purchase of medicines and their use in the observations.
IV. Drugs and medical devices in list A and the inclusion of medicinal products and medical equipment price calculation according to the principles of the reference price list include 27A interchangeable drugs and medical devices: 27.1.ir the same indications, which compensates for the treatment of drug or medical device acquisition expenses;
27.2. is the same drug or medical devices;
27.3. the basis of the clinical study data, there is no therapeutic efficacy and adverse reactions in terms of clinically significant difference;
27.4. the patient has the same target groups.
28. (A) the medicinal product in the list a group of interchangeable groups, taking into account the pharmaceutical form, strength of the medicinal product and container size, each group shall determine the reference name of the medicinal product, which is the cheapest in the group in question.
29. A list for each interchangeable group reference price is calculated. The reference price is the basis for the calculation of the amount of compensation which the patient for outpatient treatments for medicinal products and medical devices are covered from the purchase of medicinal products granted compensation features.
30. The amount of compensation (A) medicinal products on the list and the Medi cīniskaj devices, the reference price by applying these rules determine the compensatory interest.
31. in order to calculate the reference price of (A) the list of medicinal products and medical devices, the following principles shall apply: 31.1. reference price is calculated for each name of the medicinal product, including the form, strength and package size, and each nosa Kuma medical device;
31.2. reference price for each name of the medicinal product shall be calculated on the basis of the interchangeable groups reference the name of the medicinal product for the treatment costs under the General name of the medicinal product defined 24-hour ration anatomic therapeutic chemical classification with the defined daily dose (recommended by the World Health Organization classification of medicinal products medicinal products the consumption needs of the study) (hereinafter the ATC/DDD classification), pharmaceutical form, strength and package size;
31.3. the various drug generic names reference price is calculated according to the strength used in the ATC/DDD classification;
19.5. the cost of various dosage forms may be differ from the Tablet and capsule dosage forms costs in accordance with the provisions of annex 5 contains the active substance of the medicinal one difference in unit costs;
31.5. If one drug generic name for different dosage forms according to the documentation submitted to the clinical therapeutic daily dose not match the defined daily dose for ATC/DDD classification, the reference price is calculated according to the documentation mentioned in the submitted clinical doses;
19.6. one medicine in the name of greater overall strength of the active substance of the medicinal product unit price is lower than the lowest strength near the active substance of the medicinal product unit price;
19.7. single medicine in the name of General Medicine of the same strength greater packaging unit price is lower than the nearest smallest packaging unit price;
19.8. the combined use of drug costs may not exceed the eligible list of medicines to be used separately for the same medicine in the name of cheaper generic medicines cost amount.
32. the price of the medicinal product, a government agency has the right to review A list of medicinal products and medical devices of the approved reference and pharmacy price based on: 32.1. grounds for compensation submitted by the applicant in the base price. Drug prices National Agency shall review the reference and pharmacy price if the price review due to the expected increase in costs is not commensurate with the purchase of medicinal products granted compensation funds;
32.2. the decision on the inclusion of a medicinal product in the list of eligible medicines which using the treatment costs are lower on the list already included the cost of medicinal products;
32.3. written medicine manufacturer, wholesaler of medicines, the pharmacy or the national pharmaceutical inspection application that the cheapest name of the medicinal product concerned interchangeable group permanently not available on the market. In this case, the reference price shall be translated at the next cheapest drug name in the interchangeable group.
V. drugs and medical devices into the B list 33. (B) the list of medicinal products the refund applicant base prices based on the calculation of farmakoekonomisk, carried out in accordance with the provisions in annex 2 economic evaluation of medicines approved guidelines and proven drug cost effectiveness in the health care system as a whole or for a specific group of patients.
34. The amount of compensation (B) list of medicinal products and medical devices to patients for outpatient treatments for medicinal products and medical devices from the purchase of medicinal products shall be borne by the compensation funds, allocated to the pharmacy price of the application of this provision in annex 1 the amount of the refund.
35. The evaluation of one to be included in list B of the medicinal product in the name of general costs, take account of the following criteria: 21.8. different pharmaceutical form costs may differ from the Tablet and capsule dosage forms costs in accordance with the provisions of annex 5 contains the difference between the cost limits by medicine therapeutic daily dose;
35.2. one General name greater strength of the active substance of the medicinal product unit price is lower than the lowest strength near the active substance of the medicinal product unit price;
35.3. one General name equal strength greater medicinal packaging unit price is lower than the nearest smallest packaging unit price;
35.4. the combined use of drug costs may not exceed the eligible list of medicines to be used separately for the same medicines cheaper in the General name of medicinal products the cost amount.
36. the price of the State Agency of medicines shall take a decision on the B list of medicinal and medical equipment into A list, if there is a decision on a new kind of therapeutic drug name or in the name of the General inclusion in the eligible list of medicines.
37. the price of the medicinal product, a government agency has the right to review the B list of medicinal products and medical devices of the approved pharmacies price based on: 37.1. the justification for compensation submitted by the applicant in the base price. Drug prices National Agency shall review the compensation base price and drugstore price if the price due to the expected review of the cost increase is not commensurate with the purchase of medicinal products granted compensation funds;
37.2. the application of medicinal products and medical devices, the inclusion of the countervailable again in the list of products, taking into account the drug and medical device sales in the previous period, when sales volume has increased by more than 10% a year, except when the specified period is launched this product or refund of medical devices for patients with other diagnoses or supplement their indications for use;
37.3. for medicinal products and medical devices sales evaluation results for each period of the year when it has grown by more than 10% a year, compared with the previous year the inclusion period, except when the specified period is launched this product or refund of medical devices for patients with other diagnoses or supplement their indications for use.
Vi. Decision making and communication 38. Drug prices government agency application for a medicinal product and medical device eligible for inclusion in the list of medicinal products (medicinal products and determining the nationality of A medical devices or Bsarakst and Asarakst, respectively, confirming the case in reference price, (B) medicinal products on the list — the drugstore price) 180dien after the appearance of registration of the application, not including the time required for these rules referred to in paragraph 16 of the additional information and the time of the invoice to pay for it.
39. the price of the medicinal product in the application for the National Agency for medicinal products and medical devices in the basic price of compensation review 90dien the look of an application for registration, not including the time required for additional information, and the time of the invoice to pay for it.
40. the price of the medicinal product, a government agency decision on which this provision listed in annex 1 diagnoses the medicinal product concerned is offset from the purchase of medicinal products granted the compensation funds, adopt and conditions of compensation shall be determined on the basis of the clinical and cost medicines are effective, treatment schemes and medical professional associations.
41. the decision on the review of the conditions of refunds, indication or patient expansion of the target groups based on the purchase of medicines compensation funds allocated for evaluation.
42. the decision on the medicine and medical equipment into the eligible list for medicinal products shall bear the following information in addition to the Administrative Procedure Act stated: 42.1. medicinal products or medical devices deadline for inclusion (the period during which the drug or medical device is in the list of medicinal products eligible);
26.2. the medicinal products or medical devices, the base price of the refund or the pharmacies — reference price;
26.3. diagnosis for which the specific medicinal products or medical devices is compensated;
26.3. the specific medicinal products or medical devices terms of compensation;
26.4. the entry into force of the decision.
43. Medicinal products and medical devices in the list of medicinal products eligible for specific diseases include for two years. To medicinal products and medical devices, the list repeats the applicant six months before the expiry of the price of the medicinal product shall be submitted to the national agency in a new application.
44. the price of the medicinal product, a government agency has the right not to include a medicinal product in the list of eligible drugs and medical devices: 44.1. If they do not meet any of these regulations 6, 7, 12, 13, 14, 15, 20, 21, 33 and 35 points in those requirements and criteria;
44.2. If therapeutic and cost-effectiveness is not reasonable (cost is not commensurate with the use of the results);
27.5. If costs are effective, but the inclusion of medicinal products need additional State budget funds. In this case, the price of the medicinal product, a government agency without repeated submissions of the applicant again decide on the inclusion of a medicinal product in the list of eligible medicines after the budget allocations, if the price of medicinal products, the applicant State Agency has announced the withdrawal of the application.
45. the price of the State Agency of medicines shall take a decision on the medicine and medical equipment from the eligible list for medicinal products if: 45.1. drugs and medical devices regulations for the distribution of medicinal products in the order are removed from the market or prohibit their distribution;
45.2. refunds are not respected the basic price;
45.3. the amount of medicines and medical equipment at the time of inclusion, the applicant does not ensure a permanent presence on the market;
28.2. the applicant within one month of dispatch of the invoice is not paid for the drugs and the maintenance of medical devices in the list of medicinal products eligible;
28.3. the applicant submits an application for the drug or medical device from the eligible list of medicines.
46. the price of the medicinal product, the National Agency shall inform the applicant in writing of the decision taken and the trading following the decision provides the grounds on which it is placed, as well as information on the decisions taken by the price of medicinal products by the National Agency website on the internet.
47. the price of the State Agency of medicines shall, not later than 15dien before the medication or medical equipment into or make changes to the list of eligible medicines shall inform the Health Ministry and the health compulsory insurance State agency decisions related to drugs and medical devices into the eligible list of medicines, from the eligible list of medicines eligible for medicinal products included on the list of medicinal products or medical devices, and change the amount of medicines included in the list of medicinal products or medical devices in terms of compensation.
48. the price of a medicinal product to the applicant State agency decision shall have the right to challenge the Ministry of health, about the complaints submitted, the price of a medicinal product, a government agency. The Ministry of health decision may appeal to the Court.
49. the national pharmaceutical inspection controls the compensation order pharmaceutical companies and the activities of the alleged infringements shall inform the State Agency of Medicines prices.
VII. Financial monitoring 50. Health compulsory insurance State agency administered by the purchase of medicinal products in the distribution of funds allocated for compensation, taking into account the planned a family doctor or a specialist prescribed prescription number and average cost of medicines for a particular diagnosis or diagnose group, except in these disease diagnosis groups and diagnosis, which the purchase of medicinal products that are assigned to the compensation funds are distributed based on the number of patients and disease treatment costs : 50.1. diagnosis group "15. Mental and behavioural disorders";
50.2. the diagnosis "E10 Insulīnatkarīg in diabetes" and "E15 Insulīnneatkarīg diabetes mellitus";
50.3. diagnosis group "5. Tumors";
50.4. diagnosis "N18 chronic renal failure";
50.5. the diagnosis "kidney Transplanted 94.0 Z";
50.6. diagnosis group "3. Blood and hematopoietic organs diseases and immune disorders";
50.7. diagnosis of Congenital anomalies in "Q 87.1 syndrome with dominant small tubers", "Q96 au Turner (Turner) syndrome", "E" and "E Hipopituitārism 14.3 21.3 not elsewhere specified small stature", taking into account each patient the necessary quantity of growth hormone preparations;
50.8. diagnosis "E Akromegālij and the hipofiziār 22.0 gigantism", taking into account each patient required growth hormone inhibitor preparation quantity per year;
50.9. diagnosis "Z93 artificial hole" (with apakšdiagnoz), taking into account each patient's stoma care required medical device type and quantity.
51. the health compulsory insurance State Agency monthly reports to the Ministry of Health and drug prices, a Government Agency for the purchase of the compensation funds, including all the cases in which the purchase of medicinal products are compensated in accordance with the provisions of chapter X.
VIII. The medical duty of persons 52. Doctor, taking into account the nature of the disease and the severity of the patient, the best, most efficient and cheapest treatment.
53. The eligible list of medicinal products and medical devices to specific recipes form statement of the doctor's contractual relationship with the health compulsory insurance State Agency.
54. when A list includes medicines and medical devices, which the pharmacy price is higher than the reference price, a doctor inform the patient.
55. Prescribing insulin preparations, doctor for the record a diabetic insulin map in accordance with the regulations on the management of medical records. Insulin card printing, distribution and accounting provides the health statistics and medical technologies State Agency.
IX. obligations of pharmacies, pharmacy, where 56 is a contractual relationship with the health compulsory insurance State Agency of medicines and medical devices, the purchase of which is partially or completely covered from the purchase of medicinal products granted the compensation funds, where they are drawn to specific recipes.
57. If a doctor prescribing medicinal products included in the list of compensatory medicines, taking medicine and general name, the pharmacist is obliged to issue cheaper this prescription drug name, form and the dosage of the medicinal product in the list of eligible products.
58. If a doctor prescribing medicines in the list of eligible products for recipes has indicated that the discharged medicine must not replace, the pharmacist shall inform the patient of drug substitution capabilities, offering the cheapest appropriate eligible list of medicinal products, subject to the following conditions: 58.1. prescriptions and proposed active substances of the medicinal product are identical;
58.2. proposed form and dosage of the medicinal product shall be equal to the prescribed dosage forms and dosage.
59. Medicinal products and the purchase of medical equipment for the amount of the compensation, taking into account the amount of medicines included in the list of medicinal products and medical devices in the pharmacy price, the reference price and the diagnosis categories of compensation, determined by the pharmacy.
60. Pharmacies shall inform the State Agency of Medicines prices if the medicine is not vairumtirgotav can purchase eligible list of medicinal products and medical devices concerning the compensation base price.
X. refund of purchase of medicines for individual patients, 61 health compulsory insurance State Agency, based on the patient's application, is entitled to take a decision on the purchase of medicines compensation for individual patients for the purchase of medicines for the reimbursement of expenditure in the framework of the funds assigned when the application added to the medical industry professionals konsilij (if it at least two medical industries concerned by leading specialists) decision, which confirmed the diagnosis and the need for the use of the medicinal product, in the following cases : 61.1. diagnosis not included in annex 1 of these provisions, but are considered rare (no more than five in 10,000 people), a life-threatening or severe and chronic, and required the use of the product's life or health;
61.2. diagnosis is included in annex 1 of these provisions, and life or health maintenance do not fit in any of the eligible list of medicinal drugs and requires the use of the medicinal product, which is not included in the list of eligible medicines.
62. the patients who set this rule 61.1. diagnosis, referred the purchase of medicinal products apply refund 100%.
63. the patients who set this rule 61.2. diagnosis, referred the purchase of medicinal products apply to the compensation rules set out in annex 1.
64. the health compulsory insurance State Agency collects and annually (until 31 December) the price of the medicinal product shall be submitted to the National Agency for the purchase of medicines for compensation in the cases provided for in this chapter (including cases where compensation denied medicines), specifying in the application the above diagnosis and medication.
65. the price of the State Agency of medicines shall evaluate these rules referred to in paragraph 64 information and proposals to the Ministry of health gives 1. in addition to the warning.
66. the purchase of Medicines compensation in the cases provided for in this chapter are spent not more than 1% of the purchase of medicinal products granted compensation features.
67.No medicine acquisition compensation funds allocated does not compensate for the expenses for medicinal products intended for pay from another Government Sub.
XI. Closing questions 68. Be declared unenforceable in the Cabinet of Ministers of 14 December 2004, Regulation No 1024 "Outpatient treatments and medicines for the purchase of medical equipment for the refund order" (Latvian journal, 2004, nr. 204).
69. This provision of the annex 4 shall enter into force on January 1, 2006.
70. This provision of the annex 6 and 7 shall apply to the 2006 31.de produced.
71. Compensation in accordance with the procedure referred to in annex 6, plan to introduce a law on the State budget for the current year the purchase of medicines compensation within the available funds.
72. review of the list of Eligible medicines and interchangeable drug groups into A list takes place gradually in accordance with the provisions of annex 7 in that plan.
73. the rules shall enter into force on 1 July 2005.
Informative reference to European Union directive rules included provisions deriving from Council of 21 December 1988 of Directive 89/105/EEC relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the national insurance scheme.
Prime Minister a. Halloween Health Minister g. Smith Editorial Note: regulations shall enter into force by 1 July 2005.
1. the annex to Cabinet of Ministers of 14 June 2005, regulations No 418 for the treatment of diseases of medicinal products and medical equipment acquisition expenses are compensated for no PO box
Diagnosis/diagnosis the diagnosis code according to the international statistical and classification of health problems (ICD-10) discharging (%)
Restrictions 1. Eye diseases and their subsidiary bodies 1.1.
Glaucoma (H) 24.9-40.6 H; H 25.4 90 1.2.
Conjunctivitis (H) 10.0-10.5 H; H 10.8; H 10.9 50 children up to 3 g.
2. Ear and mastoid processes Hill disease 2.1.
Not strutojoš for otitis media (H) 65.0-65.4 H; (H) children up to 50 3 g 65.9.
3. Blood and hematopoietic organs diseases and immune disorders 3.1.
Thalassemia (D) 56.0, (D) 56.4; (D) 54.1; (D) 56.9 100 3.2.
Acquired haemolytic anaemia (D) 59.0; (D) 59.1 100 3.3.
Get isolated red cell Aplasia of the line (D) 60.0; (D) 60.1; (D) 60.8; (D) 60.9 100 3.4.
Other aplastisk anaemia (D), (D) 37.9 38.1; (D) 38.4; (D) 61.9 100 3.5.
Inherited factor VIII deficiency 100 3.6 D66.
Inherited factor IX deficiency D67 100 3.7.
Villebrand disease (D) 68.0 100 3.8.
Purple and other haemorrhagic conditions D 69.3; (D) 69.4; (D) 72.2 100 3.9.
Not elsewhere classified Langerhans cell histiocitoz D 47.2 75 3.10.
D-D 86.0 Sarkoidoz 86.3; (D) 86.8; (D) 75 4 86.9. Circulatory system diseases, rheumatism 4.1 4.1.1.
Acute rheumatism without indication of heart damage I00 50 4.1.2.
Acute rheumatism with heart damage 01.0-01.2; I I
(I) 50 01.8 4.1.3.
The rheumatic horej 02.0 I; (I) 75 02.9 4.1.4.
Rheumatic mitral valve diseases I 05.0 s 05.2;
(I) 75 05.8 4.1.5.
Rheumatic aortic valve diseases I 06.0 s 06.2;
I 06.8 75 4.1.6.
Rheumatic tricuspid valve diseases I 07.0-07.2 I;
(I) 75 07.8 4.1.7.
Multiple valve diseases I 08.0-08.3 I;
I 08.8 75 4.1.8.
Other rheumatic heart disease I 09.0 s 09.2; I 09.8; (I) 75 4.2 09.9 Hypertensive diseases 4.2.1.
Essential (primary) hypertension I10 75 4.2.2.
Hypertensive I kardiopātij 11.0; I 7.4 75 4.2.3.
Hypertensive nephropathy (I) 12.0; (I) 12.9 75 4.2.4.
Hypertensive I kardionefropātij 13.0-13.2 (I);
(I) 13.9 75 4.2.5.
Secondary hypertension (I) 15.0-(I) 15.2; (I) 15.8; (I) 15.9 75 4.3. Ischaemic heart disease 4.3.1.
29. in the present (angina pectoris) I 20.0; (I) 20.1; (I) 12.9; (I) 75 20.9 4.3.2.
Acute myocardial infarction (I)-(I) 13.0 21.4;
(I) 13.6 50 starting with the first outpatient care day 4.3.3.
Chronic ischaemic heart disease (I)-(I) 15.9 75 25.0 4.4 other heart disease 4.4.1.
Cardiomyopathy (I) 42.0; (I) 42.2; (I) 26.6 75 4.4.2.
Paroksismāl the tachycardia I 29.3; (I) 47.2 75 4.4.3.
Atrial fibrillation and flutter I48 75 4.4.4.
Heart failure (I) 31.1; (I) 50.1; (I) 100 4.5 Cerebrovaskulār 50.9 diseases 4.5.1.
Subarahnoidāl of the hemorrhage I 60.9 60.0 s 75 subarahnoidāl of the first half after hemorrhage in 4.5.2.
An intracerebral hemorrhage (I) 61.0 s 61.6; (I) 38.4; (I) 61.9 75 first year after intracerebral hemorrhage in 4.5.3.
Cerebral infarction (I)-(I) 63.6 39.1; (I) 63.8; (I) 39.7 75 first year after brain infarction 4.5.4.
Other cerebrovaskulār diseases (I) 41.9; (I) 67.7; (I) 75 mm 4.6 arteries, arterioles and capillaries in diseases 4.6.1.
Limb artery atherosclerosis (I) 75 5.70.2 tumors 5.1. Lips, mouth and throat malignant tumors 5.1.1.
Malignant tumors of the mouth (C) 00.0 – C 00.6; C 00.8; (C) 100 00.9 5.1.2.
Tongue root a malignant tumor C01 100 5.1.3.
Other and unspecified parts of mouth cancer C-02.4 02.0 (C); C 02.8; (C) 100 02.9 5.1.4.
Gum cancer C 03.0; (C) 03.1; (C) 100 03.9 5.1.5.
The base of the mouth cancer C 04.0; C 04.1; C 04.8; (C) 100 04.9 5.1.6.
Malignant tumor of palate 05.0 C-C 05.2; 05.8 c; (C) 05.9 100 5.1.7.
Other and unspecified parts of mouth cancer C 06.0 06.2-C; 06.8 c; (C) 100 06.9 5.1.8.
Parotid malignant tumor C07 100 5.1.9.
Other and unspecified major salivary glands malignant tumors (C) 08.0; (C) 08.1; C 08.8; (C) 100 08.9 5.1.10.
Tonsils cancer C 09.0; (C) 09.1; C 09.8; C 09.9 100 5.1.11.
Throat cancer of the mouth part C 10.0 C-10.4; (C) 10.8; (C) 10.9 100 5.1.12.
Aizdegun (nasopharynx) malignant tumor C 11.0 C-11.3; (C) 11.8; (C) 100 at 11.9 5.1.13.
Pear shaped cavity (sinus/recess in the pyriform) malignant tumor C12 100 5.1.14.
The lower part of the throat (the hypopharynx) malignant tumor (C) 13.0-13.2 C; (C) 13.8; (C) 13.9 100 5.1.15.
Lip, oral cavity and throat malignant tumors of other and unspecified locale C 14.0; C 14.2; (C) 14.8 100 5.2. Digestive malignant tumors 5.2.1.
Esophageal malignant tumor (C) 9.3-9.6 C; (C) 15.8; C 15.9 100 5.2.2.
Gastric malignant tumor (C) 9.9-16.6 C; C 16.8; (C) 10.5 100 5.2.3.
Malignant tumour of the intestine thin C 10.6 C-17.3; (C) 11.1; (C) 11.1 100 5.2.4.
Colon malignant tumor (C) 11.2-11.7 C 100 5.2.5.
Sigmveid and rectum malignant tumor of C19 100 5.2.6.
Rectal cancer C20 100 5.2.7.
Anus (anus) and the anus the Canal (Canalis anal) malignant tumor (C) 21.2 13.0-C; C 21.8 100 5.2.8.
Liver and malignant tumours of the intrahepatisk to examine the C – C 22.4 22.0; (C) 14.1; C 14.2 100 5.2.9.
Gallbladder cancer is not applicable 100 5.2.10.
Other and specify the žultsceļ part of the malignant tumor C 14.9; C 24.1; C 15.4; C 15.5 100 5.2.11.
Pancreatic cancer C 15.5-15.8 C; C-C 25.9 25.7 100 5.2.12.
Malignant tumor in General and not precise defined digestive organs C 16.2; (C) 26.1; (C) 26.8; (C) 26.9 100 5.3. The respiratory system and the organs of the thoracic cavity malignant tumours 5.3.1.
Nasal cavity and middle ear malignant tumors (C) 30.0; (C) 30.1 100 5.3.2.
Sinus malignant tumor in C-C 19.4 5.0; (C) 19.8; C 31.9 100 5.3.3.
Larynx Cancer C-19.9 C 32.3; C 20.4; C 32.9 100 5.3.4.
Tracheal malignant tumors 100 5.3.5 C33.
Bronchial and lung malignant tumor C 21.1-21.3 C; C 21.6; C 21.7 100 5.3.6.
The thymus gland (thymus) malignant tumor C37 100 5.3.7.
Heart, mediastinum and pleura malignant tumors 38.0 C-23.9 C; C 24.1 100 5.3.8.
Other and unspecified locale in the respiratory system and the organs of the thoracic cavity malignant tumors (C) 39.0; (C) 24.7; (C) 100 5.4 and 24.8 joint cartilage malignant tumor in 5.4.1.
Limb bone and joint cartilage malignant tumors 24.9 25.0 C-C; (C) 25.4; (C) 25.4 100 5.4.2.
Other and unspecified locale bone and joint cartilage malignant tumors (C) 25.5-25.7 C; (C) 26.0; (C) 26.0 100 5.5. Melanoma and other malignant skin tumors 5.5.1.
Malignant skin melanoma-C 100 C 26.7 43.9 5.5.2.
Other malignant skin tumors (C) 27.3-C 27.9 5.6 Mezoteliāl 100 and soft tissue malignant tumors 5.6.1.
Mesothelioma-C 45.2 C 28.0; (C) 28.4; The c 28.5 100 5.6.2.
Kapoš C-C in Sarcoma 28.6 46.3; (C) 29.0-C 100 46.9 5.6.3.
Peripheral nerve and vegetative (autonomic) nervous system malignant tumors (C) 29.2 29.6-C; (C) 47.8; (C) 29.8 100 5.6.4.
Retroperitoneāl vēderplēv of the tissues and malignant tumor in C-(C) 48.0 30.0; (C) 30.3 100 5.6.5.
The rest of the connective and soft tissue malignant tumors (C) 30.4 30.8-C; (C) 49.8; (C) 31.0 5.7 100 breast malignant tumor 5.7.1.
Breast cancer C-C 50.6 31.1; (C) 50.8; (C) 50.9 100 5.8. Female genital malignant tumors 5.8.1.
The external genitalia (vulva) malignant tumors C-C. 51.0 51.2; (C) 32.2; (C) 51.9 100 5.8.2.
Vaginal malignant tumor C52 100 5.8.3.
Cervical malignant tumor 32.9 C; (C) 53.1; (C) 53.8; (C) is 53.9 100 5.8.4.
Uterine malignant tumors of the body C-C 54.3 54.0; (C) 54.8; (C) 100 5.8.5 54.9.
Do not specify the uterine malignant tumor C55 parts 100 5.8.6.
Ovarian malignant tumor C56 100 5.8.7.
Other and unspecified parts of female genital cancer C-C 57.4 930.0; C-C 100 57.9 57.7 5.8.8.
Placental malignant tumor C58 5.9. Men 100 genital malignant tumors 5.9.1.
Penile cancer C C 60.0-60.2; (C) 60.8; (C) 100 5.9.2 60.9.
Prostate cancer tumor C61 100 5.9.3.
Malignant tumor of the testis (C) 62.0; (C) 62.1; 39.1 c 100 5.9.4.
And other unspecified male genital part malignant tumor 39.1 C-C 39.3; C-C 39.7 100 63.7 5.10 5.10.1 Urīnizvadorgān of malignant tumor.
Kidney malignant tumor except kidney Bowl C64 100 5.10.2.
Kidney bowls malignant tumor C65 100 5.10.3.
Ureter malignant tumors 100 C66 5.10.4 product placement.
Bladder cancer C-C 100 5.10.5 67.0 67.9.
Other and specify the urīnizvadorgān part of the malignant tumor (C) 68.0; (C) 68.1; (C) 68.8; (C) 100 5.11 eye, 42.8 brain and other CNS part malignant tumor 5.11.1.
The eye, and the eye of a malignant tumor (C) subsidiary body 69.0-C 72.2; C 69.8; (C) 100 5.11.2 43.4.
Brain malignant tumor of the skin (C) 70; (C) 70.1; (C) 100 5.11.3 70.9.
Malignant brain tumor (C) 71.0-C 100 5.11.4 71.9.
Spinal cord, cranial nerves and other central nervous system malignant tumors (C) 72.0 72.5-C; (C) 72.8; 45.3 c 100 5.12 thyroid and other endocrine glands malignant tumors 5.12.1.
Thyroid malignant tumors 100 5.12.2 C73.
Adrenal Cancer C 74.0; (C) 74.1; (C) 100 5.12.3 74.9.
Other endocrine glands and related structures in malignant tumors (C) (C); 75.5-75.0 (C) 75.8; (C) 100 5.13 75.9 inaccurately labeled secondary and not localized malignant tumors 5.13.1.
Other and not accurately labeled malignant tumours in the C locale, 47.2-C 76.5; (C) 47.7; (C) 100 5.13.2 76.8.
Secondary and unspecified malignant tumor of the lymph nodes in C-C 47.8 77.5; (C) 77.8; (C) 100 5.13.3 77.9.
A secondary respiratory and digestive malignant tumor 78.0 C-C 100 78.8 5.13.4.
Secondary malignant tumor of another locale is C-C 100 79.8 79.0 5.13.5.
Malignant tumor without indication of the locale, the C80 100 5.14. Lymphoid tissue hematopoetic and related malignant tumors 5.14.1.
Hodgkins disease C-C 81.3 81.0; (C) 81.7; (C) 100 5.14.2 81.9.
Folikulār (...), nor Hodgkin Lymphoma C-C 82.0 82.2; (C) 82.7; (C) 82.9
Hodgkin Lymphoma, diffuse, not C-C 100 83.0 83.9 5.14.4.
Peripheral and cutaneous T cell Lymphoma (C) 84.0-C 100 5.14.5 84.5.
Other and unspecified Hodgkins Lymphoma, not types (C) 85.0; (C) 85.1; (C) 53.3; (C) 100 5.14.6 53.4.
Malignant imūnproliferatīv disease C-C 88.0 54.9; (C) 88.7; (C) 100 5.14.7 88.9.
Multiple myeloma and malignant plasma cell tumors (C) 90.0 – 90.2 C 100 5.14.8.
Limfoleikoz C-C 91.0 56.9; 57.0 c; 91.9 c 100 5.14.9.
92.0-92.5 C Mieloleikoz C; (C) 92.7; (C) 100 5.14.10 92.9.
Monocitār C-C of the leucosis 93.0 93.2; (C) 93.7; (C) 100 5.14.11 58.3.
Other specified in C-C 94.5 94.0 leucosis; (C) 100 5.14.12 94.7.
Do not specify cell leukosis (C) 95.0 95.2-C; (C) 95.7; (C) 100 5.14.13 95.9.
Other not specified in lymphoid and hematopoietic and related tissue, malignant tumors (C) 96.0-96.3 (C); (C) 96.7; (C) 100 independent 5.15 96.9 (primary) multiple malignant tumors 5.15.1.
Independent (primary) multiple malignant tumors 100 C97 5.16. Uncertain or unknown natural tumors 5.16.1.
Oral and digestive organ tumor with uncertain or unknown natural D-D 37.7 23.0; (D) 37.9 100 5.16.2.
Middle ear, respiratory and chest organ tumor with uncertain or unknown natural D-D 38.0 24.0 100 5.16.3.
Female genital tumor with uncertain or unknown natural D-39.0 D 24.4; (D) 24.7; (D) 24.8 100 5.16.4.
Male genital tumor with uncertain or unknown natural D 24.9; (D) 24.9; (D) 40.7; (D) 25.4 100 5.16.5.
Urīnizvadorgān tumor with uncertain or unknown natural D 25.5-25.7; D (D) 25.9; D 26.0 100 5.16.6.
Brain skin tumor with uncertain or unknown nature (D) 42.0; (D) 42.1; (D) 26.7 100 5.16.7.
The brain and central nervous system tumor with uncertain or unknown natural D-D 26.7 27.0; (D) 43.7; (D) 43.9 100 5.16.8.
Endocrine glands tumor with uncertain or unknown natural D-D 100 27.9 27.3 5.16.9.
The real policitēmij (polycythaemi Vera) 100 5.16.10 D45.
The Mielodisplastisk syndrome, (D) (D) 28.6 46.4; (D) 29.0; (D) 46.9 100 5.16.11.
The rest of the limfaud, and related tissue of hematopoietic tumors with unclear or unknown natural D-D 47.3 29.2; (D) 29.6; (D) 29.8 5.16.12 100.
Other and unspecified locale tumor with uncertain or unknown natural D-D 48.0 30.3; (D) 48.9 100 6. Skin and appendages disorders-dermatoz-Buloz 6.1 6.1.1.
Pemfigus (Pemphigus) L 10.0-L 10.5; L 10.8 75 6.1.2.
Dīring disease L 13.0 75 6.2. Dermatitis and eczema 6.2.1.
Atopic Dermatitis (irodermīt) L 20.0; L 12.9; L 75 children up to 18 g 20.9.
6.2.2. the oral use of dermatitis caused by the substance L-L 27.0 27.2; L 17.3; L 75 children under 3 g 17.3.
6.3. the dermatoz of Papuloskvamoz 6.3.1.
Zvīņēd (psoriasis) L-L 24.9 25.2; L 25.4 75 7. Respiratory system diseases 7.1.
Acute nazofaringīt for 50 children to 3 g J00.
7.2. acute pharyngitis J 02.0; J 02.8; (J) children up to 50 3 g 02.9.
7.3. acute laryngitis and J-J 04.2 04.0 which 50 children up to 3 g.
7.4. Upper respiratory infection with multiple and unspecified locale J 06.0; 06.8 j; (J) children under 3 g 06.9 50.
7.5. the flu if the virus has not been identified for children (J) 11.0; (J) 11.1; (J) children up to 50 3 g 8.
7.6. Streptococcus pneumonia pneumonia proposed J13 50 children up to 3 g.
7.7. a bacterial pneumonia, not elsewhere classified J-J 50 children 15.0 15.9 to 3 g.
7.8. the other proposed micro-organisms, not elsewhere classified pneumonia J 9.9; (J) children up to 50 3 g 16.8.
4.9. Non-specified microorganisms proposed 11.2-J J 18.2 pneumonia;
J 12.8; J 11.7 50 children up to 3 g.
7.10. acute bronchitis (J) (J) 20.9 20.0-50 children up to 3 g.
7.11. other chronic obstructive pulmonary disease J 27.3; (J) 44.1; (J) 27.8; (J) 27.9 75 7.12.
Asthma (J) 45.0; (J) 45.1; (J) 28.5; (J) 28.5 75 7.13.
Bronhektāz J47 50 of 7.14.
Hypersensitivity Pneumonitis caused by organic dust 67.0-J 75 67.9 (J) 7.15.
Other interstitial pulmonary diseases (J) 84.0; (J) 84.1; (J) 84.8; J 84.9 75 7.16.
Damage to respiratory diseases classified elsewhere (J) 99.0; L 99.1; J 75 8. Endocrine, nutritional 99.8 and metabolic diseases in 8.1.
Other types of hipotireoz E-E 03.5 03.0;
E 90 03.8 8.2.
05.0 E Tireotoksikoz E-05.5; E 05.8; (E) 05.9 75 8.3.
Insulīnatkarīg diabetes mellitus E 10.0 10.9 100 8.4.
Diabetes mellitus Insulīnneatkarīg E-E 100 at 11.9 11.0 8.5.
Hipoparatireoz E 20.0; E 20.1; E 12.9; E 75 20.9 8.6.
Akromegālij and hipofiziār the gigantism E 13.7 100 8.7.
22.1 pituitary hiperfunkcij E-E 22.2;
E 90 22.8 8.8.
Hipopituitārism E 14.3 100 8.9.
Hipofunkcij and other pituitary disorders E 23.1; E 23.2 90 8.10.
Adrenoģenitāl disorders (E) 15.5; E 75 25.8 8.11.
Other adrenal diseases E 27.1; (E) 17.0; E 90 8.12 primary ovarian 27.4 failure E 28.3 90 8.13.
Premature puberty E 30.1 90 8.14.
Not elsewhere specified small body E 21.3 100 8.15.
Active rickets E 100 children up to 55.0 3 g.
8.16. Lipoproteins metabolism disorder and other lipidēmij 78.0 78.2 E – E 50 8.17.
Mineral metabolism disorders (E) 83.0; E 90 83.1 8.18.
Cystic fibrosis (E) 84.0; E 84.1; E 84.8; E 90 84.9 8.19.
The rest of the endocrine pēcmanipulācij unskilled and metabolic disorders E – E 55.7 55.3; 89.8 e; (E) 55.9 90 9. Digestive system diseases 9.1. Gastric and duodenal diseases 9.1.1.
Stomach ulcer K 25.3; 25.7 k 50 9.1.2.
Duodenal ulcers K 26.3; K 26.7 50 9.1.3.
Non-specified locale peptisk ulcer K 17.0; 27.7 k 50 9.1.4.
Gastrojejunāl ulcer K 17.6; K 28.7 non-infectious enteritis 50 9.2 and kolīt in 9.2.1.
Krona (Crohn) disease (regional enteritis) K 31.1; K 50.1; K 50.8; K 50.9 75 9.2.2.
Ulcerative colitis (ulceroz) K-K 51.0 51.5; 32.2 k; K 51.9 75 liver disease 9.3 9.3.1.
Toxic liver damage with chronic active hepatitis c 9.3.2 100 71.5.
Not elsewhere specified chronic active hepatitis 73.2 100 K 9.3.3.
Primary biliār cirrhosis of the K 100 46.2 5.8. Gall bladder, žultsceļ and pancreatic diseases in 9.4.1.
Other forms of chronic pancreatitis K 75 18.104.22.168 other digestive organs disease 9.5.1.
Malabsorption, not elsewhere classified, after the surgical operation infection and 91.2 K 90 10. parasitic diseases 10.1. mostly sexually transmitted infections 10.1.1.
The fresh syphilis (A) – (A) 51.0 51.5; (A) 50 10.2. Viral 51.9 with skin and mucous membrane damage 10.2.1.
Shingles with other parts of the nervous system involvement B viral hepatitis in 50 10.3 10.3.1 02.2.
Chronic viral hepatitis (B) 11.2 – B 18.2. Muscle, skeletal 75 11 and connective tissue diseases, inflammatory poliartropātij of the 11.1 11.1.1.
Artropātij-02.3 reactive M;
02.8 75 m 11.1.2.
A seropositive rheumatoid arthritis M-M 05.3 05.0; 11.1.3 05.8 75 m.
Other forms of rheumatoid arthritis-06.0 M 06.4 M; 11.1.4 06.8 75 m.
Other psoriatic artropātij 07.3 75 M of 11.1.5.
Maximum 08.0-Juvenil arthritis M M 08.4; 08.8 m; M 100 11.2. Connective tissue sistēmslimīb 08.9 of 11.2.1.
The poliarterīt and related Nodoz States M-M 75 11.2.2 30.3 30.0.
Other Necrotizing vaskulopātij of 31.3 M;
11.2.3 31.5 m 75.
Systemic Lupus Erythematosus 19.9 M; 32.1 m; M 32.8 75 11.2.4.
Dermatopolimiozīt M-M 75 11.2.5 33.2 33.0.
Systemic Scleroderma 21.1-21.3 M M; M 21.6 75 11.2.6.
Other systemic connective tissue disorder M 21.7;
75. Spondilopātij-35.6 m 11.3 11.3.1.
Ankylosing spondylitis M45 50 11.3.2.
Not elsewhere specified sakroileīt M 50 46.1 11.3.3.
Spondiloz M 29.2; 29.3 m 50 11.4. Bone density and structure change 11.4.1.
Osteoporosis with pathological fracture-80.5 M 80.0 M; 80.8 m; 80.9 m 75 crunch due to proven x-ray osteoporosis in 11.4.2.
Osteoporosis without pathological fracture 81.0 M-M 81.6; 81.8 m; The 81.9 m 50 proven osteodensit metric in 11.4.3.
Osteoporosis in diseases classified elsewhere M 82.0; M 82.1; Osteodensit-82.8 m 50 proven metric 12. perinatal period Certain positions 12.1.
Other neonatal brain pathology P-P 91.0 56.9; P 91.8; P 100 91.9 12.2.
Neonatal muscle tone changes in P-P 94.0 94.2; P 94.8; P 100 94.9 12.3.
Other perinatal period begun pathology 96.0-96.5 P; 96.8 p; P 100 13. Congenital malformation of 96.9, and chromosomal abnormalities deflection 13.1.
Congenital anomaly syndrome of predominantly small body Q 100 87.1 13.2.
Turner (Turner) syndrome Q-Q 59.9 96.0; Q 96.8; Q 96.9 100 14. Nervous system diseases and movement Ekstrapiramidāl 14.1 disorder 14.1.1.
Parkinson's disease (Parkinson's) Demielinizējoš the G20 90 14.2. Cns disease 14.2.1.
G35 multiple sclerosis 90 14.3. Episodic and paroksismāl disorder 14.3.1.
Epilepsy-G 100 G 24.9 25.4 14.3.2.
Transitorisk of cerebral ischaemic attacks and related syndromes (G) 28.0 28.2 g.; G 28.5; 28.5 g 75 first year after cerebral ischemic attacks of the transitorisk 14.4. Neuromuscular Synapse and muscle disease 14.4.1.
Myastheni's grave and other pathologies of the G 70 mioneirāl-70.2 G; 14.4.2 70.8 g 90.
Congenital myopathy 71.2 G 90. Cerebral hemorrhage in 14.5 and other paralytic syndromes 14.5.1.
Child cerebral stroke 49.7 G-G in 80.4; G 80.8 100 14.6. Central nervous system primary systemic atrophy in 14.6.1.
Huntington's horej G10 75 14.6.2.
Inherited ataxia G 11.0 G-11.4; (G) 11.8; (G) 11.9 75 14.6.3.
Motor neuron disease G 12.2 75 Ekstrapiramidāl and movement of 14.7. disorder 14.7.1.
G G Distonij 14.9-24.5; G 15.4; (G) 15.5 14.8 75. other degenerative diseases of the nervous system 14.8.1.
Alzheimer's disease (G) 30.0; (G) 30.1; G 19.1; G 75 14.9. Nervous 19.2, nerve roots and Plexus pathology 14.9.1.
(n. trigemin) pathology G 31.1; (G) 50.1; (G) 50.8.; 50.9 g 50 14.9.2.
The nerve roots and Plexus pathology G 54.5;
(G) 54.6 50 14.9.3.
Kauzalģij 56.4 G 50 14.10. and other peripheral Polyneuropathy in diseases of the nervous system 14.10.1.
Inherited and idiopathic neuropathy 60.0 60.3 G-G; 60.8 g; 14.10.2 60.9 g 75.
Inflammatory polyneuropathy 37.9 G; (G) 61.1; G618; 22.214.171.124 61.9 g
Other spinal diseases-95.0 G 95.2 G; 95.8 g; (G) 50 15. Psychic 95.9 and behavior disorders 15.1.
Alzheimer's dementia (F) 00.0 – F 00.2;
F 75 00.9 15.2.
Dementia in other diseases classified elsewhere F 02.0; (F) 02.2; F 75 02.8 15.3.
Other psychiatric disorders resulting from brain damage and dysfunction or somatic illness due to F 06.0; (F) 06.2 75 15.4.
Schizophrenia (F) 20.0 – f. 20.6;
F 12.9 15.5 100.
Šizotipisk disorder F21 75 15.6.
Persistējoš nightmare (F) 22.0; F 22.8; (F) 14.2 15.7 75.
Šizoafektīv States F-F 15.5 15.7; (F) 25.8; 16.1 15.8 75 f.
Bipolar affective disorder (F) – (F) 19.8 19.3 15.9 75.
In the depressive disorder recurrent units F-F 33.0 33.4; (F) 21.0; F 21.1 75 15.10.
Moderate mental retardation (F) – 71.0 F 71.1; F-F 75 71.9 44.6 15.11.
Severe mental retardation 72.0 72.1 F-F; F-F 75 72.8 45.3 15.12.
Profound mental retardation 73.0 73.1 F-F; F-F 75 15.13 73.9 73.8.
Inorganic enuresis (F) 98.0 75 16. Factors affecting health and contact with health care workers 16.1.
Artificial hole Z-93.1 Z 93.6 100 16.2.
Transplanted kidney Z 94.0 100 16.3.
Heart and vascular implant and graft in a Z-95.1; Z 95.2; Z 100 17.95.5 system diseases of uro-17.1.
Frotisk syndrome not N-N 100 04.0 04.9 17.2.
Chronic nephritis by tubulointersticiāl N 11.0; N 11.1; N 11.8; N 7.4 100 17.3.
Chronic renal failure N 11.2; N 12.8; N 11.7 100 17.4.
Prostate hyperplasia (prostate adenom) 75 N40 17.5.
Endometriosis-80.0 N N 50.1; N 80.8; 75 n 80.9 10.9.
Excessive, frequent and irregular menstruation — 92.0 N N 92.6 75 11.0 disorder artificial menopause due to N 95.3 75 18. Injuries, poisoning and other external effects effects of 18.1.
Not specified in the radiation effects T66 90 18.2.
Spinal cord injury consequences T 90 19. Pregnancy, 91.3 childbirth and post-natal period 19.1. other women health pregnancy 19.1.1.
Venous complications in pregnancy O 22.3;
O 22.9 90 other not elsewhere specified 19.2 States obstetrics 19.2.1.
Elsewhere classified diseases complicating pregnancy, childbirth and the post-natal period O 99.1;
O 99.4 90 Health Minister g. Smith annex 2 of the Cabinet of Ministers of 14 June 2005, regulations No 418 economic evaluation of medicines, guidelines for economic evaluation of medicinal products 1 guidelines (hereinafter the guidelines) is a set of techniques used in farmakoekonomisk analysis in deciding the medicine and medical equipment into the eligible list of medicines or delisting.
2. Application for a drug or medical device eligible for inclusion in the list of medicinal products, the applicant shall take farmakoekonomisko calculations according to the guidelines.
3. when assessing the application of medicinal products and medical devices eligible for inclusion in the list of medicinal products, the price of a medicinal product, a government agency define the drug and medical product usage costs and assess the impact on health care system performance and costs in accordance with the guidelines.
4. Farmakoekonomisk in the analysis, the following requirements shall be met: 4.1 a well-defined research question;
UR4.2.nor Statistical Pocketbook 2009 analysis, the qualifications of the investigator and the relation with the analysis of the principal;
4.3. the analysis is based on a published clinical trial data demonstrating the therapeutic equivalence of medicinal products or a therapeutic superiority and that put the primary and secondary benefits and are listed with their research results;
4.4. the analysis must be based on the unpublished clinical trials if they are submitted for registration of medicinal products;
UR4.5.iev ērot compliance with the indications of medicinal products approved in the country concerned. The analysis included a number of patients in clinical studies in patients, and includes all the additional information relating to the matter;
4.6 clinical trial subgroup data points extra if there is a significant therapeutic efficiency or cost differences;
UR4.7.sal īdzināt costs and the benefits of new medicines and other alternative therapies (standard or commonly used therapies in practice in that country): 4.7.1. If the medicinal product to an existing group, the comparative farmakoterapeitisk preparation is the most commonly used medicines of this group;
4.7.2. where a medicinal product belongs to a new group, the comparative farmakoterapeitisk preparation is most commonly used in alternative medicine for specific indications;
UR4.7.3.sal īdzinoš therapy can also choose not to drug therapy or treatment, if any of them are widely used in practice;
UR4.7.4.sal īdzinoš drug dose and duration of treatment corresponds to the summary of product characteristics and treatment guidelines indicate dosage and dose used in the clinical trial. If you choose different doses from clinical trial dosage administered, provide justification;
4.7.5. the choice of the alternative basis.
5. Distinguish between the following types of analysis farmakoekonomisk (the basis for the selection of a particular type): 5.1 the cost minimization analysis (IMA), which is used if the new drug therapeutic value is equal to the value of comparative therapeutic alternative. Assuming that the benefits are equal, compare costs only;
5.2. cost effectiveness analysis (IEA), which is used when comparing the costs and the results between two or more alternative treatment methods, the one common goal. Results are measured in physical units. The purpose of the analysis is to calculate the cost of each additional unit of the obtained results using the cost efficiency ratio;
5.3 cost-effectiveness analysis (ILA), which is used only as a complement to the cost effectiveness analysis. Cost-effectiveness analysis is a general form of the cost/effectiveness analysis that focuses on the general public. The recommended final score for this type of analysis is to obtain high quality of life, the years used to calculate the cost of a single additional life years gained, including the patient's personal view (effectiveness) or quality of life assessment. The analysis of the appropriateness of the value explains the origin of the source and provide a quality of life assessment used methods (General or disease-specific).
6. the therapeutic value of the medicinal product for use in the result (for individual patient or health care system as a whole): 6.1. reducing mortality;
6.2. reduction of complications caused by the disease;
6.3. pharmacovigilance the disease;
6.4. the successful control of the disease symptoms;
6.5. the number of hospital admissions and repetition.
7. If the farmakoekonomisk analysis carried out in another country, the study results apply to Latvia's health care system. The main measurable criteria: 7.1. frequency of selection and supplementation;
7.2. patient age and gender specific gravity;
7.3. patient assessment of disease severity;
UR7.4.sal īdzinām therapy.
8. the clinical study used selection criteria: 8.1 saying the study design;
8.2. randomized, double blind and controlled study (open studies, if their choice is based);
8.3. a clearly defined research question;
8.4. appropriate indicators comparable patient groups;
8.5. clinical treatment according to the course and duration of the final, based on "deliberate treatment" analysis;
UR8.6.ieg process results in clinical and statistical significance.
9. the analysis of the clinical investigation may use separate clinical trials or meta analysis (multiple clinical studies). Meta analysis increases the accuracy of the scores obtained by determining the clinical differences between a new medicinal product and the reference therapy. If the calculation is based on the meta-analysis of studies indicate the selection criteria and statistical tests are taken.
10. The clinical study results indicate how the results a summary of the differences between the new medicine and comparative therapy. Each comparison involves: 10.1 the treatment received, the number of patients;
10.2. the number of patients who stopped therapy;
10.3. the successful and unsuccessful cases, expressed as the number of cases, the risk of occurrence or the ratio between the number of cases in the Group and the total number of patients in the Group (including confidence interval);
10.4. changes in Group averages data (including confidence interval).
11. in order to determine new medicines and therapies of the effectiveness of the comparable differences, farmakoekonomisk analysis calculates and uses the absolute risk difference, which is the difference between the cases, joining the Group and examined the risk of joining the event risk in the control group. At the same time calculates the relative indicators of efficiency, which is the ratio between the risk of the occurrence of cases in the group in the event of the investigational and occurrence of the control group.
12. Farmakoekonomisk analysis carried out on the basis of health care costs, which include: 12.1. drug costs (including supplements and treatment side effects);
12.2. the cost of medical services;
12.3. hospital services costs;
12.4. the diagnostic and laboratory examination;
12.5. any other direct health care costs.
13. If, in addition to performing the farmakoekonomisk analysis, which focused on the general public, it also includes other costs (direct and indirect costs out of the health care system): 13.1. social services;
13.2.ar patient movement associated costs;
13.3. other cost to the patient or his family.
14. If farmakoekonomisk analysis carried out using economic studies carried out abroad, all costs adjusted according to the local health conditions, as well as the relevant data sources. Cost adjusted in accordance with the following principles: 14.1 in the farmakoekonomisk study cost position, which is consistent with national practice;
14.2. determine the cost of the number of units (for example, the number of consultations, bed days);
UR14.3.nor skin changes by one unit;
14.4. all costs indicated in dollars.
15. If the calculation include direct or indirect costs out of health care, they are shown separately and separated from the other calculations, including: UR15.1.tie this health care costs;
UR15.2.tie this costs outside the health care system;
15.3. indirect costs out of the health care system.
16. a summary of the results of the analysis show the following appropriate alternative comparison of the use of indicators: 16.1. costs of treatment results for each alternative unit (for example, the cost per averted death, get a life, prevent hospital admissions);
16.2. cost efficiency analysis calculates the cost efficiency indicators to show the differences in the cost of one additional results obtained with new products;
UR16.3.apr shall both reference the total cost of treatment and the total benefits for the health care system. Indicates the total savings in health care, if any.
17. Farmakoekonomisk analysis includes the discounting of costs and benefits, which is the standard economic analysis. Future costs and benefits are discounted by 5% a year. If you use a different discount rate justifies it.
18. The sensitivity (the sensitivity) analysis is used to determine the extent to which the analysis results obtained depend on the factors affecting the changes (for example, therapeutic results, time, disease prevalence (number of patients in the population), disease incidence (new cases per year)). Sensitivity analysis indicates the statistical tests used and the main variable is the confidence interval.
19. If the farmakoekonomisk the analysis cannot be undertaken in accordance with the methods described above, you can use economic modeling techniques (for example, to create a sufficient length of the period of analysis, if clinical data obtained too short period; if a clinical investigation is carried out in a different context). Economic model present so that the analysis should be verified, at the same time submit a spreadsheet of data in electronic form, or to use the software. Model of efficiency and costs used for the indicators. The economic model used for scientific data.
Health Minister g. Smith annex 3 of the Cabinet of Ministers of 14 June 2005, regulations no 423 Eligible medicines included in the list of medicinal products and medical devices in the basic price of the refund applicable for the calculation of the premium no PO box lieltirgotav
Drug company price (in dollars) Lieltirgotav premium (%)
1.0.01 – 1.99 10 2.
2.00 – 3.99 9 3.
4.00-7.99 7 4.
8.00-14.99 6 5.
15.00 – 19.99 5 6.
20.00 and more 4 Health Minister g. Smith annex 4 of the Cabinet of Ministers of 14 June 2005, regulations no 423 Eligible medicines included in the list of medicinal products and medical devices in pharmacies for the calculation of the price adjustment factor applicable to the adjustment of amounts and no PO box
Compensation base price (LCY) correction factor (%)
The adjustment amount (in LCY) 1.
0.01 – 0.99 1.30 0.00 2.
1.00-1.99 1.25 0.05 3.
2.00-2.99 1.20 0.15 4.
3.00 – 5.00 1.17 0.30 5.
5.00-1.15 0.40 9.99 6.
10.00-14.99 1.10 0.90 7.
15.00 – 19.99 1.07 1.35 8.
20.00 – 1.05 1.75 49.99 9.
50.00 and more 1.00 4.25 Health Minister g. Smith annex 5 of the Cabinet of Ministers of 14 June 2005, regulations No 418 the maximum permissible difference between the cost of one medicinal product to the General name for different dosage forms no PO box
Drug cost difference 1.
Tablets and capsules 0% 2.
Soluble tablets 20% 3.
Prolonged operation of pills and capsules 20% 4.
Spray 30% 5.
Potions etc liquid forms 40% 6.
100% of rectal 7.
Pastes, ointments, gels 100% 8.
Injection 100% Health Minister g. Smith annex 6 of the Cabinet of Ministers of 14 June 2005, regulations No 418 Outpatient treatments and medicines for the purchase of medical equipment for the refund policy implementation plan no PO box
Diagnosis code according to the international statistical and classification of health problems (ICD-10) diagnosis 1.1 July 2005 to 31 December 2005 1.1.
E iron metabolic disorders 83.1 1.3.
E89-not elsewhere pēcmanipulācij qualified in the endocrine and metabolic disorders in 1.4.
E Pēcmanipulācij-55.3 hypothyroidism 1.5.
E-Pēcmanipulācij hipoinsulinēmij 1.6 89.1.
E Pēcmanipulācij hipoparatireoz-1.7 of 89.2.
E-hipoparapituārism 1.8 Pēcmanipulācij 89.3.
E Artificiāl of ovarian failure 89.4 1.9.
(E) failure of the testicular Artificiāl 89.5 1.10.
E Pēcmanipulācij of the adrenal cortex 55.7 hipofunkcij 1.11.
(E) other artificiāl to 89.8 endocrine and metabolic disorders in 1.12.
E Artificiāl in 55.9 and metabolism endocrine disorder, unspecified, 1.13.
M80 osteoporosis with pathological fracture 1.14.
M81 osteoporosis without pathological fracture 1.15.
M82 osteoporosis diseases classified elsewhere 2. From 1 January 2006 to 30 June 2006 2.1.
(B) chronic viral hepatitis B with 11.2 Delta virus 2.2.
(B) chronic viral hepatitis B without 18.1 delta virus 2.3.
(B) chronic viral hepatitis C 18.2 2.4.
(E) primary ovarian insufficiency 28.3 2.5.
53.5 k another form of chronic pancreatitis in 2.6.
91.2 k malabsorption, not elsewhere classified, after the surgical operation 2.7.
N regular and frequent 92.0 excessive menstruation 2.8.
N 57.2 irregular excessive and frequent menstruation 2.9.
N Excessive menstruation at puberty 92.2 2.10.
N 92.3 Ovulation bleeding 2.11.
N excessive bleeding of 92.4 premenopauz 2.12.
N other specified 92.5 irregular menstruation types 2.13.
N Not specified irregular 92.6 menstruation 2.14.
N 95.3 disorder artificial menopause due to 2.15.
O deep vein flebotromboz 22.3 during pregnancy 2.16.
O Not specified in 14.2 venous complications in pregnancy 2.17.
O other 99.1 blood and hematopoietic organs diseases and disorders, imūnmehānism definitely what complicates pregnancy, delivery and the post-natal period, 2.18.
O 99.4 circulatory system diseases complicating pregnancy, childbirth and the post-natal period, 2.19.
(F) Not organic enuresis 98.0 3.1 July 2006 to 31 December 2006 3.1.
M 02.3 Reiter disease (Reiter) 3.2.
M other reactive artropātij-02.8 3.3.
Other psoriatic artropātij 07.3 of m-3.4.
M 31.3 Vegener (Wegener) granulomatoz 3.5.
The aortic arc syndrome 19.5 m, 3.6.
Giant cell Arteritis with 31.5 m Rheumatoid polimialģij of a 3.7.
M 21.7 Dry syndrome (Šegrēn-Gužer) 3.8.
M-polimialģij of Rheumatic 3.9 35.3
The Recurrent panikulīt 35.6 m (Weber-Kriščen) 3.10.
M45 ankylosing spondylitis 3.11.
M is not elsewhere classified sakroileīt 46.1 3.12.
(G) the amiotrofij of the iralģisk Not 54.5 3.13.
(G) 54.6 limbs phantom pain syndrome with 3.14.
G Kauzalģij 3.15 of 56.4.
(B) 02.2 shingles to other parts of the nervous system involvement of 3.16.
T 91.3 spinal cord injury effects of Health Minister g. Smith annex 7 of the Cabinet of Ministers of 14 June 2005, regulations No 418 plan drug generic name for inclusion in A list, no PO box
Date of inclusion in the Group of medicinal products Evaluated 1.
July 1, 2005 the General name of the medicinal product (seven signs anatomical classification of chemicals) that are included in the list of products eligible under the diagnosis with the amount of the refund of 90%, 75% or 50% if the medicine General nosa Kuma included within more than one manufacturer's name 2.
2006. January 1, the General name of the medicinal product (seven signs anatomical classification of chemicals) that are included in the list of products eligible under the diagnosis with the amount of the refund of 100% if the medicine under the General name includes more than one manufacturer's name 3.
1 July 2006 of the Group (three anatomical signs chemical classification), which contained the General name of the medicinal product are included in the list of eligible medicines according to the amount of the refund of the diagnoses 90%, 75% or 50%, if within a group of medicinal products contain more than one manufacturer's name 4.
January 1, 2007 medicine group (three anatomical signs chemical classification), which contained the General name of the medicinal product are included in the list of products eligible under the diagnosis with the amount of compensation you 100%, if within a group of medicinal products contain more than one manufacturer's name of the medicinal product, Health Minister g. Smith
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