Decree No. 92 / 2008 Coll.
Ordinance on the establishment of a list of countries of the reference basket, how to assess the amount, conditions and forms of reimbursement of medicinal products and foodstuffs for special medical purposes and the particulars of the application for the fixing of the amount of reimbursement
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Effective from 19.03.2008
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19.03.2008
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92
DECLARATION
of 7 March 2008
laying down the list of countries of the reference basket, how to assess the amount, conditions and forms of reimbursement of medicinal products and foodstuffs for special medical purposes and the particulars of the request for fixing the amount of reimbursement
The Ministry of Health provides, pursuant to § 39a (3), § 39b (7) and § 39f (7) of Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended by Act No. 261 / 2007 Coll., (hereinafter "the Act '):
INTRODUCTORY PROVISIONS
Subject matter
This decree provides
(a) a list of the countries of the reference basket;
(b) how to assess the level and conditions of reimbursement of medicinal products and foodstuffs for special medical purposes (hereinafter referred to as the product),
(c) the conditions under which the product is covered by a flat-rate payment, a prescription or a separate charge;
(d) the method of accounting and the conditions for reimbursement of the product;
(e) the structure of the data and the details of the application for payment.
LIST OF COUNTRIES OF REFERENCE BOOK
Reference basket
The Member States of the European Union with purchasing power parity close to the Czech Republic, which implement price regulation of products, are the Republic of Estonia, the French Republic, the Italian Republic, the Republic of Lithuania, the Republic of Hungary, the Portuguese Republic, the Hellenic Republic and the Kingdom of Spain.
METHOD OF ASSESSMENT OF THE AMOUNTS AND CONDITIONS OF THE BASIC REIMBURSEMENT
Basic remuneration
(1) The State Institute for Drug Control (hereinafter referred to as "the Institute") provides for a basic remuneration within the reference group, using the prices of preparations in the countries of the European Union, whose share of the total volume of sales in the Czech Republic's market of interchangeable products in the last quarter has reached at least 3% of the daily therapeutic doses of products containing the active substance concerned.
(2) The basic payment for products with different silari1) (different contents of the active substance) in the unit of the formulation is determined for a strength corresponding to the usual daily therapeutic dose.
(3) The prices of preparations in the Member States of the European Union in foreign currency are converted at the average rate published by the Czech National Bank for the last three calendar months preceding the month in which the application was lodged.
(4) For the calculation of the basic remuneration, the Institute will use the producer price, which is the final consumer price, from which the relevant trade performance premium and taxes applied in the relevant Member State of the European Union have been deducted. To this price the manufacturer of the Institute adds the amount of the premium for commercial performance and value added tax applied in the Czech Republic.
(5) If the product is made available on the market in the country of the reference basket or in another Member State of the European Union only in a different package size from that for the Czech market and the variation in the packaging size is not more than 10% of the daily therapeutic doses, the manufacturer's foreign price shall be converted into the daily therapeutic doses content of the product intended for the Czech market.
(6) The prices calculated in accordance with paragraphs 3 to 5 shall be used to calculate the basic remuneration for the usual daily therapeutic dose of the active substance contained in the preparation.
(7) In assessing the costs incurred by the use of the product for the purpose of assessing cost-effectiveness, the Institute shall use the price information provided by the marketing authorisation holders of authorised medicinal products and by domestic manufacturers or importers of non-authorised medicinal products or food for special medical purposes for which reimbursement has been provided (hereinafter referred to as "persons placing the medicinal product on the market ') pursuant to Article 39m (1) (a) of the Law.
(a) at least once a year on final consumer prices and producer prices in the Member States of the European Union on whose market the product is supplied, unless this information can be obtained from publicly available sources,
(b) by the 20th day of the calendar month preceding the calendar quarter in which the product will be placed on the market for changes in the highest price of the product at which the product will be placed on the Czech market in the next calendar month if the price of the product is not regulated by the maximum price.
Compound products
(1) For products consisting of two or more active substances, the amount of the basic payment shall be the sum of the basic payments established for each active substance. The basic remuneration thus determined may be adjusted in accordance with Part Four.
(2) Compound products shall not be considered as combinations with active substances that are not used alone and are designed to achieve or increase the effect of the product or improve its kinetics in the body.
(3) In the case of a composite product that is usable and cost-effective for an indication other than its constituents, a further remuneration may be provided for in accordance with Paragraph 39b (6) of the Law for those indications in addition to the basic remuneration.
(4) Paragraph 1 shall apply only where the treatment with a fixed combination of active substances is comparable or more favourable than that of single component products or where single component products are not available. In cases where it is demonstrated that a fixed combination of active substances has low therapeutic efficacy, the basic payment of that combination shall not exceed the sum of the basic payments established for each active substance adjusted under Section 39c (3) of the Act.
Reduction of basic remuneration with regard to the first generic
(1) The reduction in the basic remuneration of the reference group pursuant to Paragraph 39b (4) of the Act applies only if, at the time when the basic remuneration for the reference group concerned was established, no generic m2 has been placed on the market for any medicinal product included in the reference group concerned).
(2) The reduction of the basic reimbursement of the active substance not included in the reference group under Paragraph 39b (4) of the Act shall be applied mutatis mutandis.
Reduction of basic remuneration in terms of effectiveness
The Institute may reduce the basic remuneration in the reference groups of medicinal products with low therapeutic efficacy, medicines that are not used for causative treatment or are used for the treatment of non-serious diseases, if these are found in a statistically significant number of cases. Low therapeutic efficacy means a clinically significantly lower therapeutic efficacy than the standard therapy, by at least 50%. Causal treatment of the disease means any therapy leading to the correction, cessation of development or mitigation of pathological processes responsible for the development of the disease, improvement of a measurable parameter, which is generally considered significant in the pathogenesis of the disease or possible complications, stabilisation of the patient's health status or removal or mitigation of clinically significant symptoms of the disease.
METHOD OF ASSESSMENT OF THE AMOUNT OF THE PRODUCT
Evaluation
In increasing or reducing the amount of the reimbursement of the product against the basic payment, the criteria set out in Paragraph 39b (2) of the Act shall be evaluated against the product used for determining the amount of the basic payment or against any other treatment which was relevant for determining the basic remuneration. For this purpose, a comparison with a product from the same reference group may also be used, to which the amount of remuneration has already been set, if such comparison can be used. It is not possible to increase the remuneration provided for in Sections 8 to 10 for a product whose price referred to in Section 39c (2) of the Act was used to determine the amount of the basic remuneration.
Adjustment of the remuneration in terms of effectiveness and safety and the degree of patient interaction
(1) Clinical relevance is assessed in the efficacy assessment.
(a) reduction in patient mortality;
(b) prolonged median survival,
(c) reduction of morbidity and occurrence of serious complications;
(d) changes to a measurable parameter which is generally considered significant in the pathogenesis of the disease concerned and the occurrence of complications, if any; or
(e) changes in the quality of life of patients.
(2) The safety assessment shall assess the clinical relevance of:
(a) a difference in the incidence of serious adverse reactions,
(b) the difference in the proportion of patients who have to stop therapy due to adverse reactions;
(c) the occurrence of serious drug interactions.
(3) When assessing the degree of synergy of the person receiving the product,
(a) the simplicity and clarity of the dosing schedule, taking into account the necessary number of daily doses administered or their frequency over a monthly interval and the estimated total duration of therapy;
(b) ease of administration or application in relation to co-administration of food or beverages; or
(c) other restrictions resulting from the use of the product, such as the need for co-administration of other products or compliance with other conditions necessary to ensure the effect of the product.
(4) Reimbursement may be increased by a maximum of 10% for reasons of increased efficacy, a maximum of 10% for reasons of increased safety, a maximum of 5% for reasons of increased interaction between the person administering the product. The total increase in the remuneration referred to in the first sentence shall not exceed the basic remuneration by more than 15%, unless otherwise specified.
(1) If the product is significantly higher in effectiveness or safety, the remuneration of the product may be increased by up to 15% compared to the basic payment for reasons of significantly higher efficiency, for reasons of significantly higher safety, by up to 15%, with a maximum overall increase in the basic remuneration for reasons of efficiency and safety of up to 30%.
(2) A medicinal product with substantially greater efficacy shall be considered to be shown to be clinically relevant in the assessment under Section 8.
(a) a reduction in patient mortality by at least 20%;
(b) an extension of the life expectancy by at least 40% in patients with a life expectancy of less than 24 months;
(c) an extension of at least 30% until the necessary hospitalisation; or
(d) a reduction of at least 30% in serious clinically significant signs of disease.
(3) A medicinal product with substantially higher safety is considered to be a medicinal product for which clinically significant evidence of clinical relevance in the assessment under § 8
(a) the incidence of serious adverse reactions below by at least 30%;
(b) the proportion of patients who have had to discontinue therapy for adverse reactions is at least 30% lower; or
(c) serious drug interactions lower by at least 30%.
(4) If, after the evaluation, the product is less effective or less safe, the remuneration shall be reduced by analogy.
(1) If it is demonstrated that the degree of interaction of the person receiving the product is lower than that used to determine the level of the basic payment, the payment of the product concerned
(a) it may be reduced by up to 10% compared to the basic remuneration if, despite fluctuations in treatment caused by a lower degree of synergy, there is no risk to the patient's life or health by inadequate pharmaceuticals; or
(b) it shall be reduced by at least 30% from the basic remuneration if the lower level of interaction of the person poses a serious risk of serious adverse reactions.
(2) If it is demonstrated that the degree of interaction of the person receiving the product is substantially higher than
(a) the preparation used to determine the amount of the basic remuneration; or
(b) with another product of the relevant reference group, unless its reimbursement has been reduced for the reasons referred to in paragraph 1,
the payment of the product concerned may be increased by up to 10% compared to the basic payment, with a total increase of up to 30% in the basic payment.
Assessment of disease severity
(1) For the purpose of adjusting the remuneration, diseases requiring permanent or long-term hospitalisation, diseases resulting in frequent repeated hospitalisation for several years, disability or diseases resulting in permanent serious damage to health, complete or almost complete loss of vision, hearing, speech or movement, or diseases that reduce life expectancy by more than 20%.
(2) Diseases that cause only a short-term mild health disorder are considered to be a health condition for the purpose of adjusting the remuneration.
Method for assessing cost-effectiveness
(1) In the absence of data on cost-effectiveness in the Czech Republic or their procurement would be associated with difficult to overcome difficulties, the cost of use of the product under consideration can be compared to the costs of the therapeutic effect of comparable pharmacotherapy. The product is considered cost-effective if the costs of public health insurance associated with the use of the product under consideration are lower than those of public health insurance linked to the use of the least expensive pharmacotherapy of a comparable effect, both for one treated and for one successfully treated patient.
(2) A cost-effectiveness certificate is not required when the product is essentially interchangeable (Section 39c (1) of the Act) and the applicant does not require a higher remuneration or less restrictive payment conditions than those applicable to the product to which the amount and conditions of payment have already been established.
(3) In the context of the cost assessment, the amount of the basic remuneration or proposed remuneration and the amount of the reimbursement shall always be assessed in principle for the therapeutic products interchangeable. To this end, in addition to the applicant, in accordance with Section 39m of the Act, persons placing the medicinal product on the market are essentially interchangeable. The information shall include information on the final consumer price and the producer price in all countries of the European Union in which the product is on the market where such data are not available from publicly available verifiable sources.
(4) An increase or reduction in the payment of the product against the basic payment may also be made on the basis of a comprehensive pharmacological evaluation, including an assessment of the cost-effectiveness submitted by the person who requested an increased or reduced remuneration. The evaluation submitted shall include all essential characteristics of the pharmacotherapy evaluated, in particular the costs and benefits associated with it. In this case, the other provisions on changes in remuneration against the basic remuneration shall not apply, provided that the resulting payment of the product must not exceed the basic remuneration by more than 30%. The use of the product must be shown to be cost-effective even in such a adjusted remuneration.
Increase in remuneration in the public interest
(1) On the basis of the public interest (Section 17 (3) of the Act), the Institute may increase the reimbursement of medicines if the following conditions are also met:
(a) products which have been verified in practice and are necessary for health care; and
(b) products which are irreplaceable in therapy or which can only be replaced by more expensive products and an increase in remuneration is necessary for the product to remain on the market.
(2) On the basis of public interest, the Institute may also increase the reimbursement of medicines if the following conditions are also met:
(a) are products which are irreplaceable in therapy or can only be replaced by more expensive products; and
(b) the basic remuneration of the reference group or active substance has been determined in accordance with Paragraph 39c (2) (a) of the Act, whereby the lowest producer price established in any European Union country for the product responsible for determining the basic remuneration is less than 20% of the average of the three lowest prices of the producer of the same product found in the other countries of the European Union. Foreign prices shall be adjusted for this purpose in accordance with Article 3 (3).
(3) Similarly, products complying with the conditions laid down in paragraph 1 shall be treated if the basic payment of the product has been adjusted in accordance with Paragraph 39c (3) of the Act.
(4) The increase in the remuneration referred to in paragraphs 1 to 3 shall not be subject to the limitation laid down in Paragraph 22, with the fact that the conversion payment may not exceed the daily cost of comparable effective healthcare.
Reductions or cancellations in the public interest
(1) The Institute shall reduce or cancel the remuneration or additional remuneration (Paragraph 39f (6) of the Act) of the preparation in the public interest, in particular if:
(a) the product is not cost-effective on the basis of the findings; or
(b) the periodic revision of the reimbursement system (Section 39l of the Act) does not prove that the expected results of pharmacotherapy are met in the normal clinical practice conditions contained in the application for the level and conditions of reimbursement.
(2) The reimbursement of the product is reduced to meet the cost-effectiveness requirement. Reductions may also be made repeatedly. The decision to reduce the remuneration may also include an adjustment to the terms of the remuneration, so that the newly established conditions correspond to effective therapeutic intervention and cost-effectiveness.
Adjustment of the reimbursement taking into account the suitability of the route of administration and the pharmaceutical form
(1) If both oral and parenteral routes of administration are included in the reference group, the payment of parenteral formulations may be increased by a maximum of 10%.
(2) In liquid pharmaceutical forms for internal use and semi-solid formulations which allow the circulation of enterohepatic agents, if these formulations are intended for patients under 12 years of age or if patients are unable to receive oral pharmacotherapy, the remuneration may be increased by up to 10% against rigid oral forms, essentially interchangeable.
(3) In the case of treatment of highly serious diseases or antibiotic treatment, an increased remuneration may be provided in accordance with § 39b (6) of the Act for medicinal forms of fluid for internal use or semi-solid to circumvent enterohepatic circulation if these forms are intended for patients under 3 years of age.
(4) In the case of modified-release formulations, fast-soluble, retarded, depot or similarly modified formulations, the remuneration may be increased by up to 10% in relation to medicinal products essentially interchangeable in pharmaceutical forms without the above characteristics, in the case of evidence of increased efficacy or safety.
(5) The provisions of paragraphs 1, 2 and 4 shall not apply to products whose payment of the usual daily therapeutic dose is greater than 40 CZK or the payment of 1 pack exceeds 1 200 CZK.
(6) The provisions of paragraphs 1 to 5 are without prejudice to the possibility of adjusting the reimbursement of the product under Articles 7 to 14 and 16 to 22.
Adjustment of remuneration taking into account the suitability of strength
(1) Reimbursement of one usual therapeutic dose for products with different strengths (different active substance content) in the unit of the medicinal product is reduced by a coefficient of 0,667 for each doubling of strength, only if doubling of the active substance content has shown to result in an increase in therapeutic efficacy.
(2) The payment of one usual therapeutic dose increases by 1,5 per usual therapeutic dose if the therapeutic efficacy is not reduced below the level of effective therapeutic intervention at each reduction in the active substance content in the unit of the medicinal product.
(3) Coefficient adjustment does not apply to products that are used at the start of dose titration therapy if such titration lasts for a maximum of 60 days, or if different strengths are intended for the treatment of different diseases, or if a price is requested for all strengths and independent of the active substance content.
Adjustment of the remuneration taking into account the suitability of the package size
(1) For products that are in most cases administered for more than 2 months, the payment of packages containing less than 15 daily therapeutic doses is reduced by 15%.
(2) For products for the treatment of acute diseases, the payment of packs containing at least twice the daily therapeutic doses usually required for the treatment of the disease is reduced by 15%.
(3) For products whose pack size is greater than that of the normal duration of treatment or the recommended dosage as specified in the Summary of Product Characteristics (3), the payment may be reduced by an unfit pack content.
Adjustments in remuneration with regard to usual dosage and treatment time
(1) For the determination of the remuneration, the defined daily dose recommended by the World Health Organisation shall be based on, unless otherwise specified.
(2) If the recommended routine dosage referred to in the Summary of Product Characteristics is higher than the dose referred to in paragraph 1, this dosage shall be used to determine the level of payment.
(3) If the usual dosage in normal clinical practice is higher than the dose referred to in paragraphs 1 and 2, the usual dosage shall be used to determine the remuneration.
(4) If the product is given at intervals and compared with other therapies, the dosage is converted into an average daily dose for the determination of the remuneration. When given according to the patient 's body weight, the dose is recalculated with respect to the mean weight.
(5) If, due to the nature of the product, the dosage cannot be determined or determined, an appropriate unit of weight of the product shall be used for determining the reimbursement of 1 dose or, if not possible, an appropriate unit of weight of the product.
(6) For basically therapeutically interchangeable foods for special medical purposes, the primary objective of which is to replace the diet, the remuneration is determined on the basis of the quantity of food with the same number of calories (isocalorie equivalent).
(7) Where this results from the therapeutic use and the nature of the product under consideration, when comparing the substitutability of such a product with other essentially interchangeable products, the necessary duration of treatment shall be taken into account if it differs between the products being compared. The resulting remuneration shall then be adjusted in the light of differences in the duration of treatment for the comparator products.
(8) The usual daily therapeutic dose for the purpose of this decree shall consist of the amount of active substance per day of therapy adjusted in accordance with paragraphs 1 to 7.
Replacement of another product
(1) If, in principle, the product is therapeutically interchangeable with other products only in certain indications, the basic remuneration for these indications is determined. For indications in which the medicinal product is therapeutically unmistakable or interchangeable only with some of the products referred to in the first sentence, an additional increased remuneration may be provided for in accordance with Section 39b (6) of the Act on request.
(2) Products containing an active substance that can be used for the treatment of diseases that have not yet been affected by another product, or for products that represent a major improvement in treatment ("highly innovative products'), shall not be included in the reference groups in principle interchangeable products and reimbursement shall be determined within the active substance.
(3) The criteria set out in the Annex to this Decree shall be followed when assessing whether the products are highly innovative.
(4) For highly innovative products, the remuneration adjustment provided for in Sections 8 to 10, 13 and 15 shall not be made.
Expected impact of remuneration on health insurance funds
(1) When determining the amount and conditions for reimbursement of the product, the Institute shall assess whether the amount and conditions for reimbursement may significantly jeopardise the financial stability of the public health insurance system. where there is a possibility of such a risk, the Institute shall provide for restrictions on the use of such a product as referred to in Paragraph 29, where possible and effective.
(2) Similarly, the Institute assesses the possible impact of remuneration on health insurance funds in the event of a request for a change in the amount or conditions of reimbursement of the product.
Recommended procedures of professional institutions and experts
The evaluation of recommended practices of professional institutions and experts shall evaluate the information published by national and foreign professional companies, with that information being evaluated in terms of cost-effectiveness and the expected impact on health insurance funds.
Limit of increase in payment of the product
(1) The increase or reduction in remuneration according to the rules set out in Part Four shall be added together.
(2) The resulting payment of the product, adjusted in accordance with the provisions of Part Four, may not exceed the basic remuneration by more than 30% except for the increase in the remuneration provided for in Sections 13 and 15 (3) and shall not exceed the average of the three lowest prices for the final consumer of the product recorded in any country of the European Union adjusted for any differences in the amount of taxes and trade charges between the State where the price was established and the Czech Republic.
METHOD OF ACCOUNTING AND CONDITIONS OF BIRING THE MEDICINAL PRODUCT
In determining the conditions for reimbursement under § 39b (5) of the Act, the Institute shall apply in the decision the restrictions and symbols set out in § 24 to 29.
Prescription restrictions
(1) If, in view of the efficacy and safety of the product or of the public interest, this is appropriate, the payment of the product shall be limited to the prescription of such a product by the physician specialising in the decision and the decision shall bear the symbol "L '(hereinafter referred to as" the prescription restriction').
(2) A product with a prescription restriction may be prescribed for reimbursement by the health insurance company only by a doctor with a specialisation mentioned in the prescription restriction, which has a contract with the health insurance company for the provision of the health care concerned (hereinafter referred to as the "doctor with the relevant specialisation ') or by another doctor authorised by it in writing.
(3) If, in view of the efficacy and safety of the prescription, the medicinal product cannot be passed on to the physician referred to in paragraph 2, the decision shall bear the symbol "E."
Indicative restrictions
(1) If, in view of the efficacy and safety of the product or of the public interest, this is appropriate, reimbursement of the product may be made conditional on:
(a) a precise indication, if any, of the patient's clinical condition;
(b) use for listed patient groups characterised by a specific disease or clinical condition; or
(c) use in case of insufficient efficacy of standard therapy.
(2) The product thus restricted shall be identified in the decision by the symbol "P '(hereinafter referred to as the indication restriction). An indication-restricted product may be prescribed by the health care professional of the contractual medical establishment only in accordance with the indication-restriction.
(3) If, in view of the effectiveness and safety of the product or of the public interest, it is appropriate to make the payment of the product subject to approval by the health insurance undertaking's revised doctor or, where appropriate, by his authorised specialist, the decision shall bear the symbol "W '.
(4) Indicative restrictions may be combined with the other restrictions set out in Sections 24 and 26 to 29.
Increased remuneration
The increased remuneration under Paragraph 39b (6) of the Act shall be indicated in the decision by the symbol "V '. If the increased remuneration is determined in accordance with Paragraph 39b (6) of the Act, the indication restrictions shall also be laid down.
Outpatient care
The medicine given by the doctor in the course of outpatient care is indicated in the decision by the symbol "A '. Such a product shall be charged to the health insurance undertaking in connection with the respective performance as a separately charged product.
Preparations for diagnostic use
If the product is intended to be administered as part of a diagnostic exercise performed by outpatient or institutional care, the decision shall bear the symbol "D '. Such a product shall be charged to the health insurance undertaking as part of the diagnostic exercise and, if not included in the performance value, as a separately charged product.
Specialised care products
(1) If it is a product the use of which, in view of the public interest, is appropriate to concentrate in selected health facilities guaranteeing the economical use of such a product at the highest professional level (hereinafter referred to as "specialised workplace '), the decision shall bear the symbol" S'.
(2) Such a product shall only be charged to the health insurance undertaking by a specialised place of business, on the basis of a contract concluded between him and the relevant health insurance undertaking, as a separate product.
DATA STRUCTURE AND DOCUMENTATION OF THE REQUEST FOR DETERMINATION OF THE AMOUNT
(1) The applicant shall submit the application and the accompanying documentation, as a general rule, in electronic form in a format published by the Institute in a way that allows remote access.
(2) The scope of the dossier submitted with the application must correspond to the current knowledge of the preparation and include all information concerning the preparation, whether favourable or unfavourable. In particular, all relevant details concerning efficacy, safety and comparison of the costs and benefits associated with the use of the product in normal clinical practice shall be provided. The annexes to the application may be submitted in the Czech, Slovak or English language, or by agreement between the applicant and the Institute in another language.
(3) The structure of the available clinical trials under Section 39f (6) of the Act means in particular:
(a) results of meta-analyses of controlled randomised clinical trials;
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Regulation Information
| Citation | Decree No. 92 / 2008 Coll., establishing the list of countries of the reference basket, how to evaluate the amount, conditions and forms of reimbursement of medicinal products and foodstuffs for special medical purposes and the details of the request for setting the amount of reimbursement |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 19.03.2008 |
|---|---|
| Effective from | 19.03.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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