Key Benefits:
Royal Decree-Law 28/2012 of 30 November, of measures for the consolidation and security of the Social Security system, in its final provision, amended paragraph 1 of Article 94 (a) of Law 29/2006 of 26 July, for the rational use of medicinal products and medical devices, in order to equip medical prescription and hospital dispensing orders for the purpose of the contribution of users and their beneficiaries in the provision of services Outpatient pharmacist.
By this resolution the conditions of public financing of the drugs, which without the qualification of hospital use, have established singular reserves in the field of the National System of Health are modified. consistent with limiting their dispensing to non-hospitalized patients in the hospital pharmacy services. These drugs were exempt from the user's input.
On the contrary, if these drugs could have been obtained in the pharmacy by official prescription from the National Health System, they would have been subject to the corresponding contribution of the user. Article 94.a (1) of Law 29/2006 of 26 July provides that such medicinal products must also be subject to the user's contribution when they are dispensed in the hospital pharmacy services.
Royal Decree 1348/2003 of 31 October, adapting the anatomic classification of drugs to the ATC classification system, updated the relationship of the therapeutic groups and subgroups of drugs that have the consideration of reduced input. Subsequently, Royal Decree 823/2008 of 16 May 2008 establishing the margins, deductions and discounts corresponding to the distribution and supply of medicinal products for human use, amended Royal Decree 1348/2003, of 31 December 2008. October, empowering the Directorate General of Pharmacy and Health Products to ensure that, in cases of medicinal products that meet the conditions to be considered as a reduced contribution, and as soon as Annex III of the Royal Decree 1348/2003 of 31 October 2003 may provide for a reasoned determination of the reduced contribution of a given medication.
For the most part, drugs that do not have a hospital use rating have established unique reserves in the field of the National Health System, which are consistent with limiting their treatment to patients. In the hospital pharmacy services, they belong to therapeutic groups considered to be of reduced contribution. However, some of them belong to therapeutic groups that do not have it. In these cases, even if they were medicines that met the conditions to be considered as a reduced contribution, there was no need for their express recognition as these treatments were exempt from input.
The characteristics of the severity and chronicity of the pathologies in which the drugs listed in the Annex are indicated in this resolution advise that the contribution by the beneficiary be reduced because of another There would be situations of inequity in comparison with the reduced-contribution medicines which are usually dispensed in the pharmacy offices.
Law 29/2006, of July 26, establishes the percentages of contribution on the PVP according to the type of user. However, under Article 7 of Royal Decree-Law 16/2012 of 20 April, urgent measures to ensure the sustainability of the National Health System and to improve the quality and safety of its services, which regulates handling and (i) the need for medicinal products to be dispensed with the provision of medicinal products for the provision of medicinal products for the purposes of the provision of medicinal products for medicinal products; criteria for monitoring the patient and for planned medical checks. For such cases, it is necessary to set a proportionality criterion for the purposes of avoiding inequities in the calculation of the contribution.
As set out in Article 12 of the Royal Decree 200/2012 of 23 January, the basic organic structure of the Ministry of Health, Social Services and Equality is developed and the Royal Decree is amended. 1887/2011, of December 30, which establishes the basic organic structure of the ministerial departments, corresponds to the holder of the Directorate General of the Basic Portfolio of Services of the National System of Health and Pharmacy the development and implementation of the Department's pharmaceutical policy, and the competence to resolve the conditions for prescribing and dispensing medicinal products in the field of the National Health System.
Consequently, this resolution complies with the provisions of Law 29/2006 of 26 July, in Article 94.bis (1), by allocating a reduced contribution to medicinal products without the use of the The hospital has established unique reserves in the field of the National Health System, consisting of limiting its supply to non-hospitalized patients in the pharmacy services of hospitals.
The reduced contribution, as provided for in Article 94.bis of Law 29/2006 of 26 July, is 10% of the PVP of medicinal products, with a maximum currently set at EUR 4,20.
For the above, pursuant to Articles 89.1 and 94.bis.1 of Law 29/2006 of 26 July, and Royal Decree 1348/2003 of 31 October 2003, pursuant to Article 94 bis (1) of the Treaty, it is necessary to provide for the Law 29/2006, of July 26, and according to the competencies given to this Directorate General of the Basic Portfolio of Services of the National System of Health and Pharmacy, resolute:
1. Modification of the financing conditions for medicinal products included in the pharmaceutical provision of the National Health System.
As provided for in Articles 89.1 and 94.bis.1 of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices, the conditions for financing the system are amended. National of Health of the medicinal products listed in Annex 1 to this resolution, subject to input from the user.
These drugs, without having the hospital use qualification, have established singular reserves in the field of the National Health System, consisting of limiting their dispensation to non-hospitalized patients in the pharmacy services of hospitals.
2. Reduced input allocation.
Pursuant to the provisions of Royal Decree 1348/2003 of 31 October 2003 adapting the anatomic classification of medicinal products to the ATC classification system, and as soon as Annex III of the said classification is not updated Royal Decree provides for the consideration of reduced input for the medicinal products listed in Annex 1 to this resolution.
These drugs meet the conditions to be considered as a reduced contribution, as they are medications of choice in the treatment of serious or chronic diseases, and their dispensation is limited, in the of the National Health System, to the patients not hospitalized in the pharmacy services of the hospitals.
3. Calculation of the contribution.
The reduced contribution, as provided for in Article 94.bis of Law 29/2006, is 10% of the PVP of the medicinal product, with a maximum currently set at € 4.20 by the Resolution of 21 January 2013, of the General de Cartera Basic de Servicios del Sistema Nacional de Salud y Farmacia, for which the maximum amount corresponding to the drugs belonging to the reduced-contribution ATC groups is updated, and the maximum monthly contribution limits for persons who have the status of insured persons as Social Security pensioners and their beneficiaries in the outpatient pharmaceutical service.
However, when in application of the provisions of article 7 of Royal Decree-Law 16/2012 of 20 April, urgent measures to ensure the sustainability of the National Health System and improve the quality and safety of its benefits, the dispensing of the medicinal products by the hospital pharmacy services does not conform to the commercial packaging, the calculation of the contribution shall be carried out in proportion to the medication dispensed.
In this way, the calculation of the reduced contribution in these cases will be 10% of the PVP of the medicine dispensed up to a maximum of 4.20 euros per package, and the contribution corresponding to the dispensing of the package. complete, the proportion corresponding to the medication dispensed will be calculated.
4. Effects of the resolution.
This resolution shall have effect from day 1 of the month following that of its publication in the "Official State Gazette".
5. Resources.
In accordance with Articles 114 and 115 of Law 30/1992, of 26 November, of the Legal Regime of Public Administrations and of the Common Administrative Procedure, this resolution, which does not exhaust the administrative route, may be appealed to the General Secretariat for Health and Consumer Affairs of the Ministry of Health, Social Services and Equality within one month of its publication in the Official Gazette of the State.
Madrid, September 10, 2013. -Director General of the Basic Portfolio of Services of the National System of Health and Pharmacy, Agustín Rivero Cuadrado.
ANNEX 1
Medicines with unique reserves established in the field of the National Health System, consisting of limiting their supply to non-hospitalized patients in the pharmacy services of the hospitals, which remain subjected to reduced user input
Presentation Name | |
---|---|
688048 | DIFF 200 mg FILM-COATED TABLETS, 20 tablets. |
663723 | SAMSCA 15 mg. TABLETS, 10 tablets. |
663726 | SAMSCA 30 mg. TABLETS, 10 tablets. |
885905 | MIRENA 0.02 mg EVERY 24 HOURS INTRAUTERINE RELEASE SYSTEM, 1 intrauterine device. |
665772 | ELONVA 100 micrograms SOLUTION FOR injection, 1 pre-filled syringe of 0.5 ml. |
665773 | ELONVA 150 micrograms SOLUTION INJECTION, 1 syringe 0.5 mL pre- |
883108 | COPEGUS 200 mg FILM-COATED TABLETS, 168 tablets. |
756858 | COPEGUS 200 mg FILM-COATED TABLETS, 28 tablets. |
883009 | COPEGUS 200 mg FILM-COATED TABLETS, 42 tablets. |
792200 | REBETOL 200 mg HARD CAPSULES, 140 capsules. |
792242 | REBETOL 200 mg HARD CAPSULES, 168 capsules. |
650508 | REBETOL 40 mg/ml SOLUTION ORAL, 1 bottle of 100 ml. |
673688 | RIBAVIRIN NORMON 200 mg FILM-COATED TABLETS, 168 tablets |
681790 | RIBAVIRIN SANDOZ 200 mg HARD CAPSULES, 168 capsules. |
674172 | RIBAVIRIN SANDOZ 200 mg FILM-COATED TABLETS, 168 tablets. |
674166 | RIBAVIRIN SANDOZ 200 mg TABLETS EFG FILM-COATED, 42 TABLETS |
662851 | RIBAVIRIN TEVA 200 mg HARD CAPSULES, 168 capsules |
662850 | RIBAVIRIN TEVA 200 mg HARD CAPSULES, 140 capsules. |
663704 | RIBAVIRIN TEVA PHARMA BV 200 mg FILM-COATED TABLETS tablets |
663703 | RIBAVIRIN TEVA PHARMA BV 200 mg FILM-COATED TABLETS, 42 tablets. |
689402 | RIBAVIRIN VEGAL 200 mg FILM-COATED TABLETS, 168 tablets |
764050 | VALCYTE 450 mg FILM-COATED TABLETS, 60 tablets |
684655 | INCIVO 375 mg FILM-COATED TABLETS, 168 tablets. |
682555 | VICTRELIS 200 MG HARD CAPSULES, 336 capsules. |
665954 | Zutectra 500 IU SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, 5 1 ml pre-filled |
836577 | SYNAGIS 100 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, 1 vial + 1 solvent ampoule. |
836668 | SYNAGIS 50 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, 1 vial + 1 solvent ampoule. |
662369 | TEMODAL 100 mg HARD CAPSULES, 20 capsules. |
662368 | TEMODAL 100 mg HARD CAPSULES, 5 capsules. |
662371 | TEMODAL 140 mg HARD CAPSULES, 20 capsules. |
662370 | TEMODAL 140 mg HARD CAPSULES, 5 capsules. |
662372 | TEMODAL 180 mg HARD CAPSULES, 5 capsules. |
662367 | TEMODAL 20 mg HARD CAPSULES, 20 capsules. |
662366 | TEMODAL 20 mg HARD CAPSULES, 5 capsules. |
664203 | TEMODAL 5 mg HARD CAPSULES, 5 capsules. |
665819 | TEMOMEDAC 100 mg HARD CAPSULES, 20 capsules. |
665818 | TEMOMEDAC 100 mg HARD CAPSULES, 5 capsules. |
665821 | TEMOMEDAC 140 mg HARD CAPSULES, 20 capsules. |
665820 |
TEMOMEDAC 140 mg HARD CAPSULES, 5 capsules. |
665822 | TEMOMEDAC 180 mg HARD CAPSULES, 5 capsules. |
665817 | TEMOMEDAC 20 mg HARD CAPSULES, 20 capsules. |
665816 | TEMOMEDAC 20 mg HARD CAPSULES, 5 capsules. |
665823 | TEMOMEDAC 250 mg CAPSULES DURAS EFG, 5 capsules. |
665815 | TEMOMEDAC 5 mg HARD CAPSULES, 5 capsules. |
665831 | TEMOZOLOMIDE HOSPIRA 100 mg HARD CAPSULES, 20 capsules. |
665830 | TEMOZOLOMIDE HOSPIRA 100 mg HARD CAPSULES, 5 capsules. |
665833 | TEMOZOLOMIDE HOSPIRA 140 mg HARD CAPSULES, 20 capsules. |
665832 | TEMOZOLOMIDE HOSPIRA 140 mg HARD CAPSULES, 5 capsules. |
665834 | TEMOZOLOMIDE HOSPIRA 180 mg HARD CAPSULES, 5 capsules |
665829 | TEMOZOLOMIDE HOSPIRA 20 mg HARD CAPSULES, 20 capsules. |
665827 | TEMOZOLOMIDE HOSPIRA 20 mg HARD CAPSULES, 5 capsules |
665835 | TEMOZOLOMIDE HOSPIRA 250 mg HARD CAPSULES, 5 capsules. |
665826 | TEMOZOLOMIDE HOSPIRA 5 mg HARD CAPSULES, 20 capsules |
665825 | TEMOZOLOMIDE HOSPIRA 5 mg HARD CAPSULES, 5 capsules. |
665799 | TEMOZOLOMIDE SANDOZ 100 mg HARD CAPSULES, 20 capsules. |
665798 | TEMOZOLOMIDE SANDOZ 100 mg HARD CAPSULES, 5 capsules. |
665805 | TEMOZOLOMIDE SANDOZ 140 mg HARD CAPSULES, 20 capsules. |
665803 | TEMOZOLOMIDE SANDOZ 140 mg HARD CAPSULES, 5 capsules. |
665808 | TEMOZOLOMIDE SANDOZ 180 mg HARD CAPSULES, 5 capsules. |
684868 | TEMOZOLOMIDE SUN 100 mg HARD CAPSULES, 20 capsules. |
696517 | Temozolomide SUN 100 mg hard capsules, 20 capsules |
684754 | TEMOZOLOMIDE SUN 100 mg HARD CAPSULES, 5 capsules. |
696519 | Temozolomide SUN 100 mg hard capsules, 5 capsules |
684869 | TEMOZOLOMIDE SUN 140 mg HARD CAPSULES, 20 capsules. |
696521 | Temozolomide SUN 140 mg hard capsules, 20 capsules. |
684759 | TEMOZOLOMIDE SUN 140 mg HARD CAPSULES, 5 capsules. |
696520 | Temozolomide SUN 140 mg hard capsules, 5 capsules. |
684872 | TEMOZOLOMIDE SUN 180 mg EFG HARD CAPSULES, 20 capsules. |
696461 | Temozolomide SUN 180 mg hard capsules, 20 capsules. |
684760 | TEMOZOLOMIDE SUN 180 mg HARD CAPSULES, 5 capsules. |
696462 | Temozolomide SUN 180 mg hard capsules, 5 capsules. |
684853 | TEMOZOLOMIDE SUN 20 mg HARD CAPSULES, 20 capsules. |
696522 | Temozolomide SUN 20 mg hard capsules, 20 capsules. |
684766 |
TEMOZOLOMIDE SUN 20 mg HARD CAPSULES, 5 capsules. |
696523 | Temozolomide SUN 20 mg hard capsules EFG, 5 capsules. |
684873 | TEMOZOLOMIDE SUN 250 mg HARD CAPSULES, 20 capsules. |
696515 | Temozolomide SUN 250 mg hard capsules, 20 capsules. |
684767 | TEMOZOLOMIDE SUN 250 mg HARD CAPSULES, 5 capsules. |
696516 | Temozolomide SUN 250 mg hard capsules, 5 capsules. |
684867 | TEMOZOLOMIDE SUN 5 mg HARD CAPSULES, 20 capsules. |
696524 |
Temozolomide SUN 5 mg hard capsules, 20 capsules. |
684768 | TEMOZOLOMIDE SUN 5 mg HARD CAPSULES EFG, 5 capsules. |
696525 | Temozolomide SUN 5 mg hard capsules, 5 capsules. |
664671 | TEMOZOLOMIDE TEVA 100 mg HARD CAPSULES, 20 capsules |
664670 | TEMOZOLOMIDE TEVA 100 mg HARD CAPSULES, 5 capsules. |
664674 | TEMOZOLOMIDE TEVA 140 mg HARD CAPSULES, 20 capsules. |
664673 | TEMOZOLOMIDE TEVA 140 mg HARD CAPSULES, 5 capsules. |
664675 | TEMOZOLOMIDE TEVA 180 mg HARD CAPSULES, 5 capsules. |
664669 | TEMOZOLOMIDE TEVA 20 mg EFG HARD CAPSULES, 20 capsules. |
664668 | TEMOZOLOMIDE TEVA 20 mg HARD CAPSULES, 5 capsules |
664676 | TEMOZOLOMIDE TEVA 250 mg HARD CAPSULES, 5 capsules. |
664667 | TEMOZOLOMIDE TEVA 5 mg HARD CAPSULES, 5 capsules. |
697757 | Capecitabine Accord 150 mg film-coated tablets 60 tablets |
697764 |
Capecitabine Accord 500 mg film-coated tablets 120 tablets |
695768 | CAPECITABINE ACTAVIS 150 MG FILM-COATED TABLETS, 60 tablets. |
695769 | CAPECITABINE ACTAVIS 500 MG FILM-COATED TABLETS, 120 tablets |
697407 | CAPECITABINE FRESENIUS KABI 150 MG FILM-COATED TABLETS, 60 tablets. |
697406 | CAPECITABINE FRESENIUS KABI 500 MG FILM-COATED TABLETS, 120 tablets. |
698180 | CAPECITABINE SANDOZ 500 MG FILM-COATED TABLETS, 120 tablets. |
686774 | XELODA 150 mg FILM-COATED TABLETS, 60 tablets. |
686782 | XELODA 500 mg FILM-COATED TABLETS, 120 tablets. |
779652 | GLIVEC 100 mg FILM-COATED TABLETS, 60 tablets. |
741975 | GLIVEC 100mg HARD CAPSULES, 120 capsules. |
779660 | GLIVEC 400 mg FILM-COATED TABLETS, 30 tablets. |
662980 | IRESSA 250 mg FILM-COATED TABLETS, 30 tablets. |
652160 | TARCEVA 100 mg FILM-COATED TABLETS, 30 tablets. |
652161 | TARCEVA 150 mg FILM-COATED TABLETS, 30 tablets. |
652159 | TARCEVA 25 mg COATED TABLETS WITH FORMULA, 30 tablets. |
656864 | SUTENT 12.5 mg HARD CAPSULES, 30 capsules. |
656863 | SUTENT 25 mg HARD CAPSULES, 30 capsules. |
656865 | SUTENT 50 mg HARD CAPSULES, 30 capsules. |
656938 | NEXAVAR 200 mg FILM-COATED TABLETS, 112 tablets. |
652769 | SPRYCEL 50 mg FILM-COATED TABLETS, 56 tablets. |
656939 | SPRYCEL 20 mg FILM-COATED TABLETS, 56 tablets. |
652751 | SPRYCEL 70 mg FILM-COATED TABLETS, 56 tablets. |
661144 | TYVERB 250 mg COATED TABLETS WITH FORMULA, 140 tablets. |
665955 | TYVERB 250 mg FILM-COATED TABLETS, 140 tablets. |
665944 | TASIGNA 150 mg HARD CAPSULES, 112 capsules. |
660235 | TASIGGNA 200 mg HARD CAPSULES, 112 capsules. |
663793 | AFINITOR 10 mg TABLETS, 30 tablets. |
663792 | AFINITOR 5 mg TABLETS, 30 tablets. |
684619 |
VOTUBIA 2.5 mg TABLETS, 30 tablets. |
684617 | VOTUBIA 5 mg TABLETS, 30 tablets. |
665806 | VOTRIENT 200 mg FILM-COATED TABLETS, 30 tablets. |
665807 | VOTRIENT 400 mg FILM-COATED TABLETS, 60 tablets. |
665781 | SIKLOS 1,000 mg FILM-COATED TABLETS, 30 tablets. |
687105 | SIKLOS 100 mg FILM-COATED TABLETS, 60 tablets |
926410 | TARGRETIN 75 mg, SOFT CAPSULES, 100 capsules. |
683759 | ZYTIGA 250 mg TABLETS, 120 tablets. |
741496 | PEGINTRON 100 micrograms POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED PEN, 1 pre-filled pen. |
741710 | PEGINTRON 120 micrograms POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED PEN, 1 pre-filled pen. |
741777 | PEGINTRON 150 micrograms POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED PEN, 1 pre-filled pen. |
873018 | PEGINTRON 50 micrograms POWDER AND SOLVENT FOR SOLUTION INJECTION, 1 vial + 1 ampoule of solvent |
740753 | PEGINTRON 50 micrograms POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PEN PRE-PRE, 1 pre-filled pen. |
741066 | PEGINTRON 80 micrograms POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IN PRE-FILLED PEN, 1 pen prefilled. |
677727 | PEGASYS 135 micrograms SOLUTION FOR INJECTION IN PRE-FILLED PEN, 4 pre-filled pens of 0.5 ml. |
677728 | PEGASYS 180 micrograms SOLUTION FOR INJECTION IN PRE-FILLED PEN, 4 pre-filled pens of 0.5 ml. |
747956 | PEGASYS, 135 micrograms, SOLUTION INJECTION IN PRE-FILLED SYRINGE, 4 pre-filled syringes of 0.5 ml. |
< Centro_table_body"> 748095 | PEGASYS, 180 micrograms, SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE, 4 pre-filled syringes of 0.5 ml. |
693932 | ORENCIA 125 mg solution for injection, 4 pre-filled syringes of 1 ml. |
684644 | ENBREL 10 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION FOR PAEDIATRIC USE, 4 vials + 4 pre-filled syringes Solvent |
839282 | ENBREL 25 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, 4 vials + 4 pre-filled syringes of solvent. |
655950 | ENBREL 25 mg SOLUTION FOR INJECTION IN PRE-FILLED SYRINGES, 4 pre-filled syringes of 1 ml. |
655949 | ENBREL 25 mg/ml POWDER AND SOLVENT FOR SOLUTION INJECTION FOR PAEDIATRIC USE, 4 vials + 4 pre-filled syringes of solvent |
655953 | ENBREL 50 mg SOLUTION FOR INJECTION IN SYRINGES PRE-FILLED, 4 PRE-FILLED SYRINGES of 1 |
663133 | ENBREL 50 mg SOLUTION FOR INJECTION IN PRE-FILLED PENS, 4 pre-filled pens of 1 |
664247 | CIMZIA 200 mg SOLUTION INJECTION, 2 1 ml pre-filled |
665779 | STELARA 45 mg SOLUTION INJECTION IN PRE-FILLED SYRINGE, 1 pre-filled syringe of 0.5 ml. |
662133 | STELARA 45 mg SOLUTION FOR injection, 1 vial of 0.5 ml. |
651197 | BONDRONAT 50 mg FILM-COATED TABLETS, 28 tablets. |
682806 | XGEVA 120 mg SOLUTION FOR injection, 1 vial of 1.7 |
672225 | SATIVEX 2.7 mg/2, 5 mg SOLUTION FOR MOUTH SPRAY, 3 pack of 10 ml. |
652563 | XOLAIR 150 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION, 1 vial + 1 ampoule |
662444 | XOLAIR 150 mg SOLUTION INJECTION, 1 1 ml pre-filled |
662443 | XOLAIR 75 mg SOLUTION FOR injection, 1 pre-filled syringe of 0.5 ml. |
909713 | VIUDYNE 15 mg POWDER FOR SOLUTION FOR INFUSION, 1 vial. |
689247 | LACTEST 0.45 G POWDER FOR ORAL SOLUTION, 1 on. |