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Resolution Of 10 Of September Of 2013, Of The Address General Of Portfolio Basic Of Services Of The System National Of Health And Pharmacy, By Which Is Comes To Modify The Conditions Of Funding Of Drugs Included In The Provision...

Original Language Title: Resolución de 10 de septiembre de 2013, de la Dirección General de Cartera Básica de Servicios del Sistema Nacional de Salud y Farmacia, por la que se procede a modificar las condiciones de financiación de medicamentos incluidos en la prestación ...

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TEXT

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

National Code

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.