Order Ssi/2160/2015, October 14, That Proceed To The Update Of The Reference Drug Pricing System In The National Health System.

Original Language Title: Orden SSI/2160/2015, de 14 de octubre, por la que se procede a la actualización del sistema de precios de referencia de medicamentos en el Sistema Nacional de Salud.

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Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-11177

The system of reference prices, applicable funding of medicinal products by the national health system and set out in article 98 of the text revised law of guarantees and rational use of medicines and sanitary products, approved by Royal Legislative Decree 1/2015, of 24 July, has manifested itself as an essential control of pharmaceutical spending tool necessary for the sustainability of the public health system.

He development regulatory necessary for to make effective the mandate legal of establish, with periodicity annual, them new sets of reference of drugs, as well as of proceed to the review of them prices of reference of them joint already existing, is is established in the Real Decree 177 / 2014, of 21 of March, by which is regulates the system of prices of reference and of groupings homogeneous in the system national of health and certain systems of information in matters of finance and prices of medicines and sanitary products.

Article 5.1 of the Real Decree 177/2014, 21 March, instructs the person holder of the Ministry of health, social services and equality so that, with periodicity yearly, using the corresponding order and prior agreement of the delegate Commission of the Government for Economic Affairs, established new datasets and their reference prices as well so check the reference prices of drugs submissions included in existing datasets and , in his case, proceed to the Suppression of them joint when have left of meet them requirements required for its establishment.

The latest update of the sets of reference drugs and their prices of reference occurred through the order SSI/1225/2014, 10 July, that proceed to the update of the reference drug pricing system in the national health system.

Through the present order ministerial is comes to the update of them joint and prices of reference established by the order SSI / 1225 / 2014, of 10 of July, and for this is determine them new joint and is set their prices of reference, as well as is reviewed them prices of reference set by the same. Also is the abolition of the sets of reference previously determined for non-compliance, for reasons which have arisen, the requirements for its establishment.

For the establishment of new sets of reference of drugs and the maintenance of them joint established by means of the order before cited, as well as to the Suppression of joint of reference, is have had in has them provisions collected in the article 3 of the Real Decree 177 / 2014, of 21 of March.

For the fixing of the reference prices of drugs submissions integrated in the new sets of reference drugs and for the review of drug submissions previously integrated sets reference prices, have been followed the provisions laid down in article 4 of the aforementioned Royal Decree.

This order is dictates in accordance with the enabling specific planned in the article 5.1 of the Real Decree 177 / 2014, of 21 of March, and in process of audience is has given transfer to them administrations health of them communities autonomous, to them entities managing of it provision pharmaceutical of the system national of health, to them laboratories pharmaceutical interested, to them entities of distribution of drugs , as well as representative of the sectors concerned institutions, including associations of consumers and users.

By virtue, I resolve: first.

Establish new sets of reference and the reference prices of drugs submissions included therein, as well as review the reference prices of drugs submissions included in previously existing assemblies.

In the annex 1 of this order is relate them sets of reference of presentations of drugs are by offices of pharmacy through recipe medical official u order of dispensation, with indication of the price industrial of reference and PVPIVA of reference set for each presentation.

They are newly created the listed sets of C-427 to the said Annex C-465.

In annex 2 of this order relate to the sets of reference drugs of hospital presentations and presentations on clinical package, with an indication of the industry reference price fixed for each submission.

Are of new creation the joint listed of the H-99 to the H-107 and of the EC-138 to the EC-141 of the said Annex.

To facilitate compliance with the provisions of the additional provision second of Royal Decree 177/2014, 21 March, in annexes 1 and 2 identify the presentations of medicines whose reference price has been determined by the rules laid down in paragraphs 3 and 4 of article 4 of the Royal Decree.

Second.

For informational purposes, in annex 3 of this order all medications reference sets are related to indication of the price tag of each set (PRC), identifying medication whose cost/treatment/day (CTD) has determined it.

There is also information of defined daily doses (DDD) each set of reference drugs used for the calculation of the cost per treatment per day (CTD) of drug submissions integrated therein pursuant to article 4 of Royal Decree 177/2014, 21 March.

Also, is identified them sets of reference of drugs formed by the existence of a medication biosimilar and those others formed without the existence of a drug generic or biosimilar according to it established in the article 3 of the Real Decree 177 / 2014, of 21 of March.

Third party.

In application of the provisions of article 5 of Royal Decree 177/2014, on 21 March, the sets of reference drugs that no longer comply with the requirements for its establishment shall be deleted.

In annex 4 of this order relate to the sets of reference drugs suppressed, with an indication of the reason for its deletion.

Room.

In annex 5 of this order relate to presentations of medications declared as innovations dose of therapeutic interest prior to the entry into force of the Royal Decree-Law 16/2012, April 20, on urgent measures to ensure the sustainability of the national health system and improve the quality and safety of their benefits, excluded from the system of reference prices whose declaration as galenic innovation expires after the date of this order.

The said Annex 5, pursuant to paragraph 1 of the third additional provision of Royal Decree 177/2014, 21 March, indicated the period of exclusion from the system of reference prices for each drug submissions. After the period of exclusion, shall apply the provisions of paragraph 2 of this provision.

Fifth.

For the purposes of the additional provision seven of Royal Decree 177/2014, 21 March, in annex 6 of this order are related to drug submissions and their licenses for which has not formed set of reference in accordance with the provisions of article 3(2) of the Royal Decree.

6th.

For purposes of implementation of provisions of article 5.3 of the Real Decree 177/2014, of March 21, the reference price to presentations of drugs included in the pharmaceutical provision of the national health system before is set to the date of this order, but whose effectiveness of inclusion in the pharmaceutical provision, in accordance with the provisions of the sixth additional provision of the Royal Decree It had not occurred to date 13 April 2015, date of commencement of the procedure of elaboration of this order.

In annex 7 of this order drugs presentations are related to indication of the set of reference that will be integrated and the industrial price of reference for each submission.

Seventh.

This order will produce effect from the day following its publication in the "Official Gazette".

Eighth.

Contentious-administrative appeal within the period of two months from the day following its publication before the Chamber of administrative litigation in the Supreme Court, in accordance with the provisions of article 12 of law 29/1998, of 13 July, regulating the administrative courts may be brought against this order, which puts an end to the administrative procedure, or Optionally, with previous character, administrative appeal of replacement within the period of one month before the Minister of health, social services and equality, in accordance with the provisions of articles 116 and 117 of the law 30/1992, of November 26, legal regime of public administrations and common administrative procedure.

Madrid, 14 of October of 2015.-the Minister of health, services social and equality, Alfonso Alonso Aranegui.

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