The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024
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Change 1
8 Insertion of new regulation 3D
After regulation 3C (reference prices for older presentations), insert— Determination of reference prices 3D (1) The Secretary of State must determine the reference price for an older presentation in accordance with this regulation. (2) The reference price for a presentation that was an older presentation on or after 1st January 2015 and is supplied for health service use by a manufacturer or supplier who is an originator, originator licensee, vaccine originator or vaccine originator licensee or a person who is in the same group as the originator, originator licensee, vaccine originator or vaccine originator licensee in relation to that presentation, where it was first made available for health service use— (a) before the reference anchor date, is the average selling price of the presentation during the full calendar year before the presentation became an older presentation; or (b) on or after the reference anchor date, is the average selling price during the full year before the presentation became an older presentation of the most relevant comparator with the same virtual therapeutic moiety as the presentation that was first made available for health service use on or before the reference anchor date. (3) The reference price for a presentation which was an older presentation before 1st January 2015 and is supplied for health service use by a manufacturer or supplier who is an originator, originator licensee, vaccine originator or vaccine originator licensee or by a person in the same group as the originator, originator licensee, vaccine originator or vaccine originator licensee in relation to that presentation, where it was first made available for health service use— (a) before the reference anchor date, is the maximum price of the presentation on the reference anchor date reduced by 12.5%; or (b) on or after the reference anchor date, is to be determined based on the maximum price of the most relevant comparator for the same virtual therapeutic moiety as the presentation that had been made available for sale for health service use on or before the reference anchor date, reduced by 12.5%. (4) The reference price for a presentation which is an older presentation and is supplied for health service use by a manufacturer or supplier who is not an originator, originator licensee, vaccine originator or vaccine originator licensee or a person in the same group as the originator, originator licensee, vaccine originator or vaccine originator licensee in relation to that presentation, where it was first made available for sale for health service use— (a) before the reference anchor date and— (i) there is an alternate presentation with the same virtual medicinal product pack available before the reference anchor date which was supplied for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee, is the maximum price of the alternate presentation on the date the presentation was first made available for sale for health service use, reduced by 12.5%, or (ii) there is no alternate presentation with the same virtual medicinal product pack supplied for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee on or before the reference anchor date, is to be determined based on the most relevant comparator maximum price with the same virtual therapeutic moiety as the presentation on the date the presentation was first made available for sale for health service use, reduced by 12.5%; or (b) on or after the reference anchor date and— (i) there is an alternate presentation with the same virtual medicinal product pack available before the reference anchor date which was supplied for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee, is the maximum price of the alternate presentation on the reference anchor date reduced by 12.5%, or (ii) there is no alternate presentation with the same virtual medicinal product pack supplied for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee before the reference anchor date, is to be determined based on the maximum price of the most relevant comparator with the same virtual therapeutic moiety as the presentation that had been made available for sale for health service use on or before the reference anchor date, reduced by 12.5%. (5) When determining the reference price the Secretary of State may have regard, among other factors, to any one or more of the following— (a) available presentations or maximum prices for presentations supplied by the manufacturer or supplier of the applicable presentation; (b) available presentations or maximum prices for presentations supplied by a different manufacturer or supplier; (c) the active ingredients, strength, excipients, pack size, method of administration or formulation of an applicable presentation; (d) the virtual therapeutic moiety or the virtual medicinal product pack, as applicable, of an applicable presentation; (e) the similarities and differences between applicable presentations to be compared; and (f) the period an applicable presentation has been made available for health service use before or after the relevant reference anchor date. (6) Where there is no or incomplete average selling price or maximum price information available for a relevant date or period for an applicable presentation, the Secretary of State may rely on any available information the Secretary of State considers appropriate for comparison purposes, including— (a) the closest available data for calculating average selling prices for the applicable calendar year; and (b) the maximum price that is the closest in date to the 1st January of the relevant calendar year as published in the medicines information standard. (7) In this regulation— “applicable presentation” means the presentation for which a reference price is to be applied or an alternate presentation to be relied on as a comparator, as the case may be; “reference anchor date” means in relation to— an older presentation supplied by a manufacturer or supplier who is an originator, originator licensee, vaccine originator or vaccine originator licensee of that presentation, is the 1st January of the year before that presentation finally ceased to be a newer presentation in accordance with regulation 3B; or an older presentation supplied by a manufacturer or supplier who is not an originator, originator licensee, vaccine originator or vaccine originator licensee of that relevant medicine, is the 1st January of the year before the earliest supply of a presentation for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee with the same relevant virtual therapeutic moiety as the presentation which has finally ceased to be a newer presentation; and “virtual medicinal product pack” means an abstract representation of a relevant medicine as formulated in the medicines information standard which has any one or more of the characteristics of active ingredients, strength, excipients, pack size, method of administration or formulation in common with similar presentations which have been placed on the market for health service use by any manufacturer or supplier. .
8 Insertion of new regulation 3D
After regulation 3C (reference prices for older presentations), insert— Determination of reference prices 3D (1) The Secretary of State must determine the reference price for an older presentation in accordance with this regulation. (2) The reference price for a presentation that was an older presentation on or after 1st January 2015 and is supplied for health service use by a manufacturer or supplier who is an originator, originator licensee, vaccine originator or vaccine originator licensee or a person who is in the same group as the originator, originator licensee, vaccine originator or vaccine originator licensee in relation to that presentation, where it was first made available for health service use— (a) before the reference anchor date, is the average selling price of the presentation during the full calendar year before the presentation became an older presentation; or (b) on or after the reference anchor date, is the average selling price during the full year before the presentation became an older presentation of the most relevant comparator with the same virtual therapeutic moiety as the presentation that was first made available for health service use on or before the reference anchor date. (3) The reference price for a presentation which was an older presentation before 1st January 2015 and is supplied for health service use by a manufacturer or supplier who is an originator, originator licensee, vaccine originator or vaccine originator licensee or by a person in the same group as the originator, originator licensee, vaccine originator or vaccine originator licensee in relation to that presentation, where it was first made available for health service use— (a) before the reference anchor date, is the maximum price of the presentation on the reference anchor date reduced by 12.5%; or (b) on or after the reference anchor date, is to be determined based on the maximum price of the most relevant comparator for the same virtual therapeutic moiety as the presentation that had been made available for sale for health service use on or before the reference anchor date, reduced by 12.5%. (4) The reference price for a presentation which is an older presentation and is supplied for health service use by a manufacturer or supplier who is not an originator, originator licensee, vaccine originator or vaccine originator licensee or a person in the same group as the originator, originator licensee, vaccine originator or vaccine originator licensee in relation to that presentation, where it was first made available for sale for health service use— (a) before the reference anchor date and— (i) there is an alternate presentation with the same virtual medicinal product pack available before the reference anchor date which was supplied for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee, is the maximum price of the alternate presentation on the date the presentation was first made available for sale for health service use, reduced by 12.5%, or (ii) there is no alternate presentation with the same virtual medicinal product pack supplied for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee on or before the reference anchor date, is to be determined based on the most relevant comparator maximum price with the same virtual therapeutic moiety as the presentation on the date the presentation was first made available for sale for health service use, reduced by 12.5%; or (b) on or after the reference anchor date and— (i) there is an alternate presentation with the same virtual medicinal product pack available before the reference anchor date which was supplied for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee, is the maximum price of the alternate presentation on the reference anchor date reduced by 12.5%, or (ii) there is no alternate presentation with the same virtual medicinal product pack supplied for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee before the reference anchor date, is to be determined based on the maximum price of the most relevant comparator with the same virtual therapeutic moiety as the presentation that had been made available for sale for health service use on or before the reference anchor date, reduced by 12.5%. (5) When determining the reference price the Secretary of State may have regard, among other factors, to any one or more of the following— (a) available presentations or maximum prices for presentations supplied by the manufacturer or supplier of the applicable presentation; (b) available presentations or maximum prices for presentations supplied by a different manufacturer or supplier; (c) the active ingredients, strength, excipients, pack size, method of administration or formulation of an applicable presentation; (d) the virtual therapeutic moiety or the virtual medicinal product pack, as applicable, of an applicable presentation; (e) the similarities and differences between applicable presentations to be compared; and (f) the period an applicable presentation has been made available for health service use before or after the relevant reference anchor date. (6) Where there is no or incomplete average selling price or maximum price information available for a relevant date or period for an applicable presentation, the Secretary of State may rely on any available information the Secretary of State considers appropriate for comparison purposes, including— (a) the closest available data for calculating average selling prices for the applicable calendar year; and (b) the maximum price that is the closest in date to the 1st January of the relevant calendar year as published in the medicines information standard. (7) In this regulation— “applicable presentation” means the presentation for which a reference price is to be applied or an alternate presentation to be relied on as a comparator, as the case may be; “reference anchor date” means in relation to— an older presentation supplied by a manufacturer or supplier who is an originator, originator licensee, vaccine originator or vaccine originator licensee of that presentation, is the 1st January of the year before that presentation finally ceased to be a newer presentation in accordance with regulation 3B; or an older presentation supplied by a manufacturer or supplier who is not an originator, originator licensee, vaccine originator or vaccine originator licensee of that relevant medicine, is the 1st January of the year before the earliest supply of a presentation for health service use by an originator, originator licensee, vaccine originator or vaccine originator licensee with the same relevant virtual therapeutic moiety as the presentation which has finally ceased to be a newer presentation; and “virtual medicinal product pack” means an abstract representation of a relevant medicine as formulated in the medicines information standard which has any one or more of the characteristics of active ingredients, strength, excipients, pack size, method of administration or formulation in common with similar presentations which have been placed on the market for health service use by any manufacturer or supplier. .
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