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1、MARKET REVIEW EUROPEAN GENERIC MEDICINE MARKETSPOLICY OVERVIEW2023 2023 Market Review|European Generic Medicines Market Policy Overview|Authors:Maja Graf,Associate Director Policy&Market Access-Alejandro Pacheco,Market Access Officer.Credit photos:Fotolia|Graphic Design:Jos Antonio Garca Snchez|Issu

2、ed in June 2023 Belgium|Medicines for Europe Generic Medicines Group|Rue dArlon 50 B-1000 Brussels BelgiumThe 2023 Market Review European Generic Medicine Markets Policy Overview is the property of the Generic Medicines Group,a sector group of Medicines for Europe.The 2023 Market Review European Gen

3、eric Medicine Markets Policy Overview is intended as a reference tool only.All information obtained by the Generic Medicines Group from various sources is as current and accurate as possible.However,due to human or mechanical errors and to constant changes in the rules and regulations in the studied

4、 markets,the Generic Medicines Group cannot guarantee the accuracy,adequacy,or completeness of any information,andcannot be held responsible for any errors or omissions,or damages arising from the use thereof.Country National Association/Member Company Contact PersonACKNOWLEDGEMENTS 2Austria OeGV Wo

5、lfgang AndielBelgium Medaxes Wim VermaetBulgaria Bulgarian generic pharmaceutical association Evgeni TassovskiCroatia Croatian Employers Association Pharmaceutical Industry Association Milka KosanovicRepublic of Cyprus Sandoz Elena ArmelidouCzech Republic CAFF Jana BenovDenmark IGL Peter JrgensenEst

6、onia Sandoz Roland LepikFinland Finnish generic pharmaceutical association Heikki BothasFrance GEMME Sebastien Trinquard Germany Pro Generika Gloria von SchorlemerGreece Panhellenic Union of Pharmaceutical Industry Marc OllandezosHungary MAGYOSZ/Generikus Egyesulet Zsuzsanna Illes/Dora OrosIreland M

7、edicines for Ireland David DelaneyItaly Egualia Camilla FaletraLatvia Sandoz Dagnija PoreitereLithuania VGA Rasa BrikienMalta Sandoz Elena ArmelidouNetherlands Bogin Jean HermansPoland M4PL Krzysztof KopecPortugal APOGEN Ana ValenteRomania APMGR Valentina BAICUIANUSlovakia GENAS Michaela PalagyiSlov

8、enia LEK d.d Uros ZivecSpain AESEG Angel Luis RodriguezSwitzerland Viatris Claude EggerSweden FGL Kenneth NyblomUnited Kingdom BGMA Robert Russell PavierThe Generic Medicines Group Market Access Committee is pleased to present the 2023 Market Review European Generic Medicine Markets Policy overview.

9、The purpose of this Market Review is to provide a general overview of the policies that are currently in place for Generic Medicines in the different European countries allowing the reader to get a clear overview on how generic medicines policies are set in the reviewed countries.The 2023 Market Rev

10、iew covers the following policies:Pricing&Reimbursement systems,Control of excess spending,Generic medicines substitution and Procurement of medicines.The European countries covered in this edition of the Market Review are:Austria,Belgium,Bulgaria,Croatia,Cyprus,Czech Republic,Denmark,Estonia,Finlan

11、d,France,Germany,Greece,Hungary,Ireland,Italy,Latvia,Lithuania,Malta,Netherlands,Poland,Portugal,Romania,Slovakia,Slovenia,Spain,Switzerland,Sweden and United Kingdom.INTRODUCTIONAdrian van den HovenMedicines for Europe Director General3PRICING&REIMBURSEMENT SYSTEMS.5CONTROL OF EXCESS SPENDING.14GEN

12、ERIC MEDICINES SUBSTITUTION POLICIES.20PROCUREMENT OF MEDICINES.22 a)Hospital tendering.22b)Retail tendering.27TABLE OF CONTENTS4In the EU,medicinal products can only be placed on the market after they have been authorised by the European Commission or the competent national authorities.Marketing au

13、thorisations are granted in accordance with common EU rules intended to ensure the quality,safety,and efficacy of medicines.Member States are responsible for controlling the prices and reimbursement of medicines in view of promoting the health of their citizens and the financial sustainability of th

14、eir social security systems.Therefore,pricing and reimbursement rules in Europe fall under the responsibility of the Member States.The pharmaceutical market in each Member State is highly regulated.The most common types of policies to set the prices of generic medicines are:External reference pricin

15、g:An approach where the price of a medicine is set according to the benchmark prices for the same or similar type of medicine in comparable countries previously defined in the policy.Usually,policymakers adjust prices over time depending on the changes 1available in the countries used as reference a

16、nd use different formulas to calculate this price.Set%below originator price:Type of policy where the price of a medicine should be below a previously determined specific percentage,having as a starting point the price of the originator medicine.(e.g.,Companies should set the price 30%below the pric

17、e of the originator medicine).Reference groups:When applied,prices are set according to the prices of a previously determined group of medicines(e.g.,average price of medicines with the same type of active substance-ATC-5).Maximum price:Policy where generic medicines cannot be higher than a predefin

18、ed maximum price.Negotiation:When this policy is applied,the price of a generic medicine is negotiated between the company and the payers.Current pricing policies,aimed at constantly lowering medicine prices,result in market concentration,and consequently medicines shortages and health inequalities.

19、External reference pricing is not a proper tool to ensure competitive pricing in the off patent market Highly resilient and future-proof strategies should be promoted to counteract rising inflation and address market challengesRESOURCES:Medicines for Europe paper new pricing modelsMedicines for Euro

20、pe position on ERP PRICING&REIMBURSEMENT SYSTEMS(1)Guidelines Review Committee.(2020,September 28).WHO guideline on country pharmaceutical pricing policies.https:/who.int/publications/i/item/97892400118785Regulated pricing(1)Generic reimbursement pricing is governed by the General Social Security Ac

21、t(ASVG).(2)In general,all reimbursed medicines are regulated.There can be exceptions-list of ATC group stated in MoH decree.These ATC groups are deregulated-meaning that the product has to declare a maximum price(increase one time per quarter,decrease every month).General rules for listing ATC group

22、 as deregulated:-at least 4 brands in ATC group and specific route of administration-public interest”(3)Reimbursed prescription drug prices are nationally regulated to ensure optimal pricing.The prices of over-the-counter and non-discounted medicines are not regulated,their pricing is free(4)The pri

23、cing is dependent on the originatorsFree pricingAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUKComments2314PRICING&REIMBURSEMENT SYSTEMS61.What kind o

24、f pricing system is in place for generic medicines(reimbursed)?ItalyLatviaExternal reference pricingSet%below originator priceMaximum priceNegotiationOther(1)1st generic medicine:-50%of the reference drug.2nd generic medicine:-18%of 1st generic medicine 3rd and subsequent generic medicine:-15%of pre

25、vious generic medicine.Reference drug must reduce its price by-30%after three months from the introduction of the 1st generic medicine.After introduction of 3rd generic medicine,all medicines(original and all already reimbursed generic medicines)must reduce to 3rd generic medicine price.Regulation a

26、s of 1/1/2024:-48%/-15%/-10%.Ox-30%after 3 months and analog further reduction to 3rd Gx price.Further regulation:Price band:max.price difference of drugs with the same active ingredient:+20%above the respective cheapest.Price basis:price of the key strength(the most frequently prescribed dose stren

27、gth).Excluding products below prescription fee.As of 1.1.2024:Level pricing at the lowest price can be enforced by the authorities by procedure.(2)Set%below originator price depending on the type of reimbursement category and turnover of originator(3)Generic product entry into reimbursement requires

28、 30%lowering of price vs originator.Next entry-10%(4)50%for most,40%for products with a device(5)Rebate Contract,Price Freeze,Internal Reference Price,Dispension of 4 cheapest products in pharmacy(6)Following the percentage of the generic already on the market(40%-20%-10%-5%-5%-5%)(7)Balduzzi Decree

29、 voluntary and automatic method to determine the price of a new generic(8)Tendering system by health insurers and hospitals(9)For the first generic entering the reimbursement list,price level must be minimum 25%lower vs originator,however in practice price entry level is lower and depends on the spe

30、cific case(10)The reimbursed price will have to be approved by TLV(pricing agency).When Generics enter the market,they can have the same price as the originator or lower.If price competition starts(price drops of more than 70%by competition)the originator must lower their price by approximately 65%6

31、 months after patent expiry(if they want to stay reimbursed-if they skip reimbursement,that price(-65%)will be the maximum price for generics(and originators).If the product is not reimbursed,there is free pricingAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNeth

32、erlandsPolandPortugalRomaniaSlovakiaSpain MaltaPercentage below originator priceCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUKComments50%30%20%40%30%50%35%40%60%20%30%30%25%50%35%49%68%40%12345678210PRICING&REIMBURSEMENT SYSTEMS760%Country2.Which criteria is used to set theprices?9ItalyLat

33、viaESTONIALATVIALITHUANIAPOLANDSLOVAKIACZECH R.SLOVENIAIRELANDNETHERLANDSCROATIAPORTUGALGREECECYPRUSBULGARIAROMANIAPRICING&REIMBURSEMENT SYSTEMSCOUNTRIES USING ERP8CountryCroatiaCyprusCzech Republic1EstoniaGreeceIrelandLatvia2LithuaniaNetherlands3PolandPortugalRomaniaSlovakiaSloveniaPRICING&REIMBURS

34、EMENT SYSTEMSBulgariaHow to read:The rows represent the countries that use ERP and the columns represent the countries used as reference(countries included on the basket for ERP)(1)European Union member states,especially Latvia,Lithuania and Slovakia.(2)Countries in EURIPID database(3)Also including

35、 Lichtenstein and Iceland9AustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandItalyNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCroatiaCyprusEstoniaLatviaLithuaniaSloveniaSwitzerlandSwedenUKNorway3.Countries using external referencepricing as criteria to set the

36、pricesLuxembourg 9Comments(1)ERP is used for all price settings(originator and generics)and for reimbursement.(2)And benchmarking with other countries(3)In the Netherlands it is necessary to pay a so called distribution fee to the wholesaler.That is part of the reference price,hence the Dutch net pr

37、ices are much lower than stated in the pricelist(4)Average of the 3 lowest prices(5)Average of the two lowest different prices from the Eurozone countries(6)Not higher as second lowest.Not higher as in other Baltic countries(Latvia,Lithuania)(7)Average of 5 lowest prices of INN from EURPID(8)Lowest

38、price is the price in the pricelist and the product does not have to be on the market(9)The average of the three(3)lowest EU pricesAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCountryCroatiaCyprusEstoniaLithuani

39、aSloveniaSwitzerlandSwedenUKPrice for originators(ERP is indirectly applied to generics as it is used to determine the price of originators,whichultimately influences the price of generics)Price for generics(ERP is directly appliedto generics)Benchmarking with other countriesCommentsLowest price in

40、reference countriesAverage price of reference countriesOther1345678PRICING&REIMBURSEMENT SYSTEMS105.What formula is used when applying external reference pricing?4.What is determined using external reference pricing?ItalyLatviaAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHung

41、aryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)There should be one application for P&R.Generic has 2 possibilities for setting price and reimbursement:1.external referencing(general process)-longer process 2.process of s

42、imilar product-faster process-new product asks for price and reimbursement of an already reimbursed product(with same active substance)(2)The reimbursement of generics is fast,however,the Dutch Z-index system causes delays and is open for changes once a month,therefore,sometimes it can take max 6 we

43、eks before a product is visible on the market(3)Basic requirements for P&R:Marketing AuthorisationPublication in the List of Goods”(4)To increase attractiveness of market and competition,authorities have set a simplified MAH process to attract parallel trade import into the country.Ordinary MAH is 2

44、10 days,while simplified MAH is only 30 days.Prerequisite for submission of a simplified MAH process is to already be registered as ordinary MAH in Estonia.(5)With marketing authorisation and national price listing,the product is automatically reimbursed(6)No reimbursement system in MaltaSingle proc

45、essSeparate process(One process for pricing and a separate process for reimbursement)CommentsDaysCommentsYesCommentsNo11359012012090603034141504530904530110030901209030503023456PRICING&REIMBURSEMENT SYSTEMS94116.Is the application for pricing&reimbursement of a generic medicine a:7.On average,how lo

46、ng(in days)?does it take for a generic medicine to receive its P&R approval from the day of application?8.Is a marketing authorization necessary to apply for reimbursementof generic medicines?ItalyLatviaAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPol

47、andPortugalRomaniaSlovakiaSpain MaltaCountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)It is INN based reference pricing for generic medicine(2)Reference groups are based on therapeutical interchangeability medicines and similar clinical effect.There is a MoH decree on reference grou

48、ps(several ATC7 in one reference group).(3)Groups are established by similar pack sizes(4)ATC-4 with the application EDQM criteria(form,dosage,release,strength and indication)Generics of all high-cost medicines(Law 3816)are grouped in ATC-5 category.(5)Some jumbo groups exist based on ATC-4(6)ATC5:A

49、ctive substance,pack size,then dosing and formulation(Berekening maximumprijzen|Prijsvorming|Farmatec).YesNoCommentsBy active substance(ATC-5)By pharmacological class(ATC-4)OtherBy therapeutic class(ATC-3)Comments123456PRICING&REIMBURSEMENT SYSTEMS11 Market Review European Generic Medicine Markets 2

50、023129.Is there a reference pricing reimbursement system(like jumbo groups)for generic medicinesin your country?10.How is the reference group established?ItalyLatviaAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaC

51、ountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)Price of the originator(2)5%volume market share in the therapeutic group for the respective time period(3)The reference price is determined by adding EUR 0.50 to the retail price of the cheapest product of each reference group.Several

52、products can be reimbursed simultaneously.(4)Depending on the reference price level,criteria are lowest priced medicines in accordance with sold volume(5)Average of the two lowest different prices in the Eurozone(6)Jumbo groups:average price of medicinesThere are other requirements:reference product

53、 should have a minimum percentage of the market share”(7)Based on the average of the 5 lowest priced medicines of the same group of active substances(8)Basket of all EU countries,the average of the three(3)lowest EU prices(9)The Positive List is named Erstattungskodex(Reimbursement Code).It contains

54、 all secured suppliable drugs that may be dispensed to patients on account of healthcare providers.There is also a negative list,which is a list of criteria for drugs that are generally not reimbursable(e.g.products that are mainly used in hospitals,or products that are not used for the sick,such as

55、 contraceptives,vitamin preparations,etc.).(10)Positive list:Defined non-RX medicines can be part of reimbursement;Negative lists:1.So-called lifestyle medicines are not part of reimbursement;2.List of medicines with are subject of limited prescription scope(11)The minister decides which medicines a

56、re reimbursed.This work is done by the Zorg instituut(12)All drugs that are reimbursed are on www.spezialitaetenliste.chAverage price of generic medicinesLowest priced medicineLowest priced generic medicinePositive listNegative ListCommentsNo listAverage price of medicinesExternal reference pricingO

57、therComments1234567891112PRICING&REIMBURSEMENT SYSTEMS1311.On what basis is the referenceprice established?12.Are there positive and/or negativelists for generic medicines in your country?10ItalyLatviaCONTROL OF EXCESS SPENDINGPolicymakers apply different policies to control pharmaceutical budgets a

58、nd the economic burden of healthcare.Mechanisms that can be used to control spending are different types of patient participation in the form of out-of-pocket payments.Other cost containment measures are aimed directly at the manufacturers of medicines and seek to decrease the level of spending on p

59、harmaceutical products.Common policies are mandatory discounts and/or rebates,or clawback/payback schemes.Clawback/payback definition:Payback/clawback policies require manufacturers to pay back a share of their revenue if a pre-specified budget ceiling for public pharmaceutical expenditure is exceed

60、ed.Discounts,clawback and payback policies can easily be overused and severely impact the economic viability and sustainability of supply.RESOURCES:BGMA VPAS position14AustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain Mal

61、taCountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)There is no obligatory co-payment for any medicines(generic included).Co-payment is subject to the market behavior of MAHs and levels of reimbursement.(2)Every Rx medicine(applied for both-Gx and Originators)has co-payment of 2.5eur

62、 as prescription cost,this does not depend on reimbursement level(3)Patients must pay a prescription fee per dispensed pack.For 2023,the amount is EUR 6,85(3b)The patient always pays the part of the price of the drug that exceeds the limit of reference price.Depending on the reimbursement level,an o

63、ut-of-pocket cost applies-reimbursement for the different types of medicines can be 25%,50%,75%and 100%and the co-payment is 75%,50%,25%and 0%respectively.(4)Gradual reimbursement.The maximum yearly expense is EUR 600(5)The patient always pays the part of the price of the drug that exceeds the limit

64、 of reference price.A 2.5 fixed prescription fee also applies.Then according to the severity of the disease,partial reimbursement can be applied and depending on that,an out-of-pocket cost applies-eg.50%,75%or 100%reimbursement with co payment of 50%,25%and 0%accordingly(6)There are three categories

65、:Basic rate of reimbursement 40%Lower special rate of reimbursement 65%Higher special rate of reimbursement 100%.A co-payment of EUR 4.50 per medicine and per purchase is charged.In 2023 the annual maximum is set at EUR 592.16 after which co-payment is EUR 2.50 for each reimbursable medicine”(6b)10%

66、extra payment for every prescribed product(min.EUR 5,max.EUR 10)(6c)First 85 euro is paid by a family per month.Private payment out of pocket.No medical card in both cases.If a patient has a medical card,they receive their medicines free(7)Regions(21)are allowed to require the payment of a“ticket”on

67、 the medical prescription or pack.70%of the regions has a co-payment ticket.(8)Difference between base price and reimbursement price(9)Capped on EUR 250(9b)There are 4 levels of co-payment:1)free of charge,2)lump sum,3)30%,4)50%-co-payment level is defined for each product on reimbursement list,calc

68、ulated basing on price limit(10)For products where fixed co-payment is not defined by rules,then ratio between reimbursement and co-payment should be kept(11)The patient pays 100%of the cost up to a certain level,then 50%,25%,10%and finally gets all the medicines totally free(if the product is withi

69、n the reimbursement system).After a 12 month period this system starts all over again.NoCommentsFixed amount per prescription/pack(Co-payment)%Of cost of medicines is partially reimbursed(Co-insurance)Difference above reference pricePatient annual/monthly consumption(DDD)Insurance takes effect when

70、a certainthreshold has been reached(deductible)OtherComments1234567891011CONTROL OF EXCESS SPENDING1513.Is there any type of out-of-pocket(OOP)payment for generic medicines?Yes14.What type of cost sharing or outof-pocket payment by patients is used?3b6b6c9bItalyLatviaAustriaBelgiumBulgariaCzech Repu

71、blicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)The cheapest generic has zero co-payment.The difference in Euro for all other generics and Originator with Higher w/s prices,are pai

72、d by the patient as co-payment(2)In addition,the difference between the Reference Price and the public price of the product sold by the pharmacist has to be paid,all over the country,by the patient if he doesnt accept the substitution with generic(3)In the pharmacy list,there is co-payment for all m

73、edicines,in drug programs(hospital)there is no co-payment(4)MEA contracts are used by originators,contract between MoH SR and MAH concerning special price discounts.Conditional reimbursement(valid untill the end of July 2022)(5)Above 10 Euros there is a rebate of 35%,from 10-5 euros a rebate of 30%,

74、from 5-3 Euros 22%and below 3 euros 12%(6)Clawback is capped and differentiated(25%innovative.20%imported generics,15%locally produced).It is applied on the quantities sold in the reimbursement system(7)There are no such regulations for generic medicines.Only for certain patent-protected originals.(

75、8)Only for some generic medicines,not for all.Usually for those that enter some financial agreements where originator already had an agreement in place before generics entered(9)In general,there is no obligatory payback.In individual cases(especially for highly innovative products under patent prote

76、ction)there could be agreement between MAH and health insurance companies for payback-these agreements can be part of budget impact analyses(in case budget impact or CUA unacceptable before agreement).But it is up to MAH and health insurance companies as to what is real form and amount of payback in

77、 these agreements.(10)Clawback is based on the contract with the government and usually related to originators and bio products.(11)There are several clawbacks:1:20-28%of the reimbursement must be paid by the MAH.2:10%of the reimbursement where there is no competitor.3:rep fee.4:price-reimbursement

78、agreement.5:clawback for excess spending(all excess spending is paid by the MAHs based on their market share in reimbursement)(12)Applied for originators only(13)There are pre-access negotiations with the government for products above 20 MIO per year or if for 50.000 per patient then 10 mio per year

79、,but that is for new specialty products(14)Extraordinary Contribution for the Pharmaceutical Industry:14.3%in hospital and 2.5%in the retail market.This applies to all generic sales and it is not linked to an excess spending of the pharmaceutical budget”(15)National legislation defines clawbacks,but

80、 it is not implemented in practice(16)For medicines marketed with a brand name,which includes branded generics and branded for commercial.It does not apply to unbranded generics.NoCommentsMandatory discounts/rebates Percentage applied for mandatory discounts/rebatesOtherClawback/payback None of the

81、aboveComments12335%35%456789101112131415CONTROL OF EXCESS SPENDING1615.Do the out-of-pocket payment schemes for generic medicines differ from the reference originator medicines?Yes16.Which of the following measures are applied in your country in the case of excess spending in the pharmaceutical budg

82、et?16ItalyLatviaAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)Spending in the respective therapeutic area(2)It is applied to all products except t

83、he innovator products(3)Yearly sales are determined in contract with government.Its not a specific percentage(4)The total budget is divided into two channels i.e.Hospitals and Outpatient.In 2022,the outpatient budget was split further into 2 sub-budgets:(a)Retail(reimbursed products provided through

84、 the private pharmacies)and(b)High cost medicines mainly provided through EOPYY(the main SSF)owned pharmacies”(5)According to specific contract descriptions.Yearly overspend of specific INN and/or diagnosis(5.1)The clawback is capped and differentiated:-25%innovative,-20%imported generics,-15%locall

85、y produced(6)Base for payback is sum of sale of the product for 12 months before observing period.MoH SR takes a budget on each product reimbursed over 1,5 mio EUR.All sales over budget are considered as paybacks to HCIs(7)Clawback only applied to originators(7.1)If the actual branded medicines expe

86、nditure goes above the allowed amount,sellers of branded generics pay a percentage of their national health system revenues so the industry pays for any overspend.(8)Either as a fixed%of the healthcare expenditure or as the difference between the planned budget and expenditure for the respective tim

87、e period(9)The calculation is based on market share and growth(70%and 30%respectively)(10)It is different for every product(11)There is no fixed percentage of the clawback/payback applied.It depends on the excess budget locked each year.(12)The clawback percentage is not fixed as it depends on the e

88、xcess over the budget limit.e.g.for 2021,the clawback was 27%on average over the ex-f price for the EOPYY outpatient channel.This,combined with the compulsory rebate(ranging from 14-30%;average 2021:17%)results in a total burden(rebate&clawback)of 44%on average.Please note that in 2022 an extra reba

89、te of 5%was introduced for the products included in positive list clusters with annual sales(of the total cluster)20 mn EUR(12b)Payback applies in case the budget for reimbursement is exceeded.The calculation is based on product market share and growth(13)26.5%in the voluntary branded scheme,27.5%in

90、 the shadow statutory schemeSegmented pharmaceutical target budget(e.g.,hospital vs retail or innovator vs off-patent)Pharmaceutical expenditure growth rateOtherBased on market shareBased on revenueOtherBased on growthCommentsPercentageComments123456781011124%100%5-20%1%Notfixed1%100%1%50%20%1%CONTR

91、OL OF EXCESS SPENDING960%17Global pharmaceutical target budget18.How is the clawback/payback calculated?19.What is the percentage of the clawback/payback applied to the base selected above?17.How is the target spending determined when clawback/payback is applied?5.1Notdefined7.11326.%and27.5%12bItal

92、yLatviaESTONIALATVIAPOLANDSLOVAKIAGREECECYPRUSBULGARIAROMANIASLOVENIACROATIAUNITED KINGDOMBELGIUMHUNGARYITALYFRANCECOUNTRIES USING CLAWBACKCONTROL OF EXCESS SPENDING18AustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain Malt

93、aCountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)The clawback%varies from year to year(2)Generics are not under clawback as the cost containment is covered by INNs quarterly price referencing system.Generics might be subject to clawback for rare diseases and biosimilars(3)The only

94、difference is that generics and off-patent medicines dont contribute to overspending of innovative products(4)No clawback on generics(5)Clawback is 15%for locally produced medicinesNoCommentsYesPercentage1234100%4%1%1%100%100%10%50%100%50%15%Notdefined1%CONTROL OF EXCESS SPENDING60%1920.Is there a d

95、ifferentiated clawback/payback for generic medicines compared to the originator?21.What percentage of the budget overrun is paid back by the pharmaceutical industry?CommentsIt isnotconstant25%5ItalyLatviaGENERIC MEDICINES SUBSTITUTION POLICIESGeneric medicine substitution policies aim to provide phy

96、sicians and pharmacists with incentives to prescribe(in the case of physicians)and dispense(in the case of pharmacists)generic medicines which will ultimately provide patients access to medicines and at the same time use economic resources wisely.20AustriaBelgiumBulgariaCzech RepublicDenmarkFinlandF

97、ranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCountryCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)The only situation when pharmacists can substitute the prescribed product is if it is out of stock on the market and then the pharmacist can dispense a

98、ny product with the same or lower price.Otherwise substitution is not allowed(2)Its mandatory(3)There is INN prescription with substitution in pharmacies.(4)There is even an incentive at pharmacy level(interesting for pharmacist to switch short term to generics),however margins are lower for low cos

99、t treatments,therefore not interesting for long term Patients to switch them(5)There is an obligation to substitute with the economically most advantageous medicine(6)If there are more medicines in the same ATC-7 group,then the pharmacist has to offer the medicine with the lowest co-payment.(7)By la

100、w(8)According to the framework,pharmacists should offer patients the cheapest medicine,or the ones within the reference price limit(9)There is an obligation to substitute with the most economically advantageous medicine(10)INN prescription for reimbursed medicines(11)There is a guideline for pharmac

101、ists on how to substitute because some therapies should not be substituted.(12)Allowed and mandatory(13)Patients who refuse substitution will have to pay the difference to the reference price(14)Physicians are obliged to prescribe INN for nave patients(15)Dutch MEB:Responsible switching guideline(or

102、ange and red products).List is included as pdf(16)Pharmacists may substitute(17)Physicians do this often for therapies where they do not want to have a switch due to medical reasons such as special indications like CNS(18)If the prescriber refuses,the patient will be fully reimbursed.If the patient

103、refuses to substitute,the patient will not be reimbursed at all(needs to pay the full price)(19)Physicians can prevent it by selecting a specific brand which the pharmacist has to dispense.NoCommentsYesNoCommentsYesPhysicians need to explicitly give permissionPhysicians can prevent itPharmacists are

104、 obliged to substitutePharmacists are obliged to inform the patientPatients can refuseOtherComments123456789101112131415161718GENERIC MEDICINES SUBSTITUTION POLICIES2122.Is generic medicines substitutionlegally allowed?23.Are there recommendations to substitute generic medicines?24.Which statement d

105、escribes pharma-ceutical substitution in your country?1913ItalyLatviaPROCUREMENT OF MEDICINESHospital tenderingTender procedures are widely used in the hospital setting in most European countries.The organisation of tenders varies and can have a national(centralised),regional or individual hospital(

106、facility-based)scope.The procurer can be a national or regional authority or health insurance fund or an individual hospital procurer(on behalf of an individual or a group of hospitals).The shows that procurers are focused primarily on cost-minimisation,through price-only,European Commissions study

107、single-winner tenders.This encourages bidders to offer the lowest-price possible and provides no reward for security of supply measures or environmentally sound manufacturing.This leads to overreliance on a single manufacturer to supply the market and increases the risk of serious shortages.This ris

108、k is compounded by mounting inflation across Europe and the increase in global production costs leading to consolidation at all levels of the pharmaceutical supply chain.RESOURCES:Medicines for Europe Position paper on best procurement practices 22AustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFr

109、anceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)They tender in groups and when a company bids the lowest price it is not possible to know which products have been bought by the hospitals,but if products are

110、not in stock then there is a fine(2)Tenders for national level are carried out by EKAPY,a body under the supervision of the Ministry of Health(3)Clusters of regions tendering togetherNationalRegionalHospital(individual or group)National governmentRegional governmentHealth insurance fundsIndividual h

111、ospitalsOtherCommentsYesnoGroup of hospitalsCommentsOther213PROCUREMENT OF MEDICINESHospital tendering23Country25.Is there a tendering system in place for generic medicines in the hospital market?26.What is the scope of the tenders?27.Which body is in charge of the tendering system?ItalyLatviaAustri

112、aBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)No hospital in the Czech Republic is able to tender all medicines.The average of pharmaceuticals bought in tender

113、s is between 50-75%,cheap medicines and medicines for the public part of the hospital pharmacy are often bought directly without tender.(1b)Formal hospital tenders are for high cost products,and generally when the budget impact is greater then 350k per year in the hospital(1c)The Agreement is by Tra

114、de name.(2)Inpatient care-MoH and the antimonopoly body prefer to tender by active substance and this process is being increasingly used(but some hospitals prefer to tender by specific brand,especially in biological treatments).Outpatient care(public part of hospital pharmacy)-mainly tender by speci

115、fic brands.(3)By brand name(4)By therapeutic indications in selected cases only(5)Each group makes its own rules(6)Only exceptionally(7)It is allowed but seldom used(8)The three lowest bidders are awarded with percentages of 50%,30%and 20%respectively of the tender volume(9)At hospital level(individ

116、ual or group)its not allowed more than one winner.By active substanceBy therapeutic indicationsOtherMonthsCommentsAll pharmaceuticalsOff-patent pharmaceuticalsOtherCommentsCommentsYesNoComments1248121212-24361212241224121236122412or 24121212122412345678PROCUREMENT OF MEDICINESHospital tendering1224C

117、ountry28.To whom are the tenders applied?31.Does a single tender contract allow for more than one winner?30.What is the average contractduration of the tender?(in months)29.How are tendering contracts awarded?9241C1b24ItalyLatviaAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHu

118、ngaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)Its set as a desired volume,but not limited to this number only and hospitals have the right to exceed this volume(2)It is tendered on volume but in practice the manufacturer can

119、not rely on this(2b)Estimated minimum and maximum quantities are provided in the tender agreement,but are not binding(3)Minimum usually not defined but fines might be enforced for stock outs.Sometimes maximum volume is defined.(3.1)Volumes provided but not guaranteed(4)It depends on contract conditi

120、ons(5)For this,so called mini tenders can be announced,to check if prices are lower or new competitors enter(6)Companies cannot change with the increase of inflation,if a product is out of stock there is a fine(7)Only due to reference pricing change(8)If a company lowers the pharmacy price,the tende

121、r price must follow down but not up(9)Contract parties can agree that specific price is subject to trade secret and will not be publically available.(10)Only applies to General Insurance Company(VSZP)YesNoCommentsMinimum volumeMaximum volumeNoneCommentsYesNoComments12345678910PROCUREMENT OF MEDICINE

122、SHospital tendering25Country33.After granting the tender,are prices subject to change before the next tender?34.Is the winning price from the tender transparent to other competitors?32.Is there an agreed minimum or maximum volume as a result of winning the tender?3.12bItalyLatviaAustriaBelgiumBulgar

123、iaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)It can be price-only as well(2)Only in one case.There was one tender with ecological and regional factors(3)The primary criteri

124、a to win a tender is based on the lowest price.However,there are prerequisites to participate in the tender bidding such as quality criteria regarding the supplier,i.e.proven record of supply and ISO certification and active MA in the country(3b)Product packaging,SmPC exact comparison or better than

125、 the originator is required,extended stability data for products compounded.distribution process in country and track record(4)Tender specifications(4b)Other criteria than price are rare,and low influence on final scoring(5)Introduction of social value weighting and KPIs on supply performanceYesNoCo

126、mments1234PROCUREMENT OF MEDICINESHospital tendering26Country35.Are factors other than the lowest price considered when determining the winner of the tender?53b4bItalyLatviaAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandItalyNetherlandsPolandPortugalRomaniaSlovaki

127、aSpain MaltaCroatiaCyprusEstoniaLatviaLithuaniaSloveniaSwitzerlandSwedenUK(1)There are specific situations in the retail market-several pharmacy chains have a majority in the market share and hundreds of independent pharmacies.Pharmacy chains provide their own tenders according to their own policies

128、(its not public procurement).(2)Special binding system(3)Based on the owner of the pharmacy(pharmacy chains)(4)Number of people insured by the specific sick funds(5)Health insurers(6)Based on the owner of pharmacy(pharmacy chains)(7)Tenders methods differs for each health insurerNational RegionalHos

129、pital(individual or group)NoCommentsOtherCommentsNational governmentRegional governmentHealth insurance fundsGroup of hospitalsIndividual hospitalsOtherComments1234567PROCUREMENT OF MEDICINESRetail tenderingIn some European countries,namely the Czech Republic,Germany and the Netherlands,tendering is

130、 also applied in the retail market.27Country36.Is there a tendering system in place for generic medicines in the retail market?Yes37.What is the geographical scope of the retail tenders?38.Which body is in charge of the retail tendering system?AustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFrance

131、GermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCroatiaCyprusEstoniaLithuaniaSloveniaSwitzerlandSwedenUK(1)It depends on the pharmacy chain-mainly by active substance or specific brand.MonthsGroup of active substancesBy therapeutic indicationsYesNoOtherCommentsMinimum v

132、olumeMaximum volumeNoneYesNo24241PROCUREMENT OF MEDICINESRetail tendering28Country39.How are retail tendering contracts awarded?By active substance40.What is the average contract duration of the tender?(in months)41.Does a single contract tender allow more than one winner?42.Is there an agreed minim

133、um or maximum volume as a result of winning the tender?43.After granting the tender,are prices subject to change before the next tender?ItalyLatviaAustriaBelgiumBulgariaCzech RepublicDenmarkFinlandFranceGermanyGreeceHungaryIrelandNetherlandsPolandPortugalRomaniaSlovakiaSpain MaltaCroatiaCyprusEstoni

134、aLithuaniaSloveniaSwitzerlandSwedenUKNoYesNoPROCUREMENT OF MEDICINESRetail tendering29Country44.Is the winning price from thetender transparent to othercompetitors?Yes45.Are factors other than the lowestprice considered when determining the winner of the tender?ItalyLatviaMedicines for EuropeRue dArlon 50-1000 Brussels-BelgiumT:+32(0)2 736 84 11-F:+32(0)2 736 74 medicinesforEU