Table A1.
Country | Key supply and demand-side reforms |
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AT – Austria | Generic pricing (mixed approach) Initially first generic 48% below originator, with originator mandated to lower its price by 30% for continued reimbursement; second generic 15% below the first to be reimbursed; third generic 10% lower than the second (overall 60% below pre-patent loss prices) Market forces after that with physicians incentivized to prescribe cheapest branded generics Demand-side measures Education – includes guidance and benchmarking Economics – includes financial incentives for physicians to enhance efficient prescribing including the cheapest generic in the class Enforcement – Prescribing restrictions for both atorvastatin and rosuvastatin (prior approval scheme via the Chief Medical Officer of the patient's social health insurance fund) |
DE – Germany | Generic pricing Market forces for generics along with reference pricing in the class (PPIs and statins) Demand-side measures (variation among the States) Educational initiatives – include prescribing guidance, quality circles and web based training programs Economics – includes budgets, financial incentives linked with prescribing targets and patient co-payments for a more expensive molecule than the referenced priced product (molecule or class) Engineering – includes Disease Management programs, price: volume agreements, rebate contracts between pharmaceutical companies and Sickness Funds and prescribing targets Enforcement – Atorvastatin delisted from the normal reimbursement list in 2003 following the instigation of reference pricing for the statins (“Jumbo Class”) |
EE – Estonia | Generic pricing Third generic 43% below originator prices; market forces after that Demand-side measures Education – prescribing information to physicians Economics includes co-payment for the PPIs and statins PPIs – 50% co-payment Statins – 10–25% co-payment, rosuvastatin 50% co-payment in patients with familial hypercholesterolemia (total cholesterol > 8 mmol/l) and following a CV event (total cholesterol > 4.5 mmol/l) Enforcement for the statins – reimbursement only for restricted indications otherwise 100% co-payment |
ES – Spain and regions (Catalonia) | Generic pricing Currently market forces driving down generic prices. This may change to a mixed approach Demand-side measures (some variation among Autonomous Communities including Catalonia) Education – includes benchmarking, guidance and educational courses Economics – includes financial incentives for physicians to meet agreed prescribing targets Engineering – includes prescribing targets Enforcement – includes mandatory for pharmacists to dispense cheapest molecule if the prescribed product is more expensive than current reference price, which is usually a generic. This must be generic if the same price as the drug prescribed. No opportunity for patients to cover any additional costs themselves |
FI – Finland | Generic pricing Mixed approach to the pricing of generics. The price of the first generic has to be 40% lower than the price of the original product to be reimbursed Prices of subsequent generics must not be higher than the first generic to be reimbursed with market forces driving down prices with the introduction of generic substitution with the cheapest product from 2003. Substitution mandatory unless forbidden by the physician or patient; although there can be higher co-payments for more expensive products Demand-side measures Education – clinical guidelines as well as EBM initiatives to enhance the quality of prescribing. However, no prescribing targets as seen in a number of other European countries Economics – principally via patient co-payments 2001: PPIs – €8.41/purchase plus 50% co-payment (Basic Refund Category), similarly for statins for most patients. Patients with familial hypercholesterolemia or coronary artery disease entitled to lower co-payment at €4.20/ purchase and 25% co-payment 2007: PPIs 58% co-payment; similarly for the statins unless familial hypercholesterolemia or coronary artery disease entitlement where only 28% co-payment (applied to 15% of statin users) Enforcement – in 2006 atorvastatin and rosuvastatin restricted to second line as appreciably more expensive than other statins with limited additional benefit (restriction for atorvastatin subsequently abolished in 2009 with the availability of generic atorvastatin and reference pricing for the molecule) |
FR – France | Generic pricing Prescriptive pricing for generics with the first generic priced 55% below the originator for reimbursement. Prices further reduced by 7% after 18 months. Demand-side measures Education – includes campaigns to enhance the prescribing and dispensing of generics through for instance benchmarking of physician prescribing and campaigns to allay fears regarding generics Economics Incentives to physicians, patients and pharmacists to enhance the prescribing and dispensing of generics versus originators including encouraging physicians to prescribe by INN name Co-payments – working out on average 20% for PPIs and statins (when factoring in patients with long term illness) Engineering Price: volume agreements for existing compounds) Campaigns from 2009 to enhance the prescribing of generics in a class through prescribing targets linked with financial incentives (CAPI – Contrats d'amélioration des pratiques individuelles) prescribing targets (engineering) |
GB – England | Generic pricing Market forces with transparency in pricing of generics coupled with high INN prescribing. This has typically resulted in low prices for generics Demand-side measures (national and local with some variation among Primary Care Trusts) Education – includes for instance national and local prescribing guidance (e.g., NICE, British National Formulary and PCT prescribing guidance), benchmarking and academic detailing Economics – budget devolution, Practice Based Commissioning and physician financial incentives Engineering – includes Better Care, Better Value indicators for low cost PPIs and statins as well as prescribing support programs encouraging active therapeutic substitution. In addition, proactively managing the introduction of new generics through encouraging the prescribing of patent protected products in a class that will soon lose their patent ahead of other single sourced products in a class |
GB – Scotland | As for England However, budgets not devolved locally (GPs responsible for their drug budgets but not accountable) |
HR – (Croatia) | Generic pricing Mixed approach. The first generic should not be priced higher than 70% of the originator pre-patent price to be reimbursed (originator price dropping by at least 10%) Second generic – a maximum of 90% of the price of the first generic for reimbursement; third generic maximum price of 90% of the second with market forces further lowering prices with patients paying the difference for a more expensive molecule than the current reference Demand-side measures Education – National formulary providing prescribing guidance, with only a limited number of treatment guidelines Engineering includes – price: volume agreements – although applies to new drugs Economics includes higher co-payments for more expensive products that the reference molecule. It also includes co-payments for the statins and PPIs For the statins – in 2003 – 25% co-payment for secondary prevention in patients with ischemic heart disease or cerebrovascular disease and with patients with diabetes with a TC > 5 mmol/l; 75% for patients for primary prevention whose 10-year chance of CHD >20% or will be at the age of 60. Reimbursement only if treatment initiated for patients <70 years In 2006, similar to 2003 for secondary prevention (25%). Primary prevention includes TC > 7 mmol/l after 3 months diet (75% co-payment). In 2008 (outside study period), no co-payment for patients meeting criteria for primary and secondary prevention – co-payment only if they wish originator atorvastatin For the PPIs – typically no co-payment in patients where H2 blockers no longer working for esophageal reflux, alternatively for Zollinger Elisonov syndrome or eradication of Helicobacter pylori; otherwise 100% co-payment Enforcement – Access to patient history to check criteria for reimbursement, e.g., statins and PPIs |
IE – Republic of Ireland | Generic pricing Overall mixed approach with the recent introduction of a two step price reduction process for patent expired products – 20% reduction on patent expiry (in 2007) followed by a further 15% reduction after 22 months (in 2011) (expected to realise €275 mn by 2011) Demand-side measures Limited demand-side reforms to date to encourage the prescribing of generic drugs first line |
IT – Italy | Generic pricing The first generic 20% below the originator; market forces after that Demand-side measures (Variation among health authorities) Educational initiatives – guidelines, academic detailing and benchmarking Economics – financial incentives for GPs, additional patient co-payment for more expensive molecules than the reference molecule Engineering – capping ambulatory care budgets Enforcement – prescribing restrictions for certain indications |
LT – Lithuania | Generic pricing Currently first generic 30% below originator, second and third generics 10% below this; market forces after that Demand-side measures Education – some guidelines in place to encourage rational use of medicines but not obligatory. In addition auditing of prescribing habits with possible financial penalties for excessive costs Economics – includes co-payments for PPIs and statins, as well as possible financial penalties for physicians (above) PPIs – 50%+ for majority of indications Statins - Only 20% co-payment. Initially statins only reimbursed for secondary prevention (post event) and for only 6 months. Reimbursement restrictions now lifted for generic statins Engineering – includes obligatory INN prescribing unless concerns ( compulsory from 2010 unless prior authorization from Hospital or Polyclinic Therapeutic Committee) Enforcement (statins only) – reimbursement only post AMI and only for 6 months (reimbursement restrictions now lifted for generic statins). In addition, the first prescription must be written by a cardiologist otherwise 100% co-payment |
NO – Norway | Generic pricing Aggressive prescriptive pricing policy for generics with high volume generics 85% below originator prices Demand-side measures Limited educational initiatives during the study period Enforcement PPIs – prescribing of esomeprazole restricted in 2007. Specialists though required to verify the diagnosis and recommend therapy Statins – atorvastatin restricted from 2005 (rosuvastatin not reimbursed) with physicians encouraged to actively substitute patients currently prescribed atorvastatin. Spot checks undertaken amongst physicians if abuse suspected |
PO – Poland | Generic pricing Market forces driving down generic prices. In addition reference pricing in a class and across therapeutic groups (ATC Levels 3 and 4) Demand-side measures Education – generally limited educational interventions; although variable among the regions Economics – includes co-payment for the indication as well as additional co-payment for a more expensive brand than the reference product (molecule, class, or therapeutic area) PPIs – 30% (apart from esomeprazole which is not reimbursed) Statins – 30% (apart from rosuvastatin which is not reimbursed) Enforcement – Pharmacists are obliged to inform patients about generic products if they have the same active ingredient, dosage, package and route of administration as the prescribed product but cheaper (as branded generics in Poland) |
PT – Portugal | Generic pricing Mixed approach to the pricing of generics with the first generic priced at least 35% below the originator; this reduces to 20% if the originator price is below €10/pack. Further price reductions in 2005, 2007, and 2008 2005 and 2007 – 6% price reduction for all reimbursed medicines After March 2007 also annual price reductions for generics depending on the market share of each active substance (5, 9, or 12%) 2008 – further 30% price reduction for generic medicines 2010 – further changes to try and reduce prices within homogeneous groups, i.e., same active substance, pharmaceutical form, strength and route of administration In addition, ongoing activities by pharmaceutical companies to suspend market authorization for generics as a counter measure. The official database from Infarmed (July 2010) includes 17 active substances and more than 500 medicines (packages) where marketing authorization has been suspended |
Demand-side measures Education – includes guidelines (although not mandatory) and campaigns promoting generics. The latter include patient campaigns via TV, radio, leaflets in hospitals and community pharmacies as well as physicians updated every quarter by INFARMED of available generics Economics – includes establishing a Reference Price System (RPS) in 2002 defining a fixed amount paid by the NHS for homogeneous groups. In May 2010 no co-payment for pensioners (100% reimbursement) whose income is below the national minimum wage (the so called Special Regime). In June 2010, new legislation reimbursing 100% only the five cheapest medicines in a homogeneous group Engineering – Agreements between the Portuguese Pharmaceutical Industry (represented by APIFARMA) and the Ministry of Health with the objective of limiting the growth in the NHS expenditure on pharmaceuticals Enforcement – includes since 2002 an obligation for physicians to prescribe by INN for medicines with approved generics; however they can prohibit substitution where patient concerns. Pharmacists are allowed to substitute generics where physicians have prescribed by INN name and have not prohibited substitution, and should also inform patients about generic prices versus originators (however no financial incentives for this) |
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RS – Serbia | Generic Pricing Mixed approach with the first generic priced at least a minimum of 80% of average current prices in three reference countries (Slovenia, Croatia and Italy) Subsequent generics should be priced similar or lower to gain market share with the lowest price product establishing the reference price for the molecule In addition, to help further lower prices originator and generic drugs must now have the same price for reimbursement with no opportunity for patients to pay an additional co-payment for a more expensive product Demand-side measures Economics - Patients initially required to pay an additional co-pay for a more expensive product than the current reference price (same INN name - ATC Level 5) - now changing (above). Prescribing efficiency helped by early availability of generics – similar to the situation in Poland (above) Enforcement – Prior authorization schemes in place for selected premium priced drugs based on step therapy approaches |
SE – Sweden | Generic pricing Market forces driving down prices with compulsory generic substitution Demand-side measures (some variation among the Counties) Education – includes a range of measures incorporating prescribing guidance and guidelines, routine benchmarking against colleagues and against recommended drugs, as well as electronic prescribing support systems Economics – includes devolved budgets and financial incentives Engineering – includes prescribing targets such as % of statins as generic statins Enforcement – includes prescribing restrictions for rosuvastatin (since launch) and atorvastatin (post 2007) |
SI – Slovenia | Generic pricing First generic no higher than an average of 82% of prices in Austria, France and Germany; market forces after that Demand-side measures Education – includes the Health Insurance Institute organizing therapeutic meetings and undertaking audits of prescribing habits Economics – includes additional co-payments for more expensive compounds than the reference product Enforcement – includes prescribing restrictions for certain drugs based on their more limited value versus current standards |
TR – Turkey | Generic pricing The first generic must be priced no higher than 66% of the originator's pre-patent loss price; subsequently subject to a 11% price reduction Demand-side measures Education – limited activities to date Enforcement – some prescribing restrictions but not applying to PPIs or statins |