Use of national reference pricing

2.1. Development of national systems

The use of national reference pricing has been the subject of much debate within governmental in-stitutions and with major stakeholders such as industry, the medical profession and patient groups. In Europe, the system has been adopted in countries such as Germany in 1989, Denmark in 1991, The Netherlands in 1993, Italy in 1995, and Spain in 1999. It is not used in large markets such as France and the UK, though in the latter country the setting of acceptable prices for generics follows a similar approach. Reference pricing has also been widely adopted in Central and Eastern European countries

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(CCEE). Historically, the use of national reference pricing in Europe first attracted countries with high drug prices, a large generic competitive market and large price differences between the various versions of multi-source drugs – a set of factors which rendered this approach both necessary and feasible. In recent years countries with lower drug prices have also adopted the approach (e.g., Spain and CCEE).

Outside Europe, reference price approaches have been applied in British Columbia (Canada) since 1995, and in New Zealand. The possibility of adopting the system was also discussed in Japan in 1998.

In countries, such as some of the member states of the European Community, where social health insurance funds are the largest purchasers of drugs, national reference pricing can have a considerable effect on corporate strategies for R&D and on marketing policies.

Setting a National Reference price system involves four main decisions:

– defining the number and scope of each class of “interchangeable” drugs for which a reference price is to be set;

– determining the way in which the reference reimbursement level is to be calculated for each indi-vidual class of drugs;

– establishing a procedure for defining the classes and setting acceptable reimbursement levels;

– setting mechanisms to permit exceptions where these are justified.

2.2. Definition and scope of drug classes

In order to implement such a system, one must define the various classes within which drugs are considered “interchangeable”, and one must define the market segment within which the system is to be implemented. Several options exist: one can for example limit the system to certain drug categories, usually those representing a major share of a drug budget; one can apply different criteria to the various classes in order to decide on the degree of interchangeability of the drugs within each; and one can choose to introduce the method gradually, experimentally or incrementally, perhaps in order to arrive ultimately at a comprehensive reference system.

Criteria used to define drug classes vary country by country and according to the market segment which is considered for reference pricing. A class may simply comprise drugs having the same active ingredient (as is the case of Germany for level I drugs), or it may extend to drugs with ingredients which are pharmacologically and therapeutically closely similar (Germany for level II drugs and British Columbia); in the broadest approach, a class may comprise all drugs with a similar therapeutic indication (The Netherlands).

The following are some country examples on the definition and scope of drug classes for a national reference price system.

Germanywas the first country in Western Europe to introduce a reference price system, initially based on classes of drugs having the same active ingredients, and later moving to classes with therapeutic comparability. The system was designed to apply both to research-based and generic drugs, which were to be included three years after patent expiration. The length of this period was judged sufficient to ensure that generic competition would allow a fair representation of market prices.

Three types of drug classes were then defined:

1. Drugs having identical active ingredients (Level I).

2. Drugs having therapeutically comparable active ingredients (especially drug containing similar chemical ingredients) (Level II).

3. Drugs with a comparable pharmacological profile (especially fixed combinations).

Level I drugs were grouped easily, but decisions on level II and III were more complex and only a selection of these drugs were clustered within the reference price system.

Spain has introduced very restrictive reference pricing, limited to level I drug classes in the German definition, involving 50 drugs with identical ingredients [9].

British Columbia(Canada), under its Pharmacare programme, introduced reference pricing in five drug classes only, chosen primarily because of the level of expenditure which they represent in the drug budget:

NSAIDs, histamine-2 receptor antagonists, oral nitrate, ACE inhibitors and dihydropyridine calcium-channel blockers (BC Pharmacy Association).

The Netherlandsuses for its reference price system (known as the GVS), the principle of therapeutic substitution [3,7]. The government identifies drug classes having the same therapeutic indication, mainly by using the ATC classification. This classification adopted by the Nordic Council and used by the World Health Organization, has been described earlier in this volume. It is considered an adequate basis for therapeutic classification for the purpose of reimbursement. The Dutch government also introduced some modifications to take into account therapeutically relevant side-effects which are not reflected in the ATC classification, but which in some cases provide a reason for classifying certain drugs into separate clusters.

2.3. Calculation of an acceptable reimbursement level

Techniques used to set the level of reimbursement prices also vary considerably from country to country. As a rule, countries calculate their reimbursement price for a particular drug class by using a (weighted) average of the prices of drugs in the group as sold on the domestic market. However, in countries where generic competition is substantial and leads to large price differences among products, the health funds or governmental agencies/commissions taking the decisions give a greater importance to the cheapest generic prices. With the growth of economic evaluation studies and investigations into cost effectiveness, some policy makers also introduced other criteria to calculate an acceptable reimbursement level based on the most cost effective therapy available (e.g., British Columbia).

The following are examples of the manner in which different countries have calculated an acceptable reimbursement level:

InGermany,the reference price is fixed in such a way that within each drug group a sufficient number of drugs remains reimbursable, thus ensuring that there is a degree of choice and sufficient availability of drugs falling within the selected reference price level, to supply the national market [1,8]. Within a comparable group, the reference price usually tends to be close to some of the lowest pharmacy prices.

A model of the structure of the pharmaceutical market for each drug class is then constructed to take into account prices, pack sizes and dosages, and to estimate – through a regression technique – the prices for different dosages and pack sizes. However, there is not necessarily any justification for a linear relationship between various prices and dosage levels [8].

InBritish Columbia, the authorities have sought to take as a standard the reference drug that is most cost-effective within its class[2], based their choice on the scientific evidence as accepted by the national regulatory body. The figures for cost-effectiveness take into account the cost structure of the Canadian health system, but not necessarily the health care structures specific to the British Columbia province.

InThe Netherlands, for each drug group recognized within the GVS, a reimbursement price is set per defined daily dose (DDD), in order to be able to compare drug prices within a reimbursement group.

Instead of the treatment cost per day, the cost of an entire course of treatment is considered [7].

2.4. Use of international comparisons

Usually the price information used to set the reimbursement level reflects the price structure within the country that is implementing the system. It is therefore influenced by the results of the various tradeoffs in domestic price negotiations that have led to the prevailing national price structure within each drug class. Some countries may however, as noted above, opt to rely in part on international sources of price information in setting their reimbursement reference price levels. The Netherlands for instance, uses price comparisons with other European countries, such as France, Germany, the UK and Belgium, to determine maximum prices which then in turn affect the reimbursement price. The selection of countries in such a case is based on the criterion of similar identical close purchasing power.

2.5. The decision making process

The definition of drug classes and the setting of an acceptable reimbursement level is a highly political process, in particular since it may have major economic implications for industry. Most government agencies have set up committees drawn only from the Sick Funds or with participation of the Sick Funds, the medical professions or academic experts. In Germany for instance, the Federal Commission of Physicians and the health insurance funds specify the pharmaceuticals for which reference prices are to be determined [1]. The Board of the Health Insurance Funds sets the reference prices. In British Columbia, an independent advisory committee is in charge of thorough reviews of the published scientific evidence on cost-effective therapies.

2.6. Exception mechanisms

As pointed out already, physicians may not be willing to switch all their patients from the drugs which they have come to prefer to drugs falling within the reference price; they may have various reasons for objecting, one being a belief that another drug is better suited to a particular patient’s needs. Some countries have therefore introduced into the design of their national reference price systems mechanisms to allow for exceptions to be made where these are justified. For instance, in British Columbia physicians can choose not to switch medications for particular patients if side effects or other adverse consequences are expected to result. A physician may present the case to the sick fund, arguing that the patient should be fully refunded, but the patient may ultimately have to pay the difference in order to receive a more expensive drug.