WHO: Generic and Biosimilar Uptake Must Be Fostered Through Policy and Education

The World Health Organization (WHO) has published a new report on reimbursement policies in Europe that provides a comparative review and analysis of the policies employed by 45 different European countries, and says that promoting the uptake of lower-priced medicines such as generics and biosimilars can “facilitate efficiency gains without disadvantaging patients.”

In most of the countries studied, WHO found that generic substitution is practiced at the pharmacy level; in 29 countries, substitution of a cheaper generic by a pharmacist is allowed and the practice is mandated. in 12 countries. Only 4 countries—Austria, Bulgaria, Luxembourg, and the United Kingdom—do not permit a pharmacist to substitute a cheaper generic. Some countries even give financial incentives to pharmacists to make substitutions; in Switzerland, pharmacists receive a fee for doing so.

Read more about pharmacy-level substitution.

In many cases, patients can still receive a more expensive brand-name drug without a doctor’s written justification, though they may pay more in out-of-pocket costs if they refuse a generic.

One measure that has allowed for greater generic uptake, says the report, is prescribing medicines by international nonproprietary name (INN) rather than by brand name, allowing pharmacists to dispense the lowest-cost option with the same active ingredient. INN prescribing is allowed in 22 countries surveyed and is mandatory in another 19.

While these policies have allowed for the wide uptake of generics, the policy landscape for biosimilars is less defined. One commonly used strategy for biosimilars is to set the price of biosimilars at a particular percentage beneath the price of the originator (a strategy the WHO calls a “price link”), and to set maximum prices for originator biologics by external reference pricing, as is practiced in Bulgaria, the Czech Republic, Iceland, Malta, Latvia, Serbia, and Slovenia.

Campaigns targeting physicians’ prescribing practices are also increasingly common; in France, for example, physicians are encouraged to prescribe biosimilars for at least 20% of insulin glargine users, and in Norway, physicians must follow a ranking of tendered products and use the lowest-priced drug. Norway’s strategy has resulted in a market share for biosimilar infliximab of more than 95%, the report notes.

Pharmacy-level substitution for biosimilars has proven to be more complex than for generics; in Latvia, for example, pharmacy-level substitution is permitted, and patients have the right to refuse the biosimilar. However, these patients must pay the price difference between the originator and biosimilar. Meanwhile, in Poland, substitution is allowed by law, but the patient must be consulted.

The WHO says that educational policies—including local initiatives among physicians in hospitals or in the outpatient setting—will be of key importance to greater biosimilar uptake in these nations, because acceptance and trust in biosimilars among healthcare providers is a driver of uptake.

“Evidence from the literature and analysis done for this study show the importance of ensuring trust in the quality of generics and the relevance of demand-side measures to promote the uptake of generics and other lower-priced medicines,” said the report’s authors.