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Driving down drug prices: how regulators can influence affordability

In recent years there has been increasing global concern over drug prices and their affordability. And what is the role played by regulators in drug pricing? This is the subject of discussion in a recent paper co-authored by the European Medicines Agency’s (EMA) Executive Director Guido Rasi, its Senior Medical Officer Hans-Georg Eichler, the Executive Director of Dutch Medicines Evaluation Board Hugo Hurts, and the President of the German Federal Institute for Drugs and Medical Devices Karl Broich [1]. Although the price of medicines is not within the regulatory remit, the authors find this an inescapable subject for debate and they outline possible regulatory interventions that could drive down drug prices.

Generics in seizure control

Are generic medicines for the control of epileptic seizures bioequivalent to their brand-name counterparts? Steven Karceski [1] has recently reviewed a study carried out by researchers at the Johns Hopkins University School of Medicine, Baltimore, MD, USA in which they determine the bioequivalence of generic seizure control medications [2].

The satisfaction of healthcare payers, patients and physicians with generic imatinib

With the begining of the era of tyrosine kinase inhibitors (TKIs), chronic myeloid leukaemia (CML) became a chronic disease, in which good responding patients usually have a life expectancy similar to the age- and sex-matched normal population [1]. In many countries, the first-line treatment of chronic phase CML is imatinib mesylate (IM). Whereas, especially in some developed countries, second generation TKIs (dasatinib, nilotinib) which have deeper and faster responses, but are also more expensive than IM, are utilized in the upfront setting. The introduction of TKIs increased the prevalence of CML, and optimal responders to IM should continue therapy indefinitely, so the originator TKI treatment (Gleevec) surely put a strain on healthcare providers even in developed countries.

Ways to reduce drug costs in Australia

Drug costs in Australia are increasing at an alarming rate. This is driven mainly by expensive biological therapies, antiviral therapies for HIV and hepatitis C and new cancer treatments.

AES position statement on substitution of generic anti-epileptics

A paper by the American Epilepsy Society (AES) discusses how the society’s position on generics substitution of anti-epileptic drugs has changed according to the results of bioequivalence studies [1].

Reasons for the success of a generics company in the Sudan market

An exploratory, qualitative study carried out by colleagues from the University of Khartoum (Sudan) and Abertay University (UK) examined the reasons behind the success of a generics company that has been the market leader in Sudan for a decade from the perspective of employees and customers [1].

Pharmacists prefer generic OTC medicines

In the US, the use of generics has been lacking due to hesitation from consumers over whether generics are as safe and effective as brand-name medications. Pharmacists, on the other hand, have the education and training to know that generics are both safe and effective.

Enhancing prescribing efficiency in the Republic of Srpska

It has been claimed that countries with smaller populations have difficulties obtaining considerable price reductions for generics. However, evidence from the Republic of Srpska, which is one of the two constitutive entities of Bosnia and Herzegovina, with a population of only 1.43 million, proves otherwise [1].

Equivalence of generic immunosuppressants

There are no compelling pharmacological arguments against the sensible use of the generic immunosuppressants ciclosporin, tacrolimus and mycophenolate mofetil in clinical practice, argue pharmacologists working in drug evaluation in The Netherlands [1].

Alleviating concerns around generic antiepileptic medications

Reports that some patients with epilepsy were more likely to experience seizures and hospitalisation after switching from brand-name drugs to generic alternatives have led to concerns about generic antiepilepsy drugs (AEDs). A recent review, however, argues that the onset of seizures following a switch may be due more to the disruption of normal routine than the choice of medication. The authors suggest that AEDs are relatively safe and effective compared to innovator drugs.

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