Reforms and Initiatives in Scotland in Recent Years to Encourage the Prescribing of Generic Drugs, Their Influence and Implications for Other Countries

Brian Godman; Iain Bishop; Alexander E Finlayson; Stephen Campbell; Hye-Young Kwon; Marion Bennie

Disclosures

Expert Rev Pharmacoeconomics Outcomes Res. 2013;13(4):469-482. 

In This Article

Abstract and Introduction

Abstract

Scotland has introduced a number of initiatives to enhance the prescribing of low-cost generic drugs versus originators and patent products in a class where these are seen as similar. The objective of this review is to appraise the influence of the various measures on subsequent utilization patterns and expenditure in high-volume classes to provide guidance. This review is principally a narrative review of published studies. The authors' found supply-side measures resulted in generic prices as low as 3% of pre-patent loss prices. Multiple demand-side measures resulted in high international non-proprietary name prescribing, and a considerable increase in prescribing efficiency for the proton pump inhibitors, statins, renin–angiotensin inhibitor drugs and selective serotonin reuptake inhibitors. There were no specific activities encouraging the prescription of losartan versus other angiotensin receptor blockers or risperidone versus other atypical antipsychotic drugs following generics and no change in their utilization patterns post generics. The authors can conclude multiple measures are needed to change physician prescribing habits. Authorities cannot rely on any 'spillover' effects to affect future prescribing, even in closely related classes.

Introduction

Scrutiny on pharmaceutical expenditure has intensified in recent years among health authorities and health insurance companies across Europe, with growth rates averaging 50% in real terms among Organisation for Economic Co-operation and Development countries between 2000 and 2009.[1–5,101] This growth will continue unless addressed, driven by well-known factors including changing demographics, rising patient expectations and the continued launch of new premium-priced drugs.[3,4,6,7]

As a result, health authorities across Europe have introduced multiple reforms and initiatives to slow down growth rates or even reverse them. The objective being to maintain the European ideals of equitable and comprehensive healthcare.[3–7]

Key areas for reforms and initiatives have been measures to enhance the utilization of low-cost generic drugs versus originators or patented products in a class or related class, where the products are seen as similar in all or nearly all patients.[1–5,8–10] As a result, release considerable resources to fund new premium priced drugs and increased drug volumes without compromising patient care.[3–5,8–11] Initiatives in Scotland include measures to lower generic prices (supply-side measures) as well as enhance their utilization (demand-side measures).

Supply-side measures and initiatives for generics in Scotland include the introduction of the 'M' (Manufacturer) and 'W' (Wholesaler) scheme in April 2005 to increase transparency in the manufacture and pricing of generics as well as any discounts and rebates offered by generic manufacturers to wholesalers and pharmacists to enhance the dispensing of their generics.[5,9,11,102] This led to an average 32.4% reduction in the prices of generics within the first year, resulting in an overall 2% reduction in pharmaceutical expenditure for that year.[4,5,11,102] Prices of high-volume generics are now as low as 2–3% of pre-patent loss originator prices in the UK.[3–5,9,11]

Concomitant with this, there have generally been no patient concerns with the prescribing of generics versus originators in Scotland. This is apart from a limited number of well-known cases including cyclosporine, lithium, phenytoin, theophylline modified release as well as long-acting/modified release diltiazem and nifedipine.[11–13] This is reflected by generally high voluntary international non-proprietary name (INN) prescribing rates in Scotland. These currently average over 80% across all products, rising to over 98% for high-volume generics including generic lisinopril, omeprazole and simvastatin.[4,5,9,14] These high rates have been achieved through all physicians now trained in Scottish medical schools to prescribe by INN, with follow-up in the community coupled with IT systems.[3,5,9,10,14] Follow-up in the community typically includes decision-support software as well as monitoring the prescribing of generics, which is seen as good-quality prescribing.[5,9,14] This compares with Austria where there is currently no INN prescribing with branded generics.[15] There is a similar situation in Germany with the manufacturers of branded generics offering discounts to the Sickness Funds to have their branded generic preferentially prescribed.[4] Similarly in Korea, with currently over 500 local generic manufacturers promoting their branded generics to physicians and pharmacists with limited demand-side measures.[16] Consequently, the current focus in Scotland regarding generics has been on seeking ways to enhance their prescribing versus patented products in a class or related class where pertinent and without compromising patient care.

The proton pump inhibitors (PPIs), statins and renin–angiotensin inhibitor drugs are seen as essentially similar in all or nearly all patients,[2–5,8–11,14,17] Consequently, providing an opportunity to increase the prescribing of multiple sourced versus patented products in each class or related class. As a result, conserving resources without compromising care. This has resulted in multiple policies among the Health Boards in Scotland to enhance the prescribing of generics versus patented PPIs, statins and angiotensin receptor blockers (ARBs).[3,4,9,10,14] There have also been initiatives to enhance the prescribing of generic selective serotonin reuptake inhibitors (SSRIs) versus patented escitalopram.[103–105] The SSRIs have largely superseded traditional treatments such as tricyclic antidepressants (TCAs) in the management of depression in ambulatory care due to lower side effects and safety in over dose.[18–22] They are all typically seen as having similar effectiveness and safety profiles, although potentially interpatient variation in their effectiveness and side effects. This also applies to escitalopram,[103–105] for example, in 2002, the Scottish Medicines Consortium stated that "Escitalopram has been shown to be as effective as citalopram in short-term use and the health economic model submitted suggests that it is also cost-effective. However, the resource usage assumptions and clinical evidence underpinning the model are not robust and no clear benefits are demonstrated over citalopram or other effective and cheaper agents".[103] This lack of any perceived appreciable clinical difference between escitalopram and the other SSRIs, although considerable differences in acquisition costs, resulted in measures and initiatives among Health Boards in Scotland to limit its utilization. These included prescribing indicators limiting the prescribing of escitalopram to less than 5–10% of all SSRI prescriptions,[104,105] with follow-up by Health Board pharmacists and others.

The availability of generic atypical antipsychotic drugs should also be welcomed in Scotland with generally low prices for generics versus the originator.[9,23] Clozapine was the first atypical antipsychotic drug to lose its patent, with published studies showing no difference in outcomes between the originator and generics once the problem with the first formulation in the USA had been resolved.[24–27] More recently, generic risperidone became available in Scotland. However, it is recognized that schizophrenia and bipolar disorders are complex diseases to treat[28–30,106] and that atypical antipsychotic drugs should not be considered as a single class in view of the heterogeneity of their mechanism of action.[29,30,106] In addition, there can be substantial variation in the effectiveness of the different antipsychotic medicines between individual patients, and the number of side effects can also differ substantially between patients. As a result, various authorities in Europe and the USA recommend that treatment should be individualized,[30,31,106] thus consequently potentially limiting the number of demand-side measures that could possibly be introduced in Scotland to preferentially enhance the prescribing of generic oral atypical antipsychotic drugs first line where pertinent. This is apart from possibly educational initiatives suggesting to psychiatrists that they should start patients on a generic oral atypical antipsychotic drug where possible. This mirrors the advice given by NICE.[106]

The Health Boards in Scotland also faced challenges following the introduction of generic clopidogrel in August 2009. The challenges resulted from manufacturers able to address the technicalities of PLAVIX's European patent through producing clopidogrel in a different salt.[23] However, generic clopidogrel was only initially launched for secondary prevention of atherosclerotic events, that is, without the acute coronary syndrome (ACS) indication.[23] The EMA subsequently approved various generic clopidogrel preparations through its centralized procedure in 2009. However, concerns were raised by the manufacturers and others whether changing the salt would subsequently alter the toxicity, stability and rate of absorption of the active drug.[23] Concerns over the quality of generic clopidogrel were also raised by the originator company when the EMA in March 2010 recalled one of the generic clopidogrel preparations due to concerns with its manufacture.[23] However, the prescribing of generic clopidogrel could potentially release considerable resources in Scotland and other European countries given its existing high sales.

The objective of this review article is to appraise the influence of the variety of measures and initiatives introduced in Scotland during the past decade among a number of high-volume classes on their subsequent utilization patterns and expenditure. Subsequently, use the findings to give guidance on possible measures and initiatives that health authorities or health insurance companies in other countries could potentially introduce to further enhance their prescribing efficiency.

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