Reforms and Initiatives to Encourage Prescribing of Generics
Reforms and Initiatives to Encourage Prescribing of Generics
Table 1 contains the details of the multiple demand-side measures instigated for both the PPIs and statins in Scotland between 2001 and 2007 to improve the quality and efficiency of prescribing for acid-related stomach disorders and hypercholesterolemia. Generic omeprazole became available in 2002 and generic simvastatin in 2003. These have been collated under the 4Es: education, engineering, economics and enforcement. Education refers to initiatives such as guidelines, benchmarking and academic detailing; engineering refers to organizational or managerial interventions such as prescribing indicators; economics refers to financial incentives such as physician financial incentives for achieving agreed prescribing targets and enforcement refers to regulations such as prescribing restrictions, which have been introduced for the statins in a number of European countries including Austria, Croatia and Sweden, and compulsory generic substitution, as seen in Sweden. There are currently no prescribing restrictions in Scotland; consequently this is not contained within Table 1.
This is similar to the multiple demand-side measures introduced in Sweden to enhance prescribing efficiency (Table 2). Both greater than the more limited demand-side measures introduced for the PPIs and statins in France, Ireland and Portugal between 2001 and 2007 (Table 2), although this is changing in France with the introduction of pay-for-performance programs since 2009 (Table 2).
PPIs The multiple demand-side measures introduced in Scotland between 2001 and 2007 (Table 1) resulted in omeprazole continuing to drive the increase in PPI utilization, with stable utilization of the other PPIs including esomeprazole. Omeprazole was almost exclusively generic omeprazole on a defined daily dose (DDD) basis once available, with rates of over 98% of total omeprazole utilization since 2006.
Expenditure/DDD for generic omeprazole continued to fall following the various demand-side initiatives (Table 1) as well as following the introduction of the 'M' and 'W' scheme. These supply- and demand-side measures continued after 2007 resulting in expenditure/DDD of generic omeprazole in 2010, 91% below 2001 originator prices. As a result, expenditure/1000 inhabitants/year in 2010 in Scotland was GB£5481 (€6301), 56% below 2001 levels despite a threefold increase in utilization during this period.
The authors calculated expenditure/1000 inhabitants/year for the PPIs in 2010 would have been GB£35,934 (€41324) assuming no reductions in expenditure/DDD for the PPIs since 2001 and similar utilization patterns. This led to potential savings of over GB£159 million alone in 2010 in Scotland for the 5.2 million population.
Statins
Simvastatin continued to dominate statin utilization from 2001 onwards, reaching 57–58% of total statins (DDD basis) between 2007 and 2010 following the multiple demand-side measures (Table 1), with stable utilization of both atorvastatin and rosuvastatin. This was increasingly higher strength statins for both simvastatin (Figure 1) and atorvastatin helped by the inclusion of lipid level targets in the Quality and Outcomes Framework (QoF) (Table 1), as well as published studies and SIGN guidance advocating 40 mg simvastatin (Table 1).
(Enlarge Image)
Figure 1.
Number of different strength simvastatin tablets dispensed in Scotland 2000–2010. Reproduced with permission from [9].
Higher strength simvastatin (40 and 80 mg) accounted for 85% of total simvastatin DDDs in 2010; slightly greater for higher strength atorvastatin (20, 40 and 80 mg) at 94% of total atorvastatin DDDs. This was nearly all 40 mg for simvastatin, averaging 94–97% of higher strength statins between 2005 and 2010.
Simvastatin was typically generic simvastatin, averaging 98% of all simvastatin utilization on a DDD basis since 2006. This coupled with continued low prices for generic simvastatin, at 97% below 2002 originator prices in 2010, led to reimbursed expenditure up only 7% in 2010 compared with 2001, at GB£11,420/1000 inhabitants (€13,113). This was despite a 6.2-fold increase in statin utilization during this period. The authors believe that expenditure/1000 inhabitants/year for the statins in 2010 would have been GB£67,256 (€77,345) assuming no reduction in expenditure/DDD for the statins since 2001 and similar utilization patterns. This leads to potential savings of over GB£290 million in 2010.
Comparison with other European countries
There were limited demand-side measures in France, Ireland and Portugal encouraging the preferential prescribing of generic PPIs and statins between 2001 and 2007 (Table 2) compared with Scotland (Table 1). This resulted in a decrease in the utilization of omeprazole, and an increase in the utilization of esomeprazole, in each of these three countries following the availability of generic omeprazole. Similarly in these three countries during this time, an increase in the utilization of patented atorvastatin and rosuvastatin following the availability of generic simvastatin was noted. As a result, considerable differences were noticed in overall prescribing efficiency between Scotland and these three countries between 2001 and 2007 following the availability of generic omeprazole and simvastatin, with all PPIs and statins seen as essentially similar in all or nearly all patients (Table 3).
Multiple demand-side measures (Table 2) also appreciably enhanced prescribing efficiency in Sweden for both the PPIs and statins between 2001 and 2007, for example, PPI and statin utilization increased by 42% and 2.5-fold, respectively but expenditure decreased by 48 and 51%, respectively. As a result, expenditure/1000 inhabitants/year for both classes in 2007 was under Euro6000, a tenth of that seen in Ireland, although for a less co-morbid population.
ACEIs versus ARBs Various demand-side measures were implemented in Scotland between 2001 and 2007 to enhance the prescribing of generic angiotensin-converting enzyme inhibitors (ACEIs) versus patented ARBs (Table 4), with the drugs in both classes seen as essentially similar in most patients. This was because prospective clinical studies showed that a dry cough only occurred in approximately 10% of patients prescribed ACEIs, with only 2–3% of patients in ACEI clinical trials actually discontinuing these drugs due to a dry cough. These findings led the Office of Fair Trading to suggest that ARBs should only comprise a maximum of 5% of total prescriptions of all renin–angiotensin inhibitor drugs. Having said this, published studies have shown that a dry cough can occur in up to 25% of patients in selected populations especially those prescribed higher doses.
These activities led to low utilization of ARBs in Scotland versus Portugal between 2001 and 2007 (Figure 2), with limited demand-side measures in Portugal during this period (Table 4). There were similar ARB utilization patterns in Scotland to both Austria and Croatia (Figure 2). The authorities in both these countries had instigated prescribing restrictions limiting the prescribing of ARBs to patients experiencing tolerance or side-effect problems with ACEIs. These restrictions were backed up with financial penalties for physicians suspected of abuse to help enhance adherence, although their intensity varied between the two countries. There was greater follow-up of prescribing restrictions in Croatia, leading to differences in practice in subsequent ARB utilization profiles between these two countries (Figure 2).
(Enlarge Image)
Figure 2.
Percentage utilization of angiotensin-converting enzyme inhibitors versus all renin–angiotensin inhibitor drugs (defined daily dose basis) during 2001–2007 among selected European countries. Data taken from [23].
As a result, there was stable expenditure on renin–angiotensin inhibitor drugs in Scotland between 2001 and 2007 versus growing expenditure in Portugal (Figure 3). This was despite a 159% increase in utilization (DDD basis) in Scotland between 2001 and 2007, helped by low prices for generic ACEIs and limited utilization of ARBs. Utilization of renin–angiotensin inhibitor drugs increased by 69, 89 and 72% in Austria, Croatia and Portugal, respectively between 2001 and 2007. Generic enalapril and lisinopril were 88% below pre-patent loss prices in Scotland in 2007, and accounted for 98–99% of total enalapril and lisinopril on a DDD basis in 2007.
(Enlarge Image)
Figure 3.
Expenditure/1000 inhabitants/year for renin–angiotensin inhibitor drugs among selected European populations. Data taken from [14].
Losartan versus Patented ARBs Losartan's patent expired in the UK in March 2010, with the first generics reimbursed in Scotland in July 2010 when losartan was listed on the Drug Tariff. Consequently, Health Boards should be active in Scotland encouraging GPs to start patients on losartan when an ARB is indicated, as well as switching patients on other ARBs to losartan. This particularly as GB£26.27 million was spent on ARBs in Scotland in 2009, making ARBs the seventh most expensive drug class in Scotland, and the price of losartan was falling rapidly following its availability. In addition, all ARBs are seen as equally effective for the management of hypertension and heart failure at appropriate doses, although care may be needed with switching patients with heart failure to losartan to save costs.
However, there were no specific activities among the Health Boards to increase the prescribing of generic losartan versus existing patented ARBs. This was because therapeutic switching programs and other active measures would entail considerable Health Board resources both in time and costs when generic valsartan, candesartan and irbesartan would shortly become available on the Drug Tariff. In addition, other higher priority areas had already been identified to improve the quality and efficiency of primary care prescribing in Scotland in 2012 and some of these would be compromised by concentrating on generic losartan. Multiple demand-side measures had also already successfully limited ARB utilization in Scotland (Figure 2), and there would be savings anyway from the availability of generic losartan versus the originator due to the low envisaged price for generic losartan.
There was no appreciable change in the utilization of losartan following the availability of generics, rising by 4% on a moving annual total basis (DDDs) 1 year after the availability of generic losartan. There was a similar pattern when assessing the utilization of losartan as a % of all single ARBs following the availability of generic losartan (Table 5). This was different to the significant increase in losartan utilization in Austria and Belgium following the availability of generic losartan (Table 5). In both countries, prescribing restrictions were removed for losartan but not for the other ARBs. The other ARBs could only be prescribed in patients intolerant to ACEIs or experiencing unacceptable side effects. In Sweden, multiple demand-side measures were introduced similar to those for PPIs and statins (Table 2) along with therapeutic switching. This also resulted in a significant increase in the utilization of losartan post-generic availability (Table 5). There was also an appreciable increase in the utilization of losartan versus other ARBs in Bury PCT following generics and therapeutic switching programs combined with other measures including guidelines, prescribing targets and financial incentive programs in March 2011.
Losartan was typically generic losartan in Scotland after its launch, averaging between 98 and 99% of all losartan on a DDD basis from August 2010.
In March 2012, the reimbursed price (Drug Tariff price) of losartan 50 mg in Scotland was GB£0.056p/day, 88% below pre-patent loss prices. This led to estimated savings of nearly GB£8 million/year in Scotland just from the availability of generic losartan alone versus the pre-patent loss situation.
The demand-side measures among the Health Boards in Scotland described earlier, following advice from SMC, led to low utilization of escitalopram in Scotland (Table 6). This compares with Ireland and Portugal (Table 6) with their limited demand-side measures generally to combat pharmaceutical company marketing activities (Table 2 & Table 4).
There was also high INN prescribing for the SSRIs on a DDD basis in Scotland in 2007 suggesting limited concerns with generic SSRIs in practice, for example, fluoxetine, paroxetine and sertraline were 98% generics in 2007 and citalopram 99%. This coupled with low prices for generic SSRIs, for example, generic citalopram in 2007 was 84% below pre-patent loss prices, generic fluoxetine in 2007 was 88% below and generic sertraline 89% below pre-patent loss prices in 2007, substantially lowered SSRI expenditure in recent years in Scotland (Table 7). This compares with appreciably increased expenditure in both Ireland and Portugal in 2008 and 2007 versus 2001, respectively (Table 7).
Overall between 1998 and 2007, the utilization of SSRIs increased 2.37-fold in Scotland but overall expenditure decreased by 59%. This resulted in considerable resource savings without appearing to compromise care. However, specific research is needed among patients before we can make any definitive statements.
There was limited Health Board activity in Scotland following the availability of generic oral risperidone in view of the recognized need to tailor therapies for patients with schizophrenia or bipolar disorders. This was apart from suggesting to psychiatrists that they start patients on a generic oral atypical antipsychotic drug where possible.
There was a 53% increase in the utilization of selected atypical antipsychotic drugs in Scotland in recent years, rising from 3.4 DDDs/1000 inhabitants/year in 2005 to 5.1 in 2010. This was driven by increasing utilization of olanzapine, quetiapine and aripiprazole, although there have been concerns with some of the marketing activities of companies. There was limited influence of the availability of generic oral risperidone in April 2008 on its subsequent utilization. Overall, the utilization of risperidone decreased steadily from 21% of total atypical antipsychotic drugs (DDD basis) in 2005 to 16% in 2010. This mirrored the situation in other European countries during this period with again increasing recognition of the need to tailor treatment with atypical antipsychotic drugs.
There was again high utilization of oral generic risperidone in Scotland. INN prescribing averaged 93–98% of total oral risperidone on a DDD basis following the availability of generics. This suggests no problems with generic oral risperidone in practice. However, specific research among patients is needed before we can make any definitive statements.
Reimbursed expenditure for the selected atypical antipsychotic drugs grew by 42% during this period, increasing from GB£4662/1000 inhabitants/year in 2005 to GB£6512/1000 inhabitants/year in 2010. This was lower than the increase seen with their utilization, facilitated by reimbursed expenditure/DDD for generic oral risperidone at GB£0.47p in 2010, 84% below pre-patent loss prices. This reduction in expenditure/DDD for generic oral risperidone reduced expenditure for risperidone in 2010 in Scotland by GB£3.19 million compared with the pre-patent loss situation. Expenditure on atypical antipsychotic drugs should start falling in Scotland with oral olanzapine losing its patent at the end of 2011 and quetiapine in March 2012, with these two the most prescribed atypical antipsychotic drugs in Scotland.
In Scotland, there was a pragmatic approach to the availability of generic clopidogrel with Health Board Drugs and Therapeutics Committees recommending its prescribing rather than PLAVIX. This was in view of the potential resource savings and no perceived problems with generic clopidogrel. A similar situation was seen among a number of other European countries and regions despite the efforts of the originator company, endorsing the approach taken in Scotland. The authorities in France recently fined the originator company for the disinformation regarding generic clopidogrel further endorsing the approach in Scotland. Hopefully, this will reduce such activities by companies in the future.
Again, the prescribing of generic clopidogrel was enhanced by high INN prescribing rates in Scotland (Education) generally coupled with benchmarking and academic detailing (Education) as well as financial incentives for general practitioners (Economics). The only current recommendations regarding generic clopidogrel are concerning specific salts to dispense in nursing homes when the packs are broken down for unit dispensing, as there can be stability concerns.
This contrasts with Korea where the originator PLAVIX still accounted for over 80% of clopidogrel utilization in 2009 despite 37 branded generics launched between 2006 and 2009. Limited supply-side measures meant the cost of PLAVIX only decreased by 13% in 2009 compared with pre-patent loss prices whereas there was a 40% price reduction for generics. Utilization of clopidogrel rose by 173% between 2006 and 2009, with most of this increase attributable to the originator (126% increase). The lack of measures and initiatives in Korea such as a reference pricing system for the molecule, limited transparency in the pricing of generics as well as no demand-side measures such as INN prescribing or generic substitution appreciably, reduced resource savings in Korea versus Scotland. Generic clopidogrel in Scotland was already 93% below pre-patent loss prices by July 2011.
Results
PPIs & Statins
Table 1 contains the details of the multiple demand-side measures instigated for both the PPIs and statins in Scotland between 2001 and 2007 to improve the quality and efficiency of prescribing for acid-related stomach disorders and hypercholesterolemia. Generic omeprazole became available in 2002 and generic simvastatin in 2003. These have been collated under the 4Es: education, engineering, economics and enforcement. Education refers to initiatives such as guidelines, benchmarking and academic detailing; engineering refers to organizational or managerial interventions such as prescribing indicators; economics refers to financial incentives such as physician financial incentives for achieving agreed prescribing targets and enforcement refers to regulations such as prescribing restrictions, which have been introduced for the statins in a number of European countries including Austria, Croatia and Sweden, and compulsory generic substitution, as seen in Sweden. There are currently no prescribing restrictions in Scotland; consequently this is not contained within Table 1.
This is similar to the multiple demand-side measures introduced in Sweden to enhance prescribing efficiency (Table 2). Both greater than the more limited demand-side measures introduced for the PPIs and statins in France, Ireland and Portugal between 2001 and 2007 (Table 2), although this is changing in France with the introduction of pay-for-performance programs since 2009 (Table 2).
PPIs The multiple demand-side measures introduced in Scotland between 2001 and 2007 (Table 1) resulted in omeprazole continuing to drive the increase in PPI utilization, with stable utilization of the other PPIs including esomeprazole. Omeprazole was almost exclusively generic omeprazole on a defined daily dose (DDD) basis once available, with rates of over 98% of total omeprazole utilization since 2006.
Expenditure/DDD for generic omeprazole continued to fall following the various demand-side initiatives (Table 1) as well as following the introduction of the 'M' and 'W' scheme. These supply- and demand-side measures continued after 2007 resulting in expenditure/DDD of generic omeprazole in 2010, 91% below 2001 originator prices. As a result, expenditure/1000 inhabitants/year in 2010 in Scotland was GB£5481 (€6301), 56% below 2001 levels despite a threefold increase in utilization during this period.
The authors calculated expenditure/1000 inhabitants/year for the PPIs in 2010 would have been GB£35,934 (€41324) assuming no reductions in expenditure/DDD for the PPIs since 2001 and similar utilization patterns. This led to potential savings of over GB£159 million alone in 2010 in Scotland for the 5.2 million population.
Statins
Simvastatin continued to dominate statin utilization from 2001 onwards, reaching 57–58% of total statins (DDD basis) between 2007 and 2010 following the multiple demand-side measures (Table 1), with stable utilization of both atorvastatin and rosuvastatin. This was increasingly higher strength statins for both simvastatin (Figure 1) and atorvastatin helped by the inclusion of lipid level targets in the Quality and Outcomes Framework (QoF) (Table 1), as well as published studies and SIGN guidance advocating 40 mg simvastatin (Table 1).
(Enlarge Image)
Figure 1.
Number of different strength simvastatin tablets dispensed in Scotland 2000–2010. Reproduced with permission from [9].
Higher strength simvastatin (40 and 80 mg) accounted for 85% of total simvastatin DDDs in 2010; slightly greater for higher strength atorvastatin (20, 40 and 80 mg) at 94% of total atorvastatin DDDs. This was nearly all 40 mg for simvastatin, averaging 94–97% of higher strength statins between 2005 and 2010.
Simvastatin was typically generic simvastatin, averaging 98% of all simvastatin utilization on a DDD basis since 2006. This coupled with continued low prices for generic simvastatin, at 97% below 2002 originator prices in 2010, led to reimbursed expenditure up only 7% in 2010 compared with 2001, at GB£11,420/1000 inhabitants (€13,113). This was despite a 6.2-fold increase in statin utilization during this period. The authors believe that expenditure/1000 inhabitants/year for the statins in 2010 would have been GB£67,256 (€77,345) assuming no reduction in expenditure/DDD for the statins since 2001 and similar utilization patterns. This leads to potential savings of over GB£290 million in 2010.
Comparison with other European countries
There were limited demand-side measures in France, Ireland and Portugal encouraging the preferential prescribing of generic PPIs and statins between 2001 and 2007 (Table 2) compared with Scotland (Table 1). This resulted in a decrease in the utilization of omeprazole, and an increase in the utilization of esomeprazole, in each of these three countries following the availability of generic omeprazole. Similarly in these three countries during this time, an increase in the utilization of patented atorvastatin and rosuvastatin following the availability of generic simvastatin was noted. As a result, considerable differences were noticed in overall prescribing efficiency between Scotland and these three countries between 2001 and 2007 following the availability of generic omeprazole and simvastatin, with all PPIs and statins seen as essentially similar in all or nearly all patients (Table 3).
Multiple demand-side measures (Table 2) also appreciably enhanced prescribing efficiency in Sweden for both the PPIs and statins between 2001 and 2007, for example, PPI and statin utilization increased by 42% and 2.5-fold, respectively but expenditure decreased by 48 and 51%, respectively. As a result, expenditure/1000 inhabitants/year for both classes in 2007 was under Euro6000, a tenth of that seen in Ireland, although for a less co-morbid population.
Renin–angiotensin Inhibitor Drugs
ACEIs versus ARBs Various demand-side measures were implemented in Scotland between 2001 and 2007 to enhance the prescribing of generic angiotensin-converting enzyme inhibitors (ACEIs) versus patented ARBs (Table 4), with the drugs in both classes seen as essentially similar in most patients. This was because prospective clinical studies showed that a dry cough only occurred in approximately 10% of patients prescribed ACEIs, with only 2–3% of patients in ACEI clinical trials actually discontinuing these drugs due to a dry cough. These findings led the Office of Fair Trading to suggest that ARBs should only comprise a maximum of 5% of total prescriptions of all renin–angiotensin inhibitor drugs. Having said this, published studies have shown that a dry cough can occur in up to 25% of patients in selected populations especially those prescribed higher doses.
These activities led to low utilization of ARBs in Scotland versus Portugal between 2001 and 2007 (Figure 2), with limited demand-side measures in Portugal during this period (Table 4). There were similar ARB utilization patterns in Scotland to both Austria and Croatia (Figure 2). The authorities in both these countries had instigated prescribing restrictions limiting the prescribing of ARBs to patients experiencing tolerance or side-effect problems with ACEIs. These restrictions were backed up with financial penalties for physicians suspected of abuse to help enhance adherence, although their intensity varied between the two countries. There was greater follow-up of prescribing restrictions in Croatia, leading to differences in practice in subsequent ARB utilization profiles between these two countries (Figure 2).
(Enlarge Image)
Figure 2.
Percentage utilization of angiotensin-converting enzyme inhibitors versus all renin–angiotensin inhibitor drugs (defined daily dose basis) during 2001–2007 among selected European countries. Data taken from [23].
As a result, there was stable expenditure on renin–angiotensin inhibitor drugs in Scotland between 2001 and 2007 versus growing expenditure in Portugal (Figure 3). This was despite a 159% increase in utilization (DDD basis) in Scotland between 2001 and 2007, helped by low prices for generic ACEIs and limited utilization of ARBs. Utilization of renin–angiotensin inhibitor drugs increased by 69, 89 and 72% in Austria, Croatia and Portugal, respectively between 2001 and 2007. Generic enalapril and lisinopril were 88% below pre-patent loss prices in Scotland in 2007, and accounted for 98–99% of total enalapril and lisinopril on a DDD basis in 2007.
(Enlarge Image)
Figure 3.
Expenditure/1000 inhabitants/year for renin–angiotensin inhibitor drugs among selected European populations. Data taken from [14].
Losartan versus Patented ARBs Losartan's patent expired in the UK in March 2010, with the first generics reimbursed in Scotland in July 2010 when losartan was listed on the Drug Tariff. Consequently, Health Boards should be active in Scotland encouraging GPs to start patients on losartan when an ARB is indicated, as well as switching patients on other ARBs to losartan. This particularly as GB£26.27 million was spent on ARBs in Scotland in 2009, making ARBs the seventh most expensive drug class in Scotland, and the price of losartan was falling rapidly following its availability. In addition, all ARBs are seen as equally effective for the management of hypertension and heart failure at appropriate doses, although care may be needed with switching patients with heart failure to losartan to save costs.
However, there were no specific activities among the Health Boards to increase the prescribing of generic losartan versus existing patented ARBs. This was because therapeutic switching programs and other active measures would entail considerable Health Board resources both in time and costs when generic valsartan, candesartan and irbesartan would shortly become available on the Drug Tariff. In addition, other higher priority areas had already been identified to improve the quality and efficiency of primary care prescribing in Scotland in 2012 and some of these would be compromised by concentrating on generic losartan. Multiple demand-side measures had also already successfully limited ARB utilization in Scotland (Figure 2), and there would be savings anyway from the availability of generic losartan versus the originator due to the low envisaged price for generic losartan.
There was no appreciable change in the utilization of losartan following the availability of generics, rising by 4% on a moving annual total basis (DDDs) 1 year after the availability of generic losartan. There was a similar pattern when assessing the utilization of losartan as a % of all single ARBs following the availability of generic losartan (Table 5). This was different to the significant increase in losartan utilization in Austria and Belgium following the availability of generic losartan (Table 5). In both countries, prescribing restrictions were removed for losartan but not for the other ARBs. The other ARBs could only be prescribed in patients intolerant to ACEIs or experiencing unacceptable side effects. In Sweden, multiple demand-side measures were introduced similar to those for PPIs and statins (Table 2) along with therapeutic switching. This also resulted in a significant increase in the utilization of losartan post-generic availability (Table 5). There was also an appreciable increase in the utilization of losartan versus other ARBs in Bury PCT following generics and therapeutic switching programs combined with other measures including guidelines, prescribing targets and financial incentive programs in March 2011.
Losartan was typically generic losartan in Scotland after its launch, averaging between 98 and 99% of all losartan on a DDD basis from August 2010.
In March 2012, the reimbursed price (Drug Tariff price) of losartan 50 mg in Scotland was GB£0.056p/day, 88% below pre-patent loss prices. This led to estimated savings of nearly GB£8 million/year in Scotland just from the availability of generic losartan alone versus the pre-patent loss situation.
Selective Serotonin Reuptake Inhibitors
The demand-side measures among the Health Boards in Scotland described earlier, following advice from SMC, led to low utilization of escitalopram in Scotland (Table 6). This compares with Ireland and Portugal (Table 6) with their limited demand-side measures generally to combat pharmaceutical company marketing activities (Table 2 & Table 4).
There was also high INN prescribing for the SSRIs on a DDD basis in Scotland in 2007 suggesting limited concerns with generic SSRIs in practice, for example, fluoxetine, paroxetine and sertraline were 98% generics in 2007 and citalopram 99%. This coupled with low prices for generic SSRIs, for example, generic citalopram in 2007 was 84% below pre-patent loss prices, generic fluoxetine in 2007 was 88% below and generic sertraline 89% below pre-patent loss prices in 2007, substantially lowered SSRI expenditure in recent years in Scotland (Table 7). This compares with appreciably increased expenditure in both Ireland and Portugal in 2008 and 2007 versus 2001, respectively (Table 7).
Overall between 1998 and 2007, the utilization of SSRIs increased 2.37-fold in Scotland but overall expenditure decreased by 59%. This resulted in considerable resource savings without appearing to compromise care. However, specific research is needed among patients before we can make any definitive statements.
Generic Atypical Antipsychotic Drugs
There was limited Health Board activity in Scotland following the availability of generic oral risperidone in view of the recognized need to tailor therapies for patients with schizophrenia or bipolar disorders. This was apart from suggesting to psychiatrists that they start patients on a generic oral atypical antipsychotic drug where possible.
There was a 53% increase in the utilization of selected atypical antipsychotic drugs in Scotland in recent years, rising from 3.4 DDDs/1000 inhabitants/year in 2005 to 5.1 in 2010. This was driven by increasing utilization of olanzapine, quetiapine and aripiprazole, although there have been concerns with some of the marketing activities of companies. There was limited influence of the availability of generic oral risperidone in April 2008 on its subsequent utilization. Overall, the utilization of risperidone decreased steadily from 21% of total atypical antipsychotic drugs (DDD basis) in 2005 to 16% in 2010. This mirrored the situation in other European countries during this period with again increasing recognition of the need to tailor treatment with atypical antipsychotic drugs.
There was again high utilization of oral generic risperidone in Scotland. INN prescribing averaged 93–98% of total oral risperidone on a DDD basis following the availability of generics. This suggests no problems with generic oral risperidone in practice. However, specific research among patients is needed before we can make any definitive statements.
Reimbursed expenditure for the selected atypical antipsychotic drugs grew by 42% during this period, increasing from GB£4662/1000 inhabitants/year in 2005 to GB£6512/1000 inhabitants/year in 2010. This was lower than the increase seen with their utilization, facilitated by reimbursed expenditure/DDD for generic oral risperidone at GB£0.47p in 2010, 84% below pre-patent loss prices. This reduction in expenditure/DDD for generic oral risperidone reduced expenditure for risperidone in 2010 in Scotland by GB£3.19 million compared with the pre-patent loss situation. Expenditure on atypical antipsychotic drugs should start falling in Scotland with oral olanzapine losing its patent at the end of 2011 and quetiapine in March 2012, with these two the most prescribed atypical antipsychotic drugs in Scotland.
Clopidogrel
In Scotland, there was a pragmatic approach to the availability of generic clopidogrel with Health Board Drugs and Therapeutics Committees recommending its prescribing rather than PLAVIX. This was in view of the potential resource savings and no perceived problems with generic clopidogrel. A similar situation was seen among a number of other European countries and regions despite the efforts of the originator company, endorsing the approach taken in Scotland. The authorities in France recently fined the originator company for the disinformation regarding generic clopidogrel further endorsing the approach in Scotland. Hopefully, this will reduce such activities by companies in the future.
Again, the prescribing of generic clopidogrel was enhanced by high INN prescribing rates in Scotland (Education) generally coupled with benchmarking and academic detailing (Education) as well as financial incentives for general practitioners (Economics). The only current recommendations regarding generic clopidogrel are concerning specific salts to dispense in nursing homes when the packs are broken down for unit dispensing, as there can be stability concerns.
This contrasts with Korea where the originator PLAVIX still accounted for over 80% of clopidogrel utilization in 2009 despite 37 branded generics launched between 2006 and 2009. Limited supply-side measures meant the cost of PLAVIX only decreased by 13% in 2009 compared with pre-patent loss prices whereas there was a 40% price reduction for generics. Utilization of clopidogrel rose by 173% between 2006 and 2009, with most of this increase attributable to the originator (126% increase). The lack of measures and initiatives in Korea such as a reference pricing system for the molecule, limited transparency in the pricing of generics as well as no demand-side measures such as INN prescribing or generic substitution appreciably, reduced resource savings in Korea versus Scotland. Generic clopidogrel in Scotland was already 93% below pre-patent loss prices by July 2011.
Source...