Understanding profit margins of medical providers from prescription drugs: evidence from Taiwan.

BACKGROUND: This study empirically estimates the magnitude and associated determinants of profit margins that medical providers earn from prescription drugs based on Taiwan's pharmaceutical market. METHODS: Our main data set is from the population-based claims data compiled by the National Health Insurance Research Database covering three waves of price adjustment: July-December 2004, October 2007-September 2008 and October 2009-September 2010. Only drugs whose reimbursement prices were adjusted using the R-zone formula were used as samples for this study. By calculating the difference between retail and wholesale prices for 796 pharmaceutical products, we can estimate the profit margin determinants using the regression model. RESULTS: We found evidence that suppliers of generic drugs tend to offer larger discounts to medical providers than suppliers of brand-name drugs. In addition, the countervailing power of wholesale pharmaceuticals, as measured by the discount rate offered by pharmaceutical manufacturers, is positively associated with the degree of competition within the pharmaceutical market and the size of the market itself. CONCLUSIONS: Our findings imply that the profit-seeking behaviour exhibited by medical providers is the engine of competitive forces in Taiwan's prescription drug market. This creates financial incentives for them, which in turn influences their choices of prescription drugs.

Association between gifts from pharmaceutical companies to French general practitioners and their drug prescribing patterns in 2016: retrospective study using the French Transparency in Healthcare and National Health Data System databases.

OBJECTIVE: To evaluate the association between gifts from pharmaceutical companies to French general practitioners (GPs) and their drug prescribing patterns. DESIGN: Retrospective study using data from two French databases (National Health Data System, managed by the French National Health Insurance system, and Transparency in Healthcare). SETTING: Primary care, France. PARTICIPANTS: 41 257 GPs who in 2016 worked exclusively in the private sector and had at least five registered patients. The GPs were divided into six groups according to the monetary value of the received gifts reported by pharmaceutical, medical device, and other health related companies in the Transparency in Healthcare database. MAIN OUTCOME MEASURES: The main outcome measures were the amount reimbursed by the French National Health Insurance for drug prescriptions per visit (to the practice or at home) and 11 drug prescription efficiency indicators used by the National Health Insurance to calculate the performance related financial incentives of the doctors. Doctor and patient characteristics were used as adjustment variables. The significance threshold was 0.001 for statistical analyses. RESULTS: The amount reimbursed by the National Health Insurance for drug prescriptions per visit was lower in the GP group with no gifts reported in the Transparency in Healthcare database in 2016 and since its launch in 2013 (no gift group) compared with the GP groups with at least one gift in 2016 (-€5.33 (99.9% confidence interval -€6.99 to -€3.66) compared with the GP group with gifts valued at €1000 or more reported in 2016) (P<0.001). The no gift group also more frequently prescribed generic antibiotics (2.17%, 1.47% to 2.88% compared with the ≥€1000 group), antihypertensives (4.24%, 3.72% to 4.77% compared with the ≥€1000 group), and statins (12.14%, 11.03% to 13.26% compared with the ≥€1000 group) than GPs with at least one gift between 2013 and 2016 (P<0.001). The no gift group also prescribed fewer benzodiazepines for more than 12 weeks (-0.68%, -1.13% to -0.23% compared with the €240-€999 group) and vasodilators (-0.15%, -0.28% to -0.03% compared with the ≥€1000 group) than GPs with gifts valued at €240 or more reported in 2016, and more angiotensin converting enzyme (ACE) inhibitors compared with all ACE and sartan prescriptions (1.67%, 0.62% to 2.71%) compared with GPs with gifts valued at €1000 or more reported in 2016 (P<0.001). Differences were not significant for the prescription of aspirin and generic antidepressants and generic proton pump inhibitors. CONCLUSION: The findings suggest that French GPs who do not receive gifts from pharmaceutical companies have better drug prescription efficiency indicators and less costly drug prescriptions than GPs who receive gifts. This observational study is susceptible to residual confounding and therefore no causal relation can be concluded. TRIAL REGISTRATION: OSF register OSF.IO/8M3QR.

Cancer History, Health Insurance Coverage, and Cost-Related Medication Nonadherence and Medication Cost-Coping Strategies in the United States.

OBJECTIVES: To evaluate the relationship between cancer history and cost-related medication nonadherence (CRN) as well as cost-coping strategies, by health insurance coverage. METHODS: We used the 2013 to 2016 National Health Interview Survey to identify adults aged 18 to 64 years with (n = 3599) and without (n = 56 909) a cancer history. Cost-related changes in medication use included (1) CRN, measured as skipping, taking less, or delaying medication because of cost, and (2) cost-coping strategies, measured as requesting lower cost medication or using alternative therapies to save money. Separate multivariable logistic regressions were used to calculate the adjusted odds ratios (AORs) of CRN and cost-coping strategies associated with cancer history, stratified by insurance. RESULTS: Cancer survivors were more likely than adults without a cancer history to report CRN (AOR 1.26; 95% confidence interval [CI] 1.10-1.43) and cost-coping strategies (AOR 1.10; 95% CI 0.99-1.19). Among the privately insured, the difference in CRN by cancer history was the greatest among those enrolled in high-deductible health plans (HDHPs) without health savings accounts (HSAs) (AOR 1.78; 95% CI 1.30-2.44). Among adults with HDHP and HSA, cancer survivors were less likely to report cost-coping strategies (AOR 0.62; 95% CI 0.42-0.90). Regardless of cancer history, CRN and cost-coping strategies were the highest for those uninsured, enrolled in HDHP without HSA, and without prescription drug coverage under their health plan (all P<.001). CONCLUSIONS: Cancer survivors are prone to CRN and more likely to use cost-coping strategies. Expanding options for health insurance coverage, use of HSAs for those with HDHP, and enhanced prescription drug coverage may effectively address CRN.

Easy cuts, easy rebound: Drug expenditures with massive price cuts in Korea.

BACKGROUNDS: Since 2012, the Korean government has introduced 46.5% price cut for off-patent medicines in order to reign everescalating drug expenditure. This study sought to appraise the impact of the price cut measure (in the context of Korean National Health Insurance system). METHODS: We employed Korean National Health Insurance database from January 2007 until December 2016 for 120 month period. An interrupted time series analysis with segmented regression analysis was conducted to estimate the impact of price cut on overall drug spending. RESULTS: Drug spending significantly dropped with the price cut by 186.22 billlion Korean Won (KRW) (p < 0.0001) and the trend after the price cut has also significantly decreased by 1.33 billion KRW (p = 0.002). However, it was predicted that total expenditures showed an increasing trend and bounced back to the original level. Quantity prescribed had no significance with the price cut. Unit price had a substantial drop (ß = -41.68, p < 0.0001) with the price-cut, but the trend after the intervention has increased (ß = 0.16, p = 0.656) with no significance. CONCLUSIONS: Although the price cut has successfully countered the everescalating pharmaceutical expenditures in Korea, the impact was temporary. A lack of demand-side measures resulted in an ineffectiveness and unsustainability of policy effect. Thus, more aggressive demand-side measures should be introduced in the Korean context,and both the demand and supply-sides should be balanced.

[The patients' cost of the montelukast therapy due to the generic substitution]. / A montelukasztterápia betegterheinek változása a generikus árverseny hatására.

INTRODUCTION AND AIM: The aim of our study was to analyse the public price of the montelukast sodium therapy in Hungary. METHOD: Data derived from the nationwide pharmaceutical database of the Hungarian National Health Insurance Fund Administration. We observed the turnover and price of the medicaments containing the active substance montelukast sodium from 2007 to 2015. Accordingly, our indicators were: consumer price, DCT (daily cost of therapy), co-payment, quasi co-payment, DOT (days of treatment). RESULTS: Due to the increasing DOT, the total amount of the public price paid by the patients increased until 2011, reaching the amount of 1 million USD; then, due to the generic competition and the blind bid methods, it decreased to 490 000 USD. The total amount of the public price of the brand-name Singulair moved to the generics during 3 years (2011-2014). The DCT of the originator Singulair 10 mg tablets decreased from 1.1 USD to 0.34 USD; the DCT of the generic product Montelukast TEVA decreased from 0.67 USD to 0.16 USD in the period under review. CONCLUSION: Due to the generic competition, the patients' access to drugs containing montelukast sodium increased significantly: the DOT increased, the co-payment decreased. Orv Hetil. 2018; 159(17): 682-687.

Clinical and Economic Benefits of Pharmacist Involvement in a Community Hospital-Affiliated Patient-Centered Medical Home.

BACKGROUND: The primary goals of an accountable care organization (ACO) are to reduce health care spending and increase quality of care. Within an ACO, pharmacists have a unique opportunity to help carry out these goals within patient-centered medical homes (PCMHs). Pharmacy presence is increasing in these integrated care models, but the pharmacist's role and benefit is still being defined. OBJECTIVE: To exhibit the clinical and economic benefit of pharmacist involvement in ACOs and PCMHs as documented by clinical interventions (CIs) and drug cost reductions. METHODS: This is a retrospective quality improvement study. All interventions made by the pharmacist during the study period were documented using TAV Health. The interventions were then analyzed. Specific identified endpoints included the total number of documented interventions and number of CIs from each category, transition of care (TOC) medication reconciliations performed, discrepancies identified during TOC medication reconciliation, and cost savings generated from generic and therapeutic alternative use. CI categories were collaborative drug therapy management, medication therapy management (MTM), medication reconciliation, patient and provider education, and drug cost management. RESULTS: During the study period (October 2016-March 2017), a pharmacist was in clinic 8 hours per week. Sixty-three patients were included in the study. There were 283 CIs documented, with a majority of the interventions associated with MTM or cost management (94 and 88 CIs, respectively). There were 37 education CIs, 36 TOC medication reconciliations performed, and 28 collaborative drug therapy management CIs. From the 36 TOC medication reconciliations, 240 medication discrepancies were found, with a majority associated with medication omission. A cost savings of $118,409 was gained from generic and therapeutic alternative substitutions. CONCLUSIONS: Clinical benefit of pharmacy services was demonstrated through documented CIs. Pharmacists can have a dramatic and quantitative effect on reducing drug costs by recommending less expensive generic or therapeutic alternatives. Documenting CIs allows pharmacists to provide valuable evidence of avoided drug misadventures and identification of medication discrepancies. Such evidence supports an elevated quality of care. DISCLOSURES: No outside funding supported this study. The authors have nothing to disclose. Study concept and design were contributed by Tate and Hopper, along with Bergeron. Tate collected and interpreted the data, as well wrote the manuscript, which was revised by all the authors.

Economic evaluation of weekends-off antiretroviral therapy for young people in 11 countries.

OBJECTIVES: To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs. METHODS: We conduct a hierarchical cost-effectiveness analysis based on data on clinical outcomes and resource use from the BREATHER trial. BREATHER is a randomized trial investigating the effectiveness of SCT and continuous therapy in 199 participants aged 8 to 24 years and taking efavirenz-based first-line ARV drugs in 11 countries worldwide. Alongside nationally representative unit costs/prices, these data were used to estimate costs and quality adjusted life years (QALYs). An incremental cost-effectiveness comparison was performed using a multilevel bivariate regression approach for total costs and QALYs. Further analyses explored cost-effectiveness in low- and middle-income countries with access to low-cost generic ARV drugs and high-income countries purchasing branded ARV drugs, respectively. RESULTS: At 48 weeks, SCT offered significant total cost savings over continuous therapy of US dollar (USD) 41 per patient in countries using generic drugs and USD 4346 per patient in countries using branded ARV drugs, while accruing nonsignificant total health benefits of 0.008 and 0.009 QALYs, respectively. Cost-effectiveness estimates were similar across settings with access to generic ARV drugs but showed significant variation among high-income countries where branded ARV drugs are purchased. CONCLUSION: SCT is a cost-effective treatment alternative to continuous therapy for young people infected with HIV in countries where viral load monitoring is available.

Fármacos biosimilares: un nuevo escenario en las terapias biológicas / Biosimilars: a new scenario in biologic therapies

No cabe duda de que los productos biológicos aportan un valor añadido a los sistemas de salud, aunque también plantean grandes interrogantes debido a su especial naturaleza, lo que obliga a ser muy rigurosos y exigentes en su control de calidad y seguimiento. Este hecho se ha visto reforzado por la entrada en escena de los fármacos biosimilares, cuyo menor coste está permitiéndoles alcanzar un mayor protagonismo en el mercado mundial. El propósito de este artículo es revisar en profundidad los principales interrogantes que se plantean en su producción, distribución y control, así como los aspectos más importantes relacionados con su seguridad en la práctica clínica. En este trabajo revisamos lo que representa la farmacovigilancia de estos productos, prestando especial atención a su trazabilidad, como herramienta fundamental para la detección precoz de acontecimientos adversos (AU)

There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events (AU)

Do newly marketed generic medicines expand markets using descriptive time series analysis and mixed logit models? Korea as an exemplar and its implications.

BACKGROUND: There have been concerns in Korea that the availability of cheaper generics can appreciably increase prescribed volumes thereby negating their beneficial effects on overall pharmaceutical expenditure. Consequently, this study aimed to explore market changes after newly entered generics including market expansion and substitution effects, and to examine factors contributing to the prescribing of newly entered generics using atorvastatin as an exemplar. This is because previous studies have shown market expansion had occurred following generic atorvastatin. METHODS: Explore market expansion effects by extracting all statins users from July 2008 to June 2010 from the nationally representative dataset of 2008, combined with the National Health Insurance Claims data, with atorvastatin's patent expiring in July 2008. The data consisted of medical visit episodes of patients who had been prescribed statins at least once during the observational period. Patients who had been prescribed any statin before the observation period were classified as the previously treated group and those who had not as the newly treated group. Descriptive time series analysis was conducted and the mixed logit model applied to understand factors contributing to generic atorvastatin prescriptions. RESULTS: Market expansion was observed after generic atorvastatin availability with an appreciable increase in number of newly treated patients, whereas substitution effect was found among previously treated patients. Newly treated patients tended to get significantly lower daily doses (p < 0.0001). According to the mixed logistic analysis, newly treated patients were more likely to be prescribed generic atorvastatin (OR = 2.58; 95% CI, 2.05-3.26) than their counterparts. Clinicians and secondary hospitals were also key drivers of generic atorvastatin (ORs were 10.41 and 9.81, respectively). CONCLUSIONS: Newly marketed generic statins in Korea resulted in an expanding market by substantially increasing the number of new patients with clinics and hospitals appreciably using newly marketed generics. However lower doses of statins were prescribed. Policy makers do recognize that generic availability can save costs so should be encouraged. However, this is a concern when generic availability appreciably expands the market, potentially increasing the financial burden. This needs to be addressed. Additionally in Korea, the quality of prescribing should be monitored, especially focusing on clinics and secondary hospitals.

[The effect of generic price competition on drug consumption and health insurance pharmaceutical expenditures in Hungary]. / A generikus árverseny hatása a gyógyszerforgalomra es a társadalombiztosítási támogatás kiáramláisra Magyarországon.

AIM: The aim of our study was to analyze the Hungarian montelukast sodium drug market. We examined the effect of the appearance of generic drugs on the price and turnover of the brand-name drug, Singulair. DATA AND METHODS: Data derived from the nationwide pharmaceutical database of Hungarian National Health Insurance Fund Administration (2007-2014). We analized the turnover and price of the medicaments containing the active substance montelukast sodium. Accordingly our indicators were: consumer price, social insurance subsidy, patients' co-payment and days of treatment (DOT). RESULTS: First the generics started from a significantly lower price of 18 USD which was lower than the price of brand-name Singulair (32 USD). Then the prices of the generics started to diminish. While in 2007 the DOT was below 2 million, it increased over 10 million days by 2014. The increase of DOT was followed by the increase of health insurance subsidy until 2011. Then the amount of health insurance subsidy decreased from 10,5 million USD to 7 million USD in 2012. In 2013 and 2014 there was a further reduction, the amount of the health insurance subsidy decreased to 4,1 million USD in 2013, and in 2014 it was reduced to 2.2 million USD. CONCLUSIONS: Following the introduction of generic drugs, the price of the medicaments containing montelukast sodium was significantly reduced, while the days on treatment (DOT) increased. The patients' access to drugs containing montelukast sodium increased significantly. The annual health insurance subsidy was significantly reduced as well.

New Highly Active Antiretroviral drugs and generic drugs for the treatment of HIV infection: a budget impact analysis on the Italian National Health Service (Lombardy Region, Northern Italy).

BACKGROUND: In the healthcare sector, it is crucial to identify sustainable strategies in order to allow the introduction and use of innovative technologies. Now, and over the next few years, the expiry of patents for different antiretroviral drugs offers an opportunity to increase the efficiency of resources allocation. The aim of the present study was to assess the impact, on the budget of the Italian National Healthcare Service, of generic antiretroviral drugs and of new antiretroviral drugs entering the market from 2015 to 2019. METHODS: A budget impact model was developed in order to forecast the rate of use of ARTs, based on trends observed within the Lombardy Region (Italy), on clinical experts' opinion, and the consequent impact on the Italian NHS budget in a five year time horizon. Different scenarios were developed, considering the sole introduction of generic drugs, of new drugs, and their cumulative effects. A multivariate sensitivity analysis was also performed. RESULTS: The cumulative use of generic drugs and new drugs would lead to annual savings of 4.6 million € (-0.6 %) in 2015; 16.9 million € (-2.1 %) in 2016; 19.4 million € (-2.4 %) in 2017; 51.1 million € (-6.1 %) in 2018 and -110.3 million € (-12.8 %) in 2019. The impact of new drugs in percentage terms is +2.0 % in 2015, +3.4 % in 2016, +3.9 % in 2017, +5.7 % in 2018 and +7.7 % in 2019. The impact of generic drugs would lead to savings of 4.9 million € in 2015, 18.6 million € in 2016, 22.8 million € in 2017, 76.5 million € in 2018 and 187.4 million € in 2019. The sensitivity analysis showed annual mean savings for the Italian NHS ranging from 12.6 million €, -1.5 % compared to the base case scenario (decreasing all the rates of transition used in the simulation, and increasing the cost of generic drugs) to 76.0 million €, -9.1 % (increasing all the rates of transition used in the simulation, and decreasing the cost of generic and new drugs). CONCLUSIONS: The use of antiretroviral generic drugs may lead to savings that would compensate the expenditure increase due to new, innovative drugs available on the market.

How Do US Gastroenterologists Use Over-the-Counter and Prescription Medications in Patients With Gastroesophageal Reflux and Chronic Constipation?

BACKGROUND: The aim of this study was to assess how US gastroenterologists perceive and utilize over-the-counter (OTC) and prescription medications for gastroesophageal reflux disease (GERD) and chronic constipation (CC). METHODS: A total of 3,600 randomly selected American Gastroenterological Association (AGA) members were mailed a 27-question survey that assessed their perceptions and use of OTC and prescription medications. The χ(2) test and Student's t-test were utilized for bivariate analysis. RESULTS: A total of 830 gastroenterologists (23.1%) completed the survey. For the typical acid reflux patient, 50% of gastroenterologists recommended OTC proton pump inhibitors (PPIs), 13% recommended an OTC histamine2 receptor antagonist, whereas 33% recommended a prescription PPI. However, in the typical CC patient, 97% of gastroenterologists initially utilized OTC treatments. The vast majority of gastroenterologists felt that OTC brand name and store brand PPIs (76%) and polyethylene glycol (PEG 3350; 90%) were equally effective. Despite this, a minority "always" or "very often" directed their patients to purchase a store brand PPI (35%) or laxative (40%). In addition, gastroenterologists tended to underestimate the cost savings associated with store brand medicines and had limited knowledge regarding the regulation of store brands. CONCLUSIONS: Among US gastroenterologists, OTC medications now dominate primary therapy of GERD and CC. Despite feeling that name brand and store brand PPIs and laxatives are equally effective, the majority of gastroenterologists recommend brand name medicines and underestimate the cost savings associated with store brands. In this age of accountable care, greater efforts to help physicians and patients to better utilize their health-care dollars is warranted.

Services provided by community pharmacies in Wayne County, Michigan: a comparison by ZIP code characteristics.

OBJECTIVE: To document the availability of selected pharmacy services and out-of-pocket cost of medication throughout a diverse county in Michigan and to assess possible associations between availability of services and price of medication and characteristics of residents of the ZIP codes in which the pharmacies were located. DESIGN: Cross-sectional telephone survey of pharmacies coupled with ZIP code-level census data. SETTING: 503 pharmacies throughout the 63 ZIP codes of Wayne County, MI. MAIN OUTCOME MEASURES: The out-of-pocket cost for a 30 days' supply of levothyroxine 50 mcg and brand-name atorvastatin (Lipitor-Pfizer) 20 mg, availability of discount generic drug programs, home delivery of medications, hours of pharmacy operation, and availability of pharmacy-based immunization services. Census data aggregated at the ZIP code level included race, annual household income, age, and number of residents per pharmacy. RESULTS: The overall results per ZIP code showed that the average cost for levothyroxine was $10.01 ± $2.29 and $140.45 + $14.70 for Lipitor. Per ZIP code, the mean (± SD) percentages of pharmacies offering discount generic drug programs was 66.9% ± 15.0%; home delivery of medications was 44.5% ± 22.7%; and immunization for influenza was 46.7% ± 24.3% of pharmacies. The mean (± SD) hours of operation per pharmacy per ZIP code was 67.0 ± 25.2. ZIP codes with higher household income as well as higher percentage of residents being white had lower levothyroxine price, greater percentage of pharmacies offering discount generic drug programs, more hours of operation per week, and more pharmacy-based immunization services. The cost of Lipitor was not associated with any ZIP code characteristic. CONCLUSION: Disparities in the cost of generic levothyroxine, the availability of services such as discount generic drug programs, hours of operation, and pharmacy-based immunization services are evident based on race and household income within this diverse metropolitan county.

Drug substitution associated with a hospital stay in Belgium: a retrospective analysis of a claims database.

OBJECTIVES: This study measures the extent of drug substitution associated with a hospital stay in Belgium. METHODS: Data were extracted from the 2006-2007 dataset of the Belgian Agency of Health Insurance Funds on drug use of patients hospitalized in acute hospitals. Reimbursed drugs received in ambulatory care during the 3 months prior to hospitalization were compared with drugs received during the 3 months following hospital discharge. Both a narrow definition and a broad definition were used for drug substitution. Narrow substitution (switches between generic and originator drugs) was computed for 14 drug classes for chronic conditions with the highest public expenditure. Broad substitution (changes between chemical substances within the drug class at ATC level 4, changes in brand name) was calculated for statins and proton-pump inhibitors only. KEY FINDINGS: The database included 17 764 patients (mean age 66 ± 17 years; 60% female). In 71% of cases an originator drug was received prior to and following hospitalization. A generic drug was received prior to and following hospitalization in 25% of cases. Some form of narrow substitution occurred in 4% of cases: a generic drug was replaced by an originator drug in 2% of cases and an originator drug was replaced by a generic drug in 2% of cases. Some form of broad substitution occurred in 25% of cases for proton-pump inhibitors and 13% of cases for statins. CONCLUSIONS: Hospitalization was not a trigger for changes between originator and generic versions of a drug. Broad substitution associated with a hospital stay was relatively limited for statins and proton-pump inhibitors.

[The costs of new drugs compared to current standard treatment]. / Die Preise neuer Arzneimittel im Vergleich zu ihren therapeutischen Alternativen.

BACKGROUND: Until AMNOG came into effect Germany had free pricing of new drugs. Our exemplary work investigates the costs of new drugs that were licensed in the two years prior to AMNOG, and compares them to the costs of standard treatment that has been used in pivotal trials. Also, the important components of pharmaceutical prices will be illustrated. METHOD: We retrospectively analysed the European Public Assessment Reports of proprietary medicinal products that the European Medicinal Agency initially approved in 2009 and 2010 and that were tested against an active control in at least one pivotal trial. RESULTS: If the standard treatment was a generic, the average pharmacy retail price of new drugs was 7.4 times (median 7.1) higher than that of standard treatment. If the standard treatment was an originator drug the average price was 1.4 times (median 1.2) higher than that of the new drug. There was no clear correlation of an increase in costs for new drugs and their "grade of innovation" as rated according to the criteria of Fricke. Our study shows that prices of new drugs must be linked to the evidence of comparative benefit; since German drug pricing is complex, cost saving effects obtained thereby will depend on a range of other rules and decisions.

[Generic drugs and the consumption trends of antihypertensives in Morocco]. / Les médicaments génériques et l'évolution de la consommation des antihypertenseurs au Maroc.

BACKGROUND: To evaluate the evolution of consumption of antihypertensive drugs generic among 1991-2010, to assess the impacts after the institution of Mandatory Health Insurance and the marketing of generic drugs. METHODS: We used sales data from the Moroccan subsidiary of IMS Health Intercontinental Marketing Service. RESULTS: Consumption of generic antihypertensive drugs increased from 0.08 to 10.65 DDD/1 000 inhabitants/day between 1991 and 2010. In 2010, generic of the calcium channel blockers (CCBs) represented 4.08 DDD/1 000 inhabitants/day (82.09%), followed by angiotensin converting enzyme inhibitors (ACEI) by 2.40 DDD/1 000 inhabitants/day (48.29%). The generics market of CCBs is the most dominant and represented in 2010, 79.21% in volume and 62.58% in value. CONCLUSION: In developing countries like Morocco, the generic drug is a key element for access to treatment especially for the poor population.

Does generic entry lower the prices paid for pharmaceuticals in Australia? A comparison before and after the introduction of the mandatory price-reduction policy.

OBJECTIVE: We investigated the relationship between the number of generic medicines and pharmaceutical prices over time in Australia. METHODS: A dataset was utilised containing 76 items for 4 years (2003-2007) on the national subsidy scheme - the Pharmaceutical Benefits Scheme (PBS) - for which a generic brand is available. The PBS price was used as the dependent variable, and the number of generics available the key explanatory variable. The ordinary least-squares estimator was adopted for estimation. In the robustness analysis, an instrumental-variables method was used to account for potential endogeneity. RESULTS: Results suggested that the effect of increased generic medicine sellers on reducing the prices paid for generics is marginal but statistically significant. CONCLUSIONS: It is suggested that structural changes to the way generic prices are determined needs to be reconsidered by the Australian government if the policy aim of using increased 'competition' to lower prices is to be maximised.

Projecting expenditure on medicines in the UK NHS.

BACKGROUND: Expenditure on medicines is a readily identifiable element of health service costs. It is the focus of much attention by payers, not least in the UK even though the cost of medicines represents less than 10 % of total UK National Health Service (NHS) expenditure. Projecting future medicines spending enables the likely cost pressure to be allowed for in planning the scale and allocation of NHS resources. Simple extrapolations of past trends in expenditure fail to account for changes in the rate and mix of new medicines becoming available and in the scope for windfall savings when some medicines lose their patent protection. The objective of this study is to develop and test an improved method to project NHS pharmaceutical expenditure in the UK for the period 2012-2015. METHODS: We have adopted a product-by-product, bottom-up approach, which means that our projections are built up from individual products to the total market. Our projections of the impact of generic and biosimilars entry on prices and quantities of medicines sold, and of the rate of uptake of newly launched medicines, have been obtained from regression analysis of UK data. To address uncertainty, we have created a baseline and two other illustrative scenarios. We have compared our projections with actual expenditure for 2012. RESULTS: Our projections estimate that, between 2011 and 2015, with no change in policy or price regulation, the UK total medicines bill would increase at an average compound annual growth rate (CAGR) of between 3.1 and 4.1 %. Total NHS spending on branded medicines and total NHS spending on generics are projected to increase at average CAGRs of 0.5-1.8 and 10.0-11.0 %, respectively, over the same time period. For the total market, the actual growth rate for 2012 lay within our projected range. CONCLUSIONS: Our methodology provides a useful framework for projecting UK NHS medicines expenditure over the medium term and captures the impacts of existing medicines losing exclusivity and of new medicines being launched onto the market.