Katri Aaltonen

A 3-Dimensional View of Access to Licensed and Subsidized Medicines under Single-Payer Systems in the US, the UK, Australia and New Zealand

AbstractIntroduction: Patients’ access to medicines can be profoundly affected by the decisions made by medicine licensing bodies and public reimbursement agencies. The present study compares access to licensed and subsidized medicines under a single-payer system in each of the US, the UK, Australia and New Zealand (NZ). These systems are the US Department of Veterans Affairs National Formulary (VANF), the UK NHS for England and Wales, Australian Pharmaceutical Benefits Scheme (PBS) and NZ’s Pharmaceutical Management Agency (PHARMAC). The VANF, PBS and PHARMAC all use positive lists of medicines that are subsidized, along with pharmacoeconomic analysis and price negotiations with suppliers. The NHS uses a negative list of medicines that are not to be subsidized, along with pharmacoeconomic analysis of a small number of medicines and caps on manufacturers’ profits. Objective: Our objective was to compare licensed and subsidized medicines in terms of the following: (i) total numbers of entities (unique Anatomical Therapeutic Chemical [ATC] codes); (ii) times since first registration (age) of the entities; and (iii) numbers of innovative entities. Methods: This was an observational study in order to test pre-defined hypotheses. All products listed in a major prescribing reference in each country were included in the study. All products were classified by ATC code and their registration dates recorded. Products were collapsed by ATC code to determine ‘best-case’ licensing and subsidy for each entity, along with the date of first registration. Innovative entities selected for ‘fast-track’ approval by the US FDA or as a ‘breakthrough or substantial improvement’ by the Canadian Patented Medicines Prices Review Board were identified. Results were verified by a sensitivity analysis that excluded entities only available in injectable formulations (as these may not always be listed in general prescribing references), and by a parallel analysis done by active agent rather than ATC code. Results: Of the 918 entities and 64 innovative entities licensed in the US, 505 and 20, respectively, were subsidized by the VANF. In the UK, this was 1020 and 58 (1016 and 58 NHS subsidized); in Australia, this was 879 and 49 (567 and 30 PBS subsidized); and in NZ, this was 765 and 39 (503 and 19 PHARMAC subsidized). With the exception of the UK, entities licensed in the US were newer than elsewhere. The median ages were as follows: 6607 days in the US (VANF subsidized 8203 days; p<0.001); 7319 days in the UK (NHS subsidized 7319 days; p=0.903); 7795 days in Australia (PBS subsidized 8065 days; p=0.406); and 8936 days in NZ (PHARMAC subsidized 10724 days; p < 0.001). NHS subsidized entities were newer than elsewhere. VANF and PHARMAC subsidized entities were significantly older than licensed entities in their respective countries. Conclusion: The single-payer systems examined differ in the number and age of licensed and subsidized entities, along with access to innovative entities. The NHS subsidized the most entities, the newest entities and the most innovative entities. NZ’s PHARMAC system subsidized the fewest and oldest entities, and the fewest innovative entities. The VANF and PBS consistently fell between the other two systems in terms of the number of subsidized entities, age of subsidized entities and number of subsidized innovative entities.

From systemic hormone therapy to vaginal estrogen - a nationwide register study in Finland, 2003-2012.

OBJECTIVES To assess the patterns of use of reimbursed systemic hormone therapy (HT) and vaginal estrogen preparations among women aged 45 and older in Finland. STUDY DESIGN Reimbursed purchases of prescribed systemic HT and vaginal estrogen preparations for the years 2003-2012 were obtained from a nationwide prescription registry. Systemic preparations included estrogen patches, gels and tablets, tibolone, continuous combination preparations and sequential combination preparations. Prescribed vaginal estrogens included a vaginal ring and vaginal tablets. MAIN OUTCOME MEASURES Annual period prevalence for systemic HT and vaginal estrogen use. RESULTS The total prevalence of prescribed HT use remained relatively constant (at 26-27%) throughout the studied period, but the share of women using systemic preparations decreased from 21% to 12%, while the share of women using vaginal estrogens increased from 9% to 19%. Decreases were observed for all classes of systemic preparations, although the decrease was largest for sequential combination preparations (from 4.9% to 1.6%) and estrogen tablets (from 5.2% to 2.9%). Continuous combination preparations remained the most commonly used types of systemic preparation (5.4-4.2%). Systemic HT use decreased most among 45-49 year old women (9.5-4.3%), while the use of vaginal estrogens increased most among those aged 65 and over. CONCLUSIONS Based on the register data, the trends in HT use indicate changed prescribing patterns in accordance with clinical guidelines. It is notable that since 2009, vaginal estrogen was more commonly prescribed than systemic HT.

The authors' reply to wonder and milne: "comparing subsidized access to medicines across payer systems".

We thank Wonder and Milne [1] for their insightful comments. We were unable to cite their analysis as our article was already in press [2, 3]. Wonder and Milne [1] query whether the Department of Veterans Affairs National Formulary (VANF) is comparable to the other systems. Each comparator is of course in some way sui generis. This is not a reason to exclude the VANF, as sufficient similarities exist to compare like with like [3, 4]. As Wonder and Milne [1] point out, funding systems may differ in coverage for children. We have carried out a full analysis of coverage for children in these four systems, and presented this separately [4, 5]. We agree with Wonder and Milne [1] on the importance of accounting for differences in the funding of hospital products and vaccines. Therefore, we incorporated a sensitivity analysis that excluded injectable-only products [3, 4]. The results did not change significantly. While Wonder and Milne [1] correctly point out that what is prescription only in one country might be nonprescription in another, our analysis collapsed multiple products down to entities [3, 4]. Very few entities for serious conditions are available only in non-prescription forms in any of these countries. Wonder and Milne [1] question whether the systems differ in the funding of medicines that were innovative in past decades (such as penicillin). This seems unlikely, as all four systems use pharmacoeconomics and clinical evidence in their decision making [4]. The types of medicines subsidized were also very similar in all four systems [3, 4]. Wonder and Milne [1] correctly point out that a regulator’s definition of an innovative medicine might differ from a payer’s. (Patients often find an innovative medicine is licensed but not subsidized.) Using definitions from both a regulator (US FDA) and a payment agency (Patented Medicines Prices Review Board) highlights this dilemma better than lists from payment agencies alone [3, 4]. Wonder and Milne [1] ask if our findings regarding innovative entities might have been different if we had started the analysis from 1999, when the National Institute for Health and Clinical Excellence (NICE) began operating in the UK. Starting the analysis from a date significant to only one country would have risked biasing a four-country comparison. One could just as reasonably choose the year the Pharmaceutical Management Agency (PHARMAC) began operating, for instance. Wonder and Milne [1] suspect that the systems provide different levels of access to older and newer entities. Our analysis clearly shows this to be the case (see Table V in our article [3]). This is supported by analysis of entities that are subsidized in one system but not in another [4]. We heartily agree with Wonder and Milne [1] that what matters is the impact access to medicines has on public This reply refers to the comment available at doi:10.1007/s40273-012-0010-9.

Growth of diabetes drug expenditure decomposed—A nationwide analysis

OBJECTIVES The aim of this study was to quantify different factors underlying the growth of diabetes drug expenditure in Finland. METHODS Data representing purchases of antidiabetic agents between 2003 and 2015 were extracted from a nationwide prescription register. By using Fishers Ideal Indexes, the per capita expenditure growth for both insulins and non-insulin antidiabetic agents was decomposed into six different determinants: purchase volume, purchase size, switches between therapeutic classes, switches within therapeutic classes, unit costs and switches to generic alternatives. RESULTS Between 2003 and 2015, the per capita expenditure on insulins increased by €8.64 and on non-insulins by €13.73. For insulins, holding other factors constant, change in the number of purchases represented a €4.67 increase in expenditure, change in the size of purchases a €4.33 increase and switches between therapeutic classes a €4.07 increase. For non-insulins, change in the number of purchases represented a €10.22 increase in expenditure and switches between therapeutic classes, a €10.17 increase. Changes in purchase size increased the non-insulin per capita expenditure by €1.48. For both insulins and non-insulins, changes in prices and product level switches had decreasing effects on expenditures. CONCLUSIONS The main drivers of the growth in diabetes drug expenditure were volume growth and switches to newer and more expensive drugs. Price changes, however, had a decreasing effect on the overall diabetes drug expenditure.