Appl Health Econ Health Policy 2006; 5 (4): 270-272CORRESPONDENCE 1175-5652/06/0004-0270/$39.95/0

© 2006 Adis Data Information BV. All rights reserved.

drug regulatory agency approves will be approvedThe Author’s Reply by another. We readily acknowledge that there maybe drugs indicated for the disease areas mentioned

The purpose of our analysis[1] is to give a com- above that the FDA did and the European and Brit-parative assessment of individual dimensions of pa- ish regulatory bodies did not approve. Several stud-tient access to pharmaceuticals in the UK and US. ies we have conducted have demonstrated that dif-The first step towards providing such an assessment ferences persist between numbers of approvals inis to identify dimensions of access, one of which is the US and Europe across many therapeutic catego-coverage. Other dimensions include approvals and ries.[3,4] For some categories, the US approves moretiming of approvals by respective drug regulatory pharmaceuticals, for others Europe approves more.agencies, cost sharing, conditions of reimbursement, Hay questions whether our assessment is “bal-speed to reimbursement following marketing ap- anced.” We are unsure why he comes to that conclu-proval, evenness of distribution of coverage, and the sion, especially in light of our findings that indicateextent to which individuals have control over their an even split between the UK and US in terms of thechoice of drug benefit. Hence, we do not limit our scoring of the degrees to which the eight dimensionsanalysis strictly to coverage as Hay[2] seems to im- of access are met in each system. In some areas,ply. Twice he critically assails our analysis as an such as speed to reimbursement, conditions of reim-“assessment of drug coverage between [the US and bursement,1 and flexibility, the US performs better,UK].” It is important to note in this regard that while in others, such as cost sharing and equity, thealthough we do draw conclusions on the degree to UK does. We are particularly puzzled as to why Haywhich individual dimensions of access are met in the takes aim at our conclusion that “US patients haveUK and US, we are careful not to draw conclusions higher cost sharing than the UK and coverage is lessthat one system has better access than the other. This evenly spread across the population.” In support ofwould require weighing the importance stakeholders his criticism of this conclusion, Hay points to the– patients, healthcare providers, policy makers, special provisions in place for low-income Medicarethird-party payers and the pharmaceutical industry – beneficiaries. We acknowledge the fact that costattribute to each dimension of access in order to sharing exemptions apply to dual eligibles. In addi-derive a composite access index. tion, with between 85% and 90% of Medicare bene-

The second step in our assessment is to measure ficiaries enrolled in Part D, Medicare has taken athe degrees to which individuals dimensions of ac- major step towards reducing the numbers of benefi-cess are met in the UK and US for a sample of ciaries without insurance for outpatient pharmaceu-pharmaceuticals. As a benchmark from which to tical care. Nevertheless, we stand by our conclusionstart our analysis, we chose all 71 drugs evaluated that, on average, Medicare beneficiaries have muchby the British National Institute for Health and higher cost sharing than NHS beneficiaries, and thatClinical Excellence (NICE) between its inception in coverage is less evenly spread across the population.1999 and March 2005. We consider this to be a valid Not only are per prescription charges higher onstarting point for our analysis as these are recently average for Medicare beneficiaries,2 but most Medi-approved, high-cost, high-impact drugs, spanning a care beneficiaries are faced with deductibles and/orbroad spectrum of disease areas, from depression, gaps in coverage that their NHS counterparts areepilepsy and Alzheimer’s disease, to a variety of not. Furthermore, close to 5 million Medicare bene-cancers. Our study shows that the US FDA did not ficiaries, including dual eligibles, have not (yet)approve seven of the 71 drugs. Not all drugs that one signed up and therefore do not have coverage, while

1 Contrary to Hay’s claim, we do not ignore indication restrictions as an access dimension. In fact, we explicitlyinclude indication restrictions as a subset of conditions of reimbursement. Indeed, we found that the UK imposes moreindication restrictions than our sample of US plans.2 Note that well over 50% of NHS beneficiaries are exempt from co-payments for their prescription drugs.

Letter to the Editor 271

all NHS beneficiaries are automatically covered for drug benefit is shifting drug spending from the pri-pharmaceutical care. vate sector and Medicaid to Medicare, making

Medicare the nation’s de facto leading prescriptionHay is correct to assert that there are “majordrug purchaser.4 As such, Medicare Part D is fore-differences in philosophies [between the US andcast to become a major driver of formulary manage-UK] regarding the roles of government and marketsment strategies targeted at both the non-commercialin healthcare.” These differences point to the perilsand commercial populations.[5] Whether, as Hayof comparative analysis. Comparisons lose theirsuggests, “private drug coverage options are oftenmeaning without proper contextualisation of themore generous than Medicare Part D plans in termsfacts. However, this should not deter researchersof formulary coverage and patient cost sharing” isfrom pursuing comparative analysis, provided theyan empirical question that has yet to be fully ad-present the appropriate contexts. We believe that indressed. In fact, recent findings by Hoadley et al.[6]the limited space granted to us, we have presentedcall into question Hay’s statement, especially withthe reader with sufficient context. Moreover, thoughrespect to patient cost sharing.we concur with Hay that we might have been more

Joshua Cohencautious in drawing general conclusions from bothTufts Center for the Study of Drug Development,our sample of 71 drugs and our sample of seven US

Tufts University School of Medicine, Boston,plans with which to compare the British NHS, weMassachusetts, USAtake issue with his suggestion that our samples con-

cern a “very narrow subgroup of US coverage deci-sions.” Acknowledgements

We acknowledge that a more comprehensiveThe author has no conflicts of interest that are directlycomparison would have to include not only Medi-

relevant to the content of this letter.caid, the privately insured non-Medicare and non-Medicaid population, but also the uninsured popula-tion. However, for the purpose of feasibility and Referencescommensurability – the need to compare like with 1. Cohen J, Cairns C, Paquette C, et al. Comparing patient access

to pharmaceuticals in the UK and US. Appl Health Econlike – we examined pharmaceutical access in twoHealth Policy 2006; 5 (3): 177-87

nationally administered public programs, the British 2. Hay JW. Comparing patient access to pharmaceuticals in theUK and US [letter]. Appl Health Econ Health Policy 2006; 5NHS and the US’s Medicare.3 Hay suggests that the(4): 269-70Medicare population is “far from representative of

3. Cohen J, Faden L, Predaris S, et al. Patient access tothe entire US population.” While several features of pharmaceuticals: an international comparison. Eur J Health

Econ. In pressthe Medicare population, including age, disability4. Cohen J, Paquette C, Cairns C. Can Medicare draw lessons fromand disease (e.g. end-stage renal disease) status Dutch experience with a national formulary? Drug Information

J. In pressmake it uniquely different from the rest of the US5. Atlas R. The role of PBMs in implementing the Medicarepopulation, the formulary management strategies

prescription drug benefit. Health Aff 2004 Jul-Dec; Suppl Webthat third-party payers use for the Medicare popula- Exclusives: W4-504-15

6. Hoadley J, Hargrave E, Cubanski J, et al. An in-depth examina-tion will probably have influence on the strategiestion of formularies and other features of Medicare drug plans.they employ for their commercial population as April 2006 [online]. Available from URL: http://www.kff.org/

well. Implementation of the Medicare prescription medicare/upload/7489.pdf [Accessed 2006 Nov 2]

3 Needless to say, we are fully aware of the many differences between the NHS and Medicare. For example, while bothprogrammes are national in scope and administration, they delegate considerable decision-making responsibilities withrespect to delivery and coverage of care to local organisations – the NHS to hundreds of local primary and acute caretrusts, Medicare to local contractors and third-party payers.4 We say “de facto” because the US federal agency that administers Medicare – Centers for Medicare and Medicaid –is not a monopsonist. It leaves most coverage and purchase decisions to local contractors and purchasers.

© 2006 Adis Data Information BV. All rights reserved. Appl Health Econ Health Policy 2006; 5 (4)