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Patient access to pharmaceuticals: an international comparison

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Abstract

We have identified eight sub-dimensions of patient access to pharmaceuticals: marketing approvals, time of marketing approval, coverage, cost sharing, conditions of reimbursement, speed from marketing approval to reimbursement, extent to which beneficiaries control choice of their drug benefit, and evenness of the availability of drugs to the population. For a sample of commonly used best-selling drugs in the United States (US), we measured these eight access sub-dimensions across four health systems: France, the Netherlands, the United Kingdom (UK), and the US. Although the US approved between 15 and 18% more drugs than the other three countries, the US was slower than France and the UK to approve drugs licensed in all four countries. The percentage of drugs covered is approximately the same for all four countries. For covered drugs, we observe the least cost sharing by patients in the Netherlands. The Netherlands imposes conditions of reimbursement on a much larger percentage of drugs. France seems to be the slowest in respect of speed from marketing approval to reimbursement. The US is the most flexible in terms of the extent to which beneficiaries control their choice of drug benefit but it is the least universal in terms of evenness of the availability of drugs to the population. Our study confirms the frequently cited problems of access in European countries: lag between marketing approval and reimbursement, and inflexibility in respect of the extent to which beneficiaries control their choice of drug benefit. At the same time, our study confirms, qualitatively, different kinds of access problems in the US: relatively high patient cost sharing for pharmaceuticals, and wide variation in coverage.

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Notes

  1. Inpatient drugs may be subject to hospital budget caps.

  2. The Omnibus Budget Reconciliation Act of 1990 requires manufacturers to pay a rebate to the Medicaid program. For brand-name drugs, the rebate is equal to the greater of 15.1% of the average price paid to a manufacturer for the drug and the difference between this price and the lowest price paid by any private-sector purchaser for the drug.

  3. All direct federal purchasers of health care services, for example the Department of Veterans Affairs (VA), can purchase drugs at prices listed in the Federal Supply Schedule (FSS) for pharmaceuticals. The VA negotiates FSS prices with manufacturers on the basis of the prices that manufacturers charge their most-favored commercial customers. These prices are usually up to 50% off of the average wholesale price.

  4. We filled gaps in our database of drug approvals by means of personal communications with officials at the respective drug-regulatory agencies.

  5. Note that of the 100 drugs all four regulatory agencies approved 87 with the same active ingredient, but only 79 with the same formulation and dosing in addition to same active ingredient.

  6. Prior authorization requires that some drugs be pre-authorized before their being dispensed to be eligible for reimbursement.

  7. Note, the IMS database does not take into account delays because of launch delays.

  8. Personal communication [Lucy Betteron, NICE, October 10, 2005].

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Correspondence to Joshua Cohen.

Appendix

Appendix

Table 7

Table 7 The appendix below contains a list of the drugs approved by all four agencies, categorized into therapeutic classes. The first 30 are drugs with sales of over $1 billion annually

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Cohen, J., Faden, L., Predaris, S. et al. Patient access to pharmaceuticals: an international comparison. Eur J Health Econ 8, 253–266 (2007). https://doi.org/10.1007/s10198-006-0028-z

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