Active pharmaceutical management strategies of health insurance systems to improve cost-effective use of medicines in low- and middle-income countries: a systematic review of current evidence.

Objectives: Health insurance systems have great potential to improve the cost-effective use of medicines by leveraging better provider prescribing, more cost-effective use by consumers, and lower prices from industry. Despite ample evidence from high-income countries, little is known about insurance system strategies targeting medicines in low- and middle-income countries (LMIC). This paper provides a critical review of the literature on these strategies and their impacts in LMIC.

Competitiveness in follow-on drug R&D: a race or imitation?

The development of 'follow on' or 'me too' drugs - generally defined as a drug with a similar chemical structure or the same mechanism of action as a drug that is already marketed - has attracted contrasting views. Some have argued that follow-on drugs often provide useful alternative or enhanced therapeutic options for particular patients or patient subpopulations, as well as introducing price competition. Others, however, consider that the development of such drugs is duplicative and that the resources needed would be better directed elsewhere.

Off-label use reimbursement.

In this study, the authors examine factors underlying payer off-label use reimbursement policies. Updating a study published 14 years ago, presenting the results of the survey of 179 payers administering public (Medicare and Medicaid) pharmacy benefits. The focus is on payers administering pharmacy benefits in the public sector for two reasons: First, transparency; there is a tendency for such payers to reveal more about their decisionmaking processes than payers that exclusively deal with the commercial market.

Are Medicare plans complying with CMS regulation?

Objectives: The US Centers for Medicare and Medicaid Services (CMS) have put forth guidance recommending coverage of 75% of the costs of 'all or substantially all' drugs in six therapeutic categories deemed medically necessary for Medicare beneficiaries: anticonvulsants, antidepressants, antineoplastics, antipsychotics, HIV/AIDS and immunosuppressants. For 2007 filings, we analyzed compliance by 36 leading prescription drug plans with the CMS guidance.

Methods: Using databases at the Tufts Center for the Study of Drug Development, we identified 201 drugs approved by the US FDA between 1962 and 2007 in the six therapeutic categories mentioned above.

Racial disparities among clinical research investigators.

Evidence shows that minority patients are underrepresented in clinical trials. The development of new drugs and treatments, however, requires that clinical research studies include representative participants, particularly in light of evidence indicating that minority populations sometimes respond differently to prescription medications. Racial disparities among clinical investigators are often cited as a major reason why minority patients are underrepresented in clinical trials.

Patient access to pharmaceuticals: an international comparison.

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.

Comparing patient access to pharmaceuticals in the UK and US.

Background: The debate on access to new drugs has focused on the time lag between applications for approval and granting of marketing authorisation. This delay was identified as the first barrier with respect to patient access to new drugs, encompassing the hurdles of safety, efficacy and quality. Additional barriers have since been identified.

Monoclonal antibody successes in the clinic.

Most monoclonal antibodies in clinical trials are owned by small biotech companies. But with blockbuster-sized revenues and approval rates higher than those for small-molecule drugs, that all may be set to change.