Principles for evidence-based drug formulary policy

Simon, Gregory E.; Psaty, Bruce M.; Hrachovec, Jennifer; Mora, Marc

doi:10.1111/j.1525-1497.2005.0232.x

Cited by 23 publications

(15 citation statements)

References 48 publications

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“…For example, insurers and health care systems in many countries provide formulary coverage for prescription medications and must balance rising costs against appropriate access to new treatments [2]–[4]. A number of agencies help to determine whether new drugs should be listed in drug formularies, and the principles that drive their decisions (such as evidence of effectiveness and safety, evidence of need, and cost implications) have been reviewed [2], [3], [5]. Although cost-effectiveness criteria are used to guide policy related to drug coverage in many countries, drug reimbursement decisions within publicly funded health care settings in the US largely exclude considerations of cost [4].…”

Section: Introductionmentioning

confidence: 99%

The Timing of Drug Funding Announcements Relative to Elections: A Case Study Involving Dementia Medications

et al. 2013

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BackgroundFollowing initial regulatory approval of prescription drugs, many factors may influence insurers and health systems when they decide whether to add these drugs to their formularies. The role of political pressures on drug funding announcements has received relatively little attention, and elections represent an especially powerful form of political pressure. We examined the temporal relationship between decisions to add one class of drugs to publicly funded formularies in Canada's ten provinces and elections in these jurisdictions.MethodsDates of provincial formulary listings for cholinesterase inhibitors, which are drugs used to treat Alzheimer's disease and related dementias, were compared to the dates of provincial elections. Medical journal articles, media reports, and proceedings from provincial legislatures were reviewed to assemble information on the chronology of events. We tested whether there was a statistically significant increase in the probability of drug funding announcements within the 60-day intervals preceding provincial elections.ResultsDecisions to fund the cholinesterase inhibitors were made over a nine-year span from 1999 to 2007 in the ten provinces. In four of ten provinces, the drugs were added to formularies in a time period closely preceding a provincial election (P = 0.032); funding announcements in these provinces were made between 2 and 47 days prior to elections. Statements made in provincial legislatures highlight the key role of political pressures in these funding announcements.ConclusionsImpending elections appeared to affect the timing of drug funding announcements in this case study. Despite an established structure for evidence-based decision-making, drug funding remains a complex process open to influence from many sources. Awareness of such influences is critical to maintain effective drug policy and public health decision-making.

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Section: Introductionmentioning

confidence: 99%

The Timing of Drug Funding Announcements Relative to Elections: A Case Study Involving Dementia Medications

et al. 2013

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“…Simon et al [13] described specific principles for applying research evidence to formulary decisions. Similar criteria can be formulated to establish reference drug groups: (1) experimental data should take precedence over epidemiologic data and models; (2) morbidity or mortality outcomes should take precedence over surrogate or intermediate outcomes; (3) claims for advantages of new treatments should consider the full range of alternatives rather than those selected by industry.…”

Section: Clinical Rationale For Rdps: Therapeutic Substitutionmentioning

confidence: 99%

Reference drug programs: Effectiveness and policy implications

Schneeweiß¹

2007

Health Policy

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In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs (RDPs) or similar therapeutic substitution programs. This paper summarizes the mechanism and rationale of RDPs and presents evidence of their economic effectiveness and clinical safety. RDPs for pharmaceutical reimbursement are based on the assumption that drugs within specified medication groups are therapeutically equivalent and clinically interchangeable and that a common reimbursement level can thus be established. If the evidence documents that a higher price for a given drug does not buy greater effectiveness or reduced toxicity, then under RDP such extra costs are not covered. RDPs or therapeutic substitutions based on therapeutic equivalence are seen as logical extensions of generic substitution that is based on bioequivalence of drugs. If the goal is to achieve full drug coverage for as many patients as possible in the most efficient manner, then RDPs in combination with prior authorization programs are safer and more effective than simplistic fiscal drug policies, including fixed co-payments, co-insurances, or deductibles. RDPs will reduce spending in the less innovative but largest market, while fully covering all patients. Prior authorization will ensure that patients with a specified indication will benefit from the most innovative therapies with full coverage. In practice, however, not all patients and drugs will fit exactly into one of the two categories. Therefore, a process of medically indicated exemptions that will consider full coverage should accompany an RDP.In the current economic environment, health care systems are constantly struggling to contain rapidly rising costs. Drug costs are targeted by a wide variety of measures. Many jurisdictions have implemented reference drug programs, and others are considering them. This paper summarizes the mechanism and rationale of RDPs, presents evidence of their economic effectiveness and clinical safety, and concludes with some practical implications of implementing RDP policies.

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“…Step therapy, a tool used by many but not all Part D plans, facilitates multiple antidepressant trials while helping reap the economic benefits of restricting first-line treatments to the least expensive alternative. 7 The implementation of these tools, however, needs to be carefully designed to minimize administrative burden and maximize prescriber and patient awareness to guard against unintended consequences (such as a reduction in the number of patients starting treatment and an increased number of patients discontinuing treatment).…”

mentioning

confidence: 99%