Pharmaceutical policies: effects of restrictions on reimbursement.

BACKGROUND: Public policy makers and benefit plan managers need to restrain rising pharmaceutical drug costs while preserving access and optimizing health benefits. OBJECTIVES: To determine the effects of a pharmaceutical policy restricting the reimbursement of selected medications on drug use, health care utilization, health outcomes and costs (expenditures). SEARCH STRATEGY: We searched the 14 major bibliographic databases and websites (to January 2009). SELECTION CRITERIA: Included were studies of pharmaceutical policies that restrict coverage and reimbursement of selected drugs or drug classes, often using additional patient specific information related to health status or need. We included randomised controlled trials, non-randomised controlled trials, interrupted time series (ITS) analyses, repeated measures studies and controlled before-after studies set in large care systems or jurisdictions. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data and assessed study limitations. Quantitative re-analysis of time series data was undertaken for studies with sufficient data. MAIN RESULTS: We included 29 ITS analyses (12 were controlled) investigating policies targeting 11 drug classes for restriction. Participants were most often senior citizens or low income adult populations, or both, in publically subsidized or administered pharmaceutical benefit plans. Impact of policies varied by drug class and whether restrictions were implemented or relaxed. When policies targeted gastric-acid suppressant and non-steroidal anti-inflammatory drug classes, decreased drug use and substantial savings on drugs occurred immediately and for up to two years afterwards, with no increase in the use of other health services (6 studies). Targeting second generation antipsychotic drugs increased treatment discontinuity and the use of other health services without reducing overall drug expenditures (2 studies). Relaxing restrictions for reimbursement of antihypertensives and statins increased appropriate use and decreased overall drug expenditures. Two studies which measured health outcomes directly were inconclusive. AUTHORS' CONCLUSIONS: Implementing restrictions to coverage and reimbursement of selected medications can decrease third-party drug spending without increasing the use of other health services (6 studies). Relaxing reimbursement rules for drugs used for secondary prevention can also remove barriers to access. Policy design, however, needs to be based on research quantifying the harm and benefit profiles of target and alternative drugs to avoid unwanted health system and health effects. Health impact evaluation should be conducted where drugs are not interchangeable. Impacts on health equity, relating to the fair and just distribution of health benefits in society (sustainable access to publically financed drug benefits for seniors and low income populations, for example), also require explicit measurement.

Information system support as a critical success factor for chronic disease management: Necessary but not sufficient.

UNLABELLED: Improvement of chronic disease management in primary care entails monitoring indicators of quality over time and across patients and practices. Informatics tools are needed, yet implementing them remains challenging. OBJECTIVE: To identify critical success factors enabling the translation of clinical and operational knowledge about effective and efficient chronic care management into primary care practice. DESIGN: A prospective case study of positive deviants using key informant interviews, process observation, and document review. SETTING: A chronic disease management (CDM) collaborative of primary care physicians with documented improvement in adherence to clinical practice guidelines using a web-based patient registry system with CDM guideline-based flow sheet. PARTICIPANTS: Thirty community-based physician participants using predominantly paper records, plus a project management team including the physician lead, project manager, evaluator and support team. ANALYSIS: A critical success factor (CSF) analysis of necessary and sufficient pathways to the translation of knowledge into clinical practice. RESULTS: A web-based CDM 'toolkit' was found to be a direct CSF that allowed this group of physicians to improve their practice by tracking patient care processes using evidence-based clinical practice guideline-based flow sheets. Moreover, the information and communication technology 'factor' was sufficient for success only as part of a set of seven direct CSF components including: health delivery system enhancements, organizational partnerships, funding mechanisms, project management, practice models, and formal knowledge translation practices. Indirect factors that orchestrated success through the direct factor components were also identified. A central insight of this analysis is that a comprehensive quality improvement model was the CSF that drew this set of factors into a functional framework for successful knowledge translation. CONCLUSIONS: In complex primary care settings environment where physicians have low adoption rates of electronic tools to support the care of patients with chronic conditions, successful implementation may require a set of interrelated system and technology factors.

Improving population health or the population itself? Health technology assessment and our genetic future.

The province of British Columbia (BC), Canada is developing its first population-wide prenatal genetic screening program, known as triple-marker screening (TMS). TMS, initiated with a simple blood test, is most commonly used to screen for fetuses with the chromosomal abnormality known as Down syndrome or neural tube disorders. Women testing TMS-positive are offered diagnostic amniocentesis and, if the diagnosis is confirmed, selective second-trimester abortion. The project described in this study was initiated to address the broad range of issues arising from this testing technology and provides an example of the new type of health technology assessment (HTA) contribution emerging (and likely to become increasing necessary) in health policy development. With the advent of prenatal genetic screening programs, would-be parents gain the promise of identifying target conditions and, hence, the option of selective abortion of affected fetuses. There is considerable awareness that these developments pose challenges in every dimension (ethical, political, economic, and clinical) of the health-care environment. In the effort to construct an appropriate prenatal screening policy, therefore, administrators have understandably sought guidance from within the field of HTA. The report authors concluded that, within the restricted path open to it, the role of government is relatively clear. It has the responsibility to maintain equal access to prenatal testing, as to any other health service. It should also require maintenance of medical standards and evaluation of program performance. At the same time, policy-makers need actively to support those individuals born with disabilities and their families.

Informing, advising, or persuading? An assessment of bone mineral density testing information from consumer health websites.

UNLABELLED: Greater access to web-based information on health-care interventions might result in greater participation by patients in care and self-care decisions, but only improve health outcomes if the indicated actions produce the intended benefits. Unbiased research on benefits and harms of health information can provide a basis for evidence-based patient information systems. OBJECTIVES: To evaluate the quality of the information content on bone-mineral density (BMD) testing posted on consumer health websites (CHWS). METHODS: Five popular engines (Yahoo, MSN, AOL, Lycos, and Go.com) were used to search for patient information on bone densitometry. The fifteen websites that supplied relevant content and were identified by three of the five search engines were selected in order of popularity of the search engine and primacy of placement. Six BMD reports from health technology assessment (HTA) organizations were used as a standard of scientific quality. These were identified from the HTA Database at York University United Kingdom and published between 1996 and 2001. Content was extracted from both document types, and these sets were compared independently by two reviewers. RESULTS: The majority of CHWS identified by popular search engines do not disclose the limited capacity of BMD to discriminate between low-risk individuals and those who will suffer future fractures. CHWS generally present BMD testing as quick, painless, noninvasive, and as being recommended, based on risk factors that are widespread among the general public. BMD testing information is prominently paired on CHWS sites with information on osteoporosis, with an emphasis on "silent disease" and the devastating consequences of advanced disease. Sponsors of CHWS sites are frequently either providers of BMD testing or companion drugs, and consequently in a position of conflict of interest with regard to decisions to undergo BMD testing. HTA organizations have no documented conflict of interest, nor do they invoke emotional arguments. Their approach is to emphasize the effects of testing on populations, on the basis of referenced research findings. CONCLUSIONS: Content analysis demonstrates the omissions and divergence of information on BMD testing available to consumers on the Internet, as compared with HTA reports. The content of HTA reports has undergone rigorous systematic and peer review; therefore, their findings may be useful to consumers. This information is not generally accessible to patients using the most popular Internet search engines. Inaccurate and incomplete information may cause harm by deflecting patients from optimal decisions.

Beyond effectiveness: the evaluation of information systems using A Comprehensive Health Technology Assessment Framework.

A Comprehensive Health Technology Assessment Framework is presented as a conceptual tool for decision-making about health technologies, including information technologies. The aim of the model is to provide an empirical, evidence-based foundation for health technology decisions. The major framework dimensions are (1) population at risk, (2) population impact, (3) economic concerns, (4) social context (including ethical, legal, and political concerns), and (5) technology assessment information. This multi-disciplinary approach provides guidelines on use of appropriate information in aligning 'stakeholder wants' and 'population needs'.