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At least 19 recordsLinked to original sources

Pricing Combination Therapies: A Systematic Review of Value Attribution, Cost-Sharing Mechanisms and Policy Frameworks.

BACKGROUND: Combination therapies are increasingly central to modern pharmacotherapy, particularly in oncology and other high-burden diseases. However, pharmaceutical pricing and reimbursement systems remain largely designed for single-product-single-indication interventions. When multiple patented medicines are used together, especially when owned by different manufacturers, conventional pricing frameworks may struggle to align prices with the value of the combination while preserving incentives for innovation and timely patient access. OBJECTIVE: To identify, describe, and critically assess the methods, models, and policy frameworks proposed in the literature to establish prices for combination therapies, with particular attention to value attribution mechanisms, cost-sharing arrangements between manufacturers, and budget impact considerations. METHODS: A systematic literature review was conducted in accordance with PRISMA guidelines and a pre-registered Open Science Framework protocol. Searches were performed in MEDLINE, Scopus, Web of Science, EconLit, CRD databases, and grey literature sources for publications up to July 2025. Eligible studies analysed pricing approaches, economic models, reimbursement mechanisms, or policy frameworks relevant to combination therapies, including more recent multi-indication pricing literature. Given the heterogeneity of the literature, findings were synthesized using a structured narrative and thematic approach. RESULTS: Sixty-nine studies met the inclusion criteria. The literature was dominated by conceptual and policy analyses, with relatively few empirical or implementation-oriented studies. Value attribution emerged as the central methodological challenge in pricing combination therapies. Several complementary approaches were proposed to operationalise value attribution, including adaptations of indication- or pathway-based pricing, manufacturer cost-sharing arrangements, managed entry agreements, and outcome-based reimbursement mechanisms. Empirical evidence suggests that health systems continue to rely primarily on pragmatic and often partial solutions rather than fully specified pricing frameworks. A complementary review of the multi-indication pricing literature indicates that, although the two fields address different pricing problems, they share important methodological and institutional lessons that can inform the development of pricing frameworks for combination therapies. CONCLUSIONS: The literature provides a growing repertoire of conceptual approaches for pricing combination therapies but limited empirical evidence on implementation. Pricing frameworks should place value attribution at their core while combining complementary policy mechanisms adapted to national pricing and reimbursement systems. Lessons from multi-indication pricing provide a valuable foundation but require additional governance mechanisms to address value attribution, multi-manufacturer negotiation, and implementation challenges specific to combination therapies.

Journal Article

Policy process framework: a systems approach to policy development.

This paper discusses a framework for understanding policy analysis and development. The framework presented can be used in the policy development process or post facto in policy analysis. The usefulness of the framework is that it provides a means to think about a policy and its development. It is not prescriptive, nor is it predictive about any particular policy. Policy analysis has tended to rely too heavily on technical analysis, with insufficient attention to other dimensions. This framework offers a basis for people to talk across organizations and cultures.

Decision Making

Nurse practitioner research: selected literature review and research agenda.

Selected literature is reviewed to illustrate current conceptual and methodological issues in nurse practitioner research. Concepts of style of practice, acceptance, satisfaction, and outcome are discussed. Methodological issues are linking process to outcome, complexity measures, use of existing data, and the effect of nurse practitioner education and experience on interpretation of findings. A research agenda with two objectives is proposed: studies designed to improve rather than evaluate practice and studies designed with a policy framework in mind.

Clinical Competence

Doctors as managers: poachers turned gamekeepers?

Doctors in health care systems of different types are coming under increasing pressure to take on active roles in management. Mounting concern among governments over the escalating costs of health care, coupled with a desire to improve the quality of care and render services more responsive to user preferences has resulted in management being viewed as offering an effective means of tackling these issues. Until recently, the favoured strategy was to strengthen management in order to curb doctors' discretionary decision-making. There is now a shift towards creating managers out of doctors with all that this implies for the future shape of health services. There are also issues about the training and development required for a management role, the stratification of roles within the medical profession, and the future status of lay, or non-medical managers. The paper reviews the debate about doctors and managers and their distinctive value bases. It suggests that doctors can be involved in management as managers at two levels--meso and micro--and considers the issues raised at each level. The paper presents an analysis of the wider context in which the debate about doctors as managers is taking place. The main thesis put forward is that far from managers incorporating doctors, the end result may prove to be the other way round with 'provider capture' of the management agenda in health services a distinct possibility. In contrast to managers, doctors retain enormous public respect and support. As long as it is so doctors will remain powerful stakeholders in defining and controlling the shape and range of health services available. Their active involvement in management could lead to a strengthening of their position. It is argued that, paradoxically, this could make it more difficult for governments to challenge doctors' work practices. Medicine's traditional preoccupations and its resilience to change are likely to remain as strong as ever thereby disappointing advocates of a health and social care system located in a broader policy framework which emphasises health gain and a holistic approach to health.

Attitude of Health Personnel

Current ethical issues in IVF.

This article has briefly reviewed the range of public policy issues and ethical questions raised with respect to IVF. It then discussed selected issues that are now under policy debate and decision. Given the wide acceptance of IVF as a medical procedure for married couples, what variants might also be ethically defensible? IVF for unmarried couples appears defensible under specific conditions that are equally applicable to married couples. Involvement of third parties (gamete donation and gestational surrogacy) is more complex and needs case by case examination. Sperm donation appears to generate little that is ethically new when coupled with IVF but requires the same care and concern as AID. Egg or embryo donation, however, does raise new ethical questions that need close attention and continuing analysis. Freezing of human embryos also breaks new ethical ground, particularly in the options it generates beyond a narrowly defined medical domain. Certain of these options are better not undertaken without further public policy decision. Improvement of current procedures and techniques through effective clinical trials can be ethically carried out in terms of scientific and medical perspectives. However, efforts in this direction will be more effective if undertaken within a public policy framework that clearly defines acceptability during a transitional period of confidence-building.

Adoption

Challenges of genomic testing for patients and clinicians in Latin America: Foundations of a qualitative multi-country study.

Genomic medicine is expanding across Latin America (LATAM), yet access to essential ancillary services such as genetic counselling remains limited. 'Latin-SEQ' is a study that provides whole exome sequencing (WES) for neuromuscular diseases across 18 countries, aiming to improve diagnostic rates and generate region-specific genetic insights. However, funding constraints exclude genetic counselling and cascade testing, raising concerns about equitable and harm-free care. This paper reports early findings from 'Latin-SEQ Plus,' a mixed-methods study exploring patient and healthcare practitioner (HCP) perspectives on WES and genetic counselling. Data were generated via surveys with patients and HCPs, and participatory workshops with HCPs across six countries. We found that patients strongly valued genetic testing for diagnostic clarity, improved care, and family planning. HCPs acknowledged the diagnostic benefits of WES but highlighted absence of local genetic counselling services, inconsistent pre and post-test practices, and uncertainty in managing incidental findings and variants of uncertain significance (VUS). Psychological impacts related to WES results are not always addressed, underscoring risks of psychological and emotional harm for patients. Access to WES and genetic counselling is limited in LATAM due to financial hardship and the absence of a clear genetic counselling infrastructure. Our findings also reveal a mismatch between patient expectations and HCPs' capacity to deliver comprehensive genomic care. We argue for urgent investment in genetic counselling infrastructure, HCP training, culturally tailored resources, and policy frameworks to support equitable implementation of genomic medicine in LATAM.

Humans

The politics of universal access: the Massachusetts Health Security Act of 1988.

This article analyzes the passage of an unprecedented state law, promising every resident access to affordable health insurance. The Massachusetts Health Security Act of 1988 was the product of a set of political and financial pressures that had been developing for nearly a decade. Hospital, insurance, and business interests were unable to reach a new accommodation on hospital payment. This logjam created the opportunity for a policy breakthrough, but did not inherently lend itself to progressive reform. It was consumer activism that forced the traditional powers in health policy to address the interests of the uninsured. By imposing a more public-interest agenda on the process, consumers were able to change the configuration of the stalemate, but could not resolve it. The particular terms of the stalemate, however, made possible a new, more aggressive role for state government in health policy. Unable to satisfy their competing interests within a policy framework that had universal access as a goal, traditionally powerful interest groups found themselves increasingly dependent on the state to broker a new agreement. While the many concessions made to these groups are likely to prove to be the bill's undoing, the unraveling of the agreement will not end the story. The same pressures which led to passage of the Massachusetts law and which are now causing other states to act will continue to exert their effect until a more durable solution is found.

Health Services Accessibility

Child health in America: toward a rational public policy.

Analysis of currently available data on mortality and morbidity indicates that the major organic illnesses of childhood, and their developmental consequences, are susceptible in part to the technical interventions of American medical science. Environmental forces, however, exert a powerful impact on the health of children in the United states, manifested both in the disproportionate toll of most organic diseases on poor and nonwhite populations and in such increasingly important symptoms of familial, social, and behavioral distress as child abuse, accidents, and childhood suicide. Review of the nature, quality, and distribution of child health services demonstrates a systemic inability to reach and treat the children most in need of them. A rational basis for child health policy includes: appropriate concepts of health, disease, and preventive and therapeutic intervention; a capacity to acknowledge, to measure, and to act on the familial and environmental, as well as the medical, sources of illness; an orientation to the developmental and social implications of good and poor child health; and a commitment to enable all children to receive health services. The data and this policy framework lead to these program recommendations: the channeling of resources into a more rational system which guarantees equity and access; a planning and program implementation mechanism which addresses the health needs of diverse local populations and which makes real the advocacy concept; a screening, evaluation, and surveillance methodology; a delivery system which both applies preventive and curative health technology and addresses basic life needs of children; and a coherent program for the training, assignment, and supervision of the several kinds of manpower which such a system would require.

Adolescent

A residency policy for pregnancy and parental leave.

Residency programs need to anticipate the parental needs of their residents as more residents have children during residency. Ad hoc or crisis mode responses to resident pregnancy result in individual and group distress and dysfunction. Described in this paper is a maternity and parental leave policy for a psychiatric training program at a military hospital. This policy provides a framework for policies in other residency and military work situations.

Absenteeism

A framework for a limitation policy of the population exposure to natural radiation in Belgium.

The conclusions are put forward that are adopted by a discussion group preparing the framework for a limitation policy of the radon problem in Belgium. Existing and future situations are treated in a coherent policy that is adequate for practical implementation. An action level is defined, together with a hierachy of levels for new constructions. The decision logic for the acceptance of building materials is explained.

Belgium

Public policy analysis for registered nurses in a baccalaureate curriculum.

As nurses become more involved in the macro-decision-making arena, they need policy analysis skills in order to make effective recommendations on policy alternatives. Dunn's policy analysis framework, useful for examining and understanding policy issues, is relevant to nursing education and practice and provides guidance for effective action. This framework guided an educational experience for registered nurse (RN) students in a baccalaureate nursing program. The students participated in community-based policy analysis, examining public policies affecting the health of individuals, families, groups, and populations. Dunn's framework and this policy experience can be incorporated into formal education courses or continuing education programs.

Curriculum