New treatments: costs, benefits and decision-making procedures (original) (raw)
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Journal of Pharmaceutical Policy and Practice
Background: The affordability of essential medicines is a challenge in achieving Universal Health Coverage (UHC). One of The Lancet Commission's recommendations on financing of essential medicines is to ensure governments and national health systems include essential medicines in the benefit packages provided by public and private healthcare sectors. Currently in South Africa (SA), there is a dearth of information on the processes for medicines selection for private sector medical scheme formularies. This study aimed to improve the understanding of how formulary managers of selected medical schemes made decisions for the selection of medicines for their formularies. This paper described their opinions obtained from in-depth interviews. Methods: Qualitative in-depth interviews were conducted with 10 individuals from 7 private sector medical schemes and administrators in SA. All participants interviewed were involved in formulary development and management. Interviews were conducted from June 2013-January 2015. Interviews were guided by a discussion guide and audio recorded. Recorded interviews were transcribed verbatim. Transcripts were coded by the first author, corroborated by the second author, reconciled, and imported into NVIVO for data analysis. Results: Schemes and administrators had similar formulary decision making and management committees in place (viz. Clinical and Therapeutics committees). The process of and criteria for medicines selection and evidence based review of formularies were also similar. Selection of medicines was inherent in the formulary review process. Medicine price was important in the decision taken to list medicines. Most schemes expressed a difficulty with lack of information to support pharmacoeconomic evaluations of medicines for inclusion on the formulary. This together with the basic monitoring of use of medicines by patients for most schemes left room for improvement in the decision making process for those schemes.
Expensive lifesaving treatments: allocating resources and maximizing access
Israel journal of health policy research, 2018
Avisar et al. present an exemplary model for outreach aimed at ensuring that a maximum of patients eligible for expensive Hepatitis C (HPC) drugs receive treatment. We enlarge the picture to put their model in the political, economic and regulatory framework for financing and providing these drugs in Israel and a number of other countries. We then return to delivery system level and consider issues such as cost of outreach, the need for health care coordinators and dealing with Hepatitis C patients not yet entitled to receive the drugs under national health coverage determinations.Regarding national coverage decisions, we find that countries such as Australia, New Zealand, the United Kingdom and Israel all extended coverage for Hepatitis C drugs, given the clear high effectiveness of the latter. However, to limit budget impact, all these countries target coverage to patients based on disease genotype and stage.The model presented by Avisar et al., while impressive, leaves some items...
Medicine in the early twenty-first century: paradigm and anticipation -EPMA position paper 2016
Challenges of “standardisation” and “individualisation” have always been characteristic for medical services. In terms of individualisation, the best possible individual care is the ethical imperative of medicine, and it is a good right of any patient to receive it. However, in terms of standardisation, all the available treatments are based on guideline recommendations derived from large multicentre trials with many thousands of patients involved. In the most optimal way, the standardisation and individualisation should go hand-in-hand, in order to identify the right patient treating him/her with the right medication and the right dose at the right time point! Further, in paradigm and anticipation, there is a big discrepancy between “disease care” and “health care” which dramatically impacts ethical and economical aspects of medical services. Several approaches have been suggested in ancient and modern medicine to conduct medical services in a possibly optimal way. What is the difference amongst all of them and how big is the potential beyond corresponding approach to satisfy the needs of the individual, the patient, professional groups involved and society at large? On behalf of the “European Association for Predictive, Preventive and Personalised Medicine,” the dedicated EPMA working group provides a deep analysis in the issue followed by the expert recommendations considering the multifaceted aspects of both “disease care” and “health care” practices including ethics and economy, life quality of individuals and patients, interests of professional groups involved, benefits of subpopulations, health care system(s) and society as a whole.
The value of medicine in improving the quality of care
Patients expect the provision of quality care from the healthcare system, whether they are in the public sector or the private sector. One method amongst many of ensuring the provision of quality care is through the use of medicine. This paper aims to answer the question: what is the value of medicine and how is this related to the quality of the care that patients receive? To this end, the paper explores these concepts through a structured approach, firstly discussing the value and quality of care. By drawing on debates that have taken place in the international literature and applying these to the South African environment, an approach is provided to discuss the quality of care patients receive within the context of medicine consumption. Numerous tools are provided, including the three dimensions of quality and the different perspectives on quality. To improve the quality of care, consideration should be given to the regulatory framework, continuous quality improvement models, market competition and payment incentives. The paper has not aimed to provide readymade solutions for quality gaps in the healthcare system, nor does it pretend that a solution is easily achievable without concerted effort from all healthcare stakeholders. The paper makes a contribution to the growing body of knowledge accessible to healthcare stakeholders with which to discuss the value of medicine in improving quality of care.
Hyper-expensive new therapies and the prioritisation of R&D
2011
This background paper-produced for the Nuffield Council on Bioethics Forward Look Seminar 2011-provides a summary of the ethical arguments and policy issues which arise in considering very expensive medical treatments and their place within a fixed healthcare budget such as the NHS.
Understanding medicine access strategies for innovative medicines registered in South Africa
Research Square (Research Square), 2024
Background South Africa is composed of two tiers, viz. A private healthcare system that is funded through medical insurance, comprised of people who can afford to make monthly payments towards their medical insurance, and a government-funded public healthcare system, which covers the majority of the population. This study explored the barriers that exist in South Africa that hinder access to innovative medicines, along with the current strategies being utilised by the pharmaceutical industry to increase access to medicines. Objectives The objectives of the study were to (1) quantify and classify innovative medicines registered between 2010 and 2020 by the South African Health Products Regulatory Authority (SAHPRA), (2) identify barriers to accessing innovative medicines in South Africa through interviews with market access managers from innovator companies, and (3) explore the current market access strategies used by the pharmaceutical industry. Design This study employed a quantitative and qualitative methodology, whereby the former involved the extraction of a list of innovator medicines from the regulator database, and the latter involved 9 semi structured interviews. Purposive sampling was conducted through pharmaceutical association member companies. The interviews included seven market access managers and two medicine managers from one of the payers in South Africa. Thematic analysis was used to interpret the data collected from the study. Results According to the regulator database, during the review period, 238 innovative medicines were registered. Only 14.77 % were available in the public sector in the form of tenders, whereas in the private sector (based on the products having a SEP), 76.92 % were available. From the interviews, six themes emerged: reimbursement of medicines, types of reimbursement, partnerships, technology, legislative challenges, and other factors (e.g., real-world evidence). Conclusion Access to innovative medicines in South Africa is a challenge, as the price of these therapies is high. Therefore, various stakeholders in the health sector must collaborate to identify and implement solutions that are locally relevant. The government needs to proactively update policies that would allow for alternative reimbursement methods to be explored.
Frontiers in Public Health
Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases, and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growth in both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated to finance new medicines as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimize the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.