Browsing by Subject "managed entry agreement"
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(2023)Orphan medicinal products (OMPs) are pharmaceuticals, that are utilized in the treatment of rare diseases. Rare diseases are diseases with a prevalence of at most five individuals out of 10 000. Clinical trials with statistically robust clinical data are challenging to conduct with rare diseases, since patient populations are small and the amount of trial subjects enrolling into these trials are usually scarce. Rare diseases also represent a variety of different diseases with divergent properties (5000-8000 identified). This presents challenges in health technology assessment (HTA) when reimbursements for these treatments are assessed and decided, especially when these treatments are usually considerably expensive and burdening to national health care systems. The main objectives for this study and master´s thesis was to research via interviews with experienced professionals from pharmaceutical industry and officials as how to define, monitor and assess the clinical effectiveness of OMP treatments, how to enhance their market access, and how to develop the current conditional reimbursement system in Finland. The interviewees (n=12) all represented from their respective backgrounds and introduced opinions from their own occupational positions and frameworks based on their professional experience. The study was executed as a qualitative study utilizing semi-structured interviews with predetermined questions and themes between 6th of April 2023 and 8th of June 2023. The interviewees were initially contacted via email and phone by one of this thesis supervisors from a professional pool of individuals identified using purposive sampling. The interview transcriptions were examined and analyzed using content analysis, and they were coded and grouped into themes. When inquired, the most common opinions regarding how to define and monitor clinical effectiveness of OMP treatments, the most common answers emphasized individual clinical assessment, real world data (RWD) collection, consideration of symptom control and overall quality of life, economic effectiveness, and clinical expert assessment. Market access of OMPs could be enhanced with more flexible and bold applications for negotiations and agreements, and a need for uniform, predictable MEA procedures, parameters for treatment discontinuation, outcomes-based models, and earlier proactive start for initial negotiations on behalf of the payer (society). The existing conditional reimbursement system might be developed with outcomes-based models, increased dialogue and trust between companies and officials within the realm of negotiations, uniform and predictable MEA procedures, and already established MEA negotiation frameworks to fast tract OMP market access. Development of the existing conditional reimbursement scheme, as well as objective to enhance market access environment in Finland could be accomplished by novel, flexible, patient specific, holistic and bold systems with an emphasis on systematic collection of RWD. Uniform and predictable MEA procedures with predetermined negotiation frameworks could bring value through faster market access and valuable predictability for pharmaceutical companies in their operations. Rapid market access of OMPs could be beneficial via clinical effectiveness of the treatments, as well as through collecting valuable clinical data from the medicinal products.
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(2019)Conditional reimbursement was introduced in Finland in January 2017 as a temporary addition in the Finnish Health Insurance Act. An agreement can be made between a marketing authorisation holder (MAH) and the Pharmaceuticals Pricing Board. Conditional reimbursement status can be allowed for a medicinal product if the drug is addressing unmet medical need and there are uncertainties associated to the medicinal product considering i.e. therapeutic value or cost-effectiveness, when traditional reimbursement procedures are not suitable. Risk-sharing is an essential part of the agreements and the results are monitored. Types of agreements are divided into financial- and performance-based agreements. Conditional reimbursement in Finland has not yet been studied in a large extent since its introduction. The aim of this study was to create an overview of the medicinal products with conditional reimbursement in Finland, how the unmet medical need is addressed, and which treatment options are available. Also, benefits and risks of the different stakeholders of risk-sharing agreements (RSA), why these agreements are worth to implement, earlier experiences from the European Economic Area (EEA) countries and what pharmaceutical companies should consider prior to negotiations were investigated. A document analysis was performed for investigating the medicinal products with conditional reimbursement status in Finland. A systematic literature review was conducted for collecting information and earlier experiences of RSAs and managed entry agreements (MEA) in the EEA-countries. On February 1st, 2019 there was 19 medicinal products with conditional reimbursement in Finland. These drugs are successfully addressing unmet medical need. All stakeholders of RSAs encounter benefits and risks of these agreements but the MAH is the one carrying the largest responsibilities and risks. Risk-sharing agreements gained in popularity since the early 2000s in the EEA-countries. There is no golden standard for types of agreements made but MEAs are enshrined in legislation in most countries. The pharmaceutical company should as early as possible start shaping details and collect information of the product for which conditional reimbursement will be proposed to. Negotiations might be challenging, but the aim is an agreement in which both the MAH and the payer are content with. Finland is following a similar trend as other EEA-countries, since most of the medicinal products with conditional reimbursement are oncology medicines. The use of the drugs has been limited through reimbursement number codes for certain patients who are most likely to benefit from the treatment. Rationales for introducing RSAs in EEA-countries were similar, e.g. working with finite resources, improving access, reducing uncertainty and prices, managing budget impact and improving cost-effectiveness. It seems like Finland is unique by the temporary introduction of conditional reimbursement in legislation and in other countries it has been introduced as permanent. Starting the preparations early for negotiations could save time and resources. When a RSA is made and the medicinal product shows the benefits expected, this is the ideal situation where all stakeholders benefit.
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