Market Access Agreements Research Articles

PNS83 Analysis of Market Access Agreements in Turkey

PNS83 Analysis of Market Access Agreements in Turkey

PNS98 Market Access Agreements: Implementation in Algeria

PNS98 Market Access Agreements: Implementation in Algeria

Analysis of Market Access Agreements in Turkey

BACKGROUND: Reimbursement agencies are increasingly adopting innovative reimbursement approaches for new and expensive technologies. Social Security Institution (SSI), Turkey`s reimbursement agency, established the Alternative Reimbursement Commission (ARC) on February 10, 2016. This study aimed to understand the implementations of market access agreements in recent years in Turkey.METHODS: Decisions of the Health Services Pricing Commission published in the official gazette , and information from the Turkey Pharmaceuticals and Medical Devices Agency, the Abroad Drug List, Health Implementation Communique published by SSI with additional lists, such as the Annex-4A List of Reimbursed Medicines and the Annex-4C Abroad Drug Price List, were used. The data was transferred to Windows Office Excel files, and a descriptive analysis was conducted and evaluated by two market access experts.RESULTS: There were 57 drugs included in the coverage of reimbursement with alternative reimbursement since the application was started in Turkey. 35 of them were added to Annex-4A and 22 of them to Annex-4C. Furthermore, 45.6% of the drugs had an Anatomic Therapeutic Chemical Classification (ATC) code of l-antineoplastic and immunomodulating agents, 28% were orphan drugs, 44 of them had a confidential discount rate, and financial-based agreement models were preferred for nearly all agreements.CONCLUSIONS: Turkey has been implementing market access agreements since mid-2016. In the past 3 years, 57 drugs have been covered for reimbursement under the new implementation. Further analysis should be conducted to understand the decision-making process involved.

STAKEHOLDER PERCEPTION OF EU FOOD SAFETY GOVERNANCE: THE CASE OF EU FRUIT AND VEGETABLE IMPORTS FROM SOUTHERN MEDITERRANEAN COUNTRIES

Abstract Despite the advantages ensuing from preferential market access agreements, trade exchanges between Southern Mediterranean Countries (SMCs) and the EU are often hindered by food safety issues. These are particularly relevant for fruit and vegetables, which are subject to heterogeneous regulations in SMCs. This paper seeks to outline governance solutions to improve ex-ante compliance capacity of SMCs production and to enhance integration with the EU market. A set of research hypotheses, concerning the difficulties and benefits related with food safety compliance, are formulated. These hypotheses are then discussed in the light of the empirical evidence gathered from (i) public bodies involved in food safety enforcement and (ii) a direct survey conducted on 37 stakeholders in the fruit and vegetable supply chain in Italy. The main problems identified relate to the scarce harmonization among control systems in EU Member States and insufficient checks in exporting countries. The main benefits include the reduction of sanitary risk and the reinforcement of long-term trust-based relations along the supply chain. The most promising strategies encompass the improvement of inspections on production sites and of infrastructures in the countries of origin. Further areas of intervention concern the harmonization of food safety regulation between EU countries and SMCs and the development of bilateral cooperation and technical training programs.

PNS188 ANALYSIS OF MARKET ACCESS AGREEMENTS IN TURKEY

Reimbursement agencies are increasingly adopting innovative reimbursement approaches for new and expensive technologies. Social Security Institution(SGK), Turkey`s reimbursement agency has been established the Alternative Reimbursement Commission(AGOK) on 10 February 2016. After the implementationt, SGK announced several market access agreements decisions. The aim of study is to understand implementations of market access agreements for recent years in Turkey. Decisions of the Health Services Pricing Commision published in the Official Gazette between 10.02.2016 - 01.02.2019, Turkey Pharmaceuticals and Medical Devices Agency dated 01.02.2019 Abroad Drug List, Health Implementation Communique published by Social Security Institution with additional lists Annex-4A List of Reimbursed Medicines and Annex-4C Abroad Drug Price List were used. Data has been transferred to Windows Office Excel and conducted descriptive analysis which was evaluated by 2 market access experts. There are 57 drugs included in the coverage of reimbursement with Alternative Reimbursement since the application was started from February 2016 up to February 2019 in Turkey. 35 and 22 of them were added to the Annex-4A and Annex-4C, respectively. 45.6% of the drugs have ATC code of L-Antineoplastic and Immunomodulating Agents, 28% are orphan drugs. 44% have confidential discount rate. In additional, financial-based agreement models are preferred nearly for all agreements. Turkey has been implemented market access agreements in beginning of 2016. In the past 3 years, 57 drugs have been covered reimbursement under the new implementation. It is needed to conduct further analysis for understanding the decision making process of market access agreements in Turkey.

Developing Trade

Executive SummaryThe UK faces no easy options in determining how to develop its approach to international trade post-Brexit. If it finally decides to leave the European Customs Union and Single Market, it faces the possibility either of simply crashing out of the EU without a deal; trying to form market-access agreements and Free Trade Areas (FTAs) with the EU and other countries; or unilaterally reducing tariffs and liberalising trade with all countries. Each course raises significant practical difficulties, and entails major disadvantages compared with staying in the Customs Union and Single Market.The economic costs of a ‘no-deal’ approach stand to be very large, including inevitable tariffs, obstruction of UK access to EU markets, physical disruption at borders, a damping of investment and the much-discussed problem of the Irish border. Assuming ‘no-deal’ does not happen, negotiating FTAs with other countries would be possible only after a lengthy transition period, as in the Withdrawal Agreement voted down in Parliament, and would depend on the shape of the ultimate post-Brexit trading relationship between the EU and the UK. The process would be difficult, costly, and protracted; would likely be concluded on disadvantageous terms; would be even harder to apply to trade in services; and would yield extremely small gains given the volume of UK non-EU trade that is already covered by FTAs. Finally, unilateral liberalisation, while ameliorating some of the drawbacks of the first two options, faces the same problems of loss of access to European markets and disruption to trade; and would entail severe economic pain with only very gradual gains.The UK needs to conduct a much more profound and considered debate on these issues before deciding to set aside the large benefits of membership of the Customs Union and Single Market for the significant difficulties and tenuous gains offered by the alternatives. Public debate on the economic effects of trade policy has so far lacked the detailed but necessary analysis of these questions. It seems essential to establish a national policy review institution, modelled on the Australian Productivity Commission, in order to stimulate such a debate.

PHP352 - SUCCESS FACTORS FOR THE IMPLEMENTATION OF MARKET ACCESS AGREEMENTS IN EMERGING MIDDLE-INCOME MARKETS IN PREPARATION FOR OUTCOMES BASED CONCEPTS

Market access agreements (MAA) are an accepted tool to increase patient access to innovative medicines and to facilitate reimbursement in high-income markets. Based on this experience, health systems are increasingly embracing outcomes based concepts. Yet, adoption of MAA in emerging middle-income markets appears to be slow. Thus, the aim of this study is to understand challenges and success factors for MAA in emerging markets to overcome potential limitations and to prepare for outcomes based concepts in these geographies. Literature review to analyze MAA from an emerging markets perspective and to understand stakeholders’ perceptions of MAA, particularly in South-Eastern Europe, Middle East, and Africa. In-depth case study research for Serbia, Lebanon, and South Africa based on interviews with local market access experts and secondary data analysis. Cross-case synthesis to compare approaches and to identify common success factors for the implementation of MAA. Identified success factors for MAA in the analyzed emerging middle-income countries include: Shared understanding of local specifics and access hurdles across all involved parties Co-creation of tailored solutions that respect local particularities, product specifics, and health system needs Minimizing burden of data collection and contract management Closely measure and track the impact of the agreement. Research revealed that fit-for-purpose MAA are an adequate tool to increase patient access to innovative medicines in emerging middle-income countries provided that the aforementioned success factors are considered. Additionally, no evidence could be found that would prevent a future advancement towards outcomes based concepts if key success factors are met.

PHP340 - Market Access Agreements: What Impacts Drugs Purchasing in French Hospitals

PHP340 - Market Access Agreements: What Impacts Drugs Purchasing in French Hospitals

The Use of Surrogate and Patient-Relevant Endpoints in Outcomes-Based Market Access Agreements : Current Debate.

The high cost of novel treatments is the major driver of negative or restricted reimbursement decisions by healthcare payers in many countries. Costly drugs can be subject to Market Access Agreements (MAAs), which are financial (Commercial Agreements [CAs]) or outcomes-based (Payment for Performance Agreements [P4Ps] or Coverage with Evidence Development agreements [CEDs]). Outcomes in outcomes-based MAAs are assessed through changes in surrogate endpoints (SEPs) or patient-relevant endpoints (PEPs). In May 2015, we reviewed published and grey literature on MAAs between manufacturers and large, institutionalised payers from all geographical areas, and classified the schemes into CAs, P4Ps and CEDs, as well as by therapeutic area and country. Outcomes-based MAAs were further categorized by the endpoint used. Overall, we identified 143 MAAs, 56 (39.2%) of which were pure CAs, 53 (37.1%) were CEDs, and 34 (23.8%) were P4Ps. Among the CEDs, 49 were PEP CEDs and four were SEP CEDs; of the 34 P4Ps, 29 were SEP P4Ps for 30 drugs, and five were PEP P4Ps for at least six drugs; and among 87 outcomes-based MAAs (CEDs+P4Ps), PEP CEDs were the most common (56.3%), followed by SEP P4Ps (34.1%). The high proportion of SEPs used in P4Ps contrasts with the high proportion of PEPs used in CEDs. CEDs employ PEPs and it appears that they are used to reduce uncertainty about a drug's clinical outcomes and/or real-life use, and thus allow payers to align a product's value with price. We argue that P4Ps do not reduce uncertainty about real-life effectiveness and can only constitute an outcome guarantee for payers if they are based on PEPs or validated SEPs.

Patient access schemes in Asia-pacific markets: current experience and future potential.

ObjectivesPatient access (or risk-sharing) schemes are alternative market access agreements between healthcare payers and medical product manufacturers for conditional coverage of promising health technologies. This study aims to identify and characterize patient access schemes to date in the Asia-Pacific region.MethodsWe reviewed the literature on patient access schemes over the last two decades using publicly available databases, Internet, and grey literature searches. We extracted key features of each scheme identified, including the drug, clinical indication, stakeholders involved, and details of the scheme. We categorized schemes according to a previously published taxonomy of scheme types and by country.ResultsWe identified 3 schemes in South Korea, 5 in New Zealand, and 98 in Australia. Most (97.2%; n = 103) schemes focused on pharmaceuticals, few on medical technologies. More than half of the schemes related to treatments for cancer and inflammatory diseases such as rheumatoid arthritis. The majority (77.4%; n =82) involved pricing arrangements. Evidence generation schemes were rarely used. About half (41.8%; n = 41) of schemes in Australia were hybrid by nature, consisting of pricing arrangements with a conditional treatment continuation component.ConclusionsAustralia has the most experience with patient access schemes and its experience may provide useful insights for other Asia-Pacific countries. The main targets are pharmaceuticals likely to have high budget impact (due to high per-patient costs and/or large volumes of use), and pharmaceuticals that may be adopted more widely than indicated. With the proliferation of high-cost medicines, the use of schemes may increase to address rising cost pressures, consumer demands, and uncertainties, while attempting to provide patient access to innovative care within finite budgets. Future research is warranted to evaluate the performance of patient access schemes.

Market-access agreements for anti-cancer drugs.

Newly marketed pharmaceuticals command increasingly high prices, particularly in oncology where single treatment cycles can be very costly, even though data at market approval are usually inadequate to describe thoroughly their effectiveness and cost-effectiveness. Both manufacturers and payers have shown interest in solutions to achieve rapid access for patients – known as ‘market-access agreements’. Although the literature offers a variety of definitions, these agreements can be roughly grouped under two main types: financial-based and performance-based. Financial-based schemes focus on the budget impact of a new drug and usually consist of price/dose discounts. Performancebased schemes involve collecting clinical evidence once a new drug has been marketed in a healthcare system and lead to payment only for patients responding to therapy, an objective which is methodologically and practically challenging while not without political appeal. The underlying strategy is to help reduce the likelihood of payers adopting technologies that turn out not to be cost-effective, while at the same time helping manufacturers increase market access time and take profit. Market-access agreements can also be considered an opportunistic way for manufacturers to keep official prices high such as maintaining a common European price, while granting health authorities confidential rebates, thus preventing parallel trade and undermining effective external reference pricing. The English and Italian health services have been the first countries to introduce market-access agreements on specific drugs. These contracts are now called Managed Entry Agreements (MEA) in Italy and Patient Access Schemes (PAS) in England and Wales. We focus on the area of oncology, where many new drugs are costly and fall under these arrangements. Italy

PHP96 - Nature Of Endpoints In Market Access Agreements

PHP96 - Nature Of Endpoints In Market Access Agreements

Market access of cancer drugs in European countries: improving resource allocation

Public health systems need to make well-founded choices in order to distribute their scarce resources in the most efficient way. Given the number of cancer patients, public/private investments in oncology research, the growing number of new anti-cancer agents and consequent budget impact of cancer care, market access of cancer drugs has become delicate over the last decade. Furthermore, decision makers are challenged by ethical objections and endeavour to provide fair and equal access to treatments for cancer patients. The aim of this study is to generate an overview of market access procedures for cancer drugs in eight European countries and formulate advice for improvement of resource allocation. Results are obtained through a literature review and a qualitative questionnaire and validated by experts with proven knowledge about procedures for price setting and reimbursement of drugs. Diverse measures are applied in the studied countries to optimize reimbursement of cancer drugs such as adjusted cost-effectiveness threshold, regulations for off-label use and new market access agreements. Additionally, innovative cancer drugs are excluded from explicit cost control measures such as payback of budget excess by pharmaceutical companies and lump-sum payments per diagnostic related groups (DRG) in the hospital. The results suggest that cancer is prioritized above other disease areas. Further research is necessary to address the question if society attaches higher value to cancer drugs than to treatments for other diseases.

Médicaments innovants et contrats d’accès au marché

Market Access Agreements (MAA) for drugs have emerged in response to the need to control health expenditures, as well as to the uncertainty about the true benefit of a drug. It is possible to group MAA in two types of agreements: financial agreements and outcome-based agreements. MAA is a growing trend and is shifting towards conditional access. However, the willingness to use these contracts and their implementation differ across countries, and some are still resistant to put them in place. The MAA challenges to overcome encompass the complexity of the schemes, the administrative burden and the difficulty of evaluating MAA. It is likely that these agreements might experience further evolution in the future to become a faster pathway for therapeutic innovations, at a fair price.

Symposium: Australia–US Economic Relations and the Regional Balance of PowerAustralia, the United States and the Trans-Pacific Partnership: Diverging Interests and Unintended Consequences

When the talks for a Trans-Pacific Partnership (TPP) were launched in 2010, there appeared to be a coincidence of interests between the American and Australian governments in negotiating a high-quality, ‘21st-century’ trade arrangement that would multilateralise the bilateral and minilateral trade agreements that have proliferated in the Asia-Pacific region in the last 15 years. As the negotiations progressed, however, a divergence between American and Australian interests became apparent. Protectionist interests in the United States have prevented the administration from improving on market access agreements in the current preferential trade agreements with TPP partners, thereby undermining the multilateralisation objective. Some of the elements of the US template for 21st-century trade agreements, notably enhanced protection for intellectual property, and the inclusion of investor–state dispute resolution, clash with Australian trade priorities. Moreover, the central role of the TPP in the US ‘pivot to Asia’ has led to perceptions that it is part of a strategy to encircle China: consequently the TPP may force Australia to make the very choice between China and the United States that the government wishes to avoid.当2010年启动跨太平洋伙伴关系时，在谈判高质量、“21世纪”的贸易安排时美国和澳大利亚政府的利益似乎走到了一起。这种贸易安排会使过去十五年里亚太地区繁荣的双边及微关系多边化。在谈判进行的过程中，美澳之间的分歧却变得明朗了。美国的保护主义利益集团阻碍政府在现行的与亚太伙伴的最惠贸易协定中改善贸易准入协定，因此损害了多边化的目标。美国21世纪贸易协议的模式，明显加强了知识产权的保护，而且包含了投资者—国家争端解决的内容，与澳大利亚贸易优先的考虑发生了冲突。但亚太伙伴关系在美国重心移往亚洲的计划中至关重要，让人觉得就是包围中国战略的一部分。因此亚太伙伴关系会迫使澳大利亚在中美之间做澳政府并不愿意做的选择。

Market access agreements for pharmaceuticals in Europe: diversity of approaches and underlying concepts

BackgroundMarket Access Agreements (MAA) between pharmaceutical industry and health care payers have been proliferating in Europe in the last years. MAA can be simple discounts from the list price or very sophisticated schemes with inarguably high administrative burden.DiscussionWe distinguished and defined from the health care payer perspective three kinds of MAA: Commercial Agreements (CA), Payment for Performance Agreements (P4P) and Coverage with Evidence Development (CED). Apart from CA, the agreements assumed collection and analysis of real-life health outcomes data, either from a cohort of patients (CED) or on per patient basis (P4P). We argue that while P4P aim at reducing drug cost to payers without a systematic approach to addressing uncertainty about drugs' value, CED were implemented provisionally to reduce payer's uncertainty about value of a medicine within a defined time period.SummaryWe are of opinion that while CA and P4P have a potential to reduce payers' expenditure on costly drugs while maintaining a high list price, CED address initial uncertainty related to assessing the real-life value of new drugs and enable a final HTA recommendation or reimbursement and pricing decisions. Further, we suggest that real cost to health care payers of drugs in CA and P4P should be made publicly available in a systematic manner, to avoid a perverse impact of these MAA types on the international reference pricing system.

Design of Patient Access Schemes in the UK

Patient Access Schemes (PAS) are alternative market access agreements between the UK Department of Health and drug manufacturers. They are implemented to enable the UK National Institute for Health and Clinical Excellence (NICE) to recommend expensive medicines for use in the UK NHS. We aimed to analyse the extent to which NICE drug appraisals influence the construction of PAS and what rationale underlies the variety of approaches to their design. We analysed publicly available documentation on PAS developed as a part of the NICE Health Technology Assessment process. We demonstrate how the design of PAS is determined by the kind of evidence that is available to model cost effectiveness of a drug and by the incremental cost-effectiveness ratio that is deemed acceptable in a given patient population. PAS aimed to reduce drug cost to the NHS by means of various discounts or rebates on a per-patient basis rather than by lowering the list price of drugs. While almost all schemes were proposed by the industry in reply to negative draft recommendations by NICE, motivations of the stakeholders to implement PAS are not disclosed in the publicly available documentation. A more transparent process might be necessary to protect against a perverse impact of PAS on international reference pricing that uses list prices rather than the real cost of purchasing medicines that the NHS incurs.

WTO Decision - Making for the Future

Decision making in the WTO has become ever more difficult as the number of members increases and the range of issues tackled broadens. This paper looks at reasons why aspects of decision-making might be changed and discusses a number of potential pitfalls that change would have to avoid, such as a dilution of commitments and fragmentation of the multilateral trading system. It then takes a detailed look at the notion of critical mass decision-making. It argues for this approach under certain conditions, as it would: i) allow for the emergence of a more progressive and responsive WTO agenda; ii) blunt the diversion of trade cooperation initiatives to RTAs; iii) allow more efficient differentiation in the levels of rights and obligations among a community of highly diverse economies; and iv) promote greater efficiency in multilaterally-based negotiations on trade rules, and perhaps, sectoral market access agreements.

Biosecurity, international trade and invasive species: improving US capacity to assess risk

Well-informed policy decisions are based upon high-quality data. In September 2005, the US Environmental Protection Agency engaged the International Union for Conservation of Nature to evaluate opportunities for routine evaluation of the linkages between the US market access agreements and invasive species. This study, led by the authors of this article, assessed the ability of US commodity inspection information systems under the auspices of the Department of Homeland Security, Customs and Border Protection and the US Fish and Wildlife Service to provide reliable, accessible data on invasive species occurrence. Here, we review study implications in the context of US biosecurity. Results indicate that the 'pest' interception data collected by these agencies are inadequate for making well-informed trade policy decisions, especially regarding new market access agreements. Recommendations are offered to enhance US inspection capacity and improve the ability of other governments to reduce the risk of biological invasion via trade pathways.

China's WTO accession: commitments and implications

One hundred years after its adoption, China's Open Door policy is bearing fruit: China has concluded expansive market access agreements with its major trading partners that have paved the way for its becoming a Member of the World Trading Community. As a necessary cost of the WTO accession, China has made remarkable commitments, particularly in relation to its current trade practice. These commitments raise the question of whether China will be able to surpass the formidable barriers of implementation in order to become an honourable Member of the World Trading Community. In an effort to provide some answers in this regard, this article examines the process of China's WTO accession process, and the positive links between China's internal reform and its external economic integration. The focus of the analysis is on measuring the gap between China's commitments for WTO membership and its current practice. The article further assesses the factors that affect the implementation of China's commitments, i.e. its law concerning international agreements, the inherent domestic constraints, and the outside monitoring. The analysis allows the tentative conclusion that the internal drive for openness evidenced in recent practice, and the outside monitoring assisted with persuasion will outweigh the negative historical context.