Perspectives to mitigate payer uncertainty in health technology assessment of novel oncology drugs

Solà-Morales, Oriol; Volmer, T.; Mantovani, LG

doi:10.1080/20016689.2018.1562861

Cited by 11 publications

(11 citation statements)

References 33 publications

(35 reference statements)

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“…Moreover, the traditional methods of health technology assessment used to support decisions may not be enough by themselves in this context. As a result, more robust and innovative models including multicriteria decision analysis (MCDAs) may be required to aid decision making although there have been concerns with MCDAs which are being addressed (8,91,115,(207)(208)(209)(210).…”

Section: Discussionmentioning

confidence: 99%

“…These agreements are principally aimed at enhancing the affordability and value of new medicines at launch and post launch given their frequent substantial budget impact and clinical uncertainty in routine clinical care at the time of their launch (9,18,67,69,(93)(94)(95)(96)(97)(98)(99)(100)(101)(102)(103)(104)(105)(106)(107)(108)(109). This is particularly the case of new medicines for oncology and orphan diseases (68,93,104,(110)(111)(112)(113)(114)(115).…”

Section: Rationale Behind Managed Entry Agreements (Meas)mentioning

confidence: 99%

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Integrative Review of Managed Entry Agreements: Chances and Limitations

et al. 2020

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Introduction: Managed Entry Agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high-and middle-income countries. Methods: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior level co-authors including key South American markets. Afterall, involved senior level decision makers and advisers providing guidance on potential advantages and disadvantages of MEAs and ways forward. Results: 25 studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%), and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. Conclusion: We are likely to see a growth in MEAs with the continual launch of new high priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome based MEAs could be an important tool to improve access to new innovative medicines there are critical issues to address. Comparing knowledge, experiences and practices across countries is crucial to guide high-and middle-income countries when designing their future MEAs.

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Section: Discussionmentioning

confidence: 99%

Section: Rationale Behind Managed Entry Agreements (Meas)mentioning

confidence: 99%

Integrative Review of Managed Entry Agreements: Chances and Limitations

et al. 2020

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“…There are strong opinions about approval and reimbursement in the absence of mature OS data, reflecting the high stakes at play, with concerns over delay in patient access set against concerns about the potential for treatments not to fully provide this anticipated benefit after longer follow-up and mature data. 2,3 As payers have accountability to weigh the patient health benefit of new medicines against budget requirements, we see differences in expectations for OS among payers, and between payers and other stakeholders. [4][5][6] In some cases, we see that regulators, clinicians and patients place different values on non-OS endpoints from payers.…”

Section: Introductionmentioning

confidence: 99%

The Impasse on Overall Survival in Oncology Reimbursement Decision-Making: How Can We Resolve This?

Lux¹,

Ciani²,

Dunlop³

et al. 2021

CMAR

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“…Australia 3 and the UK 4 undertook the first reimbursement evaluations the same year with approvals for funding granted the following year 5,6 . However, the initial costs of these drugs have caused anxiety among health care providers, patients, payers and researchers, as countries have to balance affordability and timely access to these drugs 7,8 …”

Section: Introductionmentioning

confidence: 99%

“…To meet this challenge, reimbursement agencies have developed several approaches to ensure appropriate access whilst managing the financial risk to health care budgets. Health technology assessment (HTA) is now being used almost ubiquitously to assist health care providers and payers decide whether new therapies, such as ICI medicines represent good value for money 8 . HTA is the systematic evaluation of direct and indirect effects of health technology, 9 and the subfield of health economic modelling is an integrated part of decision analysis when assessing the cost effectiveness of these drugs 10 .…”

Section: Introductionmentioning

confidence: 99%

Cost‐effectiveness and financial risks associated with immune checkpoint inhibitor therapy

Kim

Liew

Goodall

2020

Brit J Clinical Pharma

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The reimbursement of immune checkpoint inhibitors is challenging. Funding these technologies involves the careful balance between awarding innovation and ensuring affordability as increases in drug spending compete directly with other health care and social expenditure. This narrative review examines the recommendations of 2 health technology assessment agencies—the Australian Pharmaceutical Benefits Advisory Committee and the British National Institute of Clinical Excellence—to determine the factors that contribute to the approval and rejection of immune checkpoint inhibitors as well as the use of manage entry schemes and risk management strategies to control expenditure. Reimbursement decisions from 6 immune checkpoint inhibitor drugs (ipilimumab, pembrolizumab, nivolumab, durvalumab, atezolizumab, avelumab) covering 10 different cancers were examined. The extrapolation of survival beyond the clinical trial and lack of head‐to‐head evidence are some of the main issues relating to cost effectiveness. Payers managed financial risks using different mechanisms such as risk share agreements and financial caps. This review of the reimbursement decisions and subsequent financial impact in Australia and the UK suggests budgets for immune checkpoint inhibitor therapy have been well managed so far. Through risk agreements and managed entry programmes, the example of immune checkpoint inhibitor therapies illustrates that industry and payers can effectively collaborate to ensure that innovative, but expensive, drugs can be made readily available to patients.

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Perspectives to mitigate payer uncertainty in health technology assessment of novel oncology drugs

Cited by 11 publications

References 33 publications

Integrative Review of Managed Entry Agreements: Chances and Limitations

Integrative Review of Managed Entry Agreements: Chances and Limitations

The Impasse on Overall Survival in Oncology Reimbursement Decision-Making: How Can We Resolve This?

Cost‐effectiveness and financial risks associated with immune checkpoint inhibitor therapy

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