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E. Richardet
Moderator of
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SC29 - Access, Value Assessments and Affordability of Novel Therapies (ID 353)
- Event: WCLC 2016
- Type: Science Session
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 5
- Moderators:M. Krzakowski, E. Richardet
- Coordinates: 12/07/2016, 11:00 - 12:30, Strauss 1
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SC29.01 - Affordability of Novel Therapies: A Global Challenge (ID 6721)
11:00 - 11:20 | Author(s): R. Sullivan
- Abstract
Abstract not provided
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SC29.02 - Value-Based Assessments in Lung Cancer Therapy: The North American Perspective (ID 6722)
11:20 - 11:40 | Author(s): R.J. Kelly
- Abstract
- Presentation
Abstract not provided
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SC29.03 - Value-based Assessments in Lung Cancer Therapy: The ESMO Perspective (ID 6723)
11:40 - 12:00 | Author(s): N. Cherny
- Abstract
Abstract:
The value of any treatment is determined by the magnitude of its clinical benefit (MCB) balanced against its cost. Whereas costs of procurement and out-of-pocket expenditures vary from country to country, the MCB, as derived from well-designed clinical trials, is a relative constant. Consequently, meaningful discussion of value and relative value are predicated on an understanding of the MCB. MCB in this context refers to the added benefit, usually compared to a control (the best current standard care). Until recently there was no standard tool for grading the MCB of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long term survival). Recognising the importance of presenting clear and unbiased statements regarding the MCB from new therapeutic approaches derived from high quality clinical trials the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the MCB for cancer medicines, the ESMO MCB Scale (ESMO-MCBS). This tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost effective and affordable cancer care. The ESMO-MCBS v1.0 [1]has been developed and validated for solid cancers. The tool is presented in two parts. Form 1 is used to evaluate adjuvant and other treatments with curative intent. Form 2 (a, b or c) is used to evaluate non-curative interventions, with form 2a for studies with OS as the primary outcome, form 2b for studies with PFS or TTP as primary outcomes, 2c for studies with QoL, toxicity or response rate as primary outcomes and for non-inferiority studies. Form 2a is prognostically sub-stratified for studies where the control arm produced OS greater or less than or equal to 1 year, and form 2b is stratified for studies where the control arm PFS is <6m or >6mth. Version 1.0 can be applied to comparative outcome studies evaluating the relative benefit of treatments using outcomes of survival, QoL, surrogate outcomes for survival or QoL (DFI, EFS, TTR, PFS and TTP) or treatment toxicity in solid cancers. Eligible studies can have either a randomised or comparative cohort design or a meta- analysis which report statistically significant benefit (P>0.05, upper limit of 95[th] percentile for HR <1) from any one, or more of the evaluated outcomes. For treatments with curative intent, the scale is graded A, B or C. Grades A and B represent a high level of clinical benefit . For cancers treated without curative intent, the scale is graded 5, 4, 3, 2, 1, where grades 5 and 4 represent a high level of proven clinical benefit. The scale incorporates a “dual rule” taking into account the variability of the estimated HR from a study, the lower limit of the 95% Confidence Interval (CI) for the HR is compared to specified threshold values; and second the observed absolute difference in treatment outcomes is compared to the minimum absolute gain considered as beneficial. Different candidate threshold values for HR and absolute gains for survival, DFS and PFS, adjusted to represent as accurately as possible the expert opinion of the oncology community, have been explored through extensive simulations. In all forms HR thresholds refer to the lower extreme of the 95% CI, analogous to the convention of evaluating null effect by the upper limit of the 95%CI <1. The performance of the evaluation rule based on the lower limit of the 95% CI of HR, was compared to the simpler rule of using a cut-off for the point estimate of HR, in conjunction with the additional rule on the minimum absolute gain in treatment outcome. The simulation results under different HR values and corresponding power, favoured the proposed approach to use the lower limit of the 95% CI which takes into account the variability of the estimate. The concern that small studies generate wider confidence intervals is real and justified, however in the ESMO-MCBS v1.0 all high grading scores in a non-curative setting incorporate both HR and absolute gain to mitigate against over valuing small studies with wide HR. This structured and disciplined approach to deriving estimates of clinically meaningful benefit from published data can be used in a range of settings: it can help public policy-makers advance “accountability for reasonableness” in resource allocation deliberations, contribute to formulation of clinical guidelines , in the clinic it can help clinicians to weigh the relative merits of competing relevant therapeutic options in situations in which there is no direct comparative data and grading may also be of benefit when explaining the relative merit of therapeutic options to patients and their families. Finally ESMO-MCBS may be of use to editors, peer reviewers and commentators in considering the clinical significance of research findings from randomised clinical studies, cohort studies and meta-analyses with statistically significant positive findings. Experience accrued in evaluating trials in the management of non small-cell lung cancer have been critical in the development process of v1.0, particularly with regard to the interpretation of PFS is studies with extensive crossover on progression that precludes meaningful OS survival results. In this cohort of studies, the inclusion of QoL evaluation was able to generate confirmatory secondary evidence to support the clinical significance of the PFS findings. The proliferation of new agents targeting NSCLC with specific mutations that have been approved on the basis if Phase I-II data have challenged the working group to expand the scope of the scale to include single arm studies. This new subscale will be among the amendments in the planned revision that is under development and scheduled for publication early next year. 1. Cherny NI, Sullivan R, Dafni U et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Annals of oncology 2015; 26: 1547-1573.
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SC29.04 - Solutions for Low-Income Countries (ID 6724)
12:00 - 12:15 | Author(s): G. Lopes
- Abstract
Abstract not provided
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SC29.05 - The Thai Experience to Overcome High Cost Drug in Cancer (ID 6725)
12:15 - 12:30 | Author(s): S. Thongprasert
- Abstract
Abstract:
With limited resources for health, Low and Middle Income Countries (LMICs) struggle to guarantee all members of their society toget cancer treatments, especially the innovative but expensive cancer medicines[1, 2]. Cancer is a leading cause of deathin Thailand, which is an upper-middle income country in South-East Asia. From 2003 to 2011, the mortality rate from cancer rose from 79 to 95 per100,000 populations. [3].Since the Thai health care reform in 2001[4, 5] several stakeholders have initiated policies andprogramsto facilitate access to medicines. The Thai NLEM is different from the one listed by WHO, due to the fact that WHO listed only the minimum required medicine, while the Thai list included an optimum list. At the present, the Thai NLEM has more than 700 items of active ingredients and 1000 dosage forms [6, 7]. When the NLEM was first introduced in 1981, only cost, safety, and efficacy were considered as criteria for inclusion whereas effectiveness was added to the list of criteria in 2004. Since 2008, economic evidence has become important for the Sub-committee of the NLEM to justify the new costly medicines such as type E2 to be included in the list of NLEM. As of 2009, the NLEM can be divided into six categories, which are A, B, C, D, E1, and E2. Type A: Basic medicines that every health facility must make available Type B: Alternative, second line medicines of those in category A Type C: Medicines prescribed only by specialists TypeD: Medicines used only for particular indications and diseases Type E1: Medicines used only for special or vertical programs Type E2: Medicines that are high costs but are important for particular groups of patients Heath Care Coverage for Thai residences are divided into 3 categories 1. Universal Coverage Scheme (UCS) Cover 75% of Thai population 2. Social Security Scheme (SSS) Cover 19%, Private sector employees, excluding dependants 3. Civil Servant Medical Benefit Scheme (CSMBS) Cover 9%, Government employees plus dependants (parents, spouse and up to two children age <20) The CSMBS has covered most of the cancer drugs including the expensive drugs, however UCS and SSS have covered only drugs listed in the NELM; thus there are unmet need for cancer patients with these two healthcare schemes. Thai government set up several policies to enable access to the cancer drugs such as Compulsory Licensing, Pooled purchasing (price negotiation), Special marketing arrangement (price negotiation), and E2 access program. Several pharmaceutical companies provide their own scheme for patients who are willing to pay for the drug by themselves (patient access program) Even with all the programs available, the problem of accessibility of costly anticancer drugs still persists. There should be more input into this problem. References 1. Kanavos P, Das P, Durairaj V, Laing R, Abegunde DO (2010) Options for financing and optimizing medicines in resource-poor countries World Health Organization. 2. American College of Physicians (2011) How can our Nation Conserve and Distribute Health Care Resources Effectively and Efficiently? Philadelphia: American College of Physicians. 3. MoharaA,YoungkongS,PérezVelascoR,WerayingyongP,PachaneeK,etal.(2012)UsinghealthtechnologyassessmentforinformingcoveragedecisionsinThailand.JComparEffectRes.1:137–146. 4. Damrongplasit K, Melnick GA (2009) Early results from Thailand's 30 Baht Health Reform: something to smile about. Health Aff (Millwood). 28: w457–466. doi: 10.1377/hlthaff.28.3.w457 PMID: 19336469 5. Towse A, Mills A, Tangcharoensathien V (2004) Learning from Thailand's health reforms. BMJ. 328: 103–105. PMID: 14715608 6. Yoongthong W, Hu S, Whitty JA, Wibulpolprasert S, Sukantho K, et al. (2012) National drug policies to local formulary decisions in Thailand, China, and Australia: drug listing changes and opportunities. Value Health. 15: s126–131. doi: 10.1016/j.jval.2011.11.003 PMID: 22265059 7. Turongkaravee S, Rattanavipapong W, Khampang R, Leelahavarong P, Teerawattananon Y, et al. (2012) Evaluation of high-cost medicine scheme (Category E2) under the 2008 National List of Essential Medicines. Nonthaburi: Health Intervention and Technology Assessment Program.
Author of
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SC17 - Lung Cancer: A Global Cancer with Different Regional Challenges (ID 341)
- Event: WCLC 2016
- Type: Science Session
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:C. Vallejos, P.A. Bunn, Jr.
- Coordinates: 12/06/2016, 14:20 - 15:50, Strauss 1
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SC17.04 - Lung Cancer in Latin America: Challenges and Perspectives (ID 6669)
15:05 - 15:20 | Author(s): E. Richardet
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
