HealthEconomics.Com Connected. Community. Fri, 23 Oct 2020 16:49:43 +0000 en-US hourly 1 ISPOR Invites Applications For President-Elect or Director Fri, 23 Oct 2020 16:49:43 +0000 The ISPOR Nominations Committee is now inviting members to nominate themselves or a colleague or to serve as President-Elect or Director for the 2021–2022 Board of Directors. ISPOR is a member-driven organization that relies on the leadership, expertise, and vision of its members to fulfill the organization’s mission. ISPOR is fully committed to diversity and highly encourages its members to apply for Board positions. Applications are available through January 1, 2021. Note that members must log in to their ISPOR account to submit an application. Submit your nomination here.

Value-based Care at Risk Fri, 23 Oct 2020 15:43:11 +0000 An April survey by the National Association of ACOs showed that more than half the organizations in at-risk models planned to drop out of the program because of pandemic-related losses.  In response, CMS Administrator Seema Verma waived consideration of COVID-19 costs when calculating ACO savings and losses this year. These new emergency regulations also reduced the amount of downside risk. It is unknown if the rrelaxed requirements will maintain the current level of engagement. The pandemic-induced revenue collapse has revealed the dark truth behind the ‘one foot on the dock, one foot in the canoe’ metaphor. Read more here.

(Source: Merrill Goozner; Modern Healthcare; 9/14/20)

Payers: The New Catalysts of Better Health Fri, 23 Oct 2020 15:00:18 +0000 As health care delivery is getting more complex, the traditional definition of healthcare is evolving. This shift is necessitating the move to more vertically-integrated patient care that is focused on holistic well-being, not just treatment episodes. Payers have the power to be agents of that change. As the central hub around which healthcare transactions revolve, payers have a more complete picture of a patient’s healthcare journey than any other stakeholder. To that end, Managed Healthcare Executive has published a white paper outlining four data-driven strategies that will help payers create a health plan for the new era. Download here.

Trial Site Networks: Create Positive Change Through A Shift in Perspective Fri, 23 Oct 2020 14:27:58 +0000 COVID-19 represents a stress test of sorts for our global healthcare system that will hopefully lead to positive changes over the long-term. In the short-term, there are pressing concerns about the feasibility of continuing clinical development in the context of widespread transmission of COVID-19. To remain viable, sponsors will need to consider trial site networks as partners to continue bringing important therapies to patients in need. This can be best achieved through maintaining a thorough site relationship strategy for ongoing programs as part of a more holistic approach to trial design. Read more here.

(Source: Mark Brown; Applied Clinical Trials; 10/20/20)

Patient Intelligence and Insights Reports Available from Self Care Catalysts Thu, 22 Oct 2020 22:05:48 +0000 Patients negotiate a shifting landscape of goals and aspirations. They have to navigate unmet needs, barriers to care, influencers and supporters, and various sources of information.

Self Care Catalysts’ Health Storylines Patient Intelligence and Insight Reports identify the key domains of patient experience in the context of their lived experience. This is done by weaving social media analysis into patient experience that is data collected in real time in the real world, uncovering actionable insights pertinent to the entire product lifecycle management. Find out more here.

Submit Your Abstracts for Virtual ISPOR 2021 Thu, 22 Oct 2020 21:00:02 +0000

Abstract Submissions Are Open for Virtual ISPOR 2021; May 17 – 20: “HEOR: Evolving for Tomorrow’s Challenges” Submit under the following categories:

  • Issue Panel Proposals
  • One-hour oral presentations with scheduled time for Q&A.
  • Workshop Proposals
  • One-hour oral presentations with time for viewer interaction.
  • Research Abstracts
  • Virtual poster presentations or 15-minute oral podium

Submit your abstract here.

Adaptive Trial Designs in Early Oncology Thu, 22 Oct 2020 20:45:58 +0000 Our understanding of the genetic and molecular mechanisms that lead to cancer have improved greatly over the past decade thanks to significant advancements. Despite this, only 10 percent of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) demonstrate an overall survival benefit. Now, precision medicine is making waves and shifting how early-phase oncology trials are conducted, including many Phase 1 trials with preliminary response rates. This white paper addresses clinical trials in precision medicine and explores the expanding role of adaptive trial designs in Phase 1 and Phase 2 oncology studies. Download the full white paper here.

Bart Heeg on New Trends in HEOR Thu, 22 Oct 2020 20:08:43 +0000 In this two-part blog series, Bart Heeg, Vice President HEOR and Founder at Ingress Health (A Cytel company) discusses trends in HEOR and explains why Bayesian methods are also important for Health Economics. Read part 1 here and part 2 here.

(Source: Cytel Blog; 10/22/20)

Draft Scoping Document for the Assessment of Alzheimer’s Disease Posted by ICER Thu, 22 Oct 2020 15:00:23 +0000 Yesterday the Institute for Clinical and Economic Review (ICER) posted a Draft Scoping Document detailing the planned review of the comparative clinical effectiveness and value of aducanumab (Biogen) for Alzheimer’s disease. An FDA decision on aducanumab is expected in early 2021.Comments and suggested refinements meeting ICER’s formatting specifications are welcome and should be submitted by email to no later than  5 PM ET on November 10, 2020.

All comments submitted must meet ICER’s formatting specifications. Additional guidance for submitting comments can be found in ICER’s Patient Participation Guide and Manufacturer Engagement Guide. ICER also welcomes submissions from stakeholders on examples of low-value care practices within this clinical area to help develop a report section on strategies to reduce waste and preserve resources for high-value, potentially higher-cost treatments.

FDA Approved NDA for KOSELUGO™ (selumetinib) Thu, 22 Oct 2020 14:16:40 +0000 Recently the FDA approved AstraZeneca’s KOSELUGO™ (selumetinib) for treatment of pediatric patients two years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

In support of the application, AstraZeneca’s submitted a natural history study of NF1, Study 01-C-0222 (NCT00021541; n=62). According to an FDA spokesperson, the results of the natural history study were supportive because the study “…provided sufficient evidence that spontaneous tumor regression or spontaneous reductions in PN-related morbidities do not occur as part of the natural history of disease, the observed effects (on NF1-related PN shrinkage) in the SPRINT trial could be reliably attributed to the selumetinib treatment effect.” However, the FDA did not find the natural history study to be suitable for any comparative analyses. Read more here.

(Source: Christina Purpura and Elizabeth Dabrowski; Aetion; 10/16/20)