The Institute for Clinical and Economic Review has received industry backlash over changes to its value-assessment process it proposed in June. The changes, if implemented, would lower the threshold ranges for cost-effectiveness down to $50,000 to $100,000 a year, a net drop of $50,000 at each end of the range. The outgoing ICER president Steve Pearson noted that these changes are not going to be immediately implemented and are still under consideration.
The Institute for Clinical and Economic Review (ICER) will perform a value-assessment on KarXT (xanomeline tartrate/trospium chloride), Karuna Therapeutics’ experimental therapeutic for schizophrenia. Public discussion of the assessment will take place next February at the 2024 New England CEPAC meeting.
The Institute for Clinical and Economic Review (ICER) has announced that its founder, Steve Pearson, MD, will step down from his role as president later this year. ICER’s COO Sarah Edmond will take over the position as president, while Pearson will move to an advisory position for the organization, which performs value-assessments on therapeutics.
The Institute for Clinical and Economic Review (ICER) has announced it will perform a value-assessment for Merck’s sotatercept for the treatment of pulmonary arterial hypertension. The organization has been in talks with patient groups, clinical specialists, manufacturers, and patient advocates and will present its report at the Midwest CEPAC meeting this coming December.
In a new draft guidance, the UK’s National Institute for Health and Care Excellence (NICE) decided against recommending Ipsen’s small molecule drug Cabometyx (cabozantinib) for the treatment of differentiated thyroid cancer (DTC). The recommendation comes after approval for the indication was made last year.
Earlier this month, ISPOR’s Board of Directors announced they appointed a new CEO to guide the organization, Rob Abbott. Mr. Abbott has over 20 years of executive experience and lead Health Technology Assessment International as CEO and executive director. He took over the new leadership role at ISPO after the retirement of the former CEO, Nancy S. Berg.
The US House Energy and Commerce Committee voted on Friday, March 24th, to advance a bill to a full House vote that would ban the use of quality adjusted life years (QALY) in therapeutic value-assessments. Some representatives argue that the bill is necessary, alleging the metric discriminates against people with disabilities. Other representatives argue the bill overreaches and would complicate upcoming drug price negotiations.
While disability advocates and lawmakers have decried the use of quality-adjusted life years (QALY) in recent years, some argue that it is an indispensable measure that is unfairly maligned. For example, patient advocates argue that the focus on quality of life devalues the lives of disabled people and patients with chronic illness. Writers from the Center for the Evaluation of Value and Risk in Health (CEVR) contend this is a misunderstanding.
Quality-adjusted life years (QALY) is a metric widely used when determining the cost-effectiveness of a drug, often when deciding upon or recommending drug prices. A new bill was approved by the US House Energy and Commerce Health Subcommittee that would, if passed, end the practice of using QALY in drug value-assessments. Proponents of the ban say relying on QALY undervalues the positive effects of therapeutics on people with disabilities.
The UK’s National Institute for Health and Care Excellence (NICE) gave Novo Nordisk’s weight loss drug Wegovy its recommendation for coverage today, March 8th. In response, Novo Nordisk is making plans to bring the wildly popular drug to the UK market. However, the drug will be more tightly controlled than in the US or EU markets, where the drug has taken off with celebrities and influencers.
As patients begin taking the first doses of Leqembi (lecanemab), Eisei and Biogen’s new amyloid-targeting Azlheimer’s therapy, many patient advocates are lambasting the high price of the treatment. The criticism comes after a value-assessment estimated a fair price for the drug that is significantly lower than the one set by the manufacturer.
At The American Journal of Managed Care’s Institute for Value-Based Medicine event that took place this past October, speakers discussed the high cost of new therapeutics. A balance must be struck, according to Kevin Cohen, MD, of Optum Care, using data analytics to optimize care quality and costs.
The Institute for Clinical and Economic Review (ICER) has issued a report evaluating the value and cost-effectiveness of two amyloid-targeted therapeutics for Alzheimer's disease. Biogen and Eisai’s lecanemab was deemed by the agency to be cost effective if priced between $9,000 and $21,000, whereas Eli Lilly’s donanemab was valued between $14,500 and $46,900, although evidence was limited regarding the latter.
The Institute for Clinical and Economic Review (ICER) has released a newly revised evidence report covering several therapies for multiple sclerosis, comparing their clinical efficacy and relative value. The treatments include five monoclonal antibody therapies and eight oral drugs. Although the analysis was unable to differentiate the value of individual monoclonal antibody treatments, they were collectively deemed cost-effective at annual prices ranging from $16,500 to $34,900.
A new report published by the Institute for Clinical and Economic Review (ICER) lays out a list of the top 10 therapeutics that had unsupported price hikes last year. Among the top ten were several high-price drugs that contributed significantly to US drug spending. Seven of the top 10 list were hiked without any new evidence.
Two sickle cell gene therapies will be assessed for value and efficacy by the Institute for Clinical and Economic Review (ICER), according to an announcement today, November 23rd. The institute will investigate lovotibeglogene autotemcel (“lovo-cel”, bluebird bio) and exagamglogene autotemcel (“exa-cel”, Vertex Pharmaceuticals and CRISPR Therapeutics). Public discussions will take place at a June 2023 CTAF meeting.
Accession has announced that its digital platform pathwaypro® has hit 7 years of product development, completing a major goal set by the company 7 years ago. The platform allows healthcare organizations and decision-makers to model drug optimization and value-assessment. In a recent annual ranking of pharma companies in the UK, Accession was rated “one to watch”.
Denmark established the Danish Medicines Council (DMC) back in 2017 to help make assessment of medicines faster, transparent, and more consistent. In a recent Amerisource Bergen article, Flemming Axelsen, MSC, looks back at the past five years of the DMC, explaining its successes, failures, and the lessons that can be gleaned from both.
ISPOR will shortly open up applications for peer-reviewers for its upcoming ISPOR 2023 conference. Nominees will review research abstract submissions to ensure that research presented at the conference will meet ISPOR’s high standards. Reviewers are required to be non-student members of ISPOR and must have time to review abstracts from January 20th to February 3rd, 2023. Submissions open November 18th and close December 6th.
Global Pricing Innovations (GPI) has announced the launch of its new GPI Horizon platform. GPI Horizon is an analytics-based tool to expedite value-assessment and price prediction across the entire life cycle to help drive market access and reduce payer risk. The program is part of GPI’s larger offerings, but can be used in a self-service model.
This year’s Patient-Centered Oncology Care 2022 saw several talks about defining value in oncology care, according to Dr. Kashyap Patel of Community Oncology Alliance and Carolina Blood and Cancer Care Associates. Patel spoke about this and other topics covered at the conference with the AJMC staff in a video interview.
A revised evidence report has been published by the Institute for Clinical and Economic Review (ICER) detailing the effectiveness and value of two gene therapies for hemophilia A and B. The gene therapies offer nearly complete remission of bleeds for a period of time without the need for prophylactic factor replacement.
In the US, prescription drugs tend to increase in price faster than inflation and launch for prices far exceeding value to patients. In a newly released final report, ICER investigated unsupported price increases in California using data made available by SB-17, a law ensuring the transparency of drug costs from manufacturers and payers.
There has been a push towards value-based pricing (VBP) for prescription drugs, especially with new drug pricing reform in the US. Reaching this goal will require extensive data to determine the value of medications. An important resource is electronic health records (EHR), but these sources are rarely interoperable. In a new article on Healthcare IT Today, Girisha Fernando of Lyfegen discusses why data interoperability is so essential for VBP.