Boston, Mass., November 24, 2015 – The Institute for Clinical and Economic Review (ICER) has posted the final report PCSK9 Inhibitors for Treatment of High Cholesterol: Effectiveness, Value, and Value-Based Price Benchmarks, and its accompanying Action Guides to the New England Comparative Effectiveness Public Advisory Council website. This final report is an update to ICER’s earlier draft report on the two PCSK9 inhibitors approved by the FDA earlier this year: Alirocumab (Praluent®, Regeneron/Sanofi) and evolocumab (Repatha™, Amgen). The final report incorporates the results of the deliberation and voting on the strength of evidence by the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). In addition, the final report includes an updated value-based price benchmark for PCKS9 inhibitor drugs and policy recommendations for coverage policy and for clinical practice generated by discussion with clinical experts, payers, patients, and other stakeholders at the public meeting of the New England CEPAC. To accompany the final report ICER has released an Action Guide for policymakers and clinicians, as well as a separate guide for patients. The Action Guides further distill key policy recommendations and provide resources to support their implementation.
ICER Announces Initial List of Topics for 2016 New Drug Reports on Effectiveness, Value, and Value-Based Price Benchmarks
Drugs to be evaluated include high-profile treatments for Asthma, Diabetes, Lung Cancer, Muscular Dystrophy and other conditions
Contact: Mitchell Stein, 617-528-4013 ext. 7010, firstname.lastname@example.org
Boston Mass., November 19, 2015 – The Institute for Clinical and Economic Review (ICER) has released the slate of new drugs it plans to review in 2016. These reviews are a continuation of the new drug assessment program begun in the Fall of 2015. The list of drugs to be reviewed is based on ICER’s discussion with multiple payers and other stakeholders to prioritize the most important new drugs in the pipeline with expected FDA approval between late 2015 and mid-2016. Due to the uncertain timing and outcomes of FDA decisions, ICER may revise this schedule as necessary.
“The Obama Administration’s encouragement of a meaningful dialogue around the issue of drug pricing in tomorrow’s Health & Human Services forum represents an important shift in the national conversation,” stated Steven D. Pearson, MD, MSc, President of ICER. “We hope that our reports – which include a value-based price benchmark for new drugs, information on how well the drugs work compared to existing treatments, and what their impact could be on health system budgets – can inform the conversation around this critical issue.”
For each drug ICER will produce a report that includes a systematic review of the published evidence and an economic analysis. The reports will also feature a value-based price benchmark for each drug derived from an analysis of comparative cost-effectiveness relative to the current standard of care, and the potential short-term budget impact for health systems.
All reports will be the subject of public hearings held to debate the evidence and provide recommendations for insurance coverage and practice policies. These hearings will be held under the auspices of three independent groups convened by ICER: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC).
As previously announced, the first report of 2016 will cover insulin degludec (Tresiba®, Novo Nordisk) for diabetes and mepolizumab (Nucala®, GlaxoSmithKline) for asthma.
A partial list of additional drugs currently expected to be reviewed in 2016 include those below. Generic drug names are bolded and followed by trade name (when available) and manufacturer in parentheses.
- Obeticholic acid (Intercept Pharmaceuticals) for the treatment of primary biliary cirrhosis. This drug is of heightened interest in part because of its potential off-label use to treat nonalcoholic steatohepatitis (NASH), the most common form of liver failure in the United States.
- Drisapersen (Biomarin) and eteplirsen (Sarepta Therapeutics) for the treatment of Duchenne Muscular Dystrophy (DMD). DMD is a rare genetic disorder in which patients typically develop muscle weakness in early years of life, become wheelchair-bound in their early teens, and die before the age of 30. No FDA-approved treatments currently exist for DMD.
- Class review of drugs for the treatment of non-small cell lung cancer:
Rociletinib (Clovis Oncology), AZD-9291 (AstraZeneca), Necitumumab (Eli Lilly), nivolumab (Opdivo®, BMS) and pembrolizumab (Keytruda®, Merck) are all used for treatment of non-small cell lung cancer, the most common cause of cancer death in the United States. The availability of multiple new “breakthrough” therapies for this cancer has raised important questions about their comparative effectiveness and value.
- Class review of drugs for the treatment of multiple sclerosis:
Fingolimod (Gilenya®, Novartis), Dimethyl Fumarate (Tecfidera®, Biogen), teriflunomide (Aubagio®, Genzyme), alemtuzumab (Lemtrada®, Genzyme), and daclizumab (Zinbryta, Biogen) are among the more recent group of drugs approved or under consideration for treatment of multiple sclerosis, a relapsing condition in which there are many uncertainties regarding comparative effectiveness and value of different treatments.
- Class review of drugs for the treatment of psoriasis and psoriatic arthritis:
Ixekizumab (Eli Lilly and Co.) and brodalumab (AstraZeneca) represent a new class of monoclonal antibody treatments that have the potential to change the treatment paradigm for patients with psoriasis and psoriatic arthritis.
Please note again that this is a list of tentative topics. Additional drugs may be added and some may be removed based on actions by the FDA or the manufacturer. The list does not reflect full consideration of the existing drugs that may be included as comparators to new drugs in the reviews. The list was created using the best currently-available information regarding the FDA’s timeline for approval and the likelihood of approval of the selected drugs. Specific drugs will be announced approximately five months before each public meeting. Details of the process can be found here and the library of our announcements can be found here.
Learn more about ICER’s new drug assessment program here.
Learn more about the transparent process used to create the reports here.
Learn more about ICER’s Value Assessment Framework here.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit health care research organization dedicated to improving the interpretation and application of evidence in the health care system. ICER directs three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). For more information about ICER, please visit ICER’s website, www.icer-review.org.
For more information about the Midwest CEPAC, visit the ICER website.