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ICER Weekly View: Our MLD Evidence Report, the ICER-PHTI Digital Health Framework, & ICER on angering both sides of the drug pricing aisle

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Weekly View


September 15, 2023

From the desk of Priya Ranade

Good morning, everyone.

Yesterday, ICER posted an Evidence Report assessing the comparative clinical effectiveness and value of atidarsagene autotemcel (“arsa-cel”, Orchard Therapeutics) for metachromatic leukodystrophy (MLD). ICER’s Chief Medical Officer David Rind, MD explained:


“MLD is a devastating disease for children and their caregivers. It is extremely rare, and most doctors have never seen a case. Parent testimony shared throughout this report has provided a window into the hope and frustration that families are feeling as new treatments become available. With arsa-cel, we see a gene therapy again filling the promise of possible treatments for conditions that previously were untreatable.”

 

This Evidence Report will the basis for our September 29th virtual public meeting, where an independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate on the treatment’s comparative clinical effectiveness, other potential benefits, and long-term value for money. Register here.

Let's see what else happened this week...

ICER in the News

Angering both sides of the Drug pricing aisle

Nature Reviews Drug Discovery

ICER’s President-Elect, Sarah Emond, discussed drug pricing, multimillion dollar gene therapies and innovation incentives with Asher Mullard at Nature Reviews Drug Discovery. Below is a brief excerpt from their conversation: 


"Some of the work that we [ICER] have done shows that when manufacturers swing for the fences and hit it out of the park, even prices like US$1–2 million or more are fair. That's exactly the innovation signal that we want to trickle back into the investment community...


I think it's okay to ask whether or not the innovation signals that we have set up right now are the ones that we want. And I think if we can really anchor the conversation again back to value, and reward those big Health gains for patients, then we can have all the innovation signals that we need."

Peterson Health Technology Institute Releases New Digital Health Assessment Framework

Peterson Health Technology Institute (PHTI)

On Tuesday, the ICER-PHTI Assessment Framework for Digital Health Technologies (DHTs) was released, the result of a months-long collaboration between ICER and PHTI to develop a framework specific for the DHT space.


Each element of the ICER-PHTI Assessment Framework is grounded in evidence-based standards specifically designed for the unique attributes of digital health technology. The framework development process involved a range of experts in health technology assessment, clinical care delivery, health economics, and patient perspectives.

Pharmaceutical News

MUST READS


Legal battle over drug negotiations could collide with 2024 race

Axios

Today, a federal judge in Ohio will hear oral arguments on the U.S. Chamber of Commerce's request to halt the program before Oct. 1, the deadline for companies to agree to Medicare negotiations on the first 10 selected drugs.


The Biden administration and the Chamber are expected to clash over when exactly drug companies will face "harm" from the Inflation Reduction Act program.

House transparency, PBM reform bill gains bipartisan support

STAT

Frank Pallone (D-N.J.), has signed on to a legislative package that would require health care transparency by law and enact modest payment reforms to pharmacy middlemen and hospitals, increasing its chances of passing the House of Representatives.


Republicans conceded to a few tweaks to the legislation to ensure that transparency regulations for hospitals were at least equal to current regulations, which gained the endorsement of Pallone, the Democratic House Energy and Commerce Committee ranking member.

Employers Say Medicare Drug Negotiations Could Cost Them More

Bloomberg

Employers that sponsor health plans are concerned Medicare’s new drug price negotiations will leave them paying higher prices. The Medicare drug price negotiations that are starting under the Inflation Reduction Act could mean higher prices for self-insured employer health plans that pay their employees’ claims, said Margaret Rehayem, vice president of the National Alliance of Healthcare Purchaser Coalitions.


Employer groups had called on lawmakers to extend drug price reforms to include commercial plans, but the provision didn’t make it through Congress. Now employers say they are worried that drug manufacturers will try to make up for lower prices from the government by charging more for drugs purchased by commercial plans, such as those sponsored by companies.

In new Regeneron deal for Covid drug, White House imposes price limits for first time

STAT

A new deal between the Department of Health and Human Services and the pharmaceutical company Regeneron marks the first time the Biden administration has directly used its leverage to challenge drugmakers’ list prices, experts told STAT.


The contract between Regeneron and the government requires that the list price for a future monoclonal antibody drug to prevent COVID-19 is the same or lower in the United States as in other high-income countries. The release doesn’t explain which countries the government will be comparing prices with, or how pricing data will be determined.

OTHER HEADLINES


  • Michigan Public Radio Network: Senate Dems introduce Prescription Drug Board bills, industry reps voice doubts


  • Inside Health Policy: Consumer Groups Rally For Patent Reforms To Be In Senate Rx Pricing Package


  • Pink Sheet: US FDA Commissioner Pushes Real-World Evidence To Guide Use Of Alzheimer’s, Obesity Drugs


  • JAMA Network: Spending on and Use of Clinician-Administered Drugs in Medicare


  • The Wall Street Journal: Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them


  • The Associated Press: Psychedelic drug MDMA eases PTSD symptoms in a study that paves the way for possible US approval


  • The New York Times: C.D.C. Recommends New Covid Vaccines for All Americans

ICER Analytics

ICER Analytics revolutionizes your ability to plan drug development, establish drug pricing, negotiate drug reimbursement, and explore new ways to apply evidence in a drive toward a health system that can achieve fair prices and fair access for all. ICER Analytics is comprised of two tools:

 

  • The ICER Evidence Compendium™: leverage a rapidly searchable and sortable summary of results from ICER’s library of evidence reports.


  • The ICER Interactive Modeler™: analyze key aspects of over 35 economic models produced for ICER evidence reports, and update parameter inputs based on your own prices, your own data on patient characteristics, or your own assumptions about drug performance and uptake.

 

Email [email protected] for more information or to get started on a free 30-day trial of ICER Analytics. 

Join ICER!



This post first appeared on Clinical Trials News, please read the originial post: here

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ICER Weekly View: Our MLD Evidence Report, the ICER-PHTI Digital Health Framework, & ICER on angering both sides of the drug pricing aisle

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