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Under the Inflation Reduction Act, government bureaucrats will unilaterally decide how much a treatment selected for price setting is worth. To make matters worse, the price setting process is a black box. No one knows how exactly the government is determining the value of medicines selected for price setting or how much input it will use from patients, providers and other stakeholders — but, alarmingly, we do know they expressed significant interest in using flawed cost-effectiveness metrics. In the 2023 final guidance for the first year of the price setting process, CMS stated that it: “…will review and consider cost-effectiveness measures and studies that use such measures for initial price applicability year 2026.”

Concerningly, one organization eager to weigh in is the Institute for Clinical and Economic Review (ICER). The group holds itself out as an expert in assessing the value of medicines despite relying on outdated and discriminatory cost-effectiveness metrics. And, as patient advocates and others have warned, ICER’s one-size-fits-all approach that ignores the unique needs of different patient populations can lead to discriminatory outcomes. Government adoption of flawed value assessments like these could be devastating for patients.

A recent analysis by Cencora (formerly Xcenda) looked at treatment options for five serious, complex medical conditions that are covered by Medicare Part B and have been evaluated by ICER. Cencora considered what would happen if the government adopted ICER’s value assessments as the basis for its coverage decisions. The results were startling:

  • In 2020, nearly 185,000 Medicare Part B beneficiaries with multiple myeloma, asthma, multiple sclerosis, non-small cell lung cancer and rheumatoid arthritis used a physician-administered product evaluated by ICER.

  • If the government adopted an ICER-based formulary for the Part B program, 63% of these Part B beneficiaries, or nearly 117,000 individuals, could lose access to their current treatment.

  • The results were even worse for certain diseases, including 99% of Part B patients with multiple sclerosis losing access to their preferred treatment, 85% of Part B patients with non-small cell lung cancer and 83% of those with multiple myeloma.

“If the government used ICER-like assessments to set prices for medicines, many patients could lose access to the treatments that they and their physicians had previously determined were best for them based on individual needs and preferences, after careful consideration of the nuances of a patient’s condition,” explained Cencora.

Government shouldn’t interfere in decisions best left to patients and their doctors. The Inflation Reduction Act already threatens seniors’ access to care. Injecting ICER’s flawed value assessments to an already flawed government decision making about drug payment could further jeopardize patients’ ability to get the lifesaving treatments they need. 

Nicole Longo

Nicole Longo is Deputy Vice President of public affairs at PhRMA focusing on Medicare, 340B, importation and more. She previously worked for a D.C.-based public affairs firm where she assisted a wide range of clients with communications efforts on everything from trade policy to agriculture policy to health care policy. Outside the office, Nicole can be found trying new restaurants (usually Italian), taking an occasional barre class and cheering on the Cincinnati Bengals.

Nicole Longo

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CMS undermines medical progress with MFN price controls 

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MFN drug pricing risks reviving a harmful metric the U.S. rejected

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MFN undermines U.S. biopharmaceutical innovation

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CMS puts patients and innovation at risk with MFN

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New “Balance the Scales” campaign highlights why Americans pay more for prescription medicines

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Three reasons Congress should fix the IRA’s pill penalty

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PhRMA CEOs Tee Up Next Week's Health Care Conference

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September 25, 2024

Three ways state drug price setting boards fail patients

September 18, 2024

The Inflation Reduction Act could increase costs and reduce access for millions of seniors

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September 16, 2024

Did the administration consider the importance of autoimmune disease medicines to patients in price setting process?

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Did the administration consider the value of innovative diabetes medicines in price setting process?

August 28, 2024

New survey: Insurers confirm IRA will reduce patient treatment options

August 20, 2024

The unintended consequences of government price setting in Medicare Part D

August 16, 2024

Don’t put the government between patients and their medicines

August 7, 2024

Biosimilars continue to drive market competition and increase savings for seniors

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Case study: How seniors could face access disruptions because of the IRA’s price setting provisions

July 22, 2024

PhRMA reiterates concerns with IRA price setting program, urges CMS to mitigate harm

July 3, 2024

More than 60 researchers advocate on Capitol Hill

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The IRA could lead to higher out-of-pocket costs for 3.5 million Medicare patients in 2026

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ICYMI: Health care policy should be driven by patients, not politics

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ICYMI: Misaligned policies undermine patient access

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ICYMI: Innovation transforms lives but misguided federal policies threaten patient outcomes

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How the IRA is more coercive than any European government price setting scheme

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How government price setting fails to address systemic health care inequities

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Government price-setting boards: Why Minnesota needs to take a better approach

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IRA is already negatively impacting access to medicines in Part D

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Government price setting won’t help patients in Illinois

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New analysis of patient access restrictions in the United Kingdom

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ICYMI: 3 takeaways on the IRA’s unintended consequences from America’s Physician Groups’ 2023 annual fall conference

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4 truths about state government price setting

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Correcting the record: IRA’s government price setting provisions are unconstitutional

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IRA changes to Part D risk access to medicines

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Three concerns about Colorado's approach to government price setting

August 23, 2023

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Michigan proposal jeopardizes access to medicines

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New report shows how the Inflation Reduction Act stifles innovation for small molecule medicines

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New resource underscores the importance of small molecule medicines

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CMS guidance on IRA price setting process doubles down on bad policy

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New global analysis shows patient access challenges around the world

April 12, 2023

ICYMI: PhRMA President and CEO Stephen J. Ubl discusses patient affordability

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MedPAC proposal threatens access to medicines in Part B

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CMS coverage policy is detrimental to Alzheimer’s patients

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New Report: More than 400 medicines in development for leading chronic conditions affecting older Americans

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Medicare Part B spending in four points

March 28, 2023

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IRA Impacts: Cancer treatment research and development

March 23, 2023

Celebrating 40 years of the Orphan Drug Act on Rare Disease Day

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WTAS: Inflation Reduction Act already impacting R&D decisions

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Using traditional HTAs to determine coverage threatens patient access to medicine

December 14, 2022

ICYMI: PhRMA COO Lori Reilly speaks about the health care agenda for the next Congress

December 9, 2022

Traditional HTAs keep diverse patients out of the conversation

December 7, 2022

How HTA-based price controls could worsen health outcomes and health disparities

November 22, 2022

New government price setting policy threatens post-approval research

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Traditional HTA methods treat everyone like the “average” patient

November 7, 2022

Biosimilar uptake is increasing and so are health savings

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September 9, 2022

CMS coverage policies restrict patient access to important treatment options for Alzheimer’s disease

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New survey: Voters seriously concerned about fine print in reconciliation bill

August 12, 2022

This week’s reading list: All the reasons the Senate-passed drug pricing bill is bad policy

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Value assessment should include all aspects of value that matter to patients

August 10, 2022

Myth vs. Fact: The Senate’s latest price setting proposal

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An open letter to Congress: Stand with patients and future cures

August 4, 2022

ICYMI: Patients across the country are sharing concerns about government price setting

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The Senate’s latest price setting proposal will undermine U.S. economic growth

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Celebrating Medicare’s 57th anniversary

August 2, 2022

New analysis finds deeper impact of drug pricing bill on biopharmaceutical researchers

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ICYMI: A patient, physician, biotech investor and industry leaders warn about the dangers of government price setting bill

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The Senate’s latest price setting proposal will undermine: Patient access to medicines

July 26, 2022

The Patient Perspective: Government price-setting harms patients

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New research shows competition driven by biosimilars helps control costs in Part B

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Polling continues to show voters reject so-called Medicare “negotiation” once they learn about consequences for patients

July 12, 2022

By the Numbers: Patients lose when the government sets prices

July 8, 2022

CMS coverage decision restricts access to treatments for Alzheimer’s disease

June 22, 2022

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June 16, 2022

PhRMA presents research at ISPOR 2022

May 26, 2022

Guest Post: If we truly want to cure complex diseases, politicians should reject price setting

March 14, 2022

Veterans Affairs 101: Three charts show how the VA system differs from Medicare

March 11, 2022

Government price setting leaves behind families counting on new medicines

February 23, 2022

Part B 101: Three charts show the program helps control costs for health care system and enrollees

February 18, 2022

PhRMA submits comments urging CMS to withdraw coverage proposal

February 11, 2022

Government price setting won’t stop insurers from shifting costs to patients

February 2, 2022

It’s a new year, but sadly Congress is still pursuing flawed price setting policies

January 25, 2022

Post-approval research save lives. Why is Congress trying disincentivize it?

December 17, 2021

A price control by any other name would still put patients at risk and threaten innovation

December 9, 2021

Guest post: Congress should not put future innovation at risk

November 29, 2021

What is missing in the current drug pricing plan

November 23, 2021

In the current health care debate, Congress has lost sight of what matters to U.S. voters

November 15, 2021

Making medicines more affordable: Modernizing Medicare

November 11, 2021

What they are saying: Government price setting for medicines is not the answer

November 4, 2021

ICYMI: New study confirms policies like H.R. 3 could significantly reduce drug development

October 18, 2021

Five reasons tying VA prices to Medicare Part D misses the mark

September 22, 2021

Recent polling misrepresents public support for Medicare “negotiation”

August 31, 2021

What they’re saying: Patient advocates want to protect Medicare from government interference

August 24, 2021

Creating a new patient risk paradigm in American health care

May 18, 2021

The ABCs (and Ds) of Medicare

May 13, 2021

H.R. 3 threatens access to medicines, future innovation and American jobs

May 4, 2021

New analysis finds stark difference in coverage of breast cancer medicines for seniors in the United States and England

December 10, 2020

No matter how you look at it, the Most Favored Nation rule is bad policy

December 1, 2020

PhRMA submits comments to CMS on policy changes for in-home care under Part B during COVID-19

May 6, 2020

Three reasons the Administration should abandon its International Pricing Index proposal

January 31, 2020

New analysis: Government intervention in Part B threatens patient access to medicines

August 19, 2019

Setting the record straight on international reference pricing

July 16, 2019

No matter how you structure it, government arbitration is wrong for Medicare drug coverage

June 27, 2019

What you should know: Government arbitration is the wrong way to change Medicare

June 10, 2019

By the numbers: A look at the Part B International Pricing Index Model

June 6, 2019

Event tomorrow: Improving access and affordability for America’s seniors

May 7, 2019

Fact Check: How the Part B International Pricing Index Model replaces market competition with government-set prices

May 3, 2019

340B continues to drive shift in site of care for physician-administered medicines to more expensive hospital settings

April 5, 2019

Fact Check: How the Part B International Pricing Index model threatens patient access

March 29, 2019

New analysis finds Average Sales Price system has led to significant cost savings for Medicare and seniors

March 7, 2019

New “Prescription for Medicare” campaign focuses on impacts of wrong and right solutions for Medicare

March 6, 2019

In survey, PhRMA member companies highlight impact of IPI on R&D

February 5, 2019

ICYMI: New study reinforces dangers of proposed IPI model

January 15, 2019

PhRMA comments to administration on International Pricing Index Model

January 3, 2019

10 things you should know about medicine spending and costs

January 2, 2019

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