not used title
not used title
Medicare beneficiaries from underserved communities with certain life-threatening diseases and few other options are gaining access to innovative medicines because of the accelerated approval pathway, according to a new analysis conducted by Avalere.
Details: Relying on data from the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services, Avalere looked at treatments across three disease areas with accelerated approval between 2012 and 2021 and how those treatments are being used by Medicare beneficiaries.
Key findings from the analysis include:
The accelerated approval pathway is driving medical progress for patients with cancers and blood disorders. The number of accelerated approval medicines for blood cancers grew from 23 treatments in 2012 to 48 in 2021 — a 109% increase. The number of available treatments with accelerated approval nearly tripled for other forms of cancer (up from 23 treatments to 63) and doubled for certain blood disorders (up from two treatments to four) such as beta thalassemia and sickle cell disease.
Patients in urban areas are far more likely to have access to treatments with accelerated approval. People living in urban areas are eight times more likely to have to access to new cancer treatments with accelerated approval than their peers living in rural areas. For patients with certain blood disorders who receive a drug for iron overload, those living in urban communities are 14 times more likely to receive accelerated approval treatments than patients living in rural areas.
The accelerated approval pathway is delivering more treatment options to historically underserved patients. While a majority (73%) of all Medicare beneficiaries relying on the analyzed accelerated approval treatments were white, those receiving treatments for iron overload disorders were predominately from Black or Asian communities and dual-eligible beneficiaries (i.e., individuals receiving Medicare and Medicaid benefits). As the study notes, accelerated approval is providing treatments for beneficiaries “who are disproportionately affected by these conditions,” which can “lead to improved clinical outcomes for patients with unmet medical needs.”
The accelerated approval pathway is making a positive difference in the lives of people facing life-threatening diseases and closing gaps in care for underserved communities. The Avalere analysis only seeks to serve as another reminder of how the accelerated approval program improves the lives of patients and why it deserves continued support.
Learn more about accelerated approval.
Andrew Powaleny
Andrew Powaleny is the Deputy Vice President of Public Affairs at PhRMA, where he leads communications on scientific, regulatory and intellectual property issues, highlighting the biopharmaceutical industry’s efforts in developing innovative medicines and vaccines while promoting an environment that encourages necessary risk-taking. For five years starting in 2019, he launched and led PhRMA’s grassroots initiative, Voters for Cures, bringing patients and caregivers together to advocate for access to medicine and biopharmaceutical innovation. He also co-founded and co-chaired PRIDE Umbrella, a resource group for LGBTQ+ individuals. Prior to joining PhRMA in 2015, Andrew worked as a communications consultant in Washington, D.C., and as Deputy Press Secretary for the U.S. House Committee on Energy and Commerce under Chairman Fred Upton. He holds a degree in public policy and government from Eastern Connecticut State University, with a minor in music. Outside of work, Andrew enjoys exercise, musical theater and mentoring college students through The Fund for American Studies alumni association.
Andrew Powaleny
Author Twitter
Author LinkedIn
Bayh-Dole: The fuel for America’s innovation engine
September 2, 2026
ICYMI: Biopharmaceutical companies in America hit new investment milestone
August 14, 2026
Mass compounding puts patients at risk
July 16, 2026
World Sickle Cell Day: Recognizing the promise of gene therapy
June 19, 2026
America's cancer research progress is real and worth protecting
May 28, 2026
Ahead of ASCO: Cancer innovation is promising, but policy choices matter
May 26, 2026
How AI is transforming the drug innovation lifecycle
March 19, 2026
Advancing patient care: A look at new medicines approved in 2025
January 30, 2026
Knockoffs of FDA-approved drugs put patients at risk
December 1, 2025
PDUFA: Essential to America’s edge in drug development and patient access
October 31, 2025
What to know about vaccine ingredients: Aluminum and thimerosal
June 24, 2025
Americans are paying a 26% freerider tax on medicines because other countries don’t pay their fair share
June 17, 2025
PhRMA Foundation celebrates 60 years of investing in future scientific leaders
June 11, 2025
New report: Post-approval innovation delivers substantial patient benefits
June 2, 2025
ICYMI: PhRMA submits comments to White House on artificial intelligence
March 17, 2025
4 things to know on Rare Disease Day
February 28, 2025
Biopharmaceutical innovation for a healthier America: PhRMA releases new innovation report
February 21, 2025
New policy agenda charts solutions for a healthier America
February 20, 2025
A successful PhRMA Forum highlights our commitment to a healthier America
February 20, 2025
Guest Perspective: Prioritize Innovative Care
February 11, 2025
Major drug compounder is spending millions on misleading Super Bowl ad
February 5, 2025
Preventing and fighting disease: A look at the biopharmaceutical progress made for patients in 2024
February 3, 2025
A new administration poses new opportunities for patient access
December 17, 2024
Congratulations to our 2024 Working for Cures Employee Champions
December 11, 2024
Post-approval R&D is critical for fighting cancer. The IRA makes it more difficult.
November 13, 2024
Recent events highlight progress on health equity
October 22, 2024
ICYMI: PhRMA’s 4th Annual Pathways to Success: Virtual STEM Career Expo
October 21, 2024
Hispanic Heritage Month: Fighting for Hispanic patients
October 7, 2024
New Report: Tackling chronic conditions with preventive treatment
September 30, 2024
Addressing the mounting threat of antimicrobial resistance
September 23, 2024
PhRMA awards grants to 2024 Annual Pathways to Success: Virtual STEM Career Expo Partners
September 20, 2024
40 Years of Hatch-Waxman: What is the Hatch-Waxman Act?
September 19, 2024
New research: American biopharmaceutical investment in R&D drives transformational innovation
September 16, 2024
How to protect your children’s health this school year
August 22, 2024
Industry-backed STEM programs have supported 111 million students and nearly 183,000 teachers
August 1, 2024
More oversight needed of unapproved medicines that threaten patients’ health
August 1, 2024
Three things to know about the United Nations’ new HIV/AIDS report
July 31, 2024
New Report: Vaccines continue to drive improved health outcomes
July 16, 2024
The future of oncology R&D lies in policymakers’ hands
July 8, 2024
Showcasing the promise of biopharma at ASCO 2024
June 28, 2024
Alzheimer's & Brain Awareness Month: A conversation with Biogen
June 27, 2024
Alzheimer's & Brain Awareness Month: A conversation with Eisai
June 24, 2024
Alzheimer's & Brain Awareness Month: A conversation with Eli Lilly and Company
June 20, 2024
ICYMI: Misaligned policies undermine patient access
June 6, 2024
Women’s Health Month: A conversation with Astellas
May 31, 2024
ICYMI: Innovation transforms lives but misguided federal policies threaten patient outcomes
May 30, 2024
Mental Health Awareness Month: Supporting loved ones and improving mental health in America
May 28, 2024
How government price setting fails to address systemic health care inequities
May 24, 2024
Women’s Health Month: A conversation with Sage
May 23, 2024
The use of real-world data in drug development
May 13, 2024
Championing cancer equity: Our drive for healthier AANHPI communities
May 1, 2024
World Vaccine Congress: Building on vaccine success
April 1, 2024
The impact of innovative medicines: A caregiver's perspective
March 26, 2024
ICYMI: More evidence of the IRA’s harmful consequences on post-approval research and development
March 25, 2024
What new cures would mean to families
March 7, 2024
Watch: A conversation with Dr. Mike Ybarra on Rare Disease Day
February 29, 2024
American Heart Month: A nurse’s perspective
February 27, 2024
Proposed march-in framework would chill American innovation
February 7, 2024
Three things to know about antibody drug conjugates
February 2, 2024
Powering the next generation of therapies: A conversation with Astellas US President Mark Reisenauer
January 30, 2024
What they are saying: Experts agree that proposed march-in framework would jeopardize innovation
January 25, 2024
Novel treatments and vaccines approved for U.S. patients in 2023 reach five-year high
January 23, 2024
When it comes to the future of innovation, the ball is in policymakers’ court
January 22, 2024
Florida’s importation plan puts patients in danger
January 5, 2024
The Biopharmaceutical Industry Still Needs Clarity from the FDA on Orange Book Listings
December 19, 2023
The White House continues to attack American innovation
December 15, 2023
Taking stock of obesity and its costly effects
December 8, 2023
PhRMA provides grant funding to support the Morehouse School of Medicine Satcher Health Leadership Institute’s Health Equity Tra
December 7, 2023
Congratulations to our 2023 Working for Cures Employee Champions
December 6, 2023
Watch: Putting patients front and center for World AIDS Day
November 30, 2023
Misuse of march-in could stifle innovation
November 27, 2023
WHO Pandemic Agreement offers opportunities and risks for American innovators
November 20, 2023
The IRA’s pill penalty threatens the future of oncology R&D
November 16, 2023
Don't close the door on rare disease research
November 13, 2023
New Report: 1,600 cancer treatments and vaccines in clinical development
November 9, 2023
Word of the Month: The Bayh-Dole Act
November 8, 2023
ICYMI: 3 takeaways on the IRA’s unintended consequences from America’s Physician Groups’ 2023 annual fall conference
November 6, 2023
New social determinants of health simulation explores structural barriers patients face accessing and affording medicines
October 27, 2023
R&D leaders to Biden Administration: Your policies are undermining the Cancer Moonshot
October 18, 2023
Three things economists are saying about the Inflation Reduction Act
October 11, 2023
Celebrating Hispanic Heritage Month at PhRMA
October 11, 2023
Word of the Month: AMR
September 27, 2023
PhRMA awards grants to 2023 Annual Pathways to Success Graduate Summit Partners
September 25, 2023
New PhRMA site demonstrates how a technology-driven health care system brings benefits to patients
September 11, 2023
Watch: New video series spotlights advances in biopharmaceutical science
August 24, 2023
Decentralized clinical trials and the future of drug development
August 9, 2023
WTAS on reasonable pricing and public-private partnerships
August 8, 2023
Key considerations as Congress works towards PAHPA reauthorization
July 12, 2023
Between hope and despair: Improving cancer outcomes
July 11, 2023
New report shows high-impact R&D happens after cancer medicines are first approved
July 10, 2023
New report shows how the Inflation Reduction Act stifles innovation for small molecule medicines
June 22, 2023
How FDA’s modernization strategy could improve drug development
June 20, 2023
Biopharmaceutical science powered by PRIDE
June 16, 2023
ASCO 2023: Protecting our progress in the fight against cancer
June 15, 2023
Reject efforts to undermine America’s R&D ecosystem
June 15, 2023
Highlights from ASCO 2023
June 8, 2023
Setting the record straight on accelerated approval
May 22, 2023
Mental Health Awareness Month: Fighting the growing mental health crisis and supporting innovation
May 11, 2023
Support for continued progress is critical for pediatric drug development
May 8, 2023
New resource underscores the importance of small molecule medicines
May 4, 2023
Policies need to address the growing threat of antimicrobial resistance
April 28, 2023
World IP Day 2023: Celebrating women leaders in innovation
April 26, 2023
PhRMA awards grant to Emerson Diversity Health Foundation
April 19, 2023
PhRMA Otorga Beca a la “Emerson Diversity Health Foundation”
April 19, 2023
CMS guidance on IRA price setting process doubles down on bad policy
April 14, 2023
A guide to MedPAC’s Part B vote today
April 13, 2023
FDA should remain the authority on the safety and effectiveness of medicines
April 12, 2023
ICYMI: PhRMA President and CEO Stephen J. Ubl discusses patient affordability
April 7, 2023
MedPAC proposal threatens access to medicines in Part B
April 6, 2023
New Report: More than 400 medicines in development for leading chronic conditions affecting older Americans
March 28, 2023
Celebrating the success of the COVID-19 vaccines, and looking to the future
March 27, 2023
IRA Impacts: Cancer treatment research and development
March 23, 2023
PhRMA submits comments to OSTP on enhancing clinical trial diversity
March 21, 2023
What we’ve learned from three years of fighting COVID-19
March 20, 2023
Celebrating 40 years of the Orphan Drug Act on Rare Disease Day
February 28, 2023
PhRMA submits comments to USPTO highlighting important role of patent system in medicine development
February 23, 2023
State policymakers can protect American innovation and help Americans live longer, healthier lives
February 9, 2023
Novel medicines approved in 2022 offer increased treatment options for patients
January 23, 2023
ICYMI: PhRMA kicks off the year at the 2023 J.P. Morgan Health Care Conference
January 19, 2023
WTAS: Inflation Reduction Act already impacting R&D decisions
January 17, 2023
What you should know about real-world evidence and drug development
December 19, 2022
Using traditional HTAs to determine coverage threatens patient access to medicine
December 14, 2022
Three things to know about the accelerated approval pathway
December 12, 2022
Traditional HTAs keep diverse patients out of the conversation
December 7, 2022
Stories from the lab: Researchers discuss innovative treatments for cancers of the blood
December 1, 2022
Expanding TRIPS waiver would jeopardize biopharmaceutical research and development
November 17, 2022
Congratulations to our 2022 Working for Cures Employee Champions
November 10, 2022
New government price setting policy threatens post-approval research
November 10, 2022
ICYMI: PhRMA COO Lori Reilly Esq. speaks with Jacob Van Naarden about the future of cancer research
November 8, 2022
New paper: Addressing the growing crisis of mental health and substance use disorders
November 7, 2022
Traditional HTA methods treat everyone like the “average” patient
November 7, 2022
Protecting treatment advances for breast cancer
October 31, 2022
The law driving technology transfer and fostering innovation
October 24, 2022
Don’t take anti-innovation, activist funded academics at their word
October 18, 2022
PDUFA and BsUFA reauthorizations are wins for patients
October 5, 2022
Mental Illness Awareness Week – A time for reflection
October 3, 2022
New Report: Nearly 800 medicines in development to treat chronic conditions
September 29, 2022
Recognizing National Sickle Cell Awareness Month
September 23, 2022
ICYMI: New research builds upon growing body of evidence on value of COVID-19 treatments and vaccines
August 16, 2022
This week’s reading list: All the reasons the Senate-passed drug pricing bill is bad policy
August 10, 2022
Myth vs. Fact: The Senate’s latest price setting proposal
August 5, 2022
An open letter to Congress: Stand with patients and future cures
August 4, 2022
The Senate’s latest price setting proposal will undermine U.S. economic growth
August 3, 2022
New analysis finds deeper impact of drug pricing bill on biopharmaceutical researchers
August 1, 2022
ICYMI: A patient, physician, biotech investor and industry leaders warn about the dangers of government price setting bill
July 29, 2022
The Senate’s latest price setting proposal will undermine: American medical innovation
July 27, 2022
PhRMA member companies’ R&D investments reach record high of $102.3 billion in 2021
July 18, 2022
Increase in drug-resistant superbugs during COVID-19 highlights need for policy reforms to address antimicrobial resistance
July 14, 2022
Word of the Month: Biomarkers and surrogate endpoints
July 11, 2022
COVID-19 vaccines and treatments helped save millions of lives and billions in health care costs
July 7, 2022
CMS coverage decision restricts access to treatments for Alzheimer’s disease
June 22, 2022
You won’t fix what you don’t value: Two reasons why traditional cost-effective analyses can perpetuate health inequities
June 16, 2022
Key takeaways from ASCO's annual meeting
June 10, 2022
Biopharmaceutical researchers to discuss the value of R&D with Congress
June 9, 2022
Recognizing LGBTQ+ Pride in biopharmaceutical science
June 9, 2022
Potential gene therapies bring hope to patients with sickle cell disease
June 6, 2022
Report: More than 500 medicines in development to treat disorders of the blood
May 18, 2022
Ensuring timely reauthorization of PDUFA and BsUFA
May 11, 2022
ICYMI: PhRMA COO Lori Reilly spotlights efforts to improve health care in 2022 and beyond
May 9, 2022
Spotlighting a growing mental health challenge
May 9, 2022
ICYMI: New resource catalogs biopharmaceutical industry lessons learned from COVID-19
April 28, 2022
Stephanie Dyson of BMS on reducing health disparities
April 27, 2022
The biopharmaceutical industry leads in helping women achieve new heights, according to IAM’s diversity 100
April 20, 2022
Report: More than 600 medicines in development for diseases affecting women
March 31, 2022
The accelerated approval pathway: Helping patients with serious or life-threatening diseases
March 17, 2022
Sharing rebates can save Americans with diabetes 500 each year and improve adherence
March 16, 2022
Biopharmaceutical industry drives economic growth in all 50 states
March 14, 2022
Biopharmaceutical research and development has ushered in a decade of innovation in rare disease
February 28, 2022
4 things to know about biopharmaceutical efforts to fight cancer
February 24, 2022
What you need to know about newly authorized COVID-19 antiviral treatments
February 22, 2022
Guest post: Joining forces to combat the COVID-19 mental health crisis
February 17, 2022
PhRMA submits comments urging CMS to withdraw coverage proposal
February 11, 2022
The importance of timely PDUFA and BsUFA reauthorization
February 3, 2022
Research and development continues long after a medicine is initially approved
February 1, 2022
Protecting U.S. innovation abroad to support economic and pandemic recovery
February 1, 2022
ICYMI: New approvals by the FDA in 2021 offer greater treatment options for patients
January 26, 2022
ICYMI: New report demonstrates growing global impact of antimicrobial resistance
January 24, 2022
New data show continued decline in death rates for cancer patients related to treatment advances
January 20, 2022
New Report: Nearly 800 new medicines in development to treat rare diseases
December 16, 2021
Recap: Our inaugural graduate summit and career expo
December 8, 2021
New report details the promise of the biopharmaceutical pipeline
December 7, 2021
3 things to know about the importance of post-approval research and development
December 6, 2021
World AIDS Day: Remembering those we’ve lost and exploring the continued fight against HIV/AIDS
December 1, 2021
Guest post: Congress should not put future innovation at risk
November 29, 2021
Preventing the next public health emergency: New evidence demonstrates need to address antimicrobial resistance
November 18, 2021
Announcing CAREs Grant Round 4
November 12, 2021
Announcing CAREs Grant Round 4
November 12, 2021
New report highlights importance of IP-intensive manufacturing industries to the U.S. economy
November 1, 2021
Guest post: Continued research and development is critical for ALS patients and families
October 25, 2021
New report shows more than 260 medicines in development to fight neurodegenerative diseases
October 12, 2021
The important role of antivirals in the fight against COVID-19
October 6, 2021
Understanding Long COVID-19
September 29, 2021
Biosimilar User Fee Act (III) Performance Goals Letter will help increase options for patients and promote competition
September 28, 2021
Guest Series: PhRMA talks racial and health equity with Lauren Powell, VP US Health Equity and Community Wellness, Takeda
September 27, 2021
Meeting Tomorrow: Looking ahead to PDUFA VII
September 27, 2021
PhRMA releases 2021 industry profile
September 20, 2021