Drug Prices

AAM Submits Comments to HHS and FTC on the Impact of GPOs and Wholesalers on Access to Generic Medicines

bhart — Thu, 30 May 2024 16:29:03 +0000

AAM Submits Comments to HHS and FTC on the Impact of GPOs and Wholesalers on Access to Generic Medicines

WASHINGTON (May 30, 2024) — The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, today submitted comments to the U.S. Department of Health and Human Services and the Federal Trade Commission in response to a request for Information to better understand how the practices of pharmaceutical middlemen—group purchasing organizations and drug wholesalers—may be contributing to generic drug shortages.

“The sustainability of competitive generic and biosimilar markets and the continuing supply of Food and Drug Administration approved/licensed generic and biosimilar medicines for patients, uninterrupted by shortages, is in jeopardy,” said David Gaugh, Interim President and CEO of AAM. “Although generic and biosimilar manufacturers have contributed to dramatically lower rates of health care spending, their ability to continue to provide affordable medicines is threatened by excessive consolidation of intermediary participants – group purchasing organizations (at both the retail and hospital levels), wholesalers, and pharmacy benefit managers.

The letter requests that the FTC issue a section 6(b) Order to investigate the contracting practices of buying groups that contribute to the root causes of drug shortages. AAM also suggests that the agencies issue new Statements of Antitrust Enforcement Policy in Healthcare that lower the (now withdrawn) “market power” safe harbors for buying groups; and revise and/or clarify the Anti-Kickback Statute safe harbor provisions to exclude anticompetitive fees and charges imposed by Buying Groups.

Gaugh continued, “As AAM notes in its full written statement, without remedial action, the high concentration of buying power in the generic and biosimilar markets – combined with anti-competitive contract terms – will continue to cause harm to patients and consumers in the form of terminated or abandoned products and drug shortages. This, combined with poorly designed federal and state policies, has driven generics and biosimilars to unsustainably low prices. The agencies should act to reverse this trend by striking the right balance between affordability to the health care system and incentives to reinvigorate robust generic and biosimilar markets.”

View Full Letter

For media inquiries, contact the Communications department at media@accessiblemeds.org.

About AAM

The Association for Accessible Medicines, your generics and biosimilars industry, is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers of finished generic pharmaceuticals and biosimilars, manufacturers of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 17.5 percent of total drug spending.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

bhart Thu, 05/30/2024 - 12:29

Issues

Drug Shortages

Generic Supply Chain

Drug Prices

Seniors Pay More for Generic Medicines Every Year While Prices Continue to Fall. Why?

bhart — Wed, 17 Apr 2024 19:50:01 +0000

Seniors Pay More for Generic Medicines Every Year While Prices Continue to Fall. Why?

Avalere analysis finds Part D prescription drug plans continue to increase patient copays for generics by moving them to higher tiers

WASHINGTON (April 17, 2024) — The Association for Accessible Medicines, the leading trade association for generic and biosimilar manufacturers, commented on an analysis released yesterday by Avalere showing that Medicare plans increase patient costs for generic medicines by moving those medicines to more expensive formulary tiers. In 2011, 73% of generic drugs analyzed by Avalere were placed on Tier 1, which has a zero-dollar copay on average. Ten years later, only 15% of those drugs were still on Tier 1, despite the average price of those medicines falling by 38% between 2011 and 2019.

Despite overall prices for generic medicines continuing to drop, Avalere's analysis shows that prices paid by seniors in Medicare plans continue to increase due to health plans moving generics to higher tiers with higher co-pays said David Gaugh, Interim President & CEO of AAM. PBMs are blocking patients from the benefits of lower costing generic and biosimilar medicines. Congress, the Administration, and regulators should be asking why safe, effective, long-standing generic medicines are being moved to higher cost tiers instead of the other way around.

AAM released a blog with their analysis of the Avalere data or download a PDF below.

Read Blog

Download Avalere Analysis PDF

For media inquiries, contact the Communications department at media@accessiblemeds.org.

About AAM

About the Biosimilars Council

bhart Wed, 04/17/2024 - 15:50

Issues

Drug Prices

Medicare

Seniors Pay More for Generic Medicines Every Year While Prices Continue to Fall. Why?

msargent — Tue, 16 Apr 2024 15:46:00 +0000

Seniors Pay More for Generic Medicines Every Year While Prices Continue to Fall. Why?msargent Tue, 04/16/2024 - 11:46

Report: 2023 U.S. Generic and Biosimilar Medicines Savings Report

mstanford — Wed, 06 Sep 2023 10:00:02 +0000

Report: 2023 U.S. Generic and Biosimilar Medicines Savings Reportmstanford Wed, 09/06/2023 - 06:00

Featuring data reported by IQVIA, the 2023 U.S. Generic & Biosimilar Medicines Savings Report reveals generic and biosimilar drugs generated a record $408 billion for America’s patients and healthcare system in 2022. Generic medicines are an integral part of our health-care system, expanding patient access through competition and lower prices. And a new wave of lower-priced biosimilars is also delivering value and savings.

The report breaks savings down by state, age, payer, and common medical conditions, providing in-depth data at a time when the focus has shifted to the recent surge in drug shortages. These findings reinforce the critical importance of the often underappreciated generic and biosimilar industry to America’s patients.

Here are the topline findings:

Patients and taxpayers saved $408 billion in 2022

Up from 2021, which found $373 billion in generic and biosimilar savings, this figure indicates continued savings for the U.S. health care system, including patients, employers, and taxpayers. Generics and biosimilars have saved patients and U.S. health care system $2.9 trillion in the past 10 years.

90% of U.S. prescriptions filled, 17.5% of Rx drug spending

Although generic and biosimilar prescriptions account for 90% of prescriptions filled in the U.S., they account for only 17.5% of the country’s spending on prescription drugs. In other words, costly brand-name products account for the bulk of pharmaceutical spending. The generics and biosimilars industry bring costs down.

Less than 2% of total health care spending

Generics represent only 1.5% of all U.S. health care spending

$130 billion in Medicare and $194 billion in commercial health plan savings

Up from $119 billion and $178 billion in 2021, generics and biosimilars continue to provide critical savings throughout the health-care system and are particularly valuable to Medicare, employer-sponsored health insurance and the patients they serve. Despite these savings, many patients are paying too much for their generics as a result of increasing copays, even when the price their generic is sold for has declined.

The average generic copay is $6.16, brands cost patients almost 9X more

The amount patients pay at the pharmacy counter is where concerns lie. The average copay for brand-name drugs is more than nine times higher at $56.12. Fortunately, 93% of generic prescriptions are dispensed under $20 (as compared to 59% of brand-name drugs).

$9.4 billion in savings from biosimilars and $23.6 billion since first biosimilar entry in 2015

The market for biosimilar drugs continues to expand. The report finds the average sales price for biosimilars is on average 50% less than the reference brand biologic price was at the time of biosimilar launch. Further, competition from biosimilars has reduced the average sales price of their corresponding brand biologic by an average of 25%.

Biosimilars used in almost 694 million total days of patient therapy

Since 2015, biosimilars have been used in almost 700 million days of patient therapy with no unique clinical challenges. In fact, biosimilar competition has now supported more than 344 million incremental days of therapy — care that patients would not have received otherwise.

AAM publishes these findings annually to ensure policymakers, health-care professionals, advocates and the public know the vital role that safe, effective, FDA-approved generics and biosimilars play in health of our nation.

Download Report

View Press Release

Download Social Toolkit

Share Your Voice

To help raise awareness of the essentialness of generic medicines to patients and our healthcare system, join our industry's 4GRxANTED campaign. The #4GRxANTED campaign asks people to  record a video or share a story explaining who or what in their lives they take for granted but shouldn’t and post it on social media. For every video created, liked or shared with the hashtag #4GRxANTED, the generics industry will donate medicines to Direct Relief, a humanitarian aid organization that provides medical assistance to people affected by poverty or emergencies.

Issues

Drug Prices

AAM Requests Federal Injunction to Block Minnesota’s Unconstitutional Drug Price Law

sreilly — Thu, 06 Jul 2023 00:23:18 +0000

AAM Requests Federal Injunction to Block Minnesota’s Unconstitutional Drug Price Law

Generic Pharmaceutical Trade Group Steps in to Protect Patient Access to Affordable Generic Drugs

WASHINGTON, DC (JULY 5, 2023) – The Association for Accessible Medicines (AAM), the trade association representing America’s manufacturers of generic and biosimilar medicines, today filed a lawsuit against Minnesota Attorney General Keith Ellison, requesting that the federal district court in Minnesota enjoin the Attorney General from enforcing the price-control provisions of Senate File 2744.

The discriminatory law, an unconstitutional overreach passed in May 2023, and taking effect this month, grants Minnesota unprecedented powers to regulate the national pharmaceutical market, violating the United States Constitution and posing harm to vulnerable patient communities. The suit was filed in the United States District Court for the District of Minnesota.

The Minnesota law claims to be intended to lower drug costs, but it conspicuously does not apply to patented drugs sold by brand-name pharmaceutical companies -- which account for three-quarters of total prescription drug spending. The Attorney General’s own Advisory Taskforce acknowledged that “the most egregious examples are found in the branded and specialty drug markets” – but the new law completely exempts branded and specialty drugs and applies only to generic drugs. Taking aim at generic drugs makes no sense, because – as the Advisory Taskforce report says – encouraging the use of generic drugs helps to lower prescription drug costs.

In fact, if the legislation were to be enforced, it would most likely lead to fewer generic alternatives and less competition, which would harm and not help Minnesota patients. That is because it prohibits generic drug manufacturers from changing their prices by more than a set amount even if the cost of producing the drug increases.

The U.S. Congress and Food and Drug Administration have pointed out that many key ingredients in drug manufacturing face shortages and supply-chain disruption, yet the Minnesota legislation would require manufacturers that face such a cost increase to sell their products at a loss. That will drive generics out of the market, benefiting no one—except potentially brand-name pharmaceutical companies.

AAM has successfully sued multiple other jurisdictions that have adopted similar laws, and in each case, federal courts have blocked the unconstitutional state laws from taking effect.

David Gaugh, Interim President and CEO of AAM, said, “Rather than allow the vibrant competition in the generic drug marketplace to continue working for patients, Minnesota is rejecting generic competition in favor of more government regulation – of generic drugs, the only segment of health care costs that is actually declining.” Gaugh continued, “If this new law is enforced, it will harm patients and our communities by reducing choice and limiting access to essential medicines that people need.”

How SF 2744 is Illegal:

SF 2744 IS UNCONSTITUTIONAL & UNPRECEDENTED

Violates the Commerce Clause of the Constitution: The overreaching law claims that Minnesota has the power to regulate interstate commerce, including businesses and transactions outside the state of Minnesota. Under our Constitution, Attorney General Ellison does not have the right to govern businesses in other states. The law allows in-state pharmacies to raise prices when their costs increase – but denies that same treatment to manufacturers that face cost increases.

Violates the Constitutional Right to Due Process: The new law would allow the Attorney General to sue over transactions that have no connection to Minnesota at all — and even sue to punish companies for leaving the Minnesota market. Minnesota is one of 50 states, and it cannot threaten to enforce price regulations for the entire country.

Generic drugs are a true success story. Generic medicines account for 91% of all prescriptions, but they only account for 18.2% of drug spending. Year over year, generic drug prices fall, while brand name drug prices rise. The overall price of generics fell by more than 5% in each of the last several years. In contrast, a recent study by the federal government found, “Drug spending is heavily driven by a relatively small number of high-cost products.” Spending on brand-name drugs has continued to rise –and so has the cost per brand-name prescription.

Generics saved Minnesota $5.3 billion, including state programs and your tax dollars – last year alone.

AAM is committed to working with patients, healthcare professionals, advocacy groups, stakeholders, and policymakers to develop smart, balanced policies that expand access to lifesaving medicines. We cannot allow misguided or bad policy to hinder the progress we are making on behalf of our nation’s patients. More competition from generics is proven to lower costs and increase access for all Americans. It’s time to stop the price controls in SF 2744 and work together to pass a law that will help patients today and into the future.

MEDIA CONTACT:
Susan Reilly
Director of Communications, AAM
1.703.725.0729

About AAM
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 91 percent of prescriptions dispensed in the U.S. but only 18 percent of total drug spending.

About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

sreilly Wed, 07/05/2023 - 20:23

Issues

Drug Prices

A Look Back at Access! 2023

eklinger — Fri, 24 Feb 2023 21:58:00 +0000

A Look Back at Access! 2023eklinger Fri, 02/24/2023 - 16:58

A Fireside Chat with AAM Chair, Christine Baeder and Mark Cuban, Entrepreneur and Cost Plus founder.

eklinger — Tue, 14 Feb 2023 20:48:37 +0000

A Fireside Chat with AAM Chair, Christine Baeder and Mark Cuban, Entrepreneur and Cost Plus founder.eklinger Tue, 02/14/2023 - 15:48

Entrepreneur and founder of the Mark Cuban Cost Plus Drug Company, PBC, Mark Cuban, sat down with our new Board Chair Christine Baeder, SVP, COO for US Generics at Teva Pharmaceuticals, to discuss his efforts to reduce #drugprices and increase competition in the drug market. #Access2023 #drugprices #patientaccess

Video

A Fireside Chat at #Access2023 with AAM Chair, Christine Baeder and Mark Cuban, Entrepreneur and Cost Plus founder.

Issues

Drug Prices

AAM Applauds CMS for Requiring Health Plans to Place Generic Drugs On Generic Tiers

sreilly — Mon, 30 Jan 2023 16:21:57 +0000

AAM Applauds CMS for Requiring Health Plans to Place Generic Drugs On Generic Tiers

WASHINGTON, DC (January 30, 2023) — The Association for Accessible Medicines (AAM) applauds the Centers for Medicare & Medicaid Services (CMS) for several of the recommended provisions outlined in the proposed Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2024. In particular, AAM publicly commends the administration’s efforts to standardize plan choice by requiring generic drugs be placed on “generic” tiers and brand-name drugs on “brand-name” tiers.

Because new, lower-cost generics and biosimilars also face coverage challenges as a result of the perverse incentives of brand drug rebates, AAM further recommends that CMS and HHS take steps to ensure timely patient access to new generic and biosimilar medicines by standardizing an option for a generic and biosimilar specialty tier.

“In spite of the lower prices of generics and biosimilars, plan design too often does not optimize their use. And when this occurs, patients are forced to pay more than necessary,” noted interim CEO David Gaugh. “We look forward to working with the CMS to ensure that patients have access to and realize the full value of lower cost generic and biosimilar medicines.”

View Support Letter

MEDIA CONTACT:
Susan Reilly
Director of Communications, AAM
1.703.725.0729

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 91 percent of prescriptions dispensed in the U.S. but only 18 percent of total drug spending.

About the Biosimilars Council

sreilly Mon, 01/30/2023 - 11:21

Issues

Medicare

Drug Prices

Desi is Back Playing Soccer and Doing "Normal Kid" Stuff

eklinger — Thu, 05 Jan 2023 14:09:35 +0000

Desi is Back Playing Soccer and Doing "Normal Kid" Stuffeklinger Thu, 01/05/2023 - 09:09

Generics and Biosimilars Offer Savings for Patients Fighting Cancer, Heart Disease and Other Conditions

sskubikowski — Tue, 03 Jan 2023 17:44:15 +0000

Generics and Biosimilars Offer Savings for Patients Fighting Cancer, Heart Disease and Other Conditionssskubikowski Tue, 01/03/2023 - 12:44