STAT

OCTOBER 20, 2022

But those medicines can’t have any competing products on the market, and negotiations can’t begin until a small-molecule drug has been available for at least nine years and a biologic for 13 years. Moreover, the process does not start until 2026.

Drug Pricing 205

Drug Pricing 205

Big Molecule Watch

APRIL 6, 2023

On April 5, 2023, Goodwin’s Matt Wetzel and Heath Ingram published a client alert addressing the initial guidance memorandum issued by the Centers for Medicare & Medicaid Services (CMS) on the Medicare Drug Price Negotiation Program created by the Inflation Reduction Act of 2022. Public comments are due to CMS by April 14, 2023.

Drug Pricing 57

Drug Pricing 57

STAT

SEPTEMBER 6, 2023

29, Medicare released its highly anticipated list of 10 therapies for which it plans to establish a price by 2026.

Biosimilars 305

Biosimilars Drug Pricing 305

STAT

AUGUST 30, 2023

Department of Health and Human Services named 10 medicines that will be subject to price negotiations for the Medicare program in 2026, a milestone and a point to start appraising the impact of the law , STAT explains. Have a wonderful day, and please do stay in touch. … On Tuesday, the U.S. The landscape here is complicated.

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Biosimilars Drug Pricing 228

STAT

OCTOBER 8, 2024

The latest effort involves tripling the annual supply of the drug, a long-acting medication known as cabotegravir, in hopes of making more than 2 million doses available during 2025 and 2026.

Drug Pricing 277

Drug Pricing 277

Big Molecule Watch

NOVEMBER 6, 2023

The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act’s Drug Price Negotiation Program. FDA’s approval of WEZLANA has also been raised as a pertinent fact in one of the pending challenges to the Drug Price Negotiation Program.

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Drug Pricing Biosimilars 67

Putting Patients First Blog

JULY 2, 2024

General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare Drug Price Negotiation Program (DPNP). Active Moiety and Single Source Qualifying Drugs (Section 30.1)

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Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

Putting Patients First Blog

APRIL 27, 2023

NHC Medicare Drug Price Negotiation Program Comments April 27, 2023 By: Allen Pinn, Coordinator, Policy April 14, the National Health Council (NHC) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding the Medicare Drug Price Negotiation Program, established under the Inflation Reduction Act.

Drug Pricing 52

Drug Pricing 52

Big Molecule Watch

JULY 18, 2023

On June 30, 2023, the Centers for Medicare & Medicaid Services (CMS) released its updated final program guidance covering the Inflation Reduction Act’s Medicare Drug Price Negotiation Program for the first round of negotiations, which will occur during 2023 and 2024 and result in prices that will be effective beginning in 2026.

Drug Pricing 52

Drug Pricing 52

STAT

AUGUST 22, 2023

German drugmaker Boehringer Ingelheim is the latest pharmaceutical company to sue the federal government over a law that would allow Medicare to negotiate certain drug prices, Reuters reports. Continue to STAT+ to read the full story…

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Vaccines Drug Pricing Diabetes Pharmaceutical Companies 200

STAT

SEPTEMBER 18, 2024

  A Novo Nordisk executive believes that Ozempic, the blockbuster diabetes shot made by the company, is “very likely” to be one of the next drugs targeted for a price cut in bargaining with the Medicare program, Bloomberg News writes. The Inflation Reduction Act, which allows the U.S.

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Hospitals Drug Pricing Diabetes 229

STAT

OCTOBER 31, 2023

As Medicare prepares to negotiate prices for its first batch of medicines, an advocacy group argues the agency should factor in controversial patent maneuvers for one drug that will have cost the program nearly $2 billion in additional spending by 2026.

Drug Pricing 300

Drug Pricing 300

Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said. That leaves three years for pharma companies to prepare.

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Drug Pricing Biosimilars Drug Development 52

Big Molecule Watch

OCTOBER 2, 2023

Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the Drug Price Negotiation Program of the Inflation Reduction Act. New Complaint by Novo Nordisk Also on Friday, Novo filed a new Complaint challenging the Drug Price Negotiation Program and CMS’s actions in implementing it.

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Drug Pricing Documentation 62

Putting Patients First Blog

SEPTEMBER 3, 2024

Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drug price negotiations.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Safe Biologics

OCTOBER 10, 2023

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.

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Biosimilars Drug Pricing Drug Development 130

Big Molecule Watch

MAY 9, 2024

Quraishi) granted summary judgment for the Government in two cases, brought by BMS and Janssen, challenging the IRA’s Drug Price Negotiation Program. Briefing on dispositive motions has completed in the remaining district court challenges to the Drug Price Negotiation Program. Lead Case No.

Drug Pricing 67

Drug Pricing 67

Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

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Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. at least one drug” has been approved and marketed. The court found numerous flaws with this argument.

Dosage 62

Dosage Drug Pricing 62

Big Molecule Watch

SEPTEMBER 9, 2024

The IRA instructed HHS select certain “high priced” Medicare-covered drugs for inclusion in the first year of the Program. On August 15, 2024, the CMS announced the negotiated MFPs for the first 10 drugs selected for Medicare Price Negotiation.

Drug Pricing 48

Drug Pricing 48

FDA Law Blog: Biosimilars

JUNE 26, 2023

Kirschenbaum — As we and others closely following drug pricing have predicted, multiple additional lawsuits have followed in the wake of Merck’s challenge to the Inflation Reduction Act (IRA) price negotiation provisions in the D.C. By Faraz Siddiqui & Alan M. federal district court on June 6 (see our post here ).

Drug Pricing 57

Drug Pricing 57

STAT

MARCH 7, 2024

— Pharma industry giants including Bristol Myers Squibb, Johnson and Johnson, Novartis, and Novo Nordisk deployed a half-dozen lawyers to a courtroom here Thursday in a bid to dismantle Medicare’s new drug price negotiation program, just hours before President Biden is set to glorify it in his State of the Union.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 305

Putting Patients First Blog

MARCH 21, 2024

Medicare Drug Price Negotiation Program The rising costs of prescription drugs has consistently been an area of concern for patients and for the financial health of Medicare. The Roundtable identified lessons learned that can be used to inform future listening sessions and CMS’ broader patient engagement strategies.

Drug Pricing 52

Drug Pricing 52

Putting Patients First Blog

MARCH 21, 2024

Medicare Drug Price Negotiation Program The rising costs of prescription drugs has consistently been an area of concern for patients and for the financial health of Medicare. The Roundtable identified lessons learned that can be used to inform future listening sessions and CMS’ broader patient engagement strategies.

Drug Pricing 52

Drug Pricing 52

pharmaphorum

JUNE 2, 2022

Evaluate Pharma’s recent Orphan Drug Report subtitled its overview of the market ‘Niche no longer.’ This is based on the relative success orphan drugs have achieved, in terms of the number of approvals and the sales figures achieved for this area.

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Compounding Pharmaceutical Companies Pharmaceutical Companies Drug Pricing 52

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug.

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Labelling Drug Pricing Compounding Payment Processing 104

STAT

AUGUST 29, 2023

On Tuesday morning, the Department of Health and Human Services unveiled its long-awaited list of the 10 medicines that will be subject to price negotiation in 2026 under the Inflation Reduction Act.

Drug Pricing 233

Drug Pricing 233

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

By Faraz Siddiqui — Last week, a federal court in Ohio denied a preliminary injunction motion by four Chambers of Commerce in their lawsuit against the Medicare Drug Price Negotiation Program. Harm The Court reviewed the parties’ arguments on “irreparable harm to Plaintiffs.”

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Drug Pricing Pharmaceutical Manufacturing Immunity Immunization 57

STAT

JULY 18, 2023

WASHINGTON — Pharmaceutical giant Johnson & Johnson on Tuesday became the third drugmaker to sue the Biden administration over its new Medicare drug price negotiation program. J&J joins a flurry of litigation challenging the Medicare drug price negotiation program, which is set to start this fall.

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Drug Pricing 238

STAT

JULY 19, 2023

Johnson & Johnson became the third drugmaker to sue the Biden administration over its new Medicare drug price negotiation program, STAT notes. J&J joins a flurry of litigation challenging the Medicare drug price-negotiation program, which is set to start this fall. Chamber of Commerce have also filed suit.

Drug Pricing 200

Drug Pricing 200

Putting Patients First Blog

APRIL 14, 2023

60: Input Process for Future Program Guidance The NHC appreciates the opportunity to comment on initial program guidance for IPAY 2026 and seeks clarification on processes for seeking feedback moving forward. Including this information in the explanation will help patient advocates develop the most useful data for future negotiations.

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Drug Pricing Drug Development Documentation Communication 40

STAT

AUGUST 29, 2023

Postcards and telegrams are accepted… Medicare announced the first 10 drugs selected for a new drug-price negotiation program , STAT reports. The drugs include Eliquis, Jardiance, Xarelto, Januvia, Farxiga, Entresto, Enbrel, Imbruvica, Stelara, and a product that goes by names including Fiasp and NovoLog.

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Drug Pricing 229

Pharmaceutical Technology

AUGUST 15, 2024

The new prices are expected to save taxpayers $6bn in 2026 and provide $1.5bn in savings for patients, said the Biden Administration.

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Drug Pricing 96

BioPharma Dive

AUGUST 25, 2023

The drugmaker's lawsuit comes the week before the Biden administration is set to announce the first 10 drugs subject to negotiated prices in 2026.

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Drug Pricing 98

STAT

FEBRUARY 1, 2024

… The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, but declined to disclose any details , STAT tells us. The Biden administration will publish the final prices by Sept. Best of luck and, as always, do stay in touch.

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Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 209

pharmaphorum

OCTOBER 27, 2022

Under the legislation, which has been slammed by pharma industry groups, Medicare pricing negotiations for some high-cost drugs would get underway in 2026, with drugmakers forced to pay rebates if prices rise faster than inflation.

Drug Pricing 52

Drug Pricing 52

STAT

SEPTEMBER 3, 2024

The lower prices will result in savings of $6 billion in 2026, the first year they take effect, but a review of publicly available maximum prices set by other wealthy nations — Australia, Japan, Canada, and Sweden — show that they have negotiated far lower prices for the same drugs.

Drug Pricing 252

Drug Pricing 252