2027 and Drug Pricing - Pharmacist Digest

STAT+: Pharmalittle: We’re reading about unsupported drug price hikes, an annual HIV prevention shot, and more

STAT

DECEMBER 12, 2024

The company plans to begin the trial next year, with an eye toward regulatory filings in late 2027. The once-a-year drug is another formulation of lenacapavir, a medicine that already made headlines this year when Gilead published data showing it could prevent HIV infections with just one shot every six months.

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Drug Pricing Vaccines

STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

STAT

DECEMBER 7, 2023

One expires next year and the other in 2027, well beyond the original patent expiration date. The move meant that the company, which is now part of Bristol Myers Squibb, won several more years of valuable patent protection than it would have received had it applied for the extra patents when submitting its data to the FDA.

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STAT+: Wegovy is among drugs set to be targeted in the next round of Medicare price negotiations, researchers say

STAT

SEPTEMBER 23, 2024

Now, all eyes are on which Part D drugs will be chosen for the next round of 15 drugs. 1, and the negotiated prices of those drugs take effect in 2027. Medicare will announce that list by Feb.

Specialty Pharmacies

Specialty Pharmacies Diabetes Drug Pricing

STAT+: Key House panel proposes lowering out-of-pocket drug costs in Medicare

STAT

JULY 24, 2023

The House Ways & Means Committee package includes a new provision that would ensure that patients in the Medicare program pay for medicines they pick up at the pharmacy counter based on the discounted price that insurers negotiate with drugmakers, instead of higher sticker prices, starting in 2027.

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Packaging Drug Pricing Hospitals

South Africa launches ‘unprecedented’ investigation of Johnson & Johnson over TB drug prices

The Guardian - Pharmaceutical Industry

SEPTEMBER 21, 2023

The commission’s investigation was made public last week by the health department and the Health Justice Initiative (HJI) legal organisation at a media briefing of Médecins Sans Frontières (MSF).

Drug Pricing

NHC Provides Input on Patient Engagement in Medicare Drug Price Negotiations

Putting Patients First Blog

SEPTEMBER 20, 2024

NHC Provides Input on Patient Engagement in Medicare Drug Price Negotiations September 20, 2024 By: Allen Pinn, Coordinator, Policy August 16 marked two years since the Inflation Reduction Act (IRA) was signed into law. Earlier this year CMS released draft guidance for Initial Payment Applicability Year (IPAY) 2027.

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Drug Pricing Communication Vaccines

NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

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). Valuing life differently based on disability status, age, or other special populations is inappropriate.

Drug Pricing

Drug Pricing Insurance Coverage and Processing Labelling HIPAA

NHC Comments on Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 of the IRA ICR Forms

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.

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Drug Pricing Insurance Coverage and Processing Labelling Communication

NHC Medicare Drug Price Negotiation Program Comments

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

FDA Approves Amgen’s WEZLANA As Biosimilar to and Interchangeable With Janssen’s STELARA (ustekinumab) – Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

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

IRA Litigation Updates: D.N.J. Rejects Challenges from BMS and Janssen; Four Cases Now on Appeal

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

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

JUNE 8, 2021

.” Biogen has committed not to raise the price of Aduhelm for four years and said it has agreed access deals with some payers – including the Veterans Health Administration, CVS Health and the National Association of Free and Charitable Clinics (NAFC) – while negotiations are ongoing with Cigna and other groups. billion in 2027.

Labelling

Labelling Drug Pricing

AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

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.

Dosage

Dosage Drug Pricing

NHC Comments on IRA Guidance Response

Putting Patients First Blog

APRIL 14, 2023

The NHC requests insight on what opportunities CMS plans to put forward for stakeholders to provide formal input into adjusting future program guidance and whether there will be a comment opportunity to inform negotiation for IPAY 2027 and beyond. The negotiation program is a new policy that is being implemented in a non-traditional manner.

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STAT+: Pharmalittle: Biogen to slash 1,000 more jobs; key House panel proposes lowering Medicare out-of-pocket drug costs

STAT

JULY 25, 2023

The House Ways & Means Committee proposed a package that includes a new provision to ensure Medicare patients pay for medicines they pick up at pharmacies based on discounted prices insurers negotiate with drugmakers, instead of higher list prices, starting in 2027 , STAT reports.

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March 2024 Newsletter

Safe Biologics

MAY 10, 2024

View ASBM’s educational fact sheet “Interchangeability: US vs EU” here. Biden’s SOTU: 500 Drugs To Be Subject to Medicare Drug Price Controls On March 7th, President Biden gave his State of the Union address to Congress, wherein he laid out upcoming policy priorities for a potential second term.

Pharmacist Digest

STAT+: Pharmalittle: We’re reading about unsupported drug price hikes, an annual HIV prevention shot, and more

STAT+: ‘Learning each other’s language’: FDA, patent office seek to work together to lower drug prices

Trending Sources

STAT+: Wegovy is among drugs set to be targeted in the next round of Medicare price negotiations, researchers say

STAT+: Key House panel proposes lowering out-of-pocket drug costs in Medicare

South Africa launches ‘unprecedented’ investigation of Johnson & Johnson over TB drug prices

NHC Provides Input on Patient Engagement in Medicare Drug Price Negotiations

NHC Comments on Medicare Drug Price Negotiation Program: Draft Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027

NHC Comments on Negotiation Data Elements and Drug Price Negotiation Process for Initial Price Applicability Year 2027 under Sections 11001 and 11002 of the IRA ICR Forms

NHC Medicare Drug Price Negotiation Program Comments

FDA Approves Amgen’s WEZLANA As Biosimilar to and Interchangeable With Janssen’s STELARA (ustekinumab) – Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

IRA Litigation Updates: D.N.J. Rejects Challenges from BMS and Janssen; Four Cases Now on Appeal

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

NHC Comments on IRA Guidance Response

STAT+: Pharmalittle: Biogen to slash 1,000 more jobs; key House panel proposes lowering Medicare out-of-pocket drug costs

March 2024 Newsletter

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