Market Access & Reimbursement

Nye korte vejledninger til psykiatere og praktiserende læger om ADHD-medicin

26. maj 2026

Medicinrådet anbefaler ikke givinostat på grund af usikkerhed om størrelsen og varigheden af effekten hos patienter med Duchennes muskeldystrofi

29. juni 2026

General Principles on the use of Artificial Intelligence in the preparation of the JCA dossier

News announcement 16 July 2026 General Principles on the use of Artificial Intelligence in the preparation of the JCA dossier 1 min read

Manufacturer Effectuation of MFP Draft Guidance for 2028 Medicare Drug Price Negotiation

Fact Sheets Jul 16, 2026 Manufacturer Effectuation of MFP Draft Guidance for 2028 Medicare Drug Price Negotiation Medicare Drug Price Negotiation Program: Draft Guidance for Manufacturer Effectuation of the Maximum Fa...

Updated – Submission request template for medical devices

News announcement 16 July 2026 Updated – Submission request template for medical devices 1 min read

Thousands eligible for new chronic heart failure treatment following NICE recommendation

People in England with a type of chronic heart failure could benefit from a new treatment option. Our final draft guidance recommends finerenone for adults with chronic heart failure with preserved or mildly reduced e...

Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations

Clinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks inpu...

Dentistes : Interdiction de facturer des suppléments en ambulatoire aux bénéficiaires de l’intervention majorée

16-07-2026 - Dentistes : Interdiction de facturer des suppléments en ambulatoire aux bénéficiaires de l’intervention majorée Depuis le 1er juillet 2026, l’interdiction de facturer des suppléments aux bénéficiaires de ...

UK-donor plasma given go-ahead for new medicines

Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of UK‑donor plasma for five high‑priority plasma-derived medicinal products.

CMS Proposes Transformational Medicare Reforms to Expand Accountable Care, Modernize Physician Payment, and Shift from Sick Care to Healthcare

Press Releases Jul 14, 2026 CMS Proposes Transformational Medicare Reforms to Expand Accountable Care, Modernize Physician Payment, and Shift from Sick Care to Healthcare CMS Proposes Transformational Medicare Reforms...

Fimea käynnistää HTA-arvioinnin uudesta sairaalalääkkeestä tarlatamabi

Updated - List of joint clinical assessments

News announcement 8 July 2026 Updated - List of joint clinical assessments 1 min read

Novel life-saving liver procedure recommended, potentially enabling hundreds more transplants

A procedure that keeps donor livers supplied with oxygen inside the body before removal has been recommended for NHS use and could help more people on the transplant waiting list.

Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies

This proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule discusses the behavior ad...

Semaglutide (Wegovy) approved to treat form of liver disease

The semaglutide injection has been approved to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced liver fibrosis.

New draft PMOS guideline recommends annual review and could mean quicker diagnosis

People with polyendocrine metabolic ovarian syndrome (PMOS) should have their condition diagnosed sooner and be offered an annual review to monitor symptoms, treatment and long-term health risks, according to our draf...

Class 4 Medicines Defect Notification: Brancaster Pharma Limited, Benzylpenicillin benzathine 1.2 Million I.U. and 2.4 Million I.U. powder for suspension for injection, EL(26)A/30

Brancaster Pharma Limited has informed the MHRA that the Patient Information Leaflet (PIL) in the cartons for the batches listed in this notification were released with an outdated PIL.

Medicaid Program; Community Engagement Requirement for Certain Individuals

Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury Dialysis (AKI) Payment, and ESRD Quality Incentive Program

This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This rule also proposes to update the payment rate for renal dialysis services furnished...

Parliament has approved amendments to the Alcohol Act – the Finnish Supervisory Agency is preparing guidelines for customers

25.06.2026 Parliament has approved amendments to the Alcohol Act – the Finnish Supervisory Agency is preparing guidelines for customers

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Equines; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #109 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Equines." This guidanc...

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Ovines; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #96 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Ovines." This guidance ...

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Bovines; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #95 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Bovines." This guidance...

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Canines; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #111 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Canines." This guidanc...

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Caprines; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #97 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Caprines." This guidanc...

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Felines; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #113 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Felines." This guidanc...

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #90 entitled "Effectiveness of Anthelmintics: General Recommendations." This guidance has been dev...

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Porcines; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #110 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Porcines." This guidan...

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Chickens-Gallus Gallus; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #114 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Chickens--Gallus gallu...

New treatment option recommended for recurrent or metastatic cervical cancer

A new treatment option is now available on the NHS for cervical cancer that has come back or spread to other parts of the body, following our final draft guidance published today.

SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 ...

Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data Collection

This request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers ("PBMs") and their affiliates to inform implementation of recent legislation. It specific...

Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflicts of Interest, and Related Provisions

This final rule with comment period sets forth provisions to strengthen the oversight of Medicare national accrediting organizations by addressing conflicts of interest, establishing consistent standards, processes, a...

Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

This proposed rule would codify the Medicare Drug Price Negotiation Program ("Negotiation Program") and would establish certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Progr...

How the faecal immunochemical test is changing bowel cancer referrals and what it tells us about the power of NICE guidance

Learn how NICE's healthtech guidance is accelerating NHS adoption of a simple bowel cancer test, preventing 140,000 unnecessary urgent referrals a year while keeping cancer detection rates stable.

First GLP-1 tablet for weight loss approved in the UK

Having met the MHRA’s rigorous standards of safety, quality and effectiveness, the semaglutide tablet has been approved in the UK for weight loss and weight management.

Proposed 2026 changes to the statutory scheme for branded medicines pricing

Proposed changes to the headline payment percentage and consultation procedure of the statutory scheme to control the cost of branded health service medicines.

Guidance: AI Airlock Sandbox Phase 2 Programme Report

The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.

Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry titled "Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Simil...

Medicaid Program; Community Engagement Requirement for Certain Individuals

This interim final rule with comment period (IFC) interprets and implements the community engagement requirement in Medicaid under section 1902(xx) of the Social Security Act. States are required to implement the new ...

NICE issues new guidance on 'artificial pancreas' technology for pregnant women with type 1 diabetes

Women with type 1 diabetes who are pregnant or planning a pregnancy should be offered a pregnancy-specific 'artificial pancreas' device. That is the recommendation in draft guidance published today by NICE.

Notice of Vacatur Regarding Certain Provisions of the 2024 Nondiscrimination in Health Programs and Activities Final Rule

This is to inform the public that, on October 22, 2025, the United States District Court for the Southern District of Mississippi issued an order in Tennessee v. Kennedy, No. 1:24-cv-161-LG-BWR (S.D. Miss. Oct. 22, 20...

Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model

This final rule will update and revise the Increasing Organ Transplant Access (IOTA) Model for Performance Year (PY) 2. This final rule also includes a technical correction to the regulatory text.

Commission publishes analysis underpinning the Biotech Act proposals

News announcement 27 May 2026 Commission publishes analysis underpinning the Biotech Act proposals Commission publishes analysis underpinning the Biotech Act proposals 1 min read

Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act

In response to a suggestion by Gilead Sciences, Inc. (Gilead) that was submitted to the public docket FDA-2008-N-0567 on February 14, 2022, the Food and Drug Administration (FDA or Agency) has analyzed whether hepatit...

Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; and Other Policy Changes; Correction

This document corrects technical and typographical errors in the proposed rule that appeared in the April 14, 2026 Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Ca...

Medicaid Program; Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments

This proposed rule describes alternatives to modify the limit on the total payment rate and other requirements for State directed payments in Medicaid managed care. We propose these changes based on our authority to i...

Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program

This final rule contains provisions to improve implementation of the Patient Protection and Affordable Care Act, including payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustm...

Health Technology Assessment – Member State Coordination Group adopts guiding principles on data transparency

News announcement 18 May 2026 Health Technology Assessment – Member State Coordination Group adopts guiding principles on data transparency Health Technology Assessment – Member State Coordination Group adopts guiding...

MHRA approves beremagene geperpavec (Vyjuvek) for the treatment of dystrophic epidermolysis bullosa

As with any medicine, the MHRA will keep the safety and effectiveness of Vyjuvek under close review.