Market access and reimbursement decide whether an authorised product reaches patients and how it is paid for. Health Technology Assessment bodies evaluate clinical and economic value, the EU HTA Regulation now provides joint clinical assessments for certain medicines and high-risk devices, and pricing and coverage decisions still vary widely by country.
CMS proposes a faster pathway for manufacturers to obtain Medicare coverage of new medical devices.
US CMS Newsroom · United StatesCommission adopts rules enabling joint clinical assessments of medical devices and IVDs under the HTA Regulation.
EC Public Health · EU-wideUpdated guidance and eligibility tool published for early information submission in joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideProposed requirements for electronic prior authorization for drugs and extended interoperability standards across Medicare Advantage, Medicaid, CHIP, and QHP issuers.
US Federal Register - CMS Rules · United StatesDiGA manufacturers must implement continuous performance measurement (AbEM) and report to BfArM; up to 20% of reimbursement price becomes outcome-dependent.
BfArM DiGA Fast Track · GermanyNICE adapts its evidence standards framework for digital health technologies to support decision-making for digital care technologies in adult social care.
UK NICE · UKIDAP pilot accelerates development and market integration of innovative medical devices addressing unmet NHS clinical needs.
UK MHRA · UKDiGA reimbursement shifts to outcome-based pricing with up to 20% contingent on demonstrated healthcare effects; insurer activation codes reduced to 2-day requirement.
BfArM DiGA Fast Track · GermanyINFARMED publishes initial FAQ clarifying changes to Portugal's National Health Technology Assessment System (SiNATS) introduced by Decree-Law 118/2026.
Portugal INFARMED · PortugalCompilation of Joint Clinical Assessment reports, procedural guidance on AI use in HTA dossiers, data transparency principles, and methodological FAQs for medical devices and IVDs.
EU HTA Regulation Implementation · EU-wideFDA finalizes guidance on therapeutic equivalence evaluations and TE codes for multisource prescription drug products in the Orange Book.
US Federal Register - FDA Notices · United StatesJoint Clinical Assessments under the HTA Regulation now extend to selected high-risk medical devices and in-vitro diagnostics.
European Commission · EU-wideNew homogeneous groups added to Portugal's reference pricing system for the third quarter of 2026.
Portugal INFARMED · PortugalUpdated list of medicinal products reimbursed from public health insurance, incorporating SUKL and Ministry of Health decisions effective by 15 August 2026.
Czechia SUKL · Czech RepublicList establishes reimbursement prices, maximum manufacturer prices, and reimbursement conditions for categorised and non-categorised foods for special medical purposes covered by public health insurance.
Czechia SUKL · Czech RepublicRevised draft guidance on manufacturer communications of health care economic information about approved drugs and devices to payors and formulary committees.
US Federal Register - FDA Guidance Notices · United StatesUpdated guidance on methodology and procedure for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideGuidance clarifying methodological and procedural requirements for joint clinical assessments under the EU HTA Regulation.
EC Public Health · EU-wideCMS proposes updates to physician fee schedule, Part B payment policies, Medicare Shared Savings Program, Quality Payment Program, and Promoting Interoperability Program for calendar year 2027.
US Federal Register - CMS Rules · United StatesMedicinrådet publishes treatment algorithm and overview of recommended medicines for type 2 diabetes based on efficacy, adverse effects and price.
Medicinrådet (Danish Medicines Council) · DenmarkCzech SUKL publishes the official list of prices and reimbursements for medicinal products under public health insurance.
Czechia SUKL · Czech RepublicCMS proposes updates to Medicare home health payment rates, case-mix weights, quality reporting requirements, and DME enrollment and benefit policies for calendar year 2027.
US Federal Register - CMS Rules · United StatesGreek EOF pricing department proposes medicinal product prices for Q2 2026, open for public consultation.
Greece EOF · GreeceGreece's EOF pricing department proposes pricing decisions for new medicines, repricing of reference products, and examination of price adjustment requests for non-reimbursed formulations in Q2 2026.
Greece EOF · GreeceNICE invites input on adopting a new EQ-5D-5L value set to improve health-related quality-of-life assessments in treatment evaluation.
UK NICE · UKGuidance clarifying joint clinical assessment procedures under the EU HTA Regulation.
EU HTA Regulation Implementation · EU-wideFactsheets on joint clinical assessment and scientific consultation procedures under the EU HTA Regulation, plus implementation guidance and analysis of regional cooperation structures.
EU HTA Regulation Implementation · EU-wideILAP is a pathway to accelerate regulatory approval and NHS access for transformative new medicines.
UK MHRA · UKUpdated list of medicinal products reimbursed from public health insurance, incorporating SUKL and Ministry of Health decisions effective by 15 July 2026.
Czechia SUKL · Czech RepublicPortugal's INFARMED adds new homogeneous groups to the reference pricing system for the third quarter of 2026.
Portugal INFARMED · PortugalCMS issued draft guidance on processes and requirements for manufacturers to implement maximum fair prices in the 2028 Medicare drug price negotiation program.
US CMS Newsroom · United StatesList establishes reimbursement prices, maximum manufacturer prices, and reimbursement conditions for categorised and non-categorised foods for special medical purposes from public health insurance.
Czechia SUKL · Czech RepublicProposed rule to codify the Medicare Drug Price Negotiation Program and establish new policies for drug pricing and the prescription drug benefit under the Inflation Reduction Act.
US Federal Register - CMS Rules · United StatesNICE recommends an online therapy programme for people aged 16 and over with eating disorders awaiting specialist NHS treatment.
UK NICE · UKNICE conditionally recommends five AI technologies as decision-support tools during bowel examinations to improve early detection of precancerous growths.
UK NICE · UKSUKL publishes a corrected list of prices and reimbursements for medicinal products under the public health insurance law.
Czechia SUKL · Czech RepublicCzech SUKL publishes the official list of prices and reimbursement rates for medicinal products under public health insurance.
Czechia SUKL · Czech RepublicCzech SUKL publishes the official price and reimbursement list for foods for special medical purposes under public health insurance.
Czechia SUKL · Czech RepublicFinal rule revises Medicare Advantage, Prescription Drug Benefit, and cost plan regulations for Star Ratings, marketing, drug coverage, and enrollment.
US Federal Register - CMS Rules · United StatesIQWiG General Methods 8.0 entered force in December 2025, introducing new methods for hospital minimum volume standards and HTA assessment.
IQWiG (German HTA) · GermanyMHRA, ASA and GPhC warn businesses against unlawful promotion of newly authorised and unlicensed weight-management medicines.
UK MHRA · UKNICE recommends offering pregnancy-specific artificial pancreas devices to women with type 1 diabetes who are pregnant or planning pregnancy.
UK NICE · UKGreece's EOF pricing department proposes medicinal product prices for Q1 2026, open for public consultation.
Greece EOF · GreeceGreece EOF publishes proposed retail prices for MHSYFA products for public consultation.
Greece EOF · GreeceConsultation on amendments to the headline payment percentage and consultation procedure of the branded medicines pricing control scheme.
UK DHSC · UKGreek EOF pricing department proposes new pricing decisions for Q2 2026 including reference product re-pricing and non-reimbursed formulation price adjustments.
Greece EOF · GreeceGreece EOF pricing department proposes generic medicine prices for public consultation.
Greece EOF · GreeceFinal rule sets 2027 payment parameters, user fee rates for health plan issuers, risk adjustment provisions, and QHP certification standards including provider access and essential health benefit requirements.
US Federal Register - CMS Rules · United StatesGreek EOF pricing department proposes generic medicine prices for public consultation.
Greece EOF · GreeceMHRA-NICE aligned pathway streamlines decision-making to accelerate patient access to new medicines by 3–6 months.
UK MHRA · UK