Market Access & Reimbursement
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Joint Clinical Assessments: EU Guidance On Evidence May Be Flexible For ATMPs And Single Arm Trials
Real-world evidence and patient involvement can help developers shore up evidence from single arm trials for EU-wide joint clinical assessments.
Pharma Can Pursue Claims Against Providers For 340B Duplicate Discounts In Medicaid Managed Care, HRSA Says
The statement, which is part of a final rule on the 340B administrative dispute resolution process, could facilitate manufacturer efforts to seek repayments from hospitals in such cases.
FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Khan Says
The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.
EU Countries Offered Funding To Contribute to African Regulatory Strengthening
Training projects are intended to strengthen the African regulatory environment, boost the capacity of the African Medicines Agency, facilitate regulatory reliance, and increase joint new drug assessments.
First Of Its Kind: UK Hospital To Apply For ADA-SCID Gene Therapy Approval
Great Ormond Street Hospital is piloting a new approach to gene therapy delivery in which it will submit a marketing authorization application to the UK regulator for a lentiviral gene therapy used to treat ADA-SCID, a rare disease.
GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows
A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.
Pink Sheet Podcast: Leqembi Spending, Woodcock’s Next Act, Pneumococcal Vaccine Development
Pink Sheet editors discuss Medicare spending projections for the Alzheimer’s treatment Leqembi, Janet Woodcock’s new post-FDA role, and ongoing preparations for new pneumococcal vaccines that will reach the market soon.
Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines
Scientific advice could help companies make up for the lack of involvement in scoping, but slots are in short supply.
Medicare Reimbursement For Part B Drugs Is 48% Above 340B Prices To Hospitals, MedPAC Finds
New study updates past commission analyses and highlights the significant margin between Medicare payments for drugs and the prices paid by 340B-eligible providers.
China’s Public Payer Wants To Define Innovative Drugs As Those With ‘Novel Benefits’
China’s public payer perceives innovative drugs in a different way from that of the country’s top drug regulator, a former senior healthcare security official with knowledge of the matter reveals. The posture has unnerved pharma companies, which have been hit by sharp price discounts.
German HTA Queries Polivy Benefits Amid Lack Of Evidence
Roche’s lymphoma drug Polivy could face pricing challenges in Germany as it undergoes a full benefit assessment.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.
EU Needs Market Access Improvements Beyond New HTA Regulation
While the EU Health Technology Assessment Regulation could reduce divergence in reimbursement decisions made across member states, many national-level HTA hurdles and challenges will remain, market access experts from EFPIA say.
Medicare-Negotiated Drugs May Not Get Favorable Coverage In Part D: Will CMS Intervene?
Insurance plans put on notice that CMS is concerned about restrictions on drugs with negotiated prices, but it’s not clear what the agency can or will do about it.
‘Unbalanced’ EU HTA Timelines Exacerbated By Rare Disease & Cancer Drugs
As it stands, drugmakers will have just 90 days to prepare their dossiers for EU-wide joint clinical assessments under the new Health Technology Assessment Regulation. Market access experts from EFPIA tell the Pink Sheet that this short deadline could delay patient access to complex medicines, such as innovative cancer drugs.
National Drug Stockpiles Create ‘False Sense Of Security’
The generics and biosimilars industry body Medicines for Europe says disparate national stockpiling requirements are not a solution to shortages and can bring “significant risks” for the supply chain and access to medicines.
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