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Market Access & Reimbursement

Set Alert for Market Access & Reimbursement

UK Early Access Scheme Treatments More Likely To Get Faster NICE Stamp Of Approval

The UK’s Early Access to Medicines Scheme celebrated its tenth birthday in April. In the first of two articles on experience with the scheme, the Pink Sheet looks at how far the inclusion of a product on the EAMS affects its chances of securing a positive HTA recommendation from NICE.

Europe United Kingdom

Looming Step Therapy Ban In Illinois Is ‘Game Changer,’ Could Start Trend

Federal legislation on PBM reforms has stalled, but state efforts remain active. Illinois’ Healthcare Protection Act includes several other limits on insurer power, including prohibiting prior authorization for inpatient mental health care.

PBMs Reimbursement

Final Funding Blow For J&J’s Spravato In England, Despite Reimbursement In 26 Other Countries

J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.

BioPharmaceutical Neurology

Nordic HTA Collaboration Expands To Boost Joint Assessments

The five-country JNHB says that joint assessments mean HTA applications will be handled “efficiently and simultaneously” across the Nordic region, with one point of contact instead of multiple parallel processes.

Europe Health Technology Assessment

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add three new products, including Qalsody, Biogen's treatment for amyotrophic lateral sclerosis associated with a mutation in the superoxide dismutase 1 gene.

Europe Approvals

EU HTA Regulation: Draft Conflicts Of Interest Rules Fail To Consider Orphan Drugs

Coupled with a recent top court ruling, the draft implementing act on CoIs under the Health Technology Assessment Regulation show a general trend towards stricter conflicts of interest rules.

Europe Health Technology Assessment

Medicare Negotiation: Therapeutic Alternatives Selection Will Become More Predictable, CMS Says

The selection process timeline will not change, but as the Medicare price negotiation matures, industry will better understand how therapeutic alternatives are chosen to inform the process, according to an official with the Centers for Medicare and Medicaid Services.

Reimbursement Medicare

Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

International Europe

House 340B Reform Bill Would Require Discount Pass Through, Define Patient, Hospital Eligibility

Legislation is the fruit of PhRMA’s lobbying collaboration with the National Association of Community Health Centers. It would also require manufacturers to supply contract pharmacies, within limits.

Pricing Debate Policy

Amended International Health Regulations Give Fresh Momentum To Pandemic Treaty Talks

The amendments agreed by the World Health Assembly include a definition of a pandemic emergency as well as ways to help improve access to health products.

International Coronavirus COVID-19

Project Orbis Led To 80% Cut In Submission Gap For Cancer Drugs In Switzerland

The international Project Orbis regulatory collaboration initiative reduced the submission gap between filings made in the US and Switzerland even more than expected, marking a step towards faster access to innovative cancer drugs, regulatory experts have told the Pink Sheet.

BioPharmaceutical Drug Review

England’s Genomics Service Working With Industry On Precision Medicine & Personalized Vaccines

England’s chief scientific officer explains how the NHS Genomic Medicine Service has led to faster access to targeted cancer drugs and outlines the organization’s ongoing work in pharmacogenomics, liquid biopsies and personalized RNA vaccines.

Europe United Kingdom

Ophthalmic Drugs Already Lead Medicare Part B Cost Drivers: How Will Gene Therapy Fit?

Gene therapy for wet age-related macular degeneration is one of two later-stage gene therapies flagged in CVS Caremark’s latest pipeline report that are outliers because they target conditions afflicting millions of patients and could dramatically increase Part B spending.

Reimbursement Gene Therapy

DREAMM Comeback Prompts GSK To Seek Fast-Track EMA Review For Blenrep

The European Medicines Agency is this week deciding whether the planned EU filings for sipavibart, lifileucel and Blenrep – which was previously approved but withdrawn in the EU and the US – merit an accelerated assessment.

Review Pathway Approvals

Feedback Sought On The Tricky Business Of Handling CoIs Under EU HTA Regulation

Representatives and individual experts taking part in joint assessments of new health technologies need to be free from conflicts of interest in relation to the industrial sector in which the health technology developer operates.

Europe Health Technology Assessment

Pandemic Treaty Talks Flounder But WHO Still Holds Out Hope For Eventual Agreement

At this week’s World Health Assembly, a working group will be set up to discuss the next steps for talks on a global pandemic treaty and try to reach a final agreement on amendments to the International Health Regulations.

International Coronavirus COVID-19
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