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Mesoblast Eyes Japan Conditional Approval After New RA Cell Therapy Data

Mesoblast is looking at a possible conditional approval pathway in Japan for its cell therapy for rheumatoid arthritis, based on promising new results from a Phase II study that showed a durable response for at least nine months from a single “dose”.

Research & Development Clinical Trials Inflammation

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Gilead, With Two PRVs In Hand, Holds Options For Accelerating Late-Stage Pipeline

Likely candidates for use of Gilead's priority review vouchers include GS-4997, a Phase III candidate for NASH, and bictegravir, its second-generation integrase inhibitor for HIV. The virology specialist previously used a PRV successfully to accelerate approval of Odefsey.

Business Strategies Research and Development Strategies

AbbVie 'Disagrees' With NICE's Draft Rejection Of Venclyxto For CLL

NICE has rejected AbbVie's BCL-2 inhibitor on grounds that evidence presented by the drug maker didn't adequately prove Venclyxto's clinical effectiveness, nor that the cancer product would be value for money.

Health Technology Assessment Market Access

Express Scripts Projects Higher Spending In Inflammation, Diabetes, Cancer

The three most expensive drug categories, on a per-member/per-year basis for the PBM's clients, increased by 19% or more in 2016, and similar growth is expected in the next three years. Per-patient spending on HCV drugs, however, declined by 34% last year.

Pharmacy Benefit Management Pricing Strategies

Laying The Groundwork For Value-Based Healthcare In Europe

Elisabeth Aloy and David Pistor, healthcare and life sciences advisors at Monitor Deloitte, outline five design principles to create a value-based care project.

Market Access Reimbursement

Pfizer To Compromise On NICE Price For Ibrance?

NICE, the HTA for England and Wales, is poised to say no to Pfizer’s Ibrance (palbociclib), because the cost of the drug is too big in relation to its benefits. The company will likely have to come back with a patient access scheme to secure reimbursement.

Commercial Market Access

Canada First To OK Sanofi/Regeneron’s Sarilumab, But Struggle To Differentiate Looms

Sanofi/Regeneron’s Kevzara (sarilumab) has won its first worldwide approval for treating moderately to severely active rheumatoid arthritis from Health Canada. But as more regulators follow, the companies will face a battle to differentiate the drug from chief rival, Roche/Chugai’s Actemra (tocilizumab).

Approvals Market Access
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