France Trades €100 Million in Price Relief for an Annual Review of Older Drugs
France has moved the reimbursement threat from price to presence: a competitor’s launch can now put an incumbent under review.
European Union
IQWiG Finds Two Conflicting Studies and No Billing Code Behind AI Lung Cancer Reading
In Germany, AI lung reading is a cost radiologists carry and payers never see, and IQWiG wants outcome trials.
Latvia Squeezes Access for 123,000 Patients Out of Price Deals as 124 Drugs Wait
Latvia is buying access with manufacturers’ money, inside a reimbursement budget NVD already expects to overrun.
EU Pharma Package Sets Nine Years’ Default Protection and Rewards Comparative Trials With a Tenth
The default gets shorter, and the route back to the maximum runs through comparative trials and filing early in Europe.
IQWiG and LSE Authors Say EU Joint Clinical Assessments Could Become a Basis for US Price Talks
A debate about who sets the evidence bar, landing the same week Germany’s health ministry proposed lowering it.
Europe Approved Leriglitazone for Boys With cALD Two Years After the EMA Recommended Refusal
A drug the EMA refused two years ago is now approved, on a narrow label and under exceptional circumstances, with Europe first.
Teva Faces New Probe in Turkey Over Conduct Flagged by EU
Not a new theory of harm. It is the European Commission’s Copaxone decision run a second time, with two of the same corporate entities named.
Imvanex Now Covers European Two-Year-Olds. The Children Carrying the Burden Are in Africa.
A type II variation in Brussels does nothing directly for a child in Kinshasa. What it does is unlock the procurement channels that reach one.
AbbVie Took Two EU Approvals in One Day, Both for Diseases Payers Have Called Cosmetic
The European Commission approved RINVOQ for non-segmental vitiligo and, the same day, for severe alopecia areata, both in adults and adolescents aged 12 and over.