CANCER MEDICINES SHORTAGES IN EASTERN EUROPE

Dr Vlad MixichHearing of European Parliament Special Committee on Beating Cancer28 January 2021

A PERFECT STORM

Member States should also ensure that the overarching values ofuniversality, access to good quality care, equity, and solidarity arerespected with regard to patients and citizens from other Member States,and that all patients are treated equitably on the basis of their healthcareneeds rather than on the basis of their Member State of affiliation.

Guiding Words

- EU DIRECTIVE 2011/24/EU

Year 2016 Year 2017 Year 2018 Year 2019 Year 2020

6,000

4,000

2,000

0

SHORTAGESNOTIFICATIONSYearly Comparison in Romania

Medicines shortages should be notified to the authorities bypatients or healthcare professionals on public websites or bypharmacies to the regulatory authorities. This can be used assignals to assess shortages risk.

Not advertising the ways to notify shortages will lead tounderreporting.

REGISTERED SHORTAGES Essential Medicines Most frequent in 2019

Bleomycin Temozolomide Cisplatin MycophenolatDacarbazine CiclosporinDasatinib NilotinibLeuprorelin 5-FluorouracilLinezolid PazopanibVinblastine ProcarbazinVinorelbin5-Fluorouraciletc.

Available Accessible

Internal PricingManufacturing

External Pricing

Supplychains

ParallelTrade

Guidelines Procurement

HTA

STATUS OF CANCER PHARMACEUTICALSPRODUCTS IN ROMANIA

Accessible47.3%

Not launched43%

Not accessible due to commercial reasons7.4% 2.2% not accessible

due to manufacturing issues

Based on the status of 150 cancer medicines analyzed in December 2019

Maini L, Pammolli F, | 2017

DELAY BY DESIGN

Average delay from EMAapproval to national access

Germany average 119 days

EU average 445 days

Romania average 775 days

SUCH A MAZEExternal Reference Pricing Significant Price Differences

One size does NOT fit all

MULTIPLECAUSESAN INTEGRATED APPROACH IS NEEDED!

Analysis based on 2016-2017 Romanian data

7 3 2

Case study

ProductsFive MarketAuthorization Holderspresent in the country.

Not availableSeven equivalent brandedproducts never launched inthe country.

Not accessibleThree products notaccessible due to

commercial issues.

Not accessibleTwo products not accessibledue to manufacturing issues.

Temozolomid: used for brain tumors

8

Limited quantitiesEight products from two MaH are availableonly in limitedquantities.

823

Parallel traded823 units parallel traded in the first half of 2019.

20

1 1

Case study

ProductsTwo MarketAuthorization Holderspresent in the country.

Not availableOne branded product neverlaunched in the country.

Not accessibleOne branded product not

accessible due tocommercial issues.

Bleomycin: used in Hodgkin limphoma & others

2

Parallel tradedNot parallel traded.

0

Available Accessible

Internal PricingManufacturing

External Pricing

Supplychains

ParallelTrade

Guidelines Procurement

HTA

Data Transparency

At least 1 year notificationprior to a product'sdiscontinuation or

withdrawal.

MANDATORYNOTIFICATIONS

Monitoring availablestocks at least at

regional level.

STOCKS

Notification ofquantities and

destination of paralleltraded products.

PARALLELTRADE

Defining alertthresholds to identifyrisk of shortages for

specific products.

ALERT LEVELS

Public shortages reporting (signals) from patients or healthcare professionals

WHAT SHOULD BE DONE?Aim high

Revamp EU Pricingmethodology

European HTASpecial rules for essential medicines Rules enforcement

NEED TO ACT

NOW!

OPEN TO QUESTIONS!

vlad.mixich@health-observatory.ro

EMAIL

www.health-observatory.ro

WEBSITE