Non-marketing of authorized products - What are the facts?

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Non-marketing of authorized products -What Are The Facts?

Dr. Frank Wartenberg President Central Europe IMS HEALTH GmbH & Co. OHG

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Disclaimer

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accessible

effective

efficient

Patient-centered

equitable

safe

Wartenberg - IMS Health - Non-marketing of authorized products -What Are The Facts?

Availability of drugs is a key dimension for quality of care

Dimensions of quality of care according to WHO

Source: WHO (2006): Quality of care – A process for making strategic choices in health systems

Delivering health care that is timely, geographically reasonable

4 4 Wartenberg - IMS Health - Non-marketing of authorized products -What Are The Facts?

However numerous product shortages across Europe occurred in recent times

Greece: temporary export bans update and lift through time according to reported shortages

Poland since July-15: any exports have to be reported and approved, in case if there are any shortages, then request will be rejected by GIF

Czech: all exports volumes must be reported to SUKL, pharmacies not allowed to buy and return to different wholesalers, etc.

Germany: as a result of AMNOG price cuts many incidents of shortages were reported in past two year, the actions on that are not known

Portugal Aug-2013: restrictions apply to the parallel export of prescription drugs deemed to be in short supply

Source: IMS Health, regional newspapers


There are three dimensions of availability which hamper patient access to drugs

Not available at all in the market

Limited patient access to drugs

Source: IMS Health

Very limited availability

Erratic availability

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Availability of new medicines varies by country and disease Global new molecular entities 2009-13; availability as of 2014

US South Korea Canada UK Spain Italy France Germany Japan China Brazil Russia Global

Jen – add Brazil panel and check Rx filter

Total 159 111 67 99 73 80 85 97 78 56 40 47 28 15 58 % of Total 70% 42% 62% 46% 50% 53% 61% 49% 35% 25% 30% 18% 9% 36% Anti-infectives & Antivirals 18 12 8 10 9 9 9 10 8 6 3 8 0 2 2 Arthritis/Pain 5 3 3 2 1 3 3 3 3 1 0 0 2 1 1 Blood 8 5 3 4 4 4 4 4 4 4 3 2 3 2 3 Cardiovascular 10 6 2 6 3 4 4 6 5 3 0 3 3 1 4 CNS 12 9 3 7 7 6 6 6 5 1 2 2 3 0 1 Dermatology 2 1 1 1 1 1 1 1 1 1 0 0 0 0 0 Diabetes 11 6 10 6 2 5 6 8 5 6 6 5 4 4 8 Gastrointestinal 6 4 1 4 2 3 3 3 4 2 1 1 0 1 3 GU & Hormones 12 7 3 8 6 7 8 7 3 7 1 2 2 1 3 Immune System 11 9 5 10 8 10 10 10 8 4 6 6 0 0 6 Metabolic 6 5 3 2 1 1 1 1 0 0 0 0 0 0 0 Oncologics 43 34 19 31 25 20 24 30 26 16 11 15 8 2 19 Ophthalmics 5 4 2 2 1 2 2 2 2 3 3 0 1 0 3 Other 3 1 1 0 0 0 0 0 0 0 0 1 0 0 0 Respiratory 7 5 3 6 3 5 4 6 4 2 4 2 2 1 5

India Mexico

Source: IMS Institute for Healthcare Informatics, June 2015



In most EU countries only ~70-90% of the top 200 selling products are available in the market

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123

EE LV

111

LU

125

HU

143

LT

192 176

ES

177 169

IT SI

190 166

AT IE

193

SK

159 189

BE CZ

189 158

PT RO

188 155

UK PL

183 149

NO NL

183 147

SE GR

180 146

FI BG

196

FR

197

DE

Availability of EU Top 200 Products across Countries

Source: IMS Health MIDAS. 2015.


Depending on the country, up to 34% of orphan drugs are not available for patients in top 5 EU

85% 78% 73% 66%

15% 22% 27% 34%

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86 86 86 86 86

not available available

Availability of orphan drugs in top 5 EU Delays in orphan drugs availability occur between regulatory approval and reimbursement: EU member states negotiates pricing separately Pharma companies tend to begin negotiations

with Member states that pay a higher price to gain advantage in reference pricing

Member states delay negotiations to avoid having to make the drug available/ postpone paying for the drug

Example: Esbriet was approved in the EU in 2011

• Beginning of reimbursement in DK 12/2011 • Beginning of reimbursement in CZ

07/2014

Source: IMS Health, Feltmate et al. (2015): Delayed access to treatments for rare diseases: Who’s to blame?; EURODIS (2014): Access to orphan drugs

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Focussing on innovative anti-diabetics shows very large country differences in uptakes

Source: IMS Health MIDAS 2015. Population figures from Eurostat. * OECD health accounts data. June 2012


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Europe: Uptake of Innovative Anti-diabetics (DDD/100,000 people) 2015

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High > $50,000

Middle : $30,000-$50,000

Low < $30,000

Many factors can affect uptake : • GDP per capita and the financial situation of the country (high - medium - low income countries) • Regional decision makers • Price premium versus existing treatment • Stakeholder attitude to innovation • If innovation is funded by the public or private payer

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Germany: Regional Uptake of Innovative* Anti-diabetics (DDD/100,000) MAT Q4 2015

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Sweden: Regional Uptake of Innovative* Anti-diabetics (DDD/100,000) MAT Q4 2015

• Regions normally share common launch dates, technology assessments, prices, reimbursement, etc.

• Analysing uptake between healthcare regions within a country exposes differences in how innovation has been used

• Differences in uptake can be based on; the criteria applied by local drug committees, budget restrictions, information availability, medical judgements

National reimbursement does not always ensure equal access within a country

Source: IMS Health Swedish PrSellOut and German. Population statistics from SCB for Sweden and Statistisches Bundesamt for Germany.


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Generics face different challenges as innovations – but with similar outcomes

Dependence on global suppliers affects many generic companies simultaneously: “The European Medicines Agency (EMA) confirmed its recommendation to suspend a number of medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India.”

Price pressure affects the profitability of generic production In fall 2012, Teva stops the production of 5-FU in their Dutch production place Haarlem due to economic reasons.

Shortage in raw material affects companies temporarily: “Estimates vary, but about 10 percent of drug shortages are thought to be related to raw material shortages.”

Source: EMA (2015): GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed studies, Spiegel Online (2012): Arzneimittel: Wichtiges Krebsmedikament geht aus, http://www.ncpa.org/pub/what-is-increasing-the-cost-of-generic-drugs-part-i-the-supply-chain

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Availability of drugs can be impeded at different stages within the supply chain

Pharmacies dispense

Wholesalers supplying pharmacies

Manufacturers allocating supply Manufacturing

Shortages in a market

Shortages at preferred wholesaler

Availability to export

Availability to export

Patient not receiving treatment

Source: IMS Health

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This shows: Root causes for drug non-availability are manifold

No/limited availability


• Complexity of products/ production problems

• Shortage of raw material • Production capacity/streamlining • Quality assurance/ compliance with

GMP guidelines • Locally divided production and

globalization

• Product is not approved (payer limit costs by delaying/not approving)

• Product is not launched (no viable price level or impact on other countries)

• Price and rebate pressure • Rebate contracts • Tendering (inpatient sector)

Regulatory/ Market Access Manufacturing

Supply chain interference Demand • Increase of demand e.g. due to

extraordinary events (swine flu pandemic and Tamiflu)

• Exportation to other countries • Distribution and storage problems

Source: IMS Health (2015): Best Practice Ansätze bei Arzneimittelengpässen im internationalen Vergleich

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On a national level, countries already use different measures to ensure availability of drugs

Close collaboration between manufacturer and regulatory agencies

Multi-Stakeholder approach ()

Establishment of central database (obligatory/ voluntary)

List of essential medicines ()

Obligatory minimum stocks

Faster approval of products and production facilities

Import regulations

Obligatory notification of out-of-trade actions for approved drugs

Price adaption of shortage products Source: IMS Health (2015): Best Practice Ansätze bei Arzneimittelengpässen im internationalen Vergleich


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1) Collaboration • Close interaction between

manufacturers and regulatory agencies

2) Multi-stakeholder approach • Coordination of actions between all

stakeholders 3) Differential pricing

• Differential pricing allows taking into account that the various EU countries have different abilities to pay

4) List of essential medicines • Defines which medicines need to be

available at any time and any place 5) Central database

• Increases transparency about shortages and availabilities

6) Minimum stock • Allows to balance erratic demands

like flue epidemics


We identified six measures which are likely to improve availability and thus access to drugs

Increased availability

Central database

Collaboration

Multi-stakeholder

approach

Differential pricing

1

2

3 4

5

Minimum Stock

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List of essential

medicines

Source: IMS Health (2015): Best Practice Ansätze bei Arzneimittelengpässen im internationalen Vergleich

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Please contact me for more information:

Dr. Frank Wartenberg President, Central Europe Telefon: 069/6604-4315 [email protected]

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