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Improving the access to Essential Medicines Dr Rino Coladangelo MB BS MRCP CEO Rephine Ltd PowerPoint Presentation
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Improving the access to Essential Medicines Dr Rino Coladangelo MB BS MRCP CEO Rephine Ltd. Rephine Ltd Founded in 1998 UK headquarters Staffed by leading experts in pharmaceutical manufacture Rephine provides : Pharmaceutical manufacturing consultancy worldwide

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Improving the access to Essential Medicines

Dr Rino Coladangelo MB BS MRCP

CEO

Rephine Ltd

Improving the access to essential Medicines Bucharest 2012

slide2

Rephine Ltd

  • Founded in 1998
  • UK headquarters
  • Staffed by leading experts in pharmaceutical manufacture
  • Rephine provides:
  • Pharmaceutical manufacturing consultancy worldwide
  • GMP audits of pharmaceutical suppliers and manufacturers
  • Supplier evaluation

Improving the access to essential Medicines Bucharest 2012

agenda
Improving the access to Essential Medicines

15 minutes!

Which medicines are essential

How to fund them

How to obtain them

Agenda

Improving the access to essential Medicines Bucharest 2012

which medicines are essential
What is an essential medicine?

All medicines available for all patients – impractical

Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. (WHO 2002)

WHO list of essential drugs

About 350 drugs on list

Romania list of approved reimbursable drugs

About 5,000 items on list

UK list of drugs and preparations 22,000 items

US FDA national drug code list 49,096 items

Which medicines are essential

Improving the access to essential Medicines Bucharest 2012

costs of branded drugs in the uk and romania
Costs of Branded drugs in the UK and Romania

Improving the access to essential Medicines Bucharest 2012

drug costs brand versus generic
Drug costs: Brand versus Generic

Improving the access to essential Medicines Bucharest 2012

drug costs branded generic versus generic example lisinopril 10mg tablet
Drug costs: Branded Generic versus Genericexample: Lisinopril 10mg tablet

Improving the access to essential Medicines Bucharest 2012

cost conclusions
Costs agreed for Branded drugs in Romania are good compared to UK

Shift from Branded to generic drugs will reduce unit costs significantly

Reduction of use of branded generics will reduce unit costs and level of co-payments

Exclusion of certain drugs from approved list will reduce total costs

Cost conclusions

Improving the access to essential Medicines Bucharest 2012

obtain supplies of essential medicines
Branded product prices are negotiated and are at similar levels to other countries in EU

There are rarely any stock issues of medicines availability

For generic drugs, the current position is that there are multiple suppliers of the same product, many foreign multinational companies and local Romanian producers

Obtain supplies of essential medicines

Improving the access to essential Medicines Bucharest 2012

the way forward
Most important step is to introduce a method of evaluation of drugs for cost-effectivenessThe way forward

Improving the access to essential Medicines Bucharest 2012

top ten romanian medicines by value 2011
Top ten Romanian medicines by value; 2011

Improving the access to essential Medicines Bucharest 2012

top ten romanian drugs 2011
Top ten Romanian drugs 2011

Improving the access to essential Medicines Bucharest 2012

evaluation of medicines for cost effectiveness
Licensing authorities, eg EMA, FDA only concerned with drug safety and efficacy. No interest in cost or comparability to similar products.

Individual country evaluation is necessary of each product

The process is long and can be difficult

Romania can use examples of evaluations from other countries

Evaluation of medicines for cost effectiveness

Improving the access to essential Medicines Bucharest 2012

the way forward1
Most important step is to introduce a method of evaluation of drugs for cost-effectiveness

Educate physicians and patients regarding generic versus branded products

The way forward

Improving the access to essential Medicines Bucharest 2012

education information
Physicians need to have the best information possible in any easily accessible format, and kept updated.

Educate patients via appropriate channels: TV, radio, newspapers, internet….

Make the generic versions of drugs attractive to the public and the prescribers

Education / Information

Improving the access to essential Medicines Bucharest 2012

the way forward2
Most important step is to introduce a method of evaluation of drugs for cost-effectiveness

Educate physicians and patients regarding generic versus branded products

Funding issues to be addressed by a combination approach

The way forward

Improving the access to essential Medicines Bucharest 2012

funding the medicines
Funds are limited so controls need be applied

Controls on supply

Reimbursement list (eg top 200 drugs =50%spend in uk)

Tariff

Costs

Manufacture quality of products; anti counterfeiting

Stocks

Control of demand

Physician information

Patient Education

Funding the Medicines

Improving the access to essential Medicines Bucharest 2012

the way forward3
Most important step is to introduce a method of evaluation of drugs for cost-effectiveness

Educate physicians and patients regarding generic versus branded products

Funding issues to be addressed by a combination approach

Seek to encourage local manufacture of medicines

The way forward

Improving the access to essential Medicines Bucharest 2012

local manufacture
Romania has a good pharmaceutical manufacturing capability; EU quality standards are being met

The biggest producer is a subsidiary of an Indian company

A lot of competition of supply from external manufacturers

Devise ways of facilitating local supply

Local manufacture

Improving the access to essential Medicines Bucharest 2012

principal messages
Develop local definition of what are essential medicines in Romania by cost effectiveness review of medicines.

Costs of individual medicines can be reduced by switch to generic, renegotiation of tariff prices, and local manufacture

Education / information of physicians and patients is integral to success

Principal messages

Improving the access to essential Medicines Bucharest 2012

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Improving the access to Essential Medicines

Bucharest 2012

Rino Coladangelo

rcc@rephine.com

Improving the access to essential Medicines Bucharest 2012

costs of certain drugs in the uk and romania 100 reimbursed
Costs of certain drugs in the UK and Romania(100% reimbursed)

Improving the access to essential Medicines Bucharest 2012