Highlights from the 2014 Pharma Pricing & Market Access Outlook Conference in London

by Patricia Ladrón de Guevara

UK – Update on VBP

Paul Catchpole announced that the Value Base Pricing implementation has been delayed until late 2014.

It was announced that the VBP scheme is going to include an annual cap on economic growth of each medicine. If the pharmaceutical company exceeds the growth agreed, a rebate of the amount exceed will have to be paid back – this amount will be visible to the public!

Referring to NICE, it was said that NICE will be a body to evaluate reimbursement not pricing. It was explained that NICE will not negotiate, publicly set or indicate prices.  The threshold will remain at the same level. NICE will evaluate Value Based Assessments from autumn 2014.

Germany – AMNOG Analysis

Dr. Meriem Bouslouk gave a rundown of recent news on the AMNOG situation expressing that the market launch and early benefit assessment run in parallel with AMNOG. The mandatory rebate of 16% was reduced to 6% the 1st of January of 2014 and will be increased to 7% the 1st of April pf 2014.

France – Medico-Economic Assessment

Professor Jean–Luc Harousseau talked about the pricing process in France.

It was explained that the drugs in France are priced in accordance to the ASMR classification. If the drug is classified in class ASMR I and II: the price will be based on IPR If the drug is classified in class ASMR III and IV: the price approved will be similar to the comparator. If the drug is classified in class ASMR V: the price approved will be cheaper than the comparator and the product will not be reimbursed.

Netherlands – Temporary Reimbursement

Martin van der Graff introduced a very important concept to bear in mind in Netherlands when launching a product in Netherlands, Temporary Reimbursement. It was explained that if you achieve all the criteria for temporary reimbursement in Netherlands, you can launch the product and negotiate the price afterwards.

Italy – Algorithm to Define Innovation

Dr Giovanni Tafuri explained the changes introduced in the evaluation system in Italy.

It was announced that currently in Italy, there is a possibility of quick access ie launch the product before starting the reimbursement process with free pricing.

There are 3 groups of medicines with a faster negotiation process: orphan drugs, hospital only use medicines and medicines of great therapeutic and social relevance.

One very important feature to highlight about the Italian System is that Dr Giovanni talked about the development of an algorithm to define innovation which is due to be completed in 2015.

Canada – Attractive Pharmaceutical Market

Neil Palmer showed the market figures for the healthcare system in Canada.

It was explained the Patented Medicine Prices Review Board (PMPRB) role: the primarily role of this board is price fixing but is not involved in reimbursement decisions. The classification system is similar to the ASMR rating in France. Also, although price setting is a central decision, reimbursement is solely decided at provincial level.

An IMPORTANT NOTE about the future – Canada is considering extending the basket of reference countries (consult Pricentric for more information)

Greece – Reactivated the Approval of New Drugs

Penny Retsa recalled to the audience that Greece has not approved new drugs in the last 2 years. However, she announced that the Ministry of Health in Greece has reactivated the approval of new drugs from the beginning of 2014.

She highlighted that in the price bulletin that has just been published there are new drug approvals for the first time in 2 years.

The Conclusions of the Conference were:

Due to the limited healthcare resources across the countries, Governments are trying to establish new legislations and rules to ensure that the resources are allocated to the most cost-effective treatment. This is resulting in ever-changing price and reimbursement legislation. For further information contact Patricia at: pricentric@alscg.com

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