Remap Perspective

PMA Perspectives July 2014


Welcome to the second newsletter from Remap Consulting. In this quarterly newsletter, we will be sharing our perspectives on the latest news, developments and thinking within the pricing and market access field. 

This issue focuses on the recent introduction of cost effectiveness data in France, interesting pricing and reimbursement articles that caught our eye and the current situation in the UK. Follow us on Twitter @remapconsulting for the latest info.

We always welcome feedback, so if you have any suggestions for us, news or articles to share, do contact us: Please let us know if you would like to be part of a PMA network that proactively reacts and comments on news in the PMA field and we will ensure to share the insights for your thoughts, prior to the next newsletter. Also, if you do not wish to receive this newsletter either unsubscribe using the link below or email us.

Paul Craddy & Virginie Lavaud
Managing Directors & Founders – Remap Consulting

Cost effectiveness data requirements and implications for France

Since October 2013, the Transparency Committee (CT) can request medico-economic assessments of drugs. The purpose of these assessments is to ensure proportional incremental effectiveness and costs of new therapies, as well as an aid to managing budgets. The good news is that these medico-economic assessments will only cover:

  • Drugs or medical devices
  • with an ASMR I to III (claimed by company)
  • With significant impact on healthcare expenses (>€20 million/year)

These criteria means that the assessments will apply to less than 20% of products (in 2012, only 15 products out of 80 achieve ASMR I – III).
The assessment will be done by the Economic and Public Health Evaluation Committee (CEESP) and in parallel to the CT assessment. It will utilise data provided by the company to compare the expected or observed efficiency of the new intervention in comparison to existing drugs or technologies. It will consider cost and comparative effectiveness and incremental cost effectiveness ratio (ICER) €/QALY at different price levels. However, there is no predefined ICER threshold. The assessment will be provided to the pricing committee (CEPS) to help inform their decision making.
The data presented by the CEESP in their final report is expected to contain either:
If negative (i.e. the cost effective analysis does not comply with the HAS guidelines)

  • Efficiency of the technology is not demonstrated
  • Major limitations of the analysis are highlighted
  • No ICER will be provided

If positive (i.e. the cost effective analysis does comply with the HAS guidelines)

  • Efficiency of the technology is demonstrated
  • ICERs will be presented at different price thresholds (but without a reference threshold)
  • Methodological limitations of the analysis are discussed, as well as uncertainties over the quantitative results and parameters

Products currently being considered for medico-economic assessments include Defibrotide, Panitumumab, Trastuzumab emtansine and Sofosbuvir.
The implications are, that for the most innovative drugs, the HAS is now expecting the drugs to prove their value on numerous economic endpoints against current products, in addition to the clinical endpoints currently required by the CT. The aim is to only pay for innovation that delivers significant clinical and economic benefit to patients above the current therapies. Future changes still being discussed include changing the P&R system into an ITR (relative therapeutic interest) system, but no timelines have yet been set.

Recommended articles that caught our attention

These excellent articles caught our attention at Remap Consulting:

  1. Discounted pricing in Germany: Germany has passed a law forcing Pharma to reveal their discounted prices, which could have a significant impact on international price referencing:
  2. High cost of Kalydeco & Zaltrap: Excellent article on the challenges of high drug prices and the market access issues facing Kalydeco (cystic fibrosis) and Zaltrap (colorectal cancer): 
  3. Comparison of medical device & pharmaceutical pathways: Insightful article comparing and contrasting the pharmaceutical and medical device approval pathways:

The UK – Value based assessment, PPRS & NICE 

The UK has had several proposed changes to its pricing system. Here is the current situation:

  • A new PPRS has been in place since 1st Jan 2014, which covers the majority of marketed pharmaceutical products
  • Value based pricing will not occur, but NICE will expand its remit to conducted value based assessments. These will include incorporating burden of illness and wider societal impact into technology assessments
  • Value based assessment will start from Autumn 2014 and only apply to new technologies

Some of the earlier, more radical, proposals have not materialised, so these changes represent minor changes, rather than a major system overhaul.

About Remap Consulting

Remap Consulting is focused on improving  pricing, reimbursement and market access outcomes. We are specialists in: 

  1. Developing and implementing pricing and market access strategies
  2. Enhancing organisational market access effectiveness
  3. Pricing & reimbursement training solutions
  4. Interim project management solutions

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