MAP present at major conferences such as ISPOR as well as publishing our own view points on particularly hot topics. See our publications, presentations and papers here with many more presentations available within our website.
The Life Sciences Industrial Strategy
The Life Sciences Industrial Strategy was published on 31st August. The report, written by life sciences champion, Professor Sir John Bell, provides recommendations to the Government on the long-term success of the life sciences sector from an industry perspective. The strategy has been developed in collaboration with industry, academia, charity, and research organisations.
The report acknowledges that the life sciences industry represents one of the dominant economic sectors in the UK and includes biopharmaceuticals, medical technology, genomics, diagnostics and digital health and has a very high productivity compared to other sectors. The industry generates a wide range of products including drugs, medical technology, diagnostics and digital tools, as well as products for consumer health. The industry is widely distributed geographically and brings growth and jobs to almost every region of the UK.
Predicting Life Expectancy for Pirfenidone in Idiopathic Pulmonary Fibrosis
Conducting an adequately powered survival study in idiopathic pulmonary fibrosis (IPF) is challenging due to the rare nature of the disease and the need for extended follow-up.
This aim of this analysis was to predict life expectancy for patients with IPF receiving pirfenidone versus best supportive care (BSC) in a population that met the inclusion criteria of patients enrolled in the ASCEND and CAPACITY trials.
Changes to access to medicines in Scotland
In January 2016, the Scottish Government asked Dr Brian Montgomery to take forward an independent review of the assessment of new medicines in Scotland. He was asked to consider the impact of changes to the Scottish Medicines Consortium (SMC) process for assessing medicines in 2014 and the wider system for patient access to newly licensed medicines.
The report was published on Wednesday 14th December 2016 and MAP's briefing provides further detail on the proposed changes and their potential impact.
The consequences of Brexit in Spain - a life sciences perspective
MAP BioPharma Limited (MAP) political and industry experts have developed this article to help the Spanish life sciences industry assess the consequences, threats and opportunities that may arise following the vote.
ISPOR 2016 - Vienna: Review of Health Technology Assessment Requirements for Rare Diseases Across European Countries
Rare diseases have become an important area of focus over the past decade due to the number of untreated rare conditions. The objective of this research was to review Health Technology Assessment (HTA) requirements currently in place for the reimbursement of rare diseases in 18 European countries, and to identify and compare differences between their approaches.
ISPOR 2016 - Vienna: Review of the Recommendation made by NICE and SMC Relating to Treatments for Rare Diseases
There are currently differences in the way that the NICE and SMC process treatments for rare diseases. Given the current and proposed differences in process for treatments for rare diseases, the objective of this research was to review all recommendations made by NICE and SMC for treatments of rare diseases to evaluate whether one is more favourable.
ISPOR 2016 - Vienna: Review of National Policies for Rare Diseases Across EU Countries
In 2009 the European Commission (EC) released recommendations on actions in the field of rare diseases. The objective of this research was to review the policies in place for rare diseases before the EC recommendations, and evaluate levels of achievement of the policies in meeting the EC recommendations, in particular, focusing on EU collaborative research, neonatal screening and the number of rare disease registries per country.
ISPOR 2016 - Vienna: Predicting Orphan Designation and Marketing Authorisation Based on a Review of the European Medicines Agency Orphan Disease Register
Current projections of European and worldwide expenditure on orphan drugs are contrasting. The aim of this research was to identify trends in the orphan drug designations (ODDs) and marketing authorisations (MAs) awarded by the European Medicines Agency (EMA) following the introduction of the EU Regulation on orphan medicinal products in 2000.
ISPOR 2016 - Vienna: A Systematic Literature Review of Health Economics Evaluations of Treatments for Rare Diseases
A systematic literature review (SLR) was conducted to critically appraise the methodological approaches frequently taken when developing health economic evaluations of treatments for rare diseases, and to assess the potential impact of data scarcity.
Brexit and the Life Sciences Sector
MAP gave a presentation at EMIG on the implications on the life sciences industry if Britain were to leave the EU which you can download here: Brexit and the life sciences sector by Chris Mockler and Madeleine Bullen.
The Patient Handbook: a Practical Guide for Research and Drug Development by Anthony Hall et al
This is meant to be a guide for patient and advocacy groups but we at MAP BioPharma think that it would be a valuable read for anyone in, or interested in, the health sector. MAP’s contribution is chapter 13.
ISPOR 2015 - Milan: The UK Pharmaceutical Price Regulation Scheme (PPRS)
The UK Pharmaceutical Price Regulation Scheme (PPRS) – Considerations of voluntary versus statutory regulations and how to negotiate pricing.
ISPOR 2015 - Milan: The Cancer Drugs Fund
The Cancer Drugs Fund in England – undermining NICE or efficient and good value for money?
ISPOR 2015 - Milan: Vaccines
Steering vaccines through the UK system – what factors influence the likelihood of positive and negative recommendations?
ISPOR 2015 - Milan: CE Marking
What is CE marking? How technologies are classified, and how to navigate the system.
EU and US Pricing and Reimbursement for Innovative Medicines
In both the EU and the US, there is an increasing focus on showing value for innovative medicines. While the mechanisms differ, this demand stems from the same developments – decreasing funds available to payers and increasing prices of innovative medicines. The payers’ responses are similar as well: proposals to limit prices and restrict availability and requiring proof of value of the innovative medicine before there will be an agreement to pay for it at any level.
Enforceability of NICE Guidance and Guidelines
Ranson. P, Hill. C. Enforceability Of Nice Guidance And Guidelines, British Society of Law Review 2015 (14) 5 182-184.
American Thoracic Society 2015
Disease-progression modeling in idiopathic pulmonary fibrosis: a prediction of time to disease progression and life expectancy with pirfenidone.
ISPOR 2015 - Philadelphia: NICE topic selection
How are topics selected and prioritised by NICE and what might be the options if a technology is not selected?
ISPOR 2015 - Philadelphia: G-BA trend analysis in Germany
Trend analysis of G-BA decisions what factors influence the likelihood of recommendations?
Ispor 2015 - Philadelphia: Implementation of NICE Guidelines
Implementation of NICE clinical guidelines and lessons learned from European cases on how to ensure that health services do not fall short of their obligations.
Ispor 2015 - Philadelphia: HTA trends in the UK and Germany
Trends in HTA recommendations from the UK and Germany. A comparison of G-BA, SMC and NICE single technology appraisal decisions.
Ispor 2015 - Philadelphia: Cost minimization is an option in HTA submissions
Trends in the use of cost-minimization analysis in economic assessments submitted to the SMC.
Ispor 2015 - Philadelphia: SME preparedness for market entry
How does a small or medium sized pharmaceutical company prepare for and navigate the Scottish market?
Ispor 2015 - Philadelphia: NICE technology appraisals – Trends
Trend analysis of technology appraisal decisions from the NICE what factors influence the likelihood of recommendations?
Ispor 2015 - Philadelphia: EU flat pricing and transparency rules
Will flat EU pricing become a reality? Considerations for the BioPharma industry and whether future EU pricing transparency rules will affect the current position.
Ispor 2015 - Philadelphia: SMC decisions – Trends
Trend analysis of SMC decisions what factors influence the likelihood of positive, restricted and negative recommendations?
Ispor 2015 - Philadelphia: SMC changes and access to Orphans
Have changes to the SMC process following the Routledge Review really improved access to orphan medications and what factors influence recommendations?
Connectivity in the Life Sciences and Healthcare Sectors: Fast-tracking BioPharma innovation to patients in Europe
Connectivity in the Life Sciences and Healthcare Sectors: Fast-tracking BioPharma innovation to patients in Europe.
The UK Pharmaceutical Price Regulation Scheme (PPRS) and the Statutory Regulations
An Overview and Outline of How the Schemes May Impact the Life Sciences Industry. Bio-Science Law Review. Vol 13 Issue 6 BSLR : Case Comments (June 2014).