Leela Barham

November 12,2015.

The new interim report on the UK's Accelerated Access Review, which aims to speed up access to innovation in the NHS, is lacking in detail, writes Leela Barham.

In the midst of a leadership vacuum at the European Medicines Agency, Pharm Exec talks with the organization’s top medical officer, Hans-Georg Eichler, about its potentially game-changing drug approval program-one designed to balance safety requirements with faster patient access to the strong science now emerging from industry labs.

October 06, 2015.

No-one can say England's Accelerated Access Review, which aims to “ensure that the UK is the fastest place in the world for the design, development and widespread adoption of medical innovations" isn't aiming high, writes Leela Barham.

Leela Barham looks at the implications of another round of cuts due to England’s Cancer Drugs Fund in November.

NICE's proposed Innovation Office emerges with a new name. Leela Barham reports.

Following the Conservatives surprise majority win in the UK election, Leela Barham asks what does it mean for pharma?

EUnetHTA has developed guidelines to help “set a general framework for EUnetHTA on how to conduct economic evaluations”, arguably HTA's most controversial element. Leela Barham reports.

Leela Barham looks at what the rival parties are promising for healthcare ahead of the UK General Election next month.

That the UK's NHS has struck a deal for a national roll-out of Bexsero, GSK's vaccine for Meningitis B in infants, is good, but it needs to do better, writes Leela Barham.

The debate around NICE's threshold for cost effectiveness has always been heated; recent theories add more fuel to the fire, writes Leela Barham.

The Cancer Drugs Fund (CDF) is a particular English approach to deal with rejections by the National Institute for Health and Care Excellence (NICE) for new cancer medicines.

NICE's David Haslam discusses the UK drug watchdog's new challenge in meeting expectations around what quantitative calculations of value mean to patient access today.

The UK’s Medicines and Healthcare Regulatory Authority (MHRA) has awarded Northwest Biotherapeutics, Inc. (Bethesda, MD) the very first “Promising Innovative Medicine”, or PIM designation, for the company’s DCVax-L product.

Value-based Pricing (VBP) was first discussed as far back as 2007 by the UK’s consumer authority, the now defunct Office of Fair Trading (OFT).

The English Cancer Drugs Fund (CDF), set up to provide funding for those products that the National Institute for Health and Care Excellence (NICE) has not recommended for use or where their guidance isn’t yet available, remains controversial.

Accessing the latest cancer drugs always seem to be controversial. Not just because of the money but also because of the complexities of accessing treatments during their development.

In the UK, Value-Based Pricing (VBP) has morphed into Value-Based Assessment (VBA), with the National Institute for Health and Care Excellence (NICE) tasked with taking the loose policy concepts (established as far back as 2010) and actually implementing them.

The Pharmaceutical Price Regulation Scheme (PPRS) is a long-standing scheme where the pharmaceutical industry, represented by the Association of the British Pharmaceutical Industry (ABPI), negotiates with the Department of Health (DH) to agree how to indirectly manage the price of branded medicines.

The incremental cost effectiveness ratio (ICER) – or the threshold for determining whether the costs of a new medicine are worth it – has been controversial since it’s inception.

Collaboration seems to be ‘in’ thing and it’s set to continue in Europe with the European Medicines Agency (EMA) and EUnetHTA agreeing a three-year joint work plan.

The European Commission mandated that all member states have a plan for rare diseases back in June 2009. With the EC deadline just weeks away, the UK has now finalized its own.

Long awaited details have been announced in the Heads of Agreement for the latest Pharmaceutical Price Regulation Scheme (PPRS). It’s worth a read in full (and you can find it here) but some highlights are set out here.

The National Institute for Health and Care Excellence (NICE) will have a vital role in the post 2014 value-based pricing (VBP) world. The Department of Health (DH), which still acts as the sponsor organization for the agency, has set out in more detail just what value assessment by NICE will need to do. Now NICE has to determine the methods and set up the governance and workable processes to deliver it.

A common gripe from those in the pharma industry in England is that even when their products have been found to be cost effective by the National Institute for Health and Care Excellence (NICE) (not always easy to do these days), uptake in the NHS can be ‘low and slow’

Value-based pricing (VBP) continues to confuse many in the UK and further afield. The Scottish Parliament’s Health and Sport Committee is the latest parliamentary committee to question civil servants about what it’s all about.

The UK’s Royal Pharmaceutical Society has joined forces with a number of other organizations, including the Association of the British Pharmaceutical Industry (ABPI), to issue new guidance on medicines optimization. Sir Bruce Keogh, Medical Director of NHS England, says it could be revolutionary.

You’d be forgiven for missing it with the vast array of new agencies and the policy documents, guidance, consultations and ‘engagement’ activity they’re doing on in the ‘new’ NHS in England, but on the 4th April NHS England (formerly the NHS Commissioning Board) set out 15 commissioning policies in 250 pages.

England’s Cancer Drugs Fund (CDF) could be in its final financial year, after running in full since April 2011. The fund covers the cost of cancer treatments either when NICE has said ‘no’, or hasn’t yet come to a view.