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Hollow victories and hepatitis C

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i4170 (Published 28 July 2016) Cite this as: BMJ 2016;354:i4170
  1. Navjoyt Ladher, analysis editor, The BMJ
  1. nladher{at}bmj.com

When Gilead Sciences introduced sofosbuvir based antivirals in 2014, the drugs were touted as a breakthrough for people with hepatitis C infection, promising high cure rates and fewer complications such as cirrhosis and hepatocellular carcinoma. But with astronomical prices challenging healthcare budgets and limiting access to these drugs, this promise remains out of reach for many patients.

A joint investigation this week by The BMJ and researchers from the University of Cambridge and the University of Bath shows the effect that highly priced medicines are having on the NHS and reveals the discord between the National Institute for Health and Care Excellence (NICE) and NHS England over their approval (doi:10.1136/bmj.i4117).

NHS England, fresh from criticism over its decision not to fund drugs for HIV pre-exposure prophylaxis (doi:10.1136/bmj.i3515), comes in for renewed scrutiny over its actions around NICE’s approval of sofosbuvir based drugs. Rather than making the drugs widely available within the statutory 90 days after approval, the investigation outlines how NHS England deployed a range of delaying tactics to limit access in light of budget concerns.

The story raises questions about the struggle between NICE and NHS England to balance cost effectiveness with budget impact. But the bigger question, raised by Mariana Mazzucato in a linked editorial (doi:10.1136/bmj.i4136) is why these medicines are so expensive in the first place.

NHS England is under unprecedented financial pressure (doi:10.1136/bmj.i4083), and it is no surprise that it cites Gilead’s pricing as a key reason why access to treatment has been delayed. An investigation by the US Senate Committee on Finance concluded that Gilead’s pricing strategy was “designed to maximise revenue with little concern for access and affordability.”

In this week’s Analysis, Victor Roy and Lawrence King describe how companies such as Gilead are acquiring promising compounds developed by smaller companies, driving up the speculative costs of drug development (doi:10.1136/bmj.i3718). With Gilead’s $35bn (£27bn) in revenue far outstripping its investment in sofosbuvir, and with profits largely directed to shareholders instead of further research and development, the classic argument that high drug prices are justified by the cost of development is on shaky ground.

In an Analysis article in The BMJ last year Narcyz Ghinea and colleagues called on drug companies to set a fair and just price for new medicines (doi:10.1136/bmj.i1284), arguing that “the triumphs of pharmaceutical innovation are hollow victories if they cripple health systems and generate massive inequities.” While healthcare systems arguably have a responsibility for delivering treatments they deem cost effective, the onus must be on drug companies to ensure that these promising treatments amount to more than hollow victories.

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