[Ip-health] Firms fight move to obtain cheap anti-blindness drug Avastin

Riaz K Tayob riaz.tayob at gmail.com
Mon Jan 3 01:46:47 PST 2011

[If this were a developing country... ]

  Firms fight move to obtain cheap anti-blindness drug Avastin

Nice moves towards official appraisal of drug to prevent a cause of 
blindness, for which makers will not seek a licence

    * Sarah Boseley <http://www.guardian.co.uk/profile/sarahboseley>,
      health editor
    * guardian.co.uk <http://www.guardian.co.uk>, Sunday 2 January 2011
      19.07 GMT
    * Article history
      A selection of drugs placed on a shelf. The National Institute for
      Health and Clinical Excellence is moving towards an offical
      appraisal of Avastin which has been used to prevent the leading
      cause of blindness. Photograph: Ben Birchall/PA Archive/PA Photos

      The NHS <http://www.guardian.co.uk/society/nhs> has moved a step
      closer to obtaining a cheap drug to prevent the leading cause of
      blindness, in spite of attempts by drug companies to block it.

      The National Institute for Health and Clinical Excellence (Nice),
      which decides which drugs
      <http://www.guardian.co.uk/science/drugs> may be prescribed on the
      NHS, has decided to move towards an official appraisal of a drug,
      Avastin, that has been widely and cheaply used to prevent wet
      age-related macular degeneration -- even though the drug companies
      that make and market it refuse to seek a licence. They have a
      licensed version which is many times more expensive.

      Avastin is licensed for bowel cancer, but ophthalmologists in the
      US discovered that -- split into tiny doses suitable for injection
      into the eye -- it could halt and even reverse the progress of wet
      AMD, which is the commonest cause of blindness. Eye specialists
      around the world have been using Avastin in this way, because
      splitting a vial into many tiny doses makes it relatively cheap.

      But the manufacturer, Genentech, and the Swiss drugs company
      Roche, which markets Avastin in Britain, have fought this use.
      Genentech has produced and licensed a very similar but far more
      costly version, which it calls Lucentis, and which has been
      approved by Nice for the NHS.

      The Royal Liverpool and Broadgreen University Hospitals pharmacy,
      which has been producing Avastin for eyes, charges £50 a dose.
      Mass production could bring the cost still lower. Lucentis costs
      around £750 a dose.

      The treatment involves one injection a month for three months, and
      more if the patient's sight continues to deteriorate. Because of
      Nice's concerns over the cost, Novartis, which markets Lucentis
      here, agreed to pay for any patient who needed more than 14
      injections of that drug. But with 20,000 people diagnosed with wet
      AMD every year in Britain, the bill is high.

      Nice rarely appraises unlicensed drugs, but has decided that it
      will do so with Avastin for eyes, subject to help from the
      licensing authority with assessing safety and quality. It now
      needs the go-ahead from the Department of Health.

      The decision will not be welcomed by the drug companies. Roche,
      which has bought Genentech, said it had decided not to apply for a
      licence for eyes "due to corporate considerations" and had no
      plans to reconsider that decision. The drug companies warned Nice
      that the safety of Avastin in eyes could not be properly monitored
      without their involvement -- and they were not willing to help.
      "As a consequence, these stakeholders suggested that an appraisal
      would not be appropriate."

      The Royal National Institute of Blind People, which receives
      funding from the companies, also opposed the appraisal, arguing --
      as the companies did -- that there was not enough evidence of
      Avastin's safety and there will not be unless the licence-granting
      bodies look at it. Nice's role, it said in its submission, "is to
      assess the efficacy and cost-effectiveness of new drugs in
      relation to existing treatments or best supportive care. Any
      attempt to change this 'division of labour' requires changes to
      the regulatory system and therefore political decisions that go
      far beyond this exploratory work."

      But in a cash-strapped NHS, there are already primary care trusts
      that have voted with their feet. Stockport PCT offers Avastin to
      patients at a private hospital, or Lucentis at an NHS hospital
      which has a waiting list of four to five weeks. Patients are given
      very detailed information about both drugs, but usually opt for
      Avastin. Stockport PCT estimates it will have 200 new patients
      every year who could benefit from the drugs. It would cost £1m
      more a year to treat them with Lucentis rather than Avastin, it says.

      Bury PCT was using Avastin before Lucentis got Nice approval but
      is going back to Avastin, adopting the Stockport model. Peter
      Elton, public health director at Bury, says there is potentially
      an even bigger issue at stake. The licensing laws at the moment
      favour the drug companies. But approval for an unlicensed use of
      Avastin could open the door for other drugs to be appraised and
      used in the NHS, especially for "orphan" conditions -- where the
      small number of sufferers does not make it commercially worthwhile
      for a drug company to conduct the trials necessary to get a licence.

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