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| NHS to save 'hundreds of millions' in landmark drug ruling in England | NHS to save 'hundreds of millions' in landmark drug ruling in England |
| (3 days later) | |
| A landmark ruling against two leading drug companies could save the NHS in England "hundreds of millions" a year. | A landmark ruling against two leading drug companies could save the NHS in England "hundreds of millions" a year. |
| Novartis and Bayer were trying to stop NHS doctors from prescribing a cheaper treatment for a serious eye condition. | Novartis and Bayer were trying to stop NHS doctors from prescribing a cheaper treatment for a serious eye condition. |
| Health bosses said the judgement in the High Court may reduce the power of companies to set prices. | Health bosses said the judgement in the High Court may reduce the power of companies to set prices. |
| Drug company Novartis said they were "disappointed" because patients were being asked to accept an unlicensed treatment to save the NHS money. | Drug company Novartis said they were "disappointed" because patients were being asked to accept an unlicensed treatment to save the NHS money. |
| The case centred on the treatment of patients with the common eye condition, wet age-related macular degeneration (AMD). | The case centred on the treatment of patients with the common eye condition, wet age-related macular degeneration (AMD). |
| Twelve NHS bodies in the north east of England were offering these patients Avastin, a cheaper alternative to the licensed drug, Lucentis. | Twelve NHS bodies in the north east of England were offering these patients Avastin, a cheaper alternative to the licensed drug, Lucentis. |
| David Hambleton, chief executive officer of NHS South Tyneside clinical commissioning group (CCG), one of the NHS groups involved in the case, welcomed the judgment, saying it was a good day for patients and the NHS. | David Hambleton, chief executive officer of NHS South Tyneside clinical commissioning group (CCG), one of the NHS groups involved in the case, welcomed the judgment, saying it was a good day for patients and the NHS. |
| "We've always said we think that it's important that patients should have the choice of a very effective treatment for wet AMD, and it's actually a fraction of the cost of the other alternatives. | "We've always said we think that it's important that patients should have the choice of a very effective treatment for wet AMD, and it's actually a fraction of the cost of the other alternatives. |
| "So I think what we do now is offer patients that choice. We believe that they will support very strongly having a cost-effective, safe treatment and saving the NHS generally a lot of money. It is a victory for common sense over commercial interests." | "So I think what we do now is offer patients that choice. We believe that they will support very strongly having a cost-effective, safe treatment and saving the NHS generally a lot of money. It is a victory for common sense over commercial interests." |
| What was the dispute? | What was the dispute? |
| The case was brought by pharmaceutical giants Bayer and Novartis against twelve NHS CCGs in the north of England. | The case was brought by pharmaceutical giants Bayer and Novartis against twelve NHS CCGs in the north of England. |
| The NHS groups were offering patients a choice between Lucentis and Eylea - drugs licensed for eye treatment - and the far cheaper drug Avastin, which is recommended by the World Health Organisation (WHO) for treating eyes, but only licensed for cancer treatment in the UK. | The NHS groups were offering patients a choice between Lucentis and Eylea - drugs licensed for eye treatment - and the far cheaper drug Avastin, which is recommended by the World Health Organisation (WHO) for treating eyes, but only licensed for cancer treatment in the UK. |
| Novartis and Bayer manufacture the two more expensive licensed drugs - Lucentis which costs £561 and Eylea which costs £800. | Novartis and Bayer manufacture the two more expensive licensed drugs - Lucentis which costs £561 and Eylea which costs £800. |
| By comparison, Avastin costs about £28 per injection. | By comparison, Avastin costs about £28 per injection. |
| Avastin is widely used around the world, particularly in the US. | Avastin is widely used around the world, particularly in the US. |
| In January, the National Institute for Health and Care Excellence (NICE) concluded that Avastin was as safe and effective as the two licensed drugs, Lucentis and Eylea. | In January, the National Institute for Health and Care Excellence (NICE) concluded that Avastin was as safe and effective as the two licensed drugs, Lucentis and Eylea. |
| What was the reaction? | What was the reaction? |
| Mike Burdon, President of the Royal College of Ophthalmologists said: "Licensing laws are designed to protect patients from poorly regulated unproven drugs, but it is the drug companies' responsibility to apply for a licence. | |
| "We are treating 40,000 new diagnoses of wet AMD annually - the saving could amount to £500m a year. This amounts to one district hospital being built annually." | "We are treating 40,000 new diagnoses of wet AMD annually - the saving could amount to £500m a year. This amounts to one district hospital being built annually." |
| What is AMD? | What is AMD? |
| David Hambleton, of NHS South Tyneside CCG, said the ruling would result in a rethink for NICE and the MHRA, the UK's drug regulatory body. | David Hambleton, of NHS South Tyneside CCG, said the ruling would result in a rethink for NICE and the MHRA, the UK's drug regulatory body. |
| "I think at least we've got some real legal clarity now, so both of the bodies - NICE and the MHRA - will need need to look at what their guidance says. | "I think at least we've got some real legal clarity now, so both of the bodies - NICE and the MHRA - will need need to look at what their guidance says. |
| "Now they have the option of allowing the use of so-called 'off-label' drugs." | "Now they have the option of allowing the use of so-called 'off-label' drugs." |
| Responding to the ruling, a spokesperson from pharmaceutical company Novartis said: "Novartis is deeply disappointed in this decision and remains of the opinion that the policy undermines the well-established legal and regulatory framework that is there to protect both patients' safety and to ensure health care professionals can prescribe with confidence." | Responding to the ruling, a spokesperson from pharmaceutical company Novartis said: "Novartis is deeply disappointed in this decision and remains of the opinion that the policy undermines the well-established legal and regulatory framework that is there to protect both patients' safety and to ensure health care professionals can prescribe with confidence." |
| Dr Sheuli Porkess, Deputy Chief Scientific Advisor to The Association of the British Pharmaceutical Industry (ABPI) said: | Dr Sheuli Porkess, Deputy Chief Scientific Advisor to The Association of the British Pharmaceutical Industry (ABPI) said: |
| "This extraordinary judgement potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust." | "This extraordinary judgement potentially undermines the regulation of all medicines and by doing that, neither patients nor doctors have clarity on what information to trust." |