Decisions to fund treatments outside their licensed indication are being left to local discretion, a Conservative peer has claimed. Skip related content
Earl Howe, an opposition health spokesman, expressed his concerns during last week's debate on primary care trusts and the off-label use of medicines in near-label conditions.
"My Lords, I am raising an issue which to the casual reader of the order paper may look rather abstruse but which is in fact the very opposite; and it is an issue which has far-reaching implications both for patients and for the NHS," he said.
"Medicines are used off label when they are not licensed for the particular indication to which they are applied."
Earl Howe said many cancers, "particularly some of the rarer cancers," are treated with a medicine used off label.
"There are also a number of less common auto-immune conditions for which the treatment is unlicensed," he added.
"Rituximab is licensed to treat rheumatoid arthritis, but doctors also use it to treat vasculitis, which is a disease affecting the blood vessels.
"Infliximab is licensed to treat Crohn's disease, ulcerative colitis and ankylosing spondylitis, among other conditions, but it is also prescribed off label for the treatment of Behcet's disease."
The National Institute for Health and Clinical Excellence (NICE) provides funding directions at a national level only for medicines used in their licensed indication, Earl Howe said.
"There can be no NICE guidance for a drug's off-label use, and hence no mandatory funding direction at national level.
"That inevitably means that decisions about the funding of treatments outside their licensed indication are left to local discretion."
And the unit cost for off-label treatments are often relatively high, leaving people suffering from cancer particularly rarer cancer vulnerable to funding decisions.
"For those who need off-label medicines, the postcode lottery is a stark reality, and health inequalities are accentuated," he argued.
Earl Howe expressed his concern at the "alarming findings" in the recent report published by the Rarer Cancers Forum.
The report highlighted that nearly a third of hospital trusts which responded to the audit said that they had "no protocol in place for off-label treatments".
He called for increased evidence about the uses of off-label medicines and their clinical outcomes.
And, a collaborative commissioning arrangement could combine the skills of hospital specialists and primary care trust (PCT) commissioners, he suggested.
Highlighting the issue of Lucentis versus Avastin in the treatment of age-related macular degeneration, Lord Kirkwood of Kirkhope (Lib Dem) argued that there are "perverse incentives for pharmaceutical companies within the licensing system".
He described indefensible" the variations of treatment across the health service.
The use of off-label treatments in rarer cancers presents a particular challenge, Baroness Thornton (Lab, Government Whip) acknowledged.
She stated that the NHS constitution includes the right to expect "rational PCT funding decisions on drugs".
The government has produced a set of public-facing principles to inform PCT decision-making, Baroness Thornton announced.
This will support the improvement of local processes.




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