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Scotland's cost effectiveness body to be more flexible in end-of-life and orphan diseases


Scotland's government has announced its cost effectiveness body is to change the way it assesses new medicines, introducing a more flexible approach when evaluating drugs for end-of-life care and orphan diseases.

In a package of measures announced on Tuesday, and debated on Wednesday in the Scottish Parliament, health secretary Alex Neil said the Scottish Medicines Consortium (SMC) will also seek patient access schemes with pharma early in the approval process if cost-effectiveness appears to be an issue.


The measures are designed to ensure Scotland's drug approval system becomes more transparent and increases access to drugs for end of life care and orphan conditions, according to documents and ministerial comment.


In a Scottish Government statement, published on Tuesday, Neil - a member of the Scottish National Party - said he had asked the SMC to conclude a review by Christmas to establish "more flexible approaches in evaluating medicines for end of life care and treating very rare conditions to increase access to new medicines for Scottish patients."


Additional steps highlighted in the statement include:


      Extending a 20 million pound (24 million euros) rare medicines drug fund until 2016;


      Improving patient support for engaging in the medicines approval process;


      Creating a peer approval system allowing clinicians to prescribe medicines not accepted for routine use by the SMC, replacing the existing Individual Patient Treatment Requests (IPTRs)


      The opportunity for the SMC to appraise new medicines not yet submitted for cost-effectiveness testing by a pharma company but considered clinically important to NHS Scotland.


Providing further details in a debate on Wednesday, Neil said companies will be granted meetings before the SMC's approval process begins "to ensure ... companies understand the process and get the best possible chance to submit high quality evidence first time."


If cost-effectiveness looks likely to prove a stumbling block as the process continues, companies and representatives of the SMC will attempt to agree on a confidential patient access scheme during a pause in the process, said Neil.


Representatives of pharma companies will also be encouraged to attend public meetings as the SMC makes its cost-effectiveness deliberations, according to Neil.


"I want to ensure that the SMC is as transparent as possible," said Neil.


The changes follow a report by Scotland's Health and Sport Committee, on access to rare medicines, which was highly critical of the existing system in Scotland.


Speaking in the Wednesday debate, Duncan McNeil, Labour MSP for Greenock and Inverclyde described the quality adjusted life year (QALY) as a "brutal and hard" route for calculating a drug's value.


"It is crucial we ask the SMC to review how thresholds (maximum acceptable cost per QALY) are applied," he said.


He added that the committee had rejected using a cancer drugs fund, favoured in England, for drugs rejected on cost effectiveness grounds by NICE.


"Cancer medicines should not be singled out in comparison with other medicines. We do not consider a cancer drugs fund as a Scottish answer," he said.


Neil Findlay, Labour MSP for Lothian added in the debate that the system for access to rare medicines in Scotland is "at best confusing and at the worst, unfair."



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