Shake-up of drugs approval system
Tuesday 8th October 2013, 12:11AM BST.
More patients could get the drugs they need on the NHS after a major shake-up of the way new treatments are approved was announced by the Health Secretary.
Alex Neil said a “comprehensive range of measures” would increase access to drugs as well as making the system more open to patients.
As part of that, the Scottish Medicines Consortium (SMC) – the body which approves new medicines for use by the NHS – has been ordered to look at how it can increase flexibility when considering what drugs can be prescribed to people with very rare conditions and terminal diseases.
This review is to be completed by the end of the year, with the aim of having new approaches in place early in 2014.
A special fund set up this year to cover the cost of medicines for individual patients with rare conditions, which are not available for routine prescription, is also being extended.
The Rare Medicines Drugs Fund had been due to finish in April next year but will now run until April 2016 – with up to £40 million being made available for this over the two years.
Investment of £1 million is being put in to make the work of the SMC more open and transparent.
Changes are also being made to the system for prescribing drugs that have not yet been approved by the SMC.
MSPs on Holyrood’s Health Committee had complained the existing Individual Patient Treatment Request (IPTR) scheme made it hard for patients, particularly those with rare conditions, to prove they are suffering from exceptional circumstances which would merit them being given the treatment.
Now, the Scottish Government is proposing a peer approval system, which will be led by local consultants, for when a clinician wants to prescribe a drug that has not been approved by the SMC.
The changes are said to be the first step in a process setting up a Scottish model, where a value-based system is used when assessing new medicines for use by the NHS.
They were announced just after the SMC decided a new breast cancer drug will not routinely be made available to patients north of the border on the NHS, but a new treatment for lung cancer can be prescribed.
Scotland has become the first part of the the UK to approve crizotinib, w hich could be an alternative to chemotherapy for some lung cancer patients, for use on the NHS.
But at the same time the SMC ruled that a new breast cancer drug Perjeta will not be recommended for use, with manufacturer Roche branding that decision an ”injustice for patients in Scotland”.
Mr Neil today said it was “only right that Scottish patients have access to medicines that are clinically justified”.
He said: ” We have listened carefully to patients, charities and consultants, and put in place a comprehensive range of measures which will increase access to new medicines and make the system better and more open for patients.
” The SMC has a pivotal role in ensuring that new medicines are thoroughly assessed for clinical effectiveness.
“However the Scottish Parliament Health and Sport Committee recognised that the existing assessments are not always appropriate for medicines for use at end of life or for medicines to treat very rare diseases.
“So, I’ve directed the SMC to conclude a review by the end of the year 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.
“I want Scotland to be able to make medicines available which represent value to patients and these changes are the first step towards this.”