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08/10/13 09:15

Improving access to new medicines

Drug approval process to be revamped.

Scottish patients will benefit from an increased range of new medicines due to changes announced today by the Health Secretary Alex Neil.

The package of measures will ensure that Scotland’s drug approval system becomes more transparent and increases access to medicines for end of life care and treating very rare conditions.

Mr Neil has directed the Scottish Medicines Consortium (SMC), the body which approves medicines for use in the NHS in Scotland, to apply different, more flexible, approaches in the evaluation for medicines for end of life care and treating very rare conditions.

Additional improvements include:

  • extension of the £20 million Rare Medicines Drug Fund to 2016
  • improved patient support for engaging in the medicines approval process
  • additional investment of £1 million to support SMC to make their work more transparent
  • creation of a new peer approval system to allow clinicians to prescribe medicines that are not accepted for routine use by the SMC – replacing Individual Patient Treatment Requests (IPTRs)
  • opportunity for the SMC to appraise new medicines which have not yet been submitted by a pharmaceutical company where these are considered clinically important to NHSScotland.

Mr Neil said:

“It is only right that Scottish patients have access to medicines that are clinically justified.

“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.”

Professor Angela Timoney, Chair of the Scottish Medicines Consortium, said:

“We share the Scottish Government’s objective of increasing access to new medicines for patients in Scotland. SMC fully supports patient access to clinically effective new medicines at a price that is fair for all. SMC are confident that we can play a key role in developing a future approach that truly reflects what people in Scotland value.”

Eric Low, Chief Executive of Myeloma UK said:

“I very much welcome the announcement from the Cabinet Secretary of a package of initiatives to improve access to new medicines in Scotland.

“I am very encouraged that the SMC will be given additional resources and a revised remit so that they can further build on and evolve their already excellent appraisal processes. It is critically important that while improvements to access to medicines are made we also ensure that we are getting genuine value for money, and that the pharmaceutical industry improves the type and quality of information it provides to get their medicines funded on the NHS. I strongly believe that the SMC are best placed to help make this happen.

“Finally, and above all else, we need to make sure that all patients get access to the most clinically and cost-effective treatment and care.”

James Jopling, Scotland Director at Breakthrough Breast Cancer, said:

“We are pleased the Scottish Government is recognising the vital importance of improving access to effective treatments at the end of life. At present women with secondary breast cancer (also known as metastatic breast cancer) have limited treatment options for what is an incurable form of the disease.

“We urge the Scottish Medicines Consortium to come back with recommendations that put much-needed value on medicines which give people additional, good quality months with their loved ones, which we know are invaluable to those with secondary breast cancer and other terminal conditions.”

The SMC will report their findings to the Cabinet Secretary before the end of the year for the new, more flexible, approach to be implemented early in the new year.

Notes to editors

  • This is the first step in a wider process to determine a Scottish model of value-based medicines assessment.
  • The SMC appraises all newly licensed medicines and provides advice to NHS Boards on their clinical and cost-effectiveness.
  • If a medicine is accepted for use by the SMC then it can be prescribed by clinicians in any health board.
  • If the medicine is not accepted then health boards do not make it routinely available. Currently clinicians can prescribe medicines that are not accepted for routine use by the SMC for individual patients in certain circumstances by special request through Individual Patient Treatment Requests (IPTR).
  • IPTR will now be replaced with a peer approved process which will be led by local consultants.
  • Under the changes SMC meetings will be held in public and patients will be invited to attend Peer Review decision-making meetings.
  • The Rare Conditions Medicines Fund was established in January 2013 to cover orphan drugs - medicines for illnesses which affect fewer than 1 in 2,000 people.
  • For interviews with James Jopling, Scotland Director at Breakthrough Breast Cancer, please contact Julie Bruce on is 0131 226 0769.
  • For interviews with Professor Angela Timoney, Chair of the Scottish Medicines Consortium, please contact Stephen Ferguson, Communications Manager at Health Improvement Scotland on 0141 225 6893.