News

HDA UK Media And Political Bulletin – 16 December 2016

New reforms for Scottish medicines approval process

Pharma Times, Selina McKee, 15 December 2016

 

The Scottish government has announced plans for new reforms to the way treatments are approved in the country, to help boost access for patients. Previous reforms to the Scottish Medicines Consortium’s medicines appraisal process in 2014 have helped to “markedly increase” the acceptance of new medicines for NHS use. To further improve access, the Scottish government said it will follow new recommendations made by his review.

 

Parliamentary Coverage

Advisory Council on the Misuse of Drugs, Report on diversion and illicit supply of medicines, 15 December 2016

 

The ACMD’s report on diversion and illicit supply of medicines (DISM) is in response to the Home Office’s commissioning letter of September 2013, in which the then Home Secretary requested the ACMD to explore the potential for medical and social harms arising from the illicit supply of medicines – predominantly controlled medicines.

 

This report sets out to:

  • explore the extent of DISM in the UK, to find out which drugs are being diverted
  • evaluate the extent of the medical and social harms of such diversion
  • assess whether DISM displaces or replaces the use of known recreational drugs of abuse, such as heroin

 

In recent years, DISM has become of increasing public concern across the globe, although the hard evidence for this constituting a major problem other than in the United States is hard to find.

 

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House of Commons Questions, 15 December 2016, NHS: Drugs

 

Jim Shannon: What recent discussions he has had with pharmaceutical companies on the price structuring of medicines they supply to the NHS.

 

Department of Health

Nicola Blackwood: Ministers regularly meet with stakeholders from the National Health Service and the Pharmaceutical industry where a range of issues are discussed. Details of external Ministerial meetings are published regularly:

https://www.gov.uk/government/publications/ministerial-gifts-hospitality…

 

Full Coverage

New reforms for Scottish medicines approval process

Pharma Times, Selina McKee, 15 December 2016

 

The Scottish government has announced plans for new reforms to the way treatments are approved in the country, to help boost access for patients.

 

According to a review of access to medicines in Scotland by former NHS Fife Medical Director Dr Brian Montgomery, previous reforms to the Scottish Medicines Consortium’s medicines appraisal process in 2014 have helped to “markedly increase” the acceptance of new medicines for NHS use, rising from 48 percent between November 2011 and October 2013 to 75 percent between May 2014 and March 2016 for orphan, ultra-orphan and end-of-life medicines.

 

Now, to further improve access, the Scottish government said it will follow new recommendations made by his review, devising over the coming months a revised approval process for true ultra-orphan medicines which will see final decisions on low volume high cost medicines being made without the SMC.

 

The SMC will also be given new powers to consider accepting a medicine on an interim basis so its clinical effectiveness can be further assessed with on-going data collection before a final assessment is made, in a similar process to that of the Cancer Drugs Fund in England.

 

Health Minister Shona Robison also announced improvements to the processes for non-routine access to medicines on an individual case-by-case basis, including a new national appeals process that will consider equity of access with other parts of the UK as a material part of its decision-making.

 

“The reforms I am announcing today will help more patients to get better access to treatments that can give them longer, better quality lives,” said Ms Robison.

 

“The Scottish Government, the SMC and the NHS have worked hard to reform access to new medicines. However, we now need pharmaceutical companies to do their bit by bringing forward much fairer prices for new medicines so that access is as wide as possible for the people of Scotland.”

 

The report also recommends that NHS National Services Scotland should play a stronger role in negotiating the cost of medicines in Scotland.

 

​Sandra Auld, director of ABPI – Scotland, said Dr Montgomery’s comments on “earlier collaboration between NHS Scotland and the pharmaceutical industry in bringing new medicines to market are very welcome and will be important in reducing delays for patients gaining access to new medicines”.

 

“Similarly, the recommendation that we need an alternative assessment pathway for ultra-orphan medicines is one that we feel could make a real difference to patients accessing these medicines,” she added.

HDA UK Media And Political Bulletin – 16 December 2016

From Factory to Pharmacy

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