Better access to new medicines

Fresh reforms to the way new medicines are approved will mean better access for patients in Scotland.

Health Secretary Shona Robison has today confirmed she will take forward the recommendations of Dr Brian Montgomery’s Review of Access to New Medicines, published today by the Scottish Government.

Ms Robison asked Dr Montgomery to examine how changes made to the Scottish Medicines Consortium (SMC) process in 2014 affected access to medicines for rare and end-of-life conditions. The review’s recommendations set out how the process for appraising medicines can be made more open, transparent and robust.

Following his recommendations, a revised approval process for true ultra-orphan medicines will be devised in the coming months. This will see final decisions on these low volume high cost medicines being made outwith the SMC.

The SMC will also be given an additional decision option to consider accepting a medicine on an iterim basis so its clinical effectiveness can be further assessed. This means a new medicine that previously might have not been approved could potentially be accepted for use subject to on-going data collection and evaluation before a final assessment can be made.

The review found that, following recent reforms, SMC acceptance rates markedly increased. The combined acceptance rates for orphan/cancer medicines increased from 48% between November 2011 and October 2013, to 75% between May 2014 and March 2016 for orphan, ultra-orphan and end-of-life medicines.

Beyond the recommendations of the review, Ms Robison has also announced improvements to the processes for the non-routine access to medicines on an individual case-by-case basis.

The Peer Approved Clinical System (PACS), piloted in Glasgow in 2015 to handle applications for ultra-orphan medicines, has been successfully rolled out across Scotland. A second tier of PACS will now be introduced to replace and build upon the existing Individual Patient Treatment Request (IPTR) system. A new national appeals process will be introduced through this new tier of PACS. This will include consideration of equity of access with other parts of the UK as a material part of its decision-making process.

Launching the report during a visit to Maggie’s Centre in Dundee this morning, Ms Robison, said:

“I’d like to thank Dr Montgomery for his work and I’m pleased to announce that we will now work with our partners to ensure each recommendation is taken forward.

“Access to new medicines for rare or end-of-life conditions has substantially increased in recent years, but we wanted to go further. Dr Montgomery’s recommendations will help us realise this.

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

“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.” 

Dr Montgomery said:

“The key finding from the review was that access to end-of-life, orphan and ultra-orphan medicines has increased.  This was confirmed by the feedback received from a wide range of stakeholders who engaged with the review.  Stakeholders also expressed greater satisfaction with the new approach adopted by the Scottish Medicines Consortium.

“The review goes on to highlight the challenge in maintaining the increased levels of access in the future, particularly at a time when an increasing number of exciting new treatments are expected to become available for a number of conditions.

“I am pleased the Scottish Government is keen to build on the experience of the SMC’s new approach.  The collaborative approach Ms Robison proposes will be crucial when implementing the review’s recommendations.”

Gregor McNie, Cancer Research UK's senior public affairs manager in Scotland, said:

"SMC does a difficult but necessary job to assess whether new cancer drugs should be made available on the NHS. Following the SMC reforms, we've been pleased to see a significant increase in the availability of cancer drugs in Scotland and we support the review's recommendations to make further progress.

"We're particularly pleased to see the review place strong emphasis on gathering more data on the effectiveness of cancer drugs, and recommendations to ensure the system is sustainable and supports swift access to the most effective cancer drugs are positive in our view. The challenge now is to turn these recommendations into reality for patients as soon as possible."

Background:

Dr Brian Montgomery has previous experience as a GP, Health Foundation Leadership Fellow, Medical Director of NHS Fife and interim Chief Executive of NHS Fife.

A full copy of the Review of Access to New Medicines can be read here: http://www.gov.scot/Publications/Recent

The review’s recommendations also include:

• Consideration of how patient representatives could have a greater role in the SMC process.
• NHS National Services Scotland should play a stronger role in negotiating the cost of medicines in Scotland.
• Further work on collecting patient outcomes to determine the effectiveness of medicines in the real world.
• Standardise NHS Scotland’s approach to formulary development.
• A review of the definitions for end-of-life, orphan and ultra-orphan medicines to ensure they remain suitable for the assessment of new treatments.

Improvements being made for non-routine access to medicines on an individual case by case basis include:

• Updating the guidance to replace IPTR with a new tier two of PACS for all medicines other than ultra-orphan.
• While each board will operate tier two of PACS for their own area, the new system will replace the individual board appeals process with a new national appeals system.
• Tier two PACS guidance will make clear that a decision for non-routine access must not include cost-effectiveness as part of the consideration.
• Tier one of PACS to be maintained for access to ultra-orphan medicines.