Breast Cancer Drugs

Martyn Day Excerpts

Thursday 26th January 2017 Commons Chamber

[Martyn Day (Linlithgow and East Falkirk) (SNP)]

It is a pleasure to take part in today’s important debate and I thank the hon. Member for Mitcham and Morden (Siobhain McDonagh) for securing it. I am grateful to her for her contribution and the cases that she used to illustrate it. She eloquently put a human face to the problem.

The debate about access to Kadcyla and other breast cancer drugs is of immense interest to the public on both sides of the border. Breast cancer is the most common cancer, which was shown by the many individual constituency cases cited by hon. Members of all parties today.

As has been said, Kadcyla is an effective life-extending treatment, which gives some women with incurable secondary breast cancer up to nine months longer than the alternatives, and has fewer side effects and a cost of around £90,000 per patient. In Scotland, Kadcyla has never been available on the NHS.

The Scottish Medicines Consortium, which makes its decisions independently of Ministers and Parliament, decided in October 2014 not to approve Kadcyla for routine use in Scotland. After considering all the available evidence, it felt that the health benefits were not sufficient in relation to the treatment’s cost. Patients have, therefore, been able to access the drug only in exceptional circumstances through individual patient treatment requests—IPTRs. It is estimated that more than 100 women in Scotland could benefit from Kadcyla annually.

A Kadcyla discount has been offered by the pharmaceutical company Roche and it recently wrote to Scottish Government officials about a patient access scheme. Roche has now resubmitted its application to the SMC, so that it can be considered for routine use in the NHS across Scotland. That is currently being assessed—

[Kirsten Oswald (East Renfrewshire) (SNP)]

Will my hon. Friend join me in hoping for a positive outcome in relation to Kadcyla for our constituents who are affected by secondary breast cancer, to whom this debate means so much?

[Martyn Day]

I thank my hon. Friend for that point and I join her in hoping for a positive outcome. We expect a decision to be made in March with an announcement on 10 April.

The SNP Scottish Government have substantially increased access to new medicines, particularly for cancer, with plenty of reforms and investment in recent years. The Scottish Government will build on recent reforms and make further improvements, in collaboration with patients and NHS staff, by accepting the recommendations of Dr Brian Montgomery’s review. Shona Robison, Cabinet Secretary for Health, Wellbeing and Sport, has announced that the Scottish Government will take forward all 28 of the review’s recommendations. Dr Montgomery was tasked to examine how changes made to the Scottish Medicines Consortium process in 2014 affected access to medicines for rare and end-of-life conditions. His recommendations set out how the process for appraising medicines could be made more open, transparent and robust.

Among the Montgomery recommendations—the House need not worry; I will not list all 28 of them—is to give the SMC an additional decision option of an interim recommendation for use subject to ongoing evaluation, which will allow collection of more data on a medicine’s real-world effectiveness. Another is the introduction of managed access agreements, under which medicine would be provided at a discounted price for a period of time, again to collect real-world data on its effectiveness. Another recommendation is to make greater use of national procurement in NHS National Services Scotland— NSS—to lead negotiations on cost with the pharma industry to get the fairest price possible. Better capturing of patient outcome data in the real world is vital to enable us to determine whether medicines are bringing the expected level of benefits to patients.

Beyond the recommendations of the review, Ms Robison has also announced improvements to the processes for non-routine access to medicines on an individual case-by-case basis. The peer approved clinical system or 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 system. A new national appeals process will be introduced through the new tier of PACS, and that will include consideration of equity of access with other parts of the UK as a material part of its decision-making process.

In November 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.”

Breast Cancer NOW has said that

“Scottish Government reforms give fresh hope for a medicines system that will put patients and their families first.”

It also said:

“Scotland’s approach to reform is a useful example to the rest of the UK about ways in which the system can be improved.”

[Kirsten Oswald]

I thank my hon. Friend for his words about the flexibility of approach and the need to continue to keep pushing forward to ensure that we allow access to as many of these drugs as possible for the people who are in such need. Will he join me in commending the Scottish Government and the SMC for that approach, and in hoping that it will continue and make a difference?

[Martyn Day]

I do indeed join my hon. Friend in those comments.

A new and ambitious Scottish cancer strategy, launched in 2016, aims to stop anyone dying from breast cancer by 2050, and breast cancer is of course a priority in the Scottish Government’s Detect Cancer Early initiative. We need to do many things to move forward in that direction.

No debate seems complete these days without reference to Brexit, and this issue is no exception. The Health Secretary has stated that the UK will not be in the European Medicines Agency. If so, there could be implications for the way in which medicines are regulated, and marketing authorisations will be required from the Medicines and Healthcare Products Regulatory Agency for the UK. I am in no doubt that the implications will be less efficiency and possibly longer processes for obtaining authorisations, resulting—I fear—in innovative drugs taking longer to reach patients. Some industry leaders predict delays in the region of 150 days, based on the examples of Switzerland and Canada.

According to a piece that appeared last year in the Financial Times, when Sir Michael Rawlins, chair of the MHRA, was asked whether it would be able to take on all the extra work registering new drugs and medical devices currently carried out by the EMA, he said, “Certainly not”. It seems that considerable investment and recruitment will be required to re-establish it as a stand-alone national regulator. I am keen to hear from the Minister how delayed drug access for UK patients will be avoided.

[Mr Baker]

I have listened carefully to the hon. Gentleman, and of course he raises a perfectly reasonable concern, but the campaign director of Vote Leave had, as one of his particular bugbears, the costs associated with the clinical trials directive and its prejudicial effect on innovation in medicines. I hope that the Government can find a better way through than the previous system and that, in leaving the EU, we will not only solve the problem of the EMA but have a better regulatory system afterwards.

[Martyn Day]

I thank the hon. Gentleman for his intervention, and I look forward to hearing the outcome.

In conclusion, with regards to Kadcyla, I hope the company’s resubmission to the Scottish Medicines Consortium is at a fair price to allow it to be considered for approval for use in the NHS in Scotland. It would give people across Scotland the opportunity to benefit from more treatment options and could give them precious extra time with their families and loved ones. The Scottish Government, the SMC and the NHS have worked hard to reform access to new medicines, but 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. Cost-effectiveness is a key marker in ensuring that drugs are routinely available in the NHS, and I take the opportunity to emphasise that point to the pharmaceutical industry in general.