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Cancer Treatment (Cetuximab) (PE1108)
Item 2 is consideration of a current petition with which we are familiar. PE1108, which was lodged by Tina McGeever on behalf of her late husband, Mike Gray, calls on the Scottish Parliament to urge the Scottish Government to consider the provision of cancer treatment drugs, in particular cetuximab, on the national health service to ensure equity across NHS boards in determining the appropriateness, effectiveness and availability of such treatments.
Thank you very much, convener. I welcome the opportunity to update members on the progress that we have made so far in addressing the recommendations in your inquiry report.
We have questions about data gathering and quality-adjusted life years that we will submit for written responses rather than ask today.
Good afternoon, cabinet secretary and colleagues. You wrote to NHS boards on 29 January. Were their responses positive? Do they accept the need for change? What is the position on achieving a coherent picture throughout the country? You talked about clear momentum. How much more has to be done?
We have done much, but there is more to do—this is work in progress. As you said, I wrote to all NHS boards on 29 January. We received responses from all 14 territorial NHS boards. Although the evidence is anecdotal and the proof of the pudding will be in the eating, I detect a strong momentum and a clear determination in the NHS to improve the arrangements that are in place.
The committee looks forward to having input into finalising the guidance. As part of that necessarily complex process, have boards been encouraged to talk to one another?
Yes. As I said in my opening remarks, the Government's intention has been to set the strategic framework. Part of that is about ensuring that existing best practice is shared among boards so that those that do not comply with best practice are pulled up to scratch. Where, frankly, things might be done better than was the case in any NHS board in the past, we want all boards to improve on their position. Therefore, a lot of discussion has been involved. I say again that, in my experience, boards have been very up for that. Certainly, that has been the tenor of the feedback from them.
Obviously, policies should be under constant review, especially for such serious matters.
I knew that I would be asked what the drugs are called, but they are all unpronounceable—
I will not push it, then.
The three drugs are sunitinib, romiplostim and mecasermin—
That is exactly what we were thinking.
I am sure that my pronunciation is way off mark, but we can provide further details about those drugs. Sorry, what was the second part of the question?
Basically, are there any other practical examples of how things have improved because of the new modifiers that the SMC has published?
It is important to see the modifiers almost as a stand-alone. They are designed to give the SMC more flexibility than it had in situations where the standard QALY methodology—which I know all members are now well versed in—would not, in the normal course of events, lead to the approval of a drug. The modifiers apply to drugs that might, for example, deliver a significant extension to a patient's life, improve a patient's quality of life but not prolong that life or provide some other benefit for which no other therapies are available. Those are some examples of the modifiers. The three drugs that I mentioned are the only drugs that have been approved under the modified approach since that came into place in May this year. Therefore, it is reasonable to say that, in all likelihood, those three drugs would not have been approved but for the modifiers.
Absolutely. I will not ask the cabinet secretary to pronounce these if they are difficult, but could she perhaps have a go at telling us which two new cancer drugs have been approved under the patient access scheme? Is cetuximab one of those, or is it being considered?
Cetuximab is not one of the two drugs that I mentioned, but cetuximab is due to be considered under a patient access scheme proposal in the fairly near future. The two drugs—I will not pronounce them, but I will say what they do—are for the treatment of multiple myeloma and for the treatment of gastrointestinal tumours.
I understand that other drugs are currently available under the patient access scheme in England. What are those drugs? Will they become available to patients in Scotland and, if so, when will that happen?
I can provide that information to the committee, but I do not have it with me today. The arrangement that we have put in place for the consideration at a national level of patient access requests involves an assessment group that will consider applications that are made for the approval of drugs. The assessment group examines patient access scheme proposals and, if it considers them worth going ahead with, the information goes to the SMC for it to make its recommendation in the light of that. Applications that are made under patient access schemes are considered in that way. I know that applications for some of the drugs that are available in England have not yet been made in Scotland. However, that is in the hands of the drug companies and I dare say that the picture will be fast changing.
One of the issues that arose in our inquiry, which led to the progress that is being made, was regional variation in prescribing, which we are trying to overcome. Will the new guidance reduce the risk of postcode prescribing and ensure more consistency? I hope that it will. Will the decision-making process become more transparent?
The answer to both those questions is yes, I hope so. National consistency is important. The patient access scheme system and SMC modifiers operate at the national level and ensure consistency at that level. The guidance to NHS boards on the processes and systems that they should have in place for the introduction of new drugs and for exceptional prescribing—or individual patient treatment requests, as we are now calling them—will ensure much greater consistency throughout the country. I expect that there will be greater transparency as well, as the guidance to boards includes guidance on the need to put their policies in writing, to have them on their websites, to have clear arrangements for communicating decisions to patients and to have patient involvement in some of the decisions. All those things will improve the transparency.
Hopefully, the greater transparency of the system will make it obvious why certain patients do not get the decisions that they want.
The guidance will lay out the steps that the boards must take through their area drug and therapeutic committees to implement the SMC's recommendations, and it will include timescales in which those decisions must be made.
Thank you for that. There is a feeling that barriers are sometimes put in the way of patients getting SMC-approved treatments.
You referred to individual patient treatment requests. Is that the new name for them?
Yes. It is the new name for exceptional prescribing.
I thought so. I asked just for clarification.
Poor communication was one of the issues that Tina McGeever's petition highlighted. In paragraph 85, our report suggests that health boards should appoint local liaison officers, whose role would be to encourage better liaison between the clinician, the health board and the patient. Will you ask health boards to appoint local liaison officers? If not, what practical steps should they take to address such problems?
Yes. That was an important recommendation, and the guidance will direct NHS boards to put in place and to identify the staff members who have the responsibility of being liaison officers. As well as having to identify an appropriate person who is well placed to perform that role, they will have to signpost patients and the public to that person through their written policies and their website, so that it is well known who that person is and they can be easily identified by patients who require help and information.
Is local liaison better now than it was a year ago?
Yes, I think that that is the case. Is it where we want it to be in all NHS boards? Not necessarily. Many of the changes that will bring that about will follow from the guidance. As I said, boards are already working on bringing their policies and procedures into line with what they expect the guidance to say. I would not say that it is job done on that aspect or on any other aspect of the issue. We have made great progress, but some of this is work in progress, which we need to continue.
I welcome the input of health rights information Scotland to the guidance on exceptional prescribing, or individual patient treatment requests, as the issue is now referred to, but were any other bodies, such as patient bodies, involved in drawing up the guidance? We all welcome the fact that you said that you would seek comments from the committee on the draft guidance when it comes out. Will any of the patient bodies be asked to comment on the draft guidance?
The draft guidance is currently with NHS boards and other stakeholders, including patient groups. The leaflet has been sent for comment to a total of 36 stakeholders, 22 of which are cancer-related organisations. They include Breakthrough Breast Cancer, the rarer cancers forum, Macmillan Cancer Support, Bowel Cancer UK and the Scottish cancer coalition. The Scottish long-term conditions alliance, which covers a range of long-term conditions, has also been consulted on the leaflet, because it is important that we get it right.
Are there any other questions on the broad area of availability?
You talked about the desire and the need to ensure uniformity of process for patients across boards. Will there be uniformity of process for patients who wish to appeal against the decision of a board not to fund a treatment?
The guidance will make it clear to boards that they require to have in place clear and understandable arrangements for patients who want to appeal. The processes will not necessarily be identical in every part of the country, although because, as Nanette Milne said, all the policies and procedures in different board areas will be highly transparent, my view is that they will end up being very similar. The appeals system is an important part of the process, and it is just as important that that part of the process is understood as it is that earlier parts of the process are understood.
That part of the process will be as transparent as other parts of the process.
Yes.
I am grateful for that.
Good afternoon. In the context of leaflets or information generally, to what extent will boards be required to take on the fact that not everyone reads English? Not everyone's first language is English and some people simply cannot read for a variety of reasons.
It is our normal practice to make leaflets available in a range of languages and formats. I am looking for a nod to tell me that that will be the case with the leaflet that we are discussing.
Absolutely.
Thank you for that confirmation.
One of the reasons for choosing to involve health rights information Scotland was to ensure that the equality proofing was done and that the information that was produced was as widely accessible as possible. Equally, with information that is made available through NHS boards, we expect existing arrangements for engaging the public to take account of the point that you make.
I am just very glad that the issue has been taken on board at the beginning of the process, because too often it is done too late.
Do members have any more questions about availability?
On the exceptional prescribing process—that process has a new name—does every board now give each patient and clinician the opportunity to attend its meetings together when individual cases are being discussed?
Several boards already do that, but the guidance will make it clear that where that is appropriate and desirable from the patient's point of view—I will not go into all the circumstances in which it might not be appropriate or desirable—they should have the opportunity to be present.
I want to ask about the swiftness of response, never mind the disappointment of it. I refer to the petitioner's experience. How quickly would you expect people at the health board level to respond under the new criteria and guidance?
To exceptional prescribing requests?
Yes.
It is quite difficult to set absolute rules and guidance on that. The guidance that we will publish will say that the timescales that are followed must be sensitive and responsive to the patient's clinical condition. I will not spell out different circumstances, but there will be many circumstances in which quick consideration of the request and a quick decision are essential. In other cases, things may not require to be as quick. We would always want speed to be balanced with proper and full consideration of the request in all cases.
We understand that. Obviously, we wanted the timescales to be a bit firmer, but we understand the complexities that are involved.
Any failure of a board in the area that we are discussing—or in any other for that matter—to comply with guidance and meet the standards that it is expected to meet would be taken up directly with it either by me or by my officials through the normal accountability and performance arrangements that are in place for boards. The guidance is not yet in place, but it will be shortly. We intend to give it a reasonable period of operation and then review its impact by asking boards to demonstrate what it has meant to their policies and patients' experiences.
Next, we want to explore funding, which is always the more challenging area for us all. We want to explore how individuals can economically deal with demands for access to drugs.
I have just joined the committee, but I understand from my reading that revised guidelines on co-funding have been issued to NHS boards. I want to ask about those guidelines, as co-funding is obviously a major issue. What response has there been to them? Are you monitoring whether they are being applied uniformly throughout Scotland?
That is an important question. The co-funding guidance that we published back in March will be evaluated in the fullness of time in the same way that the guidance that I have mentioned will be once it has had a reasonable period of operation.
Are you effectively saying that the scenario that Tina McGeever faced cannot happen again?
I do not want to go into all the particular circumstances of Tina's case, so I will generalise rather than talk about that particular case. I might be wrong about some of this but, as I understand it, in the past, some people who have opted to pay privately for a drug have found that the other aspects of their care also have to be funded privately. The guidance seeks to ensure that, assuming that important tests can be met, the patient does not lose entitlement to other aspects of NHS care just because they choose to pay for a particular portion of it privately. That is the important difference between the new guidance and what existed previously.
Apparently, the committee suggested in its report that some form of trial could be introduced whereby a board would agree to fund an initial trial of a drug to see whether it was clinically effective for the patient. Are such trials going on?
We have not introduced trials of that nature at individual board level; we have introduced a patient access scheme at national level, which I think is more equitable and will help ensure consistency, the lack of which the committee has rightly criticised in the past with regard to other aspects of this issue. The patient access scheme means that drugs that otherwise might not be approved because of a lack of assurance about their effectiveness are given a chance, through whatever the detail of the scheme is. We are doing that at national level rather than at board level.
So you would not see any opportunity for or advantage in doing that at board level?
My preference is for what we are doing through the patient access scheme but, on an issue as emotive and important as this, I will not close my mind to anything that can help improve the situation. We will keep all this under review, but my strong feeling is that it is more equitable to have these kinds of schemes introduced nationally rather than locally. When you do these things at local level, you are more likely to end up with the postcode prescribing scenario that the committee has rightly criticised in relation to other aspects of this issue.
One issue that came up in the evidence that we received and in our discussions was about collection of data from boards. Some practitioners felt that there is little or no data collection from the boards. Has there been any improvement in the information that comes from boards and which is gathered by the Scottish Government? In relation to cancer care or any other medical care that health boards deliver, the issues that we are discussing are predicated on gathering the information that is necessary to make correct assessments of how the care is delivered. I seek assurances from the Scottish Government that the data that were referred to in our report are being collated by health boards and passed to the Scottish Government to allow it to make correct assumptions about the delivery mechanisms.
That is a fairly big question. I will do my best to cover as much of the issue as I can verbally, but the committee might want to receive further information in writing. As I said, SMC recommendations are in effect binding on boards. We have no evidence that boards do not make available drugs that are recommended by the SMC, or the equivalent. We will always act on information that that is not happening. The committee has previously raised the issue of gathering information on exceptional prescribing. We are considering how we might do that in future when the new guidance is in place and boards have had an opportunity to implement it.
I want to pull together some of the core questions, although I know that you will give us fuller responses in writing. The rarer cancers forum's report on exceptional prescribing was produced after some of the committee's discussions. Do you have any views on the funding issues that are raised in that report? Are any of its recommendations at all relevant to our discussions on the petition?
I assume that you are referring to funding in the more general sense, rather than co-funding. Funding will always be a challenging issue in the NHS. I say that in the context of NHS budgets that are rising. Next year's budget will be higher than this year's and this year's is higher than last year's. The nature of health care, particularly in relation to new drugs, means that NHS boards will always have to make difficult decisions. It is important that they have robust and transparent procedures in place for implementing SMC decisions so that they can take decisions and finance them in a managed way. I do not imagine that there is a health care system anywhere in the world in which the difficult issues of how to fund new technologies and drugs in a sustainable way are not a challenge. We are no different in that respect.
I think that you said that the deadline for comments on the draft guidance is the end of this week. I might have missed this earlier so, for my benefit, will you say when the committee will have a chance to look at the guidance?
We have asked for comments by Friday. If it is okay with the committee, we will take some time to distil the comments and to revise the draft guidance in line with them. I ask Colin Brown what a reasonable time would be. Would it be a couple of weeks?
Perhaps a bit longer.
In the near future.
Yes, in the near future. We will discuss the matter privately and come back to the committee with a more definitive timeline.
The timescale is not really the issue; it is good to have established the principle.
I am sure that you will put me back in order if what I suggest strays out of it, but would it, exceptionally, be in order for Tina McGeever to make one or two points to the cabinet secretary about what she has heard this afternoon?
This is where the committee clerk comes in.
What I have heard today has been extremely positive and I look forward to seeing everything being put into place. I feel that we are beginning to get somewhere and that real, practical solutions are being found to many of the problems that are faced by people who are going through the same process that Michael went through. Thank you for that.
Tina has been fantastic in her ability to come forward even in the most difficult of circumstances. I should add that, on Saturday, she will participate in a major conference on understanding and influencing your Parliament. She has certainly been very positive about the relationship that we have had with her over this petition.
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