New Medicines (Access) and Additional Private Care (Guidance)
The next item of business is a statement by Nicola Sturgeon on improving access to new medicines in the national health service and providing guidance for patients who seek additional private care. The cabinet secretary will take questions at the end of her statement, so there should be no interventions or interruptions.
Last October, Parliament debated the findings of the Public Petitions Committee's inquiry into the availability of cancer drugs in Scotland. At that time, I undertook to take forward all the committee's recommendations, so I thought that it would be appropriate to update members on our progress in improving the arrangements for introducing new medicines into the NHS in Scotland.
As members should be aware, drug expenditure in Scotland totals some £1.22 billion a year. That is a highly significant resource—it amounts to almost 10 per cent of the total NHS budget. Our objective must be to ensure that that investment supports equitable access to new and innovative medicines on the NHS and that every pound derives the most benefit for patients.
As we all know, tough decisions will always need to be made, so we must ensure that our decision-making processes are robust and achieve fairness and a consistency of approach and that patients, carers and the wider public have a better understanding of how and why decisions are made.
Scotland is already well served by good, internationally regarded arrangements for the introduction of new medicines through the Scottish Medicines Consortium and NHS Quality Improvement Scotland. The SMC has done much to ensure that evidence-based recommendations for Scotland are made quickly following the launch of every new medicine.
We should applaud Scotland's prominent position in life sciences developments, but we all want to ensure that more people in Scotland benefit from innovation. I am therefore announcing today a series of developments that are designed to improve access to medicines on the NHS.
The first development that I want to touch on relates to exceptional prescribing arrangements. When a medicine is recommended by the SMC, NHS boards should make it, or its equivalent, available when appropriate. I want to make it clear that patients should not have to rely on exceptional prescribing arrangements for medicines that are SMC recommended. However, when a drug is not recommended by the SMC, it is important that exceptional prescribing arrangements are in place to consider the circumstances of individual patients, which could justify the prescription of a particular medicine.
Concerns have been expressed by the Public Petitions Committee and by members in the chamber—and, most recently, by the Rarer Cancers Forum—about the lack of consistency in exceptional prescribing arrangements in different NHS boards. Following the Public Petitions Committee report, the Scottish Government wrote to NHS boards with information on the end-to-end process for the introduction of new medicines, the support arrangements and what should be provided for patients. In addition, NHS boards were provided with a framework of principles, including specific principles for exceptional prescribing, to inform decision making at NHS board level. Boards have responded positively, and the outcome of the responses received will now be used as the basis for new guidance to be issued to boards.
The new guidance will provide the basis for more effective monitoring of the arrangements throughout the NHS. I can also confirm that the Scottish Government has commissioned health rights information Scotland to produce better and clearer information for the public on the arrangements, so that the public can better understand how they work.
The second development that I am announcing today relates to greater transparency in the flexibility that can be used by the SMC in reaching decisions. I can confirm today that the Scottish Medicines Consortium will shortly publish a set of modifiers that can be applied when considering new medicines. The effect of the modifiers will be to ensure that, following the scientific, clinical and health economics evaluation of a new medicine, the full SMC can consider whether any special factors should be taken into account. That will allow greater flexibility to be exercised when there are potential clinical benefits to a drug that the standard methodology would not approve. That will apply, for example, in situations in which the drug can deliver improvements in life expectancy or substantial improvement in quality of life without necessarily improving life expectancy, or when there are no other therapeutic options.
The SMC will also retain the flexibility to consider any other special issues that have been highlighted by the manufacturer of the medicine, clinical experts or patient interest groups. I want to underline that, although this flexibility will undoubtedly be of particular importance in the case of cancer drugs or end-of-life drugs, it can be applied to any new drug coming before the SMC.
The third development on which I want to update members relates to patient access schemes, which are sometimes referred to as market access or risk-sharing schemes. The schemes allow drugs companies to offer discounts or rebates that reduce the cost of a drug to the NHS. Members will be aware of the pharmaceutical price regulation scheme, a voluntary agreement between the United Kingdom health departments and the Association of the British Pharmaceutical Industry that is designed to secure medicines at prices that are reasonable for the NHS and to provide incentives for the pharmaceutical industry to develop new medicines. Among a range of developments, the new PPRS agreement paves the way for a more systematic use of patient access schemes. I therefore asked the SMC, through a short-life working group, to advise me on the feasibility of patient access schemes in Scotland. That group has now reported to me with the conclusion that such schemes could deliver benefits to patients in Scotland as a means of improving the cost-effectiveness of new medicines and facilitating access to products that might not otherwise secure SMC approval. I therefore announce that I accept the recommendation of the SMC short-life working group that a national framework for assessing proposed patient access schemes should be established. A single national framework will avoid duplication and the potential for schemes to operate differently in different parts of the country. The new arrangements, the operational details of which will now be finalised, will maintain the integrity of the current SMC arrangements and will operate independently of ministers.
All the developments that I have announced today will, individually and collectively, improve patients' access to medicines on the NHS. They will be underpinned by work at the national level to develop new information technology and data analysis systems to support decision making and, crucially, to provide information on the uptake and use of medicines. Arrangements are in place to ensure better networking for those who are involved in planning and implementing the introduction of new medicines across the country in order to share learning and good practice. In addition, the academic sector is fully involved in taking forward the research agenda for health economics methodology and the ethics of making difficult decisions.
All of what I have talked about today is about improving access to drugs on the NHS. My objective is to ensure that we have a system in place that is, from end to end, robust, fair and well understood. Such a system should ensure that, when a patient can derive demonstrable benefit from a drug, it is available on the NHS through either SMC approval or exceptional prescribing. Conversely, when a drug is not so available, that should be because it cannot deliver sufficient benefit and not for any other reason. That should be clearly explained to the patient.
We must accept that, even when a drug is not available on the NHS, some patients will wish to exercise their right to access it privately. In such circumstances, it is important to provide clarity to patients about the implications of such decisions for the NHS care to which they would otherwise be entitled. Therefore, I am today publishing, after consultation, the final revised guidance on co-payments—those situations in which NHS patients may wish to include elements of private health care, including medicines, in the management of their clinical conditions.
Members will know from previous discussions that co-payment has proved to be a controversial and thorny issue, but I believe that, as a result of work that has been undertaken with key stakeholders, the revised guidance provides greater clarity for NHS boards, clinicians and patients. The guidance is grounded in the fundamental principles of the NHS—namely, that NHS treatment must be based on clinical need, not the ability to pay; that NHS care is free at the point of access; that patients cannot pay the NHS to top up their care; and that the NHS must not in any way subsidise private treatment.
The guidance also recognises that, when a patient chooses to pay for part of their care privately, so long as questions of patient safety, clinical governance, probity and accountability can be answered they should not necessarily lose out on the NHS care to which they would otherwise be entitled—NHS care that they have funded through their taxes. I believe that the revised guidance, which is being issued by the chief medical officer, provides a framework within which the circumstances of individual patients can be fully considered. Nevertheless, such arrangements should be and will be the exception, not the norm.
I remain committed to ensuring that people in Scotland get the best possible care. I believe that, by fully addressing the Public Petitions Committee's recommendations and going beyond them, the progress that has been made and the series of measures that I have described will improve access to new medicines in the NHS in Scotland. I commend the statement to the Parliament.
The cabinet secretary will now take questions on the issues raised in her statement.
I thank the cabinet secretary for advance sight of the statement and the guidance that is to be issued. I also thank her for properly coming to the chamber to report on progress, which we hoped that she would do. I welcome the progress that has been made and the restatement of the Government's fundamental commitment to the values and principles of the NHS. We recognise that these are serious and sensitive issues for patients and their families.
There are a couple of specific points that I would like the cabinet secretary to elaborate on. First, where will the guidance fit with drugs that are licensed but have not yet gone through the SMC process, and when does she expect further guidance in relation to improved access to new medicines to be issued? Secondly—crucially, from patients' point of view—what appeal process will be in place for patients who are turned down under the exceptional prescribing arrangements?
I am glad that I was able to live up to Cathy Jamieson's expectations in coming back to the chamber to report on progress, and I repeat what I said in my statement: I am absolutely committed to the fundamental principles of the NHS. I know that that commitment is shared across the Parliament, and I believe that what we have announced today protects those fundamental principles. That is important.
Cathy Jamieson asked two specific questions and I will try to give her two specific answers. She posed the question of where the guidance fits in relation to drugs that are licensed but have not yet gone through the SMC procedures. As Cathy Jamieson and her colleagues know, one real advantage of the SMC is that, unlike the National Institute for Health and Clinical Excellence in England, it considers newly licensed drugs very soon after they get their licences—the time gap is literally a matter of weeks. We are therefore in a good position to ensure that the guidance applies in the main to situations in which the SMC has not approved a drug.
Cathy Jamieson's second question concerned appeals processes. I expect the guidance on exceptional prescribing to clarify the different steps in that process, including any arrangements and mechanisms around appeals.
Exceptional prescribing arrangements are very important. The SMC makes recommendations that are about the generalities. No patient absolutely fits the generality, and there will be cases in which a patient's individual circumstances justify the prescription of a medicine even though the generality does not. Interestingly, statistics show that there is an approval rate for exceptional prescribing of about 85 per cent in Scotland, compared with a rate of about 76 per cent in England. That suggests that the system is working well, but I believe that it can work better, more transparently and in a way that the public can better understand.
I thank the cabinet secretary for the advance copy of her statement. The Scottish Conservatives welcome the clarity that has been brought to the issue, and it is right and fitting that we pay tribute to Michael Gray and Tina McGeever, who did so much to bring the Parliament to this point, which will surely result in benefits for many patients. We welcome the health rights information project, the patient access schemes and other initiatives.
I want to ask about co-payment. When a patient chooses to pay for part of their care privately, as recommended by their consultant, who will decide whether they will lose out on NHS care? The minister said in her statement that patients will "not necessarily" lose out on NHS care—that is not entirely clear.
The guidance says:
"NHS Boards should develop local processes … to support clinicians and patients in reaching decisions about the appropriateness of combining NHS and private healthcare".
There are 15 factors that need to be taken into account in the development of local processes. My concern is that those local processes will lead to local decisions that will mean that postcode prescribing can continue. That is against what most of us had hoped, which was that the proposal would bring an end to postcode prescribing in Scotland.
Mary Scanlon is right to welcome the clarity that the guidance brings, although she went on to suggest that the clarity might not be as great as she had hoped.
I too pay tribute to Michael Gray, who brought the petition to the Public Petitions Committee, and his wife Tina McGeever, who carried on the campaign. I hope that she is pleased with some of the developments, and I hope that he would have been pleased with them if he were still with us. I have heard Tina McGeever say that her objective is to ensure not that people can more easily access drugs privately but that they can more easily get them on the NHS. That is why much of my statement was about the latter, not the former.
Mary Scanlon is right to point out the importance of the health rights information project and patient access schemes, as they are potentially important in opening up access to new medicines.
The issue of co-payment is complex, and I do not think that we do it justice by trying to pretend that it can be completely simplified. Mary Scanlon might already have read the guidance—I see that she is indicating that she has. It lays out a framework to guide decisions. She points to the use of the word "necessarily"—we cannot say that in every single circumstance a patient can receive NHS care and private care concurrently. There might be good reasons of clinical governance and patient safety why such an arrangement is not in the patient's interests, so there must be a degree of flexibility and the potential for clinical decision making.
I hope and expect that the framework that we have laid down in the guidance will ensure that the arrangements are consistent throughout the country. It is certainly not my intention, nor the intention of anybody who is active in making the decisions, that there will be any kind of postcode lottery of care, and I believe that the guidance will help to avoid that.
I thank the cabinet secretary for the advance copy of her statement. It is the final section that concerns me: my party fears that unfortunately a two-tier system will emerge in which people who are not wealthy and who do not have the money to pay for extra treatment will be firmly at the back of the queue for the best health care.
Will the cabinet secretary assure me that doctors, health professionals and NHS officials will be instructed to bring it to her urgent attention if they detect that what I fear might happen does happen? My party wants a light on the cabinet secretary's desk to flash if any patients lose out, so that the matter can be brought back to the Parliament as a matter of urgency.
Secondly, the cabinet secretary spoke about SMC flexibility and modifiers. Is there a danger that from the drug companies' perspective—and, indeed, from the patients' perspective—the situation could turn out to be a lawyers' paradise with regard to appeals?
I do not believe that that is the case, and the guidelines that we are setting out will help to provide clarity. There will never be complete clarity in relation to individual circumstances because clinical issues have to be taken into account. One reason why I have agreed the recommendation to set a framework for assessing patient access schemes is so that the ethics, feasibility and cost effectiveness can be properly assessed.
Jamie Stone's fundamental point is important, and I give him the strongest possible assurance that, as health secretary, I will not preside over the development of a two-tier NHS. I am passionately committed to the NHS and the principles that underpin it. Everything that we are doing is done with the aim of increasing access to drugs on the NHS. If our systems work properly, when a drug can benefit a patient, that patient should be able to access it on the NHS.
Patients have choices, and there are circumstances in which a patient might choose to access a drug privately, even when a clinician tells them that the benefit is not sufficient to justify prescription. We are laying down a framework to ensure as far as possible that a patient can do that without losing the other aspects of NHS care that they would receive anyway and that—as I said earlier—they are funding through their taxes.
The principles are clear: the NHS is free at the point of need; no one can pay the NHS to get better care than someone else; and the NHS must never subsidise private care. If there is to be concurrent treatment, it must be sufficiently separate to ensure that there is no risk of subsidy.
It is a difficult issue—I do not pretend otherwise—but I believe that we have managed to lay down an overall framework that will help to guide the decisions and make them easier for those who are charged with taking them.
I congratulate the cabinet secretary on her helpful and lucid statement. I must say that a great deal of stress and anger is caused by the labyrinthine procedures—which vary among health board areas—that have until now existed in relation to a request for the exceptional prescribing of a medicine that is not recommended by the SMC but considered desirable by a clinician under specific circumstances for an individual patient. How will the cabinet secretary simplify those procedures so that they are fairer and more transparent?
I thank Ian McKee for not only his question but his introductory comments. I am not always praised for being either helpful or lucid, so it is praise indeed to be called both in one sentence.
Ian McKee has put his finger on a very important point that I highlighted earlier—patients are individuals; no two are the same. As a result, there must be mechanisms for examining each patient's circumstances and characteristics and for making decisions on that basis. That is why we have exceptional prescribing arrangements.
As has been made clear very often—the rarer cancers forum report, which was published last week, is the most recent articulation of this view—the arrangements can be confusing for patients. They are not necessarily the same from health board to health board, and patients can find it impossible to understand the various steps that have to be taken. The timescales, for example, are not always clear.
There are two parts to my response to Ian McKee's question. First, the guidance that we will issue to NHS boards will standardise the arrangements in a way that, I think, will be welcomed by patients and the clinicians who use them. Secondly, we have commissioned health rights information Scotland to produce information, which will by and large take the form of a patient public information leaflet, to explain the purpose of exceptional prescribing and the basic steps in the arrangements. Both those steps will lead to systems that are much clearer and easier for patients to navigate. After all, given that patients can be in great stress and anxiety, the easier we can make the arrangements, the better.
Like other members, I welcome the statement. Indeed, I will go a little further and congratulate the cabinet secretary on wrestling appropriately with a very difficult issue. Ultimately, medicine is not entirely a science; it is also an art, and individuals really matter.
I have a couple of specific questions. First, the cabinet secretary mentioned three of the special factors that the SMC will take into account in its approval process. When will the full list be published? Will they be consulted on before their publication? After all, the readdressing of the quality-adjusted life year measurement—and, indeed, quality of life issues—is important.
Secondly, the cabinet secretary said in her statement that no one should be refused treatment if it will have "demonstrable benefit". Of course, she has alluded to the fact that what might be seen as benefiting one person will not necessarily be seen as benefiting someone else. How will that issue be dealt with in the list of exceptional needs? Will a set of principles be established, even though it is understood that such principles will not be able to cover every individual circumstance?
I thank Richard Simpson for his questions, the first of which relates to the SMC modifiers. The SMC will shortly publish the modifiers that it intends to apply in certain cases—I will certainly alert Richard Simpson to the exact publication date.
The SMC carried out the work partly in parallel with and partly in response to NICE's work on end-of-life and cancer drugs. Being of the view—rightly, I think—that although such an approach is particularly important with regard to cancer and end-of-life drugs it should not necessarily apply only in such circumstances, the SMC has taken a slightly different approach in reaching the same outcome. As a result, the SMC modifiers are slightly more general in their application than the changes that NICE has made around the QALY measurement.
In my statement, I suggested that the modifiers might cover circumstances in which a drug improves life expectancy and quality of life, a drug benefits a particular subgroup of patients, a drug provides a bridge to another drug, or there is an absence of other therapeutic options. Obviously more detail will be available when the modifiers are published.
Richard Simpson's second question touched on the definition of demonstrable benefit. That will differ at different stages of the process. In making its general recommendations—and in defining demonstrable benefit—the SMC uses the QALY, which is based on the evidence of life years gained through clinical trials and views on the quality associated with that gain. When a drug is not recommended and a patient takes advantage of exceptional prescribing arrangements, the demonstrable benefit will be much more related to their specific circumstances.
There is a need for, and scope within the arrangements for, clinical discretion and judgment to play a bigger part. As Richard Simpson rightly says, these are complex issues. We can set out guidance and frameworks to try to simplify the issues but, ultimately, individual decisions have to be made in individual cases.
I welcome the statement enormously. Its effect is to allow co-payment when a patient and clinician believe that it is necessary, and it extends the availability of a much wider range of drugs through the NHS than hitherto, which is welcome.
I will address the same issue as Richard Simpson. Given the new modifiers and the emphasis on quality of life, can the cabinet secretary confirm what residual role she anticipates cost will have in the approval of a specific treatment? Has she given any thought to the estimate of the additional cost that might be necessary in respect of the drugs and medicines budget, and does she expect it to be accommodated within the current underspend? Finally, will she visit the new Beatson cancer research institute in Glasgow? I know that staff would be happy to see her.
I am always delighted to visit the Beatson. The new Beatson and everything that is in it is extremely beneficial, and I would be delighted to take up such an invitation.
Jackson Carlaw raised two issues. One, on modifiers, followed on from Richard Simpson's question. He asked, in light of my announcement, what weight the SMC will give to cost. Cost-effectiveness, rather than just cost, is still central to the SMC's decisions; it has to be in any system in which we are trying to deliver value for money and value to the taxpayer. The cost assessments do not go out of the window because of what I announced today. However, it opens up the possibility in particular circumstances—not in every assessment that the SMC makes but in particular circumstances—of a drug being approved even when the economic evidence does not necessarily support that. That could happen if the additional clinical benefits outweigh the economic evidence, although it is important to stress that the cost-effectiveness part of the equation still stands strongly.
I will not pretend that improving access to drugs in the NHS comes without any kind of cost implication. I said at the outset that we already spend around 10 per cent of the NHS budget on drugs. One of the advantages of the new PPRS scheme—the agreement between the United Kingdom health departments and the ABPI—is that, because of the range of factors agreed in that scheme, we are hopeful of making significant savings in the drugs budget over the coming years, which will give us scope to absorb some of the costs associated with what I have announced today. At the heart of what I have announced today is better and more equitable access to drugs in the NHS. Ultimately, that also provides value for money.
I corroborate that this is a complex and technical area. I was interested in the cabinet secretary's comment that the public had difficulty navigating it—I had difficulty navigating it, with two degrees and a clear head. I welcome the commissioning of health rights information Scotland to produce better and clearer information for the public. Can I ask that it tries the information out on me, so that I can understand the arrangements?
I am sure that I can arrange for Christine Grahame to be a one-person focus group. I think that she was making a serious point in the midst of that: the situations can be very complicated. Clinicians sometimes find it difficult to navigate their way through the system, and patients, particularly at very stressful times of their lives, find it even harder. We should do anything that we can to simplify the processes and make them more understandable.
Does the cabinet secretary accept that the co-payment arrangements that she has announced today will be tolerable only if universal access to new drugs is extended rather than reduced? In that regard, will she vigorously pursue a range of risk-sharing arrangements with the various pharmaceutical companies, whether it is a free first cycle of treatment, such as is being offered in England with the kidney cancer drug Sutent, or the more typical risk-sharing arrangement that pertains, for example, in relation to the myeloma drug Velcade?
Yes—I agree strongly with Malcolm Chisholm. I said in my statement that co-payment should be the exception, not the rule. It is right that we provide guidance and a framework on such cases, but my priority and objective is improving access to drugs on the NHS, which was the main thrust of my statement. I believe passionately that that is the right approach.
I am glad that Malcolm Chisholm asked about patient access schemes, because in many ways that issue is the most significant aspect of my announcement. I have agreed that we will set up a framework for assessing patient access schemes. Of course, it will be for the drugs companies to produce proposed schemes, which will then be judged. Under the new arrangements, which are being finalised, a proposed patient access scheme will be assessed before the SMC is asked to carry out its usual evaluation. If the scheme has been approved or recommended, the SMC will be able to take that into account. Examples of patient access schemes south of the border—such as the recent one involving the drug Lucentis—demonstrate the potential for such schemes, as long as they are assessed properly, to help us open up access to new and innovative drugs, which is what we all want.