New Medicines Reviews 2013

The Process for Medicines appraisal

3. The present process in Scotland

3.1. The Scottish Medicines Consortium (SMC) was established in 2001 to provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) in Scotland concerning the status of all newly licensed medicines, all new formulations of medicines already licensed, and new indications for established medicines (licensed from January 2002) as close to launch as possible. Its first advice was produced in April 2002 (Hems et al 2012). It meets monthly on the first Tuesday of the month. SMC does not assess vaccines, branded generics, blood products, and diagnostic drugs. SMC is a consortium of NHS Scotland's 14 Health Boards.

It also provides a horizon scanning service so that NHS Boards can be aware of new medicines in the drug development process and thus plan their budgets more effectively.

3.2. The membership of SMC (and its subcommittee, the New Drugs Committee [NDC]) consists of staff (health professionals and senior managers) from the Area Drug and Therapeutics Committees (ADTCs) in Scotland who serve for three years in the role. On SMC, there are also two representatives from the Association of British Pharmaceutical Industries (ABPI) and lay representatives, termed "public partners" who are appointed after interview. The full membership of the main committee is around 40 and that of the NDC around 20. The current membership is available on the SMC website (www.scottishmedicines.org.uk). Meetings are accepted as quorate with an attendance of 50% plus one voting member (i.e. excluding attendees or observers).

Both committees meet monthly. The Committees are supported in their deliberations by pharmacists experienced in critical appraisal and by health economists. Neither the NDC nor SMC meeting is held in public. All members are required to adhere to stringent requirements to declare relevant conflicts of interests in the manufacturers of the medicines being appraised, or in manufacturers producing competitor products.

3.3. The New Drugs Committee conduct a rapid assessment of the submissions from pharmaceutical manufacturers and then make recommendations to SMC concerning the clinical effectiveness and cost effectiveness of the medicine. Advice is generally arrived at by consensus, but a simple majority vote by full members of NDC (and SMC) can be held when necessary. NHS Boards are expected to follow SMC advice, but because most medicines appraised by SMC are for indications for which there are alternative treatments, the implementation of SMC accepted medicines is subject to local NHS Board decision. The Board can decide whether or not it will include the SMC accepted medicine in its formulary by reviewing the medicine in the light of other comparable medicines already available within the Board formulary or approved list for the same indication.

3.4. In a full submission, manufacturers are required to demonstrate that the medicine will either "provide additional health benefits that are valued by patients compared to current Scottish practice and that this is at a net cost to the NHS that offers acceptable value in relation to other uses of the same resources," or "offers equivalent levels of health benefit to patients at an equivalent or lower net cost to the NHS". (Anon. Working with SMC - A Guide for Manufacturers). The submissions are presented in a structured template to achieve efficiency and enhance the speed of the process, and consistency and comprehensiveness in information submitted. If the manufacturer wishes to make the case for use of the medicine only in one group within the licensed indication and not for the whole group represented by the licensed indications, a selective submission is possible. It is also sometimes referred to as 'niched' submission, and requires that the manufacturer should ensure that the proposed population for treatment is appropriate and valid within the licensed indication under consideration in the submission.

3.5. An abbreviated submission may be considered in certain circumstances e.g. for a new formulation of an established product, or for a medicine that has previously been accepted by SMC when the marketing authorisation is subsequently extended to include use in children or adolescents.

3.6. SMC may accept a medicine for use without restriction. In such case guidance from Scottish Government is that "there is a clear expectation that NHS Boards will consider it and will make it (or its equivalent) available" (Scottish Government 2012). It may sometimes recommend restricted use. The restriction may be for a more limited indication or patient population than the licensed indication. SMC can also issue advice that the product should not be recommended for use in Scotland. Manufacturers can resubmit to SMC on the basis of new scientific information, and also have the option to ask for an independent review of the decision. An Independent Review Panel then reconsiders the originally submitted evidence and reports its findings to SMC. If SMC issues "not recommended" advice in relation to a particular medicine, NHS Boards do not have to make it routinely available. Nevertheless, medicines "not recommended" by SMC, including those medicines "not recommended" due to a non-submission, may be made available under certain circumstances through individual patient treatment requests (IPTRs).

Recent guidance from the Chief Medical Officer for Scotland outlines good practice guidance for IPTRs (Chief Medical Officer 2011). It states that they should not be used to circumvent established assessment processes. It also notes that when SMC / NHS QIS advice is still being awaited, the policy position across Scotland is that it would not be expected that such a medicine would be routinely prescribed. The guidance does acknowledge that in such circumstances, NHS Boards may wish to consider IPTRs "where the clinician responsible for the patient believes a delay in treatment pending SMC/NHS QIS advice would result in a significant adverse outcome for the patient".

3.7. SMC, like NICE and AWMSG, bases its advice on an assessment of the cost of the medicine and the clinical benefits (likely extension of life and improvements in the quality of life) and these are commonly expressed in terms of the cost of the medicine per Quality-Adjusted Life Year (QALYs) gained. Although SMC does not have a formal cost effectiveness threshold, like NICE and AWMSG, it generally recommends clinically effective new medicines when the incremental cost effectiveness ratio or ICER (incremental costs and benefits associated with the new medicine compared to those of an appropriate existing comparator) is lower than £20,000. However the cost per QALY is only one factor informing SMC's broader judgement of the value of a new medicine (see 3.8).

3.8. Additional factors termed "modifiers" may be used to allow greater flexibility in certain circumstances. This allows SMC to accept greater uncertainty in the health economic case. In some cases it allows acceptance of or a higher cost per QALY. There are specific modifiers that apply to orphan drugs, with this specific EMA designation.

Some of the modifiers listed by SMC as potentially relevant in some cases (e.g. when the cost per QALY is high) are:

• Evidence of a substantial improvement in life expectancy (with sufficient quality of life to make the extra survival desirable). Substantial improvement in life expectancy would normally be a median gain of 3 months but the SMC assesses the particular clinical context in reaching its decision;
• Evidence of a substantial improvement in quality of life (with or without survival benefit);
• Evidence that a sub-group of patients may derive specific or extra benefit and that the medicine in question can, in practice, be targeted at this sub-group;
• Absence of other therapeutic options of proven benefit for the disease in question and provided by the NHS;
• Possible bridging to another definitive therapy (e.g. bone marrow transplantation or curative surgery) in a defined proportion of patients;
• Emergence of a licensed medicine as an alternative to an unlicensed product that is established in clinical practice in NHS Scotland as the only therapeutic option for a specific indication

3.9. SMC recognises the category of "orphan drug" using the EMA definition - "one licensed for treating or preventing life-threatening rare diseases affecting fewer than 5 in 10,000 people in the European Union". During the appraisal process, SMC is prepared to accept a greater level of uncertainty in the calculation of cost effectiveness and a higher calculated QALY (when supported by a robust clinical and economic case) if other additional factors are present, namely whether:-

• the drug treats a life threatening disease
• whether it substantially increases life expectancy and/or quality of life
• it can reverse, rather than stabilise, the condition
• or bridges a gap to a "definitive" therapy,

This list is not exhaustive, however.

SMC does not recognise the category of medicines for extremely rare conditions known as ultra-orphan medicines and so has no specific policy for their appraisal, although they clearly still fall into the EMA and (therefore SMC) orphan drug category. Ultra-orphan medicines were first separately identified by the Citizen's Council of NICE as those medicines licensed for the treatment of diseases with a UK prevalence of less than 1 in 50,000. This equates to around 100 prevalent cases in Scotland (NICE 2004). The low prevalence means that manufacturers of these medicines find it difficult to recoup the costs incurred in developing the drug and obtaining a marketing authorisation. The cost per patient is therefore generally very high with the effects that these medicines may not reach conventional "thresholds" for cost-effectiveness.

3.10. NHS Scotland accepts Patient Access Schemes proposed by the manufacturer of the medicine to improve the cost-effectiveness of medicines, so that if also deemed clinically effective, it is more likely to be approved by SMC and therefore patients will be able to access the medicine. NHS Scotland consider these schemes via a national body separate from SMC, The Patient Access Scheme Assessment Group (PASAG) consider those medicines:-

(i) that are not, or might not be, in the first instance found to be cost-effective by SMC

or

(ii) where a patient access scheme has been accepted in the context of a NICE Multiple Technology Appraisal (MTA). All PAS submitted with a NICE MTA must be evaluated for acceptability in Scotland by PASAG and the MTA endorsed by Healthcare Improvement Scotland (HIS)

3.11. SMC has established a Patient and Public Involvement Group (PAPIG), chaired by a Public Partner, to support and advise patient interest groups to make submissions to inform the HTA process. The stated aims of the group are listed on the SMC website and are to make recommendations to SMC on the development of public involvement opportunities; to monitor and report back to SMC on the effectiveness of public involvement opportunities where this information is available; to ensure that a patient/ carer perspective is prominent in all SMC assessments; to present a summary of the Patient Interest Group submissions, where these have been submitted to SMC meetings and to promote public awareness of, and involvement in, the work of SMC.

A report of the work of PAPIG in encouraging patient interest group involvement in SMC's HTA programme was published annually in the SMC annual report between 2001-02 and 2008.

3.12 Dialogue with the ABPI occurs via the User Group Forum (SMC UGF). SMC UGF consists of individuals representing the pharmaceutical industry together with selected members of SMC and NDC. Its role is to identify and resolve any issues relating to SMC's process for HTA.

3.13. In addition to its HTA role, SMC provides a horizon scanning service to named individuals within Health Boards who are involved in financial planning. This supports service planning, and is provided to key senior Health Board staff, after they have signed a confidentiality agreement, since some of the information is commercial-in-confidence. An annual report "Forward Look" has been produced each year since 2003. It projects estimates of the uptake of medicines, and the potential resultant net budget impact. This takes into account any likely replacement of existing medicines, as well as any estimated additional costs or savings associated with diagnostic testing, delivery and monitoring of the medicine.

3.14. SMC also hosts the Scottish Antimicrobial Prescribing Group (SAPG), a national clinical multi-disciplinary forum to support antimicrobial stewardship by promoting rational, safe and effective antimicrobial prescribing use in NHS Scotland, both in primary and secondary care.

4. Comments received

Written comments were received from a range of organisations, including Patient Interest Groups, pharmaceutical manufacturers and health professional groups. In addition, around 25 individuals were interviewed, either separately or in groups, either face to face or by telephone. This section condenses the views received from those consultees in relation to SMC's appraisal process. Several comments were also received concerning the IPTR process. While not within the direct remit of this part of the review, we recognise that SMC's judgements have an impact on the IPTR process, so we have included some general comments, and have made two recommendations in this area.

4.1 Patient Interest groups

In the evidence submitted by patient interest groups, there was acknowledgement that all new medicines need to be evaluated for clinical effectiveness. There was also acknowledgement that that the work of SMC was rigorous, of high quality and rapid. There was also a request that the term ultra-orphan medicine be recognised and a request that consideration should be given to the development of a separate process for assessing ultra-orphan drugs. One suggestion was that the appropriateness of a separate body to assess orphan and ultra-orphan indications, similar to the Advisory Group for National Specialised Services (AGNSS) which operates in England might be considered.

Greater and more meaningful patient involvement was called for. A specific option suggested was that that individuals as well as organisations might be able to feed into the process. Feedback from SMC about the value and impact of the submissions would also be welcomed, so that patients who had spent time sharing their experiences for the submission could be assured that their contribution had been fully considered by SMC. There was also a call for a more transparent working process to foster trust, understanding and openness, with opportunities for a patient or patient representative to attend the meeting of SMC.

4.2. Pharmaceutical Industry views.

There was an acknowledgement that the SMC process resulted in fast and efficient decision-making and it was stressed that this element must be retained. Communication with SMC was felt to be good, but may be improved further in key areas such as scoping and choice of comparators. However concern was expressed by some that patients in Scotland do not have access to innovative medicines which were available in other nations of the UK, or in other European countries. It was felt that there was a need to ensure that there was "an efficient and caring end-to-end process for patients in Scotland to be able to access the appropriate medicines, with no gaps or harmful variations between SMC, SIGN, Health Board Area Drug and Therapeutics committees, Healthcare Improvement Scotland or Regional Planning Groups, in the development of local protocols and the availability for the patient".

A view was expressed that any SMC "accepted" medicine should be available to patients in a timely manner, and there were therefore related concerns about the process by which such medicines were considered for inclusion in individual formularies, and the speed of this process. This included the need to have a simple process for non-formulary requests of accepted medicines.

There was also a desire expressed that the Health Technology Assessment (HTA) criteria should be reviewed, and concern was expressed that the introduction in the use of modifiers had not had a major impact on the decision-making process or outcomes. In addition, it was noted that there were examples of poor implementation of SMC advice, and that a monitoring tool was necessary to address this.

4.3. Views of health professionals and NHS managers in Scotland

There was widespread acknowledgement and support by this group of the quality SMC's HTA process, as well as its speed, rigour, comprehensiveness and value for money. There was also strong support for the two-stage process in which NDC's advice is considered, and sometimes modified, by SMC. The engagement between SMC and clinicians in Scotland was also cited as strength. The independence of SMC in arriving at difficult decisions was greatly appreciated and consultees noted that this independence must be retained, as it is valued so highly by health professionals in NHS Scotland. It was also observed that by offering PAS schemes, SMC was improving access to medicines for patients, whilst also achieving value for money for NHS Scotland. However some concerns were expressed about the transparency of the use of the modifiers in the HTA process, and that that the process may not fully take into account the value of different stages of life and other societal influences.

Concerns were raised concerning the lack of uniformity of the IPTR process, including variation in time taken to decisions across Scotland.

4.4. Views of health economists

All the health economists involved with the SMC HTA process, some SMC core staff and other independent commissioned consultants, believed that the health economic component of the present SMC process was robust and efficient, even if further improvements were possible. All the health economists consulted stated that they believed the QALY to be still the best available measure of utility, whist recognising its weaknesses and deficiencies. They all stated that they believed that Quality Adjusted Life Year (QALY) methodology, when used appropriately, represents an effective tool to calculate cost-effectiveness of new innovative medicines in terms of off-setting the cost of the medicine against potential savings.

There was broad general support for having a policy for HTA of ultra-orphan as well as orphan medicines. It was felt to be very important that ultra-orphan products should undergo health economic appraisal, since there was an opportunity cost associated with the purchase of all medicines. The general view was that the NHS should not pay whatever premium price was required for medicines to treat patients with very rare diseases.

All felt that the use of modifiers was appropriate in certain circumstance. No-one had any criticisms of the "modifiers" identified, and felt them to be helpful in interpreting the health economic data. No potentially important new modifiers were considered to be missing in the existing list.

5. Findings

We were provided with all the relevant documents required to examine the HTA process in detail. The processes detailed in these documents were robust and appropriate for the purpose for which they had been developed.

5.1. The remit of Scottish Medicines Consortium (SMC) to provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) in Scotland concerning the status of all newly licensed medicines, all new formulations of medicines already licensed, and new indications for established medicines (licensed from January 2002) as close to launch as possible is unique in the UK, making it the most comprehensive of the three existing UK HTA bodies (NICE, SMC and AWMSG). When comparisons have been made between the recommendations of these HTA bodies, they have generally shown reasonably close concordance (Cairns 2006, Webb et al 2006, Dear et al 2007, Barbieri et al 2009). The speed and timeliness of the process is an important strength. One factor associated with variation in uptake of advice may be delay between the UK launch of a medicine and initial advice from the HTA body (Bennie et al 2010) so the timeliness associated with the SMC process (without sacrifice of rigour) is valuable in promoting more consistent uptake of advice.

The service which SMC provides is of great benefit to the Health Boards in ensuring that clinically effective and cost effective medicines are available in a timely fashion. The need for timely SMC advice, as early as possible after launch of a new medicine in the UK was illustrated by a review of SMC "not recommended" decisions. There was a pattern of increasing use of the new medicine the further the SMC advice was issued from the launch date (SMC Evaluation Project Team 2008). There is also evidence that since SMC began its work, the decisions made by ADTCs concerning local implementation of medicines have been more consistent and comprehensive and that it has reduced duplication of effort. (Hems et al 2012).

Its horizon scanning service provides valuable early intelligence in a timely manner so that NHS Boards plan their budgets as effectively as possible, given the uncertainties of the drug development process. The annual report "Forward Look" is of high quality, comprehensive and informative in this regard.

5.2. The membership of SMC (and its subcommittee, the New Drugs Committee [NDC]) is appropriate and representative of those groups which should be expected have an influence in the process. This includes having representatives from the Association of British Pharmaceutical Industries (ABPI) and "public partners" as lay representatives. SMC and NDC meet sufficiently frequently to provide a timely HTA service, generally the quickest of the three UK services. SMC's committees and processes are strongly supported in their work by experienced pharmacists and health economists.

5.3. It adds to the efficiency of the process that NDC first conducts a review of the submissions concerning the clinical effectiveness and cost effectiveness of the medicine. This allows SMC to then also take broader matters into account, including societal issues.

5.4. The documentation developed to support the appraisal of full submissions is well-structured, enhancing the efficiency of the process. The information provided to manufacturers on the website in relation to full submission is clear and informative.

5.5. The approach of allowing abbreviated summaries allows flexibility and is proportionate. The information provided to manufacturers on the website in relation to full submission is also clear and informative.

5.6. The existence of an Independent Review process adds to the responsiveness and robustness of the HTA process. It is appropriate that the Independent Review panel feeds back its findings to SMC to inform any subsequent HTA decision.

5.7. SMC is not alone in using the cost of the medicine per Quality-Adjusted Life Year (QALYs) gained in the process used to assess the cost effectiveness of medicines. NICE and AWMSG have adopted the same measure. The US Panel on Cost-Effectiveness in Health and Medicine has also chosen the QALY when making judgements around cost-effectiveness (Weinstein et al 2009). The QALY takes into account the increased survival achieved by treatment and the quality of that increased life. It also allows different treatments to be compared for different conditions, thus affording a "common currency" for decision making (National Institute of Health and Clinical Excellence 2008).

The assumptions underlying the QALY are well described by Weinstein and colleagues (Weinstein et al 2009). The QALY (sometimes termed the "conventional QALY") does not take into account issues of fairness and equity. That is why QALY estimates are only one component of the HTA process, and must be used alongside judgements of the importance of these broader societal issues, including social value judgements (Littlejohns et al 2012). Rawlins has stated that such issues are societal because they "relate to society rather than basic or clinical science" (Rawlins MD 2012) He identifies some of these social values, including whether the NHS should be prepared to pay more to extend the life of a child compared with an adult, whether treatments which prolong life at the end of life should be considered more favourably than others, whether greater weight should be given to medicines for treatments for serious conditions, and whether the NHS should be prepared to pay premium prices for treatments for very rare conditions. He points out that consideration of such social values in decision making should be determined by the values of the public who own and fund the NHS (Rawlins MD 2005). This issue is also discussed later in 5.7.

Other criticisms of the QALY include that it lacks sensitivity when comparing two competing but similar medicines, and when assessing the treatment of less severe health problems (Phillips CJ 2005). It has been noted that the QALY may be of less value in chronic diseases, where quality of life is more important than survival in calculating the QALY and the QALY assumes that the utility of a health state is not affected by the time the patient spends in that health state. Phillips has also pointed out the criticism that QALYs may attach inadequate weight to emotional and mental health problems (Phillips CJ 2005). However it was the universal view of the health economists consulted that QALYs remain the best available explicit measure of cost-effectiveness, and are appropriate for the comparisons made during HTA of medicines. They were also unanimous in the view that the use of the QALY represents an effective tool to calculate cost-effectiveness of innovative medicines in terms of off-setting the cost of the medicine against potential savings. They should be considered alongside all of the other available sources of evidence by NDC and subsequently SMC.

We note that SMC does not have a formal cost effectiveness threshold because the QALY is only one (albeit important) factor informing the process of arriving at a recommendation on a specific medicine. SMC's policy is clearly stated on the website and is that "a cost per QALY of under £20,000 is generally considered acceptable value for money. For a medicine with a cost per QALY between £20,000 and £30,000 SMC might accept this if the medicine gives significant benefits over existing treatments". This policy is also closely in line with the policies of the other HTA bodies in the UK (NICE and AWMSG).

As stated earlier, decisions about medicines should not be based on evidence of relative costs and benefits alone. Littlejohns and colleagues have recently examined the websites of SMC, NICE and AWMSG to references to social value statements that have a role to play in health policy decision making (Littlejohns et al 2012). They found that all three HTA bodies contained statements addressing important aspects of the framework for social values applicable to health priority setting outlined previously (Clark and Weale 2011)

5.8. We agree with the principle that the use of modifiers may allow SMC to accept greater uncertainty in the health economic case or to allow acceptance of or a higher cost per QALY in some cases. The modifiers listed earlier (2.8) are all reasonable and we cannot suggest any major factors which are not present in that list.

5.9. In the same way, the use of additional factors in appraising orphan drugs is a valid approach, and the factors identified by SMC are all relevant, we cannot identify any major omissions in the list, which SMC clearly acknowledges in its supporting documents is not an exhaustive one.

The issue of ultra-orphan medicines deserves special mention. In 2004, NICE set up a "Citizens Council", consisting of 30 individuals (none of them health professionals) living in England and Wales, to help provide advice about social values relating to HTA decision-making. Sixteen members considered that NHS should consider paying premium prices for drugs to treat patients with very rare diseases, providing certain conditions applied. Four members considered that the NHS should pay whatever premium price was required to purchase medicines to treat patients with very rare diseases. Seven felt that the NHS should not consider paying premium prices for medicines to treat patients with very rare diseases. Instead decisions should be made using the same criteria as those used for treatments for conditions that were not considered rare. The main criteria that the Council felt should be considered in the decision were in decreasing order of importance, the degree of severity of the disease, whether the treatment would provide health gain, rather than just stabilisation of the condition, or if the disease or condition were life-threatening. (NICE2004).

In contrast, a recently published choice-based experiment in over 4000 UK adults using web-based surveys did not support the special funding status for treatments of rare diseases per se (Linley and Hughes 2012). The experiment did support the use of the criteria for medicines treating severe diseases, those addressing unmet needs, those that were innovative (provided they offered substantial health benefits), and had wider societal benefits. However ultra-orphan diseases, as well as being extremely rare, are often severe, life threatening or chronically debilitating (Hughes et al 2005). In addition, medicines developed to treat them may also fulfil several other criteria listed above that the public consider as important in making choices.

One HTA body in the UK (AWMSG) has appraised ultra-orphan medicines since 2002 and has developed a policy to address HTA of these particular medicines, and it's most recent policy (approved in July 2012) reads as follows.

"AWMSG / NMG (New Medicines Group, analogous to the NDC in Scotland) will consider the same criteria for clinical effectiveness and cost-effectiveness of ultra-orphan medicines as those applied to other medicines. The rarity of the disease is not, in itself, a reason why an economic assessment cannot be made. However, AWMSG / NMG recognise that the evidence base will necessarily be weaker. AWMSG also recognise that the incremental cost-effectiveness ratios (ICERs) of many ultra-orphan medicines will exceed the threshold cost-effectiveness range. In such cases, AWMSG / NMG will consider evidence on the following to inform their decisions (in descending order of priority):

• The degree of severity of the disease as presently managed, in terms of quality of life and survival
• Whether the medicine can reverse, rather than stabilise the condition
• Whether the medicine may bridge a gap to a "definitive" therapy (e.g. gene therapy), and that this "definitive" therapy is currently in development
• The innovative nature of the medicine. AWMSG / NMG will consider whether the medicine:

I. represents a significant improvement on existing therapy (e.g. the medicine is able to treat a condition where there was previously no effective treatment) and;

II. whether it can plausibly generate substantial health gains over existing treatments for the individual (e.g. >1 quality-adjusted life year [QALY]) "

III. "Ultra-orphan medicines are appraised on a case-by-case basis, and all patients receiving approved medicines should be entered into registries for recording prospective measures of clinical outcome".

"An advice review date may be set to ensure that additional clinical trial evidence or clinical audit data is reviewed, and this may require an additional submission" ( All Wales Medicines Strategy Group 2012).

We note the strength of views expressed by several consultees that ultra-orphan medicines should be recognised as a distinct and important and group of medicines within the orphan medicine category. Therefore we recommend below that SMC consider developing a policy for ultra-orphan medicines (see recommendations in Section 6 and also in Summary).

5.10. We endorse SMC's view that the use of Patient Access Schemes is a valuable approach in improving the cost-effectiveness of medicines, and therefore patient access to medicines. The criteria for accepting these schemes used by SMC are appropriate and robust. It is also appropriate that the process in Scotland is at arms-length to SMC via the separate body, the Patient Access Scheme Assessment Group (PASAG)

5.11. The Patient and Public Involvement Group (PAPIG) plays an important role in encouraging patient and carer involvement in SMC's work. The stated aims of the group as listed on the SMC website are comprehensive and chosen to promote public awareness of, and involvement in, the work of SMC.

The reports of the work of PAPIG published annually in the SMC annual report for the period in which they are available (between 2001-02 and 2008) are clear, informative and promote transparency.

5.12. Discussion with the pharmaceutical industry through the vehicle of a User Group Forum (UGF) is important in ensuring that the processes are responsive to the companies submitting their medicines for advice and SMC UGF is a useful way of ensuring relevance and usability of SMC's HTA processes.

5.13. In addition to its HTA role, SMC has a horizon scanning service on behalf of Health Boards. This supports financial planning, and is provided to key senior Health Board staff, after they have signed a confidentiality agreement, since some of the information is commercial-in-confidence. An annual report about the horizon scanning role, "Forward Look" has been produced each year since 2003. It gives estimates of the estimated uptake of medicines, and the estimated resultant net budget impact. This takes into account any likely replacement of existing medicines, as well as any estimated additional costs or savings associated with diagnostic testing, delivery and monitoring of the medicine. This publication is clear, informative and appreciated by those with the responsibility for financial planning, and SMC are to be commended for it.