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SMC Minutes - Monday, 30 September 2002


Present:

Professor David Lawson (Chairman); Professor Martin Brodie; Mrs Michelle Caldwell; Professor Karen Facey; Dr John Forbes; Dr Barclay Goudie; Dr David Hood; Ms Moira Howie; Mrs Chris McBeath; Dr Chris Lush; Ms Wendy Nganasurian; Dr Marianne Nicholson; Dr Ken Paterson; Dr Philip Rutledge; Ms Fiona Scott; Dr Sandy Simpson; Ms Angela Timoney; Ms Helen Tyrrell; Mr Mike Wallace; Professor David Webb;Dr Leslie Wilkie

In Attendance:

Dr Corrie Black; Mrs Jill Mitchell; Mr Rob MacPhail; Ms Rosie Murray; Ms Pamela Warrington

Apologies:

Mr Jeff Ace; Dr Keith Beard; Mrs Marion Bennie; Mr Tom Divers; Ms Morag Ferguson; Professor Angus Mackay; Mr Chris Nicholson; Dr Brian Paice; Dr Keith Ridge; Dr John Webster; Dr Derek Yuille; Mr Hector Mackenzie; Mr Hugh Whyte

1 Welcome and Apologies for Absence

1.1 The Chairman welcomed members to the meeting.  Apologies for absence were noted.

2 Declarations of Interest

2.1 The Chairman requested that members declare interests in the products to be discussed and the comparator drugs as noted on the assessment reports.

3 Minute of the Previous Meeting (03.09.02)

3.1 The minutes of the meeting of 3 September, 2002, were agreed as an accurate record of the meeting.

3.2 The Minutes of the meeting of 3 September, 2002, will be posted on the website on Friday 4 October, 2002.

4 Matters Arising From the Previous Minutes

4.1 Insulin glargine (Lantus®) (No. 11/02): Aventis

4.1.2 The Chairman advised that the recommendation for Insulin Glargine (Lantus®) for the treatment of patients with diabetes mellitus, will be posted on the SMC website on Friday 4 October, 2002.

4.2 Tacrolimus ointment 0.1% and 0.03% (Protopic®) (No. 12/02): Fujisawa

4.2.1 The Chairman advised that the recommendation for Tacrolimus ointment 0.1% and 0.03% (Protopic®) for the treatment of adults with atopic dermatitis intolerant of or unresponsive to conventional treatments, and for children aged 2 years or over who are unresponsive to conventional topical therapies will be posted on the SMC website on Friday 4 October, 2002.

4.2.2 It was highlighted that the recommendation for Tacrolimus stipulated that a register of recipients should be established and maintained and clarification was sought regarding responsibility and resource allocation.  The Chairman advised that SMC are encouraging the development of a register for Tacrolimus and other products, but do not have adequate resources to maintain.  He advised that discussions are ongoing with NHS Quality Improvement Scotland to determine feasibility of resources.

4.3 Drotrecogin alfa [activated] (Xigris®) (No. 13/02): Eli Lilly

4.3.1 The Chairman advised that the recommendation for Drotrecogin alfa [activated] (Xigris®) for the treatment of patients with severe sepsis with multiple-organ failure will be posted on the SMC website on Friday 4 October, 2002.

4.4 Public Involvement

A document regarding public involvement detailing guidance for patient representative organisations on submission of evidence was tabled for review. Discussions are ongoing regarding the involvement of patients in the decision making process through voluntary organisations but the process will depend on pharmaceutical companies providing information to the voluntary sector. The ABPI representative stated that industry would welcome the involvement of voluntary organisations. The group agreed that this is an excellent concept and agreed to the Patient Involvement Group setting up an initial meeting with 10 voluntary organisations. The Chairman requested members review the document and feedback comments to the secretariat within the next couple of days. Concern regarding secretarial resource was highlighted and this will be monitored. Appended to  Minutes (Appendix I).

5 Appeals Update

5.1 The Chairman advised that minor modifications are being made to the Appeals/Review document.  The revised document will be attached to the minutes and posted on the SMC website imminently.  Appended to Minutes (Appendix II).

6 Clinical Trials Pre/Post Marketing

6.1 Following on from previous discussion regarding Scottish wide guidance regarding clinical trials pre/post marketing, a paper was presented for discussion. It was noted that many issues are already covered by ABPI codes and guidance and the Chairman requested members take note of the contents.  The paper will be appended to the minutes as a public record (Appendix III).  Appendices to the paper are available at the secretariat upon request.

7 New Drugs Committee Update (Update from NDC Chairman)

7.1 Health Economic Sub Group

7.1.1 An update from the Health Economic Sub Group was provided. The main points noted were:

  • A column has been added to the product list highlighting if a review by NICE has taken place or is imminent.
  • Health economic methods worked have been reviewed.
  • The use of clinical experts would offer huge benefits.
  • A sub-group of the User Group Forum has been formed to revise the current submission form and their advice will be reported to the SMC.

7.2 Resource to maintain and monitor register of patients

7.2.1 Clarity regarding resource allocation to maintain and monitor register of patients was sought. It was confirmed that discussions are underway (see point 4.2.2).

7.3 Competitor submissions

7.3.1 A request was made for competitor submissions to be shown to companies as examples of good practice and clarity regarding confidentiality was sought. The ABPI representatives confirmed that individual companies do not wish their submissions to be used in this way as examples, for commercial reasons.   

8 NDC Recommendation Reports

8.1 Bexarotene (Targretin) (No. 14/02): Elan Pharma

8.1.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

8.1.2 The SMC Vice Chair provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and amendments were noted in relation to the recommendation document.  Bexarotene (Targretin) was recommended for restricted use within NHS Scotland for the treatment of patients with advanced (stages IIb or III) cutaneous T-cell lymphoma.

8.1.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 October, 2002.

8.1.4 The Chairman highlighted that a recommendation context has been added to the recommendation providing a summary of documents used in assessment. The group agreed that this is an excellent idea.  The recommendation context will be appended to future press releases.

8.2 Omega-3-Acid Ethyl Esters (Omacor) - Treatment of secondary prevention after MI (No. 15/02): Solvay Healthcare Ltd

8.2.1 No declaration of interests were recorded in relation to this product and the comparator drugs.

8.2.2 The NDC Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation. Detailed discussion followed and amendments were noted in relation to the recommendation document. Omega-3-Acid Ethyl Esters (Omacor) was recommended for general use within NHS Scotland as an additional treatment for the secondary prevention after myocardial infarction.

8.2.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 October, 2002.

8.3 Omega-3-Acid Ethyl Esters (Omacor) - Treatment of hypertriglyceridaemia (No. 16/02): Solvay Healthcare Ltd

8.3.1 No declarations of interest were recorded in relation to this product and the comparator drugs.

8.3.2 The NDC Vice Chairman provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and amendments were noted in relation to the recommendation document. Omega-3-Acid Ethyl Esters (Omacor) was not recommended for use within NHS Scotland for the treatment of hypertriglyceridaemia.

8.3.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 October, 2002.

8.4 Escitalopram (Cipralex) (No. 17/02): Lundbeck

8.4.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

8.4.2 The SMC Vice Chair provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and amendments were noted in relation to the recommendation document.  Escitalopram (Cipralex) was not recommended for use within NHS Scotland for the treatment of major depressive episodes.

8.4.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 October, 2002.

8.5 Fondaparinux (Arixtra) (No. 18/02): Sanofi Synthelabo

8.5.1 Declarations of interest were recorded in relation to this product and the comparator drugs.

8.5.2 The NDC Vice Chair provided a detailed overview of the assessment, the key issues identified and draft recommendation.  Detailed discussion followed and amendments were noted in relation to the recommendation document. Fondaparinux (Arixtra) was recommended for use in NHS Scotland for patients for whom antithrombotic therapy is appropriate, recognising that other antithrombotic agents and other approaches to prophylaxis may be more suitable in some situations.

8.5.3 The SMC advice will be issued to ADTCs and NHS Boards on 4 October, 2002.

8.6 Anakinra (Kineret) - REVIEW (No. 05/02): Amgen

8.6.1 No declarations of interest were recorded in relation to this product and the comparator drugs.

8.6.2 The Chairman stated that this is the first SMC review procedure and provided an overview of the initial assessment and recommendation, stating that Anakinra was not recommended initially as it offers no proven clinical advantages over the other available biological agents (infliximab and etanercept) for the treatment of rheumatoid arthritis.  No economic model was provided with the submission.  No evidence was provided that patients who do not respond to the anti-TNF biological agents respond to anakinra.

8.6.3 The NDC Chairman provided a detailed overview of the review assessment, the key issues identified and draft recommendation.  Detailed discussion followed.

The NDC Chairman advised that Amgen had not presented any new information that had convinced the NDC to deviate from their original recommendation.

The group were carefully guided through the letter of appeal from the company and the NDC response to the points raised.

Guidance from the British Society for Rheumatology was reviewed and their conclusions noted.

It was reported that although the analysis of studies was thorough it still appeared that the drug is less effective than the other biological agents.  The relative efficacy of anakinra and TNF-a blockers in retarding radiological progression is not clear and no firm conclusion can be reached in the absence of a head to head trial of such agents.  It was recognised that it may offer benefits to particular patients who are eligible to receive the drug after all other anti TNFs have failed but there are no data to support this theory. 

It was highlighted that anakinra has been associated with a high incidence of sepsis and a common adverse effect of the drug is local injection site infections, although it was recognised that there are benefits in terms of administration.

It was reported that the new economic model provided by the company was a mapping exercise providing no primary data and no direct measure in the trials.  It was noted that in general the drug is slightly less effective than other biological agents and is as expensive and therefore not a cost effective option.

It was noted that NDC had made an initial error in the original recommendation stating that etanercept plus methotrexate was a licensed regime in EU, where it is not. Such a licence is in effect in USA.

It was identified that studies are still ongoing and that in the future there may be additional data, which may show the drug in a more favourable light. It was noted that NICE would review in August 2003, by this stage there should be additional data to review.  The Chairman advised that Anakinra will be reviewed by NICE next year and until then SMC recommendations would stand.

It was noted that the consortium disagreed with a comment in the economic response to the health economic model,  where it stated in the conclusion 'from a pragmatic policy viewpoint it could be argued that as we are already using etanercept/infliximab and anakinra has a similar, but inferior cost and effect profile, this drug should be considered part of the treatment strategy.'

It was agreed to include NDC review summary in the SMC response to the company.

Following extensive discussion, the group concluded that as the company have produced no additional data to indicate a susceptible target population for this expensive biological product which does not appear to be as effective as competitor products. A vote was taken with 2 members against the proposed recommendation and the remaining members in favour.  On the basis of currently available evidence anakinra should not be recommended for use in NHS Scotland.

8.6.4 The SMC advice will be issued to ADTCs and NHS Boards on 7 October, 2002.

9  Forthcoming Submissions

9.1 List of Forthcoming Submissions

9.1.1 A revised list of forthcoming submissions was reviewed.

9.2 Information to ADTCs/Website - SMC products under review

9.2.1 A list of products to be circulated to ADTCs was reviewed and agreed.  The document will be posted on the SMC website in the forthcoming weeks.
 

10 Communication

10.1 Disclosure of product information - update from ABPI

10.1.1 The ABPI representative confirmed that ABPI supports the inclusion of products in the published programme when information about the regulatory status of the product is in the public domain, or at any earlier date with the prior consent of the company concerned.

10.2 Update on Conference - Wearing Someone Else's Shoes in Northern Ireland

10.2.1 The Chairman provided an update and reported that there is considerable enthusiasm for Northern Ireland to join in the Consortium and that further feedback is awaited.

11 Any Other Business

11.1 Workload 2002/03

11.1.1 The Chairman congratulated the secretariat on the management of paperwork.   A document detailing proposed workload was reviewed.  It was identified that additional resources are required to assess the number of assessments targeted for each month as it is anticipated that between 5 and 7 submissions per month will be assessed from now on.   It is hoped that the work of the User Group and new guidance notes will prove beneficial.

11.1.2 SMC Meeting - 7 January, 2003

It was identified that due to the Christmas and New Year holidays it may be difficult to distribute paperwork to members for the meeting scheduled for 7 January, 2003.  It was therefore agreed to cancel the January meeting and hold an extended meeting on 4 March, 2003.  Members agreed to start the meeting at the usual time.  It was agreed that the NDC January meeting would also be cancelled with an extended meeting in February.

12 Date of Next Meeting

12.1 The date of the next meeting was confirmed as Tuesday 5 November, 2002,  at 12.30 pm (lunch from 12 noon), in HTBS Headquarters, Delta House, 50 West Nile Street, Glasgow G1 2NP. The Chairman advised that he will be on annual leave and the Vice Chair will lead the forum.


ADDENDUM TO MINUTES

Appendix I

GUIDANCE FOR PATIENT REPRESENTATIVE ORGANISATIONS ON SUBMISSION OF EVIDENCE

Introduction

The Scottish Medicines Consortium (SMC) is part of NHSScotland. It is a central point of advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) about the effectiveness of all newly licensed medicines, all new major formulations of existing medicines and any major new indications of established medicines. It benefits patients by providing NHSScotland with advice about the value of each new medicine and the patients for whom it would be of most help. SMC advice will help the NHS plan the speedy introduction of beneficial treatments across Scotland and, over time, will help reduce postcode prescribing.

A Question and Answer leaflet is attached to provide further information.

1. SMC normally meets on the lst Tuesday of each month. The assessment process is as follows:

2. Application for assessment by pharmaceutical company (the company provide epidemiological, clinical, economic and research data). Patient representative organisations have the opportunity to submit complementary evidence based upon a user perspective.

3. Economic, clinical and pharmaceutical data reviewed by the scientific subcommittee of SMC, called the New Drugs Committee (NDC),  which includes pharmacists, clinicians and economists. 

4. SMC meets to consider all relevant data including evidence related to the user perspective and makes its recommendation as to the availability, or not, of this medicine within NHSScotland.

5. NHS Boards and the pharmaceutical company advised of recommendation.

Recommendation published on SMC website one month after NHS Boards and the pharmaceutical company have been advised of the SMC recommendation.

Requests for a review of a previous SMC recommendation can only be made by those who have been involved at the submission stage.

What does SMC need from patient representative organisations?

The SMC has access to literature/research reviews, economic analysis and specialistist/expert opinion in relation to each medicine. However, in order to ensure that the SMC's recommendations are patient-centred it is important to hear the experience of those who suffer from the health problems to which a medicine is directed.

Because of the timescale involved, contributions from individual patients and carers cannot be made direct to SMC.  Patient representative organisations e.g. National Asthma Campaign, Diabetes UK, High Blood Pressure Foundation, etc. have the opportunity to present their evidence to the SMC. Interested individual patients/carers are encouraged  to contact the relevant representative group/organisation so that  their contributions can be added to the weight of evidence the organisation may wish to submit.

How can patient representative organisations submit information?

1. Monitor the SMC work schedule displayed on its website (www.scottishmedicines.org.uk) to check if any medicines due for review may be relevant to your organisation. If you do not have access to the Internet or this presents any difficulties you can contact SMC secretariat (0141 225 6999) who will provide a hard copy of the schedule, including large print version.

2. The schedule will show the name of the medicine, its therapeutic area (i.e. the health problems to which it is targeted) and the name of the pharmaceutical company that manufacture the medicine. You can contact the pharmaceutical company's Medical Information Department (MID) for more information about the medicine or ask SMC secretariate if the company has made available a contact name.

3. Contact SMC secretariat to ascertain submission deadline. It is essential that you meet this deadline since the timescale within which SMC works is extremely tight and material received outside the deadline cannot be considered.

4. Your submission will be acknowledged but no further communication will be entered into until SMC has made its recommendation.

5. SMC normally meets on the first Tuesday of each month. Recommendations are made public 4 weeks after the meeting week. SMC will not enter into further communications unless a request has been received to ask for a review of the SMC decision by one or more of the parties originally involved in the submission. (see website for Review Process).

What should a submission include?

It is important to remember that it is the user-perspective we are seeking and any evidence in relation to this will be extremely helpful to SMC. All information should be anonymised and organisations are reminded of the Data Protection Act and Human Rights Act. SMC will treat all submitted information in confidence. The submission should be no more than 4 sides of A4.

It will be helpful if your submission is divided into two sections: namely, general introductory information (this may be equally relevant to each submission you make)  and information specific to the medicine under consideration.

The kind of general information SMC would find helpful would include:

  • brief information about the organisation making the submission, its aims and membership
  • information about the level of disease in Scotland
  • general and specific issues relating to existing medicines/treatments
  • user needs/preferences and experiences in relation to medicines

Information specific to the medicine under consideration would include;

  • potential impact upon the lives of patients/carers
  • perceived specific advantages or disadvantages of this medicine or its mode of delivery
  • wider implications for sufferers/carers eg. reduced hospitalisation, less time off work, quality of life issues etc.

We would be grateful if you cite sources that inform your submission e.g. conversations with sufferers/carers; helpline data; focus groups;  published user-perspective literature; and so on,  in order that we have an indication of the breadth and depth of feeling.

How can we help you?

We will be holding a half-day workshop twice a year. During these informal workshops we will explain further the role of SMC and its related committees and elaborate on SMC processes. There will be plenty of opportunity to ask questions and listen to the experience of organisations who have submitted information.

If you have any problems accessing the internet or, for whatever reason, find it difficult to use the process as outlined above or to present information in the manner suggested, please contact SMC secretariat and we will attempt to facilitate your submission. It is not, however, possible for submissions to be made in person before the SMC.

We are keen to learn from experience and develop as user-friendly process as possible. To this end, we would be grateful for feedback and comment from organisations who have submitted information or may be considering so doing.

Public Involvement Subcommittee

Key Points:

1. Public Involvement is now recognised as a sine qua non in the effective working of all public bodies in the UK. NHS Scotland is committed to patient, carers and public involvement.
 
2. User perspective data, grounded within Scotland, is a valuable adjunct to clinical, pharmaceutical and economic data used to inform SMC decisions.
 
3. For logistic reasons, user perspective data should be submitted by patient representative organisations rather than individuals.
 
4. Representative organisations need access to SMC's forthcoming work schedule together with guidance on the process of making a submission and its content.

Recommendations

We recommend that SMC:

  • Continue to provide the public and their representative organisations with information about SMC via its website and, in particular, access to the Question and Answer section. The Q and A section must now be supplemented with one final question explaining public involvement.
  • Provide interested representative organisations with the names of medicines scheduled for SMC recommendations in the following 3 months, together with an indication of the therapeutic area and a contact number enabling them to liaise with the relevant pharmaceutical company. This information would normally be contained within SMC website but hard copies should be made available upon request via the Secretariat.
  • Develop a submission process that is economical of SMC secretariat resources. (see draft Guidance Sheet attached)
  • Provide guidance on both submission process and content in the form of a leaflet (see draft Guidance Sheet attached). Once again, this can be posted on SMC website but should be available in hard copy upon request via the Secretariat.
  • Once SMC has considered the draft Guidance Sheet cited above, following necessary revision, the Public Involvement Subcommittee seek early feedback from both the user group and voluntary health sector on this document.
  • Support representative organisations through a workshop, repeated twice a year. Support would also be available through members of the Public Involvement Subgroup.
  • When submissions from patient representative organisations are received, they will be distributed to all SMC  members with the agenda. At SMC a member of the Public Involvement Subcommittee will summarise the pertinent issues raised within the submission.
  • During the first year of operation, it may be necessary to proactively seek submissions from relevant organisations. A database will be developed from existing sources as a means of targeting such organisations.
  • Feedback will be sought  from both organisations who have and have not chosen to submit evidence in order that SMC may learn from their comments and refine its public involvement strategy.

Appendix II

PROCESS FOR REVIEWING DECISIONS

Background

Processes have evolved in the UK over a number of years in relation to the licensing of medicines which have stood the test of time and provide a good, appropriate model for an appeal process.

The concept of decisions being made by the CSM based on recommendations from the MCA staff, with disputes or disagreements being addressed by the wholly independent Medicines Commission (MC) appears to be effective and offers natural justice. It is acknowledged that scientific support of both the CSM and MC is provided by the MCA, but difficulties are avoided in cases of appeal by ensuring that work for the MCA is carried out by persons within the MCA who have not been involved in any way in the case in question.

SMC would like to see the principles of the CSM/MC also applied. However, it is recognised that some special circumstances may apply in Scotland. The pool of available expertise within Pharmatrak (who support SMC and NDC) may not be large enough to ensure that any review is handled by completely separate people. It is also recognised that the pool of experts from which the SMC and NDC seek to draw their expertise is limited.

Introduction

The open and consultative working procedures and methodology envisaged by the SMC for the New Drugs Committee (NDC), and those who will be preparing reports for the committee ie Pharmatrak will, it is hoped, reduce the number of occasions when reviews are required to a very small number. It is anticipated that a dialogue involving interested parties will be a distinguishing feature of the method of operation of all SMC activities.

However, it is recognised that there will be times when disagreements arise, and there is the need for a suitable process for use in these situations. Two types of situation can be envisaged: one relating to the process by which the SMC report has been developed, and one to the scientific conclusions reached. These are addressed separately below. Reviews may be triggered, using the procedures set out below, by the applicant company, or by other stakeholders with a genuine interest, but only those who have been involved in some way with the original application.

Parties utilising the Review process detailed below are expected to abide by the spirit as well as the letter of the process. NHSScotland, the Scottish Executive and the pharmaceutical industry have all worked together to develop SMC systems that provide as much flexibility as possible whilst also defining procedures for applicants and others to follow. For this approach to work effectively all parties are required to abide by both the spirit and the letter.

Process issues

Throughout discussions on its establishment the SMC has sought to be open and inclusive. A major effort has been made to remain flexible in the approach taken so that adaptations can be made as experience is gained. It is recognised that this may lead - at least initially - to some uncertainty, but this is to be preferred to the 'tablets of stone' approach.

In the event that any stakeholder feels aggrieved about the actual process followed by the SMC any concern can be expressed initially by direct discussion with the Secretariat and/or the Chairman either of the SMC itself or the NDC.

Companies, in submitting an original application to the SMC, have a duty and a responsibility to submit all relevant data in that application, as they do to the Licensing Authority.

Scientific issues

It is acknowledged that, in spite of the intention to have an inclusive process, there will be (hopefully) rare times when there is a genuine difference of scientific opinion and/or interpretation of available data. It should be kept in mind that at this stage the following organisations will have been involved in collating, reviewing and assessing the information submitted:

  • Pharmatrak
  • New Drugs Committee
  • Scottish Medicines Consortium

In such cases, it is envisaged that the following review procedure will be implemented. Given Scotland's population  there may be a need to go outwith Scotland for a sufficient number of experts to deal with the review procedure. 

A request for review will be submitted to the Chairman of the SMC who shall discuss the case with the applicant:

  • In the event that there is a complaint relating to SMC's processes this will be reviewed by SMC/NDC Senior Officers, and failing resolution may lead to Judicial Review.
  • In the event that it is agreed that there are substantial new data, the case shall in effect be treated as a new case and referred to Pharmatrak/NDC and go through the normal SMC process.
  • In the event that any disagreement cannot be resolved, the Chairman shall report the facts to the next meeting of the SMC itself, and establish a group to carry out an independent review of the science once it is satisfied that there are no preliminary issues relating to the substance of the appeal.
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