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SMC Minutes: Tuesday 01 March 2011

 

 

Minutes of the SMC Meeting
held on Tuesday 01 March 2011
NHS Quality Improvement Scotland, Delta House, 50 West Nile Street, Glasgow, G1 2NP

Present:
Professor Ken Paterson (Chairman), Mrs Laura Ace, Ms Sandra Auld, Professor James Barbour, Dr Keith Beard, Dr Keith Brown, Mrs Margo Biggs, Mr Robert Calderwood, Ms Sara Davies, Dr David Dunlop, Dr Jonathan Fox, Dr John Gemmill, Dr Barclay Goudie, Dr Jan Jones, Professor Stephen Lawrie, Dr Chris Lush, Dr Frances Macdonald, Dr John McElhinney, Mrs Margo McGurk, Dr Paul McNamee, Dr Simon Maxwell, Dr Mercia Page, Dr Andrew Power, Dr Brian Robson, Mr Keith Thompson, Ms Angela Timoney, Mrs Sheila Tunstall-James, Dr Andrew Walker.

In Attendance: 
Mrs Corinne Booth, Ms Jennifer Boyle, Mrs Helen Cadden, Ms Eilidh Clark, Ms Jennifer Devine, Mrs Susan Downie, Ms Dale Gracie, Mr Steven Laggan, Mrs Anne Lee, Ms Marie McHenery, Mrs Anne Murray, Ms Rosie Murray, Ms Emma Riches, Ms Alex Robertson, Mrs Maureen Stark, Ms Lyndsay Steel, Ms Rona Steven, Mr Neil Stevenson, Mr Taylor Wylie.

Apologies:
Ms Ailsa Brown, Mr Colin Brown, Professor Scott Bryson, Dr Jennifer Burns, Mr Dave Carson, Dr Dominic Culligan, Mr Stephen Ferguson, Dr Jacqui Howes, Dr Alan MacDonald, Dr James McLay, Mrs Sandra McNaughton, Ms Aileen Muir, Professor Dilip Nathwani, Ms Veronica Moffat, Dr Anthony Ormerod, Dr Robert Peel, Mrs Catherine Tait, Dr Sarah Taylor, Mr Alistair Thorburn, Professor David Wray.

1. Welcome and Apologies for Absence

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

1.2 A welcome was extended to the following observers:

• Mrs Helen Cadden, Public Partner Designate
• Mrs Anne Murray, Public Partner Designate
• Ms Lyndsay Steel, Prescribing Support Pharmacist, Port Glasgow Health Centre, who has joined SMC as a Clinical Assessor on a part-time basis.
• Undergraduates from Dundee Medical School, who are undertaking a module on “Prescribing: Right Drug, Right Patient, Right Time”:Jennifer Boyle, Steven Laggan, Neil Stevenson,Taylor Wylie, Jennifer Devine,  Dale Gracie, Rona Steven, Eilidh Clark.

1.3 Chairman’s ThanksMrs Margo Biggs and Mr Keith Thompson, Public Partners, attended their last meeting, having completed their term of membership.  The Chairman thanked them both for their significant contributions to the work of SMC and their active involvement in developing patient and public involvement.  The Chairman expressed his good wishes to them for the future.

2. Declarations of Interest

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

3. Minutes of the Previous Meeting (01 February 2011)

3.1 The minutes of the SMC meeting held on 01 February 2011 were accepted as an accurate record of the meeting.

4. Matters Arising

Deferred Submission

4.1 pazopanib 200mg, 400mg film-coated tablets (Votrient®)  GlaxoSmithKline UK SMC No. (676/11)

The SMC advice for pazopanib (Votrient®), for first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease, will be published on the SMC website on Monday, 07 March 2011.

Full Submissions

4.2 dalteparin sodium, 5,000IU/0.2mL, 7,500IU/0.3mL, 10,000IU/0.4mL, 12,500IU/0.5mL,  15,000IU/0.6mL, 18,000IU/0.72mL solution for injection (Fragmin®) Pfizer Ltd   SMC No. (683/11)

The SMC advice for dalteparin sodium (Fragmin®), for the extended treatment of symptomatic venous thromboembolism (VTE) and prevention of its recurrence in patients with solid tumours, will be published on the SMC website on Monday, 07 March 2011.

4.3 adapalene 0.1%/benzoyl peroxide 2.5% gel (Epiduo®) Galderma SMC No. (682/11)  
 
The SMC advice for adapalene (Epiduo®), for cutaneous treatment of acne vulgaris when comedones, papules and pustules are present, will be published on the SMC website on Monday, 07 March 2011. 
                                                                                     
4.4 vernakalant 20mg/ml concentrate for solution for infusion (Brinavess®) MSD Ltd SMC No. (685/11)

The SMC advice for vernakalant (Brinavess®), for rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, will be withheld pending confirmation of licence and availability.

4.5 vinflunine ditartrate 25mg/ml concentrate for solution for infusion (Javlor®) Pierre Fabre Ltd    SMC No. (686/11)       
                                                                 
The SMC advice for vinflunine ditartrate (Javlor®), for monotherapy, for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract (TCCU), after failure of a prior platinum-containing regimen, will be published on the SMC website on Monday, 07 March 2011.

4.6 exenatide, 5 or 10 micrograms, solution for injection, pre-filled pen (Byetta®) Eli Lilly and Company Limited SMC No. (684/11)

The SMC advice for exenatide, (Byetta®), for the treatment of type 2 diabetes mellitus in combination with thiazolidinediones with or without metformin in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies, will be published on the SMC website on Monday, 07 March 2011.

Resubmission

4.7 botulinum toxin type A 50 unit, 100 unit and 200 unit powder for solution for injection (Botox®) Allergan Ltd SMC No. (80/03)

The SMC advice for botulinum toxin type A (Botox®), for the treatment of focal spasticity, including the treatment of wrist and hand disability due to upper limb spasticity associated with stroke in adults, will be published on the SMC website on Monday, 07 March 2011.

Abbreviated Submissions

4.8 adrenaline tartrate 150 and 300 microgram solution for injection in a pre-filled pen (Jext®) ALK-Abelló Ltd SMC No. (687/11)

The SMC advice for adrenaline tartrate (Jext®), for emergency treatment of severe acute allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise induced anaphylaxis, will be withheld pending confirmation of licence and availability.

4.9 sildenafil citrate 0.8mg/mL solution for injection (Revatio®) Pfizer UK   SMC No. (688/11)         
                                                                                  
The SMC advice for sildenafil citrate for injection (Revatio®), for the treatment of patients with pulmonary arterial hypertension who are currently prescribed oral sildenafil and who are temporarily unable to take oral medicine, but are otherwise clinically and haemodynamically stable, will be published on the SMC website on Monday, 07 March 2011.

Non-Submission

4.10 botulinum toxin type a (Bocouture®) Merz Pharma SMC No. (695/11)

The SMC advice for botulinum toxin type a (Bocouture ®), for the temporary improvement in the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows) seen at frown, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient, will be published on the SMC website on Monday, 07 March 2011.

Deferred Advice

4.11 Nothing to report.

Amended Advice

4.12 fosaprepitant dimeglumine 150 mg powder for solution for infusion (IVEmend ®) MSD Ltd (No. 678/11)

Advice for  fosaprepitant dimeglumine 150 mg powder for solution for infusion, (IVEmend 150 mg®), for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults,  will be published on the SMC website on Monday 07 March 2011.  However, it has been brought to our attention that fosaprepitant 115mg powder for solution for infusion, which was previously recommended by SMC in combination with oral therapy, for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy in adults (No. 506/08), ceased to be available from 15th February 2011.  The   SMC website will be updated accordingly.

4.13 exenatide, 5 or 10 micrograms, solution for injection, pre-filled pen (Byetta®)  Eli Lilly and Company Limited SMC No. (684/11)

SMC reviewed a submission for exenatide (Byetta) on 04 February 2011 and accepted it for restricted use, for the treatment of type 2 diabetes mellitus in combination with thiazolidinediones with or without metformin in patients who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.  It is restricted to use in combination with metformin and a thiazolidinedione as a third-line pre-insulin treatment option.

As a result of comparator comments, amendments have been made to the Summary of Clinical Effectiveness.  Revised Advice will be published on the SMC website on Monday 07 March 2011.

5. Appeals Update

5.1 Nothing to report.

6. Patient and Public Involvement Group (PAPIG)

6.1 Minutes  of the previous meeting of PAPIG

The Minutes of the previous meeting, held on 01 February 2011, were noted.

6.2 PAPIG Members

Mrs Tunstall-James endorsed the Chairman’s remarks made to Mrs Margo Biggs and Mr Keith Thompson, attending their last meeting of SMC.

Mrs Tunstall-James also expressed her sincere thanks to Dr Andrew Power, who has completed his term of office as Vice- Chair of the New Drugs Committee and member of PAPIG.

Mrs Helen Cadden and Mrs Anne Murray, Public Partners Designate, will now take up PAPIG membership but there remains a vacancy for an SMC Executive member. The SMC Chairman would be pleased to discuss with interested parties. 

7. New Drugs Committee: Chairman’s Report

7.1 Nothing to report.

8. Chairman’s Business

8.1 NICE Single Technology Appraisal Guidance No 214 – bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer

NICE has issued advice for bevacizumab, in combination with a taxane for the first-line treatment of metastatic breast cancer, as follows:
 
• Bevacizumab in combination with a taxane is not recommended for the first-line treatment of metastatic breast cancer.
• Patients currently receiving bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

The Scottish Medicines Consortium published advice on this medication for this indication in June 2007, which stated that, in the absence of a submission from the holder of the marketing authorization, bevacizumab (Avastin) in combination with paclitaxel is not recommended for first-line treatment of patients with metastatic breast cancer.

There is no material difference between the recommendations of the NICE STA and the SMC.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland therefore NHS Boards should continue to adhere to the SMC advice.

8.2 NICE Single Technology Appraisal Guidance No 215 – pazopanib for the first-line treatment of advanced renal cell carcinoma

NICE has issued advice for pazopanib, for the first-line treatment of advanced renal cell carcinoma, as follows:

Pazopanib is recommended as a first-line treatment option for people with advanced renal cell carcinoma:

• who have not received prior cytokine therapy and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and
• if the manufacturer provides pazopanib with a 12.5% discount on the list price, and provides a possible future rebate linked to the outcome of the head-to-head COMPARZ trial, as agreed under the terms of the patient access scheme and to be confirmed when the COMPARZ trial data are made available.
• People who are currently being treated with pazopanib for advanced metastatic renal cell carcinoma but who do not meet the criteria should have the option to continue their therapy until they and their clinicians consider it appropriate to stop.

The Scottish Medicines Consortium has received a submission from the manufacturer of pazopanib and is due to publish a Statement of Advice on this medication, for this indication, in March 2011. Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.  When available, NHS Scotland should adhere to the SMC Advice.

9. NDC ASSESSMENT REPORTS

FULL SUBMISSIONS

9.1 bendamustine hydrochloride 25mg, 100mg soluble powder for solution for infusion (Levact®)  Napp Pharmaceuticals Limited  SMC No. (694/11)

9.1.1 A declaration of interest was recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the meeting for this part of the agenda.

9.1.2 The NDC Chair provided an overview of the assessment, draft advice, expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from the Chronic Lymphocytic Leukaemia Support Association.  Detailed discussion followed and the group agreed that bendamustine hydrochloride (Levact®), should be accepted for use in NHS Scotland, for first-line treatment of chronic lymphocytic leukaemia (CLL) (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.  Bendamustine showed significantly improved response rates and progression free survival when compared with another alkylating agent in patients with previously untreated advanced CLL, although the patients studied may have been younger and fitter than those eligible to receive bendamustine in Scottish clinical practice.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.1.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011.

9.2 calcium acetate 435mg, magnesium carbonate 235mg tablet (Osvaren)  Fresenius Medical Care   SMC No. (693/11)

9.2.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.2.2 The NDC Vice Chair provided an overview of the assessment, draft advice and expert comments.  Detailed discussion followed and the group agreed that calcium acetate/ magnesium carbonate tablet (Osvaren), should not be recommended for use in NHS Scotland, for the treatment of hyperphosphataemia associated with chronic renal insufficiency in patients undergoing dialysis (haemodialysis, peritoneal dialysis).  The combined preparation of calcium acetate/magnesium carbonate has been shown to reduce hyperphosphataemia associated with chronic renal disease. However, the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC.   Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.2.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011.

9.3 botulinum toxin type A 50 unit, 100 unit and 200 unit powder for solution for injection (Botox®)  Allergan Ltd.  SMC No. (692/11)

9.3.1 A declaration of interest was recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the meeting for this part of the agenda.

9.3.2 The NDC Chair provided an overview of the assessment, draft advice, revised expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from the Migraine Trust.  A further patient interest group submission was presented but not disclosed.  Detailed discussion followed and the group agreed that botulinum toxin type A (Botox®), should not be recommended for use in NHS Scotland, for the prophylaxis of headaches in adults with chronic migraine (headaches on at least 15 days per month of which at least 8 days are with migraine).  In pooled analysis of two phase III studies, botulinum toxin type A was superior to placebo for the primary endpoint, headache days.  However, there were weaknesses in the clinical data that limit the ability to assess its likely clinical effectiveness in the target treatment population.   Overall the manufacturer did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.   Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.3.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011.

RESUBMISSION

9.4 drospirenone/ethinylestradiol 3mg/30 micrograms, film-coated tablets (Yasmin®)  Bayer Schering Pharma   SMC No. (23/03)  

9.4.1 A declaration of interest was recorded in relation to this product/comparator drugs.  A member with a personal specific interest left the meeting for this part of the agenda.

9.4.2 The NDC Vice Chair provided an overview of the assessment, draft advice, revised expert comments, revised data/analyses and comments received from the company.  A member of PAPIG presented a patient interest group submission from the Family Planning Association.  Detailed discussion followed and the group agreed that drospirenone/ethinylestradiol (Yasmin®), should not be recommended for use in NHS Scotland, for oral contraception. Drospirenone/ethinylestradiol has been shown to have similar contraceptive effectiveness to other combined oral contraceptives in routine use, with no significant differences in adverse event profile.  The manufacturer did not present a sufficiently robust economic case to gain acceptance by SMC.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.4.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011.                                   

ABBREVIATED SUBMISSION / RESUBMISSION

9.5 sevelamer carbonate 800mg film-coated tablets and 2.4g of anhydrous powder for oral suspension (Renvela®)  Genzyme Therapeutics Ltd  (No: 641/10)

9.5.1 There were no declarations of interest recorded in relation to this product/comparator drugs.

9.5.2 The NDC Chair provided an overview of the assessment, and draft advice.  Detailed discussion followed and the group agreed that sevelamer carbonate (Renvela), should be accepted for restricted use in NHS Scotland, for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Use of sevelamer carbonate is restricted to the second-line management of hyperphosphataemia in adult patients receiving haemodialysis.  Sevelamer carbonate has been shown to be therapeutically equivalent to sevelamer hydrochloride in reducing serum phosphorus in patients with chronic kidney disease on haemodialysis. For patients in whom sevelamer hydrochloride is an appropriate choice of phosphate binder, the carbonate salt provides an alternative at no additional cost.  Sevelamer carbonate is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus = 1.78 mmol/L.  As the manufacturer’s submission related only to the control of hyperphosphataemia in adult patients receiving haemodialysis SMC cannot recommend the use of sevelamer carbonate in pre-dialysis patients or in peritoneal dialysis patients.  Assessors in liaison with the Secretariat, to make appropriate amendments for review by the Chairman prior to distribution of the advice.

9.5.3 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011. 

NON SUBMISSIONS

9.6 bendamustine (Levact) Napp Pharmaceuticals (No. 700/11)

9.6.1 In the absence of a submission from the holder of the marketing authorisation, bendamustine (Levact) for the front-line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment, should not be recommended for use within NHS Scotland.

9.6.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011.

9.7 bendamustine (Levact) Napp Pharmaceuticals (No. 701/11)

9.7.1 In the absence of a submission from the holder of the marketing authorisation, bendamustine (Levact), for the front-line treatment of indolent non-Hodgkin's lymphomas as monotherapy in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab containing regimen, should not be recommended for use within NHS Scotland.

9.7.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011.

9.8 paliperidone (Invega) Jansen Cilag (No. 702/11)

9.8.1 In the absence of a submission from the holder of the marketing authorisation, paliperidone (Invega), for the treatment of psychotic or manic symptoms of schizoaffective disorder should not be recommended for use within NHS Scotland. Effect on depressive symptoms has not been demonstrated.

9.8.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011.

9.9 cannabinoid (Sativex) Bayer (No. 703/11)

9.9.1 In the absence of a submission from the holder of the marketing authorisation, cannabinoid (Sativex), as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy, should not be recommended for use within NHS Scotland.

9.9.2 The SMC advice will be issued to NHS Boards and ADTCs on Friday, 04 March 2011.

10. SMC User Group Forum (UGF)

10.1 Minutes  of the previous meeting of the UGF

The Minutes of the previous meeting, held on 25 January 2011, were noted.

10.2 Membership of the  UGF

There is currently a vacancy on the UGF, for a member who represents a non-ABPI affiliated company.  A recruitment exercise is in the final selection phase.  One third of all submissions to SMC are from companies who are not affiliated to ABPI or the  Ethical Medicines Industry Group (EMIG), therefore it is crucial that there is a mechanism in place to increase  contacts with these companies.  

Goals for the  User Group Forum

The UGF  are currently pursuing  the following goals:

• to increase contact  with companies who submit to SMC;
• to develop/improve guidance to manufacturers;
• to study progress and outcomes from emerging methods for assessing ultra-orphan medicines.

11. Forthcoming Submissions

11.1 A list of forthcoming submissions was tabled and noted.

12. Area Drug & Therapeutics Committee (ADTC) Issues

12.1 Nothing to update.

13. Any Other Business

13.1 SMC Evaluation Programme

Dr Beard asked whether there has been any progress with the SMC Evaluation Programme.   Members can anticipate a progress report around May 2011.

13.2 Move Towards Electronic Distribution of SMC Meeting Papers

Dr McElhinney asked if any progress has been made toward moving to electronic distribution of SMC meeting papers to members.  The SMC Executive consider the matter a priority however at present the transition  from NHS Quality Improvement Scotland (NHS QIS) to Health Improvement Scotland (HIS)  will take precedence for the next few months.  SMC currently works under the umbrella of NHS QIS and will also transit to HIS.

14. Date of the Next Meeting

14.1 The date of the next meeting was confirmed as Tuesday, 05 April 2011 at 12.30 pm (lunch from 12 noon), in NHS Quality Improvement Scotland (Glasgow Office), Delta House, 50 West Nile Street, Glasgow G1 2NP.

NICE Publications

8.1 NICE Single Technology Appraisal Guidance No 214 – bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer

NICE Guidance

1.  Bevacizumab in combination with a taxane is not recommended for the first-line treatment of metastatic breast cancer.

2.  Patients currently receiving bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

http://www.nice.org.uk/nicemedia/live/13342/53165/53165.pdf

The Scottish Medicines Consortium (SMC) published a Statement of Advice (387/07) on this medication for this indication in June 2007. This stated that:
In the absence of a submission from the holder of the marketing authorization, bevacizumab (Avastin) in combination with paclitaxel is not recommended for first-line treatment of patients with metastatic breast cancer.

Access the advice of the Scottish Medicines Consortium:

There is no material difference between the recommendations of the NICE STA and the SMC.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

NHS Boards should continue to adhere to the SMC advice.

8.2 NICE Single Technology Appraisal Guidance No 215 – Pazopanib for the first-line treatment of advanced renal cell carcinoma
 
NICE Guidance

1. Pazopanib is recommended as a first-line treatment option for people with advanced renal cell carcinoma:

• who have not received prior cytokine therapy and have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and
• if the manufacturer provides pazopanib with a 12.5% discount on the list price, and provides a possible future rebate linked to the outcome of the head-to-head COMPARZ trial, as agreed under the terms of the patient access scheme and to be confirmed when the COMPARZ trial data are made available.

• People who are currently being treated with pazopanib for advanced metastatic renal cell carcinoma but who do not meet the criteria in 1 should have the option to continue their therapy until they and their clinicians consider it appropriate to stop.

http://guidance.nice.org.uk/TA215

The Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of pazopanib and is due to publish a Statement of Advice on this medication for this indication in March 2011. When this is available, NHS Scotland should adhere to this advice.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.

8.3 NICE Single Technology Appraisal Guidance No 216 – Bendamustine for the first-line treatment of chronic lymphocytic leukaemia

Bendamustine is recommended as an option for the first-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.

http://guidance.nice.org.uk/TA216

The Scottish Medicines Consortium (SMC) has received a submission from the manufacturer of bendamustine and is due to publish a Statement of Advice on this medication for this indication in April 2011.  When this is available, NHS Scotland should adhere to this advice.

Recommendations of NICE Single Technology Appraisals (STAs) have no status in NHS Scotland.