CONFIRMED

MINUTES OF THE MEETING OF THE FIFE AREA DRUG AND THERAPEUTICS COMMITTEE HELD AT 12.30PM ON WEDNESDAY 15 APRIL 2015 IN THE BOARD ROOM, HAYFIELD CLINIC, KIRKCALDY. Present: Dr F Elliot (Chair)

Dr S Ainsworth Dr L Anderson Mr S Garden Ms K McDougall Dr A McGovern Dr J McLaren Mr D Mitchell Mr I Mohammed Ms N Platt Dr D Reid Mr E Reid Dr S Rogers

In attendance: Mrs S MacDonald (minutes) ACTION 1 APOLOGIES FOR ABSENCE Apologies for absence were noted from G Birnie, I Gourley, E McPhail, J

Owens, C Potter and S Tyson.

2 MINUTES OF PREVIOUS MEETING The minutes of the meeting held on 18 February 2015 were confirmed as a

true record.

3 MATTERS ARISING FROM THE MINUTES 3.1 Nalmefene - Letter from GP Clinical Steering Group Dr McGovern briefed the ADTC on the background to the letter from the

GP Clinical Steering Group in response to the proposed inclusion of Nalmefene in the Fife Formulary for prescription by GPs. The ADTC noted the recommendations of the GP Clinical Steering Group that Nalmefene should not be prescribed by General Practitioners in Fife and the reasons for this recommendation. The ADTC agreed that Nalmefene should not be included in the Fife Formulary for general use. Mr Mohammed advised that a Formulary submission for specialist use only is being considered. Revision of the Alcohol Guidance which was discussed previously at the ADTC is on hold pending consideration of the Formulary submission for specialist use.

Fife NHS Board

2

3.2 ADHD in Children & Adolescents Shared Care Protocols - Letter from GP Clinical Steering Group

Dr McGovern briefed the ADTC on the letter from the GP Clinical Steering

Group in relation to the updated Shared Care Protocols for Methylphenidate and Atomoxetine and proposed Shared Care Protocols for Lisdexamfetamine and Dexamfetamine. The ADTC noted that the updated Shared Care Protocols for Methylphenidate and Atomoxetine and proposed new Shared Care Protocols for Lisdexamfetamine and Dexamfetamine have not been accepted by the GP Clinical Steering Group on the grounds of safety. For the sake of continuity of patient care those patients currently receiving Atomoxetine and Methylphenidate through their practices should continue to do so. A lengthy discussion followed on the way forward. Dr Ainsworth highlighted discussions between CAMH and paediatrics regarding development of the service for children and adolescents with ADHD however discussions are at an early stage. Dr Ainsworth agreed to follow up with CAMH colleagues. The Shared Care Protocols to be included in these discussions. In the meantime the existing Shared Care Protocols for Methylphenidate and Atomoxetine remain extant.

SA

4 DECLARATION OF INTERESTS There were no declarations of interests. 5 ANNUAL DECLARATIONS OF INTEREST ADTC members were asked to complete an annual declarations of interest

and return to Sandra MacDonald.

6 COMMITTEE MEMBERS ATTENDANCE 2014-15 The committee members’ attendance 2014-15 was noted. 7 PRESCRIBING OF BIOSIMILARS 7.1 National Prescribing Framework for Biosimilar Medicines Mr Garden took the ADTC through the draft National Prescribing

Framework for Biosimilar Medicines. Mr Garden highlighted that one of key points in the framework is the establishment of clinical registers, however it is unclear at this stage what these will look like. Positive comments were received and the ADTC were supportive of the framework and agreed to work within the final version.

7.2 NHS LMEN Review - Answers to Commonly asked Questions about

Biosimilar Versions of Infliximab

3

The advice issued by the London Medicines Evaluation Network was

noted. It was agreed that it was a useful and informative document and was beneficial in getting a better background understanding of the issues related to the availability of biosimilars.

8 NOVEL ORAL ANTICOAGULATION PATIENT SAFETY CARD Dr Anderson introduced the hand-held Novel Oral Anticoagulation Card

(NOAC) developed by the Heart Disease MCN and briefed the ADTC on the background to the development of the NOAC.

The ADTC noted the following:

The NOAC has been developed specifically for patients who receive non-vitamin-K anticoagulants for atrial fibrillation and has been adapted from the European Heart Rhythm Practical Guide for Use of New Oral Anticoagulants.

The two other indications for anticoagulant therapy, DVT and Pulmonary Embolism are not included in the NOAC.

At a recent Health Improvement Scotland ADTC meeting it was stated that a national NOAC leaflet is being developed however there is no timeframe of when this is likely to be produced.

The availability of leaflets produced by pharmaceutical companies which include patient alert cards were highlighted. It was noted that these relate to specific drugs and bear the drug company’s logo and the Heart Disease MCN felt that an NHS Fife generic leaflet would be more appropriate. Feedback from GPs on the ADTC would suggest that GPs would be in favour of an NHS Fife produced leaflet.

The ADTC agreed to the use of an NHS Fife Novel Oral Anticoagulation Card pending the outcome of work around the development of a national card. It was agreed that the Heart Disease MCN be asked to either amend the NHS Fife card to include sections on DVT and Pulmonary Embolism in addition to atrial fibrillation or produce a separate card for each indication. It was noted that the card tabled is very generic and it was suggested that the Heart Disease MCN give consideration to the inclusion of more information on individual products, diseases and advice about taking medication. Dr Anderson agreed to feed back to the Heart Disease MCN.

LA

9 SMC 9.1 SMC Recommendations issued February and March 2015 The ADTC decisions are recorded in Appendix 1. 9.2 SMC Recommendation - Harvoni® SBAR regarding new Hepatitis C Drugs

The ADTC decision is recorded in Appendix 1.

4

9.3 Hepatitis C National Approach - Proposal for ADTCs Dr Elliot introduced the document “Proposed Approach to Developing

National Recommendations for ADTC Ratification on the Place of Hepatitis C Medicines in Treatment Protocols” and briefed the ADTC on the background to this. The ADTC agreed to support the proposals for a Hepatitis C national approach.

9.4 Deferred Decisions - Aztreonam lysine (Lothian Decision) The ADTC decision is recorded in Appendix 1. 9.5 SCAN Formulary Submissions Approved by Lothian Formulary

Committee February - March 2015

The ADTC decisions are recorded in Appendix 1. 10 FORMULARY 10.1 Updated Minor Ailments Service (MAS) Formulary Mr Mohammed introduced the updated Minor Ailments Service (MAS)

Formulary and highlighted the key changes. Mr Mohammed highlighted the information in the MAS Formulary regarding the treatment of conjunctivitis. It was noted that the recommendation in the MAS Formulary currently is that treatment should be given if the condition does not clear within five days, however feedback from pharmacists is that they would wish to initiate treatment after three days. Following discussion the ADTC agreed to a change in the recommendation from five to three days. It was noted that the MAS Formulary will be available in electronic format rather than paper booklets which will allow changes to be made on a regular basis when Formulary sections are reviewed. It was suggested that circulation of the MAS Formulary could be used as a promotional opportunity. No further comments were received and the ADTC approved the updated Minor Ailments Service Formulary.

10.2 Formulary Submission – Fidaxomicin (Dificlir®) Mrs Platt introduced the request submitted by Dr Priya Venkatesh,

Consultant Microbiologist and Rachel Crick, Antimicrobial Pharmacist to add Fidaxomicin to the Fife Formulary for first line treatment of Clostridium difficile infections in patients who are believed to be at risk of recurrence. The ADTC noted the following:

Fidaxomicin was approved by the SMC in 2012 for treatment of adults with a first Clostridium difficile infection recurrence on the advice of

5

local microbiologists or specialists in infectious diseases. It was not approved by the SMC for first-line use in adults with severe Clostridium difficile infection as the submitting company did not present a sufficiently robust economic analysis.

It is proposed that Fidaxomicin be approved for restricted hospital use for first line treatment of Clostridium difficile infections in patients who are believed to be at risk of recurrence on the advice of local microbiologists.

The Formulary submission estimates that a potential maximum of 10 patients per year would require treatment, however the ADTC noted that patient numbers would be likely to be higher based on the proposed high risk criteria.

There is lack of new evidence in the submitted papers to support Fidaxomicin as a cost effective first line treatment option in preventing relapse in patients at high risk of recurrence.

The ADTC requested more information on the cost effectiveness of Fidaxomicin for the proposed indication. In the meantime it was decided that Fidaxomicin should not be approved for first line treatment of Clostridium difficile infections in patients believed to be at risk of recurrence.

10.3 Formulary Submission - Co-dydramol 20/500, 30/500 Mr Mitchell introduced the request by Deborah Steven, Lead Pharmacist,

Pain Management and Dr Jane Timperley, Lead Clinician for Chronic Pain, to add Co-dydramol 20/500 & Co-dydramol 30/500 to the Formulary as a 2nd line alternative analgesic to codeine/co-codamol. The ADTC noted the following:

The current formulary choices for the proposed indication are Co-codamol 30/500, Co-codamol 15/500 (1st line) and Tramadol (2nd line).

There has been a change in legal status of Tramadol to a Schedule 3 Controlled Drug.

It is proposed that Co-dydramol 20/500 and Co-dydramol 30/500 would provide an alternative opioid for codeine non metabolisers (approximately 10% of the population) and an alternative opioid before initiation of Tramadol. The proposal would be to retain Tramadol on the Formulary as a 3rd line treatment option.

Following discussion the ADTC agreed that Co-dydramol 20/500 & Co-dydramol 30/500 should be added to the formulary for specialist initiation by the Pain Management Service as a 2nd line alternative analgesic to codeine/co-codamol.

10.4 Formulary Submission - Imipramine for Neuropathic Pain Mr Mitchell introduced the submission by Deborah Steven, Lead

Pharmacist, Pain Management and Dr Jane Timperley, Lead Clinician for Chronic Pain, to add Imipramine Hydrochloride to the Formulary for the treatment of neuropathic pain.

6

The ADTC noted the following:

The current Formulary choices for the proposed indication are Amitriptyline (1st line) and Nortriptyline (2nd line).

The proposed indication for neuropathic pain would be an off-label use. Imipramine is currently on the Formulary for depression and nocturnal enuresis

Imipramine is more cost effective than Nortriptyline. Amitriptyline remains the most cost effective option.

Imiprimine has a better side effect profile than Amitriptyline but poorer side effect profile than Nortriptyline. Efficacy is similar to Amitriptyline and Nortriptyline.

The proposal is that Nortriptyline be retained on Formulary as a 3rd line option and restricted to use in patients at higher risk of seretonergic syndrome.

A number of other Health Boards have included Imipramine on their Formularies as an alternative second line option.

There is lack of clarity on the dose of Imipramine that would be used for the proposed indication.

Following discussion the ADTC agreed that, subject to clarification on the expected dose, Imipramine Hydrochloride should be added to the formulary as a 2nd line option for neuropathic pain. Amitriptyline remains the 1st line option.

10.5 Formulary Submission - Oxycodone M/R (Longtec®, Shortec®) Mr Mitchell introduced the Formulary Amendment request to change the

preferred brands for oxycodone to Longtec® and Shortec®.

The ADTC noted the following:

NHS Fife previously endorsed the prescribing of oxycodone by brand name to improve patient safety and reduce the number of accidental supplies of modified release preparations against prescriptions for immediate release. The brands available at that time were Oxycontin® (MR) and Oxynorm® (IR).

Oxycodone has now come off patent and there are a number of more cost effective preparations available, including Longtec® and Shortec®.

A change to Longtec® and Shortec® would make prescribing easier and potentially result in improved patient safety due to clearer product names for modified release and immediate release.

The proposed change would potentially generate prescribing efficiencies of approximately £100K per annum in Primary Care and approximately £3K in Secondary Care.

The place in therapy of Longtec® and Shortec® would be 2nd line choice after Morphine (preferred brand Zomorph®) for the treatment of moderate to severe pain.

Following discussion the ADTC approved the request to change the

7

preferred brands of oxycodone in the Fife Formulary to Longtec® and Shortec as 2nd line choice after Morphine for the treatment of moderate to severe pain.

10.6 Formulary Submission - Combination NRT Mr Mohammed introduced the Formulary amendment request to change

the Formulary status of combination NRT from 2nd choice to 1st choice. The ADTC noted the following:

There is evidence to suggest that the use of combination products may be more effective than single NRT products.

Review of the NHS Smoking Cessation Services Advisory Group Report (June 2014) suggests increasing access to combination NRT.

NHS Lothian advocates the use of combination NRT but only for the first few weeks.

Combination NRT would cost more than monotherapy NRT.

Currently in Fife 54% of all quits are via combination NRT and this is higher than the Scottish average of 42%.

Combination NRT would not be appropriate for all patient groups e.g. intermittent smokers, pregnant women, and patients with a recent cardiovascular event.

It was agreed that the use of combination NRT should be based on individual patient factors and after discussion with the patient.

Following discussion the ADTC did not approve the change in Formulary status of combination NRT and its local Formulary status remains as an option for clients with a high level of nicotine dependence or those who have failed with monotherapy NRT.

10.7 Formulary Submission - Varenicline (Champix®) Mr Mohammed introduced the Formulary amendment request to change

the Formulary status of varenicline from 2nd line to 1st line for CHP Stop Smoking Specialists and to remain as a 2nd line option for the Community Pharmacy Stop Smoking Service. The ADTC noted the following:

The proposed change in Formulary status of varenicline to 1st line option for one group of staff and 2nd line for another is unprecedented and would have the potential to cause confusion.

The most recent ISD figures for quit attempts suggests that 8% of prescriptions are for varenicline in Fife which is in line with the Scottish average.

A recent Cochrane Review has confirmed that varenicline is equally as effective as combination NRT.

A 12 week course of varenicline would be more cost effective than the use of combination NRT products but would be more expensive than the use of single NRT.

There is the potential for mood altering side effects with varenicline

8

and it remaining on the Formulary as a 2nd line option would reduce exposure to that risk.

Following discussion the ADTC did not approve the change in Formulary status of varenicline and its local Formulary status remains as a 2nd line option.

11 GUIDELINES 11.1 Updated - Appendix 11A - Management of Neonatal Conjunctivitis Mr Mohammed took the Committee through the updated Appendix 11A -

Management of Neonatal Conjunctivitis. The ADTC noted the key change in relation to the PCR test kit (from Remel to COBAS®). Other changes were in line with the Formulary section. No comments were received and the ADTC approved the updated Appendix 11A - Management of Neonatal Conjunctivitis

11.2 Updated - Appendix 11B - Management of Patients with Dry Eyes Mr Mohammed introduced Appendix 11B - Management of Patients with

Dry Eyes and briefed the ADTC on the background to this. The guidance was produced following concerns about the recommendation of products for the treatment of dry eyes which were not aligned to Formulary choices and which were being recommended by optometrists. The guidance gives clarification on the definition and management of mild to moderate and severe dry eyes and the products are in line with the Fife Formulary section. Mr Mohammed highlighted the recommendation in the guidance to re-cap and re-use preservative eye drops. The ADTC noted the potential risk of re-infection and did not support the inclusion of this recommendation in the guideline. Mr Mohammed highlighted comments from the Prescribing & Formulary Development Group regarding the wording in the final bullet point on page two. It was agreed that the interpretation of this would be a decision for individual GPs and no change was required. Subject to amendment to take account of the comments received the ADTC approved Appendix 11B - Management of Patients with Dry Eyes.

11.3 Updated - Appendix 4D - NHS Fife Stop Smoking Prescribing

Guidance

Mr Mohammed introduced the updated NHS Fife Stop Smoking Prescribing

Guidance and highlighted key changes.

It was noted that it is proposed that General Practitioners should no longer treat patients for nicotine addiction but should refer patients to the NHS Fife Specialist Stop Smoking Service or the Community Pharmacy Stop

9

Smoking Service. The ADTC were not supportive of this proposal and concurred that it should remain a decision for individual GPs to make with their patients.

It was noted that the “Cutting Down to Quit” harm reduction approach is recommended in the Guidance for a maximum of two weeks. The ADTC noted that this new concept is recommended in national guidance for a maximum of six weeks. The ADTC agreed that there was uncertainty around the control of the harm reduction approach and concluded that it would not be a cost effective strategy.

The Guidance makes reference throughout to CHPs, however the CHPs ceased on 31 March with the establishment of the Health and Social Care Partnership.

The ADTC did not approve the proposed amendments to the NHS Fife Stop Smoking Prescribing Guidance.

11.4 New - Appendix 4G - Chronic Non Malignant Pain - Strong Opioid

Prescribing Guideline

Mr Mitchell introduced Appendix 4G - Chronic Non Malignant Pain - Strong

Opioid Prescribing Guideline. It was noted that this is a new guideline produced by the Pain Service.

The following comments were received from the ADTC:

The ADTC concurred that it is a very comprehensive and informative document dealing with the complexity of pain management. It was envisaged that it would be a useful basis for educational sessions.

It was noted that the flowchart on page 2 specifies the maximum dose of oral morphine which should be administered to achieve pain relief however there is no maximum equivalent dose of oxycodone for patients in whom morphine is not tolerated.

“Modified Release” to be added where required in the flowchart on page 2.

Subject to amendment to take account of the comments received, the ADTC approved Appendix 4G - Chronic Non Malignant Pain - Strong Opioid Prescribing Guideline.

11.5 New - Appendix 4H - Opioids for Persistent Non Cancer Pain This item was discussed in tandem with Appendix 4G. No additional

comments were received and the ADTC approved Appendix 4H NHS Fife Quick Reference Guide: Opioids for Persistent Non Cancer Pain.

11.6 Updated - Penicillin Allergy Guidance Mrs Platt introduced the updated Penicillin Allergy guidance. It was noted

that the guidance has been amended to include cefalexin in the list of antibiotics to be avoided or used with caution in type 1 penicillin allergy.

10

No comments were received and the ADTC approved the updated Penicillin Allergy guidance.

11.7 Request to Remove Appendix 2D - Dalteparin Treatment Guidelines Mr Mohammed sought clarification from the ADTC on the request to

remove the Dalteparin Treatment Guidelines from the ADTC website. The ADTC noted the background to the request to remove the guidelines from the website. It was noted that the guidelines have passed their review date (2012) and establishment of a group to review the guidelines has proved difficult. Mr Reid confirmed that the information in the guidelines remains appropriate however discussion around extremes of body weight is required. It was suggested that the review of the guidelines should be undertaken by the Acute Division Drug & Therapeutics Committee in due course. The ADTC noted that specialists within the Acute Division and General Practice access the guidelines via the ADTC website and agreed that they should remain on the ADTC website pending a formal review by the Acute Division Drug & Therapeutics Committee in due course. Mr Garden agreed to explore a potential update to the guidelines in the interim.

SG

12 INDIVIDUAL PATIENT TREATMENT REQUESTS 12.1 Latest Submissions The updated table of Individual Patient Treatment Requests was noted. 13 MEDICATION SAFETY MHRA Drug Safety Update Mr Reid took the ADTC through the MHRA Drug Safety Updates for

February and March 2015.

14 ANY OTHER COMPETENT BUSINESS Dr Ainsworth highlighted a decision by NHS Lothian in relation to the use of

esomeprazole sachets in children with reflux. Mr Mitchell advised that the intention is to bring a Formulary submission to the next ADTC meeting.

ITEMS FOR NOTING 14.1 NICE MTA 329 - Infliximab, adalimumab and golimumab for treating

moderately to severely active ulcerative colitis after the failure of conventional therapy

The ADTC noted NICE MTA 329 - Infliximab, adalimumab and golimumab

for treating moderately to severely active ulcerative colitis after the failure of conventional therapy. Mr Reid to discuss with GI and make a Formulary submission in due course.

ER

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Dr Anderson highlighted communication issues regarding the prescribing and monitoring of drugs recommended by GI. Mr Reid to feed back to GI nurses.

ER

14.2 HIS ADTC Collaborative Flash Report For information. 14.3 SIGN 142 – Management of Osteoporosis and the Prevention of

Fragility Fractures

Mr Mohammed confirmed that the information is in line with Fife Formulary

choices. Mr Mohammed to highlight to Dr Jane Gibson. IM

14.4 ADTC Bulletin - December 14 – January 15 For information. 14.5 Fife Medicines Focus - February 15, March 15 For information. OTHER INFORMATON a Minutes of Other ADTC Meetings a.1 Lothian Formulary Committee: Minutes of meeting January 2015,

March 2015. For information.

a.2 Tayside Drug & Therapeutics Committee: Not available. b Minutes of the Fife Prescribing and Formulary Development Group:

26 February 2015

For information. c Minutes of Antimicrobial Management Team There was no meeting. d Minutes of Medication Safety Group There was no meeting. e Minutes of the NHS Fife Prescribing Efficiency Group: 11 February

2015

For information. f Minutes of Non Medical Prescribing Group: 12 November 2014 For information. g Minutes for Other MCN Prescribing Sub-Groups: Not available. h Date of Next Meeting The next meeting is to be held on Wednesday 17 June 2015 at 12.30pm

in the Board Room, Hayfield Clinic, Kirkcaldy. (The deadline for submission of papers to be considered for the agenda is 1 June 2015. Apologies for meeting to be notified to Sandra MacDonald by 1 June 2015.)

SMC Advice - Formulary Decisions

12

APPENDIX 1 Scottish Medicines Consortium Recommendations

Date Product/Manufacturer SMC Advice Decision of ADTC Rationale

February 2015 1033/15

fosfomycin 40mg/mL powder for solution for intravenous infusion (Fomicyt

®)

Nordic Pharma Product Update

fosfomycin (Fomicyt®) is accepted for restricted use within NHS

Scotland. Indication under review: for the treatment of the following infections in adults and children including neonates: - Acute osteomyelitis - Complicated urinary tract infections - Nosocomial lower respiratory tract infections - Bacterial meningitis - Bacteraemia that occurs in association with, or is suspected to be

associated with, any of the infections listed above Fosfomycin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of the infections listed above, or when these alternative antibacterial agents have failed to demonstrate efficacy. Consideration should be given to national guidance on the appropriate use of antibacterial agents. SMC restriction: initiation by microbiologists or infectious disease specialists. Unlicensed preparations of intravenous fosfomycin are commonly used in the NHS in Scotland to treat multi-drug resistant gram negative organisms. This provides a licensed preparation. Estimated patient numbers are expected to be small.

Included on the Fife Formulary. Restricted to use if recommended by a microbiologist. Add to restricted hospital antimicrobial list. Hospital use only.

Scottish Medicines Consortium fosfomycin (Fomicyt)

February 2015 1030/15

ledipasvir/sofosbuvir, 90mg/400mg, film-coated tablet (Harvoni

®)

Gilead Sciences Ltd Treatment of chronic hepatitis C (CHC) in adults Comparator Medicines: Sofosbuvir, simeprevir, daclatasvir in peginterferon-free regimens or in combination with peginterferon plus ribavirin. Telaprevir and boceprevir in combination with peginterferon plus ribavirin

ledipasvir/sofosbuvir (Harvoni®) is accepted for restricted use within

NHS Scotland. Indication under review: treatment of chronic hepatitis C (CHC) in adults. SMC restriction: genotype 1 and 4 CHC only. In three, uncontrolled phase III studies conducted in treatment-naïve and treatment-experienced non-cirrhotic and cirrhotic patients with genotype 1 CHC, ledipasvir/sofosbuvir ± ribavirin achieved sustained virological response (at 12 weeks post treatment) rates of 93% to 99%, which were significantly superior to historical control rates. No clinical or economic data were presented for genotype 3 patients with cirrhosis and/or prior treatment failure.

Included on the Fife Formulary. Restricted to use in patients with genotype 1 and genotype 4. Hospital use only.

Scottish Medicines Consortium ledipasvir-sofosbuvir (Harvoni)

SMC Advice - Formulary Decisions

13

February 2015 1026/15

idelalisib 100mg and 150mg tablets (Zydelig®)

Gilead Sciences Ltd In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): • who have received at least one prior

therapy, or • as first line treatment in the presence of

17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.

Comparator Medicines: For patients with 17p deletion and/or TP53 mutation unsuitable for chemo-immunotherapy, first-line treatment would be alemtuzumab (unlicensed) plus pulsed high dose corticosteroids. For patients with relapsed CLL treatment options include FCR, chlorambucil ± high dose steroids, chlorambucil ± rituximab, bendamustine ± rituximab, alemtuzumab (unlicensed) ± high dose steroids, rituximab plus high dose steroids, or high dose steroids alone. As noted previously, the marketing authorisation for alemtuzumab (Mabcampath

®) for

treatment of CLL was withdrawn by the company for commercial reasons. It is now available through a patient access programme.

idelalisib (Zydelig®) is accepted for restricted for use within NHS

Scotland. Indication under review: In combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): • who have received at least one prior therapy, or • as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. SMC restriction: patients with relapsed CLL who are unsuitable for chemotherapy and treatment naïve patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy. Idelalisib in combination with an anti-CD20 antibody significantly improves progression free survival compared with an anti-CD20 antibody alone in patients with relapsed CLL. The treatment effect across subgroups with 17p deletion and/or TP53 mutation was consistent with that of the total study population. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of idelalisib. It is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower

Included on the Fife Formulary. Restricted to use in patients with relapsed chronic lymphocytic leukaemia who are unsuitable for chemotherapy and treatment naïve patients with 17p deletion or TP53 mutation who are unsuitable for chemo-immunotherapy. Hospital use only.

Scottish Medicines Consortium idelalisib (Zydelig)

February 2015 867/13

ruxolitinib (as phosphate), 5mg, 15mg, & 20mg tablets (Jakavi

®)

Novartis Pharmaceuticals UK Ltd The treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis Comparator Medicines: There are no currently available licensed treatments for myelofibrosis. Hydroxycarbamide is the predominant pharmacological treatment used for splenomegaly and other agents such as anagrelide, thalidomide, danazol are used to manage haematological manifestations of myelofibrosis. None are specifically licensed

ruxolitinib (Jakavi®) is accepted for use within NHS Scotland.

Indication under review: the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. In patients with myelofibrosis, a significantly greater proportion of patients achieved a spleen response (reduction in spleen volume of at least 35% from baseline) at 48 weeks when treated with ruxolitinib compared with best available therapy. Ruxolitinib was also associated with a greater proportion of patients reporting a clinically significant reduction in myelofibrosis-related symptoms when compared with placebo.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of ruxolitinib. It is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.

Included on the Fife Formulary. Hospital use only.

Scottish Medicines Consortium ruxolitinib (Jakavi)

SMC Advice - Formulary Decisions

14

for use in myelofibrosis.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

February 2015 1029/15

apixaban, 2.5mg & 5mg, film-coated tablets (Eliquis

®)

Bristol-Myers Squibb and Pfizer Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults Comparator Medicines: Dabigatran, rivaroxaban, low molecular weight heparin and warfarin

apixaban (Eliquis®) is accepted for use within NHS Scotland.

Indication under review: treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults. Two phase III studies demonstrated efficacy and safety of apixaban. One study showed non-inferiority of apixaban versus standard anticoagulant therapy including a low molecular weight heparin in combination with a vitamin K antagonist for treatment of DVT/PE with a lower rate of major and clinically relevant non-major bleeding. In a 12 month study apixaban demonstrated superiority versus placebo for the prevention of recurrent DVT/PE with a similar bleeding profile to placebo

Not included on the Fife Formulary as the medicine does not represent sufficient added benefit to other comparator medicines to treat the condition in question.

Scottish Medicines Consortium apixaban (Eliquis) http://www.fifeadtc.scot.nhs.uk/formulary/2-cardiovascular.aspx Not preferred. Formulary choice NOAC is rivaroxaban.

February 2015 1023/15

dabrafenib, 50mg and 75mg hard capsules (Tafinlar

®)

GlaxoSmithKline Dabrafenib monotherapy for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation Comparator Medicines: Vemurafenib, ipilimumab.

dabrafenib (Tafinlar®) is accepted for restricted use within NHS

Scotland. Indication under review: monotherapy treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. SMC restriction: for use in patients with unresectable or metastatic BRAFV600 mutation-positive metastatic melanoma who have received no prior therapy. In a phase III randomised open-label study, treatment with dabrafenib extended median progression free survival by 4.2 months compared with chemotherapy. This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of dabrafenib. It is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Not included pending protocol. Scottish Medicines Consortium dabrafenib (Tafinlar) Await SCAN submission to Lothian Formulary Committee.

February 2015 1022/15

cabozantinib 20mg and 80mg hard capsules (Cometriq

®)

Swedish Orphan Biovitrum Ltd For the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. For patients in whom Rearranged during Transfection (RET) mutation status is unknown or is negative, a possible lower benefit should be taken into account before individual treatment decision

cabozantinib (Cometriq®) is not recommended for use within NHS

Scotland. Indication under review: for the treatment of adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma. In one pivotal, phase III study, cabozantinib was associated with a significant advantage in progression-free survival over placebo. However, the difference between cabozantinib and placebo did not reach statistical significance in the subgroup of patients with Rearranged during Transfection (RET) negative tumours. The summary of product characteristics therefore notes that for patients in whom RET mutation status is unknown or is negative, a possible

Not recommended. Requires submission and approval of an IPTR before prescribing.

Scottish Medicines Consortium cabozantinib (Cometriq) Lack of evidence of health benefits compared to cost.

SMC Advice - Formulary Decisions

15

Comparator Medicines: The only other medicine licensed for use for medullary thyroid cancer is vandetanib which has not been recommended for use in NHS Scotland by SMC

lower benefit should be taken into account before individual treatment decision. The submitting company did not present a sufficiently robust economic analysis and in addition their justification of the treatment’s cost in relation to its benefits was not sufficient to gain acceptance by SMC. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

March 2015 1034/15

aclidinium/formoterol fumarate dihydrate 340/12 micrograms inhalation powder (Duaklir Genuair

®)

Almirall / AstraZeneca Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Comparator Medicines: Relevant comparators to umeclidinium/vilanterol are combination treatments with an inhaled LABA and an inhaled LAMA: formoterol, indacaterol, salmeterol (LABAs) and aclidinium, umeclidinium, glycopyrronium, tiotropium (LAMAs). The combination products, indacaterol/glycopyrronium (Ultibro Breezhaler

®) and umeclidinium/vilanterol

(Anoro®) are also licensed.

aclidinium/formoterol fumarate dihydrate (Duaklir Genuair®) is

accepted for use within NHS Scotland. Indication under review: Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. In two 24-week comparator- and placebo-controlled phase III studies, treatment with aclidinium/formoterol 340/12 microgram resulted in statistically significant improvements in FEV1 % predicted pre-dose (versus a LABA) and post-dose (versus a LAMA).

Included on the Fife Formulary. For use in patients requiring a LABA/LAMA combination when treatment with aclidinium or formoterol has been ineffective.

Scottish Medicines Consortium aclidinium/formoterol fumarate dihydrate (Duaklir Genuair)

March 2015 1038/15

fingolimod 0.5mg hard capsules (Gilenya®)

Novartis Pharmaceuticals UK As single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for the following adult patient groups: - Patients with high disease activity despite

treatment with at least one disease modifying therapy (for exceptions and information about washout periods see sections 4.4 and 5.1 of summary of product characteristics [SPC]).

These patients may be defined as those who have failed to respond to a full and adequate course (normally at least one year of treatment) of at least one disease modifying therapy. Patients should have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial magnetic resonance imaging (MRI) or at least 1 Gadolinium-enhancing lesion. A “non-responder” could also be defined as a patient with an unchanged or increased relapse rate or ongoing severe relapses, as compared to the previous year.

fingolimod (Gilenya®) is accepted for use within NHS Scotland.

Indication under review: as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) for the following adult patient groups: - Patients with high disease activity despite treatment with at least one disease modifying therapy. Analysis of a subgroup of patients who had high disease activity despite prior disease modifying therapy in the year before study entry found that over a 12 month period fingolimod reduced the annualised relapse rate compared with another disease modifying therapy by 61% in patients who received prior interferon beta, and by 50% in patients who had received any prior disease modifying therapy. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of fingolimod. This advice is contingent upon the continuing availability of the patient access scheme, or a list price that is equivalent or lower, in NHS Scotland.

Included on the Fife Formulary for the new indication. Hospital use only.

Scottish Medicines Consortium fingolimod (Gilenya)

SMC Advice - Formulary Decisions

16

or Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI Comparator Medicines: Intramuscular interferon-beta 1a (Avonex,

®)

subcutaneous interferon-beta 1a (Rebif®);

subcutaneous interferon-beta 1b (Betaferon,®

Extavia®); dimethyl fumarate.

March 2015 1036/15

levonorgestrel 13.5mg intrauterine delivery system (Jaydess

®)

Bayer Contraception for up to 3 years. Comparator Medicines: Progestogen-only LARCS: levonorgestrel 52mg IUS (Mirena

®), medroxyprogesterone

acetate contraceptive injection (Depo-Provera

® and Sayana Press

®), etonogestrel

contraceptive implant (Nexplanon®).

7

Other contraceptives: combined hormonal contraceptives, progestogen-only contraceptives, intrauterine devices (e.g. copper devices).

levonorgestrel (Jaydess®) is accepted for use within NHS Scotland.

Indication under review: Contraception for up to 3 years. A phase III, open-label, randomised study confirmed the contraceptive efficacy of levonorgestrel 13.5mg intrauterine delivery system according to the Pearl Index.

Included on the Fife Formulary. 2

nd line formulary choice - only

for use in patients where the Mirena

® IUS is considered

unsuitable.

Scottish Medicines Consortium levonorgestrel (Jaydess)

March 2015 1032/15

ponatinib 15mg, 45mg film-coated tablets (Iclusig

®)

ARIAD pharmaceuticals, Inc Adult patients with

Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Comparator Medicines: Current drug treatments for CML include the first generation tyrosine kinase inhibitor,

ponatinib (Iclusig®) is accepted for use within NHS Scotland.

Indication under review: Adult patients with

Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

A non-comparative phase II study of ponatinib was conducted with primary outcomes of major cytogenetic response in patients with baseline chronic phase CML and major haematologic response in patients with baseline accelerated or blast phase CML or Ph+ALL. Ponatinib demonstrated efficacy in heavily pre-treated CML and Ph+ALL patients who had received dasatinib/nilotinib as second line or further line tyrosine kinase inhibitor therapy or who had the T315I mutation.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Included on the Fife Formulary – additional list. Restricted use for patients with a T3151 mutation or when imatinib, dasatinib and nilotinib are unsuitable. Hospital use only.

Scottish Medicines Consortium ponatinib (Iclusig)

SMC Advice - Formulary Decisions

17

imatinib (commonly used first-line) and the second generation tyrosine kinase inhibitors, nilotinib (used first- or second-line) and dasatinib (which is not recommended by National Institute for Health and Care Excellence [NICE] multiple technology appraisals [MTA] 241 and 251 and this advice has been endorsed in Scotland).

2,3

Options in patients with CML and the T315I mutation who are not suitable for allogenic SCT are considered to be palliative/supportive therapy and include hydroxycarbamide and interferon alfa.

March 2015 1035/15

sucroferric oxyhydroxide 500mg chewable tablets (Velphoro

®)

Fresenius Medical Care (UK) Ltd. For the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). It should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease Comparator Medicines: Medicines licensed to control serum phosphorus levels include: calcium salts (calcium acetate and calcium carbonate), lanthanum carbonate, sevelamer (hydrochloride and carbonate), aluminium hydroxide and colestilan. Colestilan is not recommended for use in NHS Scotland by SMC

sucroferric oxyhydroxide (Velphoro®) is accepted for use within

NHS Scotland. Indication under review: For the control of serum phosphorus levels in adult chronic kidney disease (CKD) patients on haemodialysis (HD) or peritoneal dialysis (PD). It should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues, or calcimimetics to control the development of renal bone disease. After 12 weeks, sucroferric oxyhydroxide was non-inferior to a non-calcium, non-aluminium-based phosphate binder at lowering serum phosphorus levels in adults with CKD, receiving HD or PD.

Not included on the Fife Formulary as clinicians do not support formulary inclusion.

Scottish Medicines Consortium sucroferric oxyhydroxide (Velphoro) http://www.fifeadtc.scot.nhs.uk/formulary/9-nutrition-and-blood.aspx Not preferred. Current formulary choices are Calcium salts lanthanum sevelamer.

1007/14 1006/14 November 2014 (Issued March 2015)

infliximab, 100mg, powder for concentrate for solution for infusion (Inflectra

®)

Hospira UK Ltd infliximab, 100mg, powder for concentrate for solution for infusion (Remsima

®)

Celltrion Healthcare Hungary Kft. Comparator Medicines: Infliximab (Remicade

®). Other biosimilars

may become available.

infliximab (Inflectra®) / Infliximab (Remsima

®) is accepted for

restricted use within NHS Scotland. Indication under review: Rheumatoid arthritis: in combination with methotrexate, for the reduction of signs and symptoms as well as improvement in physical function in:

adult patients with active disease when the response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate has been inadequate;

adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.

Infliximab (Inflectra

®) / Infliximab (Remsima

®) is also indicated in the

following conditions: adult and paediatric Crohn’s disease and ulcerative colitis; adult ankylosing spondylitis, psoriatic arthritis and psoriasis.

1

Not included pending protocol.

Scottish Medicines Consortium infliximab (Infectra) Scottish Medicines Consortium infliximab (Remsima) Await finalisation of national biosimilar framework.

SMC Advice - Formulary Decisions

18

SMC restriction: Infliximab (Inflectra®) / Infliximab (Remsima

®) is

accepted for use in line with the current SMC and Healthcare Improvement Scotland advice for the reference product infliximab [Remicade

®].

A phase III, randomised, double-blind, parallel-group study demonstrated similar efficacy and safety of biosimilar infliximab with originator infliximab in patients with rheumatoid arthritis. Infliximab (Inflectra

®) / Infliximab (Remsima

®) is a biosimilar product to

a reference product (infliximab [Remicade®]). The British National

Formulary advises that it is good practice to prescribe biologic medicinal products by brand name.

March 2015 1041/15

tacrolimus (as monohydrate) 0.75mg, 1mg and 4mg prolonged- release tablets (Envarsus

®)

Chiesi Ltd Product Update

tacrolimus (Envarsus®) prolonged release-tablets are accepted for

use within NHS Scotland.

Indication under review: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients and treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients.

Tacrolimus (Envarsus®) is suitable for use by patients for whom

tacrolimus is an appropriate choice of immunosuppressive therapy. It has increased bioavailability compared with other tacrolimus preparations. Tacrolimus (Envarsus

®) has demonstrated non-

inferiority to a tacrolimus immediate-release capsule and has a similar cost per equivalent dose.

Not included pending protocol. Scottish Medicines Consortium tacrolimus (Envarsus) Await Lothian and Greater Glasgow and Clyde Formulary Committee decisions. Treatment will be initiated in tertiary centres.

March 2015 1027/15

nintedanib 100mg and 150mg soft capsules (Vargatef

®)

Boehringer Ingelheim International GmbH In combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy. Comparator Medicines: Docetaxel, erlotinib and pemetrexed. Gefitinib is not recommended by SMC.

nintedanib (Vargatef®) is accepted for use within NHS Scotland.

Indication under review: in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.

Addition of nintedanib to second-line treatment of stage IIIb/IV NSCLC with docetaxel significantly increased overall survival in the subgroup patients with adenocarcinoma tumour histology.

This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of nintedanib and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Not included pending protocol. Scottish Medicines Consortium nintedanib (Vargatef) Await SCAN submission to Lothian Formulary Committee.

March 2015 1031/15

regorafenib 40mg film-coated tablet (Stivarga

®)

Bayer plc Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors

regorafenib (Stivarga®) is accepted for use within NHS Scotland.

Indication under review: Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

Not included pending protocol. Scottish Medicines Consortium regorafenib (Stivarga) Await SCAN submission to Lothian

SMC Advice - Formulary Decisions

19

(GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. Comparator Medicines: There are no treatments specifically licensed for use third-line following imatinib and sunitinib. Imatinib re-challenge is recommended by Scottish guidelines for symptomatic relief in the absence of any suitable clinical study.

In a study of patients with metastatic or unresectable GIST who had prior treatment with imatinib and sunitinib, treatment with regorafenib prolonged the median progression free survival by 3.9 months when compared with placebo. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of regorafenib and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Formulary Committee.

SMC Advice - Deferred Formulary Decisions

Date Product/Manufacturer SMC Advice Decision of ADTC Rationale

December 2014 753/12

aztreonam lysine, 75mg, powder and solvent for nebuliser solution (Cayston

®)

Gilead Life Sciences Limited Re-submission Suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged six years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Comparator Medicines: Inhaled colistimethate sodium and tobramycin.

aztreonam lysine (Cayston®) is accepted for restricted use within

NHS Scotland. Indication under review: Suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis aged six years and older. SMC restriction: When inhaled colistimethate sodium and inhaled tobramycin are not tolerated or not providing satisfactory therapeutic benefit (measured as ≥2% decline in forced expiratory volume in 1 second [FEV1]). Aztreonam lysine has demonstrated superiority in improving lung function and respiratory symptoms in one active-controlled study and two 28-day placebo-controlled studies in patients with cystic fibrosis and chronic Pseudomonas aeruginosa infection. This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of aztreonam lysine. It is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Included on the Fife Formulary for restricted use in patients where alternative treatments (colistimethate sodium, inhaled tobramycin) are ineffective or not tolerated. Specialist initiation only. Formulary status of inhaled tobramycin and colistimethate sodium changed to specialist initiation.

Scottish Medicines Consortium aztreonam lysine (Cayston)

SMC Advice - Formulary Decisions

20

Summary of Approved Lothian Formulary Committee Decisions for SCAN Medicines February 2015 - March 2015

Product Name SMC Advice Place in therapy Lothian formulary Committee Decision

Add to Fife Formulary Yes / No

Pemetrexed (Alimta®)

Indication under review: monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy. In patients with locally advanced or metastatic non-squamous non-small cell lung cancer, maintenance treatment with pemetrexed, following completion of first-line platinum-based chemotherapy, was associated with prolonged overall survival and progression-free survival when compared with placebo. This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting

Will be used in patients with performance status 0 or1, non-progression patients of advanced non-squamous non-small cell lung cancer after 4 cycles of cisplatin and pemetrexed first-line chemotherapy. There are no existing treatments currently used for maintenance therapy in this setting. The use of pemetrexed maintenance monotherapy has been shown to slightly reduce the use of second-line systemic therapy for NSCLC from 72% to 64%. Evidence showed increased survival and added benefit. Response to therapy will be assessed by CT scan every 12 weeks (4 cycles). Patient will attend for bloods (incld. FBC, U&E’s, LFT’s) and treatment administration every 3 weeks. Patients will receive the following supportive treatments: Dexamethasone PO 4mg BD for 3 days each cycle; Folic acid PO 400mcg daily throughout treatment, Vit B12 1mg IM every 9 weeks

Include on the Additional List, for Specialist Hospital Use only, for the indication in question.

Yes Hospital use only.