Appendix D - NICE s response to consultee and commentator comments on the draft scope and provisional matrix

Transcription

1 Multiple Technology Appraisal (MTA) Collagenase clostridium histolyticum for treating contracture pre-referral remit and scope Response to consultee and commentator comments on the draft remit and draft scope Appropriateness I feel that this is extremely appropriate as it is a new treatment that has the potential to create great outcomes for patients without the need for surgery. However if not properly administered and advised upon could conversely have extremely detrimental outcomes for the same patient population Highly appropriate; current treatment using Collagenase clostridium histolyticum (CCH) has only been licenced in the UK for less than 12 months. It is routinely available within the private sector, however many NHS Trusts are not providing this treatment. Information about this method of management has been publicised nationally and patients are attending clinics requesting this treatment option. There is the potential for favourable outcomes for patients with a reduced cost in terms of medical intervention, therapy intervention and socioeconomic costs. If this topic is referred to NICE by the Department of Health, it will be scheduled into the Technology Appraisal work programme. Society Yes we believe it would be appropriate. At the moment some people can have the treatment on the NHS and others can t, it would be good to have equality over the whole country. For a lot of patients this treatment will be the only thing that enables them a quick return to relatively normal life. If this topic is referred to NICE by the Department of Health, it will be scheduled into the Technology Appraisal work programme. Society for Surgery of We consider that Collagenase is an appropriate subject for study. This is a new treatment that on paper has significant potential to find a If this topic is Page 1 of 21

2 the Hand place in the management of a common and troublesome problem. Early experience of its use in clinical practice is promising referred to NICE by the Department of Health, it will be scheduled into the Technology Appraisal work programme. Pfizer Ltd, UK and Auxilium Pharmaceuticals Physiotherapy Dept RIE Royal College of Nursing (Society of Orthopaedic and Trauma To understand the role which the various interventions available should play in the Dupuytren s contracture treatment pathway, we strongly urge NICE to appraise this topic via a Clinical Guideline. In addition, a Clinical Guideline would be appropriate due to the considerable difficulties inherent in providing estimates of comparative efficacy for CCH and surgical interventions. This was evidenced from a published review of the literature by Crean et al 2011 funded by Pfizer. A clinical guideline could more appropriately manage the quality of evidence that exists for surgical treatments, which in many of the proposed options does not include data from controlled trials or an evidence based setting. We feel strongly that carrying out a technology appraisal of Collagenase Clostridium Histolyticum (Xiapex; CCH) would not be an appropriate use of NICE s resources. However, if the topic were to be referred for a technology appraisal we agree that an MTA is the appropriate process to use as the treatment of Dupuytren s contracture includes surgical procedures. Yes Yes, this is appropriate for referral and would be appropriate for a STA review. Attendees at the Scoping Worksop agreed that, in the absence of a Clinical Guideline, a multiple technology appraisal was appropriate. If this topic is referred to NICE by the Department of Health, it will be scheduled into the Technology Appraisal work programme. Attendees at the Scoping Worksop agreed that a Page 2 of 21

3 Nursing) multiple technology appraisal was appropriate given the inherent complexities of this topic. Wording No additional comment Society Yes Society for Surgery of the Hand The remit is acceptable Physiotherapy Dept RIE Yes Royal College of Nursing (Society of Orthopaedic and Trauma Nursing) Yes, it is appropriately worded. Timing Issues Feel that should be progressed quickly as the treatment is readily available within the private sector and has been for the past 9 months. Patients are potentially being treated surgically that could be treated with this new treatment. If this topic is referred to NICE by the Department of Health, it will be scheduled into the Technology Page 3 of 21

4 Society Society for Surgery of the Hand Pfizer Ltd, UK and Auxilium Pharmaceuticals Physiotherapy Dept RIE The sooner it has been approved the sooner people can get treatment that allows a quick return to normal life. Patient interest and demand and media coverage gives some urgency to this. There is currently inconsistent availability of the treatment, and clarification from NICE would be useful in setting consistent provision across NHS provision. It would be helpful to commissioning trusts if this were available promptly. If this is widely accepted it may have cost benefits and save some patients from undergoing potentially unnecessary surgery. We do not consider this to constitute an urgent topic for NICE s consideration as a technology appraisal. Urgent as being used widely in the private sector Appraisal work programme. If this topic is referred to NICE by the Department of Health, it will be scheduled into the Technology Appraisal work programme. If this topic is referred to NICE by the Department of Health, it will be scheduled into the Technology Appraisal work programme. If this topic is referred to NICE by the Department of Health, it will be scheduled into the Technology Appraisal work Page 4 of 21

5 programme. Background information Feel that this section reads well and is accurate to my knowledge. Society Information is accurate but fails to mention other forms of fibromatosis, such as plantar, penile or dorsal on the hand. NICE can only appraise a technology within its licensed indication. The marketing authorisation for collagenase clostridium histolyticum is for the treatment of contracture in adult patients with a palpable cord. Society for Surgery of the Hand We do not consider that any of the non operative treatments described are likely to be of significant benefit in Dupuytren s disease. We do not believe that they are used in any significant number in clinical practice in the UK. The idea of radiotherapy is experimental only. The comparators in the scope include surgical treatments. Pfizer Ltd, UK and Auxilium Pharmaceuticals A comment in this section that states Functional disability worsens with increasing deformity. We feel that this statement does not reflect opinion from clinical practice. Based on discussions with clinicians, we point out that functional impact can occur in a range of contractures, dependent upon the joint and digit affected, and the activities the Comments noted. The background section of the draft scope has been updated Page 5 of 21

6 patient wishes to perform. This section refers to Dupuytren s Disease when discussing prevalence. This is confusing without further context as the scope remit is for Dupuytren s contracture. It is not currently clear from the literature the numbers of patients who currently require treatment. Many patients simply have nodules or contractures which do not affect their quality of life sufficiently enough to warrant treatment. Hence using prevalence rates as the basis for calculating budget impact implications for CCH would provide misleading estimates. Estimates from an analysis of HES data from Gerber et al show that there were a mean of 12,901 admissions for Dupuytren s contracture per year between April 2003 to March 2008 (Gerber et al, 2011). This section states that Treatment seeks to restore hand function and prevent progression. We would suggest that the reference to preventing progression is removed from the scope, as it is widely recognised that Dupuytren s contracture frequently recurs and the disease is chronically progressive. This section refers to the use of non-surgical treatments. However, many of these treatments are used for Dupuytren s Disease rather than contracture. We suggest that the sentence should only include those non-surgical treatments used for the treatment of Dupuytren s contracture. Similarly, radiation therapy is referenced however it is not typically utilised to treat Dupuytren s contracture, rather is considered for the treatment of early Dupuytren s disease. (NICE Interventional Guidance No. 368) The scope states that surgery is an effective and widely used treatment. We feel this statement should include the caveat that surgical outcomes and complications can vary with the procedure used, and how effectiveness is measured. The scope states that the type of surgery depends on the severity of accordingly. Page 6 of 21

7 contractures. There are other factors which should also be considered when choosing a surgical procedure, including the number of contractures, the specific joints affected, the patient s medical conditions and comorbidities, and the patient s willingness to have an extensive or prolonged hand surgical procedure and the follow-up and disability associated with recovery from that procedure. This section does not reflect the relative frequencies with which the various surgical procedures are used. There are several sources of evidence that show that the vast majority of DC patients are treated using fasciectomy (see comments on section on comparators). Physiotherapy Dept RIE Non surgical treatments have not been shown to be effective Reference to nonsurgical treatments has been removed from the background section of the scope. The technology/ intervention It would be good to be more precise with the collagen type that the enzyme works to break down, so as not to confuse people into thinking that it is acting on all types of collagen fibres ( eg scarring and adhesions, tendons ) The background section is intended to be a brief explanation of the condition and technology. Society Description is accurate. Society for Surgery of the Hand The treatment is normally carried out in two phases- an injection if the drug on one day and manipulation the next. The extension procedure is an integral part of the treatment. The manufacturers recommend Page 7 of 21

8 splintage after treatment. Although the value of this has not been established following surgery, it is probably mainstream practice. We consider that it would be appropriate to consider off license use many surgeons are performing this with variations of the standard technique. The reason for this is that MCP and PIPJ contracture from Dupuytren s frequently occur together and at present have to be treated with two separate injections and manipulations. This makes the overall cost of treatment unattractive to commissioning trusts Pfizer Ltd, UK and Auxilium Pharmaceuticals Auxilium should also be acknowledged as a manufacturer in the description. Please note that Pfizer and Auxilium Pharmaceuticals will conclude the collaboration agreement for CCH, effective April 24th, *** ********** **** ***** ************ *** ** ************ ************** **** ***** Auxilium has been included as a manufacturer in the scope. This section does not provide a full description of the administration of CCH, as per the SmPC, this treatment for Dupuytren s contracture can be administered by a physician with appropriate training as a single intralesional injection, usually as an outpatient appointment. We note that fasciectomy has not been included as an intervention for appraisal. We feel strongly that if NICE were to appraise CCH using the MTA process, then fasciectomy should also be appraised alongside CCH. We believe that the introduction of a new minimally invasive alternative to fasciectomy means that patients would benefit from comprehensive guidance from NICE. Physiotherapy Dept RIE Said to need 2 visits:1. injection 2. manipulation Complications-bruising, skin tears need to be monitored Population No further comment Special consideration should be given to adults who are young and have a more aggressive form of the disease, as presently they are The appraisal will Page 8 of 21

9 Society viewing a life of multiple surgeries on the same hand, with increasing difficulty for the surgeon and increasing chance of unsuccessful surgery and complications. Collagenase injections cause less trauma and scarring to the hand and therefore it is more likely they can be administered repeatedly without complicating any future treatment. include adults with mild, moderate and severe Dupuytren s contracture with a palpable cord. Society for Surgery of the Hand Pfizer Ltd, UK and Auxilium Pharmaceuticals Physiotherapy Dept RIE We agree with this. This should be stratified according to number of fingers, diathesis level of affliction. The system described by Woodruff and Waldram may also be helpful The population is consistent with the licence of CCH, however the severity of the disease is an important consideration, and we request that the scope reflects the definitions of disease severity as reflected in guidelines from the BSSH. These are the most relevant clinical guidelines in the UK to date and categorise DC into mild, moderate and severe groups. yes The background section has been updated to reflect the BSSH guidelines. The population in the scope has not been changed as it is in line with the license and includes a broad population of adults with mild, moderate and severe Dupuytren s contracture with a palpable cord. Royal College of Does this need to specify, for example, adults with advanced Page 9 of 21

10 Nursing (Society of Orthopaedic and Trauma Nursing) Dupuytren s disease. NICE can only appraise a technology within its licence indication. The marketing authorisation for collagenase clostridium histolyticum is for the treatment of contracture in adults with a palpable cord. Comparators These are the current comparators and no more need to be added Society The comparators are fasciectomy, open fasciotomy and needle fasciotomy. While all these procedures have NICE guidance, it is our experience that only referral for fasciectomy is offered as standard by most GP's, and second line physicians tend to offer fasciectomy as the first option, and only when the contracture is bad enough. If fasciotomy, especially needle fasciotomy, was more commonly used the comparison would be different. Currently comparison with any treatment other than fasciectomy would be unrealistic as that is the treatment most patients receive or can look forward to at the moment. It was agreed at the workshop that all surgical treatments, including fasciectomy, open fasciotomy, needle fasciotomy, should be included as comparators. Society for Surgery of We recommend including needle fasciotomy, open fasciectomy and dermo fasciectomy and graft in this group. Page 10 of 21

11 the Hand Pfizer Ltd, UK and Auxilium Pharmaceuticals Fasciectomy is the gold standard treatment for DC. There are several sources of evidence that show the vast majority of treatments carried out in England for DC are fasciectomy. Therefore the only relevant active comparator for CCH in the appraisal is fasciectomy. 1. Gerber et al, 2011 Dupuytren s contracture: a retrospective database analysis to assess clinical management and costs in England. This publication demonstrates that for all five of the years analysed (2003 to 2008), fasciectomy consistently accounted for the large majority of procedures used for DC in England. The data show that over this period, fasciectomy constituted approximately 90% of procedures of inpatient and day case Dupuytren s contracture procedures. Over the same period, fasciotomy generally accounted for less than 5% of these procedures. 2. Bainbridge et al, 2011 Federation of European Societies for Surgery of the Hand (FESSH) 2011 poster Dupuytren s Contracture: A Retrospective Database Analysis to Assess Clinical Management and Costs in England. These data are from an analysis of HES data from England between 2003 and 2008 (also reported in Gerber et al), and use the NHS Tariff ( ) to calculate the costs of day case and inpatient procedures for DC. The analysis concludes that in addition to fasciectomy accounting for a large proportion of the procedures for DC, fasciectomy also accounts for the majority (82%) of costs for treating DC. 3. Dahlin et al (2012) Current trends in the surgical management of Dupuytren s disease in Europe: the surgeon s perspective This publication reports the data from a review of medical charts across 12 countries, including the UK provided data on the treatment patterns for DC. For the UK, this study showed that from a sample of Attendees at the Scoping Workshop agreed that it was appropriate to include all surgical treatments including fasciectomy, open fasciotomy and needle fasciotomy as comparators in the scope. Page 11 of 21

12 718 fingers from a sample of 93 surgeons (79 orthopaedic and 14 plastic), 72% of procedures were fasciectomies, 10% were fasciotomy and 5% were PNF (remaining procedures were classified as dermofasciectomy, amputation and other). The minimal use of fasciotomy, and particularly PNF, which is included under the same codes, is due at least in part, to the relatively small number of surgeons who regularly practise this non-surgical technique. In cases in which it is used, the evidence available in the clinical literature suggests that PNF in particular is a technique that is best suited to older patients with less severe or milder cases of Dupuytren s contracture (Dahlin et al, 2011; Foucher et al, 2003; NICE Procedure Guidance 43.) Physiotherapy Dept RIE yes Royal College of Nursing (Society of Orthopaedic and Trauma Nursing) There are appropriate comparators listed. We suggest the inclusion of adjunctive therapy as an outcome measure. Non-surgical treatments would be a useful comparator, although less effective treatments for Dupuytren s contracture than surgical treatments. Attendees at the Scoping Workshop agreed that nonsurgical treatments should not be included as a comparator in the scope. Outcomes Pain immediately post treatment may be worth comparing. Following therapy treatment post patients with Xiapex have significant pain but only for a short time hours. Time to resumption of normal functional activity specifically is an important factor for patients ie, back to driving, back to work/usual hobbies. Pain post treatment has not been included as it would be captured in quality of life measures and attendees at the Page 12 of 21

13 workshop agreed that data would be limited. Time to return of normal function has now been included in the scope. Society Society for Surgery of the Hand Pfizer Ltd, UK and Auxilium Pharmaceuticals Ability to work in the patient's profession should be considered as well. Recovery time, ie the time needed for wounds to heal and the hand become (fully) functional again should also be taken into account. Fasciectomy has a far higher rate of complications than collagenase injections, and treating these complications means more cost and time involved. We consider that time to reduction is instant, whether by surgery or collagenase treatment. This does not require study. The degree of reduction of the contracture and the side effect profile are important. In particular, it will be important to assess the rate and timing of recurrence. We consider that from a patient perspective recovery times of open surgery versus Collagenase injection is an important consideration We also consider that it will be important to consider the extent of disease suitable for this treatment and to stratify outcomes according to the level of the disease, the number of fingers affected, and whether this is recurrent disease. In addition to reduction of contracture, we request that increase in range of motion (ROM) should be included. Time to reduction of contracture is imprecise as the angle of contracture will change with time after the procedure. A more relevant outcome for patients should be the time to return of function (eg usual activities or return to work). Time to return of normal function has been included in the draft scope. Time to return of normal function has now been included in the scope. Time to reduction of contracture has been removed from the scope and replaced by time to Page 13 of 21

14 Existing measurements and reporting of recurrence in the literature lack a standard definition, and would provide challenges in providing any comparative assessment for this outcome. We suggest that a broad definition of recurrence is included in the scope that encompasses the need for further treatment. We request that the adverse effects of treatment should be defined to include complications of surgery and the need for further treatment including those complications that require further hospital treatment. return of normal function. Attendees at Workshop suggested that retreatment of contracture should replace recurrence of contracture, to reflect the need for further treatment. However, this was not accepted because factors other than the technology may influence retreatment. All relevant adverse effects of treatment will be taken into consideration during the appraisal. Physiotherapy Dept RIE Return to normal function This has been included as an additional outcome measure. Page 14 of 21

15 Royal College of Nursing (Society of Orthopaedic and Trauma Nursing) Yes Economic analysis Costs should consider number of fingers treated at a single intervention number of follow up clinic appointments (medical and nurse dressing clinics and therapy clinics) days lost from work Society Also to be taken into consideration should be return to work or being able to live independently again, as not working or needing help with every day tasks can be a drain on the economy and the NHS. Society for Surgery of the Hand It is probably wise to allow a two and five year follow up. The potential for the drug to entice new patients to treatment, who would otherwise never have considered surgery, must be considered, Anecdotal experience suggests this is an issue. Approval of the drug may not simply exchange surgery for the drug; it may pull more patients, with associated expense, into the system. Physiotherapy Dept RIE yes Equality There is currently a lack of opportunity for some patients attempting to access this treatment i.e. available privately but not widely on NHS. Society As long as it is licensed for any adult with a palpable cord and the right degree of contracture in one or more fingers no groups will be Page 15 of 21

16 excluded. Pfizer Ltd, UK and Auxilium Pharmaceuticals Not to our knowledge. Physiotherapy Dept RIE Need 2 clinic visits on successive days This is not considered to be an equality issue. Other considerations Data from current clinical practice within the UK will be minimal and the outcomes difficult to analyse as methods of data collection will be inconsistent. Society none Pfizer Ltd, UK and Auxilium Pharmaceuticals A sham procedure, surgical incision of the hand without removal of Dupuytren s tissue, or hundreds of repetitive needle insertions without attempted separation of the Dupuytren s cord would be unethical. CCH was evaluated versus placebo injection. Innovation This is not an overall change in the treatment globally for those with Dupuytren s, however is a significant increase in the options available for patients with palpable cords. For those patients it allows faster recovery etc and reduces the need for surgery. Data is available from trials in the USA and France Society We see the technology as innovative and offering a chance for patients to be helped without having to undergo surgery and a long term recovery period (on average 3 months). Needle fasciotomy is the closest in technology, but is not routinely Page 16 of 21

17 used in clinical practice in the UK (probably due to lack of awareness and lack of training). Needle fasciotomy also has a higher recurrence rate than collagenase injections or fasciectomy, and the chances of digital nerve damage are greater than with collagenase injections. With collagenase the manufacturers offer the training and make sure doctors are confident with the technique, thus limiting the chance of accidental injection into adjacent flexor tendons or the flexor pulley structure. We have heard of people with corneal ulcers due to poking themselves in the eye by accident with the contracted finger. This is the kind of secondary injury that would cost the NHS more money and resources if the patient can not be treated with surgery for medical reasons and collagenase were not available. We realise this kind of accident is difficult to calculate in, but it should not be disregarded..being able to work again rather than be on disability benefits. Not needing carers to help with every day tasks. Internet forum and Facebook discussions by people who had collagenase and/or surgery for Publications in Journals for Hand Surgery and plastic/orthopaedic surgery Society for Surgery of the Hand Pfizer Ltd, UK and Auxilium Pharmaceuticals This is potentially one of the biggest changes that we shall see in the treatment of Dupuytren s. The patients that we have treated both with surgery (Pre Xiapex) and with Xiapex have been very impressed with the Collagenase treatment. We consider that only gene therapy is likely now to supersede this CCH is an innovative treatment and can be considered to provide a step change in the management of Dupuytren s contracture for the following reasons. Page 17 of 21

18 It meets a need which the NHS has identified as being important. In a strategy to reduce costs, the NHS wishes to decrease the proportion of DC patients treated as an inpatient. The Department of Health s day surgery strategy for the NHS lists excision of Dupuytren s contracture as one of 25 procedures that can be performed as day surgery (DoH, 2002). As CCH can be performed in an outpatient setting it can support the NHS in providing services to DC patients outside of the theatre. CCH is a generally well tolerated and effective treatment for a wide range of severity of DC. Research on stratification shows that CCH remains generally well tolerated and effective as a treatment for DC patients with moderate disease as per the BSSH guidelines. Within this group, 88% of evaluable joints (n=65) showed a 50% reduction from baseline in contracture (flexion deformity) within 30 days of an injection. CCH fundamentally changes the way in which care is provide to DC patients who would otherwise be treated with fasciectomy; improving the patient experience by removing the requirement for fasciectomy. This is an invasive surgical procedure that is carried out as an inpatient or day case, and requires an average recommended 5.5 (SD 2.7) weeks absence from work (Dahlin et al, 2012). Return to full activity or productivity after fasciectomy seems to require about 2 months of recovery ( Foucher et al, 1985; Foucher et al, 1992; Kruger- Sayn et al, 1998; Makela et al, 1991; Tonkin et al 1984), including at least one month of postoperative physical therapy for a good recovery to be maintained (Mackin et al, 1990; Mackin et al 2000). Postoperative physiotherapy is also required, possibly including the use of night-time finger stents for up to 6 months (Larson et al 2008). Hand surgery is an intricate procedure and involves the risk of major complications (e.g. neurovascular damage and infection) (Bulstrode et al 2005) as well as a risk that the joint may lose further function (i.e. joint stiffness). Page 18 of 21

19 CCH enables patient choice, is a faster and simpler procedure for patients than fasciectomy. It s minimally invasive nature means that the complications associated with surgery are avoided and involves a quicker recovery, reducing the need for subsequent hand therapy. We propose that the preferences of patients for a non-surgical procedure would not be captured in the QALY. Physiotherapy Dept RIE This technique is only suitable for a small subgroup of Dupuytren s patients-those with palpable cords. It appears expensive so will only be cost effective if recurrence rate is markedly less. Questions for consultation Other non-surgical treatments should not be included as comparators for CCH Sub groups could include patients with single digit involvement patients with single joint involvement There are potential and significant benefits to the use of CCH, however these may not be apparent using the QALY calculation, ie life expectancy is unlikely to be affected, side effects are minor, and health-related benefits ie pain are also unlikely to be a factor. The main benefit is a functional one, including early return to usual occupation Only surgical treatments have been included as comparators int he scope. Attendees at the scoping workshop agreed that it would not be clinically relevant to include subgroups based on single digit or single joint involvement. Society Radiotherapy is an appropriate treatment for early stage Dupuytren s. However, it is only suitable before contracture has reached 10 degrees and thus not an appropriate comparator for collagenase. For fasciotomy see our comment on comparators in draft scope. Other treatments such as splinting and physiotherapy, Vit E cream and ultrasound treatment have not been proven effective in any trials Comments noted. Attendees at the Workshop agreed that radiotherapy is not used for the treatment of Dupuytren s Page 19 of 21

20 therefore should not be considered comparators. Cortico-steroid injections can help soften nodules but have no effect on contractures and a high rate of recurrence, therefore are not used in Britain and not a realistic comparator either. Supportive care is not a treatment for as it is a progressive condition, and life will become increasingly difficult for the patient without medical (or surgical) intervention. Therefore it cannot be seen as a realistic comparator. Collagenase has not been trialled per subgroup of the population, only in sufferers over the whole population. Therefore it is impossible to say if it is more effective in one group than any other contracture and it has not been included in the scope. Only surgical treatments have been included as comparators in the scope. Pfizer Ltd, UK and Auxilium Pharmaceuticals We refer to previous sections on the appropriateness of fasciectomy as the comparator for CCH. Non-surgical treatments should be excluded from the scope as there is little evidence that they offer an efficacious treatment option for patients with Dupuytren s contracture. In the particular instance of radiation therapy, this treatment is recommended for use by the NICE Interventional Procedure Guidance 368 as a treatment for early Dupuytren s disease, and therefore is not relevant for the treatment of Dupuytren s contracture. There may exist a small number of patients with Dupuytren s contracture who would be deemed as unsuitable for treatment using surgical procedures. In such instances, best supportive care would be a suitable comparator in the appraisal. Best supportive care should incorporate a lack of an active surgical intervention and should include any other care provided to help the patient manage symptoms. Evidence from the pivotal CCH studies (CORD I and CORD II) are based on a patient population with predominantly moderate and severe disease (as defined by the BSSH). A subgroup analysis demonstrates that moderate disease patients may particularly benefit Comments noted. Attendees at the Scoping Workshop agreed that it was appropriate to include all surgical treatments including fasciectomy, open fasciotomy and needle fasciotomy as comparators in the scope. Attendees also agreed that that there was unlikely to be any data for non-surgical treatments and it Page 20 of 21

21 from CCH treatment, while previous technology appraisal by the SMC has concluded that this can offer a cost saving when compared to treatment with fasciectomy. would not be possible to capture the group of people who would be unsuitable for surgery within this appraisal. Any additional comments on the draft remit No additional comment Any additional comments on the draft remit No additional comment The following consultees/commentators indicated that they had no comments on the draft remit and/or the draft scope Department of Health Page 21 of 21

22 NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Multiple Technology Appraisal (MTA) Collagenase clostridium histolyticum for treating Dupuytren s contracture Response to consultee and commentator comments on the provisional matrix of consultees and commentators (pre-referral) Version of matrix of consultees and commentators reviewed: Provisional matrix of consultees and commentators sent for consultation Summary of comments, action taken, and justification of action: Proposal: Proposal made by: Action taken: Removed/Added/Not included/noted Justification: 1. Add Arthritis and Musculoskeletal Alliance NICE Secretariat Added This organisation s interests are closely related to the appraisal topic and as per our inclusion criteria. Arthritis and Musculoskeletal Alliance has been added to the matrix of consultees and commentators. Consultation comments on the provisional matrix for the technology appraisal of collagenase clostridium histolyticum for treating Dupuytren s contracture

23 2. Add Healing Foundation NICE Secretariat Added This organisation s interests are 3. Move Dupuytren s Society to Patient Groups closely related to the appraisal topic and as per our inclusion criteria. Healing Foundation has been added to the matrix of consultees and commentators. Pfizer Re-classified This organisation has been reclassified as a patient group - consultee. 4. Add Disability Rights UK NICE Secretariat Added This organisation s interests are 5. Add Leonard Cheshire Disability closely related to the appraisal topic and as per our inclusion criteria. Disability Rights UK has been added to the matrix of consultees and commentators. NICE Secretariat Added This organisation s interests are closely related to the appraisal topic and as per our inclusion criteria. Leonard Cheshire Disability has been added to the matrix of consultees and commentators. Consultation comments on the provisional matrix for the technology appraisal of collagenase clostridium histolyticum for treating Dupuytren s contracture

24 6. Add Men s Health Forum Dupuytren s Society Not added This organisation does not wish to 7. Add Anaesthetists 8. Add Institute of Musculoskeletal Medicine 9. Add Orthopaedic Association be involved in technology appraisals. NICE Secretariat Added This organisation s interests are closely related to the appraisal topic and as per our inclusion criteria. Anaesthetists has been added to the matrix of consultees and commentators. NICE Secretariat Added This organisation s interests are closely related to the appraisal topic and as per our inclusion criteria. Institute of Musculoskeletal Medicine has been added to the matrix of consultees and commentators. Royal College of Nursing Added This organisation s interests are closely related to the appraisal topic and as per our inclusion criteria. Orthopaedic Association has been added to the matrix of consultees and commentators. Consultation comments on the provisional matrix for the technology appraisal of collagenase clostridium histolyticum for treating Dupuytren s contracture

25 10. Add NHS England NICE Secretariat Added This organisation s interests are 11. Remove Bath & North East Somerset and Wiltshire PCT Cluster 12. Remove Southampton, Hampshire, Isle of Wight and Portsmouth PCT Cluster 13. Add NHS Herts Valleys CCG (West) closely related to the appraisal topic and as per our inclusion criteria. NHS England has been added to the matrix of consultees and commentators. NICE Secretariat Removed This organisation has disbanded. NICE Secretariat Removed This organisation has disbanded. NICE Secretariat Added Our process requires the involvement of two CCGs. Therefore NHS Herts Valleys CCG (West) is now included. 14. Add NHS North Norfolk CCG NICE Secretariat Added Our process requires the 15. Move Public Health Wales NHS Trust to Associated Public Health Groups involvement of two CCGs. Therefore NHS North Norfolk CCG is now included. NICE Secretariat Re-classified This organisation has been reclassified as an associated public health group - commentator. Consultation comments on the provisional matrix for the technology appraisal of collagenase clostridium histolyticum for treating Dupuytren s contracture

26 16. Remove Bristol-Myers Squibb Pfizer Removed This organisation s interests are not closely related to the appraisal topic and as per our inclusion criteria. Bristol-Myers Squibb has been removed from the matrix of consultees and commentators. 17. Add Bone Research Society NICE Secretariat Added This organisation s interests are 18. Add Health Research Authority closely related to the appraisal topic and as per our inclusion criteria. Bone Research Society has been added to the matrix of consultees and commentators. NICE Secretariat Added This organisation s interests are closely related to the appraisal topic and as per our inclusion criteria. Health Research Authority has been added to the matrix of consultees and commentators. Consultation comments on the provisional matrix for the technology appraisal of collagenase clostridium histolyticum for treating Dupuytren s contracture

27 19. Add Public Health England NICE Secretariat Added This organisation s interests are closely related to the appraisal topic and as per our inclusion criteria. Public Health England has been added to the matrix of consultees and commentators. Consultation comments on the provisional matrix for the technology appraisal of collagenase clostridium histolyticum for treating Dupuytren s contracture