Batch 57 Block Scoping Report

Batch 57 Block scoping report

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE

CENTRE FOR HEALTH TECHNOLOGY EVALUATION Technology Appraisals

Consultation on Batch 57 draft remits and draft scopes and summary of comments and discussions at scoping workshops

Topic ID Topic title

1217 Dapagliflozin, empagliflozin and sotagliflozin, in combination with (combined insulin, for treating type 1 diabetes with 1275)

Tofacitinib for treating active psoriatic arthritis following disease- 1220 modifying anti-rheumatic drugs

1218 Tofacitinib for moderately to severely active ulcerative colitis

1237 Mepolizumab for treating chronic obstructive pulmonary disease

1232 Certolizumab pegol for treating moderate to severe plaque psoriasis

Dapagliflozin, empagliflozin and sotagliflozin, in combination with Provisional Title insulin, for treating type 1 diabetes Topic Selection 8279/8402 Wave / Round R180 ID Number TA ID Number 1217 (Combined with 1275) AstraZeneca (dapagliflozin) Company Boehringer Ingelheim and Eli Lilly (empagliflozin) Sanofi (sotagliflozin) Dapagliflozin: *** Confidential information removed ***

Anticipated Empagliflozin: licensing *** Confidential information removed *** information Sotagliflozin : *** Confidential information removed ***

To appraise the clinical and cost effectiveness of dapagliflozin and Draft remit empagliflozin within their marketing authorisation for treating type 1 diabetes. Following the consultation exercise and the scoping workshop, the Institute is of the opinion that an appraisal of dapagliflozin and empagliflozin for treating type 1 diabetes is appropriate.

The proposed remit is not appropriate and should be amended to include sotagliflozin, a dual SGLT1 and SGLT-2 inhibitor that is anticipated to have very similar licensing dates and indication to Main points from empagliflozin and dapagliflozin. consultation Stakeholders considered that the technologies could potentially lead to a step change in the management of type 1 diabetes as they would be the first licensed treatments since insulin. Stakeholders also considered that an appraisal of all three technologies in a MTA would be appropriate if the timelines for marketing authorisation align. However, the companies were concerned that an MTA may lead to less timely guidance if there are differences in the licensing dates. Up to 380,000 people in England could be eligible for treatment with these technologies (this is the approximate number of people in Population size England who have type 1 diabetes: it is not known how many would be eligible for adjunct treatment in combination with insulin). Process (TA/HST) TA

Proposed To appraise the clinical and cost effectiveness of dapagliflozin, changes to remit empagliflozin and sotagliflozin within their marketing authorisations for (in bold) treating type 1 diabetes. The annual cost of treatment with either dapagliflozin or empagliflozin is around £480 per person per year. The cost of sotagliflozin is not available but is assumed to be similar. The cost of treatment would be Costing additional to current treatment with insulin. The number of people who implications would be eligible for adjunct treatment in combination with insulin is not known; if all people in England who have type 1 diabetes were treated with dapagliflozen, empagliflozen or sotagliflozin the annual resource impact could be around £180m.

Assuming that the anticipated date of the marketing authorisations are Timeliness the latest date that we are aware of and the expected referral date of statement this topic, issuing timely guidance for these technologies will be possible.

Tofacitinib for treating active psoriatic arthritis following disease- Provisional Title modifying anti-rheumatic drugs Topic Selection 7800 Wave / Round R144 ID Number TA ID Number 1220 Company Pfizer Anticipated licensing *** Confidential information removed *** information To appraise the clinical and cost effectiveness of tofacitinib within its Draft remit marketing authorisation for treating active psoriatic arthritis. Following the consultation exercise and the scoping workshop, the Institute is of the opinion that an appraisal of tofacitinib for treating active psoriatic arthritis is appropriate. Main points from consultation The proposed remit is appropriate. No changes are required.

All consultees stated the remit and an appraisal was appropriate.

Approximately 6,500 people in England would be eligible for treatment Population size with tofacitinib. Based on the estimated prevalence of psoriatic arthritis and those eligible for TNF-alpha inhibitors. Process (TA/HST) TA

Proposed changes to remit None (in bold) Tofacitinib is licensed for another indication, moderate to severe rheumatoid arthritis however the list price of tofacitinib has a discount Costing that is commercial in confidence. If licenced, tofacitinib will provide an implications additional oral treatment option for patients with active psoriatic arthritis. Any resource impact will be as a result of the difference in cost of tofacitinib and other existing treatment options. Assuming that the anticipated date of the marketing authorisation is Timeliness the latest date that we are aware of and the expected referral date of statement this topic, issuing timely guidance for this technology will be possible.

Provisional Title Tofacitinib for moderately to severely active ulcerative colitis Topic Selection 7282 Wave / Round R105 ID Number TA ID Number 1218 Company Pfizer Anticipated licensing *** Confidential information removed *** information To appraise the clinical and cost effectiveness of tofacitinib within its Draft remit marketing authorisation for treating moderately to severely active ulcerative colitis Following the consultation exercise and the scoping workshop, the Institute is of the opinion that an appraisal of tofacitinib for treating moderately to severely active ulcerative colitis is appropriate.

Main points from The proposed remit is appropriate. No changes are required. consultation

A cost comparison is not considered appropriate because there is no comparative evidence against current comparators.

Approximately 75,900 people in England would be eligible for treatment with tofacitinib. Around 146,000 people in England have ulcerative colitis. About 52% Population size of the people affected have moderate to severe disease. This equates to 75,900 people in England. Fewer people will have received prior therapy, and would be eligible for tofacitinib. Process (TA/HST) TA

Proposed changes to remit None (in bold) Tofacitinib is an orally administered drug which provides an additional second-line treatment option for moderate or severe ulcerative colitis. Tofacitinib is licensed for another indication, moderate to severe Costing rheumatoid arthritis however the list price of tofacitinib has a discount implications that is commercial in confidence. Use of tofactinib is expected to lead to savings from oral self- administration rather than IV administration and decreased symptoms, however any potential savings cannot be quantified. Assuming that the anticipated date of the marketing authorisation is Timeliness the latest date that we are aware of and the expected referral date of statement this topic, issuing timely guidance for this technology will be possible.

Provisional Title Mepolizumab for treating chronic obstructive pulmonary disease Topic Selection 8369 Wave / Round R190 ID Number TA ID Number 1237 Company GlaxoSmithKline Anticipated licensing *** Confidential information removed *** information To appraise the clinical and cost effectiveness of mepolizumab within Draft remit its marketing authorisation for treating chronic obstructive pulmonary disease. Following the consultation exercise and the scoping workshop, the Institute is of the opinion that an appraisal of mepolizumab for treating chronic obstructive pulmonary disease is appropriate. Main points from consultation The proposed remit is appropriate. No changes are required.

The company indicated a cost-comparison case would not be applicable versus optimised standard of care.

Approximately 120,000 people in England would be eligible for Population size treatment with mepolizumab.

Process (TA/HST) TA

Proposed changes to remit None (in bold) Mepolizumab is an add-on therapy option so resource impact will depend on the cost of alternative treatment options that are displaced. Mepolizumab is licensed for another indication, treating severe Costing refractory eosinophilic asthma however the list price of mepolizumab implications has a discount that is commercial in confidence. Mepolizumab may also help in reducing symptoms and risk of exacerbations requiring admission. Assuming that the anticipated date of the marketing authorisations are Timeliness the latest date that we are aware of and the expected referral date of statement this topic, issuing timely guidance for these technologies will be possible.

Provisional Title Certolizumab pegol for treating moderate to severe plaque psoriasis Topic Selection 9112 Wave / Round R232 ID Number TA ID Number 1232 Company UBC Anticipated licensing *** Confidential information removed *** information To appraise the clinical and cost effectiveness of certolizumab pegol Draft remit within its marketing authorisation for treating moderate to severe plaque psoriasis. Following the consultation exercise and the scoping workshop, the Institute is of the opinion that an appraisal of certolizumab pegol for treating moderate to severe plaque psoriasis is appropriate.

The proposed remit is appropriate. No changes are required.

 Certolizumab pegol may be suitable for a cost comparison case. NICE issued positive (optimised) guidance on another anti-TNF Main points from drug, etanercept, for plaque psoriasis (TA103 for adults and TA455 consultation for children and young people).  Direct evidence comparing certolizumab pegol with etanercept is available (NCT02346240). A press release stated that certolizumab pegol achieved superiority at the 400mg dose and non-inferiority at the 200mg dose compared to etanercept.  There were no specific consultation comments on the suitability of cost comparison. The Psoriasis and Psoriatic Arthritis Alliance (PAPAA) noted that this is similar in action to other established anti-TNFs, and essentially a ‘me too’ drug. Approximately 172,800 people in England would be eligible for treatment with certolizumab pegol. Population size This is based on an estimated prevalence of 1.75% in adults, of whom 20% have moderate to severe psoriasis, and 90% have plaque psoriasis. Process (TA/HST) TA

Proposed changes to remit None (in bold) If licenced, certolizumab pegol will offer an additional treatment option Costing for chronic plaque psoriasis in adults. Treatment is a 2 weekly implications subcutaneous injection for 26 doses per year. The cost of the injection is £715, and the annual treatment cost is around £18,600 per person. Assuming that the anticipated date of the marketing authorisation is Timeliness the latest date that we are aware of and the expected referral date of statement this topic, issuing timely guidance for this technology will be possible.