Download Costing statement: Ulcerative colitis

Putting NICE guidance into practice
Costing statement: Ulcerative
colitis
Implementing the NICE guidance on
vedolizumab for treating moderately to
severely active ulcerative colitis (TA342)
Published: June 2015
1 Introduction
1.1
The guidance on ‘vedolizumab for treating moderately to severely
active ulcerative colitis’ (NICE technology appraisal 342) offers an
additional treatment option for treating moderately to severely
active ulcerative colitis in adults.
1.2
There is variation in current clinical practice across the country and
a lack of data on treatment outcomes. Therefore, we encourage
organisations to evaluate their own practices against the
recommendations in the guidance and assess costs and savings
locally. Some of the resource effects to be considered locally are
discussed in this statement.
1.3
Section 7(6) of the National Institute for Health and Care
Excellence (Constitution and Functions) and the Health and Social
Care Information Centre (Functions) Regulations 2013 requires
clinical commissioning groups, NHS England and, with respect to
their public health functions, local authorities to comply with the
recommendations in this appraisal within 3 months of its date of
publication.
1.4
This technology is commissioned by Clinical Commissioning
Groups (CCGs). Providers of services for ulcerative colitis are NHS
hospital trusts.
2 Guidance
2.1
The guidance states that:
 Vedolizumab is recommended, within its marketing
authorisation, as an option for treating moderately to severely
active ulcerative colitis in adults only if the company provides
vedolizumab with the discount agreed in the patient access
scheme.
National costing statement: vedolizumab for ulcerative colitis (June 2015)
2 of 10
 Vedolizumab should be given until it stops working or surgery is
needed. At 12 months after the start of treatment, people should
be reassessed to see whether treatment should continue.
Treatment should only continue if there is clear evidence of
ongoing clinical benefit. For people in complete remission at
12 months, consider stopping vedolizumab, resuming treatment
if there is a relapse. People who continue vedolizumab should
be reassessed at least every 12 months to see whether
continued treatment is justified.
3 Background
3.1
Ulcerative colitis is a chronic condition in which inflammation
develops in the large intestine. Symptoms may include bloody
diarrhoea, abdominal pain, weight loss, fatigue, anaemia and an
urgent need to defaecate.
3.2
Ulcerative colitis has a prevalence of 0.24%, which amounts to
approximately 106,000 adults in England. About 52% of the people
affected have moderate to severe disease.
3.3
Symptoms can flare up then disappear for months or even years,
but about 50% of people with ulcerative colitis will relapse at least
once a year. Ulcerative colitis can cause complications such as
primary sclerosing cholangitis (inflamed and damaged bile ducts),
bowel cancer, osteoporosis and toxic megacolon (swelling of the
colon caused by trapped gases, which can be life-threatening).
3.4
Ulcerative colitis is defined by the modified Truelove and Witts
severity index as being mild if there are fewer than 4 bowel
movements daily; moderate ulcerative colitis if there are more than
4 daily bowel movements but the person is not systemically ill; and
severe ulcerative colitis if there are more than 6 bowel movements
daily and the person is also systemically ill. Severe ulcerative colitis
is potentially life threatening and normally needs hospitalisation and
emergency care.
National costing statement: vedolizumab for ulcerative colitis (June 2015)
3 of 10
3.5
This costing statement considers people with moderately to
severely active ulcerative colitis; it does not include acute severe
ulcerative colitis (that is, severe ulcerative colitis according to the
Truelove and Witts severity index) that is a medical emergency.
Recommendations for managing acute severe ulcerative colitis can
be found in the NICE clinical guideline Ulcerative colitis:
Management in adults, children and young people and the
technology appraisal Infliximab for acute exacerbations of
ulcerative colitis.
3.6
Conventional treatment options for moderately to severely active
ulcerative colitis include oral or topical aminosalicylates
(sulfasalazine, mesalazine, balsalazide or olsalazine), or treatment
with corticosteroids if aminosalicylates are contraindicated or not
tolerated.
3.7
Some people may also be offered a TNF-alpha inhibitor if
conventional therapy fails. Recommendations for infliximab,
adalimumab or golimumab can be found in the NICE technology
appraisal infliximab, adalimumab and golimumab for treating
moderately to severely active ulcerative colitis after the failure of
conventional therapy.
3.8
If the TNF-alpha inhibitors fail the treatment options are limited to a
return to conventional therapy, or surgery. Surgery would be
considered a final treatment option (if symptoms are inadequately
controlled or if the person has a poor quality of life on conventional
therapy).
4 Resource impact
Population
4.1
Vedolizumab is indicated for the treatment of adult patients with
moderately to severely active ulcerative colitis that has had an
National costing statement: vedolizumab for ulcerative colitis (June 2015)
4 of 10
inadequate response or lost response to, or who were intolerant to
either conventional therapy or a TNF–alpha inhibitor.
4.2
Table 1 shows that 5 people per 100,000 population could
potentially be treated with vedolizumab.
Table 1 Number of people per 100,000 population potentially eligible for
treatment
Population
Percentage
Per 100,000
population
Number of adultsa
Prevalence of ulcerative colitisb
Prevalence of moderate to severe
diseaseb,c
79,234
0.24%
190
52.33%
99
16.20%
16
30%
5
Proportion of people whose condition
fails conventional therapy and who are
treated with a biologicb
Estimated uptake for treatment with
vedolizumabb
a
GP registered population 2012: Public Health England - patients registered with GP
practices, by age and sex.
b
Based on the manufacturer’s submission.
c
Ulcerative colitis is defined by the modified Truelove and Witts severity index as
being moderate ulcerative colitis if there are more than 4 daily bowel movements but
the person is not systemically ill; and severe ulcerative colitis if there are more than 6
bowel movements daily and the person is also systemically ill. Severe ulcerative colitis
is potentially life threatening and normally needs hospitalisation and emergency care.
Costs
4.3
The average annual drug cost of vedolizumab is shown in table 2.
The company has agreed a patient access scheme with the
Department of Health. The level of the discount is commercial in
confidence. The NHS list price is £2050 per 300 mg vial of
National costing statement: vedolizumab for ulcerative colitis (June 2015)
5 of 10
vedolizumab. This gives an annual cost of £16,913 in the first year
and £13,325 in subsequent years. Details on the drug and
administration costs of vedolizumab are available in Appendix A.
4.4
It is anticipated that, as with the other biologics, vedolizumab would
be added-on to existing treatments. The manufacturer’s model
assumes that while patients are receiving biologic therapies, the
costs associated with conventional non-biologic therapies will be
half of those incurred by patients who are receiving conventional
therapies only. Table 2 shows the full costs of conventional
therapies.
National costing statement: vedolizumab for ulcerative colitis (June 2015)
6 of 10
Table 2 Comparative annual costs of treatment options
Annual treatment cost per patient per drug
Treatment
Cost (£)
Vedolizumab (based
on the NHS list
price)a
Infliximab proprietaryb
Infliximab biosimilarb
Adalimumabb
Golimumabb
5-ASAs, tablets
(Ipocol)c
5-ASAs, enemas
(Asacol)c
5-ASAs,
suppositories
(Asacol)c
Azathioprined
6-mercaptapurinee
Prednisoloned
1st year
Induction (£)
Maintenance (£)
Biologics
6,150
10,250
Subsequent years
Maintenance (£)
13,325
5,035
8,392
10,910
4,532
7,553
9,819
2,817
8,867
3,052
8,393
Conventional treatments
10,611
9,919
49.50
111.83
161.33
106.88
589.75
696.63
40.49
223.41
263.90
13.40
261.15
76.70
73.93
1,441.00
-
87.33
1,702.15
-
a
The NHS list price is £2050 per 300 mg vial of vedolizumab. The company has agreed a
patient access scheme with the Department of Health. The level of the discount is commercial
in confidence.
Induction doses at 0,2 and 6 weeks. Maintenance doses every 8 weeks thereafter. NHS list
price from eMC Dictionary of Medicines May 2015. The SPC for vedolizumab states that dose
escalation is possible, but this has not been included in the calculation.
b
The drug costs for the TNF-alpha inhibitor biologic drugs are based on the calculations used
for the costing statement on TA329 Infliximab, adalimumab and golimumab for treating
moderately to severely active ulcerative colitis after the failure of conventional therapy. Please
refer to that document for the detail behind the calculations.
Dose escalation was taken into account for adalimumab from week 12 (D Wolf et al. (2014)
Escalation to weekly dosing recaptures response in adalimumab-treated patients with
moderately to severely active ulcerative colitis).
There is a patient access scheme for golimumab in which the company agrees to provide the
100 mg dose of golimumab at the same cost as the 50 mg dose. There are no patient access
schemes for infliximab or adalimumab.
c
8 week induction. Daily maintenance thereafter. Drug costs from Chemist and Druggist May
2015.
d
8 week induction. Drug costs from eMC Dictionary of Medicines May 2015.
e
8 week induction. Daily maintenance thereafter. Drug costs from eMC Dictionary of
Medicines May 2015.
National costing statement: vedolizumab for ulcerative colitis (June 2015)
7 of 10
Savings
4.5
The manufacturer suggests that there could be a reduction in the
number of drug-related adverse events compared with other
biologic drugs. Based on the estimates in the manufacturer’s
submission, there could be 189 less adverse events such as skin
reactions and serious infections. With a weighted average adverse
event cost of £1,581, this gives potential savings of around £300k
in England per year. Users are encouraged to estimate any
potential savings locally.
5 Conclusion
5.1
The guidance offers an additional treatment option for treating
moderately to severely active ulcerative colitis in adults. We
encourage organisations to evaluate their own practices against the
recommendations in the NICE guidance and assess costs and
savings locally.
5.2
There is variation in current clinical practice across the country and
a lack of data on treatment outcomes. It is anticipated that there will
be increased drug costs for clinical commissioning groups.
5.3
There may be some savings associated with a reduction in drugrelated adverse events compared with other biologic drugs.
National costing statement: vedolizumab for ulcerative colitis (June 2015)
8 of 10
Appendix A
Drug and administration costs per treatment cycle - vedolizumab
a
Units per year
Product
Vedolizumab
Mg
300
Cost
per unit
£2,050
Induction
Maintenance
Subsequent
years
Maintenance
3
5
6.5
First year
b
Drug cost per year
Induction
Maintenance
Subsequent
years
Maintenance
£6,150
£10,250
£13,325
First year
a
Administration cost per year
First year
Induction
£395
Maintenance
£535
Subsequent
years
Maintenance
£696
The number of units per cycle refers to the total number of vials, pens or syringes required. This does not reflect the number of administrations.
b
It is assumed that administration of vedolizumab will require an outpatient attendance for intravenous infusion. It is estimated that 3 attendances would be required during induction in the first
year, 5 during maintenance in the first year and 6.5 during maintenance in subsequent years, at a cost of £181 for the first attendance and £107 per subsequent attendance (Payment by results
2015-16 enhanced tariff option, 301 Gastroenterology outpatient appointment). Commissioners and providers may need to agree a payment as the cost of administration may fall between an
outpatient appointment and a day case.
National costing statement: vedolizumab for ulcerative colitis (June 2015)
9 of 10
National costing statement: vedolizumab for ulcerative colitis (June 2015)
10 of 10