SMC does not recommend Striverdi Respimat and Anoro, issues restricted approval for Jetrea

Xigduo (dapagliflozin + metformin)

AstraZeneca (UK)

983/14

-

In adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: in patients inadequately controlled on their maximum tolerated dose of metformin alone; in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products; in patients already being treated with the combination of dapagliflozin and metformin as separate tablet.

Restricted to use in patients for whom a combination of dapagliflozin and metformin is an appropriate choice of therapy, such as when metformin alone does not provide adequate glycaemic control and a sulphonylurea is inappropriate. In combination with insulin, when insulin and metformin does not provide adequate control. In combination with a sulphonylurea, when a sulphonylurea and metformin does not provide adequate control.

Abbreviated submission.

The SMC noted that dapagliflozin plus metformin was demonstrated to be bioequivalent to dapagliflozin and metformin administered separately and dapagliflozin administered twice daily have been shown to provide similar exposure to the equivalent dose administered once daily.

Jetrea (ocriplasmin)

ThromboGenics (Belgium)

892/13

No

In adults for the treatment of vitreomacular traction (VMT), including when associated with macular hole of a diameter less than or equal to 400 microns.

SMC restriction: patients with VMT plus macular hole, regardless of whether they have epiretinal membrane (ERM) formation, and in patients with VMT alone (no epiretinal membrane and no macular hole).

A significantly higher number of patients receiving Jetrea achieved resolution of vitreomacular adhesions which may correlate with improved visual acuity when compared with placebo in two randomised, controlled double-blind studies. The company submitted a cost-utility analysis in which a single intravitreal injection of Jetrea with a strategy of watch and wait in patients with VMT was compared with vitrectomy surgery as an option in both treatment groups. The results showed that for the VMT (no ERM, no macular hole) sub-group the incremental cost-effectiveness ratio (ICER) was estimated at GBP17,832 (USD29,925.8) per quality-adjusted life year (QALY) gained, and for the VMT (plus macular hole) sub-group, the ICER was GBP24,170 per QALY gained. Despite certain weaknesses, the economic case was considered as having been demonstrated.

RoActemra (tocilizumab)

Roche (Switzerland)

982/14

Yes

In combination with methotrexate (MTX) for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have either responded inadequately to, or who were intolerant of previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists. In these patients, tocilizumab can be given as monotherapy in case of intolerance to MTX, or where continued treatment with MTX is inappropriate. Tocilizumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.

Restricted to use in accordance with current eligibility and continuation rules for biologic therapies in RA.

Subcutaneous RoActemra was shown to be non-inferior to RoActemra intravenous infusion for the primary outcome of proportion of patients who achieved an American College of Rheumatology 20% response in the Phase III SUMMACTA trial conducted in adult patients with RA. The company submitted a cost-minimisation analysis comparing RoActemra SC with RoActemra IV in adult patients who have either responded inadequately to or who were intolerant of previous therapy with one or more DMARDs or TNF antagonists. Furthermore, a patient access scheme (PAS) was presented by the company, according to which a simple discount is applied to the list price of RoActemra, which was agreed to by the Patient Access Scheme Assessment Group (PASAG). When including the PAS, RoActemra SC became a cost-effective treatment option.

BindRen (colestilan)

Mitsubishi (Japan)

939/14

Yes

Treatment of hyperphosphataemia in adult patients with chronic kidney disease (CKD) stage 5 receiving haemodialysis (HD) or peritoneal dialysis

In terms of clinical evidence, although BindRen was shown to reduce serum phosphate in dialysis patients with CKD and hyperphosphataemia when compared with placebo, comparative data with another non-calcium-based, non-absorbed phosphate binder do not provide robust evidence of non-inferiority. For comparative health economic evidence, a cost-minimisation analysis was submitted by the company in which BindRen was compared with sevelamer as a second-line treatment option for HD patients requiring a non-calcium-based, non-absorbed phosphate binder, who remain hyperphosphataemic despite adherence to the maximum recommended or tolerated dose of a calcium-based phosphate binder, or who experience hypercalcaemia. The base case results demonstrated annual costs of GBP2,519.21 per patient for BindRen and GBP3,359.86 per patient for sevelamer. A PAS was submitted by the company, which was agreed to by PASAG, whereby a simple discount reducing the list price of the drug was proposed. The SMC concluded that given concerns over the robustness of the comparative clinical data underpinning the evidence for the cost-minimisation analysis, BindRen was not recommended.

Amitiza (lubiprostone, 24 microgrammes soft capsules)

Sucampo Pharmaceuticals (US)

977/14

No

The treatment of chronic idiopathic constipation and associated symptoms in adults, when response to diet and other non-pharmacological measures (educational measures, physical activity) are inappropriate.

Amitiza was shown to be associated with increased weekly frequency of spontaneous bowel movements in comparison with placebo in patients with chronic idiopathic constipation. Additionally, when compared with the placebo arm, patients receiving Amitiza reported improved symptom scores for stool consistency, straining, and constipation severity. For the health economic evidence, a cost-utility analysis was presented comparing Amitiza with prucalopride and current care, with the latter including immediate referral to investigations and invasive procedures, such as stoma surgery, sacral neuromodulation, and biofeedback. The cost per quality-adjusted life year (QALY) of Amitiza versus current care was estimated at GBP24,958 in the base case analysis. When compared with prucalopride, Amitiza was found to be cheaper and more effective, with savings estimated at GBP54, and a 0.0002 QALY gain. However, several weaknesses were identified in the analysis, and given a rather high base-case cost per QALY in comparison with current care, as well as the uncertainty associated with it, the economic case was not considered to have been demonstrated.

Hidrasec (racecadotril)

Abbott (US)

818/12

No

Complementary symptomatic treatment of acute diarrhoea in infants older than three months and in children, together with oral rehydration and usual support measures, when these measures alone are insufficient to control the clinical condition, and when causal treatment is not possible. If causal treatment is possible racecadotril can be administered as a complementary treatment option.

Although a meta-analysis showed that, when compared with placebo, Hidrasec was significantly reducing the duration of diarrhoea and stool output in children with acute diarrhoea. This is the evidence that it improves recovery rate was concluded to not be sufficient. A cost-utility analysis comparing Hidrasec plus ORT to ORT alone, for the treatment of acute diarrhoea in children aged three months to five years old was submitted by the company. Hidrasec plus ORT was shown to be dominant in comparison with ORT alone, with costs savings of GBP131 per 100 children. However, as a result of several weaknesses in the analysis, such as the sensitivity of the ICER to the relative risk of referral to secondary care at the second general practitioner (GP) visit, the economic case was not considered to have been demonstrated.

Striverdi Respimat (olodaterol 2.5-microgramme solution for inhalation)

Boehringer Ingelheim (Germany)

974/14

No

Maintenance bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD).

The clinical evidence demonstrated that there is no significant difference between Striverdi Respimat and another long-acting beta2 agonist trough forced expiratory volume in 1 second (FEV1) and FEV1 area under curve (0 to 3 hours) at week 24 in two 48-week studies. For the health economic evidence a cost-minimisation analysis comparing Striverdi Respimat versus indacaterol as maintenance bronchodilator treatment in patients with COPD was presented. The cost per patient per year for Striverdi Respimat was estimated at GBP321 and GBP356 for indacaterol. However, several weaknesses in the comparator selection and the evidence on which the analysis was based were identified, with the SMC therefore concluding that the economic case was not demonstrated.

Anoro (umeclidinium + vilanterol)

GlaxoSmithKline (GSK, UK)

978/14

No

As a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD.

Although Anoro was shown to significantly improve the lung function in comparison with an inhaled long-acting antimuscarinic after 24 weeks in 3 randomised controlled studies, according to which treatment in patients with moderate-to-very-severe COPD showed no difference between treatments in dyspnoea or health status. For the health economic evidence the company presented a cost-utility analysis for combined inhaler Anoro 55/22 microgrammes was compared with tiotropium 18 mcg, and also with the combined use of two separate inhalers: indacaterol 150 mcg (120-mcg delivered dose) plus tiotropium 18 mcg (10-mcg delivered dose). The based case results demonstrated that the Anoro dominated both comparators. However, the SMC concluded that given the uncertainties associated with the clinical evidence, the economic case was not demonstrated.