SMC publishes decisions on 13 drugs in January

Budenofalk (budesonide)

Dr Falk Pharma (Germany)

828/12

No

Symptomatic relief of chronic diarrhoea due to collagenous colitis

For the health economic evidence, the company presented a simple cost analysis to show only the drug acquisition costs of

Budenofalk and a range of other treatments; including Entocort, loperamide hydrochloride, mesalazine and azathioprine. While, when compared with Entocort it was shown as the least expensive therapy, in comparison to other potential comparators it was found to be more expensive in certain cases. However, despite certain weaknesses in the model the economic case was considered demonstrated.

Budenofalk (Budesonide 9mg gastro-resistant granules)

Dr Falk Pharma

831/12

No

Induction of remission in patients with active collagenous colitis

Budenfalk gastro-resistant granules provide a once daily alternative to Budenofalk gastro-resistant 3mg capsules at no additional cost. The granules would be preferable for patients with swallowing difficulty.

Seebri Breezhaler (glycopyrronium)

Novartis (Switzerland)

829/12

 No

As a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Seebri Breezhaler was found to be statistically superior to placebo in improving lung function after 12 weeks in two phase III studies – GLOW 1 and GLOW 2. The company further presented a cost-minimisation analysis comparing Seebri Breezhaler with tiotropium as maintenance treatment of COPD over a one year time horizon. The results of the analysis demonstrated that the total cost per patient per year is GBP334.58 (USD538.89) for Seebri Breezhaler versus GBP408.95 for tiotropium 18 micrograms and GBP431.92 for tiotropium 5 micrograms.

Zinforo (ceftaroline fosamil)

AstraZeneca (UK)

830/12

No

Treatment of complicated skin and soft tissue infections in adults. Restricted for use in patients with known or suspected meticillin resistant Staphylococcus aureus (MRSA) infection in the following settings:for Gram-positive only infections where vancomycin iv is inappropriate/has not been tolerated or treatment modification is required; and daptomycin iv or linezolid iv is normally used; and for polymicrobial Gram-positive and common Gram-negative pathogens*, where vancomycin iv in combination with gentamicin iv is inappropriate/has not been tolerated or treatment modification is required; and daptomycin iv in combination with gentamicin iv, or linezolid iv in combination with gentamicin iv, or tigecycline iv is normally used.

Intravenous Zinforo was shown to be non-inferior to intravenous vancomycin plus aztreonam in adult patients with complicated skin and skin structure infections in two Phase III trials. In addition a cost-minimisation analysis comparing Zinforo with daptomycin and linezolid in patients with monomicrobial (Gram-positive only) infections was submitted by the company. The total cost for a course with Zinforo was considered to be GBP653 while those with daptomycin, and linezolid were found to be GBP575 and GBP759 respectively. Despite certain limitations in the analysis the economic case was considered to have been demonstrated.

Dysport (clostridium botulinum type A toxin-haemagglutinin complex)

Ipsen (France)

353/07

No

For focal spasticity, including the treatment of arm symptoms associated with focal spasticity in conjunction with physiotherapy. Restricted for focal spasticity of the upper limbs associated with stroke.

The SMC considered that Dysport produced a localized reduction in muscle tone in patients with post-stroke upper limb spasticity and can improve patient disability at 16 weeks. It was further found to be effective after repeated administrations with no new apparent adverse effects. The company presented a cost-minimisation analysis which compared Dysport with Botox and Xeomin for the treatment of focal spasticity, including arm symptoms associated with focal spasticity, in conjunction with physiotherapy. The annual drug costs for Dysport was estimated to be GBP924 (1000 units), compared with Xeomin and Botox where the annual drug costs were estimated to be GBP1,385 (307 units) and GBP1,062 (221 units) respectively implying a cost saving of GBP461 with Dysport versus Xeomin and GBP138 versus Botox.

Galvus vildagliptin

Novartis (Switzerland)

826/12

No

Treatment of type 2 diabetes mellitus in adults as a monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. Restricted for use in patients for whom both metformin and sulphonylureas are inappropriate due to contraindications or intolerance

While the non-inferiority of Galvus to first-line oral anti-diabetic agents was not shown In two comparator controlled studies, a network meta-analysis demonstrated similar reductions in HbA1c at 24 weeks for Galvus versus another dipeptidyl peptidase 4 (DPP-4) inhibitor. The company submitted a cost-minimisation analysis (CMA) comparing Galvus to sitagliptin, using a five year time horizon. The total cost for Galvus was estimated to be GBP2,182 compared with GBP2,218 for sitagliptin, representing a saving of GBP36 over the five year time horizon.

Forxiga (dapagliflozin)

Bristol-Myers Squibb (BMS; US) and AstraZeneca

799/12

No

For use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as an add-on combination therapy in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. Restricted to use as dual therapy in combination with metformin, when metformin alone with diet and exercise does not provide adequate glycaemic control and a sulphonylurea is inappropriate

For the health economic evidence, the companies presented cost-utility analyses to address the use of Forxiga as an add-on to metformin compared with the current treatment options of sulphonylurea (SU), DPP-4 inhibitors or pioglitazone in type 2 diabetic patients for whom metformin alone (with diet and exercise) does not provide adequate control; and Forxiga as an add-on to insulin (with or without other oral anti-diabetic agents) compared with DPP-4 inhibitors when the underlying treatment regimen including insulin does not provide adequate control. The cost per QALY figures considered by the SMC for their decision were, GBP25,153, GBP10,000, and GBP6,661 for the comparisons against sulphonylurea, DPP-4 inhibitors and pioglitazone respectively. While the economic case was considered to have been demonstrated for the metformin add-on analysis against DPP-4 inhibitors and pioglitazone, it was not considered to have been demonstrated in the case of sulphonylureas. The Committee therefore concluded that the economic case had not been demonstrated for the insulin add-on comparison.

Kalydeco (ivacaftor)

Vertex Pharmaceuticals (US)

827/12

No

Treatment of cystic fibrosis (CF) in patients age six years and older who have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Kalydeco was shown to be superior over placebo measured by absolute change in forced expiratory volume in one second (FEV1) % predicted in two phase III, double-blind randomised studies – STRIVE and ENVISION. A cost-utility analysis comparing Kalydeco plus standard care against standard care alone to treat patients with CF caused by a G551D mutation and aged six years and older was submitted. The incremental cost per quality adjusted life year (QALY) was GBP330,657 compared to standard care alone. This was based on an incremental cost of GBP1,780,591 and incremental QALYs of 5.4. Furthermore, sensitivity analyses demonstrated that the results were subject to considerable uncertainty, especially in terms of around the long-term trend in FEV1 % predicted for patients maintained on Kayldeco.

Adcetris (brentuximab vedotin)

Takeda (Japan)

845/12

Treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option and treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (SALCL)

Non-submission. The holder of the marketing authorisation has not made a submission to the SMC regarding this product in this indication. As a result, the SMC could not recommend its use within the National Health Service Scotland.

Arcoxia (etoricoxib)

Merck Sharp and Dohme (part of Merck&Co; US)

847/12

Short-term treatment of moderate pain associated with dental surgery

Non-submission

Plenadren (hydrocortisone)

ViroPharma (US)

848/12

Treatment of adrenal insufficiency in adults

Non-submission

Dacogen (decitabine)

Janssen-Cilag (part of Johnson & Johnson, US)

846/12

Treatment of adult patients aged 65 years and above with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates for standard induction chemotherapy.

Non-submission

Cialis (tadalafil)

Eli Lilly (US)

849/12

Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

Non-submission