New projects: New NICE topic - Sodium zirconium cyclosilicate for treating hyperkalaemia

ScHARR-TAG has been allocated the following STA topic:

Sodium zirconium cyclosilicate for treating hyperkalaemia

New project: NICE topics

ScHARR-TAG has been allocated the following STA topics:

·         Moxetumomab pasudotox for hairy-cell leukaemia [ID1142]

·         Pembrolizumab for untreated gastric or gastro-oesophageal junction cancer [ID1305]

·         Clostridium botulinum neurotoxin type A for treating hypersalivation associated with neurological conditions [ID1150

New project: New NICE topic

ScHARR-TAG has been allocated the following HST topic:

• Recombinant human alpha-mannosidase for treating alpha-mannosidosis (16/27/06) [ID800]

Image: NICE by Sasha Cresdee

New project: NICE topic

ScHARR-TAG has been allocated the following STA topic:

• Sarilumab after TNFnhibitors for treating active rheumatoid arthritis [ID994] (16/108/06)

Image: Rheumatoid Arthritis in the hand by Wellcome Images

New projects: Two new NICE topics

ScHARR-TAG has been allocated the following STA topics:

• Ataluren for treating cystic fibrosis [ID955]
• Fulvestrant for untreated hormone-receptor positive metastatic breast cancer [ID951]

New project: NICE Technology Appraisal

ScHARR-TAG has been allocated the following STA topic:

• Ibrutinib for treating newly diagnosed chronic lymphocytic leukaemia [ID918]

New project: NICE Technology Appraisal

ScHARR-TAG has been allocated the following STA topic:

• Ustekinumab for treating moderately to severely active Crohn's disease after prior therapy [ID843]

Initial details are available here.

Project update: NICE DAR on sepsis

The HEDS team on this, and authors of the catchily title report “The LightCycler SeptiFast Test MGRADE, SepsiTest and IRIDICA BAC BSI assay for rapidly identifying bloodstream bacteria and fungi. A systematic review and economic evaluation”, were Matt Stevenson, Abdullah Pandor, Marrissa Martyn-St James, Rachid Rafia, Lesley Uttley, John Stevens, Jean Sanderson and Ruth Wong.

Image: Wellcome Images

From the NICE website:

“In final diagnostics guidance published today NICE has recommended that further research is carried out on 3 promising new blood tests for speeding up the identification of bloodstream bacteria and fungi in people with suspected bloodstream infections.
The LightCycler SeptiFast Test MGRADE (Roche Diagnostics), SepsiTest (Molzym Molecular Diagnostics) and IRIDICA BAC BSI assay (Abbott Laboratories) analyse whole blood samples to identify bacterial and fungal DNA. The tests aim to identify the causes of infection much quicker than traditional microbiology techniques which require blood samples to be incubated and cultured before pathogens can be identified.

The independent Diagnostics Advisory Committee concluded that, although the tests show promise, there is currently not enough evidence to recommend their routine adoption in the NHS. They felt the tests may offer clinical benefit by providing results more quickly but there was currently too much uncertainty in their accuracy for clinicians to be able to use them as the basis for clinical decision-making in people with suspected bloodstream infections, who can be acutely unwell.

The Committee therefore decided that further research should be encouraged to provide robust evidence, particularly around demonstrating the value of using the test results in clinical decision-making.”

Project update: Olaparib for ovarian cancer

From the NICE website:

"NICE recommends olaparib (also known as Lynparza, and manufactured by AstraZeneca) for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube and peritoneal cancer. The drug is for cancers in adults who have tested positive for the BRCA1 or BRCA2 mutations, and whose disease has responded to platinum-based chemotherapy.

Specifically, the recommendations say that olaparib should be available for people only if they have had 3 or more courses of platinum-based chemotherapy and the drug cost of olaparib for people who remain on treatment after 15 months is met by the company."

The ERG included HEDS’ own Paul Tappenden, Sue Harnan, Shijie Ren, Praveen Thokala, Ruth Wong and Clara Mukuria.

Project update: NICE RA biologics appraisal finishes!

It is safe to say that it appears to have been one of the more complex and controversial appraisals.  HEDS was involved throughout as the evidence review group; we can’t list everyone due to space constraints.  If you want to examine the voluminous documentation and high ICERs then look here.

From the NICE website:

“The guidance recommends adalimumab (Humira, AbbVie), etanercept (Enbrel, Pfizer), infliximab (Remicade, Merck Sharp & Dohme; Inflectra, Hospira UK; Remsima,Napp Pharmaceuticals ) ii, certolizumab pegol (Cimzia, UCB Pharma), golimumab (Simponi, Merck Sharp & Dohme), tocilizumab (RoActemra, Roche) and abatacept (Orencia, Bristol-Myers Squibb), each in combination with methotrexate.

Adalimumab, etanercept, certolizumab pegol or tocilizumab are also recommended as monotherapy for people who cannot take methotrexate.

In the case of certolizumab pegol, golimumab, abatacept and tocilizumab the recommendation is subject to the companies providing them as agreed in their patient access schemes.

The guidance states that treatment should be started with the least expensive drug (taking into account administration costs, dose needed and product price per dose).”

Image: My Arthritis

New project: NICE Technology Appraisal

ScHARR-TAG has been allocated the following STA topic:

Abaloparatide for preventing osteoporotic fractures in postmenopausal women [ID882]

Image: Wellcome Images

 

 The draft scope is available here.

Project update: Ledipasvir-sofosbuvir for treating chronic hepatitis C

The FAD has been published for this appraisal, with differing recommendations depending on genotype, previous treatment and cirrhosis status.  HEDS provided the independent assessment.  In addition to the overall critical appraisal of searches, effectiveness evidence and cost-effectiveness evidence, additional analyses were undertaken on the following:

1. Development of an ERG-preferred base case using “unblended” EMA-recommended treatment durations for LDV/SOF(+/-RBV)
2. Examination of alternative EMA-recommended treatment durations for LDV/SOF
3. Use of alternative transition probabilities based on the previous sofosbuvir STA model
4. Use of UK valued on-treatment utility increment derived by Wright et al
5. Use of shorter time horizons (5-years and 10-years) to dampen assumptions regarding no re-infection
6. Threshold analysis for SVR rates of the comparators

These highlight issues that will undoubtedly be relevant to upcoming appraisals, including, choice of transition and utility values, alternative treatment durations being appraised incrementally and the impact of reinfection on the ICER.

The HEDS team were Praveen Thokala, Emma Simpson, Paul Tappenden and John Stevens.

New projects: NICE Technology Appraisals

ScHARR-TAG has been allocated the following STA topics by NICE:

• Golimumab after NSAIDs for severe, active, non-radiographic, Axial spondyloarthritis [ID903]
• Ibrutinib for treating Waldenstrom’s macroglobulinaemia [ID884] 

Rheumatoid arthritis technology appraisal finishes!

After two and a half years, the NICE RA appraisal has been completed and is available in a handy 92 page FAD.  So here’s a summary, yes, in severe disease, if other treatments have failed, if discounts are available and only continued after 6 months if there is a moderate response, and if patients are started on the cheapest drug (including infliximab biosimilars).

Even with all of these provisos, it looks like an ICER of well over £30K per QALY:

“The Committee considered that the most plausible incremental cost-effectiveness ratio (ICER) for biological DMARDs used in severe active rheumatoid arthritis previously treated with methotrexate, was likely to lie between the Assessment Group’s base-case ICER (that is, £41,600 per quality-adjusted life year [QALY] gained) and the Assessment Group’s ICER for the severe group with the fastest Stanford Health Assessment Questionnaire (HAQ) progression (that is, £25,300 per QALY gained).”

The ERG for this appraisal was ScHARR-TAG, with the research team being Matt Stevenson, Rachel Archer, Jon Tosh, Emma Simpson, Emma Everson-Hock, John Stevens, Allan Wailoo, Monica Hernandez, Suzy Paisley and Kath Williams.  The work also spawned additional work for the NICE DSU, principally around HAQ progression, by Laura Gibson, Mónica Hernández-Alava and Allan Wailoo.

All documents are available here.

New projects

ScHARR-TAG have been allocated the following topic by NIHR/NICE:

Pertuzumab for treating early, HER 2 positive breast cancer

New project

ScHARR-TAG have been allocated the following topic by NIHR/NICE:

Eltrombopag for treating severe aplastic anaemia following insufficient response to immunosuppressive therapy [ID814]

The draft scope is available here.

Ledipasvir-sofosbuvir for treating chronic hepatitis C

In draft guidance, NICE has recommended ledipasvir-sofosbuvir (Harvoni, Gilead Sciences) as a treatment option for some adults with genotype 1 or 4 chronic hepatitis C.  It is not recommended (in combination with ribavirin) for treatment of GT3.

There have been lots of Hep C appraisals in the last couple of years; boceprevir, telaprevir, simeprevir, sofosbuvir.  An interesting difference with this appraisal is with the potential use of alternative treatment durations recommended by the EMA.  The use of these alternative durations has a substantial impact upon the cost-effectiveness of LDV/SOF; shortened treatment durations were a lot more cost-effective.

The ERG report was produced by SHARR-TAG, with the HEDS authors being Praveen Thokala, Emma Simpson, Paul Tappenden, John Stevens and Kath Dickinson.

New projects

ScHARR-TAG have been allocated the following topic by NIHR/NICE:

Certolizumab pegol for treating rheumatoid arthritis following inadequate response to a TNF inhibitor [ID824]

The draft scope is available here.

Sipuleucel-T is a ‘no’ at FAD

Sipuleucel-T, also known as Provenge, is not recommended within its marketing authorization for treating adults who have asymptomatic or minimally symptomatic Metastatic non–visceral hormone–relapsed prostate cancer for which chemotherapy is not yet clinically indicated.  The topic was one of ours, with Emma Simpson, Sarah Davis, Praveen Thokala, Penny Breeze and Ruth Wong from HEDS doing the work.

Whilst the HEDS Blog has given an overview previously, something interesting was missed out.  Adjustment for treatment switching was problematic as both the IPCW and IPE had problems…..there was not the necessary data on covariates to apply the IPCW, whilst the assumptions of the IPE were not consistent with the model structure (p79-80 of the ERG report).  More methods research on switching is required……

New projects

ScHARR-TAG have been allocated the following topics by NIHR/NICE:

ScHARR-TAG projects

• STA 14/206/02: Pirfenidone for the treatment of idiopathic pulmonary fibrosis (review of TA282)
• HTATAR 14/151/08: The prognostic value of tests and assessment tools in rheumatoid arthritis
• HTA Scoping report 14/151/09: Strategies for the management of post-menopausal osteoporosis