October’s CEAs.....

Our quick search for CEA’s published in October uncovered 40 articles.   In the right-hand column of this blog is a CEA Archive, which includes our CEA search results by month.  Below are those in our areas of interest.

• Landfeldt E, Alfredsson L, Straub V, Lochmuller H, Bushby K, Lindgren P. Economic Evaluation in Duchenne Muscular Dystrophy: Model Frameworks for Cost-Effectiveness Analysis. PharmacoEconomics. 2016.
• Park SK, Park SH, Lee MY, Park JH, Jeong JH, Lee EK. Cost-effectiveness Analysis of Treatment Sequence Initiating With Etanercept Compared With Leflunomide in Rheumatoid Arthritis: Impact of Reduced Etanercept Cost With Patent Expiration in South Korea. Clinical therapeutics. 2016.
• Keller A, Gericke C, Whitty JA, Yaxley J, Kua B, Coughlin G, et al. A Cost-Utility Analysis of Prostate Cancer Screening in Australia. Applied health economics and health policy. 2016.
• Le P, Rothberg MB. Determining the Optimal Vaccination Schedule for Herpes Zoster: a Cost-Effectiveness Analysis. Journal of general internal medicine. 2016.
• Odnoletkova I, Ramaekers D, Nobels F, Goderis G, Aertgeerts B, Annemans L. Delivering Diabetes Education through Nurse-Led Telecoaching. Cost-Effectiveness Analysis. PloS one. 2016;11(10):e0163997.
• Walusimbi S, Kwesiga B, Rodrigues R, Haile M, de Costa A, Bogg L, et al. Cost-effectiveness analysis of microscopic observation drug susceptibility test versus Xpert MTB/Rif test for diagnosis of pulmonary tuberculosis in HIV patients in Uganda. BMC health services research. 2016;16(1):563.
• Tawiah T, Hansen KS, Baiden F, Bruce J, Tivura M, Delimini R, et al. Cost-Effectiveness Analysis of Test-Based versus Presumptive Treatment of Uncomplicated Malaria in Children under Five Years in an Area of High Transmission in Central Ghana. PloS one. 2016;11(10):e0164055.
• Muduma G, Odeyemi I, Pollock RF. A cost-utility analysis of prolonged-release tacrolimus relative to immediate-release tacrolimus and ciclosporin in liver transplant recipients in the UK. Journal of medical economics. 2016;19(10):995-1002.
  
  

  

  Image: Halloween by Miala

Measurement of Health-State Utility Values for Economic Models in Clinical Studies

The ISPOR taskforce has spoken!

Press release and link to their recommendations are here.

Cochrane Collaboration Issue 10, 2016…

….is almost complete.  The website now lists protocols and methodology papers, but we’ll just flag up the notable reviews…well, notable to our work; these being……

• Insulin secretagogues for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus
• Non‐steroidal anti‐inflammatory drugs for sciatica
• Bifeprunox versus placebo for schizophrenia
• Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion

Image: B0007649 Blood cells in a blood vessel by Wellcome Images

• S‐adenosyl methionine (SAMe) for depression in adults
• Strategies to improve the implementation of healthy eating, physical activity and obesity prevention policies, practices or programmes within childcare services

Best Practices for the Design, Implementation, Analysis, and Reporting of Oncology Trials with High Rates of Treatment Switching

Over the past 18 months, Nick Latimer has been part of a team working with the Center for Medical Technology Policy’s Green Park Collaborative to develop best practice recommendations on managing treatment switching in oncology drug trials. The guidance document document has just been published, and provides recommendations on:

• Whether and when to allow treatment switching,
• Analytical methods to adjust for treatment switching,
• How to design trials to accommodate the analytical adjustment methods; and
• How to provide information to patients as part of the informed consent process

Nick presented his research at a multi-stakeholder international workshop organised by CMTP and was on the project Advisory Committee.

2nd Panel on Cost-Effectiveness in Health and Medicine

After three years for deliberation, they’ve reported!  For those of you unaware of the history, the 1st Panel was convened in 1993 and introduced a set of methods that were widely used and pre-dated just about all reimbursement guidelines.  They introduced the concept of a reference case!

The guidelines have been updated.  Most of the recommendations (which are in an e-Appendix) are largely unchanged, but here’s the most important changes that I can see…..

• Two reference cases
• Inclusion of an impact inventory
• Inclusion of future
• Design and analysis protocols
• Decision model recommendations
• Reporting checklist
• Unrelated health care costs included in additional years of life
• CEACs and CEAFs
• Value of information analysis

There is a downside to this of course……I’m going to have to re-write my lectures on our International Health Technology Assessment suite of teaching!

Cochrane Collaboration Issue 8, 2016…

….is complete.  The website now lists protocols and methodology papers, but we’ll just flag up the notable reviews; these being……

• Methotrexate monotherapy and methotrexate combination therapy with traditional and biologic disease modifying anti‐rheumatic drugs for rheumatoid arthritis: A network meta‐analysis
• Drug‐eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs
• Statins for age‐related macular degeneration
• Home telemonitoring and remote feedback between clinic visits for asthma
• Public stewardship of private for‐profit healthcare providers in low‐ and middle‐income countries
• Interventions to reduce corruption in the health sector
• Inhaled corticosteroids for cystic fibrosis

July’s CEAs.....

Our quick search for CEA’s published in July uncovered 38 articles.   In the right-hand column of this blog is a CEA Archive, which includes our CEA search results by month.  Below are those in our areas of interest.

• Greuter MJ, Berkhof J, Fijneman RJ, Demirel E, Lew JB, Meijer GA, et al. The potential of imaging techniques as a screening tool for colorectal cancer: a cost-effectiveness analysis. The British journal of radiology. 2016;89(1063):20150910.
• Hankin-Wei A, Rein DB, Hernandez-Romieu A, Kennedy MJ, Bulkow L, Rosenberg E, et al. Cost-effectiveness analysis of catch-up hepatitis A vaccination among unvaccinated/partially-vaccinated children. Vaccine. 2016;34(35):4243-9.
• Kuznik A, Habib AG, Munube D, Lamorde M. Newborn screening and prophylactic interventions for sickle cell disease in 47 countries in sub-Saharan Africa: a cost-effectiveness analysis. BMC health services research. 2016;16(1):304.
• Verhoef TI, Trend V, Kelly B, Robinson N, Fox P, Morris S. Cost-effectiveness analysis of offering free leisure centre memberships to physically inactive members of the public receiving state benefits: a case study. BMC public health. 2016;16:616.
• Wong KM, Ding K, Li S, Bradbury P, Tsao MS, Der SD, et al. A Cost-Effectiveness Analysis of Using the JBR.10-Based 15-Gene Expression Signature to Guide Adjuvant Chemotherapy in Early Stage Non-Small-Cell Lung Cancer. Clinical lung cancer. 2016.

Cochrane Collaboration Issue 7, 2016…

….is complete.  The website now lists new review protocols, but we’ll just flag up the notable reviews; these being……

• Enzyme replacement therapy for Anderson‐Fabry disease
• Routine use of patient reported outcome measures (PROMs) for improving treatment of common mental health disorders in adults
• Interventions for improving coverage of childhood immunisation in low‐ and middle‐income countries
• Rituximab for eradicating inhibitors in people with acquired haemophilia A

New ISPOR Good Research Practice Guidelines….

…. “Statistical Methods for the Analysis of Discrete Choice Experiments: A Report of the ISPOR Conjoint Analysis Good Research Practices Task Force Group”.

The ISPOR Conjoint Analysis Good Research Practices Task Force builds on two previous ISPOR Task Force Reports:

• Conjoint Analysis Applications in Health—A Checklist: A Report of the ISPOR Good Research Practices for Conjoint Analysis Task Force
• Constructing Experimental Designs for Discrete-Choice Experiments: Report of the ISPOR Conjoint Analysis Experimental Design Good Research Practices Task Force.

Image: Research by Thomas Haynie

Further information, including an approval that accepted DCE results, is available here.

Junes’ CEAs.....

Our quick search for CEA’s published in June uncovered 38 articles.   In the right-hand column of this blog is a CEA Archive, which includes our CEA search results by month.  Below are those in our areas of interest.

• Manchanda R, Legood R, Antoniou AC, Gordeev VS, Menon U. Specifying the ovarian cancer risk threshold of 'premenopausal risk-reducing salpingo-oophorectomy' for ovarian cancer prevention: a cost-effectiveness analysis. Journal of medical genetics. 2016.
• Cromwell I, Gaudet M, Peacock SJ, Aquino-Parsons C. Cost-effectiveness analysis of anal cancer screening in women with cervical neoplasia in British Columbia, Canada. BMC health services research. 2016;16(1):206.
• Hankin-Wei A, Rein DB, Hernandez-Romieu A, Kennedy MJ, Bulkow L, Rosenberg E, et al. Cost-effectiveness analysis of catch-up hepatitis A vaccination among unvaccinated/partially-vaccinated children. Vaccine. 2016.

Image: vaccination.jpg by Daniel Neville

• Pedersen K, Sorbye SW, Kristiansen IS, Burger EA. Using novel biomarkers to triage young adult women with minor cervical lesions: a cost-effectiveness analysis. BJOG : an international journal of obstetrics and gynaecology. 2016.

Health care economic information for coverage decisions

From PRNewsWire:

“The Academy of Managed Care Pharmacy (AMCP)…..released a set of recommendations that would allow biopharmaceutical companies to more easily share health care economic information (HCEI) with entities that make formulary and coverage decisions, a move that addresses the growing need to determine the "value" of new medicines.

The recommendations address restrictions in the sharing of product information that does not appear on the drug label, a prohibition that hinders decision makers from accessing HCEI on new therapies.

The recommendations are contained in the forum proceedings, published in the July issue of AMCP's Journal of Managed Care & Specialty Pharmacy (JMCP). AMCP now will lead the development of a draft guidance document to share with the FDA. This information also will be shared with Congress as it considers legislative solutions to improve sharing of HCEI.”

Image: Little Brown Bottles by PhotoAteller

Cochrane Collaboration Issue 6, 2016…

….is almost complete.  The website now lists new review protocols, but we’ll just flag up the notable review; these being……

• Fortification of staple foods with zinc for improving zinc status and other health outcomes in the general population
• Continuous subcutaneous insulin infusion versus multiple daily injections of insulin for pregnant women with diabetes
• Combination inhaled steroid and long-acting beta2-agonist in addition to tiotropium versus tiotropium or combination alone for chronic obstructive pulmonary disease
• Biologic interventions for fatigue in rheumatoid arthritis
• Systematic screening for the detection of atrial fibrillation

Image: Cochrane by Felipe L. Denham

May's CEAs.....

The CEA Registry Blog has in the past published a list of recent CEAs, from which we have flagged up studies of interest to HEDS. They have stopped publishing this, which is a shame.  So, we're doing it instead!

In the right-hand column is a CEA Archive, which includes our CEA search results by month.  Below are those in our areas of interest.

• Zur RM, Zaric GS. A microsimulation cost-utility analysis of alcohol screening and brief intervention to reduce heavy alcohol consumption in Canada. Addiction (Abingdon, England). 2016;111(5):817-31.
• Wallbillich JJ, Forde B, Havrilesky LJ, Cohn DE. A personalized paradigm in the treatment of platinum-resistant ovarian cancer - A cost utility analysis of genomic-based versus cytotoxic therapy. Gynecologic oncology. 2016.
• Garcia A, Ortiz de Lejarazu R, Reina J, Callejo D, Cuervo J, Morano R. Cost-Effectiveness Analysis Of Quadrivalent Influenza Vaccine In Spain. Human vaccines & immunotherapeutics. 2016:0.
• Gasparini R, Landa P, Amicizia D, Icardi G, Ricciardi W, de Waure C, et al. Vaccinating Italian infants with a new multicomponent vaccine (Bexsero(R)) against meningococcal B disease: A cost-effectiveness analysis. Human vaccines & immunotherapeutics. 2016:1-14.
• Russell LB, Sinha A. Strengthening Cost-Effectiveness Analysis for Public Health Policy. American journal of preventive medicine. 2016;50(5 Suppl 1):S6-s12.

CEA Registry goes selective

From the Registry Blog:

"The Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry (www.cearegistry.org), will begin to display detailed information only for selected studies considered to be high impact economic evaluations. Starting with studies published in 2015, all CEA abstracts will be reviewed by two Tufts reviewers, who will make a determination by consensus on whether the study qualifies for an extended review based on: the study’s population, the medical intervention(s) being studied, novelty of treatment, as well as the generalizability of the study’s results, as inferred from the abstract."

Image: colour impact by daviddave

Improving evidence generation for reimbursement

From EUNetHTA:

“EUnetHTA Early Dialogues aim at helping pharmaceutical and MedTech companies to understand the evidence and information needs of the HTA organisations and reimbursement bodies across Europe in order to inform decisions on coverage of newly developed health technologies. The goal is to improve the quality and adequacy of early evidence generation in order to be useful for the HTA process of reviewing and synthesising evidence to inform coverage decisions.”

As part of this work programme, EUNetHTA published its “Consolidated Procedure For Early Dialogues”.  It’s available here.  The procedure is too specific, but the templates may be a useful starting point.

Latest MIB

No, not Men in Black, it’s the NICE Medtech Innovation Briefings (MIBs).  The MIBs
review relevant published evidence and the likely costs of new technologies. They are designed to be fast, flexible and responsive to the need for information on innovative technologies.  MIBs are commissioned by NHS England.

In the first quarter of 2016, the following briefings have been published.

• EarlySense for heart and respiratory monitoring and predicting patient deterioration
• BladderScan BVI 9400 3D portable ultrasound scanner for measuring bladder volume
• MiniMed 640G system with SmartGuard for managing blood glucose levels in people with type 1 diabetes   
• Xpert Carba-R to identify people carrying carbapenemase producing organisms
• Aquilion PRIME CT scanner for imaging coronary artery disease in adults in whom imaging is difficult
• Somatom Definition Edge CT scanner for imaging coronary artery disease in adults in whom imaging is difficult
• ClearWay RX for drug delivery to coronary artery thrombotic lesions
• Icare rebound tonometer to measure intraocular pressure
• Mersey Burns for calculating fluid resuscitation volume when managing burns
• Otovent nasal balloon for otitis media with effusion
• TactiCath Quartz catheter for percutaneous radiofrequency ablation in atrial fibrillation
• ThermoCool SmartTouch catheter for percutaneous radiofrequency ablation in atrial fibrillation
• TheraSphere for treating operable and inoperable hepatocellular carcinoma
• SIR-Spheres for treating inoperable hepatocellular carcinoma

Cochrane Collaboration Issue 4, 2016…

….is almost complete.  It includes dozens of new or updated reviews, including:

• Anticoagulants and antiplatelet agents for preventing central venous haemodialysis catheter malfunction in patients with end-stage kidney disease
• Electrical stimulation with non-implanted electrodes for overactive bladder in adults
• Laparoscopic versus open distal pancreatectomy for pancreatic cancer
• Dornase alfa for cystic fibrosis
• Enzyme replacement therapy with laronidase (Aldurazyme®) for treating mucopolysaccharidosis type I
• High-frequency oscillatory ventilation versus conventional ventilation for acute respiratory distress syndrome
• Oral immunoglobulin for preventing necrotizing enterocolitis in preterm and low birth weight neonates

Appraisal methods for regenerative medicines

NICE have undertaken an exercise to assess whether changes to its methods and processes will be needed for regenerative medicines. Part of this work was to undertake a mock technology appraisal of CAR T-cell therapy for treating acute lymphoblastic leukaemia. Professor Allan Wailoo from HEDS was a member of the mock appraisal committee used in the project. 

NICE’s report of the exercise is available here, but a summary of their summary is:

“The overall findings of the exercise were that:

• The NICE appraisal methods and decision framework are applicable to regenerative medicines and cell therapies.
• Quantifying and presenting clinical outcome and decision uncertainty was key to the Expert Panel consideration of the hypothetical example products.
• Where there is a combination of great uncertainty but potentially very substantial patient benefits, innovative payment methodologies need to be developed to manage and share risk to facilitate timely patient access while the evidence is immature.”

Cochrane Collaboration Issue 3, 2016…

….is complete.  It includes dozens of new or updated reviews, including:

• Antibiotics and antiseptics for surgical wounds healing by secondary intention
• Anticoagulants (extended duration) for prevention of venous thromboembolism following total hip or knee replacement or hip fracture repair
• Antihypertensive pharmacotherapy for prevention of sudden cardiac death in hypertensive individuals
• Blood pressure lowering efficacy of beta-1 selective beta blockers for primary hypertension
• Enzyme replacement therapy with galsulfase for mucopolysaccharidosis type VI
• Blood pressure lowering efficacy of coenzyme Q10 for primary hypertension
• Teriflunomide for multiple sclerosis

Personalised medicine and co-dependent technologies, with a special focus on study design issues

EUNetHTA have put out a draft methodological reflection paper for public consultation.  Details are available here.  The consultation will take place between 11 March and 15 April 2016.