HAE in Israel - 2016 Patient Management & Healthcare Issues - - PowerPoint PPT Presentation
World Allergy Organization Scientific Congress Jerusalem, December 6-9 2016 HAE in Israel - 2016 Patient Management & Healthcare Issues Avner Reshef MD, Iris Leibovich-Nassi RN, MA, PhD student Angioedema Research Center, The Sheba Medical
Avner Reshef MD, Iris Leibovich-Nassi RN, MA, PhD student Angioedema Research Center, The Sheba Medical Center, Tel Hashomer, ISRAEL
World Allergy Organization Scientific Congress Jerusalem, December 6-9 2016
Chronic life-time, debilitating disease, characterised by relapsing attacks of swelling in different body organs, occurring in an unpredicted manner Rare disease with global prevalence of 1:50,000 Approximately 180 patients have been diagnosed in Israel (pop. 8,500,000) Calculated prevalence of HAE is therefore 1: 47,200 We estimate that only 65-70% of adults and children have been so far correctly diagnosed No estimates available for the Palestinian population (WB & Gaza)
Independent state from 1948 (68) Area: 22,072 Sq Km (59% desert land) Total population 8,500,000 (2015) Major HAE Specialty Centers :
All HAE centers are actively involved in clinical research Most patients are managed by Allergists/Immunologists and HMO GPs’ EDEMA Israel patient organization
The NIH classifies 7,000 disorders as “orphan diseases” and estimates that 25 million people are globally affected Orphan diseases are classified in the US as diagnosed in <200,000 patients and in the EC as fewer than 5 cases/10,000 Drug development for orphan diseases is one of the major investment trends in the world pharmaceutical industry Modern treatment of HAE incurs considerable economic burden on health expenditures of individuals and on national health systems Before self-administration era, emergency department and hospital costs accounted for 2/3 of costs for patients with severe attacks
http://seekingalpha.com/author/smith-on-stocks/articles
for treatment of acute attacks-“on-demand”
sufficient to treat two separate attacks
treated early
they are clearly recognized by the patient, ideally before visible or disabling symptoms develop
persist following an initial treatment
* Cicardi M et aI. International Expert Consensus (HAWK), Allergy 2012; 67: 147–157
Medical insurance is compulsory and provided to all the citizens (1994) Health services are provided by 4 certified HMO’s ("Sick funds"), financed by the taxpayers (Health Tax 3.1-4.8% of individuals’ gross income). "Basic Health Basket“- All citizens are entitled to obligatory benefit package: GPs’, specialists, para-meds, prescriptions, ER visits, hospitalization, Lab, medical equipment, Imaging, Rehabilitation Supplementary health insurance programs (additional coverage) are offered by the HMO’s for extra fee, including a broader range of services Private Medical Insurance are offered to whoever can afford them. Insurance policies have a wide range of additional benefits, services and options, including medications and procedures not included in the basic “health basket”.
Israel declare that it aspires to keep up with the advancements of modern medicine, provide health services and infrastructure oriented to society needs, and to supply the needs of all its citizens "Extended health basket” (EHB)- subsidize (co-pay) new, expensive drugs and advanced medical technologies, not covered by “basic health Basket” Most budget goes for cancer, biologicals and rare genetic disorders The law allows to update and expand the health basket from time to time, according to pharmacologic and technologic advancements in medicine A public committee is convening each year to decide, based on professional
This year >700 drugs & technologies compete on 550 miILS budget (130 miUSD)
http://www.health.gov.il/Services/Committee/vsal/Pages/default.aspx, http://www.moia.gov.il/Publications/health_en.pdf
Four new HAE drugs has been introduced into the EHB since 2010:
1.
Three C1-INH concentrates: Berinert, Cinryze, Ruconest
2.
Bradykinin-receptor blocker: Firazyr- icatibant
Current drugs are only indicated for on-demand treatment Regulatory approval was recently received for IV self-administration Following the recent registration of Berinert for STP, we are lobbying the
inclusion of ‘Berinert pre-procedural’ in the EHB, hoping to provide it for all Israeli patients
We are focusing our efforts on training patients for self-treatment , which
should reduce dependence on health resources (i.e. recent results of SC Berinert prophylaxis study)
We strive to get all HAE experts in Israel and region to collaborate and
work together
Iris Leibovich1.2, Hava Golander2, Raz Somech3, Avner Reshef1
1Angioedema Center, Sheba Medical Center, Tel- Hashomer, 2Department of Nursing, Sackler School
Doctoral Thesis
Aimed to study the association between prodromes and attacks of HAE Collecting prospective data on HAE attacks: severity, form, location, duration,
Secondary outcomes will include QoL parameter evaluating patients’ perception
regarding signs and symptoms preceding the attacks
Preliminary study, Retrospective phase, Prospective phase
The study is designed to include all HAE patients in Israel HAE-specific questionnaire was constructed and refined, based on previous
instruments used by our group and others
So far 130 patients (43 men, 57 women, mean age 36 years, range 1-69) have
been screened
Future data (prospective) will include: disease course, burden of disease,
utilization of health-system resources, patients' experience with prodromes, and whether they can predict an oncoming attack
Angioedema Type No. Age (M±SD) Range M/F Children (<18) Children Age (M±SD)
HAE I & II 130 36 ±20.5 1-69 43/57 33 11.13 ± 4.3
(Range 1-17)
11112 2 2 2 2 2 2 4 5 103
Canada Syria Algier Azerbijan Egypt Morocco Tangier Ukraine USA Turkey Romania France Russia Israel
Countries of origin:
*Data collected from Sheba (Dr. Reshef) Sourasky (Prof. Kivity) Bnay Zion (Prof. Toubi), Ha’emek (Prof. Rottem) Medical Centers
6.7 66.6 20.2 6.7
Having a prodrome before attacks
Always Frequently Rarely Never
7.1 64.3 28.6
Having a prodrome without attack
Always Frequently Rarely Never
28.6 35.7 28.6 7.1
Can predict oncoming attack based
Absolutely Usually Sometimes No
Angioedema Type No. Age (M) Range M/F Fam Child* Child
Age (M)
Type I & II 106 32.0 1-71 51/55 40 36
(M/F 18/18)
9.13
(1-17)
Type III 44 37.4 18-59 1/44 25
11** 66.8 37-80 7/4 11
25*** 71.8 51-87 14/11 25
186 52 1-87 72/114 89 36
* <18, **3 deceased, *** Acute Sheba ER cases
required
Angioedema Research Center
Sheba Medical Center, Tel-Hashomer Affiliated to Tel-Aviv University, Israel