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Public Declaration of transparency/interests*
Note: For this presentation I am not receiving any compensation
*Luca Pani, in accordance with the Conflict of Interest Regulations approved by AIFA Board of Directors (26.01.2012) and published in the Italian Government Official Journal on 20.03.2012 according to 0044 EMA/513078/2010 on the handling of the conflicts of interest for scientific committee members and experts
Interests in pharmaceutical industry NO CurrentlyLast 2 years
More than 2 years but less than 5 years ago
More than 5 years
ago(optional)
Direct interests:
Employment with a company X
Consultancy for a company X
Strategic advisory role for a company X
Financial interests X
Ownership of a patent X
Indirect interests:
Principal investigator X
Investigator X
Individual’s Institution/Organisation receives a grant or other funding
X
CME Courses X
Diabetes: not only a clinical problem
Type 2 diabetes is the most common metabolic disease in Italy and in developed countries.
It is the sixth leading chronic disease by diffusion with a crude prevalence of about 4.9%.
It is estimated that about 3,500,000 Italians suffer from this pathology.
The WHO estimates that every ten seconds a person diesfor a disease related to diabetes
Incretin-based therapies The new class of Incretin-based
therapies entered the arena, but
their place in therapy remains
difficult to determine because of
limited long-term clinical data on
both effectiveness and safety, and
the high cost of therapy. Both GLP-1 receptor agonists and
inhibitors of DPP-4 produce an
improvement in glycemic control
similar to other second-line
therapies, but show some additional
advantages with respect to weight
gain and overall hypoglycemia.
Incretin-based therapies expenditure
According to the OsMed report January-December 2012 on “The use of medicines in Italy”, the Incretin-based therapies expenditure is significantly increased.
EfficacyIncretin-based therapies have a innovative mechanism of action but they have not demonstrated a better efficacy than therapeutic alternatives, as shown by meta-analysis or clinical studies.
Safety
In the clinical studies were reported ADRs including gastrointestinal symptoms (nausea, vomiting), hypoglycemia, increase of pancreatic enzymes and pancreatitis, rhinitis, nasopharyngitis and kidney damage.
Safety
Safety
Safety
Safety
International recommendations
The main recommendation is to differentiate the target of HbA1c according to the characteristics of the patient (less stringent in the complex/fragile patient) and use the most appropriate hypoglycemic drug.
Inzucchi SE et Al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. Vol 35. June 2012.
International recommendations
Incretin-based therapies have not a better efficacy than therapeutic alternatives with a HbA1c reduction of about 0,5-1%.
Inzucchi SE et Al. Management of hyperglycaemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. Vol 35. June 2012.
The appropriate use of Incretin-based therapy, in dual or triple therapy, concerns patients with a HbA1c level between 7.5% and 8.5%. In the complex/fragile patient a less stringent HbA1c level can be considered.
RCTs ≠ Real Life Data
Real life data are essential to correctly assess the risk/benefit and benefit/cost ratio
Real life data concernig antidiabetic drugsThe experience of AIFA Monitoring Registry
Data collected by the AIFA Monitoring Registry from February 2008 to April 2012 concerned exenatide, sitagliptin, vildagliptin and, from 2010, saxagliptin and liraglutide. AIFA Monitoring Registry has the objective to monitor appropriateness of use, safety profile and effects on metabolic control.
Clinical and anthropometric baseline data
84,476 cases from the AIFA Antidiabetic Monitoring Registry were analyzed. DPP-4 inhibitors (saxagliptin, vildagliptin and sitagliptin associated or not with metformin) were prescribed in 47,566 cases and GLP-1 analogues were used in 36,910 cases.
Measures of therapeutic effect
• The mean change of HbA1c ranged from -1.02 to -0.80%.
• The proportion of cases never reaching HbA1c ≤7% ranged
from 37.5% to 62.7%.
Total treatment costs and mean cost per patient
The total economic NHS burden of cases selected from the Registry was 83,9 Million €: 42% for DPP-4 inhibitors and 58% for GLP-1 analogues. The daily mean cost per patient related to the drugs monitored in the Registry was around € 3.16.
Antidiabetics Italian NHS expenditure and consumption
(DDD) data (2008-2012)
Real-world clinical practice
AIFA Monitoring Registries have identified “niches” of inappropriate prescription of Incretin-based therapies considering the current national and international scientific evidence.
Incretin-based therapies are a concrete example of the importance of evaluating a drug's efficacy and safety in real-world clinical practice in order to define the correct risk/benefit and benefit/cost profiles.
Reimbursement (without
conditions)Refusal
Outcome based MEAs
Monitoring registers
AIFA notes
Therapeutic plans
Payment by results
Risk sharing
Oncologicals
Antidiabetics
Psoriasis
Orphans
Cardiovascular
Antireumatics
Volume agreement
s
Managing uncertainty relating to clinical benefit and cost-effectiveness
Managing budget impact
Managing utilisation to optimize performance
Non-Outcome based MEAs
Cost sharing
Budget cap
What are the AIFA's priorities? Supporting the prescription appropriateness and NHS
sustainability considering the clinical evidence reported in the national and international guidelines and real life data.
Valorization of innovation
InnovationPathology
Drug
Safety
Efficacy
Cost/Efficacy
AIFA’s new algorithm on innovation
AIFA’s new domains
Innovation must represent a therapeutic advantage
Innovation must be "measurable“ on:
Population selection. Robustness of endpoint(s). Choice of comparators. Duration of therapeutic effect
Innovation should be valued against the National context
Innovation must meet pharmaco-economic studies and HTA standards in order to determine the ratio of incremental cost-effectiveness compared to the standard reference standard
There is a need to compare the clinical trials data with the real life data to confirm the value of potential innovation. The AIFA Monitoring Registry provides the scientific community with the elements required to make choices targeted to the real needs of public health.
The therapeutic effect of drugs monitored in the Italian real-world
clinical practice in terms of HbA1c mean reduction are similar to
those recorded during phase 2-3 registration trials but with an high
proportion of patients never reaching the clinical HbA1ctarget
suggesting the need to better characterize the subset of patients in which these treatments are effective.
Data collected through the Registries are being used to evaluate the safety profile of Incretin based therapies which are today under closed scrutiny.
Conclusions