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TITLE from VIEW and SLIDE MASTER | 26 October 2016 1 |
Strategies regarding new high cost biological
medicines when developing formularies across the Interface
Interface Management of Pharmacotherapy
Barcelona – 17th October 2016
NICOLA MAGRINI
ESSENTIAL MEDICINES AND HEALTH PRODUCTS DEPARTMENT
TITLE from VIEW and SLIDE MASTER | 26 October 2016 2 |
Strategies on the selection of high priced medicines
NICOLA MAGRINI
POLICY, ACCESS AND USE ESSENTIAL MEDICINES AND HEALTH PRODUCTS DEPARTMENT
What I’ll speak about
HIS/EMP | Communications Planning HIS | EMP
Contents of the presentation
• WHO EML: a quick history • EML 2015 update and high priced medicines • The WHO strategy on
– Pharmacological class, therapeutic equivalency (EML square box) – Generics and biosimilars – Other options
First EML: 1977 36 pages, 20 references
EML 1977: early evidence-based adopter
No medicines for: • Memory loss and dementia • Hepatoprotectants • Immunostimulants
• No medicines listed subsequently
withdrawn for unexpected risks (e.g., cox-2 inhibitors)
• Important medicines for: – Antibiotics – Neglected diseases – Pain – Mental health – Chronic diseases – Cancer
• Concise and clear • Promoting uptake of best
research findings on medicines into healthcare and national policies
Essential Medicines List: Concept and Procedures 6 |
Essential Medicines
Guiding principle: A limited range of carefully selected medicines leads to better health care, better medicines management, and lower costs
Definition: Essential medicines are those that satisfy the priority health care needs of the population
Selection: Selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness
Essential Medicines List: Concept and Procedures 7 |
EML criteria (EB 109/8, 2001)
Disease burden and public health need/relevance
Sound and adequate data on the efficacy (on relevant outcomes), safety and comparative cost-effectiveness
– “Absolute cost of the treatment will not constitute a reason to exclude a medicine from the Model List that otherwise meets the stated selected criteria”
– “Affordability changed from a precondition into a consequence of the selection” (Hogerzeil, BMJ, 2004)
WHO responsible management and oversight of CoIs
2008 WHO new Guideline Manual, adopting GRADE
Considering also: regulatory status / availability, WHO guidelines
Essential Medicines List: Concept and Procedures 8 |
19th EML & 5th EMLc - 2015
19th EML: 409 medicines – 5th EMLc (children): 294 medicines
586 pages, 1082 references
Essential Medicines List: Concept and Procedures 9 |
EML 2015: tough decisions
Essential Medicines List: Concept and Procedures 10 |
EML 2015: 77 applications and a few big challenges Cancer drugs: a large comprehensive review led to 16 new
additions (including 2 mabs and imatinib)
New highly effective HCV drugs (all listed)
MDR-TB drugs (4) and 1 for TB prophylaxis
Rejections: New oral anticoagulants (NOACs), polypill(s), ranibizumab
Essential Medicines List: Concept and Procedures 11 |
Lancet editorial October 24, 2015
HIS/EMP | Communications Planning HIS | EMP
Contents of the presentation
• WHO EML: a quick history • EML 2015 update and high priced medicines • The WHO strategy on
– Pharmacological class, therapeutic equivalency (EML square box) – Generics and biosimilars – Other options
Essential Medicines List: Concept and Procedures 13 |
EML and patented drugs
EML 2013: 20 out of 374 (5.4%)
EML 2015: 39 out of 409 (9.5%)
A trend?
Biosimilars: filgrastim, trastuzumab, rituximab
Next EML 2017?
Objectives of phases I, II and III in drug registration : I: safety II: activity III: efficacy/effectiveness or B/R ratio
Drug registration and patent’s life
Patent expiry
Drug’s life and life cycle well beyond patent: the next 20 years
Medicines’ life: longer than the patent
Life after patent expiry
Essential Medicines List: Concept and Procedures 16 |
EML cancer medicines 2015 main criterion: magnitude of absolute benefits
Imatinib: vast majority of patients in remission at 7 yrs
Rituximab (large B cell lymphomas): 15% absolute increase in survival rates (from 50-55% to 70%)
Trastuzumab: early stage breast cancer: up to 13% increase in survival in high risk women (from 37% to 50% survival rates at 3-6 yrs)
Bendamustine, ATRA, …
Efficacy estimates applied to all proposed regimens
Essential Medicines List: Concept and Procedures 17 |
Essential Medicines List: Concept and Procedures 18 |
Imatinib generic prices 2016
Imatinib prices 2013 - 2016
700 USD
EML and pharmacological classes
Listing: one drug per pharmacological class … implications for selection and procurement
Essential Medicines List: Concept and Procedures 21 |
EML and therapeutic equivalency 1/3
Essential Medicines List: Concept and Procedures 22 |
EML and therapeutic equivalency 2/3
Essential Medicines List: Concept and Procedures 23 |
Example 1
Essential Medicines List: Concept and Procedures 24 |
Example 2 : limited square boxing
Essential Medicines List: Concept and Procedures 25 |
Example 3: limited square boxing
Essential Medicines List: Concept and Procedures 26 |
EML and therapeutic equivalency 3/3
WHO supports pooled procurement mechanisms that can increase competition among available alternatives/options
Generic substitution and biosimilars role
HIS/EMP | Communications Planning HIS | EMP
Contents of the presentation
• WHO EML: a quick history • EML 2015 update and high priced medicines • The WHO strategy on
– Pharmacological class, therapeutic equivalency (EML square box) and tenders
– Generics and biosimilars – Other options
• ¨Conclusions
Essential Medicines List: Concept and Procedures 28 |
Biosimilars: regulations still in progress
Recent documents
Essential Medicines List: Concept and Procedures 29 |
Essential Medicines List: Concept and Procedures 30 |
Essential Medicines List: Concept and Procedures 31 |
Essential Medicines List: Concept and Procedures 32 |
Essential Medicines List: Concept and Procedures 33 |
Essential Medicines List: Concept and Procedures 34 |
Biosimilars: no official WHO statement yet
INN, Biological standardisation and EML will be working together to define a WHO position
– Important implications on regulatory pathways, Therapeutic Committees and procurement
– Timeline: early (1st quarter) 2017?
HIS/EMP | Communications Planning HIS | EMP
Contents of the presentation
• WHO EML: a quick history • EML 2015 update and high priced medicines • The WHO strategy on
– Pharmacological class, therapeutic equivalency (EML square box) and tenders
– Generics and biosimilars – Other options
• ¨Conclusions
Public health, innovation and intellectual property 36 |
Policy options
Price controls: ‘Value-based pricing; price/volume agreements; pay for performance; risk-sharing agreement / patient access schemes; reference pricing schemes…
Differential pricing/price negotiations
Voluntary licensing agreements
Local production/import
TRIPS flexibilities, including compulsory licenses
The Un High-level Panel on Access to Medicines
On 14th September 2015
What’s in the UNHLP Report on access to medicines
• The report may spark controversy: • six panel members offered separate commentaries that either
criticized the panel for its timidity or chastised it for focusing too much on IP rights and not being fact driven.
• Some Member States have also voiced concerns about the process before the release of the report.
• Thus, it remains to be seen whether it will be discussed in the UN General Assembly, the WHO or another UN body.
What’s in the UNHLP Report on access to medicines
• The report mentions positively a number of ongoing WHO initiatives – the WHO/DNDI Global Antibiotic R&D Partnership, – the (future) WHO/TDR voluntary pooled funding mechanism for R&D, – the R&D Blueprint.
• Some of the technical recommendations—in particular, the IP-related issues and the establishment of a database on medicine prices—are already within WHO’s mandate
the UNHLP Report on access to medicines What’s new for WHO
• a database on medicine prices • Other recommendations would need endorsement by
member states, such as – the negotiation of international agreements – the SG’s establishment of an interagency task force.
HIS/EMP | Communications Planning HIS | EMP
Contents of the presentation
• WHO EML: a quick history • EML 2015 update and high priced medicines • The WHO strategy on
– Pharmacological class, therapeutic equivalency (EML square box) and tenders
– Generics and biosimilars – Other options
• ¨Conclusions
HIS/EMP | Communications Planning HIS | EMP
Conclusions EML, access and affordability
• Growing attention to the issue of access and affordability
• EML can play a role – Strong collaboration with MPP, – Fair pricing forum, – EML discussing thresholds for benefits – Biosimlars WHO GL in 2017
• together with all other stakeholders
HIS/EMP | Communications Planning HIS | EMP
Questions? All questions are welcome
all questions can be useful to understand EML role and what I just presented