Dr Cécile Macé WHO EMP Mr ArnePetter Sanne WHO MND Mr Ajuebor Onyema WHO MND NCD Programme Managers Seminar 4 June 2014 Access to NCD essential medicines on the global agenda ID: 754848
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Slide1
Access to medicines and health technologies for NCDs
Dr Cécile
Macé
WHO EMP , Mr Arne-Petter
Sanne
WHO MND,
Mr
Ajuebor
Onyema WHO MND
NCD Programme Managers Seminar
4 June 2014Slide2
Access to NCD essential medicines on the global agendaAccess to chronic disease medicines is required for the fulfilment of MDG8Governments, in collaboration with the private sector, should give greater priority to treating chronic diseases and improving the accessibility of medicines to treat them (MDG Report 2009)
Political declaration at the UN General Assembly, Sept 2011 (A/66.1, 45l)WHA 2013:Endorsement of a Global Action Plan for the Prevention and Control of Non-communicable Diseases (NCDs) focusing on cardiovascular diseases, diabetes, CRDs and cancer including palliative careSlide3
Access to NCD essential medicines on the global agendaGlobal Coordinating mechanism including one working group on access to medicines and health technologiesUN Interagency Taskforce on NCDs Universal Health Coverage and Post 2015 agendaTwo reports under finalization (EMP/MND)
To make a literature review bottlenecks for access to essential medicines and to map existing initiativesTo explore mechanisms to be put in place at global/regional level to improve availability and affordability of NCD medicinesSlide4
Monitoring FrameworkSlide5
Global Monitoring Framework Targets At least 50% of eligible people receive drug therapy and counselling (including glycaemic control) to prevent heart attacks and strokeAn 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major non communicable diseases in bothpublic and private facilities Slide6
1st Report: Approach to barrier contextsAvailabilityAffordabilityDisease specific
Demand and supply factorsHealth systems approachPublic and Private sectors Slide7
2nd Report under finalizationDocument, describe and assess existing mechanisms to improve availability and affordability of medicines
Explore the potential of adapting existing regional or global mechanisms to support country systems for NCDsProvide options and recommendations on any proposed mechanism(s) that could be established for NCDs at regional or global le
vel
(global and regional procurement/information hub/prequalification…)Slide8
NMH ToolboxSlide9
Framework architecture for Medicines toolbox
Capacity Building
Policy
Management
Planning and Budgeting
Quality Assurance
Monitoring and Evaluation
Pricing
Procurement
Selection
Quantification
Distribution
Use
Inventory Management
Storage
Intellectual PropertySlide10Slide11
Strategy alignmentToolbox Objective
Communication Objective
To assist Members
States
in meeting the voluntary global target of an 80%
availability of the affordable basic technologies and essential medicines, including generics, required to treat major noncommunicable diseases in both public and private facilities by
highlighting tools relevant for
the purpose
Ensure that
Member
States, Regional and Country Offices,
Technical
Partners, the Global Coordinating Mechanism and the UN Interagency Committee for Noncommunicable Diseases are
aware of the functions of the toolbox and how it relates to their needsSlide12
Communication structure
WHO HQ
WHO Regional / Country Offices / GCM / UN Interagency
taskforce
for NCDs
MoH
Technical Partners / Other Stakeholders
?Slide13
Target 980% availability in both public and private facilities of basic technologies and generic essential medicines required to treat major NCDs Achieved in many LMICs for vaccines, TB and malaria medicines, ARVsIn 40 LMICs, availability of generic essential medicines in public and private sector (Cameron et al, 2011)
For treatment of acute communicable diseases: 53.5% public, 66.2% privateFor chronic diseases: 36% public, 54.7% private facilitiesCosts of chronic medicine treatment can incur catastrophic health expenditure, pushing the family below the poverty line… however many of the commonly used medicines are out of patent and relatively cheap Slide14
What do NCD medicines cost without tariffs, taxes and mark-ups?
ProductUnits per month
Median Unit Cost
Monthly cost
Source
Glibenclamide
5mg tab
30
$ 0.0034
$ 0.102
MSH 2010
Metformin
500mg tab
60
$ 0.0105
$ 0.630
MSH
2010
Insulin
NPH 100IU/ml 10ml
1
$ 4.20
$ 4.20
MSH 2010
(Buy)
Salbutamol
inh
100mcg 200 doses
1
$ 1.08
$ 1.08
ADF 2011Beclometasone inh
100mcg 200 doses
1$ 1.28$ 1.28
ADF 2011Aspirin (ASA) 100mg tab30$ 0.0019$
0.0057
MSH 2010Simvastatin 20mg tab 30
$ 0.0286$ 0.858MSH 2010Hydrochlorothiazide 25mg tab
30
$ 0.0037$ 0.111MSH 2010
Atenolol 50mg tab30$ 0.095$ 0.285
MSH 2010
Tamoxifen 20MG tab30$
0.0732$ 2.196MSH 2010
Main sources: MSH International Drug Price Indicator Guide 2010 and ADF Catalogue 2011Slide15
Challenges with NCD medicinesOral medicines available as generic multisource products (Metformin, Aspirin, Hydrochlorothiazide, Tamoxifen) – cheap on the international market but not always available where patients need them, quality problems
Inhalers for asthma and insulin – available but more expensive and more sophisticated to produce and to use. For insulin, limited number of manufacturers, domination of the market by few pharmaceutical companies and specific conditions for distribution.Some products still under patent and only accessible through large access programs from pharmaceutical companies, variable access for population.
Opioid analgesics: efficacious and at affordable costs, necessary for palliative care
, not largely available due to legislative/regulatory barriers.
93,8% of all
licit
morphin
consumption by 21,8% of the world population (INCB 2010, Data for 2009)Slide16
Prices of insulin per 10ml 100 IU vialSlide17
Choice of insulin has financial implications (Kyrgyzstan)
US$ 738,936 = healthcare expenditure for ≈ 11,000 people
* - Analogue insulin or insulin in
penfillSlide18
The example of asthma medicinesHigh cost of essential asthma medicines, particularly inhaled corticosteroids, unaffordable to most patientsto buy one
beclometasone HFA 100mcg inhaler, a patient spends: over 5 days wages in Ethiopia over 8 days wages in Malawi
almost
14 days wages in
Madagascar
Source: The Union and The University of Auckland, NZ in ‘Global Asthma Report’ The Union, ISAAC, 2011
Newer asthma medicine combinations often
available at very high cost: accessible to a minority of wealthy
patients
For countries and for patients, costs increase when asthma is not treated or incorrectly
treated. There
are unnecessary expenses of emergency visits, hospitalizations, and ineffective and inappropriate medicinesSlide19
Where to start in countries…Assess the situation…Check existing STGs and NEML and coherence between them and with procurement listsIdentify the amount of governmental budget allocated to medicines and health technologies for NCDsMonitor availability and price of products in the public and private procurement systems from central to peripheral level
Map existing initiatives and partners involved in NCDsCheck training system in place for health workers (prescribers) and in initial curriculaWHO Manual
«
How to
investigate
access
to
chronic
Non Communicable
Disease
care in
Low
to Middle
Income
Countries
»Slide20
Analyses STG, EML and ProcurementHypertension7 countries: no STG
4 countries: no PL
WHO Model List of Essential
Medicines 2013
National STG (n=10)
No.
(proportion)
National EML
(n=17)
No.
(proportion)
Procurement
list (n=13)
No.
(proportion)
Bisoprolol
Tab. 1.25/5mg
Metoprolol
Carvedilol
Atenolol
Propranolol
1 (0.1)
2
2
8 (0.8)
4 (0.4)
5 (0.3)
1
2
17
(1)
12 (0.7)
0
0
0
6 (0.46)9 (0.69)Hydrochlorothiazide Tab. 12.5mgTab. 25mgAll strength combined
Bendroflumethiazide
05 (0.5)6 (0.6)2 (0.2)
1 (0.05)12 (0.7)16 (0.94)2 (0.12)02 (0.15)3 (0.23)
1 (0.08)
Enalapril Tab. 2.5mgTab. 5mgAll Strength combinedCaptoprilOther
-pril2 (0.2)5 (0.5)6 (0.6)4 (0.4)
2 (0.2)
5 (0.3)11 (0.65)14 (0.82)12 (0.7)
2 (0.12)0 (0.4)1 (0.08)1 (0.08)7 (0.54)2 (0.15)
Amlodipine
Tab. 5mgAll Strength combinedNifedipine*
6 (0.6)7 (0.7)10 (1)12 (0.7)14 (0.82)
15 (0.88)
1 (0.08)1 (0.08)7 (0.54)
Hydralazine Tab. 25Tab. 50mgInj. 20mg4 (0.4)2 (0.2)
3 (0.3)
7 (0.41)3 (0.18)11 (0.65)
2 (0.15)04 (0.3)Methyldopa Tab. 250mg
7 (0.7)
16 (0.94)11 (0.85)
*Excluded 10mg IR caps.
20Slide21
Comments:
β blockers: WHO model list 2013 nominates bisoprolol
as indicative agent of the class with
metoprolol
and
carvedilol
as alternatives. These agents were rarely included in NEMLs or procured. In 2011 the Expert Committee switched from atenolol to
bisoprolol
as indicative beta-blocker. Atenolol was listed in all 17 NEMLs and procured in 6/13 countries. Propranolol was included in 12/17 NEMLs; this beta-blocker is used for indications other than hypertension.
WHO Model List includes both hydrochlorothiazide 12.5 and 25mg strengths; most NEMLs list 25mg. Procurement of hydrochlorothiazide alone appeared low. Notably, 6 of 17 countries listed combination preparations including hydrochlorothiazide in the NEML.
ACEIs: WHO Model List nominates
enalapril
as indicative agent;
enalapril
was listed in 14/17 NEMLs however procurement was low. Captopril was more often procured but was removed as indicative ACEI agent in 2003.
Calcium channel blockers: Amlodipine replaced
nifedipine
as nominated agent in the WHO Model List in 2005. Amlodipine was listed in 14/17 NEMLs, but appeared in only 1 of 13 procurement lists.
Nifedipine
was listed on 15/17 EMLs and included in 7 procurement lists.
Angiotensin II Receptor Blockers: 6/17 countries have an ARB in the NEMLs; none are included in the WHO Model List.
Hydralazine: generally not used in hypertension. Mostly listed in NEMLs as injectable form that should be reserved for emergency use in pregnancy-induced hypertension.
Methyldopa: Only indicated for pregnancy related hypertension in the WHO Model List; was included in 7/10 country STGs for hypertension.
Overall, procurement of these nominated medicines was low; further prescription based studies are required to understand which antihypertensive agents are being used in practice. Additional work is required to disseminate and actively promote changes to the WHO Model List of Essential Medicines.
21Slide22
Access to essential medicines A Framework for action
1. Rational
selection
4. Reliable
health and
supply
systems
2. Affordable
prices
3. UHC and Sustainable
financing
ACCESSSlide23
Options to improve the situationRational selectionStandard Therapeutic Guidelines including evidence-based selection of medicines (NEML based on recommendations from WHO Expert Committee on Selection and Rational Use)Alignment of NEML and STGs as a basis for procurement, reimbursement and training of staff
Promotion of the use of STGs and NEML by health care professionals and proper training of staff on STGsFinancing and Universal Health CoverageIncrease government budget to ensure widespread access to a reduced number of NCD essential medicinesExpand coverage/health insurance and ensure NCD essential medicines are part of the essential package covered
Slide24
Options to improve the situationPriceCompetition, promotion of generics, transparent procurement procedures, substitution, reduce duties/taxes and mark-ups, monitoring pricesFor single source products or under patent, apply WTO/TRIPS flexibilities and use available differential pricing
Reliable Supply systemsSupply quality-assured products: reinforce NRAs and limit SSFFC products in the supply chainImprove quantification of needs and forecasting using good information systemsReinforce private and public supply chainsSlide25
Perspective and Role for WHO/EMPSensitize countries and partners to the barriers for access to essential medicines and health technologies for NCDsDevelop and promote monitoring tools to document the situation, to identify priority interventions and measure improvements in access over timeUpdate WHO Model List of Essential Medicines to address NCD issues (
eg: cancer section)Update and promote use of National Standard Therapeutic guidelinesContinue the country support to strengthen NRAs and supply systems and develop relevant policies (including pricing policies)Support global and regional initiatives for information sharing on medicines prices and availabilitySlide26
Perspective and Role for WHOIn collaboration with member states and partners and based on the two reports under finalization:Develop a global work plan to improve accessDevelop a research agenda
Improve market intelligence for NCD productsEstablish a collaboration platform with all involved stakeholders