NEW MARKETS : Cutting premature mortality from NCDsNEW MARKETS : Cutting premature mortality from NCDsNEW MARKETS : Cutting premature mortality from NCDsNEW MARKETS : Cutting premature mortality from NCDs

A case example of childhood cancerA case example of childhood cancerA case example of childhood cancerA case example of childhood cancer

Dr Sarah Garner Dr Sarah Garner Dr Sarah Garner Dr Sarah Garner –––– CoCoCoCo----ordinator Innovation, Access and Useordinator Innovation, Access and Useordinator Innovation, Access and Useordinator Innovation, Access and Use

24/09/2018 | Title of the presentation 2

“No family

should endure

financial

hardship for

out-of pocket

payments for

the purchase of

medicines to

treat their loved

ones, and no

man, woman or

child should die

simply because

they cannot

access the life-

saving

medicines they

need.”

A GLOBAL A GLOBAL A GLOBAL A GLOBAL COMMITMENTCOMMITMENTCOMMITMENTCOMMITMENT

SUSTAINABLE DEVELOPMENT GOAL (SDG) 3

“Ensure healthy lives and promote well

being for all at all ages”

“Achieve Universal Health

Coverage…access to safe, effective, quality,

and affordable essential medicines and

vaccines for all”

TARGET

3.8

WHO work supports the entire technology chain

R&D and innovation

Manufacturing

Marketing registration

Selection, pricing and reimbursement

Procurement and supply

Prescribing

Dispensing

Use

Legislation, regulation, governance, monitoring

PHARMACY

WHO Access

6. Monitoring and evaluation of ATM including enhancing data systems

5. Shaping markets

4. Articulating ethical and evidence

based policy options

3. Providing technical support and

building institutional capacity on

health product regulation and ATM

policies

1. Provide leadership on ATM policies

Establishing stronger national pharmaceutical

systems and capacity

Responding to evolving health product needs

Developing policy options to promote access to medicines and health

products

2. Setting product quality norms, standards, and their implementation

Sustainable access to medicines affects both high- and low-cost products

� Transparency of R&D and Pricing

� Alternative Business Models

� Shortages of Generic Medicines

� Collaboration between Payers

� Value Based Pricing

� Orphan Drugs

24/09/2018 EMP-Pricing: IPSF 6

Death rate due to Death rate due to Death rate due to Death rate due to NCDs 2000 NCDs 2000 NCDs 2000 NCDs 2000 ---- 2016201620162016

per 100,000 population per 100,000 population per 100,000 population per 100,000 population

Target 9: “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.”

Medicines. At least:• aspirin, a statin, • an angiotensin-converting

enzyme inhibitor, • a thiazide diuretic, • a long-acting calcium channel

blocker, • metformin, insulin, • a bronchodilator and a steroid

inhalant

Global NCD Action Plan 2013 Global NCD Action Plan 2013 Global NCD Action Plan 2013 Global NCD Action Plan 2013 ---- 2020202020202020

Technologies: At least:• a blood pressure measurement

device,• a weighing scale• blood sugar and blood

cholesterol measurement devices with strips and urine strips for albumin assay.

‘Best buys’ and other recommended interventions for the prevention and control of

noncommunicable diseases

Reduce tobacco use

Reduce the harmful

use of alcohol

Reduce unhealthy diet

Reduce physical inactivity

Manage cardiovascular

disease and diabetes

Manage diabetes

Manage Cancer

Manage chronic

respiratory disease

Availability of NCD medicines

WHO Global Health Observatory. http://www.who.int/gho/en/

Challenges Challenges Challenges Challenges to diagnosis & to diagnosis & to diagnosis & to diagnosis & treatmenttreatmenttreatmenttreatment

Comprehensive approach required

• Similar deficits in access to medicines compared to diagnostic and other treatment modalities

• Correlate with significant gaps in health workforce

Rapidly Rapidly Rapidly Rapidly rising rising rising rising NCD NCD NCD NCD burdenburdenburdenburden: : : : example example example example of of of of cancercancercancercancer

Cancer burden: 18.1 million cases each yearGlobally, at least 1 in 5 men, 1 in 6 women diagnosed & require care

Cancer burden: 9.6 mil deaths each yearWorse outcomes in LMIC: late diagnosis & limited access

Rapidly Rapidly Rapidly Rapidly rising rising rising rising NCD NCD NCD NCD burdenburdenburdenburden: : : : example example example example of of of of cancercancercancercancer

Childhood Cancers

80% survival in HIC vs 20-40% survival in LMIC

Cost-effective with limited

budgetary impact

Low cost medicines and

technologies (generic)

�survival rates

achievable with small

investment

Evidence of successful

capacity building

‘Best buys’ and other recommended interventions for the prevention and control

of noncommunicable diseases

Childhood Cancers

80% survival in HIC vs 20-40% survival in LMIC

Cure

Cure

Cure

Cure

Cure

30% survival loss

Childhood cancer: complexities in treatment accessChildhood cancer: complexities in treatment accessChildhood cancer: complexities in treatment accessChildhood cancer: complexities in treatment access

Consider challenges along value chain: Consider challenges along value chain: Consider challenges along value chain: Consider challenges along value chain:

Diagnostic approach needed to Diagnostic approach needed to Diagnostic approach needed to Diagnostic approach needed to

define bottlenecksdefine bottlenecksdefine bottlenecksdefine bottlenecks

R&D and innovation

Manufacturing

Marketing registration

Selection, pricing and reimbursement

Procurement and supply

Prescribing

Dispensing

Use

PHARMACY

Limited novel therapies for children vs. adults

Small quantity required ���� limited manufacturers

Unfavorable market ���� registration

nEML not inclusive of WHO EML

Facility based procurement / not centralized

Need to adapt treatment protocols

Frequent stock-outs,

low quality

Abandon

care (2+yr

treatment)

Childhood cancer: opportunities to increase access Childhood cancer: opportunities to increase access Childhood cancer: opportunities to increase access Childhood cancer: opportunities to increase access

ASPARAGINASE INJECTION. NEED FOR ACTIONASPARAGINASE INJECTION. NEED FOR ACTIONASPARAGINASE INJECTION. NEED FOR ACTIONASPARAGINASE INJECTION. NEED FOR ACTION

Demand

Supply

Quality

Procurement

Affordability

• Fragmented

• Differentiated and moving

toward higher priced markets

• Challenges to meet demand

Status Potential interventions

• Documented deficiencies

in products in the market

• Develop quality guidance

• Prequalification

• Technology transfer

• Licensing

• Increase demand visibility

• Challenge for regulators to

assess quality among products

not licensed

• Limited sources

• Increase quality of products

to secure a supply base

• Collaborative procurement

• High cost of quality products and

of new products in the market

• Access agreements

ACCESS ACCESS ACCESS ACCESS ---- A SHARED AGENDAA SHARED AGENDAA SHARED AGENDAA SHARED AGENDA

• Dialogue about the challenges being faced

• Share information • Manufacturing, forecasting demand,

registration, prequalification and access

• Pricing and mark-ups• Market issues: sources and capacity

• Collaborative solutions

*(Framework of Engagement with Non-State Actors (FENSA) permitting)