Increasing access to Hep C treatment - WHO...SOF: US FDA approval December 2013 (priority review for...
Transcript of Increasing access to Hep C treatment - WHO...SOF: US FDA approval December 2013 (priority review for...
1 | Department of Essential Medicines and Health Products
Increasing access to Hep C treatment October 2016
Swathi Iyengar EMP/PAU
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Sofosbuvir & Ledipasvir/Sofosbuvir
SOF bought in 2011 by Gilead for 11 billion: "a huge and risky bet on the next generation of hepatitis C treatments" (Reuters)
Patent situation:
Patents filed widely by Gilead (originally patents filed by Pharmasset) on compounds, pro-drugs and various combinations with other drugs
Patent expiry: 2024-2034 (SOF compounds, processes, compositions, pro-drug); 2028-2030 (LDV compounds)
Regulatory status:
SOF: US FDA approval December 2013 (priority review for a new medical entity); EMA approval January 2014, DCGI approval January 2015
LDV/SOF: US FDA approval October 2014, EMA approval November 2014, DCGI approval December 2015
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Cost of hepatitis C treatments?
Source: Hill A, Cooke G. Science 2014: Vol. 345 no. 6193 pp. 141-142
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Pricing - Policy options
Developed countries: ‘Value-based pricing’; price/volume agreements; pay for performance; risk-
sharing agreement / patient access schemes; reference
pricing schemes…
Developing countries:
– Differential pricing
– Voluntary licensing agreements
– Local production/import
– TRIPS flexibilities, including compulsory licenses
Department of Essential Medicines and Health Products 6 |
Compulsory licenses/government use
Traditionally patent laws provide for compulsory
licenses/government use to address specific public
(health) needs and abusive behavior of patent owners
WTO TRIPS agreement contains certain conditions
(article 31). It does not limit the grounds which can
include
– Insufficient availability of the invention
– Non-working of the invention
– Anti-competitive practices
– Abusive pricing policies, emergencies and others
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Comparison of nominal and PPP-adjusted prices of
sofosbuvir and ledipasvir/sofosbuvir
Iyengar S, Tay-Teo K, Vogler S, Beyer P, Wiktor S, et al. (2016) Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30
Countries: An Economic Analysis. PLoS Med 13(5): e1002032. doi:10.1371/journal.pmed.1002032
http://journals.plos.org/plosmedicine/article?id=info:doi/10.1371/journal.pmed.1002032
Price Data Collected: July-Sept 2015
8 | Department of Essential Medicines and Health Products
License Agreements
Sofosbuvir, ledipasvir, velpatasvir:
– 101 countries = around half of all middle-income countries
– 11 Indian licensees; collaboration with companies in Egypt and
Pakistan
– Allows shipment under compulsory licenses
– Shipments to non-patent territories prohibited (text unclear)
– Allows combinations with "foreign" products (e.g. daclatasvir)
Generic manufacturers: SOF/LDV Community Procurement Price
Company Country Gilead Licensee? Approx. Prices US$ (bottle of 28)
Natco Pharma India Yes 384 (printed on bottle) 169 (reported)
Sun Pharma (selling Hetero product) India Yes 384 (printed on bottle) 180 (reported)
Cipla Ltd. (selling Hetero product) India Yes 384 (printed on bottle) 181 (reported)
Zydus Heptiza (selling Natco product) India Yes 384 (printed on bottle) 205 (reported)
Mylan Pharm (selling Natco Product) India Yes 384 (printed on bottle) 215 (reported)
Dr Reddy’s (selling Hetero product) India No 384 (printed on bottle) 254 (reported)
Hetero Ltd India Yes 384 (printed on bottle) 308 (reported)
Biocon (selling Hetero product) India Yes 384 (printed on bottle) 338 (reported)
Abbott India Ltd (selling Hetero product)
India No 384 (printed on bottle)
Source: HepCAsia as of 26 April 2016
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Hep C: WHO’s role in improving access
Awareness Testing Referral Disease-
stage assessment
Treatment Monitoring
World Hepatitis Day Assistance with national planning Improved prevalence estimates
Prequalification of diagnostics Screening/ testing guidelines
Treatment Guidelines Essential Medicines List Prequalification of medicines Increase price transparency Patent landscapes Technical assistance
Screening Care Treatment
Prevention, including Injection safety Hospital infections Safe blood products Needle sharing programmes
11 | Department of Essential Medicines and Health Products
WHO Essential Medicines List(s)
Satisfy priority health care needs, should be available
at all times in appropriate dosage forms, of assured
quality at an affordable price; Price not an exclusion
criterium; affordability as consequence
Contains 400+ medicines (19th EML). Median
availability in developing countries:
– Public sector: 46%
– Private sector: 70.2%
Recent inclusions:
– All new treatments for hepatitis C
– MDR-TB (linezolid; terizodone, bedaquiline, delamanid)
– 16 new cancer medicines
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UN/WHO Prequalification
Vision: Good quality medicines for everyone
Call for Expressions of Interest Hepatitis C (May 2016)
Single ingredient Fixed-Dose Combination
Adults/
Adolescents
• Sofosbuvir tablet, 400mg
• Daclatasvir tablet, 60mg, 30mg
• Ledipasvir tablet, 90mg
• Simeprevir capsule, 150mg
• Ribavirin capsule, 200mg, 400mg,
600mg
• Sofosbuvir/ Ledipasvir tablet,
400mg/90mg
• Sofosbuvir/ Daclatasvir tablet,
400mg/60mg
• Sofosbuvir/ Daclatasvir tablet,
400mg/30mg
• Ombitasvir/Paritaprevir/Ritonavir
tablet, 25mg/150mg/100mg
Paediatric • Ribavirin, syrup, 40mg/ml (oral)
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Technical Assistance
WHO, on request, provides technical assistance to Member
States to identify best options to access new treatments
Example Egypt:
joint mission of Dep. of HIV/Hepatitis & Dep of Essential Medicines &
country office to advise Egypt on new treatments, including negotiations
with companies
2-days training involving all relevant agencies and Ministries on public
health and IP with WTO and WIPO, including WTO TRIPS flexiblities
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THANKS!