Increasing access to Hep C treatment October 2016
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1 Increasing access to Hep C treatment October 2016 Swathi Iyengar EMP/PAU 1 Department of Essential Medicines and Health Products
2 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: (SOF compounds, processes, compositions, pro-drug); (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 Department of Essential Medicines and Health Products
3 John Amis/AP Images for AIDS Healthcare Foundation
4 Cost of hepatitis C treatments? Source: Hill A, Cooke G. Science 2014: Vol. 345 no pp Department of Essential Medicines and Health Products
5 Pricing - Policy options Developed countries: Value-based pricing ; price/volume agreements; pay for performance; risksharing agreement / patient access schemes; reference pricing schemes Developing countries: Differential pricing Voluntary licensing agreements Local production/import TRIPS flexibilities, including compulsory licenses 5 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 6 Department of Essential Medicines and Health Products
7 Comparison of nominal and PPP-adjusted prices of sofosbuvir and ledipasvir/sofosbuvir Price Data Collected: July-Sept 2015 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): e doi: /journal.pmed Department of Essential Medicines and Health Products
8 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) 8 Department of Essential Medicines and Health Products
9 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
10 Hep C: WHO s role in improving access Screening Care Treatment World Hepatitis Day Assistance with national planning Improved prevalence estimates Treatment Guidelines Essential Medicines List Prequalification of medicines Increase price transparency Patent landscapes Technical assistance Awareness Testing Referral Diseasestage assessment Treatment Monitoring Prequalification of diagnostics Screening/ testing guidelines Prevention, including Injection safety Hospital infections Safe blood products Needle sharing programmes 10 Department of Essential Medicines and Health Products
11 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 (19 th 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 11 Department of Essential Medicines and Health Products
12 UN/WHO Prequalification Vision: Good quality medicines for everyone Call for Expressions of Interest Hepatitis C (May 2016) Adults/ Adolescents Single ingredient Sofosbuvir tablet, 400mg Daclatasvir tablet, 60mg, 30mg Ledipasvir tablet, 90mg Simeprevir capsule, 150mg Ribavirin capsule, 200mg, 400mg, 600mg Paediatric Ribavirin, syrup, 40mg/ml (oral) Fixed-Dose Combination Sofosbuvir/ Ledipasvir tablet, 400mg/90mg Sofosbuvir/ Daclatasvir tablet, 400mg/60mg Sofosbuvir/ Daclatasvir tablet, 400mg/30mg Ombitasvir/Paritaprevir/Ritonavir tablet, 25mg/150mg/100mg 12 Department of Essential Medicines and Health Products
13 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 13 Department of Essential Medicines and Health Products
14 THANKS! 14 Department of Essential Medicines and Health Products
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