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


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


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


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






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


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


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


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)


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


THANKS!

increasing access to hep c treatment - who...sof: us fda approval december 2013 (priority review for...

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