Negotiating affordable access to diagnostics and medicines in

Negotiating affordable access to diagnostics and medicines in Punjab for HCV Dr Gagandeep Singh Grover State Programme Officer, IDSP/HCV Punjab

• Northern State in India. • Has population of 29 mn appx • 22 districts with wide variations

Problem of HCV-Punjab • Exact magnitude was not known – Certain studies had highlighted – PSACS (NACO) data was indicative • Prevalent Genotype – Exact was not known – PGI data was the most relevant and authentic • Risk factors – Known but not able to pinpoint due to lack of evidence

HCV Prevalence in Surveyed Districts Urban%- 3. 09 Rural%- 3. 38 Total%-3. 29 3. 15 0. 28 2. 05 0. 0 4. 11 0. 00 8. 86 0. 63 0. 39 0. 46 0. 00 3. 82 1. 79 0. 00 0. 64 0. 5 0. 2 2. 16 1. 11 12. 45 3. 26 5. 83 2. 83 5. 73 4. 84 13. 64 2. 95 5. 22 High Prevalence

District Wise Seropositivity of Hepatitis C; As per Data of Punjab State AIDS Control Society (PSACS) National average <1. 0% PSACS Data 2015 (Dec)

District Wise Seropositivity of Hepatitis C; As per Data of Punjab State AIDS Control Society (PSACS) PSACS Data 2015 (Dec)

Steps by Govt of Punjab

Rate Contract for HCV Testing and Treatment • Govt. Of Punjab did tenders for injectable drugs (Interferons) in 2014 -15 – Drugs supplied by the pharmaceutical company – Inj. available at Jan Aushadhi Stores – Available to the patients at subsidized rates per injection • Drawbacks $ 46 for one inj $ 1150 for 24 weeks $ 2300 for 48 weeks Price was still high for some groups – No mechanism of track and record of the patients – No mechanism of standardized follow up – –

Dr RK Dhiman, Prof. Hepatology, PGIMER

Mukh Mantri Punjab Hepatitis-C Relief Fund (MMPHCRF) A State Initiative: a public health programme for Hepatitis-C • Launched in June 2016, – offers free treatment of Hepatits C to all residents of Punjab • Funds approved by the Government of Punjab for the Hepatitis-C relief fund • Decentralized Hepatitis C treatment – 22 District Hospitals and – 3 Government Medical Colleges

Principles of MMPHCRF • STANDARDIZATION – Testing and Treatment has been standardized – Regimens (fixed) have been designed • EQUALITY – Drugs to be provided free of cost to all – Regardless of religion, ethnicity & economic condition • AVAILABILITY – In Govt Hospitals at 3 Govt medical Colleges and 22 District Hospitals in first phase • AFFORDABILITY

Sensitization of Medical & Paramedical Personnel • Medical and Paramedical personnel involved in examining, diagnosing and providing treatment have been sensitized – Regimens, Follow ups and Testing – Co morbid conditions – Special circumstances

Sensitization before Launch of MMPHCRF • • • 80 Medical Specialists in 3 batches 50 Pharmacists in 2 batches 25 SMOs and Nodal Officers 22 Distt Epidemiologists 25 DEOs

Algorithm for Treatment of Hepatitis C in Punjab HCV RNA (+) Cirrhosis* Absent Present§ Genotype-Optional¶ Genotype-Mandatory Genotype 1 & 4 Genotype 3 Sofo+Ledipasvir +Riba for 12 wks$ Sofo+Dacla for 12 wks** Sofo+Dacla+Ri ba for 24 wks HCV RNA for ETR (Optional) Dr RK Dhiman HCV RNA for SVR (Mandatory) MMPHCRF 2016

Rate Contract for Testing • Tenders for baseline and follow up testing (Viral Load and Genotype) • Baseline testing standardized – Anti HCV-ELISA: – CBC – LFT – RFT – USG Free in 25 centres

Rate Contract for Testing • • RC with Dr Lal Path Lab Rates fixed for Viral Load and Genotype tests $ 31 for viral load (quantitative) $ 43 for genotype (for cirrhotics) • SVR test is free under MMPHCRF • 160 collection centres in State

Recommended Regimens with Treatment Durations for Patients without Cirrhosis Genotype Regimen 1 [Sofosbuvir/ Ledipasvir] Regimen 2 [Sofosbuvir/ Ledipasvir/ Ribavirin] Regimen 3 [Sofosbuvir/ Daclatasvir] Regimen 4 [Sofosbuvir/ Daclatasvir/ Ribavirin] Genotype 1 12 weeks No Genotype 2 No No 12 weeks No Genotype 3 No No 12 weeks No Genotype 4 12 weeks No Genotype 5 12 weeks No No No Genotype 6 12 weeks No No No Dr RK Dhiman MMPHCRF 2016

Recommended Regimens with Treatment Durations for Patients with Cirrhosis Genotype Regimen 1 [Sofosbuvir/ Ledipasvir] Regimen 2 [Sofosbuvir/ Ledipasvir/ Ribavirin] Regimen 3 [Sofosbuvir/ Daclatasvir] Regimen 4 [Sofosbuvir/ Daclatasvir/ Ribavirin] Genotype 1 24 weeks 12 weeks Genotype 2 No No 12 weeks No Genotype 3 No No No 24 weeks Genotype 4 24 weeks 12 weeks Genotype 5 24 weeks 12 weeks No No Genotype 6 24 weeks 12 weeks No No Dr RK Dhiman MMPHCRF 2016

Rate Contract for Drugs (DAAs) • Standardized procurement – PHSC procurement agency – RC done twice For 12 weeks (1 st tender) For 12 weeks (2 nd tender) Sof + Ledi $ 306 $ 191 Regimen 2 Sof + Ledi + Riba $ 331 $ 215 Regimen 3 Sof + Dacla $ 267 $ 105 Regimen 4 Sof + Dacla + Riba $ 280 $ 128 Regimen Drugs Regimen 1 • Storage at 3 Drug Ware Houses • District HQ

Comparison of Rates of DAAs Drug MRP ($) Market Price ($) Punjab Govt Rates ($) Sof+ Ledi 357 143 64 Dacla 100 64 13 Sofo 260 157 22 Riba 129 71 8 Prices for one bottle of 28 caps Except Riba where one bottle is of 140 cap

Follow up and Tracking of patients • Treatment Cards for patients availing MMPHCRF – Personal details – Medical details – Regimens and Follow ups • • • Master Data with UID for each case Follow up of case Centralized case record ETR (End of Treatment): Not recommended SVR (Sustained Viral Response) records: 12 weeks after ETR

Monitoring & Evaluation

MMPHCRF Patient Cascade (18. 6. 16 to 06. 04. 2017)

Case Load – Centre wise

Prevalent Genotypes

Rural/ Urban

Age wise Distribution (%)

Cirrhotic/Non Cirrhotic

SVR outcome

SVR Certificate

Awareness Campaigns

Collaborations

CHAI • Mo. U with CHAI • M&E tool for HCV cases under MMPHCRF • M&E tool enabling: – Demographic profile of the patients – Prevalence of various genotypes in different areas – Hot Spots (as per the cases recruited under MMPHCRF) – List of patients due for follow up – Any patient LFU (Lost to Follow Up) – Expected ETR and SVR dates

M&E - CHAI • Analysis – Enrollment – Outcome – LFU - tracking • GIS mapping for hotspot identification

ECHO

ECHO for HCV in Punjab • Node: PGIMER Chandigarh – Deptt of Hepatology – State Deptt of Health • Spokes – 3 GMCs – 22 DHs

ECHO Sessions

Taking small Steps towards Strengthening of surveillance with aim of Provision of quality diagnostics & drugs with vision of HCV Elimination in Punjab