AASLD Sofosbuvir/Simeprevir-What Is The Minimum costs to produce Hepatitis C Direct Acting Antivirals

Dec 9 - Fair Pricing Coalition Condemns Gilead Sciences on the High Price of New Hepatitis C Drug Sovaldi™, and Urges Rapid and Wide Dissemination of Support Program Details for Uninsured and Underinsured People Living with Hepatitis C

Nov 26 - Now FDA Approved Olysio (simeprevir) - The New Kid On The Block
OLYSIO (Simeprevir) Cost? - Janssen has priced Olysio at a wholesale acquisition price of $22,120 per bottle of 28 capsules (150 mg capsules), which is an approximately one-month supply. That's roughly $66,360 for a three-month course.

Nov 13 -Medscape - Costs for Hepatitis C Treatment Skyrocket

AASLD-What Is The Minimum costs to produce Hepatitis C Direct Acting Antivirals

A third wave of anti HCV DAA agents are currently moving through the pipeline, two new DAAs have already been reviewed by the Antiviral Drugs Advisory Committee, Gilead's Sofosbuvir and Johnson & Johnson's Simeprevir.

The result of the whole process is expected to be decided by the FDA in early December for Sofosbuvir and late November for Simeprevir.

Additionally, other new DAAs in Phase III clinical trials are able to increase SVR and shorten therapy in a significant proportion of both treatment-naïve and treatment-experienced chronic HCV infected patients.

However the drugs are expected to be expensive, patients in the US could pay anywhere from $60,000 - $100,000 per treatment. The cost for these life saving drugs will be out of reach for patients in developing countries and the uninsured.

Analysis Of Predicted Minimum Costs To Produce Hepatitis C Direct Acting Antivirals

At this months AASLD, Andrew Hill of Liverpool University and colleagues presented a new analysis of predicted minimum costs to produce Direct Acting Antivirals for the treatment of hepatitis C. The minimum cost of 12 weeks of treatment with each DAA(see below) was calculated assuming a production cost per gram of HCV DAA between 1-10 times the equivalent HIV antiretroviral and based on compound properties including chemical structure, complexity of synthesis, and daily dose. The analysis was also presented earlier this year at the 7th IAS Conference

Predicted Minimum Costs

The analysis predicted  $20-63 for a 12-week treatment of ribavirin,  $10-30 for daclatasvir, $68-136 for sofosbuvir, $100-210 for faldaprevir and $130-270 for simeprevir see charts below.

The complete analysis is available for downloading here or view the predicted costs/slides provided below.

AASLD, Washington DC

Minimum costs to produce Hepatitis C Direct Acting Antivirals

Andrew Hill and Saye Khoo, Department of Pharmacology and Therapeutics, Liverpool University, UK Bryony Simmons, Imperial College, London, UK Nathan Ford, University of Cape Town, South Africa

64th Annual Meeting of AASLD, Washington DC, United States of America, November 2013 [Poster 1097]

TREATMENT COVERAGE IS LOW EVEN IN DEVELOPED COUNTRIES

Despite the long term morbidity & mortality associated with untreated hepatitis C, data suggests that relatively few patient are being treated.

In Europe only 3.5% of infected individuals received antiviral treatment by the end of 2010 (ranging from 16% in France to <1% in Poland)

In the USA only 21% of infected individuals had received treatment by the end of 2007

Reasons for under - treatment:
• Under - diagnosis (80% of HCV cases are asymptomatic)
• Limitations of currently available medication
• The very high prices of drug treatment

THE STIMATED COST OF CURRENT TREATMENT (UK & US ESTIMATES )




HEPATITIS C GLOBAL PREVALENCE BY COUNTRY (2010)


HEPATITIS C GLOBAL PREVALENCE BY COUNTRY(2010)





PATENT EXPIRY DATES




DAA COMBINATIONS : INTERFERON - FREE REGIMENS 
Several combinations of two DAAs (with or without RBV) can cure HCV (SVR) in the majority of treatment - naïve, genotype 1 patients, without the use of interferon:



Continued......



RATIONALE

DAAs for HCV infection have similar mechanisms of action and chemical structures to antiretrovirals for HIV infection.

Generic antiretrovirals are currently manufactured at very low cost, for treatment of over ten million people with HIV in low and middle income countries.

Minimum costs of HIV antiretrovirals are 0.2-0.9/g of drug for nucleoside analogues, 0.5/g for nucleotide analogues, and 0.7-2.1/g for protease inhibitors.

For widespread treatment of HCV in developing countries to be feasible, we need short-course of antiviral treatment available at very low cost.

Using the cost of HIV drugs as a framework, we can make estimates for the potential cost of HCV DAAs

























AASLD Coverage

Commentary/Abstracts/Videos @ Healio

Capsule Summaries, review by experts and slides @ Clinical Care Options CCO

Commentary/Abstracts with coverage by Liz Highleyman @ hivandhepatitis.com

Slides/Abstracts @ NATAP

CME/CE with commentary by Michael Smith @ MedPage Today

0 comments:

Post a Comment