Here is a series of articles about drug costs, HCV or otherwise - low cost deals, generics, name brands, availabilty and the powers that be  - what's wrong with this picture?

HCV treatments valued under $100 per patient

Helio - December 12, 2016

Researchers estimated that a generic direct-acting antiviral regimen for the treatment of hepatitis C virus infection could cost less than $100 per person in the United States, according to data presented at The Liver Meeting.

Andrew M. Hill, PhD, of St. Stephens AIDS Trust at Chelsea and Westminster Hospital, London, and colleagues calculated the production costs of direct-acting antivirals (DAAs) using information from an online database of export ledgers containing per-kilogram prices and volumes of active pharmaceutical ingredients (APIs) for DAAs exported from India. The projected per-pill API expense was combined with other production costs, such as formulation and packaging, and a 50% profit margin. Since velpatasvir (Gilead Sciences), the newest DAA included in the analysis, lacks export information, the researchers used data from an analysis of chemical synthesis processes detailed in originator patents to estimate the drug's per-kg API cost.

According to the data, API volumes exported from India between January and June 2016 included 10,200 kg Sovaldi (sofosbuvir, Gilead Sciences) - equivalent to 303,000 12-week treatment courses; 5,433 kg of Daklinza (daclatasvir, Bristol-Myers Squibb) - equivalent to 1,080,000 treatment courses; and 240 kg of ledipasvir (Gilead Sciences) - equivalent to 32,000 treatment courses.

The researchers reported that average API prices decreased over time. On June 1, the estimated cost of one 12-week HCV treatment was:

·         $62 for sofosbuvir - current U.S. price is 1,355 times higher;

·         $14 for daclatasvir - current U.S. price is 4,500 times higher;

·         $96 for sofosbuvir-ledipasvir - current U.S. price is 984 times higher; and

·         $181 to $216 for sofosbuvir-velp-atasvir  current U.S. price is 346 to 413 times higher. - by Stephanie Viguers

WHO prequalifies first generic HCV medicine

Helio - July 28, 2017

WHO has prequalified the first generic version of sofosbuvir for the treatment of hepatitis C, a development that could improve access to quality-assured generic medicines, according to a press release.

Sofosbuvir, sold under the brand name Sovaldi, was approved for use in the United States in 2013 as part of an antiviral regimen for the treatment of HCV genotypes 1, 2, 3 or 4.

"Direct-acting antiviral medicines such as sofosbuvir are highly effective for treating and curing chronic hepatitis C infection. But, at best, 1 out of 10 people in need had access to these medicines in 2015," Gottfried Hirnschall, MD, MPH, director of WHO's HIV/AIDS department and global hepatitis program, said in the release.

On average, a 3-month treatment course of sofosbuvir costs approximately $260 and remains highly expensive in many countries; however, licensing agreements between the drug's developer, Gilead Sciences, and some generic manufacturers have made it possible for lower income countries to provide the medicine at more affordable prices. Many Asian and African countries are already procuring generic versions of sofosbuvir.

According to WHO, the prequalification of sofosbuvir means this new generic medication for HCV can now be procured by the U.N. and financing agencies, and it helps guarantee the quality, safety and efficacy of the product.

"This is a breakthrough medicine with a 95% cure," Suzanne Hill, PhD, director of WHO's Essential Medicines and Health Products, said. "The first WHO-prequalified generic of this product will give large procurers and countries the assurance of quality for an affordable product."

Helio - June, 2017

WHO experts added 55 medicines - 30 for adults and 25 for children - including 22 antibiotics, and specified new uses for nine drugs that had been included in past lists. The experts met at WHO headquarters in Geneva, Switzerland, in March. Drugs for hepatitis C virus, HIV, tuberculosis and cancer were added to the list, bringing the total to 433.

"Essential medicines should be available in health systems everywhere at all times," Kieny said.

Medicines added to the list this year include Epclusa (sofosbuvir/velpatasvir, Gilead Sciences), the once-daily tablet treating all six major forms of HCV; Tivicay (dolutegravir, ViiV Healthcare) for HIV infection; pre-exposure prophylaxis (PrEP) with tenofovir alone or in combination with emtricitabine or lamivudine to prevent HIV infection; ...

Non-profit: Low-cost HCV drugs available with shared negotiations

Helio - July 27, 2017

The Global Procurement Fund, created by the Center for Disease Analysis Foundation, announced that utilization of their massively discounted hepatitis C treatment negotiations has not yet happened and urged countries with high burden of disease to do so.

"It has always been assumed that price was the primary hurdle stopping developing countries accessing these drugs," Homie Razavi, PhD, managing director of CDAF, said in the release. "However, despite us negotiating prices as low as $50 for a bottleof 28 tablets of sofosbuvir, no developing country has yet placed an order through the fund."

CDAF launched the Global Procurement Fund (GPRO) in April of 2017 and worked with more than 85 countries to develop national hepatitis plans. Two years ago, the foundation launched the Polaris Observatory, which tracks the number of individuals infected with, diagnosed with and treated for HCV and hepatitis B.

The Global Procurement Fund worked with drug manufacturers and negotiated drug prices based on pre-agreed minimum volume. Once member countries provide an estimated order size, the fund combines the orders and asks the manufacturers to provide bids. Only manufacturers with the freedom to operate are considered by the fund.

"The model we use is very similar to big-box-store where we negotiate low prices for our members based on large volume orders," GPRO outlined in another release. "We are bringing an efficient competitive bidding process to countries where competition is often lacking."

According to GPRO's website, the total cost to member countries is the sum of the negotiated cost of medicines and diagnostics, plus shipping, insurance, importation taxes and the fund's 5% fee of total price of products to cover overhead expenses and set aside funds for interest-free loans to countries that require financial support.

"The big difference between GPRO and previous initiatives is that we expect the national governments to pay for purchases in the public health sector," Razavi said in the release. "We are working on lining up funds to help with the upfront financing and currency exchange risk, but at the end of the day, the national governments are expected to pay and this has not been easy for many countries. There is an expectation that if they wait long enough, donors will come forward to support hepatitis programs. We are trying to make it as easy as possible for low and middle-income countries to provide access to HCV treatment and diagnostics but we need the countries [to] take that first step of signing up and committing funds."

The fund has negotiated lowered prices for the generic products sofosbuvir, daclatasvir, ledipasvir plus sofosbuvir, tenofovir and entecavir, as well as for the Cepheid GeneXpert HCV viral load and GeneXpert HPV diagnostics. - by Talitha Bennett