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HIV Glasgow: New $90-$90-$90 Target Needed for Global Viral Hepatitis, HIV, and TB Treatment

The costs of making drugs to treat viral hepatitis, HIV, and tuberculosis (TB) are now so low that each disease could be treated for less than $90, Andrew Hill of St. Stephen’s AIDS Trust said at the opening plenary of the International Congress of Drug Therapy in HIV Infection this week in Glasgow.

[Produced in collaboration with aidsmap.com]

The cost of generic drugs to cure TB is already below $90 for a 6-month treatment course, and some antiretroviral regimens for HIV treatment have already fallen below $90 a year in lower-income countries. The cost of generic treatment for hepatitis B and C is also falling, Hill said, with potential for further reductions.

By the end of 2017 it should be possible to treat HIV for the same price in South Africa and in Europe, but hepatitis C treatment will remain very expensive in higher-income markets, Hill explained, unless pharmaceutical companies agree to lower the prices of direct-acting antivirals in return for agreements to treat larger numbers of patients, as in Australia.

A collapse in the cost of raw materials to manufacture the hepatitis C direct-acting antivirals sofosbuvir (brand name Sovaldi) and daclatasvir (brand name Daklinza) due to economies of scale has driven down the feasible price of profitable manufacture of a 12-week course of treatment to $76, and of the sofosbuvir/ledipasvir combination to $96, Hill told the conference.

Sofosbuvir alone is currently sold by Gilead Sciences for €50,426 in Germany, the highest-priced market outside the United States, where its listed retail price is $84,000 for a 12-week course.

Hill’s research group is able to project the lowest-possible manufacturing cost by analyzing trends in costs of shipments of active pharmaceutical ingredients (API), the raw material of drug manufacture, in and out of India. By calculating the amount of API needed to make a course of treatment, adding $0.04 per tablet for excipients and tableting and $0.35 for the cost of formulation, and then adding a 10% to 50% profit margin, the researchers can calculate the minimum price a generic manufacturer could make a drug for.

The price of sofosbuvir API has fallen from around US$9000 per kg in January 2015 to around $1000 per kg in August 2016.

The hepatitis B drug entecavir (brand name Baraclude) could be manufactured for a price of $36 for a year’s treatment, and will go off patent in 2017, while tenofovir/lamivudine could be manufactured for $67 a year, implying a hepatitis B treatment cost also below $90 a year.

HIV Drug Costs: Potential for 90% Reduction in Costs Coming Soon

Hill highlighted the opportunity for reducing the cost of antiretroviral therapy in Europe, North America, and Australasia over the next few years as many frequently prescribed antiretroviral drugs go off patent.

Generic competition and pricing transparency have the potential to drive down treatment costs by 90% -- if purchasers are well-informed about the real costs of manufacture.

Efavirenz (brand name Sustiva) and lamivudine (brand name Epivir) are already available as generic products, while abacavir/lamivudine (brand name Epzicom or Kivexa) and lopinavir/ritonavir (brand name Kaletra) will become available as generic products by the end of 2016.

In 2017 generic versions of emtricitabine (brand name Emtriva), tenofovir (brand name Viread), atazanavir/ritonavir (brand name Reyataz/Norvir), and darunavir/ritonavir (brand name Prezista/Norvir) will all become available -- and generic manufacturers will also be able to sell tenofovir/lamivudine combination pills already widely used in low- and middle-income countries. In most cases, the products on sale are already prequalified by the World Health Organization or the U.S. Food and Drug Administration for purchase by the Global Fund to Fight AIDS, Tuberculosis and Malaria or the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), and have passed stringent regulatory tests, ensuring rapid approval for developed-world markets.

But, said Hill, few policy-makers or purchasers of antiretroviral drugs in Europe know just how cheaply antiretroviral drugs can be manufactured, or are aware of the opportunities for profiteering by unscrupulous owners of generic products. He highlighted a recent investigation in the United Kingdom revealing overcharging up to 1000% by one generic manufacturer as an example of the risk faced by purchasers -- such as the individual National Health Service hospitals responsible for drug purchasing in many parts of England and Wales -- when generic replacements for antiretrovirals begin to appear on the market.

The problem is further exaggerated in the U.S. where insurers are liable to pay up to 4 times the price paid by the U.K.’s National Health Service for branded antiretrovirals. In 2016 the U.S. list price for a year’s prescription of Truvada (tenofovir/emtricitabine) was $21,120. In contrast, the U.K. list price for Truvada was $5553. In both cases discounts may apply. A generic tenofovir/emtricitabine pill is currently available for $67 a year for purchase by low- and middle-income countries.

"Few national health services know these costs," Hill said. "We need a lot more pricing transparency, which will have a cascade effect across therapeutic areas."

Cancer drugs can also be manufactured cheaply and as these come off patent, costs can be driven down. For example, the patent on Gleevec (imatinib) for chronic myeloid leukemia expired in 2016. The current U.S. list price of Gleevec is $146,000, the drug is currently marketed by Indian manufacturers for $803, and it could be made for $172. However, the first generic entrant to the U.S. market is charging only 10% below the current price of brand name Gleevec for its generic formulation of imatinib (see The ASCO Post for more information on what can go wrong when generics enter the marketplace).

Hill also drew attention to the impact that the arrival of generics might have on the ability of originator companies to negotiate higher prices for innovative products. Whereas companies could argue that the additional value of a product in terms of quality of life, virological superiority, or convenience justifies a premium compared to existing products -- especially previous formulations of the same drug -- companies could now be faced with having to justify premium pricing compared to low-cost generic products.

Disease elimination -- whether of HIV, viral hepatitis, or TB -- is only feasible if drugs can be accessed at low prices, within national health budgets, said Hill. Current global targets for elimination of these diseases will not be reached without price reductions, and the availability of a growing range of generic drugs to treat HIV will call into question the prices charged for branded products, he concluded.

10/24/16

Source

A Hill. Treatment for cancer, HIV and viral hepatitis in Europe using low cost generic drugs: what could be done? HIV Drug Therapy. Glasgow, October 23-26, 2016. Keynote presentation KL2.