Experts Propose Licensing Deal to Expand Access to Hep C Therapies

The development of highly effective cures for hepatitis C has prompted a panel of medical and public health experts to propose an innovative financing arrangement to make these costly therapies more available to “neglected” populations in the U.S. Wider access to new antivirals for HCV, along with better screening of patients for hepatitis and broader vaccination for HBV, would help avert 90,000 deaths by 2030, according to a new report outlining “A National Strategy for the Elimination of Hepatitis B and C” from the National Academics of Sciences, Engineering and Medicine.

To overcome the high costs that currently limit HCV treatment, particularly for Medicaid patients and incarcerated prisoners, the committee recommends establishing a voluntary bidding process for state and federal agencies to license the right to obtain antiviral therapies at low cost for limited patient populations. The six current producers of hep C therapies would bid to sell licenses to the government for use of their products in state Medicaid programs, the Indian Health Service, and prisons, which cover some 700,000 individuals now not able to obtain treatment. The committee estimates that such licensing rights would cost about $2 billion, plus about $140 million for public agencies to provide the medicine(s) to treat this population. Without such an arrangement to lower spending on these drugs, this treatment effort would cost about $10 billion over the next 12 years and reach only 240,000 individuals in these neglected groups.

The new hep C therapies are so effective that their benefits outweigh their costs, commented Rutgers University professor and committee chair Brian Strom, at a briefing March 28. High drug costs, though, have led to denial of therapy to nearly 50% of Medicaid patients and to almost all prisoners, where hepatitis is rampant. Most public programs treat only the sickest patients, which fails to limit transmission of the virus. Yet, the new drugs have patent protection until at least 2029, delaying the potential for mass treatment with generic medicines, the report points out.

The panel believes that this voluntary licensing strategy would maintain financial incentives for pharmaceutical companies to develop important new medicines and would support further research on curative therapies for HBV and a vaccine for HCV, as well as more rapid diagnostic tests and new treatments for cirrhosis and liver cancer. The licensing plan, the report states, would not set a “dangerous precedent” for government controls of expensive medicines and would avoid “overt drug rationing,” while correcting “a market failure” affecting new HCV treatments. A stated side benefit might be to discourage questionable pricing strategies by pharma companies.

The panel’s broader initiative for eliminating hepatitis includes more coordinated monitoring and analysis of HBV and HCV infection rates, particularly of pregnant women; removing barriers to adult vaccination; support for syringe exchange and opioid abuse treatment to reduce contamination; expansion of Ryan White programs to treat HCV linked to AIDS; more training of primary care providers in detecting and treating hepatitis;  and greater screening and vaccination of prisoners in correctional facilities.