November 2, 2009 - As H1N1 flu continues to spread and claim victims nationwide, there's growing pressure on the federal government to make vaccines and treatments for the nasty virus available — and more affordable.
Last month, Safety Net Hospitals for Pharmaceutical Access (SNHPA) sent a letter to the Office of Pharmacy Affairs (OPA), asking the agency to make tamiflu and other non-vaccine products used to treat hospital employees for the flu eligible for 340B pricing.
The organization is concerned that unless hospitals are able to effectively treat workers who come in contact with sick patients, they could see their work force dramatically reduced at a time when all their resources are needed.
"Flu patients are overwhelming many SNHPA member hospitals, and the sudden influx of patients exposed to, and infected with, the H1N1 flu poses a serious risk of infection not only to existing hospital patients, but also to hospital staff," SNHPA wrote.
OPA noted in a statement to the Monitor that "employees must be patients of the covered entity in order to be eligible to receive 340B drugs" and that the agency has "no authority to set aside statutory requirements."
In its letter, SNHPA wrote that hospital employees with H1N1 symptoms are often evaluated by the institution's own physicians and sent home with a prescription for flu medication written by the hospital's health department. For that reason, the organization argued, those employees should be defined as patients, and the hospital receive the 340B discount on medications used to treat such employees.
OPA said it's preparing a response.
National Emergency Opens Door for New Drugs, Treatment Forms
With President Obama declaring the flu pandemic a national emergency on Oct. 23, there are fewer restrictions on hospitals that need to accommodate a surge in patients. That means, for example, that they can now move patients off-site to isolate them from the flu, or to keep them from spreading it to other patients.
Protection for Patients
To protect patients during a health emergency, the Public Readiness and Emergency Preparedness Act set up a fund to provide benefits to patients who are injured by the administration or use of a countermeasure, in this case peramivir.
The Health Resources and Services Administration oversees the Countermeasures Injury Compensation Program. Read more about the program here.
On the same day, the U.S. Food and Drug Administration approved an emergency use of the intravenous form of antiviral peramivir for critically ill patients who don't respond to oral or inhaled therapy, or who lack other treatment options. That makes it the only intravenously administered flu treatment authorized in the United States for the 2009 H1N1 flu outbreak.
More than 25,000 Americans have been hospitalized thus far with flu symptoms, the vast majority after catching the H1N1 bug. Nearly 3,000 have died and the virus has spread to all but two states, the Centers for Disease Control and Prevention announced Friday.
Immunity for providers, makers and distributors
The government also wants to make sure 340B entities and other health care providers can treat patients sickened by the H1N1 virus without having to worry about future injury claims, and that manufacturers of the drugs enjoy the same peace of mind.
The Public Readiness and Emergency Preparedness Act (PREP), makes "covered persons" who are involved in the administration, production and distribution of "covered countermeasures" immune from liability when the Secretary of Health and Human Services (HHS) announces a public health emergency.
Late last month, Secretary Kathleen Sebelius issued such a declaration, limiting liability for antiviral peramivir.
With new H1N1 drugs on a fast-track for approval, federal health officials want to ensure there's no hold-up due to fear of future lawsuits if the treatment turns out to have unexpected side-effects.
Hospitals, Clinics on Fast-track Approval for 340B
When the government first announced a public health emergency in April, the Office of Pharmacy Affairs (OPA) decided to expedite enrollment into the 340B drug discount program. This helps the government expand access to affordable and often-critical drugs during a health emergency.
Under the policy, eligible health care providers whose applications have been processed and registered by the OPA don't have to wait until the next quarter to join as is usually the case. The ramped-up enrollment has also benefitted free-standing children's hospitals, which were only recently allowed to participate in the 340B program. (See Monitor, Oct. 19, 2009.)
So far, two hospitals and three family planning clinics have requested and been granted expedited listing, OPA said last week.
Big order for peramivir manufacturer
Alabama-based BioCryst Pharmaceuticals has an $180-million, five-year contract with HHS to develop peramivir, and recently completed a successful Phase 3 trial with intravenous peramivir in Korea.
The government's emergency use authorization makes the drug a treatment option for physicians in the U.S. as long as the emergency is in effect.
"BioCryst has worked with HHS to…rapidly deploy an initial supply of peramivir, and we are prepared to deliver more," the company's chief executive, Jon Stonehouse, pledged.
The company is completing production of an initial 130,000 courses of intravenous peramivir to prepare for orders it may receive from governments in the United States and elsewhere during the pandemic emergency.