Tom Wilemon

twilemon@tennessean.com

Sovaldi is a pill to take sitting down at the dinner table.

Costing $1,000 a dose, losing one is akin to dropping a diamond down the drain.

At a time when federal and state governments are trying to rein in health care spending through myriad initiatives, the high cost of new blockbuster drugs such as Sovaldi and specialized cancer treatments could torpedo those efforts.

But this new hepatitis C treatment is a lifesaver for people like Barry Morrow of Clarksville because it cures the virus infection when other drugs have failed. Morrow tried to beat hepatitis C in 2008, taking the only treatments available at that time. His viral load never budged.

After Sovaldi became available this year, his doctor prescribed the new drug along with the same regimen he took before. This time, no virus was detected after only four weeks of treatment. Morrow stayed on track for the full 12-week course, taking his last Sovaldi on May 23.

Last week, a followup blood test confirmed he was free of hepatitis C — in his case a particularly stubborn strain of the virus.

"I don't have words to describe how I feel," Morrow said.

Grateful could be one word. Because he is a U.S. Navy retiree, his treatments were covered by TRICARE Prime.

Sovaldi has become the symbol for exorbitant pharmaceuticals. Its maker, Gilead Science Inc., defends the price, saying it "reflects the value of the medicine" and that its cost is "comparable to the previous standard of care regimen" even though it works faster and better with fewer side effects.

But many are questioning the pricing.

America's Health Insurance Plans, the trade association for the industry, blogged about the "troubling trend" of the maker of Sovaldi and other drug innovators driving their prices to "unsustainable levels." That's a concern shared by Dr. Len Lichtenfeld, deputy chief medical officer of the American Cancer Society.

"I do think that particular hepatitis drug is going to create quite a stir and perhaps focus both legislators and regulators on the cost because it is going to have a substantial impact on budgets — not only of the insurers, but also the budgets of Medicare and Medicaid and state governments as well," Lichtenfeld said. "A lot of people who happen to get this drug are older people who are on medical assistance."

Members of the U.S. House Committee on Energy and Commerce have sent a letter to the chief executive officer of Gilead Science, requesting an explanation for its pricing. Congress, which has passed laws limiting profit margins for insurance companies and exposing hospital revenues to public view, has not regulated pharmaceutical companies to this extent. But imposing price controls or similar restrictions could impinge on the innovation that produces miracle drugs like Sovaldi.

Lichtenfeld said there's no easy answer, but better coordination between drug makers and the Food and Drug Administration about the clinical trial path is a start. Large-scale trials involving hundreds of people may not be necessary in all cases with new specialty drugs being developed that spur cancer patients' immune systems to target tumors, he said. Likewise, a better system needs to be established between doctors in private practice and institutions such as Vanderbilt University and the Sarah Cannon Research Institute, so participants can be identified for trials in a more efficient manner, he said.

TennCare cautious

Dr. Robert W. Herring Jr., a Nashville liver specialist, doesn't spend too much time worrying about the macroeconomic conditions of the pharmaceutical market. He just wants to make sure his patients get the medicines they need.

"I have written so far about 60 prescriptions for Sovaldi," Herring said. "They have all been approved except for TennCare patients."

TennCare will approve Sovaldi when criteria are met. They include a biopsy or diagnostic imagery that indicates liver damage.

"I think the biggest problem with TennCare right now is that they do not want to use Sovaldi on people unless they have very advanced disease," Herring said.

Treating prisoners

State governments are having to contend with the cost of treating prison populations, which have much higher rates of hepatitis C than the general public. The infection rate of people with chronic hepatitis C at prisons ranges between 12 and 35 percent, according to the U.S. Centers for Disease Control and Prevention. That compares with 1 to 1.5 percent for the general population.

Treating the prison population prevents former inmates from spreading the disease once released, said Dr. Anil Patel, a Clarksville liver specialist. And he said new treatments are in the pipeline that will likely be cheaper than Sovaldi.

"Right now, as I talk, there are about six or seven treatments that will be launched in the next year," Patel said. "All of them have superb results. They all work in different combinations. For right now, as far as approval, obviously Sovaldi is the best thing we have. But going forward there are going to be a lot more choices. I am sure that is going to affect the cost."

Reach Tom Wilemon at

615-726-5961 and on Twitter @TomWilemon.

Who's at risk?

Are you at risk for hepatitis C?

People born from 1945 to 1965 should get tested because they make up more than 75 percent of the people who have the virus and may be unknowingly living with the infection. Although most people know the virus can be transmitted by drug users sharing needles, many are not aware it can also be contracted by sharing razors or toothbrushes or through sexual contact.

How many have it?

About 3 million Americans are living with hepatitis C and up to 75 percent don't know they are infected — placing them at serious risk for liver disease, cancer and death.

What's the test?

The first step is asking for a hepatitis C antibody test. A person can live with the virus for decades without feeling sick.

What's the treatment?

Sovaldi, a new drug approved by the U.S. Food and Drug Administration in December, has proven to have a better than 90 percent cure rate when used in combination with antiviral drugs, such as ribavirin and interferon. However, another medicine, Olysio, used in combination with antivirals, also is effective. Other new drugs are in the development and approval pipeline.

Sources: The CDC and the American Liver Foundation

Expensive Medication Help 101

• Ask your health care provider about a prescription assistance program.

• Seek guidance from organizations such as the American Cancer Society or the American Liver Foundation.

• Learn about nonprofits that help people with medicine expenses, such as the Patient Access Network Foundation, HealthWell Foundation and Patient Advocate Foundation.

Sovaldi Economics

Drug maker: California-based Gilead Sciences Inc.

Cost per pill: $1,000

Cost for a typical treatment period: $84,000

Sovaldi revenue: $2.27 billion for the first quarter of 2014

Development costs: Gilead spent $2.1 billion on research and development in 2013 and $1.76 billion in 2012. These figures are for all the drugs in its pipeline. The company did not break down development costs by specific drug products in its earning reports.