Sovaldi, approved by the Food and Drug Administration (FDA) last year for the treatment of chronic hepatitis C (HCV), has a success rate better than 90 percent, and is ideal for use in opioid treatment programs (OTPs), yet payers are balking at covering it for patients who have a history of a substance use disorder (SUD), ADAW has learned. This is despite any labeling that indicates it is not safe for these patients; in fact, in trials it was given concomitantly with methadone with patients in OTPs, and the FDA states it can be given concomitantly with methadone, with no dose adjustments.

Sovaldi (sofosbuvir) is the first oral medication for HCV that doesn’t require interferon, an injected medication that has, for many patients, intolerable side effects, including nausea, fatigue and depression. Also last year, the FDA approved another oral medication for HCV: Olysio (simeprevir).

The problems with these medications are that they are costly: more than $60,000 for Olysio and more than $80,000 for Sovaldi. Treatment takes 12 to 24 weeks.

Still, the morbidity and mortality associated with HCV, which can lead to cirrhosis, liver failure and death, call for the use of these medications, especially in OTPs, said Elinore McCance-Katz, M.D., chief medical officer for the Substance Abuse and Mental Health Services Administration (SAMHSA), which regulates OTPs.

“I’ve been waiting for these drugs for a long time,” McCance-Katz, whose background is in infectious diseases, told ADAW last week. “This is an area that’s very near and dear to my heart.” Noting that people die from liver disease that is induced by HCV, she said that the first “Dear Colleague” letter she wrote to OTPs was about the need for testing for HCV. She just reissued that letter because the disease “is so important in terms of morbidity and mortality.”

OTPs are uniquely able to provide HCV testing and treatment because they are already required to oversee medical care, she said. “Patients must have a physical exam, be seen by a doctor, and the OTP must make sure that patients get all the care that they need,” she said.

Testing and treatment

It’s not enough to simply do an antibody test for HCV; programs also need to test for viral load, said McCance-Katz. “Not everybody who shows a positive for ever being infected is still infected,” she said. And then, it’s essential to treat the HCV, if the infection is there, she said. “It’s unfair to patients to tell them they are infected with HCV if there isn’t anything that’s being done on it,” she said.

If patients have a viral load, they need to be referred to medical care, said McCance-Katz, adding that the care doesn’t necessarily need to be provided in the OTP. “Another physician could do the workup,” she said, adding, “not everybody with a viral load is going to be treated, because they may not be at a point where that is clinically indicated.”

Hepatitis C is generally transmitted parenterally — via injection with infected needles, or a blood transfusion before 1992, when the supply was tested.

The FDA requires testing medications with methadone, and that was done for Sovaldi — another reason that OTP patients are uniquely suited to this medication, said McCance-Katz. There are no contraindications to giving both medications, and no dose adjustments are required.

Welcome from OTPs

OTPs are on the one hand delighted that they can offer this medication to their patients, but on the other hand cynical about whether payers will pay for it. “Over the next 10 to 20 years we can expect increased morbidity in terms of cirrhosis and liver cancer,” said Alain H. Litwin, M.D., who helped develop the HCV screening and treatment programs at the Albert Einstein College of Medicine in New York City. “But this can be avoided with treatment.” The Einstein OTP has treated 500 patients for HCV over the years, and Litwin is thrilled that Sovaldi is now available to these patients. “The time is now,” he said. “There’s always been excuses to wait — treatments aren’t effective, the OTP population is too complicated, there are too many competing priorities.” But now, with one pill a day, a 95 percent cure rate and very few side effects, there is no reason to back off treatment for what is a leading cause of death in OTP patients, he said.

Einstein has been treating patients with interferon, with injections given on site twice a week. Side effects are problematic. But the switch to Sovaldi is likely to be constrained by payers, he said.

OHSU-Medicaid report

In particular, Litwin cited a report issued in May by the Center for Evidence-Based Policy at Oregon Health and Science University (OHSU), supported by state Medicaid directors, that seeks to deter payments for Sovaldi, discrediting the trials and taking issue with the practice guidelines issued by the American Association for the Study of Liver Disease, which support the use of Sovaldi. The report singles out drug users as a group that should not be given the medication, saying that “patients with alcohol or drug use within the past year” should be excluded from treatment.

“Now we have this great treatment, but let’s restrict it to people who are not actively using drugs — that is contrary to everything society should stand for,” said Litwin. “It’s unjust.” In New York state, 65 percent of OTP patients have chronic HCV, he said. “Other than addiction, hepatitis C is the leading chronic illness,” said Litwin. Einstein’s model of care is group treatment — a shared medical visit in which everyone gets their medication. Now, with genotypes 2 and 3 of HCV, interferon-free is the best treatment, he said. The OTP could easily observe administration of the oral medication. About 30 percent of the OTP’s patients have those genotypes and are getting Sovaldi, said Litwin. For genotype 3, Sovaldi must be taken for 24 weeks, at a cost of $168,000, said Litwin. “At some point, this does not become cost-effective,” he said. “Everyone needs to contribute to this equation.”

Hours on pre-authorization

At CODAC Behavioral Health Care based in Providence, Rhode Island, the OTP is spending hours on getting documentation together to get Sovaldi for HCV patients. At one point, 85 percent of patients were infected with HCV; that is now down to 50 percent, largely as a result of the recent expansion of patients from 700 three years ago to 1,400 now. The newer patients are “more savvy in terms of taking care of their health, and not sharing needles,” said Diane Plante, CODAC nurse manager. “We do rapid HCV testing, and all patients who come back positive are sent to another clinic for viral load testing,” said Plante. Depending on the genotype, patients get Sovaldi or Olysio; no patients get interferon due to the significant side effects, she said.

Clinically, everything is going well. But the problem is getting paid, said Plante. “We’ve prescribed and we’re still muddling through the prior authorization process,” she said. A nurse and an aide spend several hours per patient documenting the need for these medications, with private insurance companies and Medicaid alike, she said.

“The insurance companies aren’t responsive when it comes to the request to use these new medications,” said Michael Rizzi, CODAC president and CEO. “They want us to use old protocol first, which is throwing good money down the tube.” The patient experience of using interferon “causes as much frustration as the disease” of HCV, he said.

Rizzi noted that $84,000, the cost of 12 weeks on Sovaldi, is much less than one acute hospitalization of a week in the ICU. “They’re going to pay for it one way or another,” he said of insurance companies and HCV treatment. He also thinks that patients in OTPs are being discriminated against if insurance companies think that everyone who is in recovery is a bad risk for reinfection.

“They wouldn’t say to a guy who needed another bypass that he couldn’t get it because he didn’t change his diet,” said Rizzi.

One concern is “warehousing” — that patients will be stuck using interferon until there are less expensive versions of Sovaldi on the market.

Medical discrimination

The National Association of Medicaid Directors (NAMD) circulated the OHSU report to state Medicaid directors, saying that the high cost of the medication “requires careful consideration of how to responsibly decide how to best use this new treatment option,” especially considering that there are 3 million people with HCV. “Nobody is demonizing drug users and saying that they shouldn’t be treated/cured,” said Matt Salo, NAMD executive director, in an email to ADAW. “But the practical implications of administering a 12-week course of treatment that can cost between $84–140K need to at least take into consideration a variety of factors,” he said. “Those factors may well include current drug use, in part because it may make adherence/compliance more difficult, but also because of the potential repercussions of successfully curing an individual only to have the risk of reinfection.”

We asked if he had any evidence that OTP patients or drug users are more likely to have a reinfection of HCV or be less compliant with medication. “I’m not sure that I have evidence on any of those things, per se,” he said, but he pointed out that isn’t NAMD’s role. “But we have heard (in a few states) that they’ve already spent more on Sovaldi in the first quarter of 2014 than they did for liver transplants in all of 2012 and 2013 combined.”

“NAMD has no opinion on whether or not any individual or group of individuals should or shouldn’t get treatment for anything,” said Salo. “We do stand behind the ability of states (who have to make difficult decisions about this and many other things every day) to make those types of decisions, however.”

Valerie King, spokeswoman for the OHSU project, said that the published studies on Sovaldi “all excluded subjects with active substance misuse,” and that is why the report concluded that these patients should not get the medication. She noted that there is no published research about using Sovaldi with naltrexone or buprenorphine.

Gilead responds

The maker of Sovaldi, Foster City, Calif.–based Gilead Sciences, “disputes and strongly disagrees with the conclusions of the OHSU report, commissioned by the National Association of Medicaid Directors (NAMD), regarding the use of sofosbuvir for chronic hepatitis C,” according to a spokeswoman for the company. “The report runs counter to the conclusions of regulatory authorities and expert professional groups that have licensed and endorsed sofosbuvir based on a well-designed and well-conducted clinical program demonstrating its ability to consistently deliver cure rates of over 90 percent.”

Sovaldi has been studied in subjects who were taking methadone, and the success rates were comparable to overall outcomes, according to Gilead. Methadone use was permitted in clinical trials, after the potential for drug interaction between Sovaldi and methadone was assessed in Phase I and it was found that the medications did not affect each other in terms of levels.

Concerns with alcohol

Because alcohol accelerates the damage caused by HCV and leads to the more rapid development of cirrhosis, clinicians caution HCV patients to abstain from alcohol, the spokeswoman said. However, based on the Sovaldi label, alcohol or other drug use is not a contraindication, she said.

In the trials, HCV patients were counseled to discontinue alcohol use, the spokeswoman said. “Patients who were actively abusing alcohol were excluded from the clinical trials,” she said. “However, a history of alcohol abuse or ongoing alcohol use was not exclusionary; approximately 5–10 percent of patients in the Phase 3 studies self-reported this medical history, and there was no significant difference in [success] rates among these groups.”

Stigma

But OTPs are still concerned about patients not being able to afford the medication, especially if they pick up on the OHSU language.

For example, the Virginia Medicaid formulary states that patients “must be evaluated for current history of substance abuse and alcohol with validated screening instruments” in order to get Sovaldi. “The prescriber can submit clinical rationale for treatment continuation, for positive tests that are false positives and not thought to be due to a relapse in alcohol or substance abuse,” according to the formulary.

New York has a generous Medicaid benefit, but some states don’t even pay for OTP treatment, much less HCV treatment. “That’s the tragedy of our system,” said Litwin. “These people are going to die, and society is okay with that.”

“That’s part of the stigma, isn’t it?” said McCance-Katz. “People who receive treatment in methadone programs are not relapsing,” she said. “There’s no reason to discriminate against them.” But even if there were a relapse, that doesn’t mean the patient shouldn’t be treated for HCV, she said.

McCance-Katz added that patients in methadone treatment are being diligently monitored and therefore would be better candidates than other patients for Sovaldi. “If you are not in an OTP, they’re probably not even going to be monitoring, not even doing drug screens,” she said.

“This is something that’s killing our people,” said McCance-Katz. “I think OTPs are well-positioned to provide and to help to provide this care, and our patients deserve to have all of their issues that they bring to treatment addressed.”

Gilead has established a patient assistance program to help patients with high copays or without insurance.

For the OHSU report, go to http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy-center/med/upload/Sofosbuvir_for_HepatitisC_FINALDRAFT_6_12_2014.pdf.

Bottom Line…

An oral drug with few side effects and a 90-percent cure rate is now available to treat hepatitis C, which is prevalent in OTP patients, who are ideally suited for this medication. The hitch: It’s too expensive.