Seacia Pavao Photography: Robert F. Forman, PhD, of Alkermes

When pharmaceutical company Alkermes, Inc.decided to include treatment professionals in long-term recovery in its “Touchpoints” recovery support campaign for Vivitrol, its medication to treat alcohol dependence, the Cambridge, Mass., company hit on something important. Alkermes' approach recognizes that addiction treatment programs, historically resistant to medication treatments, are more likely to listen to people in recovery than to sales representatives. And the professionals Alkermes has enlisted are spreading the message with a sincerity that at once elevates the conversation beyond the profit motive and brings it down to the level of patient and counselor.

“Throughout my career in the addictions treatment world, this is the first time I've agreed to help a pharmaceutical company with a message,” says Christopher R. Wilkins Sr., president of the Pittsford, N.Y.-based Loyola Recovery Foundation and one of about 20 consultants for Alkermes on Vivitrol, together a group representing every key sector of the field. “I did this because I've been in recovery for 17 years, and I remember what those early years were like trying to keep off craving, just with rational support. I would just want someone to lock me in a room so I couldn't hurt myself.”

Wilkins' own anxiety-ridden moments during early recovery could have been prevented by Vivitrol, he says, adding that every treatment provider should want to give this chance to patients.

Approved by the Food and Drug Administration (FDA) in 2006, Vivitrol is an injectable form of the drug naltrexone that stays in the body for 30 days. The medication directly affects the part of the brain where the drive to drink is located, but for it to be effective, counseling is necessary as well.

In essence, then, the message about Vivitrol's role in overall treatment is not all that different from that used to promote other alcohol treatment medications that preceded it. What differs this time, and what might vault Vivitrol to the kind of marketing success that has eluded other drug companies, is the extent to which Alkermes has reached out to non-physician providers in the addiction treatment field, using some of these targeted individuals' colleagues to spread the word.

Johnny W. Allem, the former president of the Johnson Institute and in recovery for 20 years, is another of Alkermes' consultants for Vivitrol. Far from believing that what they did-“white-knuckle” sobriety without a “crutch”-can and should be done by everyone, Allem and Wilkins say in their roles as leaders in the recovery movement that the treatment field should welcome anything that can help patients get and stay sober.

But treatment program resistance to medications is “deep in the culture,” says Allem. And while the physicians who provide office-based treatment alone might think Vivitrol will “cure” alcoholism on its own, they're mistaken-counseling is necessary as well, he says. Having people such as him and Wilkins communicate to providers gives Vivitrol credibility with the non-prescribers who work most closely with patients, Allem says.

By virtue of their own recovery, these Alkermes consultants can “share testimonies, not something everybody in the pharmaceutical field can do,” says Allem, who also urges people in recovery who have used Vivitrol to speak up and who says treatment providers should encourage their patients to do so. “Part of my job is to speak to recovering community people and let them know this is a safe thing to do,” he says. “Programs will not believe it unless they hear somebody testify.”

Treatment program resistance to medications stems from the fact that treatment was kept out of the medical field, says Allem, noting that alcoholism traditionally was considered a sin, not a disease. “As 12-Step recovery took hold, treatment still remained outside the healthcare system, as it does to this day,” he says. Allem calls on treatment providers to insist that they are part of the healthcare system. “We have to change how we think of ourselves.”

Wilkins says most programs he has spoken to do want to provide Vivitrol to their patients, but he concedes that some programs “have become so rooted in a 12-Step philosophy that they may not want to venture beyond that.” But an even bigger obstacle, many providers tell him, is the cost-more than $900 for a one-month dose. “I talked to several programs that said that if they had the resources, they would want to provide this,” he says.

First dose free

Alkermes is responding to these financial constraints with an offer that is extraordinary in the pharmaceutical world: a free initial dose for everyone who is in treatment. To get enrolled for any patient's first free dose, treatment programs need only to call a hotline at 1-800-VIVITROL (1-800-848-4876).

As of October, Alkermes had reached 2,500 treatment providers through the 50 community forums it had sponsored throughout the country.

“The first free dose ships in 48 hours with no strings attached,” says Robert F. Forman, PhD, director of clinical resources and education for Alkermes. The enrollment form, which the treatment provider and patient complete and is necessary for the first free dose, includes the patient's insurance information. Then the clock starts ticking, and gives the “hub”-the people who process the forms and get out the doses-almost a month before the next dose to verify insurance benefits, says Forman. Alkermes has not tracked how many patients go on to receive a second dose of medication.

The cost of each monthly injection is $920 if the patient is paying cash, but much less for other payers such as Medicaid, says Forman. Addiction treatment providers can call the hotline and find out details about insurance reimbursement for subsequent doses, he says. Some plans do cover it, sometimes with a prior authorization, or a letter of medical necessity, he says.

“We're helping the treatment community understand these access pathways,” Forman says. There is also a patient assistance program for individuals who are eligible.

Because of its composition, Vivitrol must be shipped in a refrigeration bag to a specialty pharmacy, says Forman. “We work with 30 specialty pharmacies, and then it goes to the physician.” The drug cannot be shipped directly to a patient for safety reasons. “If it sat in a hot car, the microspheres could melt, and then it shouldn't be injected,” Forman says.

Many providers are ordering multiple vials, says Forman. “They can buy 10 vials, and have 75 days to pay, at a discounted cost,” he says.

Allem, a businessman, calls Alkermes' outreach to the addiction treatment field “extraordinary.” He adds that he already has a sense, based on reactions from providers who have attended Alkermes-sponsored community forums across the country, that the treatment field is warming toward medication-assisted treatment.

A medication regimen that may run “$4,000 to $8,000 to $15,000 for outpatient care including counseling for the first year freaks out the healthcare management system,” says Allem. But treatment providers need to stand up for their worth, he insists. “With our tight margins, our low salaries, our low self-image, those numbers seem astronomical,” he says, but he notes that a month of residential treatment with no aftercare can cost more than a year of Vivitrol treatment with counseling.

As of October, Alkermes had reached 2,500 treatment providers through the 50 community forums it had sponsored across the country, according to Forman. The attendee mix is about one-third counselors or other therapists, one-third program CEOs or supervisors, and one-third prescribers, according to the company.

How it works

At Alkermes, officials know they need buy-in from treatment programs, not just from prescribers, for Vivitrol to be successful. “This isn't rocket science,” says Stephen King, the pharmaceutical company's vice president of commercial operations. “It's just a matter of listening to the customer, and the customer isn't just the person who writes the prescription-it's the entire treatment team.”

The injectable form of naltrexone removes the constant temptation to drink because it blocks the effects of alcohol. It works directly on the limbic system of the brain, which controls unconscious drive, King explains. This allows the patient to work on the conscious part of the brain-the cortex-without being distracted by constant craving.

“We believe, when Vivitrol is on board, that the psychosocial treatment is more effective because the patient isn't sitting there having the messages blurred by the urge to drink,” says King. Patients know they can't get “high” when on naltrexone, and if they do drink, they'll find there won't be any effect from the alcohol, he says.

As Allem puts it, Vivitrol gives patients a physical foundation for sobriety, and “buys them some time in the limbic region, so they can cognitively grasp the principles of resistance to the first drink.”

And Alkermes consistently delivers the message that counseling is essential to the success of its medication. “Vivitrol will not get you a sponsor, it won't get you a home group, and it won't help you understand your personal issues,” says Forman.

Patients as well as prescribers need to be told that Vivitrol isn't a panacea. Wilkins says they should be educated about the brain science, about how Vivitrol will affect the limbic system but not the cortex. Wilkins recommends telling patients, “Based on what we know, we hope you will experience a reduction in craving, but you need to come in and process your experience of recovery.”

Vivitrol takes effect within one to two days, and should be taken for more than just one month. The clinical trials that have been conducted to study the drug's effects have been six months in duration. The main side effects that have been observed are nausea in some patients and irritation at the injection site (it is administered as an intramuscular injection into the buttocks).

Taken at recommended doses, naltrexone does not appear to be hepatotoxic, but it is contraindicated in patients with cirrhosis, as well as those receiving or dependent on opioids.

30-day dosing

Vivitrol of course is naltrexone, which is also available in an oral form that must be taken daily. The extended-release injectable form's 30-day dosing is a key to its anticipated success, Alkermes officials believe. Oral naltrexone has been found to have compliance problems: Patients just wouldn't take it on days when they wanted to get high.

“Oral naltrexone would do the same thing as Vivitrol, if people would take it,” says Forman. “The problem is taking the medication day in and day out, when there's such ambivalence about sobriety.” Instead of having to make a decision every day to take a pill, the patient has to make that decision only once a month with the injection, says Forman. “That's a powerful thing,” he says.

“If the pill compliance worked, that would have advanced the state of the art 30 years ago,” adds Allem. If patients do their homework during that first 30 days, and build up their defenses against the first drink in the part of their brain where they learn, they will be taking full advantage of the Vivitrol, he says. “If they don't do their homework, they'll want to go out and get drunk anyway,” he says, noting that with the oral medication, it's easy to do that by simply not taking the pill. Patients on Vivitrol have to wait for the 30 days to elapse, and that gives them-and their counselors-a chance to work on cognitive recovery issues.

The Touchpoints campaign, in which more than 3,800 patients had enrolled as of October, focuses on the ability of Vivitrol to “give patients a better chance at recovery,” says Forman, who urges treatment providers to sign patients up for the first free dose. “Ambivalence about staying sober is part of the disease, especially in early recovery,” he says. “Vivitrol was created to address that ambivalence.”