Genotype Testing Is Crucial to Course of Therapy for Hepatitis C Patients

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Featured Story December 30, 2008

Genotype Testing Is Crucial to Course of Therapy for Hepatitis C Patients

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help

health plans, PBMs, providers and employers manage costs more aggressively and

deliver biotechs and injectables more effectively.

By Maas, Managing Editor, (amaas@...)

With hepatitis C patients, the length of treatment depends upon which of the six

hepatitis C genotypes the person has. According to Beckie Fenrick, Pharm.D.,

director of clinical pharmacy at Blue Cross and Blue Shield of Florida, the

treatment regimen for genotypes 2 and 3 is generally 24 weeks, while the regimen

for 1, 4, 5 and 6 is 48 weeks. The most common genotypes in the U.S. are 1, 2

and 3.

Many health plans require physicians to provide the organization with the

genotype information so they can be sure the patient is receiving the

appropriate length of therapy. According to Enoch Strollo, vice president of

sales and marketing for BioPlus Specialty Pharmacy, genotype testing costs

typically between $450 and $600, and health plans typically cover this expense.

Some plans that spoke to SPN say they require genotype testing either before

therapy begins or shortly thereafter.

According to Beverly lin-, Northeast regional pharmacy director for

BlueCross BlueShield of Tennessee, BCBST allows patients to immediately begin

treatment but then requires the physician to follow up with the patient's

genotype. " This minimizes impediments to treatment initiation, allowing a

patient to immediately fill the prescriptions for the hepatitis C medications, "

she says. After a physician notifies BCBST of the patient's genotype, " an

approval for a specific duration of treatment is granted, " she explains. " A

nurse contacts the prescriber to assure that certain tests are being performed

and to obtain the results of those tests so that the duration of treatment can

be determined and authorization loaded. No prior authorization is required to

begin therapy; however, to continue treatment beyond the first few months,

clinical parameters such as genotyping must be obtained. "

The Florida Blues plan requires physicians to determine patients' genotype so it

can make sure patients undergo the appropriate length of therapy. The plan also

has practitioners notify it of patients' viral loads at the 12-week mark. If

there has been " an appropriate reduction, the approval for additional weeks

occurs, " Fenrick explains. CIGNA HealthCare also requires a follow-up lab test

after the first 12 weeks of therapy, says Todd man, Pharm.D., director of

specialty pharmacy clinical program development.

Mark Leeper, vice president of marketing and clinical program development for

PrecisionRx Specialty Solutions, WellPoint, Inc.'s specialty pharmacy, says that

when a plan does not require genotype testing, " we do highly encourage it. " He

explains that " a member's hepatitis C genotype will drive treatment and

monitoring. Type 1 genotype is more difficult to treat and requires members to

stay on the therapy longer. Also, changes in viral load are influenced by

genotype. We conduct baseline information on viral load, and then repeat testing

for all genotypes at four, 12 and 24 weeks. For Type 1, we continue testing at

36 weeks and 48 weeks. This schedule is important to allow physicians to adjust

dosing to respond to the patient's viral load. "

He says if those patients with genotype 1 " don't respond by week 12, they are

unlikely to respond, and continuing with therapy is not productive. "

Sara Deno, Pharm.D., a manager of clinical services for BioScrip, Inc., who also

oversees the adherence and therapy optimization program BioScripCare for

hepatitis C, says that plans can structure prior authorizations so that patient

response is checked at various intervals.