Targeted therapies are increasingly available for an ever-growing number of cancer types, but the downside is that these agents come with a very high price tag.
Two HER2-targeted agents — trastuzumab emtansine (Kadcyla) and pertuzumab (Perjeta) — have recently come on the market for breast cancer. Although they offer the promise of improved outcomes, the high cost associated with these regimens raises questions about access to treatment.
There was "an immediate request for those drugs as soon as they became available on the market.... Breast cancer patients were following this news just as closely as the physicians," said Sandra M. Swain, MD, from the MedStar Washington Hospital Center in Washington, DC, who participated in an expert panel discussion that was convened by the American Journal of Managed Care.
The panel was moderated by Michael E. Chernew, PhD, from the Department of Health Care Policy at Harvard Medical School in Boston, who is coeditor-in-chief of the American Journal of Managed Care, and featured Lee N. Newcomer, MD, MHA, senior vice president of oncology for UnitedHealthcare.
Trastuzumab emtansine, also known as T-DM1, was approved by the US Food and Drug Administration earlier this year as a second-line therapy for patients with HER2-positive metastatic breast cancer who have been previously treated with the anti-HER2 therapy trastuzumab (Herceptin) and a taxane chemotherapy.
"As far as the use of pertuzumab, the current indication is for patients who present with metastaticHER2-positive breast cancer or who have had adjuvant treatment and then have a recurrence, so it is first-line treatment for HER2-positive breast cancer," Dr. Swain explained.
According to media reports, pertuzumab costs about $6000 per month and T-DM1 costs around $9800 per month.
High Cost But Real Value
These drugs are having a significant clinical effect and a "substantial impact on both survival and how long the tumor stays away," Dr. Newcomer noted. "That has very real value," he continued. "The question is how much we can afford to pay for those kind of responses."
The situation is slightly more palatable because there are relatively few patients who are eligible for the therapy (8000 to 9000 a year). "When you spread the cost over a large population of insured patients, it is not very big," Dr. Newcomer pointed out.
Cost to Patients
Dr. Newcomer emphasized that he does not know of any health plan that is discouraging access to these drugs, including his own. "I can't imagine an oncologist not talking about this to his or her patients, and I can't imagine a health plan telling an oncologist not to talk about it."
"The key question is how we budget so we have enough money to pay for it," he explained.
Dr. Swain expressed concern that the cost is not only being borne by insurers, but that patient copays could be very high, resulting in large out-of-pocket expenses. This could put treatment out of reach for some patients, "so we do need to look at the exorbitant cost of these drugs," she said.
Insurance companies generally divide drugs into 4 main tiers. Drugs that are placed in the top specialty tier tend to be the most innovative and expensive. Many insurance plans, including those in Medicare Part D plans, put certain drugs on a specialty tier, which means that patients must pay a percentage of the cost. Depending on the plan, this can run as high as 25% to 33%, resulting in high out-of-pocket costs.
Dr. Newcomer noted that at UnitedHealthcare, there is a maximum out-of-pocket expense that is met by the patient. Depending on the policy, it can be as low as $1000 or as high as $10,000. After that expense is paid, the patient has no further out-of-pocket costs.
"You can't have breast cancer in this modern age without hitting that maximum when you take into account surgery, radiation, and chemotherapy," he said. "It doesn't take very long to hit $10,000."
Although $10,000 can seem like a lot of money, Dr. Newcomer emphasized that because it is for a life-prolonging therapy, it should be worth it to patients and their families.
However, because trastuzumab emtansine and pertuzumab are given as infusions in a physician's office, specialty tiers rarely, if ever, apply to these treatments, he explained, so they would generally not be associated with a high copay.
Dr. Newcomer pointed out that plans at companies other than UnitedHealthcare place a higher burden on patients. "They are structured that way to bring costs down," he said.
Medicare and Medicaid
Medicare patients, however, are at a disadvantage because there is no cap for out-of-pocket expenses. They "are paying copayments or coinsurance forever," Dr. Newcomer explained.
The low rate of Medicare reimbursement for these drugs might also be having an effect on overall healthcare costs.
"What we are already seeing is that patients who are on Medicare are coming to hospital settings; they are not being treated at their doctor's office or their infusion center because the doctors can't afford to do it," said Dr. Swain. The doctors would actually lose money on this, so the patients are coming to a higher-priced facility — a hospital — to get their infusion, she explained. "I think it is really going to have an effect, not on the patients but on the economy in general," she added.
However, Dr. Newcomer pointed out that "Medicare doesn't see it that way."
"Medicare pays a hospital less for chemotherapy than a physician, and they underpay both of them," he said.
Another issue is access to expensive therapies under Medicaid. Each individual state has its own Medicaid rules; there are no standards. The decline in Medicaid budgets has added challenges to medication access for recipients of this program. Dr. Swain noted that she is worried about access for this population.
The patients who are actually seen in clinical practice are much different than the ones who participate in clinical trials, he added. "It is important to be able to get back to oncologists and tell them how this is working in the real world."
The panelists concluded by discussing their concerns about excessive cost in the current healthcare system in the United States.
"We are going to have to do something to figure out how we take waste out of this system and how we remove those unnecessary things to allow some payment for drugs that make a difference. Pharma has a responsibility to get their costs down," said Dr. Newcomer. "We have to find a way to produce these drugs less expensively if we are going to continue to make them accessible to patients."
Diagnostics and Measuring Real-World Efficacy
Dr. Chernew asked the panelists about diagnostic testing. Dr. Newcomer and Dr. Swain agree that companion diagnostics are being used appropriately, are an essential component to targeted therapies, and do not have real limitations imposed on them. In addition, they agree that immunohistochemistry testing for HER2 is standard for patients.
Dr. Newcomer noted that tools are being developed to measure relapse rates and overall survival rates for a treatment regimen. "We are getting comfortable that this is something we can measure over time," he said. "We can look at what is happening in the real world — how a regimen is working and what results we are getting."
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