HMOs could decide the future of Monsanto pain killer
Sunday, January 17, 1999
By Robert Steyer
Of The Post-Dispatch
With comments ranging from "yes, but" to "it depends," managed-care
companies are taking a cautious view of Monsanto Co's new arthritis drug,
Celebrex.
Health maintenance organizations and other medical firms will play a critical
role in Monsanto's efforts to market the drug.
"Just because the Food and Drug Administration approves a drug, that doesn't
mean a drug is absolutely needed," said Dr. Emil Miskovsky, medical director
at Cigna Healthcare of St. Louis.
"It probably won't be a first-line therapy in the beginning," said Dr. Daniel J.
Murphy, a medical director at Group Health Plan in St. Louis. "We've become
cautious as the FDA approves drugs faster. Sometimes, after six weeks, you'll
see side effects that didn't show up in [a company's] tests."
Dr. Stephen Spurgeon, chief medical officer for United Healthcare of the
Midwest, is more optimistic about Celebrex's acceptance. "It can give great
relief and protect the stomach, and we would encourage physicians to use this
as a first-line therapy for the clinical indications," he said.
Still, Spurgeon's organization, like other managed-care firms, must review the
medical literature and talk to doctors and pharmacists before it sets payment
policy.
Managed-care executives say they don't interfere with doctors' prescribing
medications, but they have considerable influence when they endorse drugs
and set rules for how much they will pay.
Celebrex will reach about 60 percent of U.S. pharmacies next week and all
pharmacies by mid-February. Physicians and securities analysts predict a
marketing blitz by Monsanto to convince doctors and patients that Celebrex
offers the same power as existing drugs, with fewer side effects.
Celebrex is entering a market filled with many similar medications. They belong
to a category of nonsteroidal anti-inflammatory drugs (NSAIDs). They include
aspirin, over-the-counter drugs such as Aleve, generic prescription versions of
drugs like ibuprofen and naproxen, as well as many brand-name products.
Celebrex is the first of a new class of drugs called COX-2 inhibitors.
pharmaceutical watchers expect an unprecedented sales blitz touting the new
drug.
As part of its marketing strategy, Searle often cites research at Stanford
University that shows that NSAID-induced ulcers and bleeding cause 107,000
hospitalizations annually and are linked with 16,500 deaths annually.
"The problem with NSAIDs is that you can't prove one is better than another
even though individual patients will react differently to different NSAIDs," said
Dr. Richard Brasington, director of clinical rheumatology at the Washington
University School of Medicine. He conducted clinical trials for Celebrex, and
has done some consulting work for G.D. Searle & Co., the Monsanto drug
subsidiary.
Brasington supports Celebrex as first-line therapy, especially for older
patients, people who have a history of ulcers or other gastrointestinal bleeding
or people who have unsucessfully tried many NSAIDs.
The arthritis treatment market is marked by fierce competition among big drug
companies and generic drugmakers. It is fueled by an aging population and by
patients who eagerly ask their doctors for the newest medications. Celebrex
has been approved for osteoarthritis, characterized by a wearing down of
joints, and for rheumatoid arthritis, a disease of the body's immune system that
usually attacks younger adults.
Searle will focus on tests that show Celebrex causes fewer ulcers and other
gastrointestinal problems than NSAIDs.
"The marketing is going to be heavy, with thousands of sales representatives
going to doctors," said Kenneth Nover, a drug industry analyst for A.G.
Edwards & Sons, the St. Louis-based investment banking firm.
"Managed-care companies have a dilemma with new drugs," he added. "The
drugs cost them more money, but it can save them money (by helping patients
avoid hospitalizations)," he said. "They also bring in more patients."
As managed care grows, more doctors and more patients are having their drug
treatment decisions affected by corporate committees that decide what drugs
will be approved for managed care programs.
"The first cut in our review is quality," said Spurgeon of United Healthcare. "Is
it a 'me-too' drug or does it have a real niche? If two drugs are alike, then we
look at cost."
Some organizations operate "closed formularies," accepting several drugs in a
disease category but rejecting others. For an approved drug, the patient
makes a modest co-payment. For a non-formulary drug, the patient absorbs
the whole cost.
A doctor can appeal to an HMO to request a non-formulary drug. "If I am
treating Mrs. Jones, and she says, 'I've tried all six drugs in the formulary and
they don't work,' I'll write a letter," Dr. Brasington said. "Usually, they are
pretty reasonable."
Many HMOs are moving to "open formularies," which have three tiers of
coverage. A typical schedule could include co-payments by patients of $5 for
generic drugs; $10 for brand-name drugs that fill special niches or have better
safety profiles than competing products; and $20 for "me-too" brand name
drugs, which the HMO hasn't evaluated or doesn't think have extra medical
value.
Over-the-counter drugs aren't covered. That can create a predicament for
arthritis patients, especially those in the early stages of the disease, who might
pay less out of pocket for a prescription drug.
Different formulary rules can create different treatment patterns. Look at
Arthrotec, which combines a painkiller and an anti-ulcer drug. Arthrotec is in
the formulary for Aetna-U.S. HealthCare but not for Cigna Healthcare. Group
Health Plan tells patients to buy generic versions of the two components of
Arthrotec, saying two generic pills are cheaper than one brand-name pill.
Studies, though show that patients are more likely to take their medicine when
they have to take fewer pills less often.
Officials at big managed-care firms serving the St. Louis area say Celebrex will
carry the highest co-payment in open formularies, at least for the next few
months. That's because their pharmacy and therapeutics committees don't
review new drugs immediately.
The committee for Prudential Healthcare meets in March. The Aetna-U.S.
Healthcare committee meets every two months. United Healthcare's
committee meets every month.
The committee for Alliance Blue Cross-Blue Shield, the biggest Missouri
managed care firm with 2 million members, meets quarterly.
Managed-care executives say they can make emergency decisions when
warranted. "We usually take two to three months after a drug is on the
market," said Mikovsky of Cigna Healthcare. "But we can be ready in time for
when the drug is ready for marketing. We would move quickly for an AIDS
drug."
Dr. Nicholas Hanchak said his managed-care organization will put Celebrex in
the highest patient co-payment category until its committee reviews the drug.
"Our mandate is to bring accountability in quality and cost of pharmaceuticals,"
said Hanchak, director of Aetna-U.S. Healthcare's pharmacy management.
Hanchak said his medical review committee has held off acting on certain
drugs because of its concern over safety tests. In two recent cases, the
committee's caution proved wise when two FDA-approved drugs were
subsequently pulled from the market.
In addition to evaluating medical literature and the cost of other drugs, review
committees may recommend limiting new drugs to certain patients.
"We look at a patient's overall health," Michael Donze, 31, pharmacy product
manager at Alliance Blue Cross/Blue Shield, which governs the BlueChoice
HMO. "If the patient is older and has been taking ulcer medications, then we'd
probably say OK. If somebody has tried many NSAIDs without relief, I doubt
we'd say no."
Searle wants to get Celebrex into closed formularies and the middle tiers of
open formularies.
"We will go to virtually every managed-care organization in the country when
they are ready to meet us," said Al Heller, Searle's chief operating officer. His
company will provide reams of research data, including some that has not been
made public at scientific conventions.
Searle has enlisted the giant Pfizer Inc. to help it sell Celebrex not only against
existing drugs but against another COX-2 medication developed by Merck &
Co.
Celebrex was approved by the Food and Drug Administration Dec. 31, after
the
agency conducted an accelerated review that took six months rather than 12
months or longer. The FDA recently granted Merck a "fast-track" review; its
drug, Vioxx, could become available in late May.
Copyright (c) 1999, St. Louis Post-Dispatch
stlnet.com |
