Accessing the abcs.

Avonex, Betaseron, or Copaxone prescriptions cost from $9,000 to $11,000 a year. Does everyone who could benefit from one of them have access?

The 3 drug companies invested in years of development and clinical trials. They are not philanthropic organizations. Their primary obligation is to stay in business. This includes paying their investors encouraging dividends. All 3 companies are seeking "second generation" MS drug--that do more and are easier to use--and this requires more investment.

The private insurance companies that sell medical coverage are also obligated first to stay in business. They too have stockholders. Moreover, an insurance company can't continue to pay benefits to anyone if it goes bankrupt To control costs, some exclude high-end treatments or deny coverage to people with expensive diseases. Or their "high-risk" enrollees are charged premiums that can range up to $20,400 a year.

Government tax-supported medical-care programs may not have stockholders, but the impact of taxes on business and on rank-and-file Americans is a hot-button issue. Nowhere is the debate between free-market capitalism and government social policy more likely to ignite into flames than when the issue is human health.

Access programs

The 3 companies marketing A, B, and C each have programs intended to alleviate the financial problem. Though sometimes referred to internally as "indigent patient programs", these programs tend to assist people who are not, technically, impoverished. The state-administered federal Medicaid program pays for drug treatment for people who are on welfare or SSI. People in serious financial straits because of the cost of an MS drug are usually "too rich to be poor". Some of them have no insurance. Many others have medical coverage with no prescription drug benefit, or a cap on annual drug benefits, or hefty co-pay requirements. This includes people on Medicare. They often have mortgages, car loans, and credit card debt as well.

InsideMS took a look at the 3 companies and the scope and function of their assistance programs.

A AVONEX is marketed by Biogen, Inc., a U.S. biopharmaceutical company that focuses on research and development. It often partners with or sells its research results to other companies. While some of its partnered drugs are for sale and the company has others in clinical trials, Avonex is the only proprietary drug Biogen currently markets. Biogen stock is publicly traded on the NASDAQ exchange (check the symbol BGEN).

InsideMS spoke to Chris Dillon, director of Avonex Service and Reimbursement at Biogen:

Avonex costs about $852 a month, depending on the pharmacy used. We invite any physician or patient who may be deterred from considering Avonex by the financial impact to call the Avonex Support Line. Specialists will research the individual's reimbursement situation. People often think they have no insurance, but we find they have coverage they're not aware of. Next, the specialists will look for other coverage, including state or federal programs, the person might be eligible for.

"If the effort fails and there really are no other resources for the person, the reimbursement advisor will help prepare a 1-page application form for the Avonex Access Program. In general, the cutoff for this program is $60,000 annual income, but exceptional expenses such as high expenses from another disease can be considered.

"The Avonex Access Program provides free or lower-cost drug. Information is taken over the phone; and filled-out forms are marled to people for theft signature and enclosures. The complete application has to include copies of the most recent federal income tax form and the physician's prescription. We do know that a certain number of people who are referred to Avonex Access never send the form back. We don't call to ask them why

"The consulting firm Covance Health Economics reviews the applications for us. People accepted into the Avonex Access Program meet the means test and are either underinsured (no drug benefits) or have no insurance. About haft are employed but underinsured.

"The program is tailored to the level of need. People who are partially insured or at higher income levels are usually given a spend-down requirement. They may pay their part of the cost as a monthly installment. Or they pay the whole cost until they reach a set level, after which their product is free.

"The product is shipped by Nova Factor, a direct delivery pharmacy The first shipment contains a 4-week supply After that, shipments contain a 12-week supply There is a $25 shipping fee each time.

"We don't collect data on adherence for people in the Access Program, so we don't know if the Access Program has any impact on staying with the drug.

"Some people who call our hot line have problems with the cost of insurance. We're not allowed by law to subsidize high insurance premiums or co-pays. Patient Services, Inc., an independent nonprofit organization, approached us because they are designed to assist in this situation. Our reimbursement specialists will inform people who might be eligible about this group, and Biogen makes an annual charitable contribution to PSI." (See page 57 for more about PSI.)

BETASERON is marketed by Beflex Laboratories, Inc., which is a subsidiary of Schering AG, an international company founded in Germany in 1871. It is not part of Schering-Plough, although the two companies share a common origin. Schering AG has several other U.S. divisions marketing MRI systems, raw materials for drugs, and agricultural products from seeds to fungicides. Beflex Laboratories currently sells drugs for leukemia, heart disease, birth control, and osteoporosis prevention in addition to its MS drug. Berlex has no direct stockholders. Stock in Schering AG is traded on the Frankfurt stock exchange (DAX).

InsideMS spoke to Michael Taylor, product manager for Betaseron:

"We knew this drug would cause significant reimbursement issues. The Betaseron Foundation was created 5 years ago to give access to people who might otherwise forgo treatment. It is an independent nonprofit entity, but not a registered charity. Beflex Laboratories is the sole source of its funds. Bedex approves the budget and provides more funds if the program runs short. We're all very proud of the fact that The Foundation has provided access to Betaseron therapy for approximately 8,900 people in its first 5 years.

"The application process is simple--most people call MS Pathways. If people call about financial matters, they are first counseled by Pathways' reimbursement experts."

According to Mr. Taylor, the counselors are often successful in persuading insurance companies to reverse denials, especially denials based on age, disability stares, or a diagnosis of progressive MS. They are also knowledgeable about Medicaid's application procedures and other benefit programs, which vary state to state. "If that doesn't work, Pathways is linked to The Foundation," Mr. Taylor said.

All paperwork, analysis, and other administration for The Betaseron Foundation is managed by the Lash Group, a professional health-care consulting firm that administers assistance programs for many companies that sell drugs or medical devices. Applicants must send detailed financial and insurance information, a copy of theft tax return or other proof of income, and a form from the physician to confirm a diagnosis of MS and the fact that the physician considers the prescription appropriate.

InsideMS spoke to Tracy Bradey, program manager for The Betaseron Foundation at the Lash Group:

"Our analysts look at all out-of-pocket medical expenses. They can't consider ordinary living expenses such as mortgages or car payments. They do calibrate for cost-of-living differentials. There's a difference between living in a city like Los Angeles and a small town somewhere. We use the federal poverty line as a guide because it fluctuates with cost of living. Our program is meant to assist people who have incomes up to 3 1/2 times over that line. [The federal poverty line is a scale based on family size. In 1999, it was $8,240 for 1 person, $16,700 for a family of 4, with higher levels in Alaska and Hawaii.]

"This means we can't help everybody who hurts financially. That wouldn't be possible. Our purpose is to broaden access. About 50% of the people in The Foundation's program are eligible for Medicare, which will not cover Betaseron. The others have no insurance, or insurance with low drag caps, no drug coverage, or large co-pays.

"People in the program get free Betaseron. The person receives a card that must be used at a retail pharmacy. The pharmacist places the order through Pathways, and the drug is ready for pickup within 2 business days. There's a monthly participation fee ranging from nothing to $25. The person pays this to the pharmacist when picking up the drug. The Foundation pays the pharmacist a dispensing fee.

"As of October 1999, just under 4,700 people are receiving free Betaseron. We approve approximately 91% of the applications. Two-thirds of the people who are ineligible turn out to have benefits or program eligibility, and either Pathways or The Foundation will help them navigate insurance company rules or apply for Medicaid or a state pharmacy benefit."

What happens to the others? The Lash Group refers them back to Pathways for further counseling. Do they call back or give up? The Foundation has a better sense of what happens to the people who are accepted. Tracy Bradey:

"The number of people helped by The Foundation is fluid because situations change all the time. In 1999, for example, about a third of the people who dropped out of the program did so because they got other private insurance coverage. They sat out a waiting period, or returned to work, or changed marital status. Others became eligible for a state pharmacy benefit program or Medicaid. Some stopped therapy to become pregnant, and some switched to another drug. Some just discontinued therapy. Our studies on compliance suggest that people in The Foundation program are less likely to discontinue therapy than those who get their product in the marketplace."

COPAXONE is marketed by Teva Marion Partners, a company formed between Teva Pharmaceutical Industries, Ltd., which specializes in R&D specifically for neurologic and autoimmune disorders, and Hoechst Marion Roussel, Inc., one of the world's largest drug companies, with leading products for infectious disease, allergy, diabetes, and neurologic and cardiovascular disorders. Teva Pharmaceutical is publicly traded on the NASDAQ exchange (check the symbol TEVA).

Teva Marion Partners created Shared Solutions, which operates a toll-free hot line. Callers who ask about financial aid or insurance problems are transferred to an advocate in the Copaxone program at Reimbursement Services Group. Like advisors in the other programs, these specialists know systems, regulations, and application procedures.

InsideMS spoke to Kay Borel, Shared Solutions program director:

"Our representatives research every possible program to see if the person can qualify. Our figures show that we've found funding for 97% of the people who asked Shared Solutions for reimbursement help."

Corinne Maioli, president of Reimbursement Services Group, explained the process: "Our job is to find funding for people. Good information is often key to good decisions by the 3-party payers. If a person has insurance that could cover the drag, we educate the person and their doctor about the reimbursement process and coordinate with the insurer. If we have complete information and documents, we can get things started within 48 hours. But sometimes it takes much more time to sort through insurance requirements.

"If reimbursement counseling fails, we look at all the other resources for the applicant. Are they eligible for Medicaid, any state pharmacy benefit program, or private insurance? We don't assume, for example, that a person insured by Medicare isn't eligible for anything else.

"We steer people who are uninsured or underinsured to the open enrollment periods. Many states have high-risk insurance pools. The premiums are not low, but they are in line with group health insurance pricing. We don't handle the applications for people, but if this is a problem, we contact the physician and find a local advocate to help.

"We can't force anyone to accept the existing options--and there isn't a solution for everyone. We try to be fair, and most applicants try hard too. They' re very motivated and they'll work through problems in order to start their therapy as soon as possible.

"Our reimbursement advocates don't do financial investigations or administer means tests. They use financial information taken over the phone. If our people fred no alternative resources, they suggest the Patient Assistance Program for Copaxone, run by National Organization for Rare Disorders, Inc., or NORD. We then fax the person's address to NORD, so NORD can mail them an application."

InsideMS spoke to Jane Keane, Copaxone coordinator at NORD:

"At this point, we need a 1-page form from the doctor, certifying a diagnosis of relapsing-remitting MS. We take the physician's word and never turn anybody down on medical grounds. We need a 6-page financial information form from the individual, with supporting documents, including 3 months' worth of bank statements with all the pages, and the most current tax return. We need this because we consider the whole picture--debt load, asset level, number of people in the family, everything.

"We consider all kinds of expenses in our review, not just medical ones. We find that some living expenses are MS-related. People have large car loans for adapted vehicles, they've used credit cards for their insurance co-pays, or they've taken second mortgages to make their home accessible. We don't use any set cutoff for income level. Our criteria aren't related to the federal poverty level.

"Once we get a completed application, we need 10 to 14 days for analysis. Almost all

denials occur because the applicant has assets. We check for holdings in stocks, bonds, CDs, rental properties, but we don't consider the appreciated value of a home.

Some decisions are very difficult--but people can appeal.

"Copaxone is the latest MS drug to gain FDA approval, so our numbers are still relatively low. Out of some 2,450 people who have applied to us since 1997, when the program began, we have denied about 24 people, less than 1%."

Another avenue?

A small group of people have found financial help from Patient Services, Inc., of Midlothian, Virginia, according to Dr. Dana Kuhn, president and cofounder of PSI. These people have been referred either by the reimbursement advisors of the Avonex Alliance or by other patient advocates including National MS Society chapter staff.

PSI is an independent nonprofit charitable organization designed to subsidize health insurance premiums and co-payments for people with specific expensive chronic illnesses. PSI was established in 1989, but only created its MS Assistance Program in 1997, after all 3 ABC drugs were on the market.

"We make payments directly to insurance companies or pharmacies. Clients don't get funds from us," said Rayer Hadad, vice president of PSI. She suggested that people go through reimbursement counseling first, to rule out other available resources or benefits. PSI's program has no set upper-income limit, but there is a means test. Full financial disclosure is required on the confidential application form. If approved, assistance is provided for 2 years. A revised application can be submitted if help is still needed after that period.

PSI's brochure notes that many people need help obtaining high-tech medical treatments while they are in the spend-down phase of qualifying for federal or state programs. The brochure suggests that PSI may be able to subsidize premiums for COBRA, conversion policies, high-risk insurance pools, and open-enrollment health insurance plans. But there is a waiting list of people who have been approved for assistance, and PSI is seeking donations. The organization is not known to 2 major groups that rate charities, the National Charities Information Bureau and the American Institute of Philanthropy.

"Currently, 350 people with MS are being assisted by PSI. Some 30 others have gone off our assistance, as they no longer needed our safety net," said Dr. Kuhn.

The bottom line

It is clear that all 3 access programs do an excellent job of helping people get maximum benefits from their existing insurance coverage and good information about assistance programs for which they might qualify.

Many people currently taking an A, B, or C drug are able to do so because of the advice they received. But does everyone who could benefit medically from an A, B, or C prescription really have access? Every program loses people during the counseling and application phases. Every program rejects some applicants. Even with individual ingenuity, persistence, and Financial sacrifice, the answer is not yet.

Access to Avonex, Betaseron, & Copaxone

THE GOODS

What do applicants who qualify receive?

A: Partly free to free Avonex

B: Free Betaseron

C: 25% to 100% of yearly Copaxone free

How?

A: By mail from Nova Factor, a direct delivery pharmacy

B: At local retail pharmacist

C: By mail from Caremark, a direct delivery pharmacy

Participation/shipping fees?

A: $25 shipping fee for a 3-month supply

B: $0 to $25/month determined by The Foundation, based on income

C: $0 to $25/month determined by Caremark, based on shipping cost

THE BIG PICTURE

Approximate number of people taking A, B, or C in 1999:

75,800

Approximate number receiving free or subsidized drug since access programs began:

17,050

Note: Data in these charts reflect reports by the respective parent pharmaceutical company and are their responsibility. No independent audit has been conducted.

Martha King is editor of this magazine.