By Michelle Meadows
FDA Consumer article, Sept-Oct 2005
- Generic Drugs
- Communicating with Your Doctor
- Medicare Prescription Drug Coverage
- Price Differences for Generics in the U.S. and Canada
- U.S./Canadian Price Comparisons
- Assistance from Pharmaceutical Companies
- Quick Tips
Many Americans have been buying prescription drugs from foreign countries as a way to cut costs, but experts at the Food and Drug Administration warn that this practice comes with potential safety risks. The safety and effectiveness of imported drugs have not been reviewed by the FDA, and their identity and potency can't be assured. Patients could get the wrong drug. Or they could get too little or too much of the right drug. All of these differences can be dangerous.
"When Americans import medicines illegally or buy medicines online from unreliable sources, they are faced with a dangerous buyer-beware situation," says FDA Commissioner Lester Crawford, D.V.M., Ph.D. "The FDA understands why people who are having a hard time paying for prescription drugs might do this. We have been expanding our generic drug program to help make more affordable prescription drugs available. This is one solution that does not put consumers at risk."
The FDA doesn't regulate drug prices, but agency experts recognize that the inability to access needed medication because of high prices is a serious public health issue. For this reason, the FDA has enhanced the process for the review and approval of generic drugs, and has taken steps to eliminate roadblocks that keep generics off the market. In 2004, the FDA approved 413 generic drugs, 320 full approvals and 93 tentative approvals. In 1999, the agency approved 266 generic drugs, 198 and 68, respectively. Tentative approval means that the product meets the FDA's standards, but can't yet be marketed because of existing patents or temporary government restrictions against competing products.
Generic drugs have exactly the same active ingredients and effects as brand-name drugs, but they can cost 30 percent to 80 percent less.
Consumers also can save money on prescription drugs by becoming smart shoppers and knowing what to discuss with their doctor or pharmacist. Having discussions on whether a less expensive drug will work, comparing prices among U.S. pharmacies in the area or online, and finding out about assistance programs and how to qualify can help.
"The FDA also encourages consumers to learn about potential savings through Medicare's outpatient prescription drug coverage," Crawford says. "This new program comes at a time when five out of six people aged 65 and older are taking at least one medication, and almost half of all elderly people take three or more."
Medicare is the national health insurance program for people ages 65 and older and for people of all ages who have certain disabilities. In January 2006, the 43 million people in Medicare will--for the first time--be eligible for prescription drug coverage as part of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA).
The new coverage will give substantial help to beneficiaries in paying for prescription drugs, regardless of their income or how they pay for health care now, according to Mark McClellan, M.D., Ph.D., Administrator of the Centers for Medicare & Medicaid Services (CMS). "The MMA also gives Medicare the ability to provide additional comprehensive help to those in greatest need--beneficiaries with very high prescription drug costs and people with low incomes," he says. On average, people with limited incomes who qualify for extra help will save about 95 percent on prescription drug costs, according to CMS spokesman Gary Karr.
Medicare has offered discount drug cards since June 2004 as a temporary measure until the Medicare benefit begins in January. The cards have made possible a discount of 10 percent to 25 percent off regular prescription drug prices. Older people with low incomes who used the cards received an additional credit of $600 in 2004 and again in 2005. As of June 2005, 6.5 million people had signed up for the discount drug cards, including 1.8 million who also received the $600 credit.
All across the country, health care professionals, government agencies, and community organizations have been working together to help Americans take advantage of the new Medicare benefits. For example, in 2004, the Access to Benefits Coalition (ABC), a network of more than 90 nonprofit organizations, was created to help Medicare beneficiaries make the best use of all available resources for lowering prescription drug costs. Those resources include prescription drug coverage through Medicare, state-sponsored programs, and patient assistance programs (PAPs) from pharmaceutical companies.
In 2004, the average price of a generic prescription drug was $28.74, while the average price of a brand-name prescription drug was $96.01, according to the National Association of Chain Drug Stores.
NDCHealth, which collects data on the pharmaceutical industry, says that in 2004 the average community retail price for brand angiotensin-converting enzyme (ACE) inhibitors was $55.84, compared with $27.75 for generic products; the average price for brand beta blockers was $41.39, compared with $18.84 for generics; the price for brand calcium channel blockers was $66.06 versus $47.40 for generics; and the price for brand potassium-sparing diuretics was $34.27, compared with $16.25 for generics. The comparisons of these blood pressure medications included similar dosing, numbers of pills and strength of prescription.
Patent protection gives brand-name manufacturers the right to be the sole source of a drug for a certain time period so they can recoup the money they invested in trying to develop the product. Once the patent protection expires, a generic version of the drug can be marketed.
"Many see generics as the only way they can afford prescription drugs," says Gary Buehler, R.Ph., Director of the FDA's Office of Generic Drugs. "Still, there are some people who doubt generics because they think that anything that costs more must be better. But the reason generic manufacturers can sell the drugs less expensively is not because the quality is lower. It's because there is competition among these generic manufacturers, who don't have to repeat the expensive safety and effectiveness testing that brand companies have already conducted." For a number of years, the FDA has been increasing public awareness and confidence in generic drugs.
Generic drug companies must perform tests and show the FDA that their drugs are equivalent in terms of therapeutic effect to the brand-name drug. These companies must show that the ingredients of the generic drug enter into the blood stream in the same way and in the same length of time as the brand-name drug.
As of June 2005, there were 11,167 drugs listed in the FDA's Orange Book, and about 8,400 had generic counterparts. The Orange Book, which is accessible online at www.fda.gov/cder/ob/, lists approved drug products with therapeutic equivalence evaluations.
Physicians and patients should discuss which drug is the best therapy. Even when a particular branded drug has no generic, a very similar member of the same drug class may be available. For this reason, instead of asking doctors whether a particular brand-name drug has a generic version, patients should ask whether there is a generic available to treat their problem, suggests Jack Billi, M.D., associate vice president for medical affairs at the University of Michigan. "Patients should ask if there is a generic in the class of drugs they are taking," he says.
For people who have insurance that pays for drugs, use of generics can make a big difference, Billi says. "Tiered co-payment structures through insurance plans encourage the use of generics," he says. "For example, there might be a copay of seven dollars for generics and 14 dollars for brand drugs."
"Even if you have a fixed copay," Billi says, "choosing generics saves your employer money, and that makes it more likely the employer will continue offering coverage. And if you don't have health insurance and you're paying out-of-pocket, generics will bring you big savings."
For more on the FDA's generic drug education program for consumers, visit http://www.fda.gov/Drugs/ResourcesForYou/ucm167906.htm
It's a good idea to tell your doctors whether paying for medicine is a problem, says Edward Langston, M.D., a family physician in Lafayette, Ind., and an American Medical Association trustee. That doesn't mean physicians can fix all the problems, Langston says, but not being able to afford medication clearly affects your health.
"I think most physicians would want to help if they knew a patient won't be able to follow the treatment," Langston says. "But many patients find it a hard subject to bring up." When Langston writes a prescription, he asks patients, "Are you going to have any trouble getting this medication?"
So what can patients struggling with drug costs reasonably expect from their doctors? Patients should feel free to ask about whether a generic can be used instead of a brand-name drug or whether there is a similar drug that is less expensive. But some doctors don't know the price of drugs, so patients might have to do their own research, says Paul Hunter, M.D., a physician with Community Care for the Elderly in Milwaukee. In some cases, there may be nonprescription drugs that might work. Loratadine for allergies is a good example of an over-the-counter (OTC) medicine that is less expensive than brand-name prescription alternatives, Hunter says. Loratadine is the active ingredient in Claritin, Alavert, and some generic allergy medicines.
The doctor's office also can serve as a valuable resource for patients for such activities as informing them about the Medicare prescription drug benefit, signing application forms for patient assistance programs, and referring patients to state-sponsored services and community assistance programs.
In a recent survey of 519 cardiologists and general internists, nearly all reported that doctors should consider these costs when writing prescriptions. The study appears in the March 28, 2005, issue of the Archives of Internal Medicine.
One-third reported knowing how much patients are spending out of pocket for prescriptions. Commonly cited barriers to discussing drug costs with patients were insufficient time and concern over possible patient discomfort.
The researchers found that switching patients to a generic or a less expensive brand-name drug, the most frequently used strategy, was likely to be beneficial. But they noted that other approaches, such as tablet splitting, needed caution. Tablet splitting is done because higher-strength tablets are sometimes not much more expensive than lower-dose tablets. For example, tablet splitting involves splitting a 40 milligram (mg) tablet to get a 20 mg dose. The researchers said that while tablet splitting can reduce costs, it can also complicate prescription regimens and can be technically difficult to do.
"We don't advocate splitting pills to save money, and this isn't something patients should do on their own," says Tom McGinnis, R.Ph., the FDA's Director of Pharmacy Affairs. "We leave it up to the doctors. If the prescriber thinks a patient could benefit from a lower dose of medication than is available or if it's the only way a patient can afford the treatment, then the doctor can direct that a patient split the tablet. Pharmacies sell inexpensive devices that help consumers easily split tablets of all shapes." McGinnis says. The major concerns over tablet splitting are that the patient may not split the pills accurately and that some tablets, such as time-release versions, should never be split.
The practice of physicians distributing free samples of brand-name drugs--another area that isn't clear-cut--was the second most likely strategy used by doctors in the study to help ease cost concerns. Hunter says he thinks free samples influence doctors to prescribe expensive, new medications, but he has also worked in clinics where patients rely on free samples to reduce their drug costs.
"The intended use of a free sample is to allow a patient to evaluate side effects and effectiveness for a couple of weeks before actually buying the drug," Hunter says. "So patients can ask for free samples, but know that they are a temporary fix." Patients can't usually expect samples to provide long-term treatment. Patients who receive free samples should still ask their physicians whether a generic drug could be satisfactory.
Nicole Petersen, Pharm.D., a community clinical pharmacist at Schnuck's Pharmacy in St. Louis, says that samples aren't always the ideal solution, but sometimes they are all a patient has. When an 86-year-old woman walked out of the pharmacy without her medicine because she couldn't afford a $70 brand-name osteoporosis drug, Petersen called the patient's doctor to see what could be done.
"There was no generic alternative, so the doctor gave her some free samples," Petersen says. "But patients have to consider how long the physician can provide the free samples and what to do when they run out."
It might make sense for patients to take free samples while they are waiting to receive drugs through a PAP, she says. "If you do take free samples, you should still let your pharmacist know so that we can stay on top of drug interactions." Also, consumers should ask their doctors for information about the sample drug's directions, side effects, and warnings.
Some doctors don't stock free samples, which are normally distributed to doctors' offices by pharmaceutical sales representatives. Billi says drug samples have been eliminated at University of Michigan clinics. "The samples are a marketing tool," he says. "They aren't intended for maintenance. Giving them out puts doctors in the position of having to act like a pharmacist because you're supposed to keep up with lot numbers and expiration dates in case there are recalls. You're also getting patients started on a more expensive drug."
Medicare Part D, the new outpatient drug coverage beginning on Jan. 1, 2006, works like other health insurance plans. Medicare beneficiaries will be able to choose from at least two prescription drug coverage plans. Those plans will cover drugs for all medically necessary treatments, will pay for brand-name and generic drugs, and will enable beneficiaries to get prescriptions at a pharmacy or through mail order.
The standard drug coverage in 2006 will require consumers to pay a $250 deductible and a monthly premium of about $35. After beneficiaries pay $250, Medicare will pay 75 percent of a beneficiary's drug expenses up to $2,250, with beneficiaries paying 25 percent of the costs.
After total drug expenditures reach the $2,250 mark, Medicare's standard coverage pays nothing until the beneficiary spends another $2,800. "It's important to know that a lot of people will never reach the $2,250 amount," says CMS spokesman Karr. After spending reaches $5,100, the Medicare benefit will cover about 95 percent for the rest of the year with beneficiaries paying only 5 percent. "None of this applies to the Medicare beneficiaries who qualify for extra help because they will have no premiums, no deductibles, and no gaps in coverage," Karr says.
Some Medicare beneficiaries already get coverage for prescription drugs through union- or employer-provided health plans. If that plan is as good or better than Medicare's prescription drug coverage, Medicare will be providing new support so that coverage stays in place. "Beneficiaries should be hearing from their former employer or union this fall about their coverage options," Karr says.
Some Medicare beneficiaries also currently get drug coverage from a Medicare Advantage plan, and those beneficiaries should expect to hear from their current plan about what kind of coverage they will be offering, he says. Some plans are likely to offer coverage that is even more comprehensive than Medicare's standard drug coverage.
The first enrollment period starts on Nov. 15, 2005, and runs through May 15, 2006. For those who don't join a Medicare prescription drug plan by May 15, 2006, the monthly premium rises 1 percent a month. So for people who wait a year to join, the premium would go up by 12 percent.
People in Medicare who also receive assistance from Medicaid will get drug coverage from Medicare instead of Medicaid starting January 1, Karr says. Medicaid is the state-administered program for people with limited incomes. "If they haven't chosen a plan before January, these ‘dual-eligibles' will be automatically enrolled in a prescription drug plan so that no gap in coverage occurs," Karr says. "But they will also have the ability to change plans once a month if they find a plan that better suits their needs." People in Medicaid and Medicare will be automatically eligible for the extra help, giving them comprehensive coverage with no premiums, no deductibles, and no gaps in coverage.
"We have about 50,000 people in Oregon who fall into this category," says Jane-ellen Weidanz, the MMA project manager for Oregon's Department of Human Services. "The automatic enrollment is good because we don't want people to fall through the cracks. At the same time, we will be letting people know they need to review the plan they've been assigned to see if it meets their needs, and we will be giving them assistance to help them make needed changes."
Each state will decide how its assistance programs will work with Medicare coverage. As of May 2005, at least 39 states had established or authorized some type of program to provide pharmaceutical assistance, and 32 states had programs in operation, according to the National Conference of State Legislatures (NCSL).
As of June 1, 2005, 23 states had enacted laws or resolutions responding to or adjusting to the Medicare prescription drug provisions. The Medicare law allows states to "wrap around" the Medicare benefit to fill in gaps in coverage.
The Alabama SenioRx: Partnership for Medication Access program was created in 2002 to help people ages 60 and older who have no prescription insurance coverage and who live below 200 percent of the poverty level. The program helps more than 26,000 Alabama seniors receive free or discounted drugs through PAPs provided by pharmaceutical manufacturers.
"We have brought in approximately 90 million dollars in free and low-cost medications in the three years we have been in operation," says Irene Collins, executive director of the Alabama Department of Senior Services. "About 80 percent of our current clients will be eligible for the low-income subsidy with Medicare Part D."
Collins says her agency continually communicates with contacts at the PAPs to find out how they will change in response to the Medicare drug benefit. "Because we anticipate changes," Collins says, "we have been working over the last several months to ensure that our clients who are eligible for Medicare savings programs are enrolled. We are also conducting many education opportunities about the changes in Medicare and providing one-on-one counseling for our clients and their families and physicians."
The Medicare drug plans starting in January 2006 are different from the Medicare discount drug cards that have been used as a temporary measure. Medicare beneficiaries who have been using the temporary discount drug cards can use those cards until May 15, 2006, or until they sign up for a plan, whichever comes first. "The card is not valid once you sign up for a plan," Karr says.
Karr says Medicare beneficiaries should watch the mail in October 2005 for the "Medicare & You" 2006 brochure. "This will show people what plans are available on a local level," he says.
Two main types of assistance are available from pharmaceutical companies. Several companies offer programs that allow consumers to take a discount drug card to the pharmacy to get a discount off of the price of prescription drugs. And most major pharmaceutical companies offer PAPs, which give free or low-cost medicines to people in need.
Because these programs typically target people without health insurance and people who don't qualify for government-funded programs, some are expected to change over the coming year with the launch of the Medicare Prescription Drug Benefit. For example, as of June 2005, GlaxoSmithKline (GSK) had about 200,000 members in its Orange Card program, according to Patty Seif, a spokeswoman for GSK. The card offers 20 percent to 40 percent off the usual price of the company's drugs, and is open to older people who are without health insurance and who have an annual income not exceeding $30,000 to $40,000 for a couple. As a program for Medicare enrollees, the Orange Card program's final year will be 2006, Seif says.
The Together Rx Card, launched by 10 pharmaceutical companies, provides financial help on prescription drugs until the Medicare drug benefit starts. The card gives U.S. residents who don't have drug coverage and who are within certain income levels average savings of 25 percent to 40 percent on their prescription drugs. The final day to use a Together Rx Card is Dec. 31, 2005.
Maggie Kohn, a spokeswoman for the drug manufacturer Merck, says that unlike many other programs, Merck's discount program offers discounts of 15 percent to 40 percent on many of the company's medicines to uninsured patients, regardless of age or income. About 15,000 people signed up for the program within the first few weeks that it began in April 2005, Kohn says.
Merck's PAP supplied 700,000 patients with 6.7 million prescriptions valued at $490 million in 2004, Kohn says. Patients may qualify if they have a household income below $19,140 for individuals, $25,660 for couples, and $38,700 for a family of four. "We do sometimes make exceptions for patients whose incomes exceed these amounts in special circumstances like if they are taking a number of medicines," Kohn says.
The Partnership for Prescription Assistance (PPA), which was launched in April 2005, is an industry initiative that's helping patients find assistance programs faster. "With one call," Seif says, "patients are directed to programs that could be most helpful." The PPA provides a single point of access to more than 275 public and private PAPs, including more than 150 programs offered by drug companies. The PPA also will show people how to contact Medicare and other government programs.
"We know that medicines, when taken as prescribed, improve lives and decrease overall health care spending," Seif says. "But for people who can't pay for them, any price is too high. That's why GSK and the pharmaceutical industry support programs that make our programs accessible." In 2004, GSK provided 372.5 million dollars' worth of free medicine.
Every company has its own eligibility criteria for PAPs, and, in most cases, U.S. citizenship and some proof of income, such as tax records or a record of social security benefits, are required.
In the April 1, 2005, issue of the American Journal of Health-System Pharmacy, researchers looked at clinics' use and assessment of PAPs. They concluded that PAPs help fill a major gap in health insurance coverage, but that consistent eligibility and application procedures are needed. The researchers identified the program's responses and changes to the Medicare drug benefit as a potential area of study.
They also reported that the benefits of helping patients get needed medication came with additional costs of clinic time spent dealing with them. Lisa McTavish, M.D., a family physician with the Arnett Clinic in Rossville, Ind., says her small office couldn't afford to help patients navigate PAPs until 2003, when a volunteer patient advocate named Susie Gray came on board. McTavish says it's been worth it. In the first six months of 2005, Gray helped patients save about $63,000 through PAPs.
"We have found that hospital and emergency admissions have decreased for most patients in the program," McTavish says. "That's because the patients are taking the medications they need and they aren't as stressed about how they will pay for them."
Gray, who works as a patient advocate two days a week, says she started with 13 patients in 2003 and now works with about 130. "I start by finding out which company makes the particular medication, then I get the forms and work with patients to fill them out," Gray says. "It takes about four to eight weeks to hear back about whether the patient is accepted." Gray also keeps track of medication orders and re-orders.
Patients who don't have access to someone like Gray can initiate the PAP process on their own by printing forms off the Internet or by calling pharmaceutical companies directly to request forms. Patients should fill out as much as possible, and then take the form to their doctor's office. PAP forms require a doctor's signature.
"At first, many of the patients who come to see me say they don't want the medication because they can't afford it, so I help them realize what their options are," says Gray, who decided to work as a patient advocate after helping her husband through three heart attacks. "I feel good about what I'm doing," Gray says. "A prescription doesn't do the patients any good if they can't get the medicine."
Many consumers who buy prescription drugs from unregulated foreign Internet sites may be saving less than they think, or even spending more than if they were careful shoppers, says Randall Lutter, Ph.D., Acting Associate Commissioner for Policy and Planning at the FDA. In 2004, the U.S. Customs and Border Patrol (CBP) detained more than 400 packages containing 807 prescription drug products received at the U.S. Postal Service International Mail facility in Miami that originated from outside the United States.
The detained packages were apparently being sent to U.S. addresses from a source in Freeport, Bahamas, by a Canadian pharmacy, Kohler's Drugstore of Hamilton, Ontario, which had set up an Internet operation--www.canadarx.net--to do business with American consumers.
Nearly half of the drugs were foreign generic drugs or drugs for which there were generic versions available in the United States. The FDA analyzed the prices actually charged on customer invoices for the detained foreign generic medications in the shipments. The FDA converted the price paid to U.S. dollars and checked the prices at the Web sites for four U.S. pharmacies. The table shows some examples of the price paid in Canada and the lowest price found from the four pharmacies. This price does not take into consideration shipping and handling charges at Canadian pharmacies, which range from $15 to $30.
Observations at the international mail facilities in July 2005 suggest that consumers continue to purchase prescription drugs from Canada that cost more than if they had purchased the FDA-approved generic version in the United States.
(strength and amount)
|Medical Use||Price Paid|
by Patient From
|U.S. Pharmacy Price**|
|Amiodarone 200mg (100)||Rapid Heart Beat||$116.97||$41.89|
|Verapamil SR 240mg (100)||High Blood Pressure||$83.90||$43.97|
|Lisinopril 20mg (100)||High Blood Pressure||$83.59||$16.19|
|Lisinopril 5mg (100)||High Blood Pressure||$47.96||$13.99|
|Terazosin 2mg (100)||High Blood Pressure, Prostate||$43.98||$17.09|
|Digitek 0.25mg (250)||Heart Medication||$51.30||$29.47|
|Diltiazem CD 240mg (100)||High Blood Pressure||$139.75||$127.99|
|High Blood Pressure||$12.73||$6.29|
|Warfarin 5mg (100)|
Prevention of Blood Clotting
|Aricept 10mg (30)||Alzheimer's Treatment||$128.65||$140.69|
*Shipping charges by Canadian pharmacies not included, but range from $15 to $30.
**Based on prices available on Oct. 4 and 5, 2004.
More on Medicare
For more information on Medicare Part D, visit www.medicare.gov or call (800) MEDICARE or (800) 633-4227; TTY (800) 325-0778.
Before calling, beneficiaries or those assisting them should know the drugs they take, the dosages, and their ZIP code. Consumers can also search for drug assistance programs at www.medicare.gov.
- Tell your doctor whether paying for prescription drugs is a problem.
- Ask your doctor about generics, another brand of the drug that may cost less, and nonprescription options.
- Find out whether Medicare Prescription Drug Coverage can benefit you and your family members.
- Check to see whether you are eligible for drug assistance programs in your state.
- Check with the pharmaceutical companies that manufacture your medicines to find out whether you qualify for assistance programs.
- Shop around your neighborhood or legitimate online pharmacies for the best prices on prescription drugs.
- The FDA recommends making sure that pharmacists are aware of all products being taken to help avoid drug interactions. These products include prescription and nonprescription drugs, drug samples, herbals, vitamins, and other dietary supplements. Whether you shop at local pharmacies or online, the FDA recommends purchasing only from state-licensed pharmacies that are located in the United States.
www.socialsecurity.gov/prescriptionhelp/: Online help with prescription drug costs from the Social Security Administration.
www.crbestbuydrugs.org/: contains important information from Consumer Reports about saving money on prescription drugs.
www.ashp.org/Import/PRACTICEANDPOLICY/PracticeResourceCenters/PatientAssistancePrograms.aspx: Created by the American Society of Health-System Pharmacists with support from the Health Resources and Services Administration. Provides information on patient assistance programs.
www.eldercare.gov: Run by the U.S. Administration on Aging. Shows drug assistance programs by state. (800) 677-1116.
www.needymeds.com: Lists information about state programs, discount drug cards, federal poverty guidelines, and patient assistance programs and includes copies of the forms.
www.rxassist.com: Run by Volunteers in Health Care. Allows searches by medicine and manufacturer, and helps find assistance programs nationwide.
www.helpingpatients.org: A resource for patient assistance programs. Run by the Pharmaceutical Research and Manufacturers of America.
www.accesstobenefits.org: Links to benefitscheckuprx, a service that allows you to search for public and private programs.
www.pparx.org: Partnership for Prescription Assistance. A resource for patient assistance programs. The PPA also will help potential recipients sign up for Medicare Part D coverage. (888) 4PPA-NOW (477-2669).