Eli Lilly and Company To Extend Patient Assistance Programs For Medicare Patients

INDIANAPOLIS, May 10 /PRNewswire-FirstCall/ -- Eli Lilly and Company announced today that it will be extending its existing patient assistance program, LillyAnswers, through the end of this year to qualifying patients currently participating in the program, to help bridge the gap in coverage for people who need Lilly medicines, but are not yet enrolled in Medicare Part D.

The company also is asking the U.S. Department of Health and Human Services Office of the Inspector General (OIG) for an opinion on the company's proposal for an "Outside Part D" patient assistance program, called LillyMedicareAnswers, which would extend assistance beyond the end of this year to Medicare patients for two drugs, Forteo and Zyprexa. A favorable opinion from the OIG would allow Lilly to continue providing Forteo(R) (teriparatide [rDNA origin] injection), a treatment for osteoporosis, and Zyprexa(R) (olanzapine, Lilly), a treatment for schizophrenia and bipolar disorder.

For patients that qualify, bridge benefits will be available for current LillyAnswers patients who are enrolled in Medicare Part D and prescribed either Forteo or Zyprexa until the OIG responds to the request for the new "Outside Part D" program or until such other date as Lilly may determine.

The OIG is providing guidance to pharmaceutical companies on the legal implications of offering assistance to Medicare Part D enrollees as the government continues implementation of the sweeping federal program for prescription drug benefits. Lilly has been helping educate patients and physicians on the new program.

Sidney Taurel, chairman and chief executive officer of Eli Lilly and Company, announced details of Lilly's Medicare patient assistance efforts at today's Kaiser Family Foundation's Kaiser Conversation on Health in Washington, DC.

"Our country's Medicare system has been strengthened and improved through the integration of a prescription drug benefit that provides affordable access to innovative medicines that help patients lead longer, healthier, and more productive lives," said Taurel.

"The actions Lilly is taking today will help to ensure the smooth implementation of the Medicare drug benefit, while helping seniors who are experiencing gaps in coverage or who have yet to select a drug coverage plan," said Taurel. "These actions also will help a subset of Lilly patients who require special attention and assistance maintaining continuity of care."

The company will provide materials to help educate patients on enrolling during the 2007 Part D enrollment period. Taurel noted that the company already has distributed educational materials to thousands of physicians and healthcare providers over the past year about the drug benefit, in addition to helping educate seniors and disabled beneficiaries on plan enrollment.

"We are very pleased that Lilly is taking this important step to help some of the most vulnerable people with Medicare by ensuring that they will continue to get the drugs they need while working with the Medicare drug benefit," said Mark B. McClellan, M.D., Ph.D., administrator for the Centers for Medicare and Medicaid Services.

Effective immediately, Lilly will take the following steps to assist Medicare-eligible patients requesting drug assistance:

* Extend the company's current patient assistance program, LillyAnswers, until Dec. 31, 2006, for certain qualifying patients for all products. Patients enrolled in LillyAnswers as of Dec. 31, 2005, but who have not yet enrolled in a Part D plan, are eligible. Patients must certify that they are not enrolled in a Part D plan. No new patients will be allowed in the program.

* Create a new "Outside Part D" program, to be called LillyMedicareAnswers, for patients taking Forteo or Zyprexa. The program would assist those meeting the following criteria: Part D enrollment, income that is below 200% Federal Poverty Level (FPL), proof of low-income subsidy denial, and signed certification that the patient will not claim or submit any cost incurred or associated with the medicines provided under the new program towards their true-out-of-pocket-cost ("TrOOP") calculation or submit any claim for reimbursement for the medicines. Patients will only be eligible to enroll in the new Forteo-Zyprexa program after a favorable OIG opinion is received by Lilly and the related infrastructure for the new program is fully operational. In order to help cover the administrative costs of running the new program, patients will be charged a $25 administrative fee per 30-day supply of the drugs that will be shipped directly to the patient's home.

* For patients that qualify, bridge benefits will be available for current LillyAnswers patients who are enrolled in Medicare Part D and prescribed either Forteo or Zyprexa until the OIG responds to the request for the new "Outside Part D" program or until such other date as Lilly may determine. Each patient will be required to provide a signed certification that he/she will not claim or submit any cost incurred or associated with the medicines provided under the new program towards their TrOOP calculation or submit any claim for reimbursement for the medicines.

LillyAnswers has provided hundreds of millions of dollars worth of free drugs to needy seniors since 2002. But in response to the implementation of Medicare Part D and statements from the OIG (OIG Special Advisory Bulletin on Patient Assistance Programs, Nov. 2005) on a "heightened risk of fraud and abuse under the federal anti-kickback statute" for companies providing assistance to Part D enrollees, Lilly had announced that Part D eligible patients would no longer qualify for LillyAnswers after May 15, 2006. After the OIG Advisory Opinion (OIG Advisory Opinion 06-03, April 2006) helped to clarify the OIG's position, Lilly quickly sought to continue its program for Forteo and Zyprexa.

Lilly will be mailing information to patients this week informing them of the changes to the company's patient assistance programs. Patients who have questions regarding the LillyMedicareAnswers program, the temporary LillyAnswers extension for Forteo or Zyprexa or the temporary LillyAnswers extension can call 1-877-795-4559.

More about Lilly's patient assistance programs

To ensure that patients who couldn't pay for them had access to Lilly's medicines, the company donated products through six patient assistance programs that last year helped more than 410,000 people. Lilly Cares, which offers free medicines to patients who can't pay for them, assisted 176,000 participants, while LillyAnswers provided low-cost prescriptions to 230,000 Medicare-enrolled customers. Other assistance programs helped customers gain reimbursement or access to drugs that battle cancer, severe sepsis, osteoporosis, and diabetes. In 2005, Lilly provided more than $425 million in patient assistance (net wholesale price), representing about 5 percent of the company's total U.S. sales.

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

C-LLY

Forteo(R) (teriparatide [rDNA origin] injection) Zyprexa(R) (olanzapine, Lilly) (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

CONTACT: Edward Sagebiel, +1-317-433-9899, or Janice Chavers,+1-317-651-6253, both of Eli Lilly and Company