Preventing Drug Coverage Disruption for Enrollees in the Replacement Drug Demo

These days, there is a lot of press and activity surrounding the implementation of the Medicare prescription drug benefit (Part D) on Jan. 1, 2006. Final regulations, bid applications for sponsors, formulary-design decisions, and outreach and enrollment issues — to name just a few — need to be addressed in an extremely compressed time frame this year. A key question is whether Medicare beneficiary enrollment will be significant. Robust enrollment is desirable for all stakeholders, especially those who wish to take part in the program; the more successful Part D is, the more likely that the program will continue.

Many people are pointing to the Medicare Drug Discount Card Program, which was implemented last June, as a benchmark. Enrollment in that program has lagged, despite multiple efforts by the Centers for Medicare and Medicaid Services. Perhaps, a more appropriate example is the current demonstration program designed to mimic many aspects — most importantly, the beneficiary cost-sharing design — of the standard Part D benefit.

The demonstration program, known as the Medicare Replacement Drug Demonstration, or MRDD, has been largely ignored due to its relatively small scope of coverage (see table on page 25). Many lessons have been learned, however, and the program continues to provide valuable insight relative to the pending implementation of Part D.

TABLE.

Drugs covered under the Medicare Replacement Drug Demonstration (Updated Feb. 7, 2005)

Demonstration-covered indication	Drug/biologic compound name (brand name)
Acromegaly	Pegvisomant (Somavert)
Ankylosing spondylitis	Etanercept (Enbrel)
Cytomegalovirus retinitis	Valganciclovir HCl (Valcyte)
Hepatitis C	Pegylated interferon alfa-2a (Pegasys)
	Pegylated interferon alfa-2b (PEG-Intron)
Multiple sclerosis	Glatiramer acetate (Copaxone)
	Interferon beta-1a (Rebif, Avonex)
	Interferon beta-1b (Betaseron)
	Repository corticotropin injection (H.P. Acthar Gel)
Paget’s disease	Alendronate (Fosamax)
	Risedronate (Actonel)
Postmenopausal osteoporosis (patient must be homebound)	Calcitonin-nasal (Miacalcin-nasal)
	Risedronate (Actonel)
	Alendronate (Fosamax)
	Raloxifene HCl (Evista)
Psoriasis	Efalizumab (Raptiva)
	Etanercept (Enbrel)
Psoriatic arthritis	Etanercept (Enbrel)
Pulmonary hypertension	Bosentan (Tracleer)
Rheumatoid arthritis	Adalimumab (Humira)
	Anakinra (Kineret)
	Etanercept (Enbrel)
Secondary hyperparathyroidism	Doxercalciferol (Hectorol)
	Anticancer drugs
Breast cancer (stage 2–4 only)	Anastrozole (Arimidex)
	Exemestane (Aromasin)
	Letrozole (Femara)
	Tamoxifen (Nolvadex)
	Toremifene (Fareston)
Chronic myelogenous leukemia	Imatinib mesylate (Gleevec)
Cutaneous T-cell lymphoma	Bexarotene (Targretin)
Epithelial ovarian cancer	Altretamine (Hexalen)
Gastrointestinal stromal tumor	Imatinib mesylate (Gleevec)
Hemorrhagic cystitis induced by ifosfamide (prophylactic agent)	Mesna (Mesnex)
Multiple myeloma	Thalidomide (Thalomid)
Non-small cell lung cancer	Erlotinib HCl (Tarceva)
	Gefitinib (Iressa)

SOURCE: CMS 2005

In this article, we will provide some background on the MRDD and share our experience as it relates to one of Amgen’s products (etanercept [Enbrel¹], a tumor necrosis factor [TNF] inhibitor) and some of the lessons that have been learned.

HISTORY REVISITED

Section 641 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 required that the Health and Human Services secretary conduct a demonstration under Part B of Title XVIII of the Social Security Act, under which payment would be made for “drugs or biologics that are prescribed as replacements for drugs and biologics described in section 1861(s)(2)(A) or 1861(s)(2) (Q)” (i.e., currently covered under Part B).

Congressional intent and CMS interpretation both played roles in determining the diseases and drugs that would be covered under the MRDD. Some of the key objectives were:

• Cover selected self-administered medications for eligible Medicare beneficiaries

• Recognize that certain diseases, such as multiple sclerosis, rheumatoid arthritis (RA), and cancer, were critical areas of concern for beneficiaries

• Provide certain drugs and biologic agents that can be taken by the patient at home, and replace drugs and biologic agents currently covered under the Part B benefit when administered in a physician’s office

• Provide transitional coverage — a bridge — until the Medicare prescription drug benefit goes into effect in 2006

• Provide insight into any potential beneficiary issues with Part D, prior to the actual implementation date of Jan. 1, 2006

• Provide information for a report to Congress that addresses patients’ access and outcomes, as well as cost-effectiveness

• Provide enrollees with significant savings on covered drugs

Despite the potential savings, however, beneficiary enrollment to date has been significantly lower than expected. The Congressional Budget Office initially estimated potential demand of 500,000 eligible enrollees in the program, but cost concerns led Congress to limit enrollment to 50,000 patients or $500 million, whichever is reached first. To manage enrollment within the 50,000 cap, CMS developed a lottery system.

CMS initially selected etanercept for coverage under the demonstration project because it is a self-injectable biologic agent that can be prescribed as a replacement to another biologic agent currently covered under Medicare Part B. By preventing TNF molecules from binding to their receptors, which causes inflammation, etanercept helps to reduce pain, relieves such signs and symptoms of inflammation as tender and swollen joints, and improves functionality in patients with moderate to severe RA. Etanercept can inhibit the progression of joint damage in RA. Etanercept is effective in other diseases in which TNF plays a critical role. For patients with ankylosing spondylitis and psoriatic arthritis, etanercept also can help to relieve pain as well as signs and symptoms of inflammation, and in the case of psoriatic arthritis, etanercept can inhibit the progression of structural damage of active arthritis. Patients with moderate to severe plaque psoriasis have demonstrated improvements in their psoriatic plaques (Lyseng-Williamson 2004).²

There are a number of actions that CMS should consider so that patients who are now enrolled in the demonstration will continue to have access to their current medications.

MRDD EXPERIENCE TO DATE

Enrollment in the MRDD commenced July 6, 2004, with the first group of patients selected on Aug. 16 and the second round of patients selected from applications received by Sept. 30. The first group of patients selected to participate in the demonstration had their prescriptions in hand by Sept. 1, 2004.

TrailBlazer, a Medicare carrier, had responsibility for eligibility verification and enrollment of beneficiaries. TrailBlazer also assisted CMS with outreach to beneficiaries and set up a call center to aid in the application process and to provide responses to questions from beneficiaries and providers. Current enrollment information and application forms can be obtained on the Medicare page of CMS’s Web site «www.medicare.gov» or by calling (866) 563-5386.

Caremark, the pharmacy benefit manager, administers the MRDD drug benefit and provides covered medications to beneficiaries through its nationwide network of retail pharmacies, as well as its specialty pharmacy and mail order programs.

The patients eligible to participate initially were selected via a lottery process. Within the first several months, more than 13,000 eligible participants were enrolled and receiving medications through the program. Unfortunately, enrollment fell short of expectations.

Consequently, CMS decided to expand the list of covered indications under the MRDD so that more beneficiaries could use the program to gain access to covered therapies. As a result, eligible patients with ankylosing spondylitis, psoriatic arthritis, and psoriasis now may obtain etanercept, as such indications — in addition to rheumatoid arthritis — now are covered under the MRDD.

As of early March 2005, only 21,334 beneficiaries, out of the potential 50,000, actually have enrolled. What happened? Going into Part D in 2006, what can we learn from the MRDD outreach-and-enrollment process?

WHY IS ENROLLMENT LOW?

Possible explanations for low enrollment in the MRDD include:

• Lack of public awareness of the program

• Government reliance on the Internet as a source of information for beneficiaries

• The complexity of the application

• Uncertainty surrounding the lottery system

• The availability of free drug programs for low-income patients

• High out-of-pocket expense for beneficiaries (this has probably been the single biggest deterrent for enrollment in the MRDD among those who did not qualify for low-income assistance)

Despite overall low enrollment, numerous patients have been able to gain access to etanercept therapy under the MRDD — many for the first time.

WHAT IT TAKES TO ENROLL PATIENTS IN PART D

Amgen has been, and continues to be successful in, reaching out to beneficiaries, educating them, and providing information regarding the MRDD application process. We have observed that Medicare beneficiaries are more likely to respond to interaction with a “live person” than to look for information on a Web site. CMS continues to step up its outreach activities that include information on patient copayment-assistance programs, which may be able to help eligible patients (CMS 2005).

POTENTIAL IMPLICATIONS FOR PART D

As the MRDD ends on Dec. 31, 2005 and beneficiaries enroll in Part D, how will patients who are currently enrolled in the MRDD be assured that access to the drug that they are taking will continue?

In the interests of patients, CMS should:

• Ensure that the Part D sponsors will have all drugs and biologic agents currently covered under the MRDD available on their formularies.

• Continue the same level of reasonable cost sharing. Without this, some patients may not be able to afford to continue on therapy.

• Provide special outreach to patients enrolled in the MRDD, and even consider instituting a program for auto-enrollment into Part D for these patients. This would be similar to what is done for dual eligibles.

• Provide outreach programs that recognize that Medicare beneficiaries prefer certain methods of receiving information over others. For instance, beneficiaries prefer to talk to someone in person or on the phone to keep up with Medicare issues or to receive mail that is easy to understand (Kaiser Family Foundation 2005).

NEXT STEPS TO ENSURE SUCCESS OF PART D

Prior experience suggests that a multipronged approach — involving industry stakeholders, not-for-profit organizations, patient groups, and state and federal government — may be needed to ensure that Part D enrollment is robust. Education, outreach, and enrollment are contingent on stakeholders recognizing what Medicare beneficiaries look for and respond to in a positive way. Older adults need time to get comfortable with and understand a program before they will enroll in it.

At Amgen, we use science and innovation to dramatically improve people’s lives. Part D was intended to assist beneficiaries who do not have prescription drug coverage in gaining access to necessary drugs and biologic agents as appropriate to improve their lives. As the MRDD has shown, access, outreach, education, and copayment assistance have been major factors in the enrollment process. To the Part D stakeholders, let’s make sure beneficiaries know about — and have access to — the biggest change in Medicare since its inception. It would be a win-win situation for everyone.