Wednesday, June 13, 2007

Costs Increase for Multiple Sclerosis Therapies; Tiering, Usage Expected to Rise

Reprinted from the June 2007 issue of SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers manage costs more aggressively and deliver biotechs and injectables more effectively.

A pair of recent drug reports shows that while the usage of multiple sclerosis (MS) treatments seems fairly even from 2005 to 2006, the costs of those therapies are rising strongly. With this in mind, more payers are continuing to designate preferred therapies among the four self-injected drugs on the market. But industry experts anticipate MS treatment usage increasing further, which could push already-high costs even higher.

A chronic, autoimmune disease that affects the central nervous system, MS can occur as one of four types, each of which may be mild, moderate or severe. While MS affects approximately 400,000 people in the U.S., the National Multiple Sclerosis Society estimates that "the average annual direct and indirect cost of MS is estimated at $57,500 per person due to lost wages, increased medical care and other expenses."

Data show that the costs are rising substantially. PBM Express Scripts, Inc.'s 2006 Drug Trend Report, which includes only those specialty drugs adjudicated under the pharmacy benefit, showed that among its covered lives, the cost per prescription for the MS therapies class increased 15.1% to $1,469.93 in 2006, from $1,277.27 in 2005. In addition, the per-member, per-year cost rose 19%, from $11.43 to $13.60.

Medco Health Solutions, Inc.'s 2007 Drug Trend

Report (which also looks at only the drugs adjudicated on the pharmacy side) shows that for Medco's covered lives in 2006, MS therapy utilization has essentially remained the same (an increase of 0.6%), but both the cost for the plan and the cost per day of the therapy have climbed, 14.8% and 14.2%, respectively. The combined result made it the third largest contributor to specialty drug trend in 2006 for Medco covered lives. The primary reason that the PBM points to for this trend is "price inflation for the leading brand-name products" - the same reason that Express Scripts cited for its data.

This refers to "manufacturer-driven pricing," explains Steve Russek, vice president of clinical product development for Accredo Specialty Services, a Medco company. "There are limited products in this category."

In an April 2006 poll of 102 managed care executives on specialty pharmacy management, MS ranked sixth out of 19 categories offered for responding to the question of which condition was in greatest need of management, says Tom Baker, senior vice president at The Zitter Group. The data are in an upcoming Zitter Group specialty pharmacy trend report created in conjuction with Wyeth Healthcare Systems. And the EMD Serono Injectables Digest, which gathered data from 69 health plans across the U.S. in the first quarter of 2007, found that MS drugs, both under the pharmacy benefit and the medical benefit, are among those therapies that plans require to be obtained from a specialty pharmacy provider.

Debbie Stern, vice president of managed care consulting firm Rxperts, Inc., says that "more emphasis on 'treatment optimization' — finding the right drug and managing the side effects so the patient stays on therapy" — may also be contributing to the cost increases.

Four of the immunomodulating agents that the FDA has approved for the treatment of MS — Betaseron (interferon beta-1b), Avonex (interferon beta-1a), Rebif (interferon beta-1a) and Copaxone (glatiramer acetate) — can be given intramuscularly and/or subcutaneously, but all may be self-administered. There is a pair of infusible treatment options: Tysabri (natalizumab) is an immunomodulating agent, while Novantrone (mitoxantrone) is both an immunomodulator and an immunosuppressant.

Coverage on Medical or Pharmacy Side?

Plans will usually, but not always, cover the infusi-bles on the medical side, but the other four drugs' coverage may differ from plan to plan, falling under both the medical and the pharmacy benefits. Many plans, however, have begun offering the self-administered MS therapies under the pharmacy benefit, which may give plans more control over utilization and lessen the cost burden for patients. Russek says Medco is seeing that "a lot of companies are moving all self-injectables - not just the MS drugs — to the pharmacy side."

In fact, the EMD Serono Injectables Digest also notes that among its respondents, MS drugs are one of the therapy classes most likely to require prior authorization under both the pharmacy and the medical benefit.

Some health plans have begun selecting a preferred MS therapy among the interferons and placing the interferons on different tiers for their patient populations. Commonly done with generic drugs that offer a less expensive option to traditional retail pharmacy, this is an idea that has not been very common in the specialty pharmacy arena, but is gaining some traction, says Russek, and not just in MS but also in areas such as rheumatoid arthritis therapies and growth hormones.

These conditions have multiple branded therapies that are somewhat similar in terms of their effectiveness and safety. When the drugs are "near-perfect substitutes adjudicated as pharmacy benefits," category management is most effective, said Baker at a 2006 Pharmaceutical Care Management Assn. (PCMA) convention, referring to research from The Zitter Group's biannual Managed Care Injectables Index.

More than half of the respondents in the Wyeth survey either agreed or strongly agreed that specialty pharmacy providers were "best for managing crowded classes," such as the main MS treatments, says Baker. About one-third of respondents said that specialty pharmacy providers "have helped them with cost savings through category 'narrowing' or management."

Data from the Managed Care Injectables Index show three of the four self-injectable therapies are often covered in plans' middle tiers, with the other agent usually in the highest tier. Drug placement in lower tiers will usually translate into lower copayments — the same survey showed these copays were, on average, about $34 — which also may translate into greater patient adherence to the therapy. That survey also broke down estimated patient cost-sharing levels for various disease states at which patient compliance will fall. For MS, it was $181.36.

Plans also can negotiate better pricing for preferred therapies and can incentivize patients to use these lower-tier products as well, noted Baker in his PCMA presentation. These therapies are considered first-line treatments for MS, says Stern.

Specialty pharmacy providers may also supply these self-administered therapies through mail order, which requires less interaction on the part of the specialty pharmacy.

Still, though, the treatments are not cheap. According to 2005 data from Caremark Rx, Inc., the average annual cost of therapy for Betaseron, Avonex, Rebif and Copaxone among Caremark covered lives is in the $20,000 to $24,000 range. That category ranked second among specialty therapeutic classes by gross cost in the PBM's 2005 book of business.

The infusibles, which also have a more severe adverse-effect profile, are considered a second-line agent for patients who are not responding to treatment, says Stern. Tysabri entered the market in November 2004 to great anticipation following promising trial data.

Manufacturers Biogen Idec, Inc. and Elan Corp. withdrew the drug, though, in February 2005 in the wake of reports of patients in clinical trials acquiring progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that often causes death or disability. When Tysabri returned to the market in July 2006, it was at an annual cost of almost $30,000 — without taking into account service costs for the infusions themselves. The companies said in early May that there have been no new reports of confirmed PML cases. Novantrone's annual price tag starts at around $10,000.

Adding to inflation "are studies coming out that recommend MS patients start on the drug earlier," says Russek. "We think utilization [of MS therapies] will go up with patients starting these treatments earlier."

Costs are also expected to continue to rise, as new therapies make their way onto the marketplace. According to a 2006 report by the Pharmaceutical Research and Manufacturers of America trade group, there are 27 medicines in development for MS. Datamonitor predicts that the MS market "will more than double in value across the seven major markets from 2006 to reach $10.7 billion in 2016."

Patients who either have not responded to current MS therapies or have discontinued the therapies due to their side effects will be among those waiting to try the new treatments. Those patients who dislike the injectable aspects of the current drugs will also have some options, as the first oral MS drugs are expected to begin hitting the market over the next few years. "Orals will obviously be better for compliance and for treating patients who don't want to inject," contends Stern.

Among those anticipated oral therapies are IVAX Corp. and Serono's Mylinax (cladribine), Novartis' Fingolimod (FTY720), sanofi-aventis' Teriflunomide (HMR 1726) and Pepgen Corp.'s Tauferon (interferon-tau). Some drugs that are approved for other indications, such as Genentech, Inc.'s Rituxan (rituximab), are also being explored as possible MS treatments.