Featured Health Business Daily Story, April 29, 2013

FDA Approves Long-Awaited Oral MS Drug; Tecfidera May Have Huge Impact on Class (Table: Most Common NDC at Usual Dose Within Prime’s Commercial Book of Business)

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, PBMs, providers and employers contain costs and improve outcomes related to high-cost specialty products.

By Angela Maas, Managing Editor
April 2013Volume 10Issue 4

In late March the FDA approved the much-anticipated oral multiple sclerosis (MS) drug Tecfidera (dimethyl fumarate). Known as BG-12 as it was undergoing clinical trials, the Biogen Idec therapy has been hailed as a potential blockbuster by industry insiders and analysts. However, it may be a bit of time before plans will make formulary decisions on the drug beyond a basic prior authorization as they wait to see what the real-world data look like.

The drug is the third oral therapy to be approved for the treatment of MS following the September 2010 approval of Novartis’ Gilenya (fingolimod) (SPN 10/10, p. 1) and the September 2012 approval of Genzyme Corp.’s Aubagio (teriflunomide) (SPN 10/12, p. 1).

As the manufacturer of MS drugs Tysabri (natalizumab) and Avonex (interferon beta-1a), Biogen Idec is quite familiar with the MS space. It also develops and commercializes Fampyra (prolonged-release fampridine tablets) — known as Ampyra (dalfampridine) in the U.S. — outside the U.S.; this drug helps improve walking in people with MS.

“Tecfidera represents an important new treatment option for persons living with MS,” says Stephen Cichy, founder and managing director of Monarch Specialty Group, LLC. “Tecfidera’s comparatively mild side effect profile, its high rate of efficacy and oral dosing lead to an expectation that it could become a leader in the multiple sclerosis to drug market, with annual sales topping $3 billion if it gains the trust of physician prescribers. Furthermore, the ease of administration with new oral agents like Tecfidera may attract more patients to treatment, thus increasing the total number of MS patients treated with a biologic agent.”

Tecfidera will cost $54,900 per patient per year. That price is less than that of oral drug Gilenya, which is $60,000, but more than the approximately $50,000 annual per-patient cost for the oral Aubagio. This is “a solid strategy,” maintains Melinda Haren, senior director of access strategy at Zitter Health Insights. Tecfidera offers “incremental improvement over the current agents, and the pricing reflects that.”

Although “the costs are comparable,” says Laurie Amirpoor, vice president of pharmacy operations for WellPoint, Inc., “whether it’s $1,000 or $2,000 less, these are still high prices.” Asked whether the price seems reasonable, she says that “reasonableness depends on where you are in the health care system. When we go higher and higher, it puts affordability of health care at risk.”

Tecfidera’s price tag is also more than most of the other MS drugs (see table, p. 11). That could prompt the lower-priced drugs to raise their prices, says Sheila Arquette, assistant director of pharmacy for Independent Health, which is what happened when Gilenya came onto the market. “It raised the bar,” she says. “We’ll probably see that again with this drug,” agrees Marty Burruano, director of pharmacy for Independent Health.

Various PBM reports consistently cite the MS drug class as one of the top three — along with autoimmune conditions and cancer — in terms of specialty drug spend and trend.

At Independent Health, MS is the No. 1 category in specialty drug spend, Burruano tells SPN. And at WellPoint, the class is “within the top 10 therapeutic classes” treated with specialty drugs, says Amirpoor. “It’s one of the highest spend classes.” It’s also within the top 10 specialty-treated classes at Aetna Inc., say Joseph Honcz, head of product development and clinical strategy/programs, and Elizabeth Engelhardt, head of clinical strategy and programs.

At Prime Therapeutics LLC, “In the top 10 pharmacy benefit specialty drugs by expense, interferon beta-1a (Rebif, Avonex) is #3 and Copaxone is #4,” says Patrick Gleason, Pharm.D., the PBM’s director of health outcomes. “Combining medical and pharmacy specialty drug expenditures, the MS category is the third highest specialty expenditure category behind only autoimmune and injectable cancer.”

“From a physician perspective, this is a new alternative for members who are needle-phobic,” says Amirpoor. However, pickup of Gilenya and Aubagio has been “not significant overall,” say Honcz and Engelhardt. “The increase in MS members receiving therapy has not increased as much as expected based upon the market information that states 25% of MS patients are needle-phobic and would choose therapy when oral therapies were made available.”

Amirpoor agrees. The two oral drugs are “seeing small growth, but not the significant growth that we had anticipated. Patients are satisfied with the agents they are already on.” That’s key with MS, says Arquette. “If people are stable on their current therapy,” physicians likely will keep them on that drug.

Drug Is Likely to Have Early PA

Because Tecfidera was so recently approved, the pharmacy and therapeutics (P&T) committees for the plans that spoke with SPN had not reviewed it yet. However, says Cichy, “MCO pharmacy directors are likely to be receptive to new MS therapies that offer a greater clinical performance over currently available therapies. I expect Tecfidera to have initial widespread inclusion on formularies, with management most likely limited to prior authorization.”

At Prime, “Tecfidera will initially roll in as a target of Prime’s existing MS ST [i.e., step therapy] and PA [i.e., prior-authorization] programs,” says Gleason. He tells SPN that “Management strategies are expected to be adjusted after P&T decisions and trade contract negotiations have been finalized.”

Haren tells SPN that she expects when it comes to their formularies, “most big payers will make decisions six months after approvals, large regionals will be about 12 months out, and smaller plans will be 12 to 18 months out.…With any launch, the first six months are about educating payers about the drug….In the short term, we’ll probably see most payers honor their current contracts.”

When the FDA approved Xeljanz (tofacitinib), the first oral drug for rheumatoid arthritis (RA) (SPN 12/12, p. 1), “some payers made decisions, mainly to cover it, sooner than they did with other drugs,” points out Lee Goldberg, director of syndicated research at Zitter Health Insights, who adds that he’s “not sure why. I suspect because it’s oral.…It will be interesting to see if Tecfidera has a similar dynamic in MS.”

Burruano says it’s not yet clear what the importance of Tecfidera’s approval is. However, he notes, “I think there may be a lot of patients in the queue for this drug in our demographic area,” which is western New York state, an area with a “high incidence of MS — one of the highest in the country,” he adds. Still, he expects that physicians initially will take a cautious approach toward it until more data are available.

Tecfidera “does have very good efficacy data and safety data,” Haren says. Biogen Idec has been “touting less side effects” for Tecfidera, says Amirpoor, and there has certainly been plenty of buzz around the drug as it made its way through clinical trials. However, she says, “when you do clinical trials, this is the perfect storm. Companies can pick the perfect patient. But in the real world, people have not been studied” while taking Tecfidera. For this reason, physicians and plans will “wait and see the safety data” based on “six to 12 months of real-world data” before making decisions about the drug.

Tecfidera has been available in Europe and other countries outside the U.S. as a psoriasis treatment. So would that have any influence on its pickup in the U.S.?

“At this point, it would be speculation, but so far we have not seen a trend towards that,” says Amirpoor. “But we recognize that Europe has a unique model.…It’s important but not a major influence.”

Dynamics within the crowded MS class, which now has eight specialty therapies, are “oftentimes correlated to RA,” says Haren. Many of the 10 approved RA agents share the same mechanism of action, but “MS is not like that. Patients tend to cycle through agents,” she says.

Amirpoor notes that “we’re not keeping disease progression at bay with the current therapies.” Haren agrees. “There is room for drugs with a third, fourth or fifth mechanism of action to step up to the plate and be dominant.…There is still a lot of unmet need. What we have now may not be the best we could have.”

“Payers see little differentiation in the efficacy among most of the agents used in the treatment of MS,” says Cichy. “Because of this, plus the large spend and trend within this category, payers are leveraging a wide range of tactics to address cost management, including prior authorization, step therapy and tiering differentials to enforce the use of preferred agents.”

If Tecfidera’s safety data are positive, says Haren, plans could very well designate Tecfidera and long-time treatments Copaxone (glatiramer acetate) and Rebif (interferon beta-1a) as preferred agents.

Prime, says Gleason, “currently administers step therapy, on behalf of our Blues plans, that requires a trial of Copaxone, Rebif or Betaseron prior to Avonex, Aubagio, Gilenya or Tysabri.”

Aetna has a preferred product strategy that requires Copaxone, Rebif or Avonex prior to the other drugs’ use, Honcz and Engelhardt tell SPN.

Independent Health has Avonex and Copaxone on tier two of its formulary, with prior authorization required except when the drugs are prescribed by a neurologist, Arquette tells SPN. Extavia (interferon beta-1b), Betaseron (interferon beta-1b), Gilenya and Aubagio are all on tier three; the two injectables have prior authorization except when prescribed by a neurologist, while the two oral drugs require prior authorization when they are prescribed. Tysabri falls under its medical benefit.

WellPoint has all of the agents on formulary, says Amirpoor, and “access is based on medical necessity and the level of progression of the disease.” The plan has step edits tied to first-line and second-line use based on the FDA-approved label or clinical literature.

Amirpoor tells SPN that because “the injectable agents have the most clinical experience,” physicians tend to “prefer them over orals.…The orals tend to be add-on therapies as the disease progresses.” It remains to be seen whether Tecfidera will be treated the same way.

Most Common NDC at Usual Dose Within Prime’s Commercial Book of Business

Multiple Sclerosis Drugs

WAC Monthly

12 Months

fingolimod (Gilenya)



glatiramer (Copaxone)



dimethyl fumarate (Tecfidera)



interferon beta-1a (Rebif)



interferon beta-1b (Betaseron)



natalizumab (Tysabri)



interferon beta-1a (Avonex)



teriflunomide (Aubagio)



SOURCE/METHODOLOGY: Prime Therapeutics LLC. Prime evaluated the primarily used National Drug Code (NDC) for each of the multiple sclerosis agents and then calculated monthly Wholesale Acquisition Costs (WAC) based on usual dosing.

© 2013 by Atlantic Information Services, Inc. All Rights Reserved.

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