Specialty Pharmacy

Developments in RSV Treatment May Widen Payers’ Approach

Reprinted from the September 2005 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.

While MedImmune's injectable drug Synagis (palivizumab) now has the corner on the market when it comes to preventing infection by respiratory syncytial virus (RSV) in high-risk infants, other developments in the industry may begin to impact the market within the next five years. Indications for the elderly in addition to infants, treatments for RSV infection and new RSV vaccines are all in some stage of development, as companies look for a share of the market — approximately $1 billion in 2004 worldwide sales.

Arrow Therapeutics, Ltd., based in London, recently announced a licensing deal with Novartis Pharma AG for A-60444, Arrow’s first-in-class oral drug that treats RSV. Not only is A-60444 notable for the fact that it is expected to be used in the treatment of RSV, rather than as a preventive measure against infection, but it is also significant because it is expected to be indicated for use in not just infants but also the elderly and the immunocompromised.

An article in the April 28 issue of the New England Journal of Medicine cites a four-year study by a research group from the University of Rochester Medical Center on the incidence of RSV in elderly and high-risk adults. The group’s research indicates that an estimated 14,000 of these patients die annually, with more than 177,500 annual hospitalizations of adults as a result of RSV. The cost for such hospitalizations? More than $1 billion.

In healthy elderly patients and high-risk adults, the study revealed that RSV infection accounted for:

• 10.6% of hospitalizations for pneumonia.

• 11.4% of hospitalizations for chronic obstructive pulmonary disease.

• 5.4% of hospitalizations for congestive heart failure.

• 7.2% of hospitalizations for asthma.

Currently, A-60444 is in two clinical trials, says Arrow CEO Ken Powell. “The major one is in stem-cell transplant patients who have severe RSV infections. This is across the adult/elderly groups,” he says, and is in Europe, Australia and the United States. A second trial in Hong Kong is treating otherwise healthy adults who have RSV. The company plans to gather data on adults before moving on to a trial that treats infants. With respect to treating those affected by the disease, he says, “our aim would be to produce a significant change in the morbidity and mortality caused by RSV.”

Biota Holdings Limited, which is headquartered in Melbourne, Australia, announced in June that it had discovered a new class of orally effective antivirals for use against RSV infection. The company has filed worldwide patents and plans preclinical development before beginning human clinical trials, but animal testing has shown the product to be effective when administered orally. It is expected to be able to treat and prevent RSV in not only high-risk infants but also children, the elderly and people with underlying respiratory conditions.

Mesfin Tegenu, who is senior vice president of pharmacy services for AmeriHealth Mercy/PerformRx, says that many of these compounds are being developed simultaneously by “a number of research-based drug companies.” Because of these drugs’ apparent effects on the RSV virus, “my understanding is that these compounds are being fast tracked by the FDA because of ‘significant unmet medical need,’” he says.

Of the Novartis involvement, Jeff Casberg, director of pharmacy for ConnectiCare, adds that “it’s usually a good sign if one of the bigger companies is backing the product.”

Questions Exist About Treatment vs. Prevention

With Synagis costing approximately $1,000 per dose, will any potential cost savings exist from treating those infected vs. those at risk? “It could be a cost-effective measure if we just treated people who got RSV,” says Casberg, “but we don’t know what the cost of the new drug will be.” He also contends that it is important to give medicine to only the people who need it, but adds that Synagis is “targeted toward a high-risk population” of infants already.

“My best guess is that good medicine and physicians would always go for prophylaxis rather than treatment,” says Paul McConnell, president and CEO of Curative Health Services, Inc. “If we have the option of not providing a medication and instead waiting until someone is affected and then treating them, I don’t think many will take this approach.” Besides echoing Casberg’s cost concerns about the drug, McConnell says that many may not want to take the chance of having an RSV-infected infant possibly not respond to treatment and then looking back and wondering if they could have prevented a serious illness or worse just by giving the baby Synagis. Expensive hospital costs may also impact the wait-and-see-what-happens issue, he says.

Powell contends that this is not simply an either-or proposition. “Our drug is for treatment rather than prophylaxis.…We estimate the market as very significant, of similar size to but distinct from that of Synagis,” he says.

Casberg also notes that “with Synagis, it hopefully prevents RSV, so we don’t know if more people would be affected if they weren’t treated. How much would RSV increase if we remove the Synagis treatment?” He also wonders if the new treatments would be an added cost to that of Synagis and whether the national guidelines would change with respect to RSV.

Not content to rest on its laurels, MedImmune itself is exploring not only a vaccine for adults but also a replacement drug for Synagis. In January, MedImmune filed an investigational new drug application for a combination RSV and parainfluenza virus type-3 (PIV-3) vaccine for adults. In April, the company announced that it had begun dosing adults in its Phase I study of this intranasal vaccine.

And a group of researchers at the University of California-Davis recently claimed that its DNA vaccine against RSV was safe and effective in infant rhesus macaques. The group contended that the results supported the viability of RSV DNA vaccines in infants.

Asked about the MedImmune vaccine, Tegenu responds: “While I don’t think this will have much effect on the overall prevention/treatment of RSV, this would provide pediatricians a non-injectable product and ease administration problems. Past experience is that vaccines for RSV have shown less than satisfactory results in humans.”

He points to MedImmune’s potential Synagis replacement as possibly the bigger news. According to the company, data from Phase I and Phase II studies have shown Numax to be safe and well tolerated among infants at high risk of RSV. The drug is “suggested to be 10 times more effective than Synagis at preventing RSV in infants, as well as providing some level of protection for URTI (e.g., otitis media),” says Tegenu.

The company has also begun a Phase II second-season study concerning the safety of redosing children who had received Numax in a previous RSV season. Tegenu also reports that “Numax is supposedly going to have an indication for use in high-risk adults, as well as infants and children.”

Issues for Payers: Cost, Diagnosis, Part D

When the question of cost is raised — the estimated five-month cost of RSV treatments is between $3,500 and $6,500 per patient — Tegenu says, “From a pricing standpoint, I would imagine that Numax would be priced on par, maybe even a bit higher than Synagis. I would certainly suggest that if Numax is proven, in the real world, to be significantly more effective in preventing RSV than its predecessor (Synagis), the cost/benefit ratio of preventative treatment for RSV might certainly have to be re-evaluated.”

Lab tests confirming an RSV diagnosis in less than 30 minutes “should create a much broader market for these drug products,” he says. “It’s very likely that health plans, PBMs and even sophisticated self-insured employers will require some proof of an actual diagnosis of RSV before approving these drugs for their members.” He believes, though, that at least initially, use of the drugs will most likely be limited to the hospital setting, “as community use will be restricted by low rates of presentation and diagnosis.”

Tegenu also contends that because adults 65 and older are hit hardest by RSV, “this will shift a significant amount of the financial burden of this type of drug therapy from the commercial markets to the new providers of MMA [i.e., Medicare Prescription Drug, Improvement and Modernization Act of 2003] Part D benefits (as A-60444 is an oral product and therefore would not be covered under Part B of MMA), and personally by individuals that are not covered by Part D. Additionally, if Numax (an office-administered injectable product) is approved for high-risk elderly individuals, this product could have a significant impact on MMA Part B providers.

“I would certainly suggest that PDPs [Prescription Drug Plans] and MA-PDs [Medicare Advantage prescription drug plans] keep a close watch on this class of products,” says Tegenu, “as the failure to integrate the potential utilization/costs associated with this class of drugs into their capitated ‘bid’ to CMS for comprehensive prescription or health care services could certainly create a few financial difficulties for any organization.”

Advertise With AIS

Privacy

Site Map