For the past couple of years, Wall Street has bet that a forthcoming Pfizer
treatment for rheumatoid arthritis called tofacitinib will become a blockbuster
and, crucially, help the drugmaker overcome the arrival of generic competition
to several of its biggest selling meds. Why are investors so keen about
tofacitinib? The drug would become the first oral biologic for treating this
particular affliction.
To be more specific, recent data indicated the Pfizer pill would offer
similar efficacy to a group of injectable meds
that collectively generate some $13 billion annually for treating
rheumatoid arthritis alone. A pill, however, is more convenient, suggesting
Pfizer can charge a premium and eventually generate some $1.5 billion in annual
sales, according to some estimates.
Such talk conjures up images of an endless stream of ringing registers. But
what do payers and rheumatologists think? When offered tofacitinib data, they
are having what might be called a show-me moment. To be specific, a new survey
finds that 55 percent of these doctors say the Pfizer pill would not replace a
med they are currently prescribing. And 96 percent of the payers say
tofacitinib would not replace a drug that is currently offered in their plans.
Why? Rheumatologists want to see better efficacy and more safety data,
while payers want more data on dosing and head-to-head comparisons with
existing biologics. They also cite cost, again because the expectation is that
Pfizer will price its pill higher than injectables. All of this suggests that
Pfizer - and any other drugmaker following in its footsteps - has a lot of work
ahead, according to Reimbursement Intelligence, a market research firm that
queried 100 rheumatologists and 50 payers.
“One key finding is that the new, oral small molecules for rheumatoid
arthritis are not necessarily a slam-dunk for either payers or
rheumatologists,” Rhonda Greenapple, who heads the market research firm, tells
us. “If the manufacturers of these novel agents – including the oral small
molecules – don’t clearly position these products in the customer’s mind,
payers will do it for them.”
Why? For one thing, most rheumatologists and payers consider the new class
of small molecule oral RA drugs to be in the same class as biologics - 57
percent and 88 percent, respectively. Those in the minority note the pills have
a different mechanism of action, but still remain targeted therapies. And
payers say any drug with a new indication is going to be compared to all drugs
with the same indication.
Consequently, 80 percent of rheumatologists and 72 percent of payers
believe there will be restricted access for tofacitinib that will require prior
authorization. In fact, 10 percent of payers expect that patient access will be
denied altogether. Meanwhile, 68 percent of the payers also say that FDA
approval of small molecule RA drugs could cause a review of the entire biologic
class.
Nonetheless, there is some good news for Pfizer - 85 percent of
rheumatologists and 60 percent of payers have a favorable impression of its
pill. And 27 percent of the rheumatologists say they would be willing to
regularly prescribe a small RA molecule, with another 46 percent reporting they
would do so within the first year of availability.
And while payers may issue restrictions, 23 percent of rheumatologists say
they would not be affected by a health plan that favored a specific treatment.
And another 24 percent would let their patient make a decision about which drug
to choose, but would explain why they did not suggest the med favored by the
health plan. Of course, this glass is also half full, or is it half empty?
Again, though, cost is expected to be factor as these dynamics play out.
“Some rheumatologists told us they thought patients will start asking about the
new oral small molecules as soon as they’re available,” says Greenapple. “The
big question is whether they’re going to be willing to pay several hundred
dollars per month for these medications.”