Why Amgen's osteoporosis drug will be a blockbuster
Novartis has been running a DTC campaign positioning Reclast as a drug that both prevents fractures and is needed only once a year. The problem is that most primary care physicians are not set up to give an IV treatment (Reclast's minimum IV infusion time is 15 minutes) and they do not get reimbursed for all their time. In fact, on the Reclast site, there are some callouts to help healthcare professionals code their treatment for reimbursement assistance. Primary care physicians are also not set up to purchase IV infusions, which leads to other potential issues. Also on their site are links for primary care docs to download referral forms (and how many will want to give up their patients?) and find infusion centers (!). Reclast has been on the market over a year now and sales are less than I would have thought for a once a year option. Patients on Reclast are also recommended to take calcium and vitamin D supplements, which could lead to compliance issues.
Primary care physicians are not set up to give IV
infusions and need to understand how they
are going to get reimbursed for their time, which
could over an hour.
Enter Amgen's
denosumab. A subcutaneous injection that not only can
prevent fractures, but can also build new bone. It is
a simple injection so physicians can treat the
patient with the minimum amount of time and effort
and get reimbursed according to their business model.
I am sure that denosumab will be expensive and as
such most payers might want HCPs to start patients on
generic bisphosphonate therapy first. However, if
Amgen can show that starting patients on denosumab
first lowers the overall health care costs of the
patient, they could get denosumab as a first line
treatment along with generic bisphosphonate therapy.
Bisphosphonate therapy can have some nasty side
effects and it is generally suggested that patients
also take calcium and vitamin D supplements. In fact
one brand, Fosamax, now comes with calcium and
vitamin D. If denosumab can prevent fractures and
build bone density with a minimum of side effects,
Amgen could quickly find that it has a winner on
their hands.
Patients who take Boniva and other bisphosphonates
have to stay upright for 60 minutes after taking
their pill and some patients experience nasty GI side
effects.
You should not
take BONIVA if you have low blood calcium, cannot sit
or stand for at least 60 minutes, have severe kidney
disease, or are allergic to BONIVA. Stop taking
BONIVA and tell your healthcare provider if you
experience difficult or painful swallowing, chest
pain, or severe or continuing heartburn, as these may
be signs of serious upper digestive
problems