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The FDA in December approved a
new HIV drug for a small patient population desperately in need of treatments
— Gilead Sciences, Inc.’s Sunlenca. In combination with other
antiretroviral(s) (ARVs), the drug is approved for HIV-1 infection in heavily
treatment-experienced adults with multidrug resistant HIV-1 infection who are
failing their current antiretroviral regimen due to resistance, intolerance
or safety considerations. The medication comes with both potential advantages
and disadvantages for patients, providers and payers, say industry experts
Sunlenca could shake up
the HIV market basket
- The
twice-yearly medication’s annual price is below the level that
respondents to a Zitter
Insights poll said they would consider a good value. (Both AIS Health
and Zitter Insights are divisions of MMIT.)
- Zitter polled
35 commercial payers covering 121.8 million lives and 27 Medicare payers
representing 40.2 million lives about their management of HIV.
Commercial payers covering almost half of lives said they expect
Sunlenca to have a moderate impact on the management of HIV, meaning
that other medications may see a change in tiering and/or utilization
management criteria.
- Payers covering
both commercial and Medicare beneficiaries said that an annualized net
price in the $60,000 to $70,000 range would be a good value for the new
agent. The drug’s wholesale acquisition cost is well below that: The WAC
for the first year is $42,250 and then $39,000 in subsequent years. But
since the drug is indicated for use in conjunction with other ARVs,
costs for those medications will need to be factored in, points out Lynn
Nishida, R.Ph., head of clinical operations at Evio.
- Sunlenca’s
twice-yearly dosing’s advantages include “not adding to pill burden”
aside from the tablets used in the starting dose, says Nicole Kjesbo,
Pharm.D., director of clinical program development at Prime Therapeutics
LLC.
- However, notes
Nishida, “Sunlenca still needs to be given in combination with other
background HIV medications to be effective,” and those agents “are
likely oral. So overall, this doesn’t necessarily reduce overall
medication schedule for complete treatment and adds in the extra step
for needing to go in to see the provider for administration.”
Patient population is
small, but needs new treatments
- The new
medication will be covered via the medical benefit, so “payers should
generally cover via their contractual arrangement with their providers,”
says Nishida. “Some may opt to provide a white-bagging option vs.
traditional buy/bill.” She adds that “for the most part,” health plans
have not placed utilization management and/or prior authorization on
such products “due to considerations of treating an unmet need that has
limited options.”
- Sunlenca is
“considered [a] last resort for patients who have become resistant to
traditional treatment regimens and thus lack options to keep their
condition in check,” says Nishida. These individuals have limited
options for HIV treatment, and there is no single approach to successful
management.
- According to
Gilead, about 2% of adults with HIV are heavily treatment
experienced.
- Specialty
pharmacies can play a key role in helping manage people with HIV,
asserts Nishida. Specifically, they can be “important for providing
services to plan payers who wish to implement white-bagging programs for
providers. These pharmacies can also aid in the role of patient tracking
and follow-up to ensure patients do not lapse in their HIV medication,
which can contribute to drug resistance.”
- Ultimately, she
says, “as long-acting ARV options develop, the hope is that this will
address the challenges of health equity, by bridging patients’ access to
care. Although long-acting oral medications and injections could be seen
as a convenience, long-acting options are also viewed as beneficial in a
medical condition where high pill burden, frequency of administration
and overall adherence are crucial for treatment success.”
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